48:00 Respiratory Tract Agents

48:02.00 ANTIFIBROTIC AGENTS

NINTEDANIB ESILATE

Limited use benefit (prior approval required).

Initial Request

Coverage is provided for a period of 7 months (6 months plus a 4 week allowance for repeat pulmonary function tests):

For the treatment of adult patients with a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF) who meet the following criteria:

  • dagnosis confirmed by a respirologist and a high-resolution CT scan within the previous 24 months; and
  • all other causes of restrictive lung disease (e.g. collagen vascular disorder or hypersensitivity pneumonitis) should be excluded; and
  • mild to moderate IPF is defined as forced vital capacity (FVC) greater than or equal to 50% of predicted; and
  • patient is under the care of a physician with experience in IPF.

Renewal at 6 months

Coverage is provided for a period of 6 months:

  • patients must not demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥ 10% from initiation of therapy until renewal (initial 6 month treatment period). If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later.

Subsequent Renewals at 12 months and thereafter

Coverage is provided for a period of 12 months:

  • patients must not demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥ 10% within any 12 month period. If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later.

Combination use of Ofev (nintedanib) and Esbriet (pirfenidone) will not be provided.

Table: NINTEDANIB ESILATE
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Capsule 02443066 OFEV BOE
150MG Capsule 02443074 OFEV BOE

PIRFENIDONE

Limited use benefit (prior approval required).

Initial Request

Coverage is provided for a period of 7 months (6 months plus a 4 weeks allowance for repeat pulmonary function tests):

For the treatment of adult patients with a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF) who meet the following criteria:

  • diagnosis confirmed by a respirologist and a high-resolution CT scan within the previous 24 months; and
  • all other causes of restrictive lung disease (e.g. collagen vascular disorder or hypersensitivity pneumonitis) should be excluded; and
  • mild to moderate IPF is defined as forced vital capacity (FVC) greater than or equal to 50% of predicted; and
  • patient is under the care of a physician with experience in IPF.

Renewal at 6 months

Coverage is provided for a period of 6 months:

  • patients must not demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥ 10% from initiation of therapy until renewal (initial 6 month treatment period). If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later.

Subsequent Renewals at 12 months and thereafter

Coverage is provided for a period of 12 months:

  • patients must not demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥ 10% within any 12 month period. If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later.

Combination use of Ofev (nintedanib) and Esbriet (pirfenidone) will not be provided.

Table: PIRFENIDONE
Drug strength and dosage form DIN Brand name Manufacturer code
267MG Capsule 02393751 ESBRIET HLR
267MG Tablet 02464489 ESBRIET HLR
801MG Tablet 02464500 ESBRIET HLR

48:10.24 LEUKOTRIENE MODIFIERS

MONTELUKAST SODIUM

Limited use benefit (prior approval required).

For treatment of:

  • asthma when used in patients on concurrent steroid therapy; or
  • asthma patients not well controlled with or intolerant to inhaled corticosteroids.

Montelukast is open benefit for children up to 17 years of age.

Table: MONTELUKAST SODIUM
Drug strength and dosage form DIN Brand name Manufacturer code
ST4MG Granules 02358611 SANDOZ MONTELUKAST SDZ
ST4MG Granules 02247997 SINGULAIR FRS
ST10MG Tablet 02374609 APO-MONTELUKAST APX
ST10MG Tablet 02401274 AURO-MONTELUKAST AUR
10MG Tablet 02445735 BIO-MONTELUKAST UNK
ST10MG Tablet 02376695 DOM-MONTELUKAST DPC
ST10MG Tablet 02391422 JAMP-MONTELUKAST JMP
ST10MG Tablet 02399997 MAR-MONTELUKAST MAR
ST10MG Tablet 02408643 MINT-MONTELUKAST MIN
ST10MG Tablet 02379333 MONTELUKAST SAN
ST10MG Tablet 02379856 MONTELUKAST PDL
ST10MG Tablet 02382474 MONTELUKAST SIV
ST10MG Tablet 02379236 MONTELUKAST SODIUM ACC
10MG Tablet 02489821 NRA-MONTELUKAST UNK
ST10MG Tablet 02373947 PMS-MONTELUKAST PMS
10MG Tablet 02440350 PRIVA-MONTELUKAST PHA
ST10MG Tablet 02389517 RAN-MONTELUKAST RBY
ST10MG Tablet 02398826 RIVA-MONTELUKAST RIV
ST10MG Tablet 02328593 SANDOZ MONTELUKAST SDZ
ST10MG Tablet 02238217 SINGULAIR FRS
ST10MG Tablet 02355523 TEVA-MONTELUKAST TEV
4MG Tablet (Chewable) 02377608 APO-MONTELUKAST APX
ST4MG Tablet (Chewable) 02422867 AURO-MONTELUKAST AUR
ST4MG Tablet (Chewable) 02442353 JAMP-MONTELUKAST JMP
ST4MG Tablet (Chewable) 02399865 MAR-MONTELUKAST MAR
ST4MG Tablet (Chewable) 02408627 MINT-MONTELUKAST MIN
ST4MG Tablet (Chewable) 02379821 MONTELUKAST PDL
ST4MG Tablet (Chewable) 02382458 MONTELUKAST SIV
ST4MG Tablet (Chewable) 02354977 PMS-MONTELUKAST PMS
ST4MG Tablet (Chewable) 02402793 RAN-MONTELUKAST RBY
ST4MG Tablet (Chewable) 02330385 SANDOZ MONTELUKAST SDZ
ST4MG Tablet (Chewable) 02243602 SINGULAIR FRS
ST4MG Tablet (Chewable) 02355507 TEVA-MONTELUKAST TEV
ST5MG Tablet (Chewable) 02377616 APO-MONTELUKAST APX
ST5MG Tablet (Chewable) 02422875 AURO-MONTELUKAST AUR
ST5MG Tablet (Chewable) 02442361 JAMP-MONTELUKAST JMP
ST5MG Tablet (Chewable) 02399873 MAR-MONTELUKAST MAR
ST5MG Tablet (Chewable) 02408635 MINT-MONTELUKAST MIN
ST5MG Tablet (Chewable) 02379848 MONTELUKAST PDL
ST5MG Tablet (Chewable) 02382466 MONTELUKAST SIV
ST5MG Tablet (Chewable) 02354985 PMS-MONTELUKAST PMS
ST5MG Tablet (Chewable) 02402807 RAN-MONTELUKAST RBY
ST5MG Tablet (Chewable) 02330393 SANDOZ MONTELUKAST SDZ
ST5MG Tablet (Chewable) 02238216 SINGULAIR FRS
ST5MG Tablet (Chewable) 02355515 TEVA-MONTELUKAST TEV

48:10.32 MAST CELL STABILIZERS

CROMOLYN SODIUM

Table: CROMOLYN SODIUM
Drug strength and dosage form DIN Brand name Manufacturer code
100MG Capsule 00500895 NALCROM SAC
2% Nasal Spray 02231390 APO-CROMOLYN APX
2% Nasal Spray 01950541 RHINARIS-CS PED
10MG/ML Solution 02046113 PMS-SODIUM CROMOGLYCATE PMS

48:48.00 VASODILATING AGENTS

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.
Table: AMBRISENTAN
Drug strength and dosage form DIN Brand name Manufacturer code
ST5MG Tablet 02475375 APO-AMBRISENTAN APX
ST10MG Tablet 02475383 APO-AMBRISENTAN APX

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.
Table: BOSENTAN MONOHYDRATE
Drug strength and dosage form DIN Brand name Manufacturer code
ST125MG Tablet 02399210 APO-BOSENTAN APX

RIOCIGUAT

Limited use benefit (prior approval required).

For the treatment of patients 18 years of age or older with chronic thromboembolic pulmonary hypertension (CTEPH) with World Health Organization (WHO) Functional Class 2 or 3 pulmonary hypertension with:

  • inoperable CTEPH, World Health Organization (WHO) Group 4;
  • or
  • persistent or recurrent CTEPH after surgical treatment; and
  • prescriber experienced in the diagnosis and treatment of CTEPH.
Table: RIOCIGUAT
Drug strength and dosage form DIN Brand name Manufacturer code
0.5MG Tablet 02412764 ADEMPAS BAY
1MG Tablet 02412772 ADEMPAS BAY
1.5MG Tablet 02412799 ADEMPAS BAY
2MG Tablet 02412802 ADEMPAS BAY
2.5MG Tablet 02412810 ADEMPAS BAY

SELEXIPAG

Limited use benefit (prior approval required).

For the treatment of adult patients with World Health Organization (WHO) functional class (FC) II to III pulmonary arterial hypertension (PAH), including idiopathic PAH, heritable PAH, PAH associated with connective tissue disorders or PAH associated with congenital heart disease:

  • patient is under the care of a physician with experience in the diagnosis and treatment of PAH; and
  • patient has failed to respond to first- and second-line PAH therapies; or
  • patient has contraindications/intolerance to first- and second-line PAH therapies.
Table: SELEXIPAG
Drug strength and dosage form DIN Brand name Manufacturer code
200MCG Tablet 02451158 UPTRAVI JSO
400MCG Tablet 02451166 UPTRAVI JSO
600MCG Tablet 02451174 UPTRAVI JSO
800MCG Tablet 02451182 UPTRAVI JSO
1000MCG Tablet 02451190 UPTRAVI JSO
1200MCG Tablet 02451204 UPTRAVI JSO
1400MCG Tablet 02451212 UPTRAVI JSO
1600MCG Tablet 02451220 UPTRAVI JSO

48:92.00 MISCELLANEOUS RESPIRATORY TRACT AGENTS

OMALIZUMAB

Limited use benefit (prior approval required).

Coverage is provided for an initial period of 24 weeks at a maximum dose of 300 mg every 4 weeks (6 injections over a 24 week period).

1. For the treatment of adults and adolescents (12 years of age or older) with moderate to severe chronic idiopathic urticaria (CIU) who remain symptomatic (presence of hives and/or associated itching) despite optimum management with H1 antihistamines; and

Prescriber is experienced in the treatment of CIU (Allergist, Dermatologist, Immunologist, or other authorized prescriber experienced in the treatment of CIU).

Treatment cessation could be considered for patients who experience complete symptom control (UAS-7 = 0) for at least 12 consecutive weeks at the end of a 24-week treatment period.

Renewal coverage is provided for 24 weeks at a maximum dose of 300 mg every 4 weeks (6 injections/24 weeks).

2. For the treatment of adults and adolescents (12 years of age or older) with moderate to severe chronic idiopathic urticaria (CIU); and

  • patient stopped omalizumab after achieving complete symptom control (UAS-7 = 0) for at least 12 weeks while on treatment, but has experienced symptom relapse; or
  • patient achieved complete symptom control, but for a period of less than 12 consecutive weeks; or
  • patient achieved a partial response to treatment, defined as a ≥ 9.5-point reduction in baseline urticaria activity score over 7 days (UAS-7).

In patients where treatment is discontinued due to temporary symptom control, treatment re-initiation may be considered should CIU symptoms reappear.

Table: OMALIZUMAB
Drug strength and dosage form DIN Brand name Manufacturer code
150MG Powder For Solution 02260565 XOLAIR NVR
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