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 4 categories:

1. What Does Your Province Cover
2. Drug Access in Canada
3. Drug Approval System in Canada
4. US System

Each province determines which drugs they will add to their list (or formulary) based on recommendations of the pan-Canadian Oncology Drug Review (pCODR) and Institut national d’excellence en santé et services sociaux (INESSS) in Quebec. This chart shows the provincial summary for reviewed drugs. For coverage of other drugs, look under the Drug Access in Canada tab and choose your province. The provincial formulary will be listed on the provinces website.

pCODR/INESSS Funding Recommendations

NameAlso Known AsPatient StatusAll Provinces Except QuebecQuebec
UpdatedWeb linkUpdatedWeb link
Arzerraofatumumabpreviously untreatedJuly 2017ViewOctober 2015View
GayzvaobinutuzumabvariousOctober 2018ViewJune 2015View
Imbruvicaibrutinibpreviously treatedOctober 2018ViewJuly 2015View
Imbruvicaibrutinibpreviously untreatedJune 2019ViewFebruary 2017View
Treandabendamustinepreviously treatedFebruary 2016ViewJune 2013View
Treandabendamustinepreviously untreatedOctober 2018ViewJune 2013View
Venclextavenetoclaxpreviously treatedOctober 2019ViewFebruary 2018View
Venclexta/Rituximabvenetoclax/rituxanpreviously treatedJune 2019ViewMay 2019View
Zydeligidelalisibpreviously treatedJune 2018ViewOctober 2015View

CLL Patient Advocacy Group is registered as a Patient Group with pCODR, INESSS and Ontario Ministry of Long Term Care. We provide input regarding living with CLL/SLL as patients and care partners, experience with current treatments and expectations for a new drug. By completing a survey for us, you’re helping to get access to new drugs for Canadians.

CLLPAG Patient Evidence Submissions

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). Click on the link to your province under the Drug Coverage by province section to find out what is available to you. 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.

CanCertainty Coalition

The CanCertainty Coalition is the united voice of 35 Canadian patient groups, cancer health charities and caregiver organizations working with oncologists and cancer care professionals to improve the price and accessibility of take home cancer treatment in Ontario, New Brunswick, Nova Scotia, Prince Edward Island and Newfoundland https://www.cancertaintyforall.ca . These provinces do not provide take home cancer drugs. Patients must access their own funding.

Drug Coverage by Province

In Canada, the provinces and territories actually decide which therapies are available and funded to their residents. Each province and territory offers a drug benefit plan for eligible persons. Some are income-based universal programs. Most have specific programs for citizens that may need increased coverage, including seniors, persons on social assistance, and persons with diseases or conditions that have high drug costs. For more details, please contact your provincial or territorial health care ministry or click on the relevant link below.

Differences in Quebec

In Quebec, drug coverage is different from other provinces. By law, all Quebec residents must have either public or private insurance coverage for prescription drugs.

Employers, unions, associations and professional organizations can give their employees or members access to a private plan as part of a benefits package.

The public plan is administered by the Régie de l’assurance maladie du Québec, and covers residents who do not have access to a private plan, including:

  • People not eligible for a private plan (self-employed workers, for example)
  • People aged 65 and over
  • People receiving financial assistance from the government
  • Children of residents covered by the public plan

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

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

Patient Support Programs

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

The Janssen BioAdvance Program for Imbruvica (ibrutinib)

Janssen BioAdvance® is a comprehensive program of personalized services and support for physicians, and patients undergoing treatment with IMBRUVICA® with a goal of facilitating the treatment process.  Janssen BioAdvance® provides IMBRUVICA® patients with personalized care, made available at no cost, throughout their treatment journey, which includes:  the one-on-one support of a BioAdvance® Coordinator who can answer questions regarding IMBRUVICA®, educational materials and tools, and, assistance navigating reimbursement options.  This program will continue to be available once provincial funding is in place.

For more information on Janssen BioAdvance® please reach out to your IMBRUVICA® Health Care Provider or to Janssen BioAdvance® at imbruvica@bioadvancemail.ca

Gilead Patient Assistance Program for Zydelig (idelalisib)

The Gilead Oncology Patient Support Program (GO-PSP)™ is a patient support program specifically designed to assist patients prescribed ZYDELIG® for the treatment of relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab, or as a monotherapy for the treatment of follicular lymphoma (FL), who have received at least two prior systemic regimens and are refractory to both rituximab and an alkylating agent.

Patients successfully enrolled into GO-PSP are eligible for financial assistance, adherence and nursing support.

To contact GO-PSP:  1-844-GLD-OPSP (453-6777)

Roche Patient Assistance Programs for Rituxan (rituximab) and Gazyva (obinutuzumab)

Roche Patient Assistance Programs help patients access Health Canada approved Roche medications.

Services include call centre support; case management; reimbursement navigation; infusion and pharmacy services.

For more information, call: 1-888-748-8926

AbbVie Care Program for People Taking Venclexta

View PDF

Drug approval goes through many stages before provinces can choose to put new drugs on their formulary. Even after Health Canada, pCODR/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 allow 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.
https://spharm-inc.com/the-drug-review-and-approval-process-in-canada-an-eguide/ . 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.

Canadian Agency for Drugs and Technology in Health (CADTH) and 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 and clinicians. CLLPAG is a registered patient group for pan-Canadian Oncology Drug Review (pCODR), the oncology drug review section of CADTH and INESSS and is committed to providing the patient voice to each submission aimed to treat CLL/SLL.

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

pan-Canadian Pharmaceutical Alliance (pCPA) was formed in August 2010 to conduct joint provincial/territorial/federal negotiations with pharmaceutical companies for brand name and generic drugs in Canada. 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/

The U.S. Food & Drug Administration Center for Drug Evaluation and Research (CDER) approves new drugs based on evidence submitted from the drug companies to prove the drug is safe and effective for intended use. It can take up to two and a half years for final approval, after which the drug becomes available for physicians to prescribe. An Accelerated Approval Pathway is available. The US does not have drug price controls in place; prices are set by pharmaceutical companies. Drugs are paid through private insurance, public insurance and privately by patients.

https://www.fda.gov/drugs/development-approval-process-drugs

What Does Your Province Cover

Each province determines which drugs they will add to their list (or formulary) based on recommendations of the pan-Canadian Oncology Drug Review (pCODR) and Institut national d’excellence en santé et services sociaux (INESSS) in Quebec. This chart shows the provincial summary for reviewed drugs. For coverage of other drugs, look under the Drug Access in Canada tab and choose your province. The provincial formulary will be listed on the provinces website.

pCODR/INESSS Funding Recommendations

NameAlso Known AsPatient StatusAll Provinces Except QuebecQuebec
UpdatedWeb linkUpdatedWeb link
Arzerraofatumumabpreviously untreatedJuly 2017ViewOctober 2015View
GayzvaobinutuzumabvariousOctober 2018ViewJune 2015View
Imbruvicaibrutinibpreviously treatedOctober 2018ViewJuly 2015View
Imbruvicaibrutinibpreviously untreatedJune 2019ViewFebruary 2017View
Treandabendamustinepreviously treatedFebruary 2016ViewJune 2013View
Treandabendamustinepreviously untreatedOctober 2018ViewJune 2013View
Venclextavenetoclaxpreviously treatedOctober 2019ViewFebruary 2018View
Venclexta/Rituximabvenetoclax/rituxanpreviously treatedJune 2019ViewMay 2019View
Zydeligidelalisibpreviously treatedJune 2018ViewOctober 2015View

CLL Patient Advocacy Group is registered as a Patient Group with pCODR, INESSS and Ontario Ministry of Long Term Care. We provide input regarding living with CLL/SLL as patients and care partners, experience with current treatments and expectations for a new drug. By completing a survey for us, you’re helping to get access to new drugs for Canadians.

CLLPAG Patient Evidence Submissions

Drug Access in Canada

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). Click on the link to your province under the Drug Coverage by province section to find out what is available to you. 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.

CanCertainty Coalition

The CanCertainty Coalition is the united voice of 35 Canadian patient groups, cancer health charities and caregiver organizations working with oncologists and cancer care professionals to improve the price and accessibility of take home cancer treatment in Ontario, New Brunswick, Nova Scotia, Prince Edward Island and Newfoundland https://www.cancertaintyforall.ca . These provinces do not provide take home cancer drugs. Patients must access their own funding.

Drug Coverage by Province

In Canada, the provinces and territories actually decide which therapies are available and funded to their residents. Each province and territory offers a drug benefit plan for eligible persons. Some are income-based universal programs. Most have specific programs for citizens that may need increased coverage, including seniors, persons on social assistance, and persons with diseases or conditions that have high drug costs. For more details, please contact your provincial or territorial health care ministry or click on the relevant link below.

Differences in Quebec

In Quebec, drug coverage is different from other provinces. By law, all Quebec residents must have either public or private insurance coverage for prescription drugs.

Employers, unions, associations and professional organizations can give their employees or members access to a private plan as part of a benefits package.

The public plan is administered by the Régie de l’assurance maladie du Québec, and covers residents who do not have access to a private plan, including:

  • People not eligible for a private plan (self-employed workers, for example)
  • People aged 65 and over
  • People receiving financial assistance from the government
  • Children of residents covered by the public plan

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

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

Patient Support Programs

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

The Janssen BioAdvance Program for Imbruvica (ibrutinib)

Janssen BioAdvance® is a comprehensive program of personalized services and support for physicians, and patients undergoing treatment with IMBRUVICA® with a goal of facilitating the treatment process.  Janssen BioAdvance® provides IMBRUVICA® patients with personalized care, made available at no cost, throughout their treatment journey, which includes:  the one-on-one support of a BioAdvance® Coordinator who can answer questions regarding IMBRUVICA®, educational materials and tools, and, assistance navigating reimbursement options.  This program will continue to be available once provincial funding is in place.

For more information on Janssen BioAdvance® please reach out to your IMBRUVICA® Health Care Provider or to Janssen BioAdvance® at imbruvica@bioadvancemail.ca

Gilead Patient Assistance Program for Zydelig (idelalisib)

The Gilead Oncology Patient Support Program (GO-PSP)™ is a patient support program specifically designed to assist patients prescribed ZYDELIG® for the treatment of relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab, or as a monotherapy for the treatment of follicular lymphoma (FL), who have received at least two prior systemic regimens and are refractory to both rituximab and an alkylating agent.

Patients successfully enrolled into GO-PSP are eligible for financial assistance, adherence and nursing support.

To contact GO-PSP:  1-844-GLD-OPSP (453-6777)

Roche Patient Assistance Programs for Rituxan (rituximab) and Gazyva (obinutuzumab)

Roche Patient Assistance Programs help patients access Health Canada approved Roche medications.

Services include call centre support; case management; reimbursement navigation; infusion and pharmacy services.

For more information, call: 1-888-748-8926

AbbVie Care Program for People Taking Venclexta

View PDF

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, pCODR/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 allow 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.
https://spharm-inc.com/the-drug-review-and-approval-process-in-canada-an-eguide/ . 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.

Canadian Agency for Drugs and Technology in Health (CADTH) and 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 and clinicians. CLLPAG is a registered patient group for pan-Canadian Oncology Drug Review (pCODR), the oncology drug review section of CADTH and INESSS and is committed to providing the patient voice to each submission aimed to treat CLL/SLL.

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

pan-Canadian Pharmaceutical Alliance (pCPA) was formed in August 2010 to conduct joint provincial/territorial/federal negotiations with pharmaceutical companies for brand name and generic drugs in Canada. 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/

US System

The U.S. Food & Drug Administration Center for Drug Evaluation and Research (CDER) approves new drugs based on evidence submitted from the drug companies to prove the drug is safe and effective for intended use. It can take up to two and a half years for final approval, after which the drug becomes available for physicians to prescribe. An Accelerated Approval Pathway is available. The US does not have drug price controls in place; prices are set by pharmaceutical companies. Drugs are paid through private insurance, public insurance and privately by patients.

https://www.fda.gov/drugs/development-approval-process-drugs

Our Advocacy Partners

cancertainty

CanCertainty

The CanCertainty Coalition is a united voice of more than 30 Canadian patient groups, cancer health charities, and caregiver organizations, joining together to significantly improve the affordability and accessibility of oral take-home cancer medications in Ontario and Atlantic Canada. Other provinces fund both injectable and oral drugs.

CanCertainty works collaboratively to ensure that all Canadians have access to fair and equal access to oral take-home cancer medications – no matter their age, cancer type, treatment type or where they live.

http://www.cancertaintyforall.ca/

Patient Power

Patient Power brings you video interviews and transcripts (in French as well as English) about CLL to help you make informed decisions in partnership with your medical team. These are patient-centric programs focused on delivering the most credible, authoritative and up-to-date health information. Founded by CLL patient-advocate, medical journalist, and author Andrew Schorr, in partnership with his wife and care partner, Esther, Patient Power goes far beyond basic health information. View the entire library of unmatched content on CLL and living with cancer at Patient Power.info.

http://www.patientpower.info/chronic-lymphocytic-leukemia

Canadian Cancer Survivors Network

A network of patients, survivors, friends, families, community partners and sponsors will work together taking action to promote the very best standard of care, support, follow up and quality of life for patients and survivors.

https://survivornet.ca

lymphoma_canada

Lymphoma Canada

Dealing with lymphoma can be overwhelming, whether you’re a patient yourself or you know someone who is. But you don’t have to face it alone. Lymphoma Canada connect patients, their family and friends, medical professionals, researchers, volunteers, and donors to build a strong lymphoma community.

www.cllinfo.ca

CLLAN – CLL Advocates Network

CLLAN enhances CLL patient care and improves outcomes by collaboratively:

  • Acting as an international collective representative of CLL patient groups,
  • Developing tools to empower patients to become advocates to influence policy makers and participate in health technology assessments, research and clinical trial development.
  • Sharing best practices and resources between patient groups through annual meetings, education and a network website to improve CLL knowledge and awareness.

http://www.clladvocates.net/

cord_logo

CORD – Canadian Organization for Rare Disorders

CORD provides a strong common voice to advocate for health policy and a healthcare system that works for those with rare disorders. CORD works with governments, researchers, clinicians and industry to promote research, diagnosis, treatment and services for all rare disorders in Canada.

https://www.raredisorders.ca/

Treatment Access News

Sub-Cutaneous Immuno Globulin (SCIG) is available in Canada. Talk to your doctor if you are receiving IVIG and would like to try to self-administer IG at home.

~ November 2019