Guest Blog By
Director of Market Access and Policy Research
PDCI Market Access
The pan-Canadian Pharmaceutical Alliance (pCPA) recently issued a communiqué outlining their initial perspective on subsequent entry biologics (SEBs) and innovative/reference biologics as it aims to establish a SEB policy framework.
It appears that the pCPA’s first principles for SEBs are targeted at ensuring that manufacturers of both SEB and innovative/reference products– i.e. not approach individual jurisdictions to seek product listing agreements once the SEB is poised to enter the market. Further, SEB manufacturers must be prepared for the pCPA to – perhaps this may involve reviewing international evidence. Although this may create some uncertainty for SEB manufacturers, it appears that the pCPA balances this with a plan to – which may mean some form of preferential listing similar to what was negotiated for Inflectra.
For manufacturers of innovative/reference biologics, these principles have clarified the pCPA’s expectations by insisting if these manufacturers put forward proposals in response to the entry of an SEB, these proposals providewith .
Finally, the pCPA is clearly moving towardsfor both SEB manufacturers and innovative/reference manufacturers who aim to renegotiate their agreements with the pCPA in anticipation of an SEB entry. Although confidential product listing agreements are well entrenched and growing in importance for innovative products, it seems that when it comes to the SEB market, public payers are keenly focused on establishing a framework that ensures a greater level of price transparency.
The table below summarizes pCPA’s negotiation expectations for the respective manufacturers in the SEB marketplace.
individual jurisdiction and should focus its negotiation efforts nationally with the pCPA.
The emergence of SEBs in the Canadian market has led the pan-Canadian Pharmaceutical Alliance (pCPA) to begin developing principles to guide more consistent negotiations for these products and related reference biologics, as the pCPA works towards establishment of a SEB policy framework.
The following first principles will guide the pCPA approach to negotiations on SEBs and reference biologics:
· All SEB and reference biologic manufacturer proposals will only be considered through the national pCPA negotiation process rather than individual or selected jurisdictions. Determination of whether or not to proceed with negotiations with the requesting manufacturer will be made at the discretion of the pCPA.
· Products under consideration by the pCPA will be informed by Health Canada's regulatory determinations (that the SEB products are safe and efficacious with no clinically meaningful differences with the comparator reference drugs), Health Technology Assessment recommendations, and/or other evidence or considerations as available.
· Consistent with its mandate that includes increasing patient access to clinically and cost-effective drug treatment options, the pCPA will encourage a competitive environment that includes SEB market growth and is conducive to long-term cost reductions and sustainability for public drug plans.
· The introduction of an SEB must provide a reduction in the drug’stransparent price to benefit all Canadians.
· Proposals from reference biologic manufacturers will only be considered if they:
· Provide overall national value to public drug plans and do not result inincremental costs to individual jurisdictions; and
· Provide at least similar overall value compared to the SEB, and must include similar or better transparent price reductions if equivalent listing status is sought.
· These first principles are a starting point and are expected to evolve through the pCPA’s engagement with stakeholders, including the pharmaceutical industry, to develop a more comprehensive SEB policy framework.