What do you see as the market access risks and challenges for manufacturers of high-cost products that are used in combination with existing agents?
The process and evidence requirements for assessing high-cost combinations are the same as for single agents; however, one of the key challenges is that, due to the significant additional costs involved, there is much greater scrutiny of the evidence, and to justify the total cost of the combination, the value of combination needs to be clear and significant. In oncology, for example, seeking reimbursement based on immature data and/or with marginal OS benefit will make pricing and market access very challenging.
Ideally, manufacturers should be able to demonstrate not only the value of the combination versus the relevant standard of care overall, but also the value of the individual products when used in combination, so that the attribution of value can be discussed when negotiating the price of the product. This is particularly important when the two products being combined are owned by separate manufacturers.
Manufacturers who are combining their product with one that they do not own and that is already on the market can also face challenges, as there are limited incentives for the manufacturer of the existing agent to reduce the price, and currently there is limited scope for payers to renegotiate the price. The onus is on the manufacturer of the new product to demonstrate the value and set the price appropriately.
What are the market access considerations for manufacturers of existing agents that are being combined with new agents?
In the future, I think there is going to be growing pressure on the price of existing agents, including the potential for price renegotiations, particularly if the use of the existing agent increases because of its use in the combination. We could even see legal action if the price of the existing product is considered to be blocking access to future innovation.
How can manufacturers prepare to overcome the market access challenges associated with high-cost combination therapies?
It seems that a lot of the decisions around the development of combinations are driven mainly by the clinical and biological rationales; however, it is important to consider the commercial viability of these combinations early on, as we know that healthcare systems will continue to struggle to fund these high-cost combinations. Considering the pricing and market access challenges and opportunities early on in development is critical.
PRMA Consulting intends to keep up to date on how high-cost combinations are assessed by pricing and reimbursement agencies, and on the evolving policy landscape. If you would like independent advice or are interested in how the PRMA Innovative Pricing Panel can help you, please contact us. Our multidisciplinary advisors meet regularly and provide unique, targeted insights on pricing challenges and policy stance across major markets. For manufacturers developing high-cost combinations, we have published a summary of recommendations from these payer and legal experts.
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