Limited Coverage Drugs – Pirfenidone

Generic Name:

pirfenidone

Strength:

Capsule: 267 mg

Tablet: 267 mg and 801 mg

Form:

capsule and tablet

Special Authority Criteria

Approval Period

Initial:

For the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in adult patients:

  • for whom a diagnosis of IPF is confirmed by a respirologist with expertise in IPF and who has had a high-resolution CT scan within the previous 24 months;

AND

  • in whom all other causes of restrictive lung disease (e.g., collagen vascular disorder or hypersensitivity pneumonitis) are excluded;

AND

  • who are under the care of a respirologist with expertise in IPF.

Notes:

For patients diagnosed with IPF, mild to moderate disease is defined as a forced vital capacity (FVC) greater than or equal to 50% of predicted.

Practitioners who are requesting initial coverage for the treatment of patients with IPF must also submit a copy of the diagnostic report from a high-resolution CT scan done within the previous 24 months.

Exclusion:

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

Initial approval: 7 months (including a 4-week period for repeat pulmonary function tests, if needed)

First renewal:

  • Prescribed by a respirologist with expertise in IPF.

AND

Patients must not demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥10% from initiation therapy until renewal. 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.

First renewal: 7 months (including a 4-week period for repeat pulmonary function tests, if needed)

Second and subsequent renewals:

  • Prescribed by a respirologist with expertise in IPF.

AND

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 experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later.

Second and subsequent renewals:

1 year (including a 4-week period for repeat pulmonary function tests, if needed)

Practitioner Exemptions

  • No practitioner exemptions.

Special Notes

  • See form for more details.

Special Authority Request Form(s)