Product Details

Sandoz Pirfenidone Tablets

Pirfenidone
801 mg
Tablet


DIN/PIN/NPN

02488515

Manufacturer

Sandoz Canada Inc.

Formulary Listing Date

2021-06-30  

Unit Price

20.1360

Amount MOH Pays

20.1360

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AX05

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02488515 Sandoz Pirfenidone Tablets 20.1360 20.1360
02514710 Jamp Pirfenidone 20.1360 20.1360
02464500 Esbriet 40.2720 20.1360
02531534 PMS-Pirfenidone 20.1360 20.1360
02537761 Auro-Pirfenidone 20.1361 20.1361
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Respirology Therapies

Pirfenidone

  • Brand(s): Esbriet and generics (see formulary for OFIs)
  • Dosage Form/Strength: 267 mg capsule, 267 mg tablet, 801 mg tablet

Initial approval criteria: 

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

  1. Diagnosis confirmed by a respirologist and a high-resolution CT scan. 

  2. All other causes of restrictive lung disease (e.g., collagen vascular disorder or hypersensitivity pneumonitis) should be excluded.

  3. Mild to moderate IPF is defined as forced vital capacity (FVC) greater than or equal to 50% of predicted.

  4. Patient is under the care of a physician with experience in IPF. 

Initial approval period: 7 months (allow 4 weeks for repeat pulmonary function tests) 

Initial renewal criteria (at 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. 

Approval period: 6 months 

Second and subsequent renewals (at 12 months and thereafter): 

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. 

Approval period: 12 months 

Documentation/information required: 

  • If high-resolution CT scan is not available, lung biopsy may be provided to support the diagnosis of IPF as applicable and available 

  • Full pulmonary function test results. 

Exclusion Criteria: 

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

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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