CMMI MFN Demos: Key Strategic Manufacturer Questions (Part Four)
In this, the last of this four-part series on CMMI MFN Demonstration projects, we’ll outline some of the key strategic questions that manufacturers must address before finalizing their overall strategy.
These key strategic questions include, but are not limited to:
What are the strategic implications of Generous being a voluntary manufacturer enrollment program with mandatory submission of confidential net international drug pricing in the 19 identified reference countries vs. Globe and Guard being mandatory enrollment programs with voluntary provision of manufacturer international net pricing?
What actions can you take to limit the risk of foreign reference pricing, and is there still sufficient time for these actions to impact MFN pricing in Generous, Globe, and Guard?
Should you volunteer to participate in Generous to obtain an exemption from mandatory participation in Globe and Guard?
What are the likely differences in MFN pricing determined by methodology I and II in Globe and Guard?
Does your organization believe that legal challenges to Globe and Guard will delay, modify, or prevent the implementation of these programs?
How will the demo programs likely evolve as Guard and Globe move from proposed to final rules, and all three programs face a potential change in Administration and Secretary of HHS in 2029, and more importantly as the 5-year performance period expires? Of these changes, what are within the authority of the Secretary of HHS to implement and what changes will require legislation?
What actions can manufacturers take to prevent the spill of demo MFN pricing to segments outside the demonstration projects and prevent the indirect impact of MFN pricing on ASP, AMP, Medicaid BP, and 340B?
How can manufacturers mitigate the risk associated with a covered entity applied modifier code as a means of preventing significant 340B duplicate discounting?
Should manufacturers participate in Generous and Guard if they do not lower patient OOP drug costs and, like 340B, have the potential for discounts to be used for unspecified and unmonitored purposes unrelated to the cost of pharmaceutical care?
How will CMS deal with pricing in one of the 19 reference countries if a drug has lost patent prior to the U.S. LOE?
What CMMI MFN actions are your competitors likely to take and how will that impact you?
How will manufacturers deal with the degree of quarterly variation in Globe MFN ASP prices?
A manufacturer’s strategy will vary dramatically by their portfolio of products, the timing of future launches, past foreign pricing practices, competitor actions, their tolerance for legal and commercial risk, and the answers to these and other key strategic questions. To address these critical questions, and navigate a rapidly changing, volatile US and Global drug pricing environment, readers are encouraged to reach out to me or to Rita Numerof.