IBD: Crohn's Disease

New Brunswick Biosimilars Initiative

What is Changing in the New Brunswick Drug Plan Coverage for Biologics?

The New Brunswick Department of Health has launched 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 21, 2021, New Brunswick’s Provincial Drug Plan 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 New Brunswick Drug Plans you may require a new prescription to continue coverage and should contact your health care professional to discuss this policy change before November 30th, 2021.

During this period, both the originator biologic and its biosimilar versions will be covered to allow prescribers and patients time to discuss treatment options and to switch patients to a biosimilar.

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 April 21, 2021 by the New Brunswick Government 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 coverage through a New Brunswick Drug 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 (November 30, 2021) 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 New Brunswick Biosimilars Initiative is a result of the New Brunswick Drug Plans’ evidence-informed strategy to better optimize our public resources, get the best value for new treatments and services, and improve access to medications for patients. Increasing the uptake of other biosimilars will provide savings that will be used to cover new drugs and contribute to the sustainability of the public drug plans.

Originator biologic drugs make up some of New Brunswick Drug Plans’ largest drug expenditures, and their costs are growing at an unsustainable rate. In 2019-20, New Brunswick Drug Plans’ spending on biologic drugs grew by 19% to $63.8 million. In the same year, biologic drugs accounted for 29.4% of drug costs but only represented 1.5% of the total number of claims.

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 November 30, 2021.

Learn More

Other Relevant Resources

New Brunswick Biosimilars Initiative

What is Changing in the New Brunswick Drug Plan Coverage for Biologics?

The New Brunswick Department of Health has launched 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 21, 2021, New Brunswick's Provincial Drug Plan 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 New Brunswick Drug Plans you may require a new prescription to continue coverage and should contact your health care professional to discuss this policy change before November 30th, 2021.

During this period, both the originator biologic and its biosimilar versions will be covered to allow prescribers and patients time to discuss treatment options and to switch patients to a biosimilar.

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 April 21, 2021 by the New Brunswick Government 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 coverage through a New Brunswick Drug 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 (November 30, 2021) 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 New Brunswick Biosimilars Initiative is a result of the New Brunswick Drug Plans’ evidence-informed strategy to better optimize our public resources, get the best value for new treatments and services, and improve access to medications for patients. Increasing the uptake of other biosimilars will provide savings that will be used to cover new drugs and contribute to the sustainability of the public drug plans.

Originator biologic drugs make up some of New Brunswick Drug Plans’ largest drug expenditures, and their costs are growing at an unsustainable rate. In 2019-20, New Brunswick Drug Plans’ spending on biologic drugs grew by 19% to $63.8 million. In the same year, biologic drugs accounted for 29.4% of drug costs but only represented 1.5% of the total number of claims.

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 November 30, 2021.

Learn More

Other Relevant Resources