pCPA Biosimilars/Biologics Policy Directions Webinar
On Tuesday September 25, 2018 the pan-Canadian Pharmaceutical Alliance Office (pCPAO) hosted a one-hour webinar for industry to introduce the Biologics Policy Directions and pCPA Negotiations document.
The objectives of the webinar were to:
- Present the pCPA Biologics Policy Directions & pCPA Negotiations document; and
- Invite and address industry feedback.
This edition of MORSE Signals provides an overview of the webinar and provides key take-aways from the session.
Webinar Presenters
- Imran Ali, Senior Manager, pCPAO
- Sang-Mi Lee, Senior Pharmacist, pCPAO
Objectives & Key Themes
Objective: The pCPA participating drug plans recognized that they are keen on promoting competition and affordability across the biologics market and are interested in funding more innovative therapies. They have also acknowledged that a well-supported, effective and sustainable biologic environment requires considerations beyond negotiations and requires the engagement of all stakeholders.
Per the pCPA Biologics Policy Directions the overarching goal of the pCPA with respect to biologics is:
To develop and pilot a clear and consistent pan-Canadian approach that encourages appropriate use of biologics in support of common pCPA mandate to enhance patient access to clinically relevant and cost-effective drug treatment options.
Key Themes:
The key themes covered during the webinar included:
- Achieving reduction of costs and maximizing access to effective treatments;
- Standardizing the negotiation process with the ability to be adaptive; and
- Operationalizing the policy directions and adapting to upcoming landscape changes.
Biologics Policy Directions & pCPA Negotiations – Overview
The pCPAO introduced the Biologics Policy Directions & pCPA Negotiations document which outlines the core features of the process that will govern pCPA negotiations and inform public drug plan reimbursement for biologics, including biosimilars.
The pCPA’s biologic and biosimilar negotiation experience thus far, evolving jurisdictional objectives, the pCPA First Principles (April 2016), and consultation sessions with industry informed the development of this document. A high-level summary of the spectrum of options for negotiation process, pricing, listing status and therapeutic equivalence which were included in the document was also presented.
Taking all these factors into account, the pCPA developed the following eight Biologics Policy Directions which were the culmination of this process:
- The pCPA is committed to a unified, pan-Canadian process governing how biologic drugs, including biosimilars, will be considered for reimbursement by Canada’s publicly funded drug plans.
- Biologics drugs will be considered on an individual basis, in their market context.
- Negotiation for biosimilar drugs will begin in parallel with the HTA process.
- Offers for biologic drugs will be accepted at any time; however, offers for biologic drugs currently reimbursed by public drug plans will not be discussed during the time that a corresponding biosimilar is under consideration by the HTA and pCPA processes.
- Offers for biologic drugs that seek to restrict or exclude biosimilar drugs will not be considered.
- Offers for (1) biologic drugs for which biosimilars are reimbursed, or (2) new biosimilar drugs will not be considered unless the offer includes a transparent list price reduction to the lowest public list price.
- Tiered listings for biologic drug products may be implemented in therapeutic areas where appropriate.
- Switching of patients from a reference biologic molecule to a biosimilar may be implemented.
Initial Feedback
The pCPAO offered general comments on the feedback they have received thus far on the Biologics Policy Directions. They noted that common responses included acknowledgement that the landscape should include both reference biologics and biosimilars in addition to questions regarding how the statements will be operationalized. Industry associations requested further clarification on transparent list price reductions, and timelines regarding parallel biosimilar negotiations. There were also concerns raised on the potential impact on competition and unintended consequences of tiering and switching.
Signals Decoded:
This document represents an evolution of the First Principles (for Subsequent Entry Biologics) improving predictability and transparency regarding negotiations of biologics, including biosimilars, and aligning with the pCPA’s overall mandate and approach to biologics to date. While there have been no drastic changes, there are several notable pieces for reflection. The third policy direction allows for initiating negotiations earlier for biosimilars in parallel to the HTA process, marking the first official pCPA commitment to such an approach with a clearly defined objective of reducing the time to listing for drug plans to maximize potential savings. The final 2 statements (7 & 8) regarding potential for tiered listings and one-way switching highlight public drug plans’ need to have flexibility and autonomy when developing significant policy within their own jurisdictions; not surprisingly, this is likely to result in variable approaches in implementation of mechanisms to encourage biosimilar uptake across the country.
Next Steps Outlined by pCPAO
The Biologics Policy Directions and pCPA Negotiations document will be publicly available on the pCPA website within one to two months.
Additional consultations are also expected to be held with industry associations in November. All stakeholders are encouraged to provide additional feedback to: pcpa@ontario.ca
Biologics Policy Directions & pCPA Negotiations
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