48:00 Respiratory Tract 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.

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.

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.

CROMOLYN SODIUM

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.

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.

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.

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.