TrumpRx unveiled the first 43 products listed as available through this direct-to-consumer (DTC) clearinghouse site, and one biosimilar is offered, at a discount of more than $300 per dose.

Pfizer’s Abrilada is being offered through TrumpRx at a price of $207.60 per 40 mg/0.8 mL prefilled pen. The prefilled syringe version is $415.20 (for a 2 pack). This represents a 60% discount off its present low-WAC price of $519, and is 46% below the lowest recorded low-WAC price of any of the adalimumab biosimilars available (Idacio), as reported by the Samsung Bioepis Biosimilar Market Report.

Pfizer’s Abrilada is only available in one low-concentration adalimumab formula, whereas the majority of the competitive biosimilars have the widely used high-concentration formulation. Furthermore, the TrumpRx site only lists one dosage of its prefilled syringe and pen, whereas the drug is available in other doses via the prefilled syringe. Abrilada does utilize the preferred citrate-free formula.

Based on IQVIA data utilized by Samsung Bioepis, Pfizer’s share of the adalimumab market is less than 2%, and thus the company may believe that it had little to lose with this DTC pricing. Cash-paying patients will comprise a very narrow share of adalimumab purchases.

With the Federal Trade Commission (FTC) settlement with Express Scripts, reported this week, the FTC ordered the PBM to make TrumpRx accessible to insured patients as well. Since insured patients (outside of an initial deductible) will generally pay considerably less than $200 per dose out-of-pocket, and to this date a cash DTC transaction does not contribute to the patient’s deductible, this will likely remain an access point for uninsured patients who can afford the DTC price.

TrumpRx will likely add other biosimilars or biologics to its list of available products in the future. However, until the mechanism is worked out to include these DTC transactions into the plan’s or PBM’s electronic systems, this access channel will remain limited for biologic agents.

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 13 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.

Perhaps the greatest effect of yesterday’s announced Federal Trade Commission (FTC) settlement with Express Scripts is its mandate on consumer exposure to net prices at the pharmacy counter as opposed to the inflated list prices of insulin products. But the implications go far beyond insulin. The settlement may contribute to the demise of high wholesale acquisition cost (WAC) pricing.

The FTC stated that Express Scripts would, as part of the agreement, now list preferred drugs under their low-WAC, not high-WAC, prices on standard formularies. In addition, Express Scripts will interface with the federal government’s TrumpRx site to allow the PBM’s members access to direct-to-consumer pricing platforms within its standard pharmacy benefit design.

Affecting Insulin and Beyond

All Big 3 PBMs were sued by the FTC over alleged insulin price fixing. To date, only Express Scripts has reached an agreement with the FTC. The settlement reached by the FTC may cause much consternation and uncertainty with big 3 leadership and investors, but it is unquestionably a step in the right direction.

When patients’ out-of-pocket costs are based on net pricing (that is, after rebates and discounts), their costs at the point of dispensing may decrease. This will not be the case for patients who are members of plans using fixed copayments for insulin and other products. But as Drug Channel Institute’s Adam Fein says, “The settlement helps shield patients from excesses of the gross-to-net bubble.”

“This settlement enables us to keep moving forward, and we appreciate the administration’s reinforcement of our commitment to pharmacy benefits that put Americans first,” Express Scripts said in the statement. “This is a meaningful step toward affordability for millions of families, and toward advancing the goal we share with the Administration of full transparency into prescription drug costs.”

Insulin is just the catalyst in this chain reaction. According to the latest Samsung Bioepis Biosimilar Market Report, the low WAC price of insulin glargine hovers around $18 for a single prefilled pen. On a per-patient basis, insulin is one of the least expensive biologics (at least facing biosimilar competition). Many more, higher-cost agents covered under the pharmacy benefit should follow suit.

The FTC has been called on for years to take a greater role in countering anticompetitive marketplace activities around biosimilars, including the use of patent thickets to block biosimilar competition and the use of misleading marketing information.

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. 

On January 12, AbbVie announced that it had reached an agreement with the Trump administration on participation in its most favored nation (MFN) pricing initiative, and making certain medications available through its direct-to-consumer platform.

With the various agreements made with 15 other pharmaceutical companies, specific drugs were not disclosed. This is the first time in the short history of the MFN initiative that it involves a reference product with active biosimilar competition—that is, of publicly disclosed information.

However, the MFN (and Medicare maximum fair price for that matter) programs were explicit in their intent to avoid interfering with the biosimilar and generic marketplaces. For their part, AbbVie may simply be seeking another access channel to forestall fading Humira volume. It is not expected that the TrumpRx direct-to-consumer channel would be particularly strong.

What Is the MFN Price of Humira Likely to Be?

What would be the MFN price of Humira? Data on which the calculation derived from the administration’s international pricing index of countries with comparable economies are a bit dated, and the source has not been verified. Based on 2023 prices, Humira pricing ranges from $875 per 40 mg dose in Italy to $316 in France (of countries included in the MFN international index). Many of the adalimumab biosimilars are already providing deep discounts (some greater than 85%), to a price range of $450 to $693 for the same dose. At least one biosimilar is available through Mark Cuban’s Cost Plus at a 92% discount. What AbbVie offers under TrumpRx is unknown, but for cash paying buyers, Humira monthly cost will likely be hundreds of dollars, and largely unaffordable for most.

The point is that the biosimilar industry needs no additional impediment to its success, and most certainly, not in the adalimumab category. The reference product still retains the largest market share, and several adalimumab biosimilar makers are hanging on with miniscule volume.

In its rush to make TrumpRx MFN deals, the administration seems to have run roughshod over its own stated intention, to protect the biosimilar segment from harm. Simply, did AbbVie seek to include Humira in the arrangement, and the administration paid inadequate attention? Or did the administration seek to include Humira because of its boldface status, which would have been even stranger?

A Lack of Foresight or Lack of Principles?

Either way, this move sends a signal that the administration is conflicted about signing MFN deals for other reference drugs with active biosimilar competition. This isn’t an unintended consequence of the MFN policy; it’s a self-inflicted wound.

My original worry was that MFN, like Medicare’s maximum fair price negotiations, will discourage investment in biosimilar development. This was a problem for prospective biosimilar developers, I thought, not those with existing, approved biosimilars.

This seeming misstep is likely the result of the same “move fast and break things” mentality that has characterized this administration from the beginning of its second term. This was not a deeply considered move.

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. 

Here’s a question that has been asked repeatedly over the last year or so: Does it make sense to have private label medical benefit-covered biosimilars?

We’ve seen the spread of private-label or “white-label” biosimilars, by the big 3 pharmacy benefit managers (PBMs) specifically, for adalimumab and ustekinumab. Although we’re not sure of current market utilization of the private-label versus non–private label products, we do know that the availability of the private-label products helped biosimilars on the road to uptake if not financial success.

We have in our sights some major medical benefit–covered reference products losing patent protection and marketing exclusivity over the next few years. These include Keytruda, Opdivo, Yervoy, Perjeta, and Ocrevus to name a few. All are high-cost agents that are important (if not critical) to patient care.

The discussion of a medical benefit private-label biosimilar must tease out the potential advantages/disadvantages for both the manufacturer and the provider (who in a buy-and-bill situation makes the initial prescribing decision) or payer (who decides on coverage/reimbursement). The first assumption is that PBMs generally deal far less with specialty drugs under the medical benefit (and especially oncology drugs). By their very name PBMs manage the pharmacy, not the medical, benefit. However, their affiliated specialty pharmacies are in a viable position to play an influential role, via white bagging. If that is the case, the provider’s buy-and-bill initiative would be lost, and they would be reimbursed solely for administration services. For PBMs, earning additional dollars through their specialty pharmacy, such white-labeled products seems highly promising.

The second assumption is that heavy competition at launch for medical benefit–covered biosimilars like Keytruda will result in huge, immediate net price discounts, as seen with the highly contested adalimumab and ustekinumab biosimilar launches. Competition is competition, regardless of how a drug is covered, so this is reasonable. The bigger question is whether Medicare price negotiation or most favored nations pricing hits before biosimilars launch (they shouldn’t, according to official and draft policy, but we should account for this anyway). A lower list price will mean lower cost savings for biosimilars.

A payer might be more neutral on the private-label issue. In general, private labels have not spelled greater net savings over low-WAC biosimilar versions of adalimumab or ustekinumab. They don’t seem to be extremely motivated to insist on non-private-label versus private-label biosimilar coverage. On the other hand, plan sponsors may think otherwise, based on the call for more PBM transparency. If the PD-1 inhibitor biosimilars, for instance, were available by private label through the specialty pharmacy, it would probably have little effect on payers except reducing buy-and-bill transactions for those specific products.

With the introduction of eight new Keytruda biosimilars competing for a $30 billion US market, discounts will quickly increase—regardless of MFP or MFN pricing. It should mean a virtual (delayed) free fall in average sales pricing (ASP), which will further dissuade providers from wanting to purchase these products and take on the risk of being caught underwater. If this follows, it drives purchases and distribution through the specialty pharmacy. Will the PBMs jump at the opportunity? Are there wholesaler or other relationships that they do not currently have to be in established first?

I don’t know the answers. I hope these thoughts spur a considered discussion of the advantages and disadvantages, and where this concept leads. Please lend your voice and comment on this topic.  

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.