Treatment Access in Canada

Research has led to a number of new therapies for CLL and SLL in recent years, which is great! Staying informed about the latest treatments allows you to have an informed discussion with your doctor and helps you make the best choices possible.

The downside of this explosion of new treatments is it has left patients and caregivers confused about what drugs are available to treat CLL/SLL in Canada. Part of the confusion is due to the US websites, list serves and social media groups that many Canadian patients read. Drug access in the US and Canada is very different because our health care systems and drug funding models are totally different.

The information below is divided into 3 categories:

In Canada, each province and territory has its own health system and makes its own decision on the treatments it will provide, including those for CLL. Our friends at Lymphoma Canada have compiled a table summarizing the treatments available in each province and territory for both the first treatment of CLL (front line therapy) and subsequent treatments for CLL (Therapy for Relapsed/Refractory CLL).

drug funding table

Federal government coverage

The federal government also provides drug coverage to certain groups of people:

  • First Nations living on reserves
  • Inmates in federal penitentiaries
  • Inuit
  • Military personnel
  • Royal Canada Mounted Police employees
  • Some recent immigrants
  • Veterans

There are many sources for payment of drugs both public and private. Most provinces have special programs for those without any coverage (i.e. Trillium plan in Ontario). Many hospitals have Drug Access Navigators, Pharmacists, Social Workers or Physicians who can help you find out what is available for you. You should be informed about access of your drug and what it might cost before you agree to treatment.

Publicly Funded Prescription Drug Insurance Coverage

Under the Canada Health Act, prescription drugs given in Canadian hospitals are provided at no cost to the patient.

Outside of the hospital setting, provincial and territorial governments are responsible for the administration of their own publicly funded drug plans. The public drug plans determine what prescriptions drugs are listed and under what conditions for their eligible recipients.

Most Canadians have some access to insurance coverage for prescription drugs through a patchwork of public and/or private insurance plans. The federal, provincial and territorial governments offer varying levels of coverage and decide who is covered and what the patient and plan pays. The publicly funded drug programs generally provide drug plan coverage for those most in need, based on age, income, and medical condition. Many Canadians and their family members have drug coverage linked to employment and some Canadians may have no effective drug coverage and pay the full cost of prescription drugs.

Private Supplemental insurance

Depending on your income, age and other factors such as whether you have a chronic illness, the drug coverage you receive from your provincial or territorial government may not be enough to pay for all or even most of the prescription medications you need. This is where supplemental insurance can add an extra layer of protection. You can buy supplemental insurance as part of a group (through your employer, union or alumni association, for example) or individually. Provinces may offer supplemental insurance programs (i.e Trillium in Ontario).

Once you have checked your province’s drug plan to see whether you have any coverage, you can decide whether it makes sense for you to buy supplemental insurance.

Special Access Programme (SAP)

When all other sources for coverage have failed, the Special Access Programme (SAP) provides access to nonmarketed drugs for doctors treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada. Drugs considered for release by the SAP include pharmaceutical, biologic, and radio-pharmaceutical products not approved for sale in Canada.

https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html

Drug approval goes through many stages before provinces can choose to put new drugs on their formulary. Even after Health Canada, CDA/INESSS, PMPRB and pCPA have approved new drugs, it is left to the provinces to decide if they will list them.

Health Canada’s Health Products and Food Branch (HPFB) is the national authority that regulates, evaluates and monitors safety, efficacy (how well a drug works) and quality of treatment and diagnostic products available to Canadians. Upon completion of the review, approved drugs are issued a Notice of Compliance (NOC) and a Drug Identification Number (DIN) that permits the sponsor to market the drug in Canada. There is a process for Priority Reviews that allows for faster approval.

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drugs-reviewed-canada.html

In Canada, the funding approval process usually starts after an NOC and DIN is issued by Health Canada. It can take up to twelve
years for a drug to be ready for review and up to two years for it to be approved by Health Canada.

A description of the drug approval process can be found here: https://spharm-inc.com/the-drug-review-and-approval-process-in-canada-an-eguide/

The Canadian Drug Agency (CDA) and the Institut national d’excellence en santé et services sociaux (INESSS) in Quebec give a recommendation to the provinces regarding funding of the drug based on submission of evidence by the pharmaceutical company, as well as supplementary evidence from patients, patient groups and clinicians. CLL Canada is committed to providing the patient voice for each CLL/SLL treatment under consideration by these agencies. Since 2014, we have made over 15 submissions to CDA and INESSS jointly with Lymphoma Canada and other patient groups.

Patented Medicines Price Review Board (PMPRB) is a federally legislated board that protects and informs Canadians by ensuring that the prices of patented medicines sold in Canada are not excessive. They also report on pharmaceutical trends.

http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1003&lang=en

The pan-Canadian Pharmaceutical Alliance (pCPA) was formed to conduct joint provincial/territorial/federal negotiations with pharmaceutical companies for the provision of brand name and generic drugs in Canada. These negociations take place after a drug has been recommended for reimbursement by the CDA. The aim of pCPA is to achieve greater value for publicly funded drug programs and patients through the combined negotiating power of the provinces and territories.

https://www.canadaspremiers.ca/pan-canadian-pharmaceutical-alliance/

Provincial Listing
Once all the above steps are completed, each province decides individually whether to list a drug on its formulary so that it becomes available free of charge to patients who reside in the province.

Pharmaceutical companies provide support for patients and physicians who are using their drugs or assist with access to their drugs. These services usually include

  • Helping patients secure access by insurance and financial assistance
  • Supporting patients in dealing with pharmacy services
  • Providing ongoing support to patients throughout their treatment journey

Roche Patient Assistance Programs for Rituxan (rituximab) and Gazyva (obinutuzumab)
Roche Canada PSPs aim to support patients with a variety of services.

The Janssen BioAdvance Program for People Taking Imbruvica (ibrutinib)
You may have questions about your treatment, or maybe you’d just like to connect with someone who can provide support and guidance. The Janssen BioAdvance® program was created to provide patients with a connected kind of care, offering comprehensive support throughout the treatment process.

AbbVie Care Program for People Taking Venclexta (Venetoclax)
The AbbVie Care Support Program offers support services for people being treated with VENCLEXTA and their care partners.

AstraZeneca Patient Support Program for People Taking Calquence (Acalabrutinib)
The AstraZeneca Patient Support Programs help patients navigate the complexities of reimbursement and provide support during the journey of their treatment.

The BeiGene Patient Support Program for People Taking Brukinsa (Zanabrutinib)
The myBeiGene® patient support program is dedicated to helping patients by providing personalized information and assistance to those living with and managing a cancer journey. The myBeiGene® program is available Monday through Friday from 8 a.m. to 5 p.m. Eastern Standard Time at 1-833-234-4366 or by email at info@mybeigene.ca.

Drug Access in Canada

In Canada, each province and territory has its own health system and makes its own decision on the treatments it will provide, including those for CLL. Our friends at Lymphoma Canada have compiled a table summarizing the treatments available in each province and territory for both the first treatment of CLL (front line therapy) and subsequent treatments for CLL (Therapy for Relapsed/Refractory CLL).

drug funding table

Federal government coverage

The federal government also provides drug coverage to certain groups of people:

  • First Nations living on reserves
  • Inmates in federal penitentiaries
  • Inuit
  • Military personnel
  • Royal Canada Mounted Police employees
  • Some recent immigrants
  • Veterans

There are many sources for payment of drugs both public and private. Most provinces have special programs for those without any coverage (i.e. Trillium plan in Ontario). Many hospitals have Drug Access Navigators, Pharmacists, Social Workers or Physicians who can help you find out what is available for you. You should be informed about access of your drug and what it might cost before you agree to treatment.

Publicly Funded Prescription Drug Insurance Coverage

Under the Canada Health Act, prescription drugs given in Canadian hospitals are provided at no cost to the patient.

Outside of the hospital setting, provincial and territorial governments are responsible for the administration of their own publicly funded drug plans. The public drug plans determine what prescriptions drugs are listed and under what conditions for their eligible recipients.

Most Canadians have some access to insurance coverage for prescription drugs through a patchwork of public and/or private insurance plans. The federal, provincial and territorial governments offer varying levels of coverage and decide who is covered and what the patient and plan pays. The publicly funded drug programs generally provide drug plan coverage for those most in need, based on age, income, and medical condition. Many Canadians and their family members have drug coverage linked to employment and some Canadians may have no effective drug coverage and pay the full cost of prescription drugs.

Private Supplemental insurance

Depending on your income, age and other factors such as whether you have a chronic illness, the drug coverage you receive from your provincial or territorial government may not be enough to pay for all or even most of the prescription medications you need. This is where supplemental insurance can add an extra layer of protection. You can buy supplemental insurance as part of a group (through your employer, union or alumni association, for example) or individually. Provinces may offer supplemental insurance programs (i.e Trillium in Ontario).

Once you have checked your province’s drug plan to see whether you have any coverage, you can decide whether it makes sense for you to buy supplemental insurance.

Special Access Programme (SAP)

When all other sources for coverage have failed, the Special Access Programme (SAP) provides access to nonmarketed drugs for doctors treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada. Drugs considered for release by the SAP include pharmaceutical, biologic, and radio-pharmaceutical products not approved for sale in Canada.

https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html

Drug Approval System in Canada

Drug approval goes through many stages before provinces can choose to put new drugs on their formulary. Even after Health Canada, CDA/INESSS, PMPRB and pCPA have approved new drugs, it is left to the provinces to decide if they will list them.

Health Canada’s Health Products and Food Branch (HPFB) is the national authority that regulates, evaluates and monitors safety, efficacy (how well a drug works) and quality of treatment and diagnostic products available to Canadians. Upon completion of the review, approved drugs are issued a Notice of Compliance (NOC) and a Drug Identification Number (DIN) that permits the sponsor to market the drug in Canada. There is a process for Priority Reviews that allows for faster approval.

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drugs-reviewed-canada.html

In Canada, the funding approval process usually starts after an NOC and DIN is issued by Health Canada. It can take up to twelve
years for a drug to be ready for review and up to two years for it to be approved by Health Canada.

A description of the drug approval process can be found here: https://spharm-inc.com/the-drug-review-and-approval-process-in-canada-an-eguide/

The Canadian Drug Agency (CDA) and the Institut national d’excellence en santé et services sociaux (INESSS) in Quebec give a recommendation to the provinces regarding funding of the drug based on submission of evidence by the pharmaceutical company, as well as supplementary evidence from patients, patient groups and clinicians. CLL Canada is committed to providing the patient voice for each CLL/SLL treatment under consideration by these agencies. Since 2014, we have made over 15 submissions to CDA and INESSS jointly with Lymphoma Canada and other patient groups.

Patented Medicines Price Review Board (PMPRB) is a federally legislated board that protects and informs Canadians by ensuring that the prices of patented medicines sold in Canada are not excessive. They also report on pharmaceutical trends.

http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1003&lang=en

The pan-Canadian Pharmaceutical Alliance (pCPA) was formed to conduct joint provincial/territorial/federal negotiations with pharmaceutical companies for the provision of brand name and generic drugs in Canada. These negociations take place after a drug has been recommended for reimbursement by the CDA. The aim of pCPA is to achieve greater value for publicly funded drug programs and patients through the combined negotiating power of the provinces and territories.

https://www.canadaspremiers.ca/pan-canadian-pharmaceutical-alliance/

Provincial Listing
Once all the above steps are completed, each province decides individually whether to list a drug on its formulary so that it becomes available free of charge to patients who reside in the province.

Patient Support Programs

Pharmaceutical companies provide support for patients and physicians who are using their drugs or assist with access to their drugs. These services usually include

  • Helping patients secure access by insurance and financial assistance
  • Supporting patients in dealing with pharmacy services
  • Providing ongoing support to patients throughout their treatment journey

Roche Patient Assistance Programs for Rituxan (rituximab) and Gazyva (obinutuzumab)
Roche Canada PSPs aim to support patients with a variety of services.

The Janssen BioAdvance Program for People Taking Imbruvica (ibrutinib)
You may have questions about your treatment, or maybe you’d just like to connect with someone who can provide support and guidance. The Janssen BioAdvance® program was created to provide patients with a connected kind of care, offering comprehensive support throughout the treatment process.

AbbVie Care Program for People Taking Venclexta (Venetoclax)
The AbbVie Care Support Program offers support services for people being treated with VENCLEXTA and their care partners.

AstraZeneca Patient Support Program for People Taking Calquence (Acalabrutinib)
The AstraZeneca Patient Support Programs help patients navigate the complexities of reimbursement and provide support during the journey of their treatment.

The BeiGene Patient Support Program for People Taking Brukinsa (Zanabrutinib)
The myBeiGene® patient support program is dedicated to helping patients by providing personalized information and assistance to those living with and managing a cancer journey. The myBeiGene® program is available Monday through Friday from 8 a.m. to 5 p.m. Eastern Standard Time at 1-833-234-4366 or by email at info@mybeigene.ca.