2026 Health Policy Update: Implications for Biopharma Heading Into 2027
Policy changes across pricing, reimbursement, and product development are converging, creating new considerations for biopharma leaders heading into 2027.
Biopharma companies are navigating simultaneous developments in most favored nation (MFN) pricing, pharmacy benefit manager reform, 340B, Average Sales Price reporting, and Medicare drug price negotiation.
Although each policy raises distinct questions, their effects may intersect across pricing, reimbursement, product development, and patient access. Product mix, payer exposure, international marketing and pricing, and business priorities will shape the implications for each company and potentially for individual products within the same portfolio.
Policy Changes Do Not Operate in Isolation
Health policy developments are often evaluated individually, but their combined effects can be harder to assess. An ex-U.S. price may affect U.S. product economics and lifecycle management; lower 340B discounts may influence hospital product selection and utilization; and Medicare Part D changes may reduce some forms of patient spending while increasing others.
In a separate analysis funded by the Biotechnology Innovation Organization, Magnolia examined how funding, regulatory, and pricing changes could collectively affect future drug development.
MFN/International Reference Pricing Becomes a Portfolio-Level Question
The impact of MFN and international reference pricing will vary by portfolio and potentially by individual product.
The administration has paired pharmaceutical tariff pressure with “voluntary” MFN agreements, including through GENEROUS, and proposed mandatory GLOBE and GUARD models. As proposed, GLOBE and GUARD would impose Medicare rebates on a portion of Part B and Part D utilization in an amount based on prices in certain ex-U.S. countries.
GLOBE is scheduled to begin October 1, 2026, and GUARD on January 1, 2027. Both final rules remained under OMB review as of August 10.
“MFN impact is going to vary from portfolio to portfolio, maybe even drug by drug.”
— Christopher Schott, Partner, Latham & Watkins LLP
Greater PBM transparency may not automatically produce the expected benefits for plans or patients.
The 2026 Consolidated Appropriations Act introduced rebate pass-through, compensation disclosure, reporting, and enforcement requirements. The Department of Labor also proposed disclosure requirements for PBMs serving self-insured employer plans, while states continued to pursue reforms involving pharmacy networks, spread pricing, reimbursement, and vertical integration.
PBMs may respond through fees or compensation arrangements not addressed by the reforms, while some employers may continue to favor predictable spending over greater transparency with more financial variability.
“There’s so much that you don’t see that goes on in the PBM world that I think we may not see the benefits that are expected out of this.”
— Tracy Baroni Allmon, Vice President, Health Policy and Market Access, Magnolia Market Access
Federal proposals, manufacturer policies, state laws, and litigation are continuing to reshape the 340B landscape.
The proposed rebate model, published by HRSA on July 31, would allow participating manufacturers to provide the 340B discount after receiving information demonstrating that a transaction qualified.
CMS has also proposed reimbursing certain 340B-acquired drugs at ASP minus 33.4% in 2027 rather than ASP plus 6%.
At the same time, manufacturers continue to implement contract-pharmacy policies as more states enact restrictions and related litigation proceeds. Stakeholders are also watching whether 340B oversight could move from HRSA to CMS, as well as 340B reform initiatives in Congress.
ASP reporting requirements create additional documentation obligations and may increase scrutiny of service-fee treatment.
At the same time, lower spending at one point in the Medicare benefit does not necessarily mean lower total costs for patients. Medicare Part D changes have limited certain out-of-pocket expenses, but some plans are applying deductibles, shifting branded drugs from fixed copayments to coinsurance, or reducing participation.
“Are these policies, in fact, going to save patients money? … It’s a lot of balloon squeezing for patients.”
— Amanda Forys, Managing Partner, Magnolia Market Access
Patients may pay less at one point while facing higher premiums, deductibles, coinsurance, or reduced plan choice elsewhere. Savings to the government, plans, or another stakeholder do not automatically become equivalent savings for patients.
As permitted by the IRA, CMS to date has issued only guidance to implement the negotiation program. Regulation is first required for IPAY 2029, and CMS issued a proposed regulation on June 12, 2026. The comment period ends on August 17, 2026.
The proposed rule’s treatment of fixed-dose combination products could affect product-development decisions. Under current guidance, a fixed-dose combination product is treated as its own qualifying single-source drug. The proposed rule could instead treat it as the same qualifying drug as another product sharing one active ingredient, making it harder to recoup development costs associated with fixed-dose combination products.
CMS has also released draft guidance for implementing the Maximum Fair Price for selected Part B drugs in IPAY 2028. Manufacturers should continue to monitor the open rulemaking and guidance processes and consider where engagement may be warranted.
What Should Biopharma Companies Consider Heading Into 2027?
The implications will differ by company and product. Key questions include:
Companies should continue to monitor proposed changes and identify opportunities to submit comments or engage with policymakers where their products and operations may be affected.
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Watch the full Magnolia Market Access webinar on 2026 Health Policy Update for additional perspective on the policy developments shaping biopharma decisions heading into 2027.
This article reflects policy developments and proposals discussed as of July 23, 2026, and updated as of August 11, 2026. It is intended for educational purposes and does not constitute legal advice.