Source: https://www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/pharmacare/prescribers/limited-coverage-drug-program/limited-coverage-drugs-pirfenidone

British Columbia Criteria effective February 6, 2018

Source: https://idbl.ab.bluecross.ca/idbl/lookupDinPinDetail.do?productID=0000084138.

Download Alberta Blue Cross Nintedanib/Pirfenidone Special Authorization Request Form (ABC 60051)

Alberta Criteria effective May 01, 2018

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 six 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).

Source: https://www.gov.mb.ca/health/mdbif/docs/edsnotice.pdf (Page 65)

Manitoba Exceptional Drug Status effective February, 2017

For the treatment of adult patients who have a diagnosis of mild to moderate idiopathic
pulmonary fibrosis (IPF)* confirmed by a respirologist and a high-resolution CT scan within the
previous 24 months.
*Mild-moderate IPF is defined as: forced vital capacity (FVC) greater than or equal to 50%
of predicted.

Source: https://formulary.drugplan.ehealthsask.ca/Bulletins/Bulletin-0162-Oct-2016.pdf

Saskatchewan Criteria effective October 1, 2016

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.

Prescribers may be asked to provide documentation to support confirmation of diagnosis.

Initial approval period: seven months (allow four weeks for repeat pulmonary function tests)

Initial renewal criteria (at six 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 six 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 four weeks later.

Approval period: six 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 four weeks later.

Approval period: 12 months

Exclusion Criteria:

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

Notes:

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

Source: http://www.health.gov.on.ca/en/pro/programs/drugs/pdf/frequently_requested_drugs.pdf (Page 286)

Ontario EAP Criteria effective September 16, 2016

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.
• 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 ≥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 required.
• Full pulmonary function test results.

Exclusion Criteria:

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

Source: https://www.ramq.gouv.qc.ca/sites/default/files/documents/liste_med_2020_04_29_en.pdf (Page 116)

En Français: https://www.ramq.gouv.qc.ca/sites/default/files/documents/liste_med_2020_04_29_fr.pdf (Page 121)

Quebec List of Medications in Force effective April, 2018

ESBRIET 267mg and 801mg tablets were listed on the Québec RAMQ Formulary as of April 18, 2018, for the treatment of idiopathic pulmonary fibrosis.

For treatment of idiopathic pulmonary fibrosis, in persons:

• whose forced vital capacity (FVC) is 50% or more of the predicted value; and
• whose carbon monoxide diffusing capacity is 30% to 79% of the predicted value corrected for hemoglobin; and
• whose ratio of forced expiratory volume in one second (FEV1) to the FVC (FEV1/FVC) is 0.70 or more.

The initial authorization and requests for continuation of treatment will be authorized for a maximum duration of 12 months.

Upon subsequent requests, the physician must provide proof of a beneficial clinical effect defined by the absence of deterioration in the patient’s condition. Deterioration is understood as a decline in FVC, expressed in a percentage of the predicted value, of 10% or more in absolute value, in the last 12 months.

Where FVC, expressed in a percentage of the predicted value, declines by 10% or more in absolute value over a 12-month period, treatment must cease.

It must be noted that pirfenidone will not be authorized in association with nintedanib.

Source: https://www2.gnb.ca/content/dam/gnb/Departments/h-s/pdf/en/NBDrugPlan/SpecialAuthorization/Special_Authorization_Criteria-e.pdf (Page 79)

New Brunswick Special Authorization Benefit Additions effective October, 2014

Initial approval criteria:
Adult patients who have a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF)* confirmed by a respirologist and a high-resolution CT scan within the previous 24 months.
*Mild-moderate IPF is defined as: a FVC between 50-80% predicted, and a Percent Carbon Monoxide Diffusing Capacity (%DLCO) between 30-90% predicted.

Initial renewal criteria:
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.

Second renewal (12 months after initiation of therapy):
Patients must NOT demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥10% since initiation of therapy (baseline). 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.

Claim Notes:
• Initial approval period: 7 months (allow 4 weeks for repeat pulmonary function tests)
• Renewal Approval period: 6 months
• Second renewal approval period: 12 months

Source: https://www.gov.nl.ca/hcs/files/prescription-special-auth-drug-products.pdf (Page 237)

Newfoundland Special Authorization effective November, 2016

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 ≥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

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

Notes:
Patients who have experienced intolerance or failure to Esbriet (pirfenidone) or Ofev (nintedanib) will be considered for the alternate agent provided that the patient continues to meet the above coverage criteria.
Please visit the link below if you require our standard special authorization form:
https://www.gov.nl.ca/hcs/files/forms-pdf-pirfenidone-nintedanib.pdf

Source: https://novascotia.ca/dhw/pharmacare/documents/Criteria-for-Exception-Status-Coverage.pdf (pg. 79)

Nova Scotia Formulary effective January, 2017

Initial approval criteria:
Adult patients who have a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF)* 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.
• Patient is under the case of a physician with experience in IPF
• Initial approval period: 7 months (allow 4 weeks for repeat pulmonary function tests)

*Mild-moderate IPF is defined as: a forced vital capacity (FVC) ≥ 50% of predicted.

Initial renewal criteria:
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 renewal criteria (at 12 months after initiation 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
Exclusion Criteria:
Combination use of Esbriet (pirfenidone) and Ofev (nintedanib) will not be funded.

Source: https://www.princeedwardisland.ca/sites/default/files/publications/pei_pharmacare_formulary.pdf (page 357)

PEI Formulary (Special Access) effective January, 2017

Initial approval criteria:
Adult patients who have a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF)* confirmed by a respirologist and a high-resolution CT scan within the prevous 24 months.
*Mild-moderate IPF is defined as: a FVC between 50-80% predicted, and a Percent Carbon Monoxide Diffusing Capacity (%DLCO) between 30-90% predicted.
Initial approval period: 7 months (allow 4 weeks for repeat pulmonary function tests)

Initial renewal criteria:
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 renewal (12 months after initiation of therapy):
Patients must NOT demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥10% since initiation of therapy (baseline). 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

Requests for Pirfenidone (Esbriet-HLR) must be made using the Esbriet Special Authorization form which is available from the Drug Programs office or on-line at http://healthpei.ca/pharmacareforms.

Patients must also apply for coverage by the High-Cost Drug Program. The patient application is available from the Drug Program Office or online at http://healthpei.ca/pharmacareforms.

Source: Yukon Drug Programs Formulary – Jan 2017 (Page 283)

https://ihs.gov.yk.ca/drugs/f?p=161:9000::SEARCH:NO:::&cs=3peCrh3rZIHN1ZdwcunLJYIESeZk

Yukon Formulary effective February, 2017

Initial Approval:
Adult patients who have a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF)

• 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. Consult to be provided.

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

Initial Renewal Criteria:

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 renewal (12 months after initiation of therapy):

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

Exclusion criteria: Combination use of Esbriet and Ofev will not be funded.

Notes: Patients who have experienced intolerance or failure to Esbriet or Ofev will be considered for the alternate agent provided that the patient continues to meet the above criteria.

Manitoba will consider Pharmacare reimbursement for Pirfenidone (Esbriet) upon an individual prescriber/patient request basis effective January 19, 2015.

December 19, 2014 – From page 4 of the Manitoba Drug Benefits & Interchangeability Formulary Bulletin #80 (http://www.gov.mb.ca/health/mdbif/docs/bulletins/bulletin80.pdf):

Esbriet pirfenidone 267 mg Capsule — For the treatment of adult patients who have a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF) confirmed by a respirologist.

We have been advised that while the official effective date is January 19 physicians (respirologists) are able to make requests for patients now.

Yukon has agreed to fund Pirfenidone (Esbriet) under certain conditions

November 4, 2014 – In order for residents of Yukon to receive funding for Esbriet, eligible patients must first receive a prescription from their respirologist, and be enrolled in the Inspiration Program, a patient support program offered by Hoffmann-La Roche Limited.

The criteria will be the same as for other provinces — adult patients who have a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF)* confirmed by a respirologist and a high-resolution CT scan within the previous 24 months. Mild-moderate IPF is defined as: a FVC between 50-80% predicted, and a Percent Carbon Monoxide Diffusing Capacity (%DLCO) between 30-90% predicted. Read more….

Saskatchewan has agreed to fund Pirfenidone (Esbriet) under certain conditions

November 4, 2014 – In order for residents of Saskatchewan to receive funding for Esbriet, eligible patients must first receive a prescription from their respirologist, and be enrolled in the Inspiration Program, a patient support program offered by InterMune Canada.

Interim funding is effective November 1, 2014. The criteria will be the same as for other provinces — adult patients who have a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF)* confirmed by a respirologist and a high-resolution CT scan within the previous 24 months. Mild-moderate IPF is defined as: a FVC between 50-80% predicted, and a Percent Carbon Monoxide Diffusing Capacity (%DLCO) between 30-90% predicted. For more information, see Saskatchewan Formulary Bulletin #150.

Nova Scotia has agreed to fund Pirfenidone (Esbriet) under certain conditions

November 4, 2014 – In order for residents of Nova Scotia to receive funding for Esbriet, eligible patients must first receive a prescription from their respirologist, and be enrolled in the Inspiration Program, a patient support program offered by Hoffmann-La Roche Limited.

Interim funding is effective October 31, 2014. The criteria will be the same as for other provinces — adult patients who have a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF)* confirmed by a respirologist and a high-resolution CT scan within the previous 24 months. Mild-moderate IPF is defined as: a FVC between 50-80% predicted, and a Percent Carbon Monoxide Diffusing Capacity (%DLCO) between 30-90% predicted. For more information, see Nova Scotia PharmacareNEWS October 2014 Volume 14-07.

Alberta has agreed to fund Pirfenidone (Esbriet) under certain conditions

November 3, 2014 – In order for residents of Alberta to receive funding for Esbriet, eligible patients must first receive a prescription from their respirologist, and be enrolled in the Inspiration Program, a patient support program offered by InterMune Canada.

Interim funding is effective November 1, 2014. The criteria will be the same as for other provinces — adult patients who have a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF)* confirmed by a respirologist and a high-resolution CT scan within the previous 24 months. Mild-moderate IPF is defined as: a FVC between 50-80% predicted, and a Percent Carbon Monoxide Diffusing Capacity (%DLCO) between 30-90% predicted.

Newfoundland and Labrador has agreed to fund Pirfenidone (Esbriet) under certain conditions

October 30, 2014 – In order for residents of Newfoundland and Labrador to receive funding for Esbriet, eligible patients must first receive a prescription from their respirologist, and be enrolled in the Inspiration Program, a patient support program offered by Hoffmann-La Roche Limited.  Esbriet will then be funded effective October 14, 2014 through the Newfoundland and Labrador Prescription Drug Program (NLPDP), based on certain clinical criteria as outlined in the Newfoundland and Labrador Prescription Drug Program Bulletin #151 dated October 30, 2014.

New Brunswick has agreed to fund Pirfenidone (Esbriet) under certain conditions

October 8, 2014 – In order for New Brunswickers to receive funding for Esbriet, eligible patients must first receive a prescription from their respirologist, and be enrolled in the Inspiration Program, a patient support program offered by Hoffmann-La Roche Limited.  Esbriet will then be funded through the New Brunswick Prescription Drug Program (NBPDP), based on certain clinical criteria as outlined on page 3 of the New Brunswick Drug Plans Bulletin #893 dated October 3, 2014..

Ontario EAP Reimbursement Criteria for Pirfenidone (Esbriet)

Ministry of Health and Long-term Care Ontario have now provided the Exceptional Access Program (EAP) Reimbursement Criteria for Pirfenidone (Esbriet) updated August 28, 2014.

Click here to view the details…