Biosimilars Initiative for Patients

PharmaCare is launching a Biosimilars Initiative to switch patients using originator (biologic) drugs for certain indications to their biosimilar versions. This initiative is happening in two phases. In the first phase, patients using Enbrel®, Remicade®, and Lantus® for affected indications will be switched to biosimilar medications. In phase two, patients who currently use Remicade to treat gastrointestinal conditions will be switched to a biosimilar. For more information, please see PharmaCare Coverage Changes below.

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PharmaCare Coverage Changes

During the six-month transition periods for each phase, PharmaCare will cover both originator and biosimilar versions of the affected drugs. These transition periods will provide time for patients to inform themselves and start the switching process with their prescriber. At the end of each phase, PharmaCare will only cover the biosimilar versions of the drugs listed below, for the affected indications.

Phase One (May 27, 2019 — November 25, 2019)

Drug	Originator	Biosimilar	Indications Affected
etanercept	Enbrel ®	Brenzys ®	Ankylosing Spondylitis Rheumatoid Arthritis
etanercept	Enbrel ®	Erelzi ™	Ankylosing Spondylitis Psoriatic Arthritis Rheumatoid Arthritis
infliximab	Remicade ®	Inflectra ® Renflexis ®	Ankylosing Spondylitis Plaque Psoriasis Psoriatic Arthritis Rheumatoid Arthritis
insulin glargine	Lantus ®	Basaglar ™	Diabetes (Type 1 and 2)

Phase Two (September 5, 2019 — March 5, 2020)

Drug

Originator

Biosimilar

Indications Affected

infliximab

Remicade ®

Inflectra ®

Renflexis ®

Crohn's Disease*

Ulcerative Colitis*

*Pediatric patients on Remicade will be switched to an infliximab biosimilar. PharmaCare is working closely with B.C. Children's Hospital to accomplish this, and pediatric patients may not be switched on the same timeline as adult patients.

Note: If you are currently using Enbrel for plaque psoriasis, you are not affected at this time.

Biologics vs. Biosimilars

Biologic drugs that are engineered using living organisms like yeast and bacteria through the use of biotechnology. They are used to treat patients with serious conditions, including some autoimmune diseases. The first version of a biologic developed is also known as the “originator drug” because they are the original composition of a biologic drug that a biosimilar is based on.

As patents expire for originator drugs, other manufacturers may produce new versions of the biologic drugs called biosimilars. Because originator drugs are often large and complex, biosimilars are highly similar, but not identical, to the originator drug. Studies comparing biosimilars to their reference biologic drugs have been shown to have no clinically meaningful differences in safety or efficacy. Since originator biologic drugs have already set the foundation of research and development for biosimilars, biosimilar drugs are more cost-effective to produce and lead to patient outcomes that are no different from the originator drug.

As biologic drugs are manufactured using living organisms with some inherent variability, there are also very small differences between different batches of the same originator drug. These differences, like those between a biosimilar and its originator drug, are not clinically meaningful.

Why is PharmaCare switching patients to biosimilars?

The three originator drugs affected represent some of the province’s largest drug expenditures. PharmaCare's decision to replace certain originator drugs with their biosimilar versions will result in major cost savings to B.C.'s health care system, and will provide better access to drugs that people need without compromising drug effectiveness.

Health Canada monitors the safety of all drugs on the market, including biosimilars. Both non-clinical and clinical studies are done to compare a biosimilar to its originator. Before a biosimilar is authorized for use in Canada, Health Canada also assesses its immunogenicity, or how a body’s immune system reacts to the drug. No clinically meaningful differences have been found between biosimilars and their originator drugs, and Health Canada supports the safety and efficacy of switching from routine use of a biologic originator to its biosimilar version for certain indications (i.e., specific diseases or medical conditions).

Affected Drugs

Etanercept


Biologic	Biosimilar	Indications
Enbrel ®	Erelzi ™	Ankylosing spondylitis Psoriatic arthritis Rheumatoid arthritis
Enbrel ®	Brenzys ®	Ankylosing spondylitis Rheumatoid arthritis

Enbrel is the brand name for the biologic version of etanercept. Erelzi and Brenzys are the brand names of the biosimilar versions of etanercept.

Patients who use etanercept are affected by the Biosimilars Initiative if:

They are covered by PharmaCare, and
They are using the Enbrel brand, and
They are being treated for ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis

Affected patients must visit their prescriber and depending on the affected indication, switch to Brenzys or Erelzi before November 26, 2019 to receive continued PharmaCare coverage. Of the two etanercept biosimilars, only Erelzi is currently indicated for psoriatic arthritis.

PharmaCare will cover all three brands of etanercept between May 27 and November 25, 2019 to give patients time to switch over. After the switch period, only the Erelzi and Brenzys brands will be covered.

For some patients, it may be medically necessary to continue using Enbrel. In this case, your prescriber must determine the medical requirement and request exceptional Special Authority approval for continued coverage of Enbrel.

Note: If you take Enbrel for plaque psoriasis, you will not be affected by biosimilar switching at this time.

Infliximab


Biologic	Biosimilar	Indications	Switch Period
Remicade ®	Inflectra ® Renflexis ®	Ankylosing Spondylitis Plaque Psoriasis Psoriatic Arthritis Rheumatoid Arthritis	Phase One: May 27, 2019 — November 25, 2019
Remicade ®	Inflectra ® Renflexis ®	Crohn's Disease* Ulcerative Colitis*	Phase Two: September 5, 2019 — March 5, 2020

Remicade is the brand name for the originator version of the drug infliximab. Inflectra and Renflexis are brand names of the biosimilar versions of infliximab.

Phase One

Patients taking infliximab are affected by phase one of the Biosimilars Initiative if:

They are covered by PharmaCare, and
They are taking Remicade, and
They are being treated for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis

Affected patients must switch to using a biosimilar version of their medication by November 25, 2019 to receive continued PharmaCare coverage. Between May 27 and November 25, 2019, PharmaCare will cover all three brands (biologic and biosimilar) of infliximab to provide time for switching. Remicade will not be covered after the switch period.

Phase Two

Patients taking infliximab are affected by phase two of the Biosimilars Initiative if:

They are covered by PharmaCare, and
They are taking Remicade, and
They are being treated for Crohn's disease or ulcerative colitis

Patients affected by phase two must switch to Inflectra or Renflexis by March 5, 2020 to receive continued PharmaCare coverage. Between September 5, 2019 and March 5, 2020, PharmaCare will cover all three brands of infliximab for gastrointestinal indications. Remicade will not be covered after the switch period.

Note: If you cannot switch to a biosimilar due to a medically necessary reason (e.g., pregnancy), your prescriber may request Special Authority approval to consider continuation of Remicade coverage.

Insulin Glargine


Biologic	Biosimilar	Indications
Lantus ®	Basaglar ™	Diabetes (Type 1 and 2)

Lantus is the brand name of the biologic version of insulin glargine. Basaglar is the brand name of the biosimilar version of insulin glargine.

The Biosimilars Initiative affects patients who:

Are using the Lantus brand of insulin glargine, and
Are covered by PharmaCare, and
Are being treated for diabetes (type 1 or 2)

Affected patients must switch to Basaglar before November 26, 2019. Between May 27 and November 25, 2019, PharmaCare will cover both brands of insulin glargine, however only Basaglar will be covered after the switch period ends.

If your prescriber determines it medically necessary for you to remain on Lantus, the prescriber may submit a Special Authority request to approve continued coverage of Lantus.

Note: If you are a Plan W beneficiary, you will not need to switch to Basaglar.

How do I keep my coverage?

If the Biosimilars Initiative affects you:

Make an appointment with your prescriber during the appropriate switch period (i.e., phase one or phase two)
Discuss the switch with your prescriber and pharmacist
Your prescriber can explain the switch process, discuss your biosimilar options, and write you a new prescription
Ensure you switch before the end of the appropriate switch period in order to maintain your PharmaCare coverage.

Resources

For more information, see: