IBD: Crohn's Disease

Quebec Biosimilars Initiative

What is Changing in the Quebec Drug Plan Coverage for Biologics?

On May 18, 2021 the Minister of Health and Social Services, Christian Dubé, announced that the Quebec government is initiating a biosimilars Initiative which involves switching patients from originator biologic drugs to their biosimilar versions. It follows the successful implementations of similar initiatives by British Columbia and Alberta. In addition, switching to biosimilars has been conducted extensively in Europe, where countries have had over 15 years of experience with biosimilars.

As of April 12, 2022, Quebec’s Health Insurance Plan (RAMQ) will only cover the use of the following biosimilars, used to treat Crohn’s disease and ulcerative colitis:

  • Inflectra®, Renflexis™ and Avosola™ (biosimilars of Remicade®)
  • Idacio®, Amgevita™, Hadlima®, Hyrimoz®, Hulio® (biosimilars of Humira®)

Those who wish to continue their coverage will be required to switch to avoid any disruption.

If you are currently receiving Remicade® or Humira® to treat your Crohn’s disease or ulcerative colitis and you depend on Quebec’s Health Insurance Plan (RAMQ) you may require a new prescription to continue coverage and should contact your health care professional to discuss this policy change before April 12, 2022.

Medically necessary exemptions will be considered on a case-by-case basis. Your healthcare professional will determine whether to request an exemption for you.

Read the statement released May 18, 2021 by the Quebec Ministry of Health and Social Services about the Biosimilars Initiative.

What is a Biosimilar?

Biologic medicine bottle (purple) VS Biosimilar Medicine bottle (pink)

A biosimilar is a drug proven to be highly similar to a biologic drug that has been authorized for sale in Canada (known as the reference biologic drug). Biosimilars have been approved by Health Canada based on a thorough comparison to a reference biologic drug and may enter the market after the reference biologic drugs’ patents and data protection has expired.

Biosimilar products first entered the Canadian market in 2009. Health Canada has already approved over 30 biosimilars, including some that are used to treat IBD (Crohn’s disease and ulcerative colitis): Inflectra (infliximab), Renflexis (infliximab), Avsola (infliximab), Hadlima (adalimumab), Idacio (adalimumab), Hyrimoz (adalimumab), Amgetiva (adalimumab) and Hulio (adalimumab).

Quality and Safety Around Biosimilars

To be approved in Canada, a biosimilar must be proven to have no clinically meaningful differences to the reference biologic. This means, studies of the biosimilar MUST show that there are no differences in outcomes for patients taking a biosimilar, compared to those taking a reference biologic drug. Rigorous standards for authorization by Health Canada mean that patients and health care providers can have the same confidence in the quality, safety and efficacy of a biosimilar.

Transitioning to a Biosimilar is Safe and Effective

Health Canada supports switching from a biologic to a biosimilar and considers that a one-time switch from a reference biologic drug to a biosimilar to be acceptable. Health Canada also recommends that the decision to switch be made by the physician/prescriber and patient, taking into account any policies of the relevant jurisdiction.

Frequently Asked Questions

1. What is a biologic?

Biologic (reference) drugs are medications made by using living organisms (such as yeast or animal cells) to produce complex proteins that are purified then administered to affect certain processes in the human body.

2. What is a biosimilar?

A biosimilar is a drug demonstrated to be highly similar to a biologic (reference) drug, that has been authorized for sale in Canada.

3. What do experts say about the safety and efficacy of biosimilars?

Health Canada is responsible for ensuring the safety, efficacy, and quality of all new drugs including biologics and biosimilars. For a biosimilar drug to be approved in Canada, Health Canada must find no meaningful differences in safety and effectiveness compared to the biologic.

“The government’s initiative to increase the use of biosimilars makes sense, as the resulting savings have been guaranteed to stay in the public drug plans to fund new drugs. Biosimilars are just as safe and effective as the originator versions, as demonstrated by the experiences in British Columbia, Alberta and Europe.” – Dr. Mark MacMillan, Gastroenterologist and Assistant Professor in Division of Digestive Care & Endoscopy at Dalhousie University Department of Medicine

See more here.

4. Do I have to switch to a biosimilar?

As part of the biosimilars initiative, if you receive coverarage in Quebec and you currently take Remicade® or Humira® for the treatment of Crohn’s disease or ulcerative colitis, you must switch to the biosimilar version before the end of the transition period (April 12, 2022) to avoid any disruption to your coverage. There may be medical reasons why you cannot switch to a biosimilar. Your healthcare provider can help you determine if it is medically necessary to remain on a biologic (reference) drug and will confirm if you qualify for an exemption.

5. Why is the change happening?

The Minister of Health and Social Services, Christian Dubé, announces that the Quebec government is initiating a shift in favor of the use of biosimilar drugs, which will generate annual savings of more than $ 100 million, only for the public health plan. drug insurance and its insureds. These savings will be reinvested in the health system, in particular to improve access to innovative drug therapies.

Despite the inclusion of several biosimilar drugs on the drug lists for many years following recommendations issued by the National Institute of Excellence in Health and Social Services (INESSS), they remain underused. This situation generates a considerable additional cost for the General Prescription Drug Insurance Plan since biosimilar drugs are significantly less expensive than reference drugs, with no difference in therapy for patients.

“Innovation is giving rise to incredible medical advances and to the development of healthcare practices and offers that are always better suited to people’s needs. The decisive shift we are taking towards the judicious use of biosimilar drugs is a good example of this. I am convinced that this will help ensure the sustainability and viability of our health system. We have the health of the population at heart and the actions taken in this matter are in the interest and for the benefit of patients.” Christian Dubé, Minister of Health and Social Services 

6. How do I maintain my coverage?

To maintain your coverage:

  • Make an appointment to speak with your health care provider to discuss switching.
  • Your healthcare provider can explain the switch process, answer any questions you may have, register you with the new patient support program, have your new prescription into place.
  • Make sure you have spoken with your healthcare provider and initiated your biosimilar switch by April 12, 2022

CDHF Resource Links

Learn More

Other Relevant Resources

Quebec Biosimilars Initiative

What is Changing in the Quebec Drug Plan Coverage for Biologics?

On May 18, 2021 the Minister of Health and Social Services, Christian Dubé, announced that the Quebec government is initiating a biosimilars Initiative which involves switching patients from originator biologic drugs to their biosimilar versions. It follows the successful implementations of similar initiatives by British Columbia and Alberta. In addition, switching to biosimilars has been conducted extensively in Europe, where countries have had over 15 years of experience with biosimilars.

As of April 12, 2022, Quebec's Health Insurance Plan (RAMQ) will only cover the use of the following biosimilars, used to treat Crohn’s disease and ulcerative colitis:

  • Inflectra®, Renflexis™ and Avosola™ (biosimilars of Remicade®)
  • Idacio®, Amgevita™, Hadlima®, Hyrimoz®, Hulio® (biosimilars of Humira®)

Those who wish to continue their coverage will be required to switch to avoid any disruption.

If you are currently receiving Remicade® or Humira® to treat your Crohn’s disease or ulcerative colitis and you depend on Quebec's Health Insurance Plan (RAMQ) you may require a new prescription to continue coverage and should contact your health care professional to discuss this policy change before April 12, 2022.

Medically necessary exemptions will be considered on a case-by-case basis. Your healthcare professional will determine whether to request an exemption for you.

Read the statement released May 18, 2021 by the Quebec Ministry of Health and Social Services about the Biosimilars Initiative.

What is a Biosimilar?

Biologic medicine bottle (purple) VS Biosimilar Medicine bottle (pink)

A biosimilar is a drug proven to be highly similar to a biologic drug that has been authorized for sale in Canada (known as the reference biologic drug). Biosimilars have been approved by Health Canada based on a thorough comparison to a reference biologic drug and may enter the market after the reference biologic drugs’ patents and data protection has expired.

Biosimilar products first entered the Canadian market in 2009. Health Canada has already approved over 30 biosimilars, including some that are used to treat IBD (Crohn’s disease and ulcerative colitis): Inflectra (infliximab), Renflexis (infliximab), Avsola (infliximab), Hadlima (adalimumab), Idacio (adalimumab), Hyrimoz (adalimumab), Amgetiva (adalimumab) and Hulio (adalimumab).

Quality and Safety Around Biosimilars

To be approved in Canada, a biosimilar must be proven to have no clinically meaningful differences to the reference biologic. This means, studies of the biosimilar MUST show that there are no differences in outcomes for patients taking a biosimilar, compared to those taking a reference biologic drug. Rigorous standards for authorization by Health Canada mean that patients and health care providers can have the same confidence in the quality, safety and efficacy of a biosimilar.

Transitioning to a Biosimilar is Safe and Effective

Health Canada supports switching from a biologic to a biosimilar and considers that a one-time switch from a reference biologic drug to a biosimilar to be acceptable. Health Canada also recommends that the decision to switch be made by the physician/prescriber and patient, taking into account any policies of the relevant jurisdiction.

Frequently Asked Questions

1. What is a biologic?

Biologic (reference) drugs are medications made by using living organisms (such as yeast or animal cells) to produce complex proteins that are purified then administered to affect certain processes in the human body.

2. What is a biosimilar?

A biosimilar is a drug demonstrated to be highly similar to a biologic (reference) drug, that has been authorized for sale in Canada.

3. What do experts say about the safety and efficacy of biosimilars?

Health Canada is responsible for ensuring the safety, efficacy, and quality of all new drugs including biologics and biosimilars. For a biosimilar drug to be approved in Canada, Health Canada must find no meaningful differences in safety and effectiveness compared to the biologic.

"The government's initiative to increase the use of biosimilars makes sense, as the resulting savings have been guaranteed to stay in the public drug plans to fund new drugs. Biosimilars are just as safe and effective as the originator versions, as demonstrated by the experiences in British Columbia, Alberta and Europe." - Dr. Mark MacMillan, Gastroenterologist and Assistant Professor in Division of Digestive Care & Endoscopy at Dalhousie University Department of Medicine

See more here.

4. Do I have to switch to a biosimilar?

As part of the biosimilars initiative, if you receive coverarage in Quebec and you currently take Remicade® or Humira® for the treatment of Crohn’s disease or ulcerative colitis, you must switch to the biosimilar version before the end of the transition period (April 12, 2022) to avoid any disruption to your coverage. There may be medical reasons why you cannot switch to a biosimilar. Your healthcare provider can help you determine if it is medically necessary to remain on a biologic (reference) drug and will confirm if you qualify for an exemption.

5. Why is the change happening?

The Minister of Health and Social Services, Christian Dubé, announces that the Quebec government is initiating a shift in favor of the use of biosimilar drugs, which will generate annual savings of more than $ 100 million, only for the public health plan. drug insurance and its insureds. These savings will be reinvested in the health system, in particular to improve access to innovative drug therapies.

Despite the inclusion of several biosimilar drugs on the drug lists for many years following recommendations issued by the National Institute of Excellence in Health and Social Services (INESSS), they remain underused. This situation generates a considerable additional cost for the General Prescription Drug Insurance Plan since biosimilar drugs are significantly less expensive than reference drugs, with no difference in therapy for patients.

"Innovation is giving rise to incredible medical advances and to the development of healthcare practices and offers that are always better suited to people's needs. The decisive shift we are taking towards the judicious use of biosimilar drugs is a good example of this. I am convinced that this will help ensure the sustainability and viability of our health system. We have the health of the population at heart and the actions taken in this matter are in the interest and for the benefit of patients." - Christian Dubé, Minister of Health and Social Services 

6. How do I maintain my coverage?

To maintain your coverage:

  • Make an appointment to speak with your health care provider to discuss switching.
  • Your healthcare provider can explain the switch process, answer any questions you may have, register you with the new patient support program, have your new prescription into place.
  • Make sure you have spoken with your healthcare provider and initiated your biosimilar switch by April 12, 2022

CDHF Resource Links

Learn More

Other Relevant Resources