IBD: Crohn's Disease

Nova Scotia Biosimilar Initiative

What is Changing in the Nova Scotia Pharmacare Coverage for Biologics?

The Government of Nova Scotia is expanding the use of biosimilar medications in Nova Scotia Pharmacare programs. Patients covered under Pharmacare will need to switch to a biosimilar version of their prescribed medication to retain coverage. The Nova Scotia initiative follows similar efforts elsewhere in Canada namely British Columbia, Alberta, Quebec, New Brunswick, and Northwest Territories. Tens of thousands of Canadians have safely switched to a biosimilar in those initiatives. They are also used extensively in Europe, where countries have had over 15 years of experience with biosimilars.

Between now and February 2023, you will need to switch to a biosimilar version of your biologic drug, unless an exemption is granted. This will include 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®)

If you are currently receiving Remicade® or Humira® to switch to a biosimilar medication, you need to:

  • check the list of medications that require switching to biosimilars
  • contact your prescriber (like a doctor, nurse or healthcare provider) if your prescribed medication is on the list of medications that require switching
  • get a new prescription for the biosimilar medication from your prescriber
  • enroll in financial or clinical biosimilar patient assistance programs if necessary (your prescriber can direct you to these programs)

Your prescriber can apply for an exemption for clinical reasons. If this exemption is not approved or if you don’t qualify for an exemption, coverage of the original biologic medication will end.

For more information from Nova Scotia Pharmacare click here.

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.

See more here.

4. Do I have to switch to a biosimilar?

As part of the biosimilars initiative, if you receive coverage through a Nova Scotia Pharmacare plan 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 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?

Much like generics, biosimilar versions of drugs become available when the original manufacturer of a biologic drug no longer has patent protection. Other manufacturers are then able to produce the same drug, making the same therapy available at a lower cost. Switching to biosimilars where they are available will save the Province an estimated $13 million annually once fully implemented. Additional savings are expected as more biosimilars become available in Canada.

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.

Learn More

Other Relevant Resources

Nova Scotia Biosimilar Initiative

What is Changing in the Nova Scotia Pharmacare Coverage for Biologics?

The Government of Nova Scotia is expanding the use of biosimilar medications in Nova Scotia Pharmacare programs. Patients covered under Pharmacare will need to switch to a biosimilar version of their prescribed medication to retain coverage. The Nova Scotia initiative follows similar efforts elsewhere in Canada namely British Columbia, Alberta, Quebec, New Brunswick, and Northwest Territories. Tens of thousands of Canadians have safely switched to a biosimilar in those initiatives. They are also used extensively in Europe, where countries have had over 15 years of experience with biosimilars.

Between now and February 2023, you will need to switch to a biosimilar version of your biologic drug, unless an exemption is granted. This will include 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®)

If you are currently receiving Remicade® or Humira® to switch to a biosimilar medication, you need to:

  • check the list of medications that require switching to biosimilars
  • contact your prescriber (like a doctor, nurse or healthcare provider) if your prescribed medication is on the list of medications that require switching
  • get a new prescription for the biosimilar medication from your prescriber
  • enroll in financial or clinical biosimilar patient assistance programs if necessary (your prescriber can direct you to these programs)

Your prescriber can apply for an exemption for clinical reasons. If this exemption is not approved or if you don’t qualify for an exemption, coverage of the original biologic medication will end.

For more information from Nova Scotia Pharmacare click here.

https://youtu.be/2luLlS0y6sQ

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.

See more here.

4. Do I have to switch to a biosimilar?

As part of the biosimilars initiative, if you receive coverage through a Nova Scotia Pharmacare plan 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 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?

Much like generics, biosimilar versions of drugs become available when the original manufacturer of a biologic drug no longer has patent protection. Other manufacturers are then able to produce the same drug, making the same therapy available at a lower cost. Switching to biosimilars where they are available will save the Province an estimated $13 million annually once fully implemented. Additional savings are expected as more biosimilars become available in Canada.

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.

Learn More

Other Relevant Resources