Biosimilar drug review process

1. Proposals for biosimilar drugs are considered through pCPA negotiation processes, not at the individual public drug plan level. 
2. Biosimilar drugs are considered on an individual basis, in their market context. 
   • Biosimilar drugs under consideration by the pCPA are informed by Health Canada’s regulatory determinations (as safe and effective, with no clinically meaningful differences to the reference biologic drug), health technology assessment (HTA) reimbursement recommendations (where applicable), and other evidence or considerations, as available.
3. The pCPA encourages a competitive environment that includes biosimilar drug market growth and is conducive to long-term cost reductions and sustainability for public drug plans. 
4. Proposals from reference biologic drug manufacturers will only be considered if they provide:
   • Overall national value to public drug plans and don’t result in incremental costs to individual jurisdictions and 
   • At least similar overall value compared to the biosimilar drug and must include similar or better transparent price reductions if equivalent listing status is sought 
5. Offers for reference biologic drugs currently reimbursed by public drug plans won’t be discussed during the time that a corresponding biosimilar drug is in a pCPA process. 
6. Offers for reference biologic drugs that seek to restrict or exclude biosimilar drugs won’t be considered.
7. Switching patients from a reference biologic drug to a biosimilar drug may be implemented.

In 2016 we released our first principles for subsequent entry biologic drugs (biosimilar drugs) and sought feedback from industry associations to develop a series of options for policy directions to guide the approach to negotiation and public reimbursement. 

In 2017 those options were presented in 4 major areas of discussion, in consultations with industry associations:

1. Negotiation process: how might negotiations through the pCPA be approached for reference biologic drugs and biosimilar drugs as the market expands?
2. Building value – pricing: how might building value through pricing be approached?
3. Building value – listing status: how might building value through listing status be approached?
4. Therapeutic equivalence: how might transitioning (switching) between reference biologic drugs and biosimilar drugs be approached? 

Industry associations and individual manufacturers also provided supplementary feedback in the months that followed. 

What we heard

• The negotiation process should be expedited, predictable, and systematic, combined with being flexible for each individual product. 
• Industry is supportive of individual pricing evaluations for biosimilar drugs.
• At the time, industry wasn’t supportive of implementing a tiered pricing framework (like what exists for generic drugs).
• Industry isn’t supportive of the entire value being provided through transparent pricing given:
  • Global and Canadian market dynamics
  • Potential differences in indications
  • Product profiles
• Industry is supportive of equitable listing, preferential listing, maximizing access to available treatment options, improving access, and respecting physician and patient choice. 
• Industry is supportive of Health Canada’s position on switching and preferential listing for a biosimilar drug presenting best value.

What it means

• Biosimilar drugs present an opportunity to adjust the time to engage in negotiations.
• Predictability of process is greatly enhanced by establishing clear expectations on pCPA interaction with biosimilar drugs manufacturers that isn’t product specific.
• There should be an opportunity to negotiate value in addition to transparent pricing reductions.
• Assessment of value should consider longer term sustainability of public funding for all drugs rather than short-term savings from any individual drug.
• An environment that supports an increased number of treatment options is beneficial to patient care.
• Approaches to formulary listing are currently variable across therapeutic areas and across jurisdictions, and listing status should continue to be adaptive to individual circumstance.
• Appropriateness of transitioning and preferential listing will vary by individual circumstances.

With an HTA not required for most drug plans, our negotiation processes can be initiated much earlier for biosimilar drugs than for other types of new drugs — up to 6 months before the drug’s Notice of Compliance (NOC) is expected from Health Canada. 

The pCPA is the initial point of contact for manufacturers seeking public reimbursement for a biosimilar drug. When they’re ready to negotiate and have received an NOC (or expect to soon), manufacturers may submit a notification of intent to negotiate.

We then send a letter of acknowledgement (LOA) to the manufacturer letting them know that the drug is under consideration for negotiation.

Notification of intent to negotiate a biosimilar form

Email us your completed form

The consideration phase proceeds like it does for other new drugs, only we draw from the NOC rather than the HTA reimbursement recommendation to inform the negotiation approach. Though CDA-AMC no longer conducts HTAs for biosimilar drugs, we may still seek their expertise when additional information is needed to support a negotiation.

The negotiation phase proceeds in much the same manner as it does for other new drugs, subject to the principles and conditions outlined above.

Notably, new biosimilar drugs are expected to include a transparent list price reduction to the lowest publicly available price in Canada. This lowers the publicly listed price of a drug, rather than relying on confidential discounts, making the price visible to all payers. This supports more consistent pricing across public drug plans, and can benefit private insurers and patients, while helping to drive competition and support faster uptake. 

Not all value needs to be offered through the list price. Agreements may also include confidential pricing components, such as additional discounts, that aren’t publicly disclosed.

Québec participates fully in the negotiation process, but unlike other jurisdictions, it requires INESSS to complete its review and issue a reimbursement recommendation.