TrumpRx is a hot topic today, especially in the context of its foundational concept: direct-to-consumer (DTC) or direct-to-patient (DTP) drug purchase and dispensing. Apparently set to launch, after the Department of Health and Human Services (HHS) issued a guidance that Secretary Robert F. Kennedy, Jr, said, “makes clear that manufacturers can offer lower-cost drugs directly to patients without kickbacks or taxpayer billing.” The site may be ready to launch as early as Friday, January 30.
There remains a good amount of confusion how, if at all, TrumpRx fits into this DTC scheme, and to what extent the very small DTC market may affect the far larger market of commercially covered pharmacy benefits. Organizations like Mark Cuban’s Cost Plus, GoodRx, Lilly Direct, and BlinkRx already exist as pharmacies where the available products, under low DTC pricing, can be purchased by patients and shipped directly to them.
TrumpRx: So What?
On its face, TrumpRx is simply a portal that would allow a search for specific drugs and then link to these DTC vendors. From the perspective of a patient, it is a gateway to vendors offering drugs that have been heavily discounted for direct purchase—no rebates, no deductibles, no counting towards deductibles, no copays. Just a straight monetary transaction at a discounted purchase price. TrumpRx does not facilitate the sale, it does not supply the discounted drugs, and it does not accept money for the purchase. It is supposed to be accessible to pretty much anyone—the uninsured, underinsured, Medicare eligibles, and Medicaid eligibles.
With any DTC purchase, none of the transactions are registered by pharmacy benefit managers or health plans: Other than the prescription made by a health care provider, no other information enters the electronic medical record or a payer’s administrative database/billing system. From the health plan, insurer, and PBM perspective, there’s not too much to love about DTC purchases.
TrumpRx makes deals with drug manufacturers to offer their products (not all, just specific ones) at a most favored nation (MFN) price to patients. If I understand the process correctly, the drugs will then be offered by the DTC pharmacies at the negotiated MFN discount. In the early infancy of the DTC movement, individual manufacturers negotiated directly with companies like Cost Plus, and the discounts could be far lower than the expected MFN price.
What Do TrumpRx Deals Actually Entail?
A completed negotiation with the White House would allow the manufacturer’s drugs to be listed on the TrumpRx site, and be exempt from tariffs. It is not clear whether we’re talking about tariff exemptions for only those specific drugs or for the entire manufacturer’s portfolio. Considering the inconsistency of pharmaceutical tariff threats by the administration, this could be a nightmare to track and administer (in either case).
It is also unclear whether a deal with TrumpRx will exempt a single drug or all the manufacturer’s drugs from participation in the Medicare GLOBE and GUARD models, which would apply to a much larger segment of the population.
According to a recent webinar by the Academy of Managed Care Pharmacy’s legislative and regulatory team of Adam Colburn and Tom Casey, the “new DTC prices may serve as benchmarks for negotiations between payers and manufacturers.” Read that quote again. They are saying that this could knock down drug pricing for the vast commercial market, not just for the market-share sliver of cash-paying customers.
Biosimilar Considerations in This Long View
I’m not ready to go that far, not yet, anyway. Think about the implications of this possibiliity though. It would be great news for payers and terrible news for the drug industry. Also, it would be a big fat negative for the biosimilar industry: This will lower potential revenue targets for biosimilar candidates (in the same way as the Inflation Reduction Act’s Medicare Maximum Fair Price initiative), making them less attractive for biosimilar development.
Remember that the sole reason for the existence of biosimilar competition (and the industry itself) is to lower pricing substantially for high-cost biologics at the end of their market exclusivity. If something like MFN pricing (based on today’s WAC prices) is used as a starting point for commercial, Medicare, and Medicaid drug pricing negotiation, it could immediately lop off half to two thirds of the price of a biologic drug. Suddenly, biosimilar competition becomes less urgent, doesn’t it?
In Other Biosimilar News
On January 27, The Centers for Medicare and Medicaid Services announced the list of the drugs subject to the third round of MFP negotiations (this year for implementation on January 1, 2028). The set of 15 drugs predicted by Cousin and co-workers, which we reported on earlier this month was nearly spot on. Several biologics that are potential biosimilar candidates were on the list, and only Simponi (golimumab) didn’t make the final cut. This leaves Cimzia, Orencia, Entyvio, Cosentyx, Xolair, and Botox as eligible biologics this year.
This article was written by our Director of Content, Stanton Mehr. Stan is has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 12 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.
