As Most Favored Nation Drug Price Deals Stay Secret, Questions Remain
This week, Director of the Center for Medicare, Chris Klomp, faced back-to-back Senate confirmation hearings for becoming Deputy Secretary of Health and Human Services. Klomp is recognized as being one of the key architects behind the administration’s push for most-favored nation drug pricing that aims to align prices with what’s paid in other comparably wealthy countries. However, by remaining largely shrouded in mystery, the MFN deals agreed to with drug makers reveal too little to properly tell how much money they’ll save federal and state governments as well as taxpayers and patients.
The most-favored nation policies being pushed by the Trump administration strive to better align prescription drug prices between the United States and peer nations. In exchange for a three-year reprieve from threatened tariffs on their products, President Trump has signed deals with 26 pharmaceutical companies. The agreements are set to expire less than three years from now.
While questioning Chris Klomp during his confirmation hearing, Sen. Elizabeth Warren of Massachusetts asked what the drug companies would be getting in return for their MFN agreements to lower prices in Medicaid. “I want to know what was given away in these contracts,” Warren, said, including whether drug firms received tariff relief, exemptions from other drug pricing demonstrations in Medicare, or fast-track Food and Drug Administration approval.
Klomp responded by saying the details needed to remain confidential to avoid releasing trade secrets and other proprietary information. Furthermore, Klomp said the deals’ “principles” or “frameworks,” as he put it, are publicly available.
Since Trump issued an executive order in May of last year to have the federal government develop MFN price targets for prescription drugs and communicate them to pharmaceutical manufacturers, it’s been difficult owing to lack of details to evaluate what these indices are and how they’ll be incorporated in the various proposed demonstration projects in the public sector. These are pilot programs run by the Center for Medicare and Medicaid Innovation — the Department of HHS’s “Innovation Center” — to design, implement and test new healthcare payment and delivery models in Medicaid and Medicare.
The Trump administration has created a number of CMMI initiatives that would use international benchmarks to lower drug prices in Medicaid and Medicare. Through the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) model, for instance, the federal government will negotiate pharmaceutical prices on behalf of state Medicaid programs based on what other countries pay . Medicaid is the main public program providing health insurance coverage for low-resourced individuals. The above-mentioned agreements between the administration and drug manufacturers serve as pillars of the GENEROUS model.
But precisely how the Centers for Medicare and Medicaid Services would go about pursuing this model hasn’t been made transparent. CMS has informed the public of a few details . We know, for example, that for the voluntary GENEROUS model in Medicaid the selected benchmark prices are intended to be the second -lowest among a basket of eight comparator countries: Canada, Denmark, France, Germany, Italy, Japan, Switzerland and the United Kingdom. But it isn’t clear how the agency addresses the considerable challenges of developing MFN price indices. Identifying what foreign countries actually pay in terms of net prices isn’t simple. Frankly, there is no reliable way to do so. Most comparator countries don’t disclose net prices. And in the case of France, the French Senate voted to block pharmaceutical net price transparency to protect its healthcare system from the spillover effects of the MFN policy. Other countries such as Spain are following suit, passing laws to ensure that the steep discounts they negotiate stay hidden from view from any entity like CMS that is trying to establish international reference indices.
Additionally, while the White House announced this week that 50 states have agreed to participate in the GENEROUS model, these agreements are only letters of intent to participate in the demonstration project. The 50 states have not signed finalized, binding operational agreements. The deadline for this is Sept. 30.
Moreover, states can individually choose which specific drugs they want to access at most-favored nation prices. But states won’t be revealing the specific products selected to the public. Under the current parameters of GENEROUS, the products chosen, the discount structures and the final net pricing remain tightly guarded secrets. Note, Medicaid already receives substantial statutory or federally mandated rebates as well as supplemental ones. States can retain their previous or ongoing agreements if they offer a better deal. But without more clues as to what the underlying deal terms entail, how do we know what path individual states will take?
Also, while the White House is claiming $64.3 billion in federal and state savings over the next decade, we have no way of independently evaluating that claim without more transparency on the confidential agreements. For example, how much of the projected $64 billion represents additional savings relative to the rebates Medicaid already receives? And, while the deals related to Medicaid could very well save the program money, enrollees in the insurance program will not see changes to what they pay out-of-pocket as their cost-sharing was minimal to begin with.
The public is privy to one presumably MFN-oriented action the administration has undertaken. And this is the creation of the TrumpRx platform, unveiled earlier this year. It serves as a clearing house for consumers who wish to find direct-to-consumer sales portals that manufacturers and others have established for pharmaceuticals like the weight loss drugs Zepbound and Wegovy. The federal government-run website is particularly appealing to cash-pay patients with high deductibles or those who don’t have coverage of certain products. However, should patients access TrumpRx they’re not going to find the “world’s lowest prescription drug prices,” which the president falsely claims . Critics have also noted that most of the pharmaceuticals currently available on TrumpRx are in the latter stages of the product life cycle, which means that they already face lower-priced generic or biosimilar competitors.
Notably, Klomp has previously said that the proposed models, including GENEROUS, aren’t intended to necessarily lower U.S. prices. In March, Klomp spoke at a STAT conference and maintained that manufacturers could “price wherever they want.” The purpose isn’t a price cap. Rather it’s to raise prices in international markets. However, it remains to be seen how feasible this goal is, as severe budget constraints throughout Europe continue to keep a lid on prices or even decrease them further in key countries such as Germany.
And so, the question is, will firms respond by withdrawing from certain international markets or simply not market their new products at all if by doing so this would disadvantage them from a pricing perspective? Some drug companies are apparently delaying the launches of new medicines in Europe to avoid triggering international price comparisons .