Product Details
PMS-Pirfenidone
Pirfenidone801 mg
Tablet
DIN/PIN/NPN
02531534
Manufacturer
Pharmascience Inc.
Formulary Listing Date
2022-12-21
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
NOEAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Respirology Therapies | Pirfenidone
Initial approval criteria: For the treatment of adult patients with a diagnosis of mild to moderate idiopathic pulmonary fibrosis (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:
Exclusion Criteria: Combination use of Esbriet (pirfenidone) and Ofev (nintedanib) will not be funded. EAP Drug Request Form: |