Medical Updates

News Regarding Esbriet

Provinces update criteria to include mild IPF

Esbriet® was originally funded in 2014 under EAP Criteria that  restricted coverage to patients with moderate IPF, that is, with FVC% between 50-80%.

The updated EAP criteria represents another gain for IPF Patients.  With the removal of the upper limit for FVC%, patients with mild IPF will also be covered provided they qualify based on other requirements.

Coverage for those earlier in their disease has been advocated for by CPFF at each and every meeting with government officials across Canada.

Be sure to check the criteria for your province.

ALBERTA

Source:  https://www.ab.bluecross.ca/dbl/pdfs/nov_dblupdate.pdf (see page 3-3 for new criteria).

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

Alberta Criteria effective October 26, 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.

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).

SASKATCHEWAN

Source: http://formulary.drugplan.health.gov.sk.ca/Bulletins/Bulletin162Oct2016.pdf (changes are indicated in bold)

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.

ONTARIO

Esbriet® was originally funded in 2014 under EAP Criteria that  restricted coverage to patients with moderate IPF, that is, with FVC% between 50-80% (page 173, http://www.health.gov.on.ca/en/pro/programs/drugs/pdf/frequently_requested_drugs.pdf).

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.

NEWFOUNDLAND
Newfoundland Special Authorization effective November, 2016

Source: http://www.health.gov.nl.ca/health/prescription/special_auth_drug_products.pdf (pg. 214)

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:
http://www.health.gov.nl.ca/health/forms/PIRFENIDONE_SPECIAL_AUTHORIZATION_REQUEST_FORM_(Esbriet).pdf

NOVA SCOTIA
Nova Scotia Formulary effective January, 2017

Source: http://novascotia.ca/dhw/pharmacare/documents/formulary.pdf (pg. 333)

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.

YUKON
Yukon Formulary effective February, 2017

Source: http://apps.gov.yk.ca/drugs/

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
Manitoba Exceptional Drug Status effective February, 2017

Source: https://www.gov.mb.ca/health/mdbif/docs/edsnotice.pdf (pg. 39)

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.

PRINCE EDWARD ISLAND
PEI Formulary (Special Access) effective January, 2017

Source: http://www.gov.pe.ca/photos/original/hpei_formulary.pdf (pg. 321)

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.

NEW BRUNSWICK
New Brunswick Special Authorization Benefit Additions effective October, 2014

Source: http://www2.gnb.ca/NBDrugPlan/formularyupdates/NBDrugPlansBulletin893.pdf (pg. 3)

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

Inspiration™ Patient Assistance Program

One-on-one support for Esbriet™ treatment

Esbriet™ (pirfenidone) is an anti-fibrotic/anti-inflammatory agent approved by Health Canada for the treatment of mild to moderate idiopathic pulmonary fibrosis in adults.

The Inspiration™ Patient Assistance Program offers a team of dedicated experts working together to provide comprehensive support services, such as help with reimbursement, medication delivery, and information about IPF and Esbriet. The program oversees many of the administrative aspects of treatment and is designed to benefit those with IPF and the healthcare professionals who care for them.

For more information, contact the Inspiration Program at 1-855-5-IPF-CARE (1-855-547-3227). Nurses are available to answer your questions Monday to Friday, 8am to 8pm EST.

© Copyright 2014-2015 Hoffmann-La Roche Limited

ESBRIET® Registered trade-mark of F. Hoffmann-La Roche AG, used under license

INSPIRATION & INSPIRATION DESIGN™ is a trade-mark of Intermune, Inc.

Esbriet® Wins 2014 Cdn Prix Galien for Pharma Innovation
We congratulate InterMune/Hoffmann-La Roche Limited on winning the Prix Galien Canada – Innovative Product Award for the most significant overall contribution to patient care in Canada in terms of efficacy, safety, benefits and innovation.  All IPF patients who participated in clinical trials and who advocated for approval and funding as well as IPF awareness share in this honour.

Provinces fund Esbriet on interim basis
The following provinces/territories have agreed to fund Esbriet on an interim basis.  The list is ordered from latest to the first announcement.
MANITOBA (MB)

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 (YK)

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 (SK)

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 (NS)

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 (AB)

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 (NL)

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 (NB)

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 (ON)

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…