Medical Updates

News Regarding Ofev

 

HeadStart™ Patient Assistance Program

HeadStart™ Patient Assistance Program now available for OFEV™ patients

OFEV™ (nintedanib) is an anti-fibrotic/anti-inflammatory agent now approved by Health Canada for the treatment of   idiopathic pulmonary fibrosis (IPF) in adults. The HeadStart™ Patient Assistance Program is now in place to assist patients who have been prescribed OFEV™.

The HeadStart™ Patient Assistance Program offers support for patients in getting started with OFEV™. The program offers support not only for patients, but for caregivers as well. The HeadStart™ Patient Assistance Program offers patients access to a team of experts working together to help guide and support patients during the treatment process and includes services such as information about IPF, access to regional resources and support groups, help with reimbursement, medication delivery, and information about OFEV™. The program oversees all aspects of treatment for the patient, designed to benefit those with IPF and the healthcare professionals who care for them.

For more information, please contact HeadStart™ at 1-844-IPF-OFEV (1-844-473-6338). Nurses are available to offer support and answer questions Monday to Friday, 8:00 am to 8:00 pm EST.

© 2015 Boehringer Ingelheim (Canada) Ltd./Ltée All rights reserved.

Please note you must have a prescription from your respirologist to participate in the HeadStart Program.

Provinces provide choice for IPF Patients

Hot on the heels of the CPFF annual IPF Awareness Day at Queen’s Park, and after a successful series of meetings and correspondence between CPFF and the Executive Officer, Ontario Public Drug Programs, Ontario has agreed to give patients a choice in IPF drugs. OFEV™ will be covered under the Exceptional Access Program (EAP) subject to clinical criteria below effective September 16, 2016.

The EAP Criteria mirrors the clinical trial criteria for nintedanib (OFEV™) that allowed patients to participate early in their disease.  Without an upper limit for FVC%, the EAP criteria represents another gain for IPF Patients as those earlier in their disease can be covered provided they qualify based on other requirements.

The Ministers, MPPs and other government officials with whom CPFF met last week were very receptive to our message: Patients should have a choice! Doctors and patients should decide which drug a patient uses.

CPFF anticipates that other provinces will follow Ontario’s lead.


Provincial Approvals

Manitoba has announced that they will be reimbursing Ofev as of January 25th, 2017 under Exceptional Drug Status.

Newfoundland has announced that they will be reimbursing Ofev as of February 1st, 2017 under Special Authorization.

Québec has announced that they will be reimbursing Ofev as of March 22nd, 2017 as Médicament d’Exception.

ALBERTA

Source: https://www.ab.bluecross.ca/dbl/pdfs/nov_dblupdate.pdf

Alberta Criteria effective November 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.

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 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 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 nintedanib must be completed using the Nintedanib/Pirfenidone Special Authorization Request Form (ABC 60051).

MANITOBA
OFEV™ Criteria effective January 25, 2017

Source: http://www.gov.mb.ca/health/mdbif/docs/bulletins/bulletin90.pdf

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

Notes:

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

NEW BRUNSWICK
OFEV™ listed as Special Authorization Benefit effective November 30, 2016

Source: New Brunswick Drug Plans Formulary – Jan 2017

For the treatment of adult patients with mild to moderate idiopathic pulmonary fibrosis (IPF) confirmed by a respirologist and a high-resolution CT scan within the previous 24 months.

Initial renewal criteria:

Patients must not demonstrate progression of disease defined as an absolute decline in percent predicted forced vital capacity (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.

Subsequent renewal criteria:

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.

Clinical notes:

• Mild to moderate IPF is defined as a FVC ≥ 50% predicted.
• All other causes of restrictive lung disease (e.g. collagen vascular disorder or hypersensitivity pneumonitis) should be excluded before initiating treatment.

Claim notes:

• Must be prescribed by, or in consultation with, physicians experienced in the treatment of IPF.
• Combination therapy of pirfenidone with nintedanib will not be reimbursed.
• Initial approval period: 7 months (allow 4 weeks for repeat pulmonary function tests)
• Initial renewal approval period: 6 months
• Subsequent renewal approval period: 12 months

NOVA SCOTIA
OFEV™ listed as Exception Drug Status effective Dec 1, 2016

Source: Nova Scotia Formulary Updates – Nov 2016

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 care 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 Ofev (nintedanib) and Esbriet (pirfenidone) will not be funded.
Note:

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

PRINCE EDWARD ISLAND
PEI criteria effective April 24, 2017

Source: http://www.gov.pe.ca/photos/original/hpei_formulary.pdf

Initial approval criteria:

For the treatment of mild to moderate idiopathic pulmonary fibrosis in adult patients confirmed by a respirologist and a high-resolution CT scan within the previous 24 months.

All other causes of restrictive lung disease should be excluded.  Mild to moderate IPF is defined as forced vital capacity (FVC) greater than or equal to 50% of predicted.

Initial renewal criteria (at 6 months):

Patients must not demonstrate progression of disease defined as an absolute decline in percent predicted forced vital capacity (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 and subsequent renewals (12 months and thereafter):

Patients must not demonstrate progession 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.

Excluded criteria:

Combination therapy of Ofev (nindetanib) and Esbriet (perfenidone) will not be reimbursed.

 

SASKATCHEWAN
Saskatchewan Criteria effective October 1, 2016

Source: http://formulary.drugplan.health.gov.sk.ca/Bulletins/Bulletin162Oct2016.pdf

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. – 2 – Initial approval period: seven months (allow four 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 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 Ofev (nintedanib) and Esbriet (pirfenidone) will not be funded. Notes: Patients who have experienced intolerance or failure to Ofev (nintedanib) or Esbriet (pirfenidone) will be considered for the alternate agent provided that the patient continues to meet the above coverage criteria.

YUKON
OFEV™ listed as Exception Drug Status effective Nov 7, 2016

Source: Yukon Drug Programs Formulary – Jan 2017

Initial approval criteria:
For adult patients with a diagnosis of mild to moderate idiopathic
pulmonary fibrosis (IPF)

  • Diagnosis confirmed by a respirologist & 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
  • Specialists consult to be provided.

Initial approval period:
Seven months (including 4 weeks allowed for repeat pulmonary function tests)

First 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 (first 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 & 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 for 12 months.
Note: Combination use of Ofev and Esbriet will not be funded. Patients
who have experienced intolerance or failure to Ofev or Esbriet will be
considered for the alternate agent provided that the patient continues to
meet the above coverage criteria.

NEWFOUNDLAND
OFEV™ listed as Special Authorization effective Feb 1, 2017

Source: Newfoundland and Labrador Prescription Drug – Bulletin No. 37

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

Notes:
Patients who have experienced intolerance or failure to Ofev (nintedanib) or Esbriet (pirfenidone) will be considered for the alternate agent provided that the patient continues to meet the above coverage criteria. If you have any questions concerning these changes, please feel free to contact the Pharmaceutical Services Division at 1-888-222-0533 or 709-729-6507.

QUEBEC
Québec OFEV™ listed as Médicament d’Exception effective March 22nd, 2017

Source: RAMQ List of Medications March 22, 2017 pg. 65 (en francais pg. 66)

NINTEDANIB ESILATE:

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 an absolute decline in predicted FVC of ≥ 10% in the last 12 months.

Where there is an absolute decline in predicted FVC of ≥10% over a 12-month period, treatment must cease.

Positive Recommendation from Canadian Drug Review

OFEV® (nintedanib) – Receives a positive recommendation from the Common Drug Review.

Some of you may recall that several months ago CPFF conducted a survey to be able to provide patient insight to the Common Drug Review (CDR) Process for OFEV® (nintedanib). Following Health Canada approval of a drug, the CDR reviews and makes recommendations to the provinces and territories whether or not a drug should be reimbursed or covered under the public drug insurance plans. We are pleased to announced that the Common Drug Review did in fact make a positive recommendation that OFEV® (nintedanib) should be covered, with certain conditions. If the provinces accept the recommendation it would mean that OFEV® (nintedanib) will be reimbursed under their public drug insurance plans and will become more accessible for IPF patients.

While this is good news, it is not the final word. We still need to convince the provincial Ministries of Health to accept the recommendation and provide coverage for the treatment. The Canadian Pulmonary Fibrosis Foundation will be working hard to make this choice of treatment more accessible to patients across Canada.

Once again, thank you to all of you who took part in our survey.

The President & Founder of CPFF has already written to the Ontario Minister of Health in this regard.

You can find the full CDR recommendation at http://bit.ly/1kLy2a4.

Health Canada Approval
CPFF Announcement

There is new hope for IPF patients with the Health Canada approval of OFEV™ (nintedanib) for IPF.

OFEV™ was approved on June 24, 2015 and we’ll have more information about availability soon.

With the approval of OFEV™, patients who are diagnosed with IPF now have a choice of therapy. Working with their doctor, patients with IPF can determine which treatment option is right for them.

The Canadian Pulmonary Fibrosis Foundation will be working to ensure affordable access to this treatment in all the provinces.

If you have any questions about this treatment and its availability please contact the Boehringer Ingelheim Customer Care Team at 1-800-263-2425.

Boehringer Ingelheim Announcement

Health Canada approves OFEV™ (nintedanib) for the treatment of idiopathic pulmonary fibrosis

New treatment option provides hope for Canadians living with fatal lung disease

BURLINGTON, ON July 6, 2015 /CNW/ – Boehringer Ingelheim Ltd. announced today that on June 24, 2015 Health Canada approved OFEV™ (nintedanib) to treat idiopathic pulmonary fibrosis (IPF) in adults. OFEV™ has been clinically proven to reduce the decline in lung function in IPF patients.

IPF is a debilitating and fatal lung disease, which causes progressive, irreversible scarring of the lungs, resulting in lung function decline and difficulty breathing. There is no cure. There are approximately 5,000 to 15,000 Canadians currently living with IPF, and the approval of OFEV™ offers IPF patients a new treatment option to manage this fatal disease.

“The approval of OFEV™ is a significant advancement for IPF patients, offering a proven treatment option to people living with this disease,” says Dr.Martin Kolb, M.D. PhD, Director, Division of Respirology at McMaster University. “Not only does OFEV™ offer another treatment choice for IPF patients to manage their disease, it has been shown to significantly reduce the risk of adjudicated acute exacerbations, which can be deadly.”

The symptoms of IPF – shortness of breath, dry hacking cough, “crackling” sounds in the lungs, and cyanosis (blue lips) – can have a significant impact on quality of life, and make it difficult to perform everyday activities. The median survival rate for people with IPF is two to three years after diagnosis; however, early and accurate diagnosis can help to ensure access to appropriate care.

“The Canadian Pulmonary Fibrosis Foundation welcomes the approval of OFEV™ as a new treatment option for IPF. Every advancement in treatment brings us one step closer to finding a cure, and putting an end to early death from IPF,” says Robert Davidson, President, Canadian Pulmonary Fibrosis Foundation (CPFF). “We must now support efforts to ensure that Canadians have full and timely access to this treatment in a disease area with few choices.”

Read More

en Français