{"id":378392,"date":"2026-04-06T19:53:13","date_gmt":"2026-04-06T19:53:13","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/378392\/"},"modified":"2026-04-06T19:53:13","modified_gmt":"2026-04-06T19:53:13","slug":"mfp-private-label-biosimilars-and-direct-to-patient-threats-for-pbms-rerun","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/378392\/","title":{"rendered":"MFP, Private Label Biosimilars, and Direct-to-Patient Threats for PBMs (rerun)"},"content":{"rendered":"

This week, we’re rerunning some popular posts while we prepare for Friday\u2019s live video webinar: PBM Industry Update 2026: Trends, Challenges, and What\u2019s Ahead<\/a>.<\/p>\n

Click here to see the original post from January 2026.<\/a>
\n<\/p>\n

\"\"<\/a>For 2026, the three largest pharmacy benefit managers (PBMs)\u2014Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)\u2014have once again excluded hundreds of drugs from their standard formularies. Our updated counts appear below.<\/p>\n

The 2026 lists highlight how formulary preferences for Humira and Stelara are dominated by private-label biosimilars affiliated with the same parent companies that operate the three largest PBMs. Many of the preferred products feature lower list prices, signaling growing tension between traditional rebate-driven formularies and emerging net-price-based competition.\n<\/p>\n

These developments matter because the pricing system that underpins PBMs\u2019 formulary leverage is weakening. The gross-to-net bubble is deflating and the industry is moving toward what we call the Net Pricing Drug Channel (NPDC).\n<\/p>\n

As low list prices, direct-to-patient distribution, and cost-plus reimbursement models gain traction, formulary exclusions will no longer deliver the economic power they once did. These changes threaten PBMs\u2019 leverage\u2014and profits.\n<\/p>\n

As usual, Mark Cuban is leading the way. AbbVie itself now appears to be following. Consider this year\u2019s formulary review a preview of what market access looks like when the rebate game starts to unwind.

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EXCLUSIONS 101\n<\/p>\n

Formulary exclusions remain one of the most powerful tools for PBMs to gain negotiating leverage against manufacturers. Manufacturers offer deeper rebates off list price to avoid having their products cut from a PBM\u2019s formulary. Exclusions are one of the key factors behind the large gap between list and net prices for brand-name drugs. (See U.S. Brand-Name Drug Prices Fell in 2025 as the Net Pricing Drug Channel Emerges<\/a>.) They can also affect a patient\u2019s out-of-pocket costs and access to a particular therapy.\n<\/p>\n

Formulary exclusions block access to specific products on a PBM\u2019s recommended national formulary. These are suggestions, not mandates. Thus, a drug\u2019s appearance on an exclusion list does not guarantee that all patients will lose access. Plan sponsors\u2014the PBM\u2019s clients\u2014can choose not to adopt their PBM\u2019s standard formulary. However, sponsors would then face reduced rebates and\/or higher plan costs.\n<\/p>\n

Here are the 2026 formulary updates for commercial clients of the three largest PBMs:\n<\/p>\n

These links are current as of this article\u2019s publication date. However, the lists can change during the benefit year, so the links and product lists may change.<\/p>\n

KEY TAKEAWAYS FROM THE 2026 EXCLUSION LISTS\n<\/p>\n

Here are our takeaways from the 2026 exclusion lists.\n<\/p>\n

1. Growth in exclusions plateaued at Caremark and Optum Rx, but grew at Express Scripts.\n<\/p>\n

Since 2012, the number of unique products excluded from the formularies of the three largest PBMs\u2014Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (UnitedHealth Group)\u2014has grown dramatically.\n<\/p>\n

The chart below shows the number of drugs that have been excluded from the 2026 national preferred formularies of the three largest PBMs. (We counted multiple formulations of a drug as a single exclusion.) Each exclusion list now contains more than 600 products\u2014a striking indicator of how crowded many therapy classes have become.\n<\/p>\n

[Click to Enlarge]<\/p>\n

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The rate of growth has slowed in the past few years, due partly to the substantial number of products that have already been dropped. The growth in excluded products shows how competitive many therapy categories have become\u2014and the undisclosed but presumably significant rebates generated by these products.<\/p>\n

Notably, we tracked a significant jump in the number of exclusions on Express Scripts\u2019 National Preferred Formulary since January 2025. Many of the newly excluded products were multisource generic drugs, relatively old brand-name drugs, branded generics, and certain diabetes products.\n<\/p>\n

2. The IRA is not yet affecting commercial formularies.\n<\/p>\n

Thanks to the Inflation Reduction Act (IRA), the Centers for Medicare & Medicaid Services (CMS) has set a Maximum Fair Price (MFP) for 10 Medicare Part D drugs in 2026.\n<\/p>\n

We found little evidence that MFP drugs have been broadly excluded from commercial formularies. This was especially notable for the brand-name drugs for which manufacturers have reduced list prices to align more closely with MFPs<\/a>.\n<\/p>\n

The other coverage changes that occurred were aimed at products facing generic or biosimilar competition. These adjustments are consistent with normal formulary dynamics, rather than a response to MFP status.\n<\/p>\n

Tier placement tells a similar story. Only Optum Rx publicly discloses the tier status of products on its formularies. MFP products were not unusually disadvantaged compared with non-MFP drugs\n<\/p>\n

3. Private label biosimilars drive PBM\u2019s formularies for biologics.\n<\/p>\n

PBMs\u2019 commercial formularies have embraced biosimilars of Humira (adalimumab) and Stelara (ustekinumab)\u2014two of the most significant pharmacy benefit biologic products.\n<\/p>\n

For 2026, the PBMs have (mostly) removed the Humira and Stelara reference products from their formularies. A majority of the marketed biosimilars are also being excluded from the larger PBMs\u2019 formularies.\n<\/p>\n

Instead, PBMs are favoring one or more of the biosimilars marketed by the private label businesses that are subsidiaries of the same parent companies that operate the largest three PBMs: Cordavis (CVS Health\/CVS Caremark), Nuvaila (UnitedHealth Group\/Optum Rx), and Quallent Pharmaceuticals (Cigna\/Express Scripts). In many cases, PBMs continue a bizarre pricing double standard, where cheaper biosimilars share space with pricier PBM-affiliated versions. (We analyze these private label businesses in Section 5.2.5. of our Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers<\/a>.)\n<\/p>\n

Consider the Humira market:\n<\/p>\n

Caremark\u2019s formulary includes biosimilars manufactured by Sandoz: a low-list price branded biosimilar from Cordavis along with Sandoz\u2019 low-list-price unbranded biosimilar and its high-list-price branded biosimilar. The formulary also includes the low-list-price biosimilar from Biocon. During 2024, CVS led the adoption of low-list-price biosimilars<\/a>.
\nExpress Scripts\u2019 2026 formulary contains Humira biosimilars manufactured by Boehringer Ingelheim, Alvotech\/Teva, and Sandoz. Oddly, both Quallent products are priced midway between the high- and low-list-price biosimilars.
\nOptum Rx\u2019s Premium and Select formularies have only two preferred formulary options: the high-list-price Amjevita from Amgen and the low-list-price Amjevita from Nuvaila (but manufactured by Amgen). Optum Rx includes Humira on tier 3 of its Select Standard formulary with prior authorization.
\nAlas, market share figures are hard to come by. As noted in the latest Samsung Bioepis US Biosimilar Market Report<\/a>, CVS Health has blocked all reporting of Cordavis sales data since last January. So much for transparency.<\/p>\n

The Stelara market is also tilting toward private label biosimilars. For mid-2025 background, see The Stelara Biosimilar Price War: How PBM-Affiliated Private Labels Are Reshaping the Market<\/a>.\n<\/p>\n

The table below provides an updated look at the Stelara market based on the January 2026 formulary status. In addition to the reference products, there are 12 biosimilars plus an unbranded biologic marketed by the reference product\u2019s manufacturer Johnson & Johnson. As a reminder, the wholesale acquisition cost (WAC) list price does not represent the price paid by any entity within the drug channel, because it excludes rebates and such other reductions as distribution fees, product returns, discounts to hospitals, price reductions from the 340B Drug Pricing Program, and other purchase discounts.\n<\/p>\n

[Click to Enlarge]<\/p>\n

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Here\u2019s a brief summary:
\nCVS Caremark\u2019s 2026 formulary includes the Stelara brand-name product, a low-list price product from Biocon, and the Cordavis-branded Pyzchiva product from Samsung Bioepis.
\nExpress Scripts includes three branded biosimilars with list prices that are 85% or more below the reference product. It also included an unbranded private label product from Quallent with a list price that\u2019s only 46% below the reference product.
\nThe Optum Rx formularies include Wezlana for Nuvaila (high list price), Wezlana for Nuvaila (low list price), and the low-list-price Yesintek from Biocon Biologics. As with Humira, Optum Rx includes Stelara on tier 3 of its Select Standard formulary with prior authorization. However, the high-list-price Wezlana is on tier 2.
\nStelara is also one of the 10 products chosen by CMS for negotiation under the IRA. For 2026, the maximum fair price (MFP) for Stelara is 66% below its 2023 list price. But as you can see above, Stelara already faces multiple biosimilar competitors, many of which have list prices that are discounted by 75% or more from Stelara\u2019s current WAC. In other words, the competitive market has already delivered prices lower than the IRA\u2019s negotiation program.<\/p>\n

WILL THE NPDC REDUCE THE POWER OF EXCLUSIONS?\n<\/p>\n

The 2026 formulary exclusion lists show that PBMs remain committed to using exclusions to shape competition, particularly in crowded biologic markets such as Humira and Stelara. However, the economic foundation of this strategy is becoming less stable.\n<\/p>\n

The gross-to-net bubble is deflating and the industry is entering the Net Pricing Drug Channel (NPDC) era\u2014a market environment in which net prices, not list prices, determine access, economics, and competitive strategy. See The Net Pricing Revolution in the Drug Channel: What\u2019s Deflating the Gross-to-Net Bubble<\/a>.\n<\/p>\n

Private-label biosimilars highlight this tension. PBMs are increasingly steering utilization toward affiliated products, even when competing biosimilars offer lower list prices. At the same time, direct-to-patient pricing models demonstrate how deeply discounted prices could reach patients without formularies, rebates, or utilization management.\n<\/p>\n

The Mark Cuban Cost Plus Drug Company (MCCPDC) pricing for a Stelara biosimilar illustrates the risk to PBMs\u2019 formulary control. It sells Starjemza for $360 per dose<\/a>, or $1,380 per year. That price is 96% below Stelara\u2019s list price\u2014and likely lower on a net basis than any competing alternative.\n<\/p>\n

When a patient\u2014or their plan\u2014can access a product at a visible, low net price, formulary exclusion loses much of its practical force.\n<\/p>\n

Early evidence from discount card usage shows that patients will bypass benefit management to obtain the therapy prescribed by their physician. See point 3 in Five Surprising Facts About GoodRx and the Discount Card Market<\/a>.\n<\/p>\n

Perhaps that\u2019s why AbbVie appears to be positioning Humira for a direct-to-patient world, judging by its recently announced a voluntary \u201cmost favored nation\u201d agreement with the Trump administration to offer lower prices on multiple products, including Humira<\/a>. While critical details are missing, it seems like Humira could show up at a discounted price on a direct-to-patient portal later this year.\n<\/p>\n

If the NPDC takes hold, then the larger PBMs\u2019 roles will radically change. Instead of arbitraging opaque rebates, PBMs may increasingly function as benefit administrators and negotiators of upfront discounts. A PBM\u2014or its plan sponsor client\u2014could need to either negotiate upfront discounts with manufacturers or rely on visible direct-to-consumer pricing for access. Formularies will not disappear\u2014but their economic power, and profitability, will look very different from today.\n<\/p>\n

The 2026 exclusion lists suggest that the NPDC transition is already underway. <\/p>\n","protected":false},"excerpt":{"rendered":"This week, we’re rerunning some popular posts while we prepare for Friday\u2019s live video webinar: PBM Industry Update…\n","protected":false},"author":2,"featured_media":252064,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[163,85,46,482],"class_list":{"0":"post-378392","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-il","10":"tag-israel","11":"tag-medication"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/378392","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=378392"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/378392\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/252064"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=378392"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=378392"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=378392"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}