Appendix A - Limited Use Benefits and Criteria

AMIKACIN SULFATE

Limited use benefit (prior approval required).

AZTREONAM

Limited use benefit (prior approval required).

For the management of cystic fibrosis (CF) in patients if the following criteria are met:

• patient has CF with chronic pulmonary Pseudomonas aeruginosa infections; and
• prescribed by a clinician with experience in the diagnosis and treatment of CF.

MEROPENEM

Limited use benefit (prior approval required).

FIDAXOMICIN

Limited use benefit (prior approval required).

For the treatment of confirmed severe* Clostridium Difficile infection (CDI); and

• fidaxomicin has been prescribed or recommended by an infectious disease specialist or gastroenterologist; and
• there is a documented allergy (immune-mediated reaction) or severe intolerance to oral vancomycin resulting in discontinuation of vancomycin.
• or
• after an unsuccessful but adequate** trial of oral vancomycin; and
• retreatment with vancomycin is not an option***; and
• the patient is at a high risk of hospitalization due to severe complications; and
• fidaxomicin is being used as monotherapy.

Notes:

*. Severe infection is defined as having any of the following symptoms: white blood cell count > 15,000 mm3 and fever; acute kidney injury with rising serum creatinine ≥ 1.5 times premorbid level or ≥ 175 micromoles/L; pseudomembranous colitis, hypotension, shock or megacolon.

**. An adequate trial of oral vancomycin is considered to be at least 10 days of therapy with a dose of at least 125mg four times daily.

***. Retreatment with fidaxomicin in recurrent CDI will be considered in symptomatic patients who require treatment of a previously resolved CDI episode. This is defined as a subsequent CDI episode occurring within 2 to 8 weeks of a previous episode from the date of diagnosis.

PIPERACILLIN, TAZOBACTAM

Limited use benefit (prior approval required).

LEVOFLOXACIN HEMIHYDRATE

Limited use benefit (prior approval not required).

Coverage will be limited to 14 tablets every 14 days, followed by a 14 day lockout.

LEVOFLOXACIN HEMIHYDRATE (QUINSAIR)

Limited use benefit (prior approval required).

For the management of cystic fibrosis (CF) in patients 18 years or older if the following criteria are met:

• patient has CF with chronic pulmonary Pseudomonas aeruginosa infections; and
• prescribed by a clinician with experience in the diagnosis and treatment of CF; and
• patient has had a previous trial of tobramycin by inhalation that has been ineffective or not tolerated or tobramycin is contraindicated; and
• patient is not using another inhaled antibiotic(s) to treat pulmonary P. aeruginosa infections, either concurrently or for antibiotic cycling during off-treatment periods.

Note: NIHB coverage is limited to 240 mg twice daily in cycles of 28 days on followed by 28 days off.

MOXIFLOXACIN HYDROCHLORIDE

Limited use benefit (prior approval not required).

Coverage will be limited to 14 tablets every 14 days, followed by a 14 day lockout.

COLISTIN

Limited use benefit (prior approval required).

For the management of cystic fibrosis (CF) in patients if the following criteria are met:

• patient has CF with chronic pulmonary Pseudomonas aeruginosa infections; and
• prescribed by a clinician with experience in the diagnosis and treatment of CF.

LINEZOLID

Limited use benefit (prior approval required).

Tablets:

• for treatment of proven vancomycin-resistant enterococci (VRE) infections; or
• for the treatment of proven methicillin-resistant staphylococcus aureus (MRSA) infections in patients who cannot tolerate vancomycin.

I.V. solution:

• when linezolid cannot be administered orally in the above mentioned situations.

Oral liquid:

• when linezolid cannot be administered orally in the above mentioned situations;
• plus at least one of the following:
• for treatment of proven vancomycin-resistant enterococci (VRE) infections
• for the treatment of proven methicillin-resistant staphylococcus aureus (MRSA) infections in patients who cannot tolerate vancomycin.

RIFAXIMIN

Limited use benefit (prior approval required).

For reducing the risk of overt hepatic encephalopathy (HE) recurrence in patients:

• who are unable to achieve adequate control of HE recurrence with a maximal tolerated dose of lactulose alone; and
• when used in combination with a maximal tolerated dose of lactulose.

ISAVUCONAZOLE (ISAVUCONAZONIUM SULFATE)

Limited use benefit (prior approval required).

For the treatment of invasive mucormycosis (IM) in adults; or

For the treatment of invasive aspergillosis (IA) in adults when treatment with oral voriconazole has failed; or

Documented intolerance or contraindication to voriconazole.

Cresemba is to be prescribed by or in consultation with an Infectious Disease specialist.

VORICONAZOLE

Limited use benefit (prior approval required).

For the treatment of patients with invasive aspergillosis; or

For the treatment of culture proven invasive candidiasis with documented resistance to fluconazole.

PEGINTERFERON ALFA-2A

Limited use benefit (prior approval required).

For the treatment of patients with chronic hepatitis B infection who have a HBV DNA concentration above 2,000 IU/mL without decompensated cirrhosis, upon the written request of a hepatologist or other specialist in this area.

PEGINTERFERON ALFA-2B, RIBAVIRIN

Limited use benefit (prior approval required).

For the treatment of chronic hepatitis C in patients who are treatment naïve, upon the written request of a hepatologist or other specialist in this area.

• for genotypes 1, 4, 5 and 6, an initial 24 week supply will be approved. A further 24 week supply may be approved if patient has a viral reduction of at least 2 logs or HCV is undetectable at 12 weeks (48 weeks total); or
• for genotypes 2 or 3, initial coverage for a maximum of 24 weeks will be approved. Renewals will not be covered.

PEGINTERFERON BETA-1A

Limited use benefit (prior approval required).

As a first-line therapy for the treatment of relapsing remitting multiple sclerosis (RRMS) diagnosed according to the 2017 McDonald clinical criteria and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist experienced in the management of RRMS.

And for patients who meet all of the following criteria:

• patient has had a clinical relapse and/or new MRI activity in the last two years; and
• patient is fully ambulatory for 100 meters without aids; and
• patient is 18 years of age or older.

ADEFOVIR DIPIVOXIL

Limited use benefit (prior approval required).

For the treatment of chronic hepatitis B infection when used in combination with lamivudine in patients who have developed failure to lamivudine, as defined by an increase in HBV DNA of ≥ 1 log10 IU/mL above the nadir, measured on two separate occasions within an interval of at least one month, after the first three months of lamivudine therapy, and when failure to lamivudine is not due to poor adherence to therapy.

ELBASVIR, GRAZOPREVIR

Limited use benefit (prior approval required).

For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet all of the following criteria:

• treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other prescriber experienced in treating patients with chronic hepatitis C); and
• laboratory confirmed quantitative HCV RNA level taken in the last 12 months;

Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis.

GLECAPREVIR, PIBRENTASVIR

Limited use benefit (prior approval required).

For treatment-naïve or treatment-experienced adult patients with genotypes 1, 2, 3, 4, 5, 6 with; or

For the treatment of direct acting antivirals (DAA)-experienced2 adult patients with genotype 1 with:

• chronic hepatitis C at any fibrosis stage (F0-F4); and
• detectable levels of HCV RNA in the last 12 months;

For genotypes 1, 2, 3, 4, 5 or 6, treatment-experienced is defined as a patient who has been previously treated with interferon, peginterferon (P), ribavirin (R) and/or sofosbuvir (SOF) (PR, SOF + PR, SOF + RBV), but no prior treatment experience with an NS3/4A protease inhibitor or NS5A inhibitor.

• For genotype 1, DAA treatment-experienced is defined as a patient who has been previously treated with DAA regimens containing NS5A inhibitor [daclatasvir (DCV) + SOF or DCV + PR or ledipasvir/sofosbuvir, but no prior treatment experience with NS3/4A protease inhibitors] or containing NS3/4A protease inhibitors [simeprevir+SOF or simeprevir+PR or boceprevir+PR or telaprevir+PR, but no prior treatment experience with an NS5Ainhibitor].

RIBAVIRIN

Limited use benefit (prior approval required).

For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet all of the following criteria:

• treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other prescriber experienced in treating patients with chronic hepatitis C); and
• laboratory confirmed quantitative HCV RNA level taken in the last 12 months;

Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis.

SOFOSBUVIR

Limited use benefit (prior approval required).

For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet all of the following criteria:

• treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other prescriber experienced in treating patients with chronic hepatitis C); and
• laboratory confirmed quantitative HCV RNA level taken in the last 12 months;

Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis.

SOFOSBUVIR, LEDIPASVIR

Limited use benefit (prior approval required).

For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet all of the following criteria:

• treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other prescriber experienced in treating patients with chronic hepatitis C); and
• laboratory confirmed quantitative HCV RNA level taken in the last 12 months;

Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis.

SOFOSBUVIR, VELPATASVIR

Limited use benefit (prior approval required).

For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet all of the following criteria:

• treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other prescriber experienced in treating patients with chronic hepatitis C); and
• laboratory confirmed quantitative HCV RNA level taken in the last 12 months;

Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis.

SOFOSBUVIR, VELPATASVIR, VOXILAPREVIR

Limited use benefit (prior approval required).

For treatment-experienced adult patients with:

• chronic hepatitis C at any fibrosis stage (F0-F4); and
• detectable levels of HCV RNA in the last 12 months;
• and
• treatment-experienced having failed a prior therapy with an HCV regimen containing:
• NS5A inhibitor: daclatasvir (Daklinza), elbasvir (part of Zepatier), ledipasvir (part of Harvoni), ombitasvir (part of Holkira Pak ), velpatasvir (part of Epclusa ) for genotype 1, 2, 3, 4, 5 or 6; or
• sofosbuvir (Sovaldi) without an NS5A inhibitor for genotype 1, 2, 3 or 4.

ABIRATERONE ACETATE

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage

For the treatment of metastatic castration resistant prostate cancer patients (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) and who have not received prior chemotherapy if they meet the following criteria:

• used in combination with prednisone; and
• patient has an ECOG performance status of 0 or 1.

For the treatment of metastatic castration resistant prostate cancer patients (mCRPC) who progressed on docetaxel-based chemotherapy if they meet the following criteria:

• used in combination with prednisone; and
• patient has an ECOG performance status ≤ 2; and
• abiraterone is not used as an add-on therapy to enzalutamide (Xtandi); and
• abiraterone has not been used in the pre-docetaxel setting.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression

AFATINIB DIMALEATE

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC) who meet all of the following criteria:

• first line treatment of patients; and
• EGFR mutation positive; and
• advanced or metastatic adenocarcinoma of the lung; and
• an ECOG performance status of 0 or 1.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

Use of afatinib precludes the use of any other EGFR inhibitor as a subsequent line of therapy.

ALECTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC); or

Second-line treatment of patients with locally advanced not amenable to curative therapy or metastatic NSCLC who have disease progression on or intolerance to crizotinib;

and

• to be used as monotherapy; and
• disease is anaplastic lymphoma kinase (ALK)-positive; and
• patient has a good performance status.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

APALUTAMIDE

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of non-metastatic castration-resistant prostate cancer patients (nmCRPC) who meet all the following criteria:

• used in combination with androgen deprivation therapy (ADT); and
• have no detectable distant metastases by either CT, MRI or technetium-99m bone scan; and
• are at high risk* of developing metastases; and
• have no risk factors for seizures; and
• have a good ECOG performance status (0 or 1)

* High risk is defined as a prostate-specific antigen doubling time of ≤ 10 months during continuous ADT

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or unacceptable toxicity.

AXITINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the second-line treatment of patients with advanced or metastatic clear cell renal carcinoma after failure of prior therapy with a first-line agent.

Patients are only eligible for either everolimus or axitinib in the second-line setting, but not sequential use of both agents except in cases of intolerance.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

BOSUTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

Patients has Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML); and

• patient has an ECOG performance status of 0 to 2;
• and
• documented resistance/disease progression to at least one prior oral tyrosine kinase inhibitor [TKI] (imatinib, dasatinib or nilotinib); or
• documented intolerance to one prior oral TKI (imatinib, dasatinib or nilotinib) where subsequent treatment with an alternative oral TKI is not clinically appropriate.

Criteria for renewal every 12 months:

Confirmation from the clinician that the patient has experienced hematologic and/or cytogenic response and is expected to continue to do so and has not developed unacceptable toxicities.

CABOZANTINIB (CABOZANTINIB MALATE)

Limited use benefit (prior approval required).

Initial coverage for 4 months:

For the treatment of patients with advanced renal cell carcinoma (RCC) who have received at least one prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.

• patient has good performance status with an ECOG of 0 to 2

Criteria for renewal every 4 months:

There is no objective evidence of disease progression.

*NIHB coverage is only provided for one of axitinib (Inlyta) or cabozantinib (Cabometyx) in the third-line setting for intermediate or poor risk patients treated with nivolumab (Opdivo) and ipilimumab (Yervoy) first-line and VEGF TKI secondline.

CERITINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

Second-line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have disease progression on or intolerance to crizotinib; and

• to be used as monotherapy; and
• disease is anaplastic lymphoma kinase (ALK)-positive; and
• patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

COBIMETINIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the first-line treatment of patients with metastatic or unresectable melanoma in combination with vemurafenib (Zelboraf).

And for patients who meet the following criteria:

• patient has documented BRAF V600 mutation-positive unresectable or metastatic melanoma; and
• patient does not have brain metastases or brain metastases are asymptomatic or stable; and
• patient has an ECOG performance status of 0 to 1.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

CRIZOTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

First-line treatment of patients with advanced non-small cell lung cancer (NSCLC); or

Second-line treatment of patients with advanced NSCLC who have received one prior chemotherapy regimen.*; and

• patient is anaplastic lymphoma kinase (ALK)-positive; and
• patient has an ECOG performance status of 0 to 2.

*Patients who have progressed during or following first-line therapy with crizotinib are not eligible to receive crizotinib as a second-line therapy.

Criteria for renewal every 12 months:

The patient has experienced a hematologic and/or cytogenic response to crizotinib and is expected to continue to do so.

DABRAFENIB

Limited use benefit (prior approval required).

1. First-line treatment of patients with metastatic or unresectable melanoma.

Criteria for initial 6-month coverage:

for the first-line treatment of patients with metastatic or unresectable melanoma as monotherapy; or

for the first-line treatment of patients with metastatic or unresectable melanoma in combination with trametinib (Mekinist)

And for patients who meet the following criteria:

• patient has documented BRAF V600 mutation-positive unresectable or metastatic melanoma; and
• patient does not have brain metastases or brain metastases are asymptomatic or stable; and
• patient has an ECOG performance status of 0 to 1; and
• patient is previously untreated.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

2. Adjuvant treatment of patients with cutaneous melanoma.

Criteria for maximum 12-month coverage:

• in combination with trametinib for the adjuvant treatment of patients with stage IIIA (limited to lymph node metastases of >1 mm) to stage IIID (8th edition of the American Joint Committee on Cancer Staging System) cutaneous melanoma; and
• patient has documented BRAF V600 mutation cutaneous melanoma; and
• disease must be completely resected including in-transit metastases*; and
• patient has an ECOG performance status of 0 to 1.

Maximum duration of therapy is 12 months.

* Presence of regional lymph nodes with micrometastases after sentinel lymph node biopsy alone is allowed.

ENZALUTAMIDE

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are/have:

asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) who have not received prior chemotherapy; and

• have an ECOG performance status of 0 or 1 with no risk factors for seizures; or
• progressed on docetaxel-based chemotherapy with an ECOG performance status ≤2 and no risk factors for seizures; and
• would be an alternative to abiraterone for patients in the post-docetaxel setting but would not be an add-on therapy to abiraterone treatment.

Patients previously treated with abiraterone would not be eligible for enzalutamide unless unable to tolerate abiraterone.

Use of enzalutamide in the post-docetaxel setting is not permitted if previously used in the pre-chemotherapy setting.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

or

Criteria for initial 12-month coverage:

For the treatment of non-metastatic castration-resistant prostate cancer patients (nmCRPC) who meet all the following criteria:

• used in combination with androgen deprivation therapy (ADT); and
• are at high risk* of developing metastases; and
• have no risk factors for seizures; and
• have a good ECOG performance status (0 or 1).

* high risk is defined as a prostate-specific antigen doubling time (PSADT) of ≤ 10 months during continuous ADT.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

ERLOTINIB HYDROCHLORIDE

Limited use benefit (prior approval required).

Treatment of non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive or unknown.

EVEROLIMUS

Limited use benefit (prior approval required).

1. Advanced breast cancer

Criteria for initial 12-month coverage:

For documented hormone receptor positive, HER2 negative advanced breast cancer; and

• used in combination with exemestane; and
• patient has an ECOG performance status of 0 to 2; and
• patient's condition recurred or progressed on a non-steroidal aromatase inhibitor.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

2. Advanced or metastatic renal cell carcinoma (mRCC)

Criteria for initial 12-month coverage:

For documented advanced or metastatic clear cell renal carcinoma; and

For use as second- or third-line treatment of mRCC.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

3. Pancreatic neuroendocrine tumors (pNet)

Criteria for initial 12-month coverage:

For documented, progressive, unresectable, well or moderately differentiated, locally advanced or metastatic pancreatic neuroendocrine tumors; and

• patient has an ECOG performance status of 0 to 2; and
• for patients previously treated with other agents.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

4. Non-functional neuroendocrine tumors (Nets) of gastrointestinal or lung origin (GIL)

Criteria for initial 12-month coverage:

For documented unresectable, locally advanced or metastatic, progressive, well-differentiated non-functional Net-GIL in adults ≥18 years of age; and

• patient has documented radiological disease progression within the previous six months; and
• patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

GEFITINIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who meet all of the following criteria:

• first-line treatment; and
• EGFR mutation positive; and
• patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

IBRUTINIB

Limited use benefit (prior approval required).

1. For the treatment of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (first-line)

Criteria for initial 12-month coverage:

As a first-line treatment option for newly diagnosed treatment naive chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); and

• patient's prescriber has deemed that it would be inappropriate for the patient to receive treatment with a fludarabine-based regimen; and
• patient has high risk CLL, such that ibrutinib is preferred over anti-CD20 therapy, with one of the following cytogenic markers:
• chromosome 17p deletion [del(17p)]
• TP 53 mutation
• unmutated immunoglobulin heavy chain variable region (IgHV)
• other reason.

Note: Anti-CD20 therapy is not funded as a sequential treatment option after ibrutinib. Choice of ibrutinib as first-line therapy must take this into account.

Ibrutinib is not funded as a sequential treatment option for patients who have progressed on idelalisib treatment in the relapsed setting.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

2. For the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) (second-line)

Criteria for initial 12-month coverage:

Demonstrated diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); and

• patient has received at least one prior therapy to treat CLL/SLL; and
• patient's prescriber has deemed that it would be inappropriate for the patient to receive treatment or retreatment with a fludarabine-based regimen.

Note: Ibrutinib is not funded as a sequential treatment option for patients who have progressed on idelalisib treatment in the relapsed setting.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

3. For the treatment of relapsed/refractory mantle cell lymphoma (MCL)

Criteria for initial 12-month coverage:

Demonstrated diagnosis of relapsed/refractory mantle cell lymphoma (MCL); and

• patient has received at least one prior therapy to treat MCL.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

IDELALISIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

• for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab. Treatment should continue until unacceptable toxicity or disease progression.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

IMATINIB MESYLATE

Limited use benefit (prior approval required).

For the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase; or

For the treatment of patients with gastrointestinal stromal tumour; or

For newly diagnosed adult patients with Philadelphia chromosome-positive (CML); or

For the treatment of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

LENALIDOMIDE

Limited use benefit (prior approval required).

1. For the treatment of Myelodysplastic syndrome (MDS)

Criteria for initial 6-month coverage:

• demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration; and
• documented presence of del(5q) abnormality by standard cytogenetic or fluorescence in situ hybridization; and
• international prognostic scoring system (IPSS) risk category low or intermediate-1; and
• transfusion-dependent symptomatic anemia.
• Criteria for renewal every 12 months:

Patient has demonstrated a reduction in transfusion requirements of at least 50%.

2. For the treatment of Refractory/relapsed multiple myeloma after one prior therapy (MM-AOPT)

Criteria for initial 12-month coverage:

• progressive multiple myeloma; and
• for use in combination with dexamethasone; and
• patient is refractory to initial or subsequent treatments or has relapsed after the conclusion of prior treatments and is suitable for further chemotherapy; or
• patient has completed at least one full treatment regimen as initial therapy and has demonstrated an intolerance to their current chemotherapy.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or development of unacceptable toxicity to lenalidomide requiring discontinuation of therapy.

3. For the treatment of newly diagnosed multiple myeloma for patients who are not eligible for autologous stem cell transplant (MM-TNE)

Criteria for initial 12-month coverage:

• as a first-line treatment option for newly diagnosed patients with multiple myeloma who are not candidates for autologous stem-cell transplant; and
• for use in combination with dexamethasone; and
• who have an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or development of unacceptable toxicity to lenalidomide requiring discontinuation of therapy.

4. For the maintenance treatment for newly diagnosed multiple myeloma post-autologous stem cell transplant

Criteria for initial 12-month coverage:

• newly diagnosed multiple myeloma; and
• the disease is stable or improved, with no evidence of progression after autologous stem-cell transplant.

Coverage is provided for lenalidomide at an initial dose of 10 mg daily. Doses adjustments of up to 15 mg daily may be required based on individual patient characteristics/response.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or development of unacceptable toxicity to lenalidomide requiring discontinuation of therapy.

LENVATINIB

Limited use benefit (prior approval required).

1. Unresectable Hepatocellular Carcinoma (HCC):

Criteria for initial 4-month coverage:

For the first-line treatment of adult patients with unresectable HCC; and

• patient has a Child-Pugh A liver function status; and
• patient has an ECOG performance status of 0 to 1; and
• patient meets the inclusion criteria of the REFLECT trial:
• patient does not have ≥50% of liver occupation;
• patient does not have clear invasion of the bile duct or portal vein at the main portal branch;
• patient does not have a history of or current brain or subdural metastases.

Criteria for renewal every 4 months:

There is no objective evidence of disease progression.

2. Differentiated thyroid cancer (DTC)

Criteria for initial 4-month coverage:

Used as monotherapy for treatment of patients with locally recurrent or metastatic, progressive DTC; and

• DTC is refractory to radioactive iodine treatment; and
• have an ECOG performance status of ≤ 2;and
• patient meets the eligibility criteria of the SELECT trial as follows:
• pathologically confirmed differentiated thyroid cancer (patients with anaplastic or medullary thyroid cancer are not eligible)
• evidence of iodine-131 refractory disease according to at least one of the following criteria:
• at least one measurable lesion without iodine uptake on any iodine-131 scan
• at least one measurable lesion that had progressed according to RECIST criteria within 12 months after iodine-131 therapy despite iodine-131 avidity at the time of treatment
• total lifetime radioactive iodine dose greater than 600 mCi (millicurie)
• radiologic evidence of progression within the previous 13 months
• no prior therapy with a tyrosine kinase inhibitor or have received one prior treatment regimen with a tyrosine kinase inhibitor

Criteria for renewal every 4 months:

There is no objective evidence of disease progression.

MIDOSTAURIN

Limited use benefit (prior approval required).

Criteria for 12-month coverage:

• patient has newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML); and
• patient's FLT3-mutation status has been confirmed; and
• midostaurin is being used in combination with standard cytarabine and daunorubicin (or idarubicin) induction and cytarabine consolidation chemotherapy; and
• patient has an ECOG performance status of 0 to 2.

NILOTINIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

Patients has newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase; or

Patient has chronic phase or accelerated phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia; and

• patient has disease progression/resistance to imatinib; or
• documented intolerance to a prior oral TKI (imatinib, dasatinib or bosutinib).

Criteria for renewal every 12 months:

Confirmation from the clinician that the patient has experienced hematologic and/or cytogenic response and is expected to continue to do so and has not developed unacceptable toxicities.

OLAPARIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

• maintenance treatment of adult patients with high grade serous epithelial ovarian fallopian tube cancer; or
• primary peritoneal cancer;
• and
• platinum-sensitive disease; and
• relapsed BRCA-mutated disease (germline or somatic as detected by approved testing)
• have completed at least two previous lines of platinum-based chemotherapy; and
• radiologic response (complete or partial response) to their most recent platinum-based chemotherapy regimen as per the SOLO-2 trial; and
• patient has an ECOG performance status of 0 to 2;
• and
• olaparib is used as monotherapy

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

OSIMERTINIB

Limited use benefit (prior approval required).

1. First-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC)

Criteria for initial 12-month coverage:

Patient with locally advanced (not amenable to curative intent therapy) or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) mutations (exon 19 deletions [exon 19 del] or exon 21 [L858R]); and

• patient is previously untreated in the locally advanced or metastatic setting; and
• patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no clinically meaningful disease progression or unacceptable toxicity.

2. Subsequent treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC)

Criteria for initial 12-month coverage:

Patient with locally advanced or metastatic NSCLC who has progressed on epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor therapy; and

• patient is EGFR T790M mutation- positive; and
• patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

PALBOCICLIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of post-menopausal clients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer; and

• the patient has not received any prior treatment for metastatic disease (first-line treatment); and
• palbociclib will be used in combination with an aromatase inhibitor; and
• patient has an ECOG performance status of 0 to 2; and
• patient is not resistant to prior (neo)adjuvant aromatase inhibitor therapy; and
• patient does not have active or uncontrolled metastases to the central nervous system.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

or

Criteria for initial 12-month coverage:

For in combination with fulvestrant, for the treatment of patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer (mBC) whose disease has progressed after prior endocrine therapy.

• patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

PAZOPANIB

Limited use benefit (prior approval required).

Initial coverage criteria (12 months)

For the first-line treatment of patients with advanced or metastatic clear cell renal carcinoma; and

• patient has an ECOG performance status of 0 to 2.

Renewal coverage criteria (12 months)

There is no objective evidence of disease progression.

POMALIDOMIDE

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of relapsed or refractory multiple myeloma who meet all of the following criteria:

• used in combination with dexamethasone; and
• patient has relapsed or is refractory to at least two treatment regimens, including both bortezomib and lenalidomide; and
• patient has demonstrated disease progression on the last regimen.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or development of unacceptable toxicity to pomalidomide requiring discontinuation of therapy.

PONATINIB HYDROCHLORIDE

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the treatment of patients who have confirmed T315i mutation positive disease, independent of previous TKI therapy; or

Treatment of last resort for patients with intolerances or contraindications to imatinib and all other second generation TKI's (dasatinib, nilotinib, bosutinib); or

For the treatment of patients with chronic phase chronic myeloid leukemia (CML) who have resistance/disease progression after at least two prior lines of TKI therapy where Iclusig would be available as third-line TKI option; or

For the treatment of patients with accelerated phase or blast phase CML or Ph+ ALL who have resistance or disease progression after at least one second generation TKI therapy;

and

• an ECOG performance status of 0 to 2.

Note: Second generation TKI's (dasatinib, nilotinib, bosutinib) are not covered as options after ponatinib.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

REGORAFENIB

Limited use benefit (prior approval required).

1. For the treatment of Gastrointestinal Stromal Tumors (GIST)

Criteria for initial six-month coverage:

For patients with Gastrointestinal Stromal Tumors (GIST) who have failed or are unable to tolerate imatinib and sunitinib therapy; and

• patient has an ECOG performance status of 0 or 1;

Note: Regorafenib will not be funded concomitantly with imatinib or sunitinib.

Criteria for assessment every 12 months:

There is no objective evidence of disease progression.

2. For the treatment of Hepatocellular Carcinoma (HCC)

Criteria for initial six-month coverage:

Patient diagnosed with unresectable HCC; and

• patient has been previously treated with sorafenib or lenvatinib; and
• patient was able to tolerate sorafenib as defined in the RESorCE trial criteria (≥400mg/day for ≥20 days of the last 28 days of treatment); and
• patient has a Child-Pugh class status of A; and
• patient has an ECOG performance status of 0 to 1

Criteria for assessment every 12 months:

There is no objective evidence of disease progression.

RIBOCICLIB (RIBOCICLIB SUCCINATE)

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For the treatment of post-menopausal clients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer:

• the patient has not received any prior treatment for metastatic disease (first-line treatment); and
• ribociclib will be used in combination with letrozole; and
• patient has an ECOG performance status of 0 to 2; and
• patient is not resistant* to prior (neo)adjuvant nonsteroidal aromatase inhibitor therapy (NSAI); and
• patient does not have active or uncontrolled metastases to the central nervous system.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or unacceptable toxicity.

*Resistance is defined as disease progression occurring during or within 12 months following aromatase inhibitor therapy.

RITUXIMAB

Limited use benefit (prior approval required).

1. For the treatment of severely active rheumatoid arthritis (RA)

Initial coverage is provided for 24 weeks at a dose of 1000 mg x 2 doses at 0 & 2 weeks.

• prescribed by a rheumatologist

For the treatment of adult patients with severely active rheumatoid arthritis who have failed to respond to a trial of an anti-TNF agent. Treatment should be combined with methotrexate. Rituximab should not be used in combination with anti-TNF agents.

For continued coverage for rituximab beyond twenty-four weeks, patient must meet all the following criteria:

• initially prescribed by a rheumatologist;
• and

Patient has been assessed after the twentieth to twenty-fourth week of rituximab therapy and meets the response criteria of:

• >20% reduction in number of tender and swollen joints; plus
• >20% improvement in Physician Global Assessment scale; plus either
• >20% improvement in Patient Global Assessment scale; or
• >20% reduction in the acute phase as measured by ESR or CRP.

2. For the treatment of granulomatosis polyangiitis or microscopic polyangiitis

Coverage is provided at a dose of 375 mg/m2body surface area, administered as an IV infusion once weekly for 4 weeks.

For the induction of remission in patients with severely active granulomatosis with polyangiitis or microscopic polyangiitis; and

• who have failed an adequate trial of cyclophosphamide; or
• who have a contraindication to cyclophosphamide.

RUXOLITINIB

Limited use benefit (prior approval required).

1. For the treatment of myelofibrosis:

Criteria for initial 6-month coverage:

• intermediate to high risk symptomatic myelofibrosis as assessed using the Dynamic International Prognostic Scoring System (DIPSS) Plus; or
• patient has symptomatic splenomegaly;
• and
• patient has an ECOG performance status of 0 to 3; and
• patient previously untreated or refractory to other treatment.

Criteria for renewal every 12 months:

• reduction in spleen size; or
• improvement in disease symptoms.

2. For the treatment of patients with polycythemia vera:

Criteria for initial 6-month coverage:

Disease is resistant to hydroxyurea (HU) according to the modified European LeukemiaNet Criteria defined as below:

After 3 months of at least 2g/day of HU or at the maximally tolerated HU dose, patient showed:

• need for phlebotomy to keep hematocrit < 45%; or
• uncontrolled myeloproliferation (platelet > 400x109/L and WBC > 10x109/L); or
• failure to reduce massive splenomegaly > 50% as measured by palpation.
• or
• Patient is intolerant to HU according to the modified European LeukemiaNet Criteria defined below:

After any dose of HU, patient showed:

• absolute neutrophil count < 1.0 x 109/L , or platelet < 100x109/L or hemoglobin < 100 g/L at the lowest dose of HU required to achieve a response (response defined as hematocrit < 45% without phlebotomy, and/or all of the following: platelet ≤ 400x109/L , WBC ≤ 10 x 109/L , and non-palpable spleen); or
• presence of leg ulcers or other unacceptable HU-related non-hematological toxicities (such as mucocutaneous manifestations, gastrointestinal symptoms, pneumonitis or fever, defined as Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade 3 or 4, or more than one week of CTCAE version 3.0 grade 2, or permanent discontinuation of HU, or interruption of HU until toxicity resolved, or hospitalization due to HU toxicity).
• and
• patient has an ECOG performance status of 0 to 3.

Criteria for renewal every 12 months:

• reduction in spleen size; or
• improvement in disease symptoms.

SUNITINIB MALATE

Limited use benefit (Prior approval required).

Criteria for initial 6-month coverage:

• For patients with histologically proven unresectable or recurrent/metastatic GIST who have failed or are unable to tolerate imatinib therapy. sunitinib will not be funded concomitantly with imatinib;

or

Criteria for initial 12-month coverage:

• Documented, progressive, unresectable, well or moderately differentiated, locally advanced or metastatic pancreatic neuroendocrine tumors; and
• patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

TRAMETINIB

Limited use benefit (prior approval required).

1. First-line treatment of patients with metastatic or unresectable melanoma.

Criteria for initial 6-month coverage:

For the first-line treatment of patients with metastatic or unresectable melanoma as monotherapy; or

For the first-line treatment of patients with metastatic or unresectable melanoma in combination with dabrafenib (Tafinlar)

And for patients who meet the following criteria:

• patient has documented BRAF V600 mutation-positive unresectable or metastatic melanoma; and
• patient does not have brain metastases or brain metastases are asymptomatic or stable; and
• patient has an ECOG performance status of 0 to 1; and
• patient is previously untreated.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

2. Adjuvant treatment of patients with cutaneous melanoma.

Criteria for maximum 12-month coverage:

• in combination with trametinib for the adjuvant treatment of patients with stage IIIA (limited to lymph node metastases of >1 mm) to stage IIID (8th edition of the American Joint Committee on Cancer Staging System) cutaneous melanoma; and
• patient has documented BRAF V600 mutation cutaneous melanoma; and
• disease must be completely resected including in-transit metastases*; and
• patient has an ECOG performance status of 0 to 1.

Maximum duration of therapy is 12 months.

* Presence of regional lymph nodes with micrometastases after sentinel lymph node biopsy alone is allowed.

VANDETANIB

Limited use benefit (prior approval required).

Criteria for initial 12-month coverage:

For patients with symptomatic and/or progressive medullary thyroid cancer with unresectable locally advanced or metastatic disease; and

• an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression.

VEMURAFENIB

Limited use benefit (prior approval required).

Criteria for initial 6-month coverage:

For the first-line treatment of patients with metastatic or unresectable melanoma as monotherapy; or

For the first-line treatment of patients with metastatic or unresectable melanoma in combination with cobimetinib (Cotellic).

And for patients who meet the following criteria:

• patient has documented BRAF V600 mutation-positive unresectable or metastatic melanoma; and
• patient does not have brain metastases or brain metastases are asymptomatic or stable; and
• patient has an ECOG performance status of 0 to 1.

Criteria for renewal every 6 months:

There is no objective evidence of disease progression.

VENETOCLAX

Limited use benefit (prior approval required).

1. Monotherapy treatment in adult patients with chronic lymphocytic leukemia (CLL)

Criteria for initial 12-month coverage:

For the treatment of CLL who meet all of the following criteria:

Venclexta will be used as monotherapy; and

• patient has received at least one prior therapy; and
• patient has failed a B-cell receptor inhibitor (BCRi) or is intolerant to prior ibrutinib therapy; and
• patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or unacceptable toxicity.

2. In combination with rituximab for the treatment of chronic lymphocytic leukemia (CLL)

Criteria for 12-month coverage of venetoclax:

For the treatment of CLL; and

• in combination with rituximab; and
• patient has received at least one prior therapy; and
• patient has an ECOG performance status of 0 to 2.

Criteria for renewal every 12 months:

There is no objective evidence of disease progression or unacceptable toxicity.

Coverage is for a maximum duration of two years.

DONEPEZIL HYDROCHLORIDE

Limited use benefit (prior approval required).

Initial 12 month coverage for cholinesterase inhibitors:

• diagnosis of mild to moderate Alzheimer's disease; and
• Mini Mental State Exam (MMSE) score of 10-26, established within the last 60 days; or
• Montreal Cognitive Assessment (MoCA) score of 10-26, established within the last 60 days; or
• Global Deterioration Scale (GDS) score between 4 to 6, established within the last 60 days.

Continued coverage beyond 12 months will be based on improvement or stabilization of cognition, function or behaviour.

Criteria for coverage at every 12 month interval:

• clinically meaningful response as determined by stabilization or improvement while on therapy; and
• Alzheimer's disease has not progressed to GDS stage 7 or MMSE or MoCA less than 10.

GALANTAMINE HYDROBROMIDE

Limited use benefit (prior approval required).

Initial 12 month coverage for cholinesterase inhibitors:

• diagnosis of mild to moderate Alzheimer's disease; and
• Mini Mental State Exam (MMSE) score of 10-26, established within the last 60 days; or
• Montreal Cognitive Assessment (MoCA) score of 10-26, established within the last 60 days; or
• Global Deterioration Scale (GDS) score between 4 to 6, established within the last 60 days.

Continued coverage beyond 12 months will be based on improvement or stabilization of cognition, function or behaviour.

Criteria for coverage at every 12 month interval:

• clinically meaningful response as determined by stabilization or improvement while on therapy; and
• Alzheimer's disease has not progressed to GDS stage 7 or MMSE or MoCA less than 10.

RIVASTIGMINE HYDROGEN TARTRATE

Limited use benefit (prior approval required).

Initial 12 month coverage for cholinesterase inhibitors:

• diagnosis of mild to moderate Alzheimer's disease; and
• Mini Mental State Exam (MMSE) score of 10-26, established within the last 60 days; or
• Montreal Cognitive Assessment (MoCA) score of 10-26, established within the last 60 days; or
• Global Deterioration Scale (GDS) score between 4 to 6, established within the last 60 days.

Continued coverage beyond 12 months will be based on improvement or stabilization of cognition, function or behaviour.

Criteria for coverage at every 12 month interval:

• clinically meaningful response as determined by stabilization or improvement while on therapy; and
• Alzheimer's disease has not progressed to GDS stage 7 or MMSE or MoCA less than 10.

TRIMEBUTINE MALEATE

Limited use benefit (prior approval required).

For the treatment and relief of symptoms associated with functional bowel disorders including Irritable Bowel Syndrome (IBS), spastic colon, spastic colitis and mucous colitis; or

In postoperative paralytic ileus in order to accelerate the resumption of the intestinal transit following abdominal surgery.

FLUTICASONE FUROATE, VILANTEROL TRIFENATATE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are not adequately controlled on medium doses of inhaled corticosteroids (e.g. fluticasone 251-500mcg daily, or the equivalent) as the sole agent and require addition of a long-acting beta agonist. Patients using this combination product must also have access to a short-acting bronchodilator for symptomatic relief.

or

For the treatment of chronic obstructive pulmonary disease (COPD) in patients who have:

• moderate to severe COPD, as defined by spirometry; or
• inadequate response to a long-acting beta-2 agonist (LABA) or a long-acting muscarinic antagonist (LAMA).

FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (ASTHMA)

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are not adequately controlled on medium doses of inhaled corticosteroids (e.g. fluticasone 251-500mcg daily, or the equivalent) as the sole agent and require addition of a long-acting beta agonist. Patients using this combination product must also have access to a short-acting bronchodilator for symptomatic relief.

FORMOTEROL FUMARATE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are using optimal corticosteroid therapy and experiencing breakthrough symptoms requiring regular use of a rapid-onset, short-duration bronchodilator; or

For the treatment of Chronic Obstructive Pulmonary Disease (COPD) in patients not adequately controlled with either ipratropium, tiotropium or a short acting beta-agonist.

FORMOTEROL FUMARATE DIHYDRATE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are using optimal corticosteroid therapy and experiencing breakthrough symptoms requiring regular use of rapid onset, short duration bronchodilator.

FORMOTEROL FUMARATE DIHYDRATE, BUDESONIDE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are not adequately controlled on medium doses of inhaled corticosteroids (e.g. fluticasone 251-500mcg daily, or the equivalent) as the sole agent and require addition of a long-acting beta agonist. Patients using this combination product must also have access to a short-acting bronchodilator for symptomatic relief; or

For the treatment of chronic obstructive pulmonary disease (COPD) in patients who have:

• moderate to severe COPD, as defined by spirometry; or
• inadequate response to a long-acting beta-2 agonist (LABA) or a long-acting muscarinic antagonist (LAMA).

FORMOTEROL FUMARATE DIHYDRATE, MOMETASONE FUROATE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are using optimal corticosteroid therapy and experiencing breakthrough symptoms requiring regular use of rapid onset, short duration bronchodilator.

INDACATEROL MALEATE

Limited use benefit (prior approval required).

For the treatment of chronic obstructive pulmonary disease (COPD) in patients who:

• are not adequately controlled with either ipratropium, tiotropium or a short acting beta-agonist; or
• have moderate to severe COPD, as defined by spirometry.

SALMETEROL XINAFOATE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are using optimal corticosteroid therapy and experiencing breakthrough symptoms requiring regular use of a rapid-onset, short-duration bronchodilator; or

For the treatment of Chronic Obstructive Pulmonary Disease (COPD) in patients not adequately controlled with either ipratropium, tiotropium or a short acting beta-agonist.

SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE

Limited use benefit (prior approval required).

For the treatment of asthma in patients who are not adequately controlled on medium doses of inhaled corticosteroids (e.g. fluticasone 251-500mcg daily, or the equivalent) as the sole agent and require addition of a long-acting beta agonist. Patients using this combination product must also have access to a short-acting bronchodilator for symptomatic relief; or

For the treatment of chronic obstructive pulmonary disease (COPD) in patients who have:

• moderate to severe COPD, as defined by spirometry; and
• inadequate response to a long-acting beta-2 agonist (LABA) or a long-acting muscarinic antagonist (LAMA).

CYCLOBENZAPRINE HYDROCHLORIDE

Limited use benefit (prior approval is not required).

For relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Coverage is limited to 60mg per day for three (3) weeks renewable every two (2) months.

TIZANIDINE HYDROCHLORIDE

Limited use benefit (prior approval required).

For treatment of spasticity in patients with multiple sclerosis, who have failed therapy with or are intolerant to baclofen.

NICOTINE (GUM)

Limited use benefit with quantity and frequency limits (prior approval is not required).

For smoking cessation:

Coverage is limited to 945 pieces during a one-year period. The year starts on the date the first prescription is filled. Once this quantity has been reached, the client is eligible again for coverage for nicotine gum or lozenges when one year has elapsed from the day the initial prescription was filled.

NICOTINE (INHALER)

Limited use benefit with quantity and frequency limits (prior approval is not required).

For smoking cessation:

Coverage is limited to 945 doses during a one-year period. The year starts on the date the first prescription is filled. Once this quantity has been reached, the client is eligible again for coverage for nicotine gum or lozenges when one year has elapsed from the day the initial prescription was filled.

NICOTINE (LOZENGE)

Limited use benefit with quantity and frequency limits (prior approval is not required).

For smoking cessation:

Coverage is limited to 945 pieces during a one-year period. The year starts on the date the first prescription is filled. Once this quantity has been reached, the client is eligible again for coverage for nicotine gum or lozenges when one year has elapsed from the day the initial prescription was filled.

NICOTINE (PATCH)

Limited use benefit with quantity and frequency limits (prior approval is not required).

For smoking cessation:

Coverage will be provided for up to the allowable number of patches for one of the following products, during a one-year period. The year starts on the date the first prescription is filled.

• NIHB clients are eligible to receive:
• up to 252 nicotine patches of any listed brand in a 12-month period; and
• one course of an as-needed nicotine replacement therapy (NRT) product (i.e. gum, lozenge or inhaler) in a 12-month period; and
• up to 180 tablets of Zyban in a 12-month period; and
• up to 165 tablets of Champix in a 12-month period.

Once this quantity has been reached, the client is eligible again for coverage for nicotine patches when one year has elapsed from the day the initial prescription was filled.

NICOTINE (SPRAY)

Limited use benefit with quantity and frequency limits (prior approval is not required).

For smoking cessation:

Coverage is limited to 3450 sprays during a one-year period. The year starts on the date the first prescription is filled. Once this quantity has been reached, the client is eligible again for coverage for nicotine spray when one year has elapsed from the day the initial prescription was filled.

VARENICLINE TARTRATE

Limited use benefit with quantity and frequency limits (prior approval is not required).

Coverage will be limited to 165 tablets during a one-year period. The year starts on the date the first prescription is filled. Once this quantity has been reached, the client is eligible again for coverage for varenicline (Champix(r)) when one year has elapsed from the day the initial prescription was filled.

POLYSACCHARIDE IRON COMPLEX

Limited use benefit (prior approval not required).

For children 12 years of age or under.

APIXABAN

Limited use benefit (prior approval required).

For at-risk patients (CHADS2 score ≥1) with non-valvular atrial fibrillation who require apixaban for the prevention of stroke and systemic embolism and in whom:

• anticoagulation is inadequate (outside the desired INR range for at least 35% of the tests) with a two-month trial of warfarin; or
• anticoagulation with warfarin is contraindicated; or
• anticoagulation with warfarin is not possible due to inability to regularly monitor via INR testing (i.e., no access to INR testing services at a laboratory, clinic, pharmacy and at home).
• or

For the treatment of venous thromboembolism: deep vein thrombosis (DVT) or pulmonary embolism (PE)

DABIGATRAN ETEXILATE MESILATE

Limited use benefit (prior approval required).

For at-risk patients (CHADS2 score ≥1) with non-valvular atrial fibrillation who require dabigatran etexilate for the prevention of stroke and systemic embolism and in whom:

• anticoagulation is inadequate (outside the desired INR range for at least 35% of the tests) with a two-month trial of warfarin; or
• anticoagulation with warfarin is contraindicated; or
• anticoagulation with warfarin is not possible due to inability to regularly monitor via INR testing (i.e., no access to INR testing services at a laboratory, clinic, pharmacy and at home).

EDOXABAN (EDOXABAN TOSYLATE MONOHYDRATE)

Limited use benefit (prior approval required).

For at-risk patients (CHADS2 score ≥1) with non-valvular atrial fibrillation who require edoxaban for the prevention of stroke and systemic embolism and in whom:

• anticoagulation is inadequate (outside the desired INR range for at least 35% of the tests) with a two-month trial of warfarin; or
• anticoagulation with warfarin is contraindicated; or
• anticoagulation with warfarin is not possible due to inability to regularly monitor via INR testing (i.e., no access to INR testing services at a laboratory, clinic, pharmacy and at home).
• or

For the treatment of venous thromboembolism: deep vein thrombosis (DVT) or pulmonary embolism (PE)

RIVAROXABAN

Limited use benefit (prior approval required).

Criteria for rivaroxaban 15 mg, 20mg tablets (Xarelto) for stroke prevention in atrial fibrillation (SPAF)

For at-risk patients (CHADS2 score ≥1) with non-valvular atrial fibrillation who require rivaroxaban for the prevention of stroke and systemic embolism and in whom:

• anticoagulation is inadequate (outside the desired INR range for at least 35% of the tests) with a two-month trial of warfarin; or
• anticoagulation with warfarin is contraindicated; or
• anticoagulation is not possible due to inability to regularly monitor via International Normalized Ratio (INR) testing (i.e., no access to INR testing service at a laboratory, clinic, pharmacy, and at home)

Criteria for rivaroxaban 15 mg, 20mg tablets (Xarelto)

For the treatment of venous thromboembolism: deep vein thrombosis (DVT) or pulmonary embolism (PE).

RIVAROXABAN (10)

Limited use benefit (prior approval not required).

For the prevention of venous thromboembolism following total knee replacement or total hip replacement surgery, for up to 35 days.

RIVAROXABAN (CAD,PAD)

Limited use benefit (prior approval required).

Rivaroxaban will be used in combination with acetylsalicylic acid for the prevention of stroke, myocardial infarction, and cardiovascular death, and for the prevention of acute limb ischemia and mortality in patients with concomitant coronary artery disease (CAD) and peripheral artery disease (PAD) as defined below:

1. Patient has CAD defined as having one or more of the following:

• myocardial infarction within the last 20 years; or
• multi-vessel coronary disease (i.e., stenosis of ≥ 50% in two or more coronary arteries, or in one coronary territory if at least one other territory has been revascularized) with symptoms or history of stable or unstable angina; or
• multi-vessel percutaneous coronary intervention; or
• multi-vessel coronary artery bypass graft surgery
• and
• aged 65 years or older; or
• aged younger than 65 years and presents with documented atherosclerosis or revascularization involving at least two vascular beds (coronary and other vascular) or has at least two additional risk factors.*

* Additional risk factors include: current smoker, diabetes mellitus, estimated glomerular filtration rate <60mL/min, heart failure, non-lacunar ischemic stroke 1 month or more ago.

and

2. Patient has PAD defined as having one or more of the following:

• previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac or infrainguinal arteries; or
• previous limb or foot amputation for arterial vascular disease; or
• history of intermittent claudication with an anklebrachial index less than 0.90 or significant peripheral artery stenosis (≥ 50%) documented by angiography or by duplex ultrasound; or
• previous carotid revascularization or asymptomatic carotid artery stenosis greater than or equal to 50%, as diagnosed by duplex ultrasound or angiography.

TICAGRELOR

Limited use benefit (prior approval not required).

For the treatment of Acute Coronary Syndrome, defined as unstable angina or myocardial infarction, when initiated in hospital in consultation with a specialist in cardiology, cardiac surgery, cardiovascular & thoracic surgery, internal medicine or general surgery. Treatment must be in combination with low dose ASA.

Special authorization may be granted for 12 months.

PEGFILGRASTIM

Limited use benefit (prior approval required).

Chemotherapy support

Primary prophylaxis

• for use in previously untreated patients receiving a moderate to severely myelosuppressive chemotherapy regimen (i.e. ≥40% incidence of febrile neutropenia). Febrile neutropenia is defined as a temperature ≥38.5°C or >38.0°C three times in a 24 hour period and neutropenia with an absolute neutrophil count (ANC) <0.5 x 109/L.

Secondary prophylaxis

• for use in patients receiving myelosuppressive chemotherapy who have experienced an episode of febrile neutropenic sepsis or profound neutropenia in a previous cycle of chemotherapy; or
• for use in patients who have experienced a dose reduction or treatment delay longer than one week, due to neutropenia.

The recommended dosage of pegfilgrastim is a single subcutaneous injection of 6 mg, administered once per cycle of chemotherapy. Pegfilgrastim should be administered no sooner than 24 hours after the administration of cytotoxic chemotherapy.

PLERIXAFOR

Limited use benefit (prior approval required).

For use in combination with filgrastim to mobilize hematopoietic stem cells for subsequent autologous transplantation in patients with:

• Non-Hodgkin's lymphoma (NHL); or
• multiple myeloma (MM);
• and
• prescribed by an oncologist or hematologist.

and if one of the following are met

• a PBCD34+ count of < 10 cells/uL after 4 days of filgrastim; or
• less than 50% of the target CD34 yield is achieved on the 1st day of apheresis (after being mobilized with filgrastim alone or following chemotherapy); or
• if a patient has failed a previous stem cell mobilization with filgrastim alone or following chemotherapy.

Reimbursement is limited to a maximum of 4 doses (0.24mg/kg given daily) for a single mobilization attempt.

The dose of Mozobil is limited to a maximum of 40mg per day

IVABRADINE (IVABRADINE HYDROCHLORIDE)

Limited use benefit (prior approval required).

For the treatment of stable chronic heart failure with New York Heart Association (NYHA) class II or III symptoms in adult patients if the following criteria are met:

• left ventricular ejection fraction ≤ 35%; and
• resting heart rate must be documented as ≥ 77 bpm on average using either an ECG on at least three separate visits or by continuous monitoring; and
• patient has had at least one hospitalization due to heart failure in the last year; and
• NYHA class II to III symptoms despite at least four weeks of treatment with an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor antagonist (ARB) in combination with a beta blocker and, if tolerated, a mineralocorticoid receptor antagonist (MRA).

ALIROCUMAB

Limited use benefit (prior approval required).

Initial Coverage (12 weeks):

• For adult patients with heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C) if the following clinical criteria are met:
• definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing;
• and

Patient is unable to reach an LDL-C target of < 2.0 mmol/L for secondary CVD prevention, or at least a 50% reduction in LDL-C from untreated baseline for primary prevention despite:

• confirmed adherence to a high-dose statin (e.g., atorvastatin 80 mg or rosuvastatin 40 mg) in combination with ezetimibe for a total of at least 3 months of continuous treatment;
• or
• patient is unable to tolerate at least two statins, with at least one statin initiated at the lowest daily starting dose; and
• for each statin (two statins in total), dose reduction was attempted to resolve intolerable myopathy or creatine kinase > 5 times the upper limit of normal rather than statin discontinuation; and
• for each statin (two statins in total), intolerable myopathy or creatine kinase > 5 times the upper limit of normal was reversed upon statin discontinuation, but reoccurred with statin rechallenge where clinically appropriate; and
• confirmed adherence to ezetimibe for a total of at least 3 months continuous treatment; and
• other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out;
• or
• patient developed confirmed and documented rhabdomyolysis;
• or
• patient has a contraindication to statins; and
• confirmed adherence to ezetimibe for a total of at least 3 months continuous treatment.

Continued coverage (6 months):

• patient is adherent to therapy; and
• patient has achieved a reduction in LDL-C of at least 40% from baseline.
• Note: Annual coverage is limited to 26 prefilled syringes or prefilled pens per year.

EVOLOCUMAB

Limited use benefit (prior approval required).

Initial coverage criteria (Initial approval for 12 weeks):

For adult patients with heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C) if the following clinical criteria are met:

• definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing; and
• patient is unable to reach an LDL-C target of < 2.0 mmol/L for secondary CVD prevention, or at least a 50% reduction in LDL-C from untreated baseline for primary prevention despite:
• confirmed adherence to a high-dose statin (e.g., atorvastatin 80 mg or rosuvastatin 40 mg) in combination with ezetimibe for a total of at least 3 months of continuous treatment;
• or
• patient is unable to tolerate at least two statins, with at least one statin initiated at the lowest daily starting dose; and
• for each statin (two statins in total), dose reduction was attempted to resolve intolerable myopathy or creatine kinase > 5 times the upper limit of normal rather than statin discontinuation; and
• for each statin (two statins in total), intolerable myopathy or creatine kinase > 5 times the upper limit of normal was reversed upon statin discontinuation, but reoccurred with statin rechallenge where clinically appropriate; and
• confirmed adherence to ezetimibe for a total of at least 3 months continuous treatment; and
• other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out;
• or
• patient developed confirmed and documented rhabdomyolysis;
• or
• patient has a contraindication to statins; and
• confirmed adherence to ezetimibe for a total of at least 3 months continuous treatment.

Note: Annual coverage is limited to 26 prefilled autoinjectors (140 mg every 2 weeks) or 12 automated Mini-Dosers with prefilled cartridges (420 mg once a month).

Renewal coverage criteria (Renewal for 6 months):

• patient is adherent to therapy; and
• patient has achieved a reduction in LDL-C of at least 40% from baseline.

Note: Annual coverage is limited to 26 prefilled Autoinjectors (140 mg every 2 weeks) or 12 automated Mini-Dosers with prefilled cartridges (420 mg once a month).

SILDENAFIL CITRATE

Limited use benefit (prior approval required).

Must be initiated by a Pulmonary Hypertension specialist

Patients with World Health Organization (WHO) class III pulmonary artery hypertension (PAH), either idiopathic (i.e. primary) or associated with a congenital or systemic condition (e.g. connective tissue disease) and confirmed by right heart catheterization.

TADALAFIL

Limited use benefit (prior approval required).

Must be initiated by a Pulmonary Hypertension specialist

Patients with World Health Organization (WHO) class III pulmonary artery hypertension (PAH), either idiopathic (i.e. primary) or associated with a congenital or systemic condition (e.g. connective tissue disease) and confirmed by right heart catheterization.

AMBRISENTAN

Limited use benefit (prior approval required).

Maximum dose covered is 10 mg once daily.

Patients with World Health Organization (WHO) class III pulmonary artery hypertension (PAH), either idiopathic (i.e. primary) or associated with a congenital or systemic condition (e.g. connective tissue disease) and confirmed by right heart catheterization; and

• who have failed to respond to sildenafil or tadalafil; or
• who have contraindications to sildenafil or tadalafil.

BOSENTAN MONOHYDRATE

Limited use benefit (prior approval required).

Maximum dose covered is 125 mg twice daily

Patients with World Health Organization (WHO) class III pulmonary artery hypertension (PAH), either idiopathic (i.e. primary) or associated with a congenital or systemic condition (e.g. connective tissue disease) and confirmed by right heart catheterization; and

• who have failed to respond to sildenafil or tadalafil; or
• who have contraindications to sildenafil or tadalafil.

PROPRANOLOL (HEMANGIOL)

Limited use benefit (prior approval required).

For the treatment of proliferating infantile hemangioma requiring systemic therapy and at least one of the following:

• life or function-threatening hemangioma; or
• ulcerated hemangioma with pain and/or lack of response to simple wound care measures; or
• hemangioma with a risk of permanent scarring or disfigurement.

EPLERENONE

Limited use benefit (prior approval required).

For the treatment of patients with New York Heart Association (NYHA) class II chronic heart failure with left ventricular systolic dysfunction (with ejection fraction ≤ 35%), as an adjunct to standard therapy.

Note: Patients must be on optimal therapy with an angiotensin-converting-enzyme (ACE) inhibitor or an angiotensin-receptor blocker (ARB), and a beta-blocker (unless contraindicated) at the recommended dose or maximal tolerated dose.

VALSARTAN, SACUBITRIL

Limited use benefit (prior approval required).

For the treatment of New York Heart Association (NYHA) class II or III heart failure if the following criteria are met:

• must be initiated by a physician experienced in the treatment of heart failure; and
• left ventricular ejection fraction < 40%; and
• NYHA class II to III symptoms despite at least four weeks of treatment with an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II receptor antagonist (ARB); or If your patient has a contraindication or intolerance to ACEI or ARBs; and
• must be used in combination with a beta blocker and an aldosterone antagonist (if tolerated); or If your patient has a contraindication or intolerance to beta blockers or aldosterone antagonists.

ACETYLSALICYLIC ACID

Limited use benefit (prior approval is not required).

ASA 80 mg tablets are a benefit to clients age 21 years and under to allow access for use in pediatric conditions (e.g. Kawasaki syndrome).

DICLOFENAC DIETHYLAMINE

Limited use benefit (prior approval not required).

Coverage is limited to 100 grams per month.

DICLOFENAC SODIUM (TOPICAL)

Limited use benefit (prior approval required).

For the treatment of osteoarthritis when:

• pain is inadequately controlled with acetaminophen and a non-steroidal anti-inflammatory (NSAID); or
• there is contraindication to acetaminophen and NSAID; or
• there is intolerance to acetaminophen and NSAID.

ACETAMINOPHEN, CAFFEINE CITRATE, CODEINE PHOSPHATE

Limited use benefit (prior approval is not required).

For safety reasons NIHB has implemented a dose limit on acetaminophen. The limit accumulates against the amount of acetaminophen claimed to the program from plain acetaminophen and/or acetaminophen in combination with opioids such as codeine (i.e. Tylenol(r) #3) or oxycodone (i.e. Percocet(r)). A total of 360 grams of acetaminophen is permitted in a 100-day period, for a total daily dose of 3600mg/day.

ACETAMINOPHEN, CODEINE PHOSPHATE

Limited use benefit (prior approval is not required).

For safety reasons NIHB has implemented a dose limit on acetaminophen. The limit accumulates against the amount of acetaminophen claimed to the program from plain acetaminophen and/or acetaminophen in combination with opioids such as codeine (i.e. Tylenol(r) #3) or oxycodone (i.e. Percocet(r)). A total of 360 grams of acetaminophen is permitted in a 100-day period, for a total daily dose of 3600mg/day.

ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE

Limited use benefit (prior approval is not required).

For safety reasons NIHB has implemented a dose limit on acetaminophen. The limit accumulates against the amount of acetaminophen claimed to the program from plain acetaminophen and/or acetaminophen in combination with opioids such as codeine (i.e. Tylenol(r) #3) or oxycodone (i.e. Percocet(r)). A total of 360 grams of acetaminophen is permitted in a 100-day period, for a total daily dose of 3600mg/day.

ACETYLSALICYLIC ACID, OXYCODONE HYDROCHLORIDE

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy, NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for chronic non-cancer pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

BUPRENORPHINE (SUBLOCADE)

Limited use benefit (prior approval required).

For the management of moderate to severe opioid use disorder in adult patients who have been inducted and clinically stabilized on a transmucosal buprenorphine-containing product; and

Patient must be induced and stabilized on an equivalent of 8 mg to 24 mg per day of transmucosal buprenorphine for a minimum of 7 days.

Note:

• the prescriber has experience in the diagnosis and management of opioid use disorder and certified under Sublocade Certification Program.
• Sublocade must be administered subcutaneously in the abdominal region by a healthcare provider.
• Sublocade should be used as part of a complete treatment plan that includes counselling and psychosocial support.
• client will be added to the Client Safety Program (CSP).

CODEINE MONOHYDRATE, CODEINE SULFATE TRIHYDRATE

Limited use benefit (prior approval required).

For treatment of:

• chronic pain and patients that requires end of life care as an alternative to products containing codeine in combination with acetaminophen or ASA with or without caffeine; or
• chronic pain and patients that requires end of life care as an alternative to regular release codeine tablets when large doses are required.

To promote safe, therapeutically effective and efficient use of drug therapy, NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for chronic non-cancer pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

CODEINE PHOSPHATE

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy, NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for chronic non-cancer pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

FENTANYL

Limited use benefit (prior approval required).

For the management of chronic pain in patients who are unresponsive or intolerant to at least one long-acting oral sustained released product, such as morphine, hydromorphone and oxycodone, despite appropriate dose titration and adjunctive therapy including laxatives and antiemetics.

To promote safe, therapeutically effective and efficient use of drug therapy, NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for chronic non-cancer pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

HYDROMORPHONE HYDROCHLORIDE

Limited use benefit.

Prior approval required for controlled release capsules only. Regular release dosage forms are full benefits and do not require prior approval.

For treatment of moderate to severe chronic pain when other opioids such as morphine have been ineffective in controlling pain or in patients experiencing intolerable side effects.

To promote safe, therapeutically effective and efficient use of drug therapy, NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for chronic non-cancer pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

METHADONE HYDROCHLORIDE (METADOL)

Limited use benefit (prior approval required) with the following criteria:

For the management of moderate to severe cancer pain or chronic non-cancer pain, as an alternative to other opioids; or

For the management of pain for patients that requires end of life care. Pharmacists may only dispense a maximum supply of 30 days at one time.

MORPHINE HYDROCHLORIDE

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy, NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for chronic non-cancer pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

MORPHINE SULFATE

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy, NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for chronic non-cancer pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

MORPHINE SULFATE (KADIAN)

Limited use benefit (prior approval required).

For the treatment of opioid dependence where methadone and Suboxone are not available or not appropriate; or

For the treatment of chronic pain.

To promote safe, therapeutically effective and efficient use of drug therapy, NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for chronic non-cancer pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

OXYCODONE HYDROCHLORIDE

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy, NIHB has implemented an opioid dose limit of 200 mg morphine equivalents per day for chronic non-cancer pain. This limit will be calculated based on the total dose of all opioids a client is receiving from NIHB within a 30-day period (i.e. 6000 morphine equivalents over 30 days).

BUPRENORPHINE (BUTRANS)

Limited use benefit (prior approval required).

For the following medical conditions:

• pain due to cancer
• chronic non-cancer pain-causing limitations in activities of daily living.
• prevention of precipitated withdrawal during buprenorphine/naloxone induction (max 3 x 20 mcg patches are covered)
• patient requires end of life care (diagnosed with a terminal illness or disease which is expected to be the primary cause of death within six months or less)

*Guidelines indicate little evidence for opioid use for fibromyalgia, headache or back or neck pain without a neuropathic component.

BUPRENORPHINE (SUBLOCADE)

Limited use benefit (prior approval required).

For the management of moderate to severe opioid use disorder in adult patients who have been inducted and clinically stabilized on a transmucosal buprenorphine-containing product; and

Patient must be induced and stabilized on an equivalent of 8 mg to 24 mg per day of transmucosal buprenorphine for a minimum of 7 days.

Note:

• the prescriber has experience in the diagnosis and management of opioid use disorder and certified under Sublocade Certification Program.
• Sublocade must be administered subcutaneously in the abdominal region by a healthcare provider.
• Sublocade should be used as part of a complete treatment plan that includes counselling and psychosocial support.
• client will be added to the Client Safety Program (CSP).

BUPRENORPHINE HYDROCHLORIDE

Limited use benefit (prior approval required).

For the management of patients with opioid use disorder, in combination with psychosocial support:

• patient is stabilized on a dose of no more than 8 mg per day of sublingual buprenorphine/naloxone for the preceding 90 days; and
• patient is under the care of a health care provider with experience in the diagnosis and management of opioid use disorder; and
• the prescriber has been trained to implant the buprenorphine subdermal implant.

Approval is for a maximum of four lifetime doses. One package of 4 implants is approved at every 6 months (e.g. four times X package of 4 implants)

BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

Limited use benefit (prior approval required).

For the treatment of opioid dependence when:

• the client must be 16 years or older.
• in cases where the client lives in a remote or isolated location, confirmation is required that the community has the ability to support buprenorphine/naloxone administration. These supports include the safe daily witnessing, storage and handling of the buprenorphine/naloxone doses. After this confirmation, NIHB will approve the buprenorphine/naloxone for the client.

ACETAMINOPHEN

Limited use benefit (prior approval is not required).

For safety reasons NIHB has implemented a dose limit on acetaminophen. The limit accumulates against the amount of acetaminophen claimed to the program from plain acetaminophen and/or acetaminophen in combination with opioids such as codeine (i.e. Tylenol(r) #3) or oxycodone (i.e. Percocet(r)). A total of 360 grams of acetaminophen is permitted in a 100-day period, for a total daily dose of 3600mg/day.

CLONAZEPAM

Limited use benefit (prior approval is not required).

To promote safe, therapeutically effective and efficient use of drug therapy NIHB has implemented a benzodiazepine dose limit of 30 mg diazepam equivalents per day. This limit will be calculated based on the total dose of all benzodiazepines a client is receiving from NIHB within a 100-day period (i.e. 3 000 diazepam equivalents over 100 days). According to the product monograph for diazepam, the recommended usual adult dosage is up to 30 mg per day.

BRIVARACETAM

Limited use benefit (prior approval required).

For adjunctive therapy in adult patients with refractory partial-onset seizures who meet all of the following criteria:

• are under the care of a physician experienced in the treatment of epilepsy; and
• are currently receiving two or more antiepileptic medications; and
• have failed or demonstrated intolerance to at least two other antiepileptic medications; and
• are not receiving concurrent therapy with levetiracetam.

ESLICARBAZEPINE ACETATE

Limited use benefit (prior approval required).

For adjunctive therapy in adult patients with refractory partial-onset seizures who meet all of the following criteria:

• are under the care of a physician experienced in the treatment of epilepsy; and
• are currently receiving two or more antiepileptic medications; and
• have failed or demonstrated intolerance to at least two other antiepileptic medications.

GABAPENTIN

Limited use benefit (prior approval is not required).

For safety reasons NIHB has implemented a dose limit on gabapentin. The limit accumulates against the amount of gabapentin claimed to the program. A total of 400 grams of gabapentin is permitted in a 30-day period, for a total daily dose of 4000 mg/day.

The gabapentin dose limit will be further reduced to 3600 mg per day. The new limit will be implemented region-by-region.

LACOSAMIDE

Limited use benefit (prior approval required).

For adjunctive therapy in adult patients with refractory partial-onset seizures who meet all of the following criteria:

• are under the care of a physician experienced in the treatment of epilepsy; and
• are currently receiving two or more antiepileptic medications; and
• have failed or demonstrated intolerance to at least two other antiepileptic medications.

OXCARBAZEPINE (SUSPENSION)

Limited use benefit (prior approval is not required).

For patients 19 years of age or over who are unable to swallow the tablet formulation due to:

• tube feeding; or
• severe dysphagia

Note: Trileptal (oxcarbazepine) suspension is an open benefit for patients 18 years of age and under and does not require prior approval for these patients.

• Oxcarbazepine tablets are an open benefit for patients of all ages and do not require prior approval.

PERAMPANEL

Limited use benefit (prior approval required).

For adjunctive therapy in patients with refractory partial-onset seizures or primary generalized tonic-clonic (PGTC) seizures who meet all of the following criteria:

• are under the care of a physician experienced in the treatment of epilepsy; and
• are currently receiving two or more antiepileptic medications; and
• have failed or demonstrated intolerance to at least two other antiepileptic medications.

PREGABALIN

Limited use benefit (prior approval required).

For the treatment of neuropathic pain in patients who have failed to effectively treat their pain with a tricyclic antidepressant (TCA); or

For the treatment of neuropathic pain in patients who have a contraindication or intolerance to a tricyclic antidepressant (TCA).

Coverage is limited to a maximum of 600mg per day.

RUFINAMIDE

Limited use benefit (prior approval required).

For the adjunctive treatment of seizures associated with Lennox-Gastaux syndrome in adults and children 4 years and older when prescribed by a neurologist or experienced specialist. Patient has failed or is intolerant to or has contraindications to at least two adjunctive antiepileptic drugs.

BUPROPION HYDROCHLORIDE (ZYBAN)

Limited use benefit with quantity and frequency limits (prior approval is not required).

For smoking cessation:

Coverage is limited to 180 tablets during a one-year period. The year starts on the date the first prescription is filled. Once this quantity has been reached the client is eligible again for coverage for bupropion hydrochloride when one year has elapsed from the day the initial prescription was filled.

ASENAPINE MALEATE

Limited use benefit (prior approval required).

For the acute treatment of manic or mixed episodes associated with bipolar I disorder as either:

• monotherapy, after a trial of lithium or divalproex sodium has failed or is contraindicated, and trials of two atypical antipsychotic agents have failed due to intolerance or lack of response; or
• co-therapy with lithium or divalproex sodium, after trials of two atypical antipsychotic agents have failed due to intolerance or lack of response.

LURASIDONE HYDROCHLORIDE

Limited use benefit (prior approval required).

For the treatment of schizophrenia and schizoaffective disorders in patients:

• who have intolerance or lack of response to an adequate trial of another antipsychotic agent; or
• a contraindication to another antipsychotic agent.

AMPHETAMINE, DEXTROAMPHETAMINE

Limited use benefit (prior approval is not required).

The NIHB Program introduced a dose coverage limit for stimulants on February 25, 2015 as part of a strategy to deal with the potential misuse and abuse of these medications. The stimulant dose coverage limit is set at 100 mg of methylphenidate equivalents* per day for adults and children. This limit is calculated based on the total dose of all stimulants that patients are receiving from NIHB. The Program will continue to monitor the utilization of stimulants and adjust the eligible dose limit as required.

* To convert to methylphenidate equivalents, 1 mg of methylphenidate, or lisdexamfetamine is equal to 0.5 mg dextroamphetamine