IBD: Crohn's Disease

Alberta Health Biosimilars Initiative

CDHF is Canada’s trusted source for timely information on the Alberta Health Biosimilars Initative

What is Changing?

As of July 1, 2020 Alberta Health will only cover the biosimilar versions of infliximab: Inflectra and Renflexis, for patients living with Crohn’s disease or ulcerative colitis. Those who wish to maintain their Alberta Health coverage for the drug molecule will be required to switch from a biologic drug to the biosimilar by July 1, 2020, to avoid any disruption to coverage.

This initiative will apply to adult members enrolled in one of these government sponsored drug plans provided through Alberta Blue Cross:

Non-Group Coverage (Group 1)
Coverage for Seniors (Group 66)
Palliative Coverage (Group 20514)
Child and Family Services (Group 20403)
Alberta Child Health Benefit (Group 20400)
Children and Youth Services (Group 19824)
Income Support (Group 19823)
Learners Program (Group 22128)
Assured Income for the Severely Handicapped (Group 19823)
Alberta Adult Health Benefit (Group 23609)
If you are currently receiving Remicade® to treat your Crohn’s disease or ulcerative colitis and you depend on Alberta Health coverage, you need to contact with your health care professional to discuss this policy change. An exceptions process will be in place should your prescriber believe there is a medical reason why a patient cannot switch to a biosimilar. For individuals starting a biologic or changing their biologic drug, a tiered framework will apply, requiring patients to try a number of first-line therapeutic options prior to being able to access a second-line agent. Patients and health providers will still have numerous treatment options, including other biologics, covered through the government sponsored drug plans.
Biosimilar

What is a Biosimilar?

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 or originator 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 15 biosimilars including 3 anti-TNF therapies: INFLECTRA® (inflixmab), and RENFLEXIS® (infliximab) with HADLIMA® (adalimumab), which is not commercially available in Canada.

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

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. Once you have switched to a biosimilar version of Remicade® (infliximab) please take our patient survey.

CDHF Resource Links

Learn More

Other Resources

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.

4. Do I have to switch to a biosimilar?

If you receive coverage through Alberta Health and you currently take Remicade® for the treatment of Crohn’s disease or ulcerative colitis, you must switch to the biosimilar version before the end of the transition period (July 1,  2020) to avoid any disruption to your coverage. There may be medical reasons why some patients cannot switch to a biosimilar. Your gastroenterologist can help you determine if it is medically necessary to remain on a biologic (originator) drug. An exception process will be in place should a prescriber believe there is a medical reason why their patient cannot switch to a biosimilar.

5. Why is the change happening?

Alberta spent more than $238 million in the 2018 to 2019 fiscal year on biologic drugs, and these costs are increasing every year. Costs per patient for originator biologics can be more than $25,000 per patient per year, with biosimilar versions costing up to 50% less than originator biologics.

Alberta is implementing the Biosimilar Initiative which will save approximately $30 million annually that can be invested into other health care services for Albertans.

6. How do I maintain my Infliximab® coverage?

To maintain your coverage:

  • Make an appointment to speak with your GI who prescribes your Remicade® to discuss switching from Remicade® to Inflectra® or Renflexis®
  • Your GI 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 GI and initiated your biosimilar switch by July 1st, 2020.

Download this content in Infographic Form

Alberta Health Biosimilars Initiative

CDHF is Canada’s trusted source for timely information on the Alberta Health Biosimilars Initative

What is Changing?

As of July 1, 2020 Alberta Health will only cover the biosimilar versions of infliximab: Inflectra and Renflexis, for patients living with Crohn’s disease or ulcerative colitis. Those who wish to maintain their Alberta Health coverage for the drug molecule will be required to switch from a biologic drug to the biosimilar by July 1, 2020, to avoid any disruption to coverage.

This initiative will apply to adult members enrolled in one of these government sponsored drug plans provided through Alberta Blue Cross:

Non-Group Coverage (Group 1)
Coverage for Seniors (Group 66)
Palliative Coverage (Group 20514)
Child and Family Services (Group 20403)
Alberta Child Health Benefit (Group 20400)
Children and Youth Services (Group 19824)
Income Support (Group 19823)
Learners Program (Group 22128)
Assured Income for the Severely Handicapped (Group 19823)
Alberta Adult Health Benefit (Group 23609)
If you are currently receiving Remicade® to treat your Crohn’s disease or ulcerative colitis and you depend on Alberta Health coverage, you need to contact with your health care professional to discuss this policy change. An exceptions process will be in place should your prescriber believe there is a medical reason why a patient cannot switch to a biosimilar. For individuals starting a biologic or changing their biologic drug, a tiered framework will apply, requiring patients to try a number of first-line therapeutic options prior to being able to access a second-line agent. Patients and health providers will still have numerous treatment options, including other biologics, covered through the government sponsored drug plans.
Biosimilar

What is a Biosimilar?

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 or originator 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 15 biosimilars including 3 anti-TNF therapies: INFLECTRA® (inflixmab), and RENFLEXIS® (infliximab) with HADLIMA® (adalimumab), which is not commercially available in Canada.

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

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. Once you have switched to a biosimilar version of Remicade® (infliximab) please take our patient survey.

CDHF Resource Links

Learn More

Other Resources

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.

4. Do I have to switch to a biosimilar?

If you receive coverage through Alberta Health and you currently take Remicade® for the treatment of Crohn’s disease or ulcerative colitis, you must switch to the biosimilar version before the end of the transition period (July 1,  2020) to avoid any disruption to your coverage. There may be medical reasons why some patients cannot switch to a biosimilar. Your gastroenterologist can help you determine if it is medically necessary to remain on a biologic (originator) drug. An exception process will be in place should a prescriber believe there is a medical reason why their patient cannot switch to a biosimilar.

5. Why is the change happening?

Alberta spent more than $238 million in the 2018 to 2019 fiscal year on biologic drugs, and these costs are increasing every year. Costs per patient for originator biologics can be more than $25,000 per patient per year, with biosimilar versions costing up to 50% less than originator biologics.

Alberta is implementing the Biosimilar Initiative which will save approximately $30 million annually that can be invested into other health care services for Albertans.

6. How do I maintain my Infliximab® coverage?

To maintain your coverage:

  • Make an appointment to speak with your GI who prescribes your Remicade® to discuss switching from Remicade® to Inflectra® or Renflexis®
  • Your GI 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 GI and initiated your biosimilar switch by July 1st, 2020.

Download this content in Infographic Form

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