Interactive Drug Benefit List
DIN/NPN/PIN 02464489 ESBRIET 267 MG ORAL TABLET PIRFENIDONE
480000 RESPIRATORY TRACT AGENTS
480200 ANTIFIBROTIC AGENTS
Date Listed/Coverage Update: 01-May-2018
Unit Price: 13.4240
LCA Price: 0.0000
MAC Price:

0.0000

Unit of Issue: Tablet
Manufacturer: HOFFMANN-LA ROCHE LIMITED (HLR)
ATC: L04AX05
1
Interchangeable Products: Yes

Coverage Status: SPECIAL AUTHORIZATION
Applies to Clients of: Non-Group Coverage (Group 1)
Coverage for Seniors (Group 66)
Palliative Coverage (Group 20514, Please note:Your client may have Group 1 or Group 66 coverage)
Child and Family Services (Group 20403)
Alberta Child Health Benefit (Group 20400)
Children and Youth Services (Group 19824)
Income Support (Group 19823)
Learners Program (Group 22128)
Alberta Human Services (AISH) (Group 19823)
Alberta Adult Health Benefit (AAHB) (Group 23609)

Special Authorization Request Form:

Nintedanib/Pirfenidone Special Authorization Request Form (ABC 60051)

SPECIAL AUTHORIZATION

"Initial approval criteria:

Adult patients with a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF):
- Diagnosis confirmed by a respirologist and a high-resolution CT scan within the previous 24 months.
-All other causes of restrictive lung disease (e.g. collagen vascular disorder or hypersensitivity pneumonitis) should be excluded.
- Mild to moderate IPF is defined as forced vital capacity (FVC) greater than or equal to 50% of predicted.
- 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 greater than or equal to 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 greater than or equal to 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

Exclusion Criteria:

Combination use of pirfenidone and nintedanib will not be funded.

Notes:

Patients who have experienced intolerance or failure to pirfenidone or nintedanib will be considered for the alternate agent provided that the patient continues to meet the above coverage criteria."

All requests for pirfenidone must be completed using the Nintedanib/Pirfenidone Special Authorization Request Form (ABC 60051).

Review Status / Past Decisions

Indication Reviewing
Body
Submission
Completion
Date
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
Review
Status
N/A Expert Committee 2017/11/14 2018/03/01 Under Review
N/A Expert Committee 2017/11/14 2018/05/01 Special Authorization
Indication N/A
Reviewing
Body
Expert Committee
Submission
Completion
Date
2017/11/14
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2018/03/01
CDR
Recommendation
Review
Status
Under Review
Indication N/A
Reviewing
Body
Expert Committee
Submission
Completion
Date
2017/11/14
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2018/05/01
CDR
Recommendation
Review
Status
Special Authorization
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