Biosimilars Initiative for Patients

The Biosimilars Initiative optimizes B.C.’s public resources by switching patients from biologic (originator) drugs to their biosimilar versions (see below). It gets the best value for new treatments and services and improves patient access to medications.

Enbrel, Remicade and Lantus made up some of B.C.’s largest drug expenditures. In 2018, the total cost was $125 million. At the same time, biosimilar versions approved by Health Canada were not being used nearly as much. These biosimilar drugs are proven to be as safe and effective as the originators.

The Initiative has successfully completed two phases. In Phase One, patients using Enbrel®, Remicade®, and Lantus® for certain health conditions switched to a biosimilar. In Phase Two, patients who took Remicade to treat gastrointestinal conditions switched to a biosimilar.

The Initiative now focuses on switching patients from originator rituximab (Rituxan®) to biosimilar rituximab. Rituxan is one of Canada’s largest biologic expenses. The switch will save B.C. at least 30% in treatment costs.

Each switch period is six months. During this period, PharmaCare covers both originator and biosimilar drugs. Patients can use this time to understand the switch and start the switching process with their prescriber. After the end of each switch period, PharmaCare covers only the biosimilar versions.

Health Canada monitors the safety of all drugs on the market, including biosimilars. Both non-clinical and clinical studies compare a biosimilar to its originator. Before a biosimilar can be used in Canada, Health Canada also assesses its immunogenicity. Immunogenicity is how a body’s immune system reacts to the drug. Health Canada finds no meaningful differences between biosimilars and their originator drugs, and supports the switch from routine use of an originator to its biosimilar version for specific medical conditions.

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Rituximab Phase (August 20, 2020 – February 18, 2021)


Drug	Originator	Biosimilar	Conditions Include
rituximab	Rituxan®	Truxima™ Riximyo™* Ruxience™	granulomatosis with polyangiitis (GPA) microscopic polyangiitis (MPA) relapsing-Remitting multiple sclerosis rheumatoid arthritis

*Riximyo cannot yet be used to treat GPA OR MPA at this time.

Patients taking rituximab are affected if:

They are covered by PharmaCare, and
They are taking Rituxan®

Patients should switch to Truxima, Riximyo or Ruxience by February 18, 2021 if they want continued PharmaCare coverage. Coverage for all brands of rituximab will be in place between August 20, 2020 and February 18, 2021. However, if coverage expires for rituximab during this time period, coverage will be renewed for biosimilar versions of rituximab only.

Starting February 19, 2021, PharmaCare will not cover Rituxan without an exceptional request. For some patients, it may be medically necessary to continue using Rituxan. To receive coverage for Rituxan after February 18, 2021, your prescriber must determine the medical requirement and request exceptional Special Authority approval. PharmaCare reviews exceptional requests on a case-by-case basis.

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

Drug

Originator

Biosimilar

Treated Conditions

infliximab

Remicade®*

Inflectra ®

Renflexis ®

Crohn's disease

ulcerative colitis

*Pediatric patients on Remicade are being switched to an infliximab biosimilar. PharmaCare is working with B.C. Children's Hospital to accomplish this. Some pediatric patients are not switched on the same timeline as adult patients.

Patients taking infliximab were affected by Phase Two of the Biosimilars Initiative if:

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

In Phase Two, patients switched to Inflectra or Renflexis between September 5, 2019 and March 5, 2020 to receive continued PharmaCare coverage. PharmaCare covered all three brands of infliximab for gastrointestinal indications during this time. Since the switch period ended, Remicade is no longer covered without exceptional request.

For some patients, it was medically necessary (e.g., pregnancy) to continue using Remicade. In these cases, their prescriber was responsible for determining the medical requirement and requesting exceptional Special Authority coverage for medical reasons.

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

Drug	Originator	Biosimilar	Treated Conditions
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)

Patients were affected in Phase One if:

They are covered by PharmaCare, and
They were taking Enbrel®, Remicade® or Lantus®, and
They are being treated for an affected indication, listed in the table above

Between May 27 and November 25, 2019, affected patients switched to an appropriate biosimilar. This allowed for continued PharmaCare coverage.

During Phase One, PharmaCare covered all originator and biosimilar brands of affected medication. After the switch period, only the biosimilar brands were covered.

For some patients, it was medically necessary to continue using the originator drug(s). Their prescriber was responsible for determining the medical requirement and requesting exceptional Special Authority coverage.

Notes during this time:

Of the two etanercept biosimilars, only Erelzi was indicated for psoriatic arthritis.
Patients taking Enbrel for plaque psoriasis were not affected.
Pediatric patients on Remicade are switched to an infliximab biosimilar. PharmaCare works with B.C. Children's Hospital to accomplish this, and some pediatric patients are not switched on the same timeline as adult patients.
Plan W beneficiaries did not need to switch to Basaglar.

Biologics vs. Biosimilars

Through biotechnology, biologic drugs are created from living organisms like yeast and bacteria. Biologics treat patients with serious conditions, including some autoimmune diseases. The first version of a biologic developed is known as the “originator drug”. This is because they are the original version of a biologic drug which a biosimilar is based on.

As patents expire for originator drugs, other manufacturers may produce new versions. These new versions are called biosimilars. Since originator drugs are large and complex, biosimilars are highly similar, but not identical, to the originator drug. Many studies compare biosimilars to their originator drugs and show no meaningful differences in safety or efficacy. Originator drugs have already set the foundation of research and development for biosimilars which means biosimilar drugs are more cost-effective to produce and lead to similar outcomes.

There are very small differences between different batches of the same originator drug. This is because they are made using living organisms with some inherent variability. The same goes for the slight differences between a biosimilar and its originator drug, which are also not clinically meaningful.

How do I keep my coverage?

If the Biosimilars Initiative affects you:

Make an appointment with your prescriber during the switch period
Discuss the switch with your prescriber and pharmacist (only your prescriber can write you a new prescription)
Your prescriber can explain the switch process, discuss your biosimilar option(s), and write you a new prescription
Ensure you switch before the end of the switch period in order to maintain your PharmaCare coverage.

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