Guest Blog By Arvind Mani
Key Takeaways
It appears that the pCPA’s first principles for SEBs are targeted at ensuring that manufacturers of both SEB and innovative/reference products must negotiate with the pCPA – 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 consider evidence beyond regulatory evaluations and health technology assessments (HTA) – 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 ensure a competitive market – 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 provide national value with no incremental costs to any jurisdictions.
Finally, the pCPA is clearly moving towards transparent prices for 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.
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Innovative/Reference Drug Manufacturer
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| National Negotiation –must not approach an
individual jurisdiction and should focus its negotiation efforts nationally with the pCPA. |
National Negotiation –must not approach an individual jurisdiction and focus its negotiation nationally with the pCPA.
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| Broader Evidence –must be prepared for the pCPA to look at other evidence beyond the Health Canada and HTA information available. | National Value –must seek negotiations focusing on national value – i.e. no incremental costs to any individual province.
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| Competitive Environment –may benefit from the pCPA ensuring the creation of a competitive environment.
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Transparent Price –must be prepared to not only provide a similar value to the SEB, but must include a similar or better transparent price.
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| Transparent Price –must provide a reduced transparent price. |
pCPA First Principles for SEBs (actual communiqué)
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: