Information for insured persons impacted by the transition to biosimilar drugs

A biosimilar drug is highly similar to a biologic drug that was already authorized for sale. Health Canada authorizes biosimilars for sale using the same rigorous regulatory as for all other biologic drugs to ensure that they are good quality, effective and safe. A biosimilar drug may enter the market once patents and data protection of the reference biologic drug are expired.

Reminder of definitions:

• Biologic drugs: Drugs that come from living organisms such as animals, bacteria or yeast.
• Biosimilar drugs: Highly similar copy of biologic drug.
• Reference biologic drugs: Drugs of biologic origin to which the biosimilar drug is compared.

All biologic drugs for which at least one biosimilar equivalent is available on the Canadian market may be impacted by this transition.

However, this mandatory transition will comply with approved Health Canada indications and with the Basic Prescription Drug Insurance Plan for insureds in Quebec and, at all times, by promoting coordination with public provincial plans, when applicable.

The list of targeted biologic drugs is subject to change and will evolve as new biosimilar drugs enter the Canadian market. Here’s the current list:

• Adalimumab - Humira^TM (AbbVie)
• Aflibercept – Eylea^TM (Bayer)
• Bevacizumab - Avastin^TM (Roche)*
• Denosumab – Prolia^TM (Amgen)
• Denosumab – Xgeva^TM (Amgen)
• Etanercept - EnbrelM^TM (Amgen)
• Filgrastim – Neupogen^TM (Amgen)
• Glatiramer – Copaxone^TM (Teva Innovation)
• Infliximab – Remicade^TM (Janssen)
• Insulin Aspart – NovoRapid^TM (NovoNordisk)
• Insulin glargine – Lantus^TM (Sanofi Aventis)
• Insulin lispro – Humalog^TM (Lilly)
• Omalizumab - Xolair^TM (Novartis)
• Pegfilgrastim – Neulasta^TM (Amgen)
• Ranibizumab - Lucentis^TM (Novartis)
• Rituximab – Rituxan^TM (Roche)
• Tocilizumab – Actemra^TM (Hoffmann-La Roche)
• Trastuzumab - Herceptin^TM (Roche)*
• Ustekinumab - Stelara^TM (Johnson&Johnson)

* These drugs are considered as hospital-use only drugs by Beneva and are only covered under exceptional circumstances.

Here are a few possible reasons:

• You may receive your personalized letter soon.
• You may not be impacted by the transition with regard to your prescription drug use, medical condition or any other exception.

It went into effect on April 13, 2022. Since then, eligible individuals under the RAMQ who use a reference biologic drug must transition to a biosimilar equivalent under the supervision of their physician, except in the event of a medical exception. This change applies only if the biologic drug to one or more corresponding biosimilar equivalents on RAMQ’s List of Medications.

Yes. In order for a biosimilar drug to be approved by Health Canada, manufacturers must demonstrate the quality of the drug and conduct comparative studies to demonstrate highly similar structure, function, efficacy and health risks to a previously authorized reference biologic drug.

Yes. Many clinical studies conducted with a number of patients demonstrated that biosimilar drugs are just as effective and safe as their biologic equivalents.

Biosimilar drugs work the same way as their reference biological drugs. A person may transition from a biologic drug to a biosimilar drug or even start treatment with a biosimilar drug. There are no clinically meaningful differences in efficacy and risks between the treatments.

If you receive a letter from us regarding the transition to biosimilars policy, you must do the following:

1. Schedule an appointment or contact your physician as soon as possible.
2. During your appointment, discuss the transition process with your physician. He or she will be able to answer your questions and register you for a support program for patients of the biosimilar manufacturer, if any.
3. If your situation qualifies as an exception under our transition policy, your physician can fill out an exception drug form and send it to us.

Make sure you have a new prescription for the biosimilar equivalent before the transition period ends. This will ensure your reimbursements are not interrupted.

If you are insured under the Régime public d’assurance médicaments du Québec Prescription Drug Insurance Plan (RAMQ), there is no action to take. Healthcare professionals who treat patients impacted by this change will contact you in due course.

Once the deadline is passed, we will no longer reimburse you for the reference biologic drug.  So it is very important for you to contact your medical team or pharmacist to continue being reimbursed without interruption.

Under certain exceptional situations, we agree to evaluate the possibility of granting a short extension period to complete your transition. These requests will be assessed on a case-by-case basis.

If your situation is impacted by the transition to biosimilars, you do not need to fill out a new form. The letter you received contains your next prior authorization renewal date.

Regardless of the province or territory, if your coverage includes coordination with a public plan, we will respect the exceptions determined or authorized by the provincial plans.

Otherwise, individuals in the following situation are subject to exceptions with regard to the mandatory transition:

• Pregnant women, they must however transition to biosimilar drugs during the 12 months following delivery.
• Pediatric patients must make the transition to biosimilar drugs during the 12 months following their 18th birthday.
• Patients with chronic illnesses who have experienced prior therapeutic failures while being treated with a least 2 other biologic drugs for the same illness.
• Patients treated with Humalog or NovoRapid insulin administered with an insulin pump do not have to transition to the biosimilar equivalent.
• Patients being treated with Lucentis^TM or Eylea^TM do not have to transition if they have monocular vision (sight in one eye).

To request an exception, please send us this completed form.

Yes. All Canadian provinces and territories have now implemented the transition to biosimilar drugs.