Trump Administration Applauds Itself for Rx Access Agreements, But Will They Help Patients?

By: Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy

In May 2025, President Donald J. Trump signed an executive order requiring, among other things, that pharmaceutical companies lower the prices of certain drugs to align with those charged in other comparably developed nations (e.g., most of Europe; Simons & Hopkins, 2025). Those companies that failed to comply with this order would be subject to administrative retaliation that imposes what the Trump Administration is calling “Most-Favored Nation” (MFN) pricing.

Photo Source: The White House

ADAP Advocacy covered this executive order last May, bringing several questions to the fore:

1. How will the U.S. Department of Health and Human Services (HHS) determine what the MFN price is for medications?
2. Which classes of medications and how many will be included in this pricing scheme?
3. Will these pricing agreements apply only to drugs purchased through public insurance programs, such as Medicaid, Medicare, and the Veterans Affairs (VA), or will these pricing agreements apply to drugs purchased using commercial insurance? (Franco, 2025)

In 2026, the Trump Administration’s "negotiations-at-gunpoint" approach has borne some fruit. The Trump Administration released a fact sheet late last year indicating that pricing and manufacturing agreements had been reached with 9 drug manufacturers (The White House, 2025). The details are available in the list below, which outlines each manufacturer’s agreement.

As with the executive order itself, the majority of the details of each manufacturer’s agreement with the Trump Administration are proprietary. What is striking about many of these deals is that the drugs sold direct-to-consumer are already off-patent, have cheaper biosimilars, or are no longer actively prescribed.

The latter is true for many of the medications used to treat HIV that will sold directly to patients, including Reyataz (Briston Myers Squibb; atazanavir), an oral protease inhibitor medication that was commonly used in combination with other medications, including Norvir (ritonavir; used to slow down the breakdown of Reyataz) and a nucleoside/nucleotide reverse transcriptase inhibitor (NRTI), such as Truvada (emtricitabine/tenofovir disoproxil fumarate).

Other drugs, such as Humira (Amgen), have multiple biosimilar options available at lower prices than Amgen's direct-to-patient pricing. Of greater concern is the possibility that these lower prices are merely stopgap measures that will remain in place only as long as the Trump Administration remains in office.

Photo Source: Houston Public Media | Win McNamee | Getty Images

While the optics of lower drug prices through forced “voluntary” negotiations look great on paper, most of these agreements come with three-year exemptions from tariffs imposed by the Trump Administration, which are currently facing a pending Supreme Court ruling on the legality of those tariffs under the International Emergency Economic Powers Act (IEEPA; Chung, 2026).

Should those tariffs be overturned by the Supreme Court or by a future president, drug manufacturers will have little incentive to honor many of the provisions of their respective deals, particularly U.S.-based manufacturing and research and development investments.

Further still, the opacity of these agreements, as well as HHS's determination of what “MFN” pricing is for individual drugs, means there remains little transparency into the drug pricing process. What’s to stop manufacturers from drastically increasing list prices to offset the “discounts” offered (Buntz, 2026)?

Finally, how many Americans will actually be able to access and afford these medications hinges on whether they have public (e.g., Medicaid, Medicare, VA) or commercial insurance (e.g., employer-sponsored, marketplace). While each manufacturer was voluntarily forced to sell medications on TrumpRx.gov, there is still no “TrumpRx”—the website is a placeholder site that promises “the lowest prescription drug prices in America,” but no details or actual drugs are listed. Instead, visitors are “graced” with a scowling (and AI-edited) photo of the president.

Photo Source: TrumpRx

The reality, here, is that Trump’s increasingly unpopular brand, as well as his long-documented failures to make good on the vast majority of his promises, are likely to drive away consumers, rather than convincing them to put their faith in anything with his name on it. But that’s the way of the day in our Trumpian dystopia: a power-hungry madman obsessed with branding everything with his name, like some heifer at the O.K. Corral.

In the short term, state Medicaid programs are the likeliest to benefit, as nearly every manufacturer has agreed to sell their medications to those programs at prices comparable to other developed nations (Lim, 2026). That will save states money, but most Medicaid patients already pay very low prices for most medications, meaning that the savings here are mostly to state governments rather than patients.

For direct-to-patient purchasing, while many patients may choose this route rather than enrolling in commercial insurance, for those who receive federal subsidies to offset monthly premiums, the complexity and secrecy of the U.S. healthcare system make it virtually impossible to determine whether patients will actually save money by skipping the middlemen.

ADAP Advocacy will continue to monitor MFN pricing and how that might impact people living with HIV/AIDS.

Drug Manufacturer MFN Agreement Outlines:

• Amgen
• Amgen will expand its direct-to-patient program, AmgenNow™, to include Aimovig® (migraine treatment) and Amjevita® (biosimilar to Humira to treat autoimmune conditions), at a discounted monthly price of $299. This expands the available drugs, which also includes Repatha® (cholesterol-lowering medication) at a monthly price of $239 (Amgen, 2025).
• Bristol Myers Squibb (BMS)
• BMS agreed to make Eliquis® (blood thinning medication) available to Medicare for free starting January 1st, 2026.
• Agreed to donate 7 tons of Eliquis to fill the U.S. Strategic Active Pharmaceutical Ingredient Reserve (SAPIR).
• Agreed to launch new medications with “…a more balanced pricing approach across developed nations”.
• Agreed to enable direct-to-patient access for cash-paying patients for Sotyktu® (plaque psoriasis), Zeposia® (relapsing multiple sclerosis and ulcerative colitis), Reyataz® (HIV), Baraclude® (Hepatitis B), Orencia® SC (autoimmune conditions).
• Each of these drugs will be sold at approximately 80% off the current list price through TrumpRx.gov (BMS, 2025).
• Boehringer Ingelheim
• Boehringer will offer medications directly to consumers through TrumpRx.gov
• Will sell Jentadueto (Type-2 Diabetes) for $55.
• Will invest $10 billion through 2028 to expand pharmaceutical research and development (R&D) and manufacturing operations in the U.S.
• Includes $1b specifically earmarked for capital expenditures (Boehringer Ingelheim, 2025).
• Genentech
• Genentech will provide medications to state Medicaid programs at prices comparable to other developed nations.
• Will allow certain drugs, including Xofluza (inflluenza) through TrumpRx.gov and through its recently established direct-to-patient program.
• Commits to increasing U.S. manufacturing, infrastructure, and R&D (Genentech, 2025).
• Gilead Sciences
• Gilead will offer discounts on certain existing medications, including those used to treat HIV, Hepatitis C, Hepatitis B, and COVID-19, for state Medicaid programs.
• Agreed to price future medications “…at parity” with other key developed nations.
• Will launch a direct-to-patient program for Epclusa® (Hepatitis C) at a discounted cash price that can be accessed through TrumpRx.gov (Gilead Sciences, 2025).
• GSK (formerly GlaxoSmithKline) / ViiV
• GSK will lower the prices of certain medications to state Medicaid programs, including most of its respiratory drug portfolio.
• GSK will also make most of its inhaled medications and other products available through a direct-to-patient program (TrumpRx.gov) at savings up to 66%.
• Will provide SAPIR with a reserve of albuterol (active ingredient in many inhalers used to treat asthma and chronic obstructive pulmonary disorder [COPD]; GSK, 2025).
• Merck
• Merck will provide direct-to-patient access to Januvia (Type-2 Diabetes), Janumet (Type-2 Diabetes), and Janumet XR through TrumpRx.gov.
• This will be expanded to include enlicitide decanoate, an investigational drug currently being developed to lower cholesterol, once it has received approval from the U.S. Food and Drug Administration (FDA; Merck, 2025).
• Novartis
• Novartis agreed to launch future medications at prices comparable with other developed nations.
• Will build direct-to-patient platforms for Mayzent (multiple sclerosis), Rydapt (acute myeloid leukemia and rare blood disorders), and Tabrecta (metastatic non-small cell lung cancer) through TrumpRx.gov.
• Will apply to participate in the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) model announced by the Trump Administration in November 2025 (HHS, 2025) aimed at improving access to medications through state Medicaid programs.
• Will support efforts to “…address the global imbalance in investment in pharmaceutical innovation” (Novartis, 2025).
• Sanofi
• Sanofi agreed to ensure that state Medicaid programs can access Sanofi medications at the same prices as other developed nations.
• Will reduce prices by an average of 61% for certain medications used to treat diabetes, cardiovascular and neurological conditions, and cancer.
• Will offer direct-to-patient access for certain drugs through TrumpRx.gov.
• Will implement a “…more balanced approach” on pricing in other nations.
• Agreed to increase investments in upgrading existing manufacturing facilities and expand manufacturing partnerships (Sanofi, 2025).

In addition to these companies, the Administration has entered into pricing and manufacturing agreements with:

• AbbVie
• AbbVie agreed to spending $100 billion in U.S. R&D and other capital investments over the next decade.
• Will provide “low prices” to state Medicaid programs.
• Will provide direct-to-consumer access to Humira (rheumatoid arthritis), Alphagan (glaucoma or ocular hypertension), Combigan (glaucoma or ocular hypertension), and Synthroid (hyperthyroidism) through TrumpRx.gov (Fidler, 2026).
• AstraZeneca
• AstraZeneca will provide direct-to-consumer sales to eligible patients with chronic diseases at a discount of up to 80% off list prices through TrumpRx.gov.
• Will invest $50 billion in manufacturing and R&D through 2030, 50% of which is expected to be generated in the U.S. (AstraZeneca, 2025).
• .ohnson & Johnson (J&J)
• J&J will provide direct-to-patient access through TrumpRx.gov.
• Will “…[enable] American patients to access medicines at comparable prices to other developed countries”.
• Will provide state Medicaid programs with access to medications at prices comparable to other developed nations.
• Announced two new U.S. manufacturing facilities in Pennsylvania and North Carolina (J&J, 2026).
• Eli Lilly
• Eli Lilly and Company will provide Medicare beneficiaries with Zepbound (weight management GLP-1 medication) and orforglipron, an investigational oral GLP-1 drug awaiting FDA approval, for no more than $50/month.
• State Medicaid programs will also be able to access these medications at reduced prices (prices not stated).
• Will enable self-paying (cash-paying) patients to access Zepbound at its lowest dose for $299, with additional doses up to $449 through direct-to-patient access, representing a $50 savings.
• Patients refilling their multi-dose pens will pay no more than $449.
• Will provide direct-to-patient orforglipron at the lowest dose for $149, with additional doses up to $399.
• Nota bene – the scope of this agreement DOES NOT include commercial pricing.
• Will add Emgality (migraines and cluster headaches), Trulicity (Type-2 Diabetes), and Mounjaro (specific to Type-2 Diabetes) to direct-to-patient channels at 50-60% off current list prices.
• Will continue to offer insulin to patients for no more than $35/month, whether a patient is commercially insured or uninsured (Eli Lilly, 2025).
• Pfizer
• Pfizer agreed to implement measures to ensure Americans receive “…comparable drug prices to those available in other developed countries,” and will price new medications at parity with other developed markets.
• Will participate in direct-to-patient sales through TrumpRx.gov, allowing Americans to purchase primary care treatments and specialty drugs at an average discount of 50% and at discounts of up to 85%.
• Committed to investing an additional $70 billion in the U.S. for R&D and capital projects over the next few years (Pfizer, 2025).

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

References:

[1] Amgen. (2025, December 19). Amgen takes action with the U.S. government to lower the cost of medicines for American patients. Thousand Oaks, CA: Amgen: Newsroom: Press Releases. https://www.amgen.com/newsroom/press-releases/2025/12/amgen-takes-action-with-the-u-s--government-to-lower-the-cost-of-medicines-for-american-patients

[2] AstraZeneca. (2025, October 10). AstraZeneca announces historic agreement with US Government to lower the cost of medicines for American patients. Cambridge, UK: AstraZeneca: Media Centre: Press Releases. https://www.astrazeneca.com/media-centre/press-releases/2025/astrazeneca-announces-historic-agreement-with-us-government-to-lower-the-cost-of-medicines-for-american-patients.html

[3] Boehringer Ingelheim. (2025, December 19). Boehringer Ingelheim announces broad agreement with the U.S. Government to lower the cost of medicines for American patients and expand its U.S. footprint. Ridgefield, CT: Boehringer Ingelheim: US: Media: Press Releases. https://www.boehringer-ingelheim.com/us/media/press-releases/boehringer-ingelheim-announces-agreement-us-government

[4] Bristol Myers Squibb. (2025, December 19). Bristol Myers Squibb Announces Agreement with U.S. Government to Improve Affordability and Access to Critical Medicines for Americans. Princeton, NJ: Bristol Myers Squibb: News: Corporate/Financial News. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Announces-Agreement-with-U-S--Government-to-Improve-Affordability-and-Access-to-Critical-Medicines-for-Americans/default.aspx

[5] Buntz, B. (2026, January 02). Drug companies sign “Most Favored Nation” deals, then raise prices anyway. Cleveland, OH: WTWH Media LLC: Drug Discovery & Development. https://www.drugdiscoverytrends.com/drug-companies-sign-most-favored-nation-deals-then-raise-prices-anyway/

[6] Chung, A. (2026, January 09). Supreme Court plans rulings for January 14 as Trump's tariffs remain undecided. London, UK: Reuters: Legal: Government. https://www.reuters.com/legal/government/supreme-court-set-issue-rulings-trump-awaits-fate-tariffs-2026-01-09/

[7] Eli Lilly and Company. (2025, November 06). Lilly and U.S. government agree to expand access to obesity medicines to millions of Americans. Indianapolis, IN: Eli Lilly and Company: News Releases. News Release Details. https://investor.lilly.com/news-releases/news-release-details/lilly-and-us-government-agree-expand-access-obesity-medicines

[8] Fidler, B. (2026, January 13). AbbVie pledges $100B to US production in drug pricing deal with Trump. Newton, MA: Industry Dive: Biopharma Dive: News. https://www.biopharmadive.com/news/abbvie-drug-price-deal-trump-most-favored-nation/809441/

[9] Franco, M. A. (2025, May 14). Trump Administration Revives Most-Favored-Nation Drug Pricing: Here's What to Know. Holland & Knight: Insights. Retrieved from https://www.hklaw.com/en/insights/publications/2025/05/trump-administration-revives-most-favored-nation-drug-pricing

[10] Genentech. (2025, December 19). Genentech Announces Agreement With U.S. Government. South San Francisco, CA: Genentech: Media: Press Releases. https://www.gene.com/media/press-releases/15094/2025-12-19/genentech-announces-agreement-with-us-go

[11] Gilead Sciences. (2025, December 19). Gilead and U.S. Government Enter Agreement to Lower Costs of Medicines for Americans. Foster City, CA: Gilead Sciences: News: News Releases. https://www.gilead.com/news/news-details/2025/gilead-and-u-s--government-enter-agreement-to-lower-costs-of-medicines-for-americans

[12] GSK. (2025, December 19). GSK enters agreement with U.S. government to lower drug prices and expand access to respiratory medicines for millions of Americans. London, UK: GSK: Media: Press Release Archive. https://www.gsk.com/en-gb/media/press-releases/gsk-enters-agreement-with-us-government-to-lower-drug-prices-and-expand-access-to-respiratory-medicines-for-millions-of-americans/

[13] Johnson & Johnson. (2026, January 08). Johnson & Johnson Reaches Agreement with U.S. Government to Improve Access to Medicines and Lower Costs for Millions of Americans; Delivers on U.S. Manufacturing and Innovation Investments. New Brunswick, NJ: Johnson & Johnson: Media Center: Press Releases. https://www.jnj.com/media-center/press-releases/johnson-johnson-reaches-agreement-with-u-s-government-to-improve-access-to-medicines-and-lower-costs-for-millions-of-americans-delivers-on-u-s-manufacturing-and-innovation-investments

[14] Lim, D. (2026, January 04). Trump’s drug-pricing deals won’t benefit most Americans today. They could over time. Politico: News. https://www.politico.com/news/2026/01/04/trumps-drug-pricing-deals-wont-benefit-most-americans-today-that-could-over-time-00706529?cid=Connatix

[15] Merck. (2025, December 19). Merck Reaches Agreement With U.S. Government to Expand Access to Medicines and Lower Costs for Americans. Rahway, NJ: Merck: Media: News Releases. https://www.merck.com/news/merck-reaches-agreement-with-u-s-government-to-expand-access-to-medicines-and-lower-costs-for-americans/

[16] Novartis. (2025, December 19). Novartis and US government reach agreement on lowering drug prices in the US. Basel, CH: News. https://www.novartis.com/news/media-releases/novartis-and-us-government-reach-agreement-lowering-drug-prices-us

[17] Pfizer. (2025, September 30). Pfizer Reaches Landmark Agreement with U.S. Government to Lower Drug Costs for American Patients. New York, NY: News: Press Release. Press Release Details. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reaches-landmark-agreement-us-government-lower-drug

[18] Sanofi. (2025, December 19). Press Release: Sanofi reaches agreement with the US government to lower medicine costs while strengthening innovation. Paris, FR: Sanofi: English: Media Room: Press Releases. https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-19-19-21-43-3208697

[19] Simons, R. & Hopkins, M. J. (2025, May 22). Is Trump's executive order on Most Favored Nations drug pricing a wet noodle? Nags Head, NC: ADAP Advocacy. https://adapadvocacyassociation.blogspot.com/2025/05/is-trumps-executive-order-on-most.html

[20] United States Department of Health and Human Services. (2025, November 06). CMS Announces New Drug Payment Model to Strengthen Medicaid and Better Serve Vulnerable Americans. Washington, DC: United States Department of Health and Human Services: Press Room. https://www.hhs.gov/press-room/cms-announces-new-drug-payment-model-to-better-serve-vulnerable-americans.html

[21] White House, The. (2025, December 19). Fact Sheet: President Donald J. Trump Announces Largest Developments to Date in Bringing Most-Favored-Nation Pricing to American Patients. Washington, DC: The White House: Fact Sheets. https://www.whitehouse.gov/fact-sheets/2025/12/fact-sheet-president-donald-j-trump-announces-largest-developments-to-date-in-bringing-most-favored-nation-pricing-to-american-patients/

Fireside Chat Retreat in Atlanta, GA Tackles Inflation Reduction Act's Adverse Impact on Patient Care

By: Brandon M. Macsata, CEO, ADAP Advocacy & Matt Toresco, Chief Executive Officer, Archo Advocacy LLC

ADAP Advocacy hosted its Health Fireside Chat retreat in Atlanta, Georgia, among key stakeholder groups to discuss the adverse impact on patient care being caused by the Inflation Reduction Act (IRA). The Health Fireside Chat was held from Thursday, September 25th, to Saturday, September 27th. It was a continuation of the conversation surrounding the IRA's drug price controls, which convened earlier this year in Minneapolis, MN. Over two dozen diverse health policy stakeholders attended the event.

Photo Source: Getty Images

The IRA discussion —including its pill penalty provisions, challenges community pharmacies are facing, more restrictive drug formularies increasing, non-medical switching, and patients absorbing greater costs due to shifts from co-pays to co-insurance—was designed to capture key observations, suggestions, and thoughts about how best to address the challenges being discussed at the Health Fireside Chat. The following represents the attendees:

• Guy Anthony, Founder & Executive Director, Black, Gifted & Whole Foundation
• Ninya Bostic,  National Policy & Advocacy Director, Johnson & Johnson
• Richard Brown, Development Manager, Patient Advocate Foundation
• Tori Cooper, Director of Community Engagement, Human Rights Campaign
• Erin Darling, Associate Vice President & Counsel for Federal Policy, Merck
• Nick Garlow, Managing Director, Rational360
• Dusty Garner, Patient Advocate
• Kathie Hiers, President & CEO, AIDS Alabama
• Mark Hobraczk, Director of Public Policy, Ai Arthritis
• Connie Jorstad, Director of Government Relations, ViiV Healthcare
• Amanda Kornegay, Owner, Kornegay Consulting, LLC
• Jen Laws, President & CEO, Community Access National Network
• Darnell Lewis, Paramedic Crew Chief & Patient Advocate
• Brandon M. Mascata, CEO, ADAP Advocacy
• Travis Manint, Director of Communications, Community Access National Network
• Michiel Peters, Head of Advocacy Initiatives, Global Coalition on Aging
• Kalvin Pugh, Director of State Policy, 340B, Community Access National Network
• Stacy Reliford, Alliance Development Director, Pfizer
• Andrew Scott, Director Strategic Alliances and Issue Advocacy, Bristol-Myers Squibb
• Larry Scott-Walker, Patient Advocate
• Ranier Simons, Consultant, ADAP Advocacy
• David Spears, Founder & Director, Magic Box LLC
• Jason Sterne, Director, Policy Advocacy and Alliances, Gilead
• Matt Toresco, CEO, Archo Advocacy
• Monique Whitney, Executive Director, Pharmacists United for Truth and Transparency
• R. Wayne Woodson, Executive Diretor, NEASM

To level set and provide background for discussions, attendees are sent suggested readings in advance. The following are just a few from the thorough list provided for this session:

• The Inflation Reduction Act (IRA): Impact on Medication Pricing, Spending, Affordability, and Access – Analysis by Pioneer Institute
• Alarm Bells are Ringing: Medicare Drug Price Negotiation Program Will Fail Without Changes – Op-Ed by B. Douglas Hoey, RPh, MBA in Drug Topics
• CMS Draft Guidance Creates Regulatory Vacuum in 340B Drug Pricing – Blog by Travis Manint, Community Access National Network
• Is Trump's Executive Order on Most Favored Nations Drug Pricing a Wet Noodle? – Blog by Ranier Simons, ADAP Advocacy
• Three reasons Congress should fix the IRA’s pill penalty – Blog by Brianna Allen, PhRMA
• The Inflation Reduction Act’s Impact Upon Early-Stage Venture Capital Investments – Article in Therapeutic Innovation & Regulatory Science

ADAP Advocacy is pleased to share the following brief recap of the Health Fireside Chat. There were two discussion frameworks:

What Does Effective Advocacy Look Like:

• Defining Effective Advocacy: Data-Guided Strategies for Patient & Policy Impact
• What Works: Cutting Through the Noise in Patient Advocacy
• Shaping Advocacy That Moves Policy
• Building the Blueprint: Effective Advocacy Together

Measuring What Success Looks Like:

• Redefining Success: Measuring Advocacy Wins for Patients & Policy
• What Counts: Defining Real Success for Patients & Policy
• From Policy to Impact: What Success Really Means & Looks Like in Action
• Measuring The Wins: Success Through Shared Impact

Every major policy fight (IRA, 340B, PDABs) ultimately comes back to protecting the patient–provider relationship and the decisions made within it. Patient advocacy is most effective on these issues through branding and and demonstrating value. To that end, patient advocacy must grow its brand and demonstrate both its current and future impact. Meanwhile, pharmaceutical industry partners need to better communicate the value of advocacy internally across medical, policy, regulatory, commercial, and patient support teams. Building capacity, whether alone or in partnership, is essential.

The group identified numerous policy priorities and the need for better coalition building. Future patient advocacy has to address gaps in access to care and treatment. The IRA weakens Medicare's Six Protected Drug Classes and policymakers need to be reminded why these health conditions were protected in the first place. Advocacy organizations need to focus on clearly describing the impacts of policy issues and helping patients see them, as is being done with educating patients on why reforms are needed to strengthen the 340B Drug Pricing Program.

The ongoing government shutdown also shaped much of the policy discussion, with an agreement that longtime allies in Congress need to be engaged but also potential new voices should be cultivated. The work done by patient advocacy groups and healthcare provider associations working with North Carolina Republican Senator Thom Tillis was cited as a prime example. Sen. Tillis has introduced legislation—"Ensuring Pathways to Innovative Cures (EPIC) Act"—to fix the Inflation Reduction Act's small molecule “pill penalty” to ensure continued R&D investments into small molecule medicines.  The Global Coalition on Aging and the Alliance for Aging Research spearheaded 70+ organizations in sending a letter to congressional leadership urging them to support the EPIC Act.

Photo Source: Government Printing Office

Some recent and upcoming milestones offer patient advocacy organizations additional opportunities to shape the policy conversation. They include:

• September 30, 2025: CMS released final guidance for third cycle (IPAY28) of the MDPNP. CMS released IPAY28 draft guidance in May 2025 for public comment, with the final guidance outlining the process for the third cycle of negotiations.
• October 2025 [Anticipated]: Release of expert report detailing drugs anticipated to be selected in 2026 for the MDPNP. Based on 2024 activities, it is expected that a new white paper or brief will be issued in September 2025 that identifies drugs that are likely to be subject to price negotiation in the third cycle of the MDPNP.
• February 1, 2026: CMS releases the list of drugs selected for negotiation. In 2026, CMS will announce the selection of 15 Part D and Part B drugs for which negotiated prices will go into effect in 2028.
• February 1 – March 1, 2026: Public input period (Information Collection Request, or ICR) following CMS announcement of drugs selected for negotiation. The ICR period is intended to help CMS understand how selected drugs are used and their relative value in clinical practice. Individuals can answer questions across varying respondent types (manufacturers, patients/caregivers, physicians, researchers, and "others"), often with a ~3,000-word limit per question. Question topics include therapeutic alternatives, clinical effectiveness, cost/affordability, unmet needs, patient experiences, and other considerations. 

Aligned stakeholders must use every opportunity to create a public record on the issues related to the Inflation Reduction Act and its impact on chronic health conditions and rare diseases.  No additional Health Fireside Chats are planned for 2025.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Fireside Chat Retreat in Minneapolis, MN Tackles Inflation Reduction Act's Adverse Impact on Patient Care

By: Brandon M. Macsata, CEO, ADAP Advocacy & Ranier Simons, ADAP Blog Guest Contributor

ADAP Advocacy hosted its Health Fireside Chat retreat in Minneapolis, Minnesota, among key stakeholder groups to discuss the adverse impact on patient care being caused by the Inflation Reduction Act (IRA). The Health Fireside Chat was held from Thursday, June 12th, to Saturday, June 14th. An analysis of the IRA's drug price controls—including its pill penalty provisions, challenges community pharmacies are facing, more restrictive drug formularies increasing, non-medical switching, and patients absorbing greater costs due to shifts from co-pays to co-insurance—were all evaluated and discussed by the 24 diverse stakeholders.

Photo Source: Getty Images

The IRA discussion was designed to capture key observations, suggestions, and thoughts about how best to address the challenges being discussed at the Health Fireside Chat. The following represents the attendees:

• Meg Beaven, Senior Director, Rational 360
• Ninya Bostic,  National Policy & Advocacy Director, Johnson & Johnson
• Grant Cale, Senior Director, Alliance Development Lead, U.S. Policy and Government Affairs, Bristol Myers Squibb
• Tori Cooper, Director of Community Engagement, Human Rights Campaign
• Jeffery S. Crowley, Director of the Center for HIV and Infectious Disease Policy at the O’Neill Institute
• Olivier Viel, Associate Director, Policy and Government Affairs, Merck
• Jazlyn Gallego, Policy and Advocacy Manager, Cancer Support Community
• Max Grechko, Associate Director, Strategic Alliances and Issue Advocacy, Novartis
• Rick Guasco, Editor-in-Chief, Positively Aware
• Connie Jorstad, Director of Government Relations, ViiV Healthcare
• Patrick Ingram, Implementation Project Manager, Midwest AETC
• Kristy Kibler, CEO, Lupus Colorado
• Amanda Kornegay, Owner, Kornegay Consulting, LLC
• Jen Laws, President & CEO, Community Access National Network
• Darnell Lewis, Paramedic Crew Chief & Patient Advocate
• Brandon M. Mascata, CEO, ADAP Advocacy
• Heidi Mesik, Senior Director, PhRMA
• Michiel Peters, Head of Advocacy Initiatives, Global Coalition on Aging
• Kalvin Pugh, Director of State Policy, 340B, Community Access National Network
• Ranier Simons, Consultant, ADAP Advocacy
• Jason Sterne, Director, Policy Advocacy and Alliances, Gilead
• Scott Suckow, Senior Consultant, Perry Communications Group
• Matt Toresco, CEO, Archo Advocacy
• Monique Whitney, Executive Director, Pharmacists United for Truth and Transparency

To level set and provide background for discussions, attendees are sent suggested readings in advance. The following are just a few from the thorough list provided for this session:

• The Inflation Reduction Act (IRA): Impact on Medication Pricing, Spending, Affordability, and Access – Analysis by Pioneer Institute
• Independent Pharmacies Reluctant to Stock Drugs in Medicare Negotiation Program, New Survey Shows – Survey by the National Community Pharmacy Association
• Executive Summary: Impact of the IRA on Patient Access & Discovery of Small Molecule Drugs – Report by the Global Coalition on Aging
• CMS Draft Guidance Creates Regulatory Vacuum in 340B Drug Pricing – Blog by Travis Manint, Community Access National Network
• How the IRA's Part B Coinsurance Inflation Adjustments Can Raise Seniors' Drug Costs – Analysis by Dr. Adam Fein, Drug Channels Institute

ADAP Advocacy is pleased to share the following brief recap of the Health Fireside Chat.

The overarching theme of the discussions was how varying aspects of issues, directly or indirectly related to the IRA, can affect patients and their access to medical care. Drug pricing was a significant thread throughout the gathering. Participants expressed a consensus that the pricing of pharmaceuticals is a complex system involving many players, with patients often being stuck in the middle or positioned at the bottom. High prescription drug expenditures are partially the result of multiple bad actors making profits at the expense of the masses who need drugs for their care. The discussion largely mirrored the conclusions reached by Kenneth E. Thorpe in his June 2024 piece in Health Affairs, "Penny Wise And Pound Foolish: IRA Impact On Chronic Disease Costs In Medicare."

In-depth dialogue occurred surrounding the IRA's effects on independent, community pharmacies. These pharmacies, in particular, routinely operate within thin margins or sometimes at a loss. Due to issues such as under-reimbursement, many pharmacies are already closing. The IRA’s Maximum Fair Price (MFP) key provision for Medicare drug price negotiation has the potential to harm pharmacies further. The MFP could negatively impact pharmacies by lowering reimbursement rates, further causing financial strain. Discourse revealed that many independent pharmacies are quietly already stating they will not be stocking many of the medications subject to the MFP because they cannot afford to. Independent pharmacies are the lifeblood of communities where larger pharmacies are not present. Closing due to financial strain would rob citizens of auxiliary services and preventative care services, in addition to drug access.

Photo Source: National Community Pharmacy Association

The conflict involving pharmacy benefit managers (PBMs) and their pharmacies was also discussed. There has been an uptick in state legislation aimed at preventing PBMs from owning and operating pharmacies in the states where they do business. Vertical integration is a problem as it allows pharmacy steering and predatory independent pharmacy contracting. When PBMs own and operate pharmacies, they manipulate pricing to their advantage, steering patients to their networks at higher costs. They also offer independent pharmacies less favorable contracts, lower reimbursements, and higher fees, among other disadvantages. Attendees gleaned from the discourse that vertical integration is considered self-dealing, which is a form of fraud. It is not ethical for a health plan to own a pharmacy, just as it is not ethical for a PBM to own one.

Moreover, under the IRA, if pharmacies choose not to participate in the MFP under the Medicare Drug Price Negotiation program, they are, in essence, excluded from participating in Medicare Part D for the drugs in question. Independent pharmacies are not in favor of the new IRA mechanism because their cash flow would be split between reimbursement from CMS and refunds from drug manufacturers to make up the difference. Pharmacies would have to suffer delays in cash flow waiting to be made whole, with the possibility of not being made whole at all. The conversation specifically acknowledged that CMS is acting as a payer without any understanding of care delivery for multiple disease states.

During the period spent discussing strategy and solutions, the underlying focus was on messaging. The concern was how to effectively convey the right message to the public and into the marketplace. Some attendees suggested that the pharmaceutical industry should be more proactive in generating opposition to the current administration. It was acknowledged that “big pharma” has taken steps, especially through extending relationships with advocacy groups. However, there remains a notion that the pharmaceutical industry needs to embrace the concept that “dead people do not buy medications.” This means that they should embrace concerted efforts to protect patients and patient access, not just from a position of altruism but as a sensible business strategy. The reality is, as Dr. Adam J. Fein of the Drug Channels Institute has pointed out, "a growing number of Part B drugs now have inflation-adjusted coinsurance rates that are rising, not falling...[and] in many cases, the rate dips temporarily before snapping back to the standard 20%." It begs the question: Are patients paying more?

Photo Source: Drug Channels Institute

Discussions of messaging also zeroed in on patient perception. The issues surrounding the IRA and its various aspects are complex, even for those well-versed in the issue. Attendees emphasized the importance of engaging patients by creating messaging that is simple yet resonates with their humanity in ways they understand. The price is being conflated with out-of-pocket costs, and messaging needs to highlight how the IRA can increase out-of-pocket costs for patients.

The Cancer Support Community (CSC) has developed patient-centered principles to help guide its advocacy work, which is available online. These patient-centered principles are also included in CSC's sign-on letter on the EPIC Act, to which ADAP Advocacy also signed.

With so many of the IRA's targeted drug price controls falling on chronic health conditions and rare diseases, such as cancer and HIV, they have the potential to fuel already exacerbated health disparities among medically underserved communities. The sole focus on "price" largely ignores the money saved by treating these conditions with life-altering and life-saving therapeutics. Sadly, proponents of these anti-patient drug price controls—including several groups financed by Arnold Ventures' special interests efforts pushing harmful state drug affordability boards, or PDABs—leverage potentially harmful metrics. Among them is the dehumanizing quality-adjusted life years (QALYs). 

Suggestions included campaign-style messaging that utilizes both traditional and non-traditional media to educate patients by making the message more personal. Presenting the public with stories that explain how specific policies directly affect aspects of their daily lives is a way to empower patients and transform the patient community into a voting bloc. Populist patient-centered messaging and actions promote community building to engage policymakers as well as empower citizens. 

Going forward, discussions also emphasized the importance of finding ways to navigate within the confines of the challenging current administration, as its operations are adversarial, unpredictable, and unprecedented. The consensus indicated that an effective way to do this is to make “new friends.” This means engaging with untapped entities, such as labor unions, insurance commissions, Ryan White service providers, and disability groups. Many entities that potentially could be drastically affected by the IRA and other issues are unaware of their risk of adverse outcomes. Forging new avenues of communication with groups like these is a way to create infrastructure that can effect change.

Woven throughout the day's policy analysis was recognition that patient advocacy groups need to push back harder against the fallacy that their advocacy efforts aren't genuine simply because they accept financial support from drug manufacturers. Ongoing attempts to discredit patient advocacy by faux news outlets, such as the 340B Report, ignore the realities that patients and drug manufacturers often have shared interests, and that the financial support provided by industry acknowledges those values. It is also disingenuous to have patients living with chronic health conditions and rare diseases be faulted by paternalistic critics who aren't patients themselves.

ADAP Advocacy would like to publicly acknowledge and thank Jen Laws, Heidi Mesik, Michiel Peters, Jazlyn Gallego, and Matt Toresco for co-facilitating this critically important discussion.

Additional Fireside Chats are planned for 2025 in Atlanta (September).

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Is Trump's Executive Order on Most Favored Nations Drug Pricing a Wet Noodle?

By: Ranier Simons, ADAP Blog Guest Contributor, and Marcus J. Hopkins, ADAP 340B Consultant

The Trump Administration’s policies continue to generate uncertainty and disarray in most sectors of the economy in the United States, especially healthcare. On May 12, 2025, another executive order aimed at “reducing prescription drug costs” was signed. The President issued Executive Order (EO) 14297, ‘Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients’, with the false claim that prescription drug and pharmaceutical prices will be reduced, almost immediately, by 30% to 80%. In actuality, the EO is vague, flawed, and has the potential to do damage to many areas within the healthcare ecosystem. The EO was presented as a strong-armed mandate to effect swift change to the status quo. However, STAT’s Matthew Herper reported, "As pharmaceutical investors see it, he stomped loudly and wielded a wet noodle" (Herper, 2025).

Photo Source: The White House

The premise of the EO is that the status quo of what the United States pays for prescription drugs compared to other developed foreign markets is unfair; thus, the imbalance needs to be corrected. The narrative presented is that drug manufacturers are taking advantage of American consumers and the government by charging the United States exorbitant prices for drugs to offset the low prices other foreign governments demand for the same drugs. A direct quote from section one of the EO states, “Drug manufacturers, rather than seeking to equalize evident price discrimination, agree to other countries’ demands for low prices, and simultaneously fight against the ability for public and private payers in the United States to negotiate the best prices for patients.”

According to the nonprofit RAND Corporation, a nonpartisan research organization, the United States pays almost three times what approximately 33 other comparatively developed nations pay for the same prescription drugs (Mulcahy, Schwam & Lovejoy, 2024). However, RAND Corporation’s 'apples to apples' findings ignore numerous factors that separate the United States from the other developed nations, thus calling into question the simplified comparison.

The following is an overview prepared by ADAP Advocacy on how the mechanisms of the EO describe solutions to the problem, including relevant notes:

1. Ordering the Secretary of Commerce to identify “foreign nations freeloading”—a catch-all term that will attempt to identify any “act, policy, or practice” that may be “unreasonable or discriminatory” or that “may impair United States national security and that has the effect of forcing Americans to pay for a disproportionate amount of global pharmaceutical research and development, including by suppressing the price of pharmaceutical products below fair market value.” (Editor's Note): This process is unlikely to consider that almost all these developed nations do not use the free-market for-profit healthcare model used by the United States, but have implemented a Universal or Single-Payer healthcare model. This means that there is one organized purchaser of these medications. If pharmaceutical companies wish to sell their products in those countries, they can either agree to the terms that those nations specify for the drugs or refrain from selling their drugs there. Meanwhile, in the United States, a patient's price for a drug can vary significantly from patient to patient, depending on their insurer. This means that every single payor (except for Medicare) must negotiate with pharmaceutical companies to determine what price they will pay, and those negotiations are protected by “trade secrets” laws that shield the entire process from consumers and most lawmakers.
2. Enabling direct-to-consumer sales of drugs from pharmaceutical companies to patients. This is an interesting proposal that can potentially eliminate several middlemen from the existing domestic drug procurement and purchasing system. (Editor's Note): Currently, by the time a patient actually purchases a medication from their pharmacist, it has already passed through at least two middlemen—drug wholesaling companies and pharmacy benefit managers (PBMs)—and each middleman is attempting to make a profit. This means that, even if the starting acquisition cost of a medication is $20/bottle, to make a profit, the wholesaler will mark up the cost to $22/bottle, which will require the pharmacy to mark up the cost to $24/bottle…but then, for the PBM to make a profit, they will pocket a percentage of the reimbursement to the pharmacy, which will necessitate increasing the price to $26/bottle in order for the pharmacy to make a profit.
3. By allowing pharmaceutical companies to sell their drugs directly to patients, the Trump Administration could potentially decrease consumer costs, but risks putting pharmacies out of business or creating a model where pharmaceutical companies could purchase pharmacies outright and increase their profits while putting local and community pharmacies out of business.
4. Enabling “Most-Favored-Nation Pricing” (MFN) by instituting price controls through administrative rulemaking. This would allow the Secretary of the U.S. Department of Health and Human Services (HHS) to request that pharmaceutical manufacturers come to the table with the federal government to agree upon a maximum price that they can charge for medications in the United States. This would first be done voluntarily…with the threat of involuntary price controls and the removal of drug approval by the U.S. Food and Drug Administration (FDA).

Photo Source: Market.us Media

If pharmaceutical companies don’t agree to the terms set forth by this administration, the various Department Secretaries are empowered to:

a.) Propose a rulemaking plan that would “impose most-favored-nation pricing;”

b.) Allow drug importation from foreign countries (a position which ADAP Advocacy vehemently opposes);

c.) “Review” potential actions that could be taken to prevent the exporting of drugs to other countries (i.e., forbid U.S.-based manufacturers from exporting drugs);

d.) Review and modify approvals granted for drugs, which would force drug manufacturers to take their medications off the market—a punitive move that is likely illegal (Payne & Silverman, 2025); and

e.) “…address global freeloading and price discrimination against Americans.”

On its face value, the EO is hazy and does not explain much of its implementation. The overall theme is ‘facilitate, study, and propose’. There are several essential questions the EO leaves unanswered:

• How will HHS determine “Most-Favored-Nation” pricing?

• Which classes and how many drugs will be included in this pricing?

• Will this only apply to drugs purchased by Medicaid, Medicare, and Veterans Affairs, or will this apply to commercial insurers and the uninsured, as well? (Franco, 2025)

Most importantly, much of what the President desires to do requires cross-agency cooperative Congressional legislative action (Payne & Silverman, 2025). Nothing in the EO represents actionable endeavors that will reduce drug prices for Americans in the immediate future. For example, the EO directs HHS to set target prices for negotiations with drug manufacturers in the next 30 days. If, after an unspecified time, drug manufacturers have not voluntarily made “significant progress,” that is when rulemaking will begin to force MFN pricing.

Politics surely makes for strange bedfellows. Congressional Democrats were quick to embrace this latest EO – evidenced by Representative Ro Khanna, who represents California's 17th congressional district, introducing legislation to codify MFN into law. Sen. Bernie Sanders, one of the pharmaceutical industry’s greatest detractors, called on Republicans to support federal legislation mirroring the EO. It is unlikely any Republican would support an effort to impose price controls on pharmaceutical products.

Photo Source: X

The top two Republican Senators, Senate Majority Leader (SD) and Senate GOP Whip John Barrasso (WY), have already expressed skepticism about an MFN pricing model. Wall Street didn't seem too alarmed by its prospects, either. POLITICO's headline read, "Wall Street shrugs at Trump’s most-favored order," in an article that featured colorful responses from investment groups. Still, some organizations remain on the fence (Gardner & Lin, 2025).

The reality is that the MFN approach to "fixing" healthcare costs associated with prescription drugs ignores the complexities of the healthcare ecosystem. Moreover, instituting MFN pricing would be financially devastating to drug manufacturers. It would result in a drastic revenue reduction in tandem with the Trump Administration’s recently threatened pharmaceutical tariffs (Reed, 2025). It is not sustainable for pharmaceutical companies to lower domestic prices to the levels of the lowest foreign countries. In speaking with the Wall Street Journal, Stephen Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota College of Pharmacy stated, “The first thing we have to realize is if another country’s getting a drug at one-tenth of the price that we are, we’re not going to get all of our drugs at one-tenth of the price we’re paying now” (Hopkins & Loftus, 2025). 

For example, instituting an international pricing model for Medicaid would cost drug manufacturers an estimated $1 trillion over the span of a decade (Hopkins & Loftus, 2025). Drug companies would have to raise the prices that other countries are paying for drugs. Coincidentally, the President stated that other countries will have to pay more for drugs to expressly pay their ‘fair share’ for innovation and development (Hopkins & Loftus, 2025). Thus, the administration aims to disrupt the global pharmaceutical market. Convincing other countries to modify and increase their expenditures drastically does not appear plausible.

MFN pricing also threatens programs like the 340B Drug Pricing Program, given that it would drastically reduce rebates. Reducing 340B funding would adversely affect providers and covered entities that serve vulnerable populations (Lopez, 2025). This change would have a devastating impact on the State AIDS Drug Assistance Programs (ADAP). There could also be unintended consequences for the Medicaid Drug Rebate program, as MFN pricing would reduce federal matching Medicaid dollars. Dangerously, the MFN idea tangentially invites using quality-adjusted life years, or QALY, to make pricing decisions. While outlawed in the United States, many foreign governments use QALYs, which are discriminatory methodologies that devalue the lives of vulnerable populations. These measures also ignore the lived experiences of diverse racial and ethnic groups (Lopez, 2025).

Photo Source: STAT News

PlusInc, a nonprofit dedicated to health equity, has demonstrated how QALYs fuel health disparities. In a recent analysis, PlusInc argued, "If the math behind QALYs seems obtuse, you’re not alone—one of the primary criticisms of the QALY is that the methodology behind determining how a QALY is measured is predicated upon a lot of assumptions that may or may not hold true across every community. Some recognized experts who have studied QALYs have expressed concern over their impact on health equity."

Mike Eging, who leads the Rare Access Action Project (RAAP), summarized many of the concerns being expressed about the proposal: "Many rare products are developed through family foundations set up by patients and families to seek therapies to treat not just loved ones, but also their patient communities. Others are discovered by passionate scientists in universities, or through emerging smaller companies with only one or two products in development. These efforts can lead to therapies, some of which are never launched overseas due to price controls and regulatory hurdles. Or, they require partnerships with larger companies to navigate an expensive launch in Europe, at a price they no longer control. Further, some emerging rare companies never launch in Europe due to these challenges. Application of MFN to rare products could have a chilling effect on investment in these situations and across the rare disease in general. Rare medicines were exempted from the first iteration of this policy. We hope that continues."

EO 14297 is rife with vagaries but has the potential to do more harm than good. Threatening pharmaceutical revenues could reduce investment in developing needed therapies (Lopez, 2025). Legally, as it stands, the government would not be able to set prices outside of the Medicare program. Mandating the pricing of commercial, privately owned companies would require acts of Congress that would take lots of time and litigation (Jacobson, 2025). Patients could lose medication access due to a complex system response to adversarial price negotiations. Disrupting foreign markets could adversely affect international relations.

The ongoing debate over drug pricing in the United States is essential to the overall healthcare conversation. However, the EO does not present a foreseeable effective path for improving the status quo. In agreement with the EO’s objective of more equitably sharing research and development costs across countries, a Lily spokesperson expertly summarized the challenge stating, “an MFN approach is not the answer to help patient affordability; instead, lower prices for consumers in the United States can only happen if intermediaries take less for themselves” (Hopkins & Loftus, 2025). For these reasons, it is hard to understand why any patient advocacy organization could find itself supporting this approach.

[1] Franco, M. A. (2025, May 14). Trump Administration Revives Most-Favored-Nation Drug Pricing: Here's What to Know. Holland & Knight: Insights. Retrieved from https://www.hklaw.com/en/insights/publications/2025/05/trump-administration-revives-most-favored-nation-drug-pricing

[2] Gardner, L., Lin, D. (2025, May 13). Wall Street shrugs at Trump’s most-favored order. Retrieved from https://www.politico.com/newsletters/prescription-pulse/2025/05/13/wall-street-shrugs-at-trumps-most-favored-order-00342967

[3] Herper, M. (2025, May 13). To understand why investors rejoiced at Trump’s attack on drug firms, think like a pharma CEO. Retrieved from https://www.statnews.com/2025/05/13/trump-drug-pricing-plan-analysis/

[4] Hopkins, J., Loftus, P. (2025, May 12). Drugmakers Avoid Worst-Case Pricing Scenario for Now. Retrieve from https://www.wsj.com/health/pharma/trump-drug-price-plan-pharmaceutical-companies-217f809b?st=UrWWgU&reflink=desktopwebshare_permalink

[5] Lopez, T. (2025, May 14). Most Favored Nation vs. Human Sustainability: How Federal Price Controls Fight Biology—and Americans Lose. Retrieved from https://nmqf.org/resource-library/most-favored-nation-vs-human-sustainability-how-federal-price-controls-fight-biology-and-americans-lose/

[6] Mulcahy, A., Schwam, D., Lovejoy, S. (2024, February 1). International Prescription Drug Price Comparisons: Estimates Using 2022 Data. Retrieved from https://www.rand.org/pubs/research_reports/RRA788-3.html

[7] Jacobson, L. (2025, May 14). Donald Trump exaggerates speed, certainty of prescription drug price reductions. Retrieved fromhttps://www.politifact.com/factchecks/2025/may/14/donald-trump/prescription-drug-price-cut-executive-order/

[8] Payne, D. & Silverman, E. (2025, May 12). Our biggest burning questions on Trump’s order to bring down drug prices. Retrieved from https://www.statnews.com/2025/05/12/trump-executive-order-drug-prices-analysts-five-questions-agency-authority-court-challenges/

[9] Reed, T. (2025, May 7). Pharma shipments surge as Trump tariff threat looms. Retrieved from https://www.axios.com/2025/05/07/tariffs-imports-drugs-pharmaceuticals

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.