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.
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.
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.
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
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.
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.
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.
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.
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.
Drug strength and dosage form | DIN | Brand name | Manufacturer code |
---|---|---|---|
150MG Powder For Solution | 02260565 | XOLAIR | NVR |