Showing posts with label cost-sharing. Show all posts
Showing posts with label cost-sharing. Show all posts

Thursday, January 22, 2026

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.

Fact Sheet: President Donald J. Trump Announces Largest Developments to Date in Bringing Most-Favored-Nation Pricing to American Patients
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.

Pfizer CEO Albert Bourla joined President Trump at the White House on Sept. 30 to announce a voluntary effort to reduce some drug prices. Pfizer was the first of 16 companies to announce a deal with the Trump administration, but the details remain under wraps. (Win McNamee | Getty Images)
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.

TrumpRx
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/

Thursday, January 15, 2026

Trump Administration Pushes Two New Rebate Models, But Will They Help Patients?

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

The Centers for Medicare and Medicaid Services (CMS) has released information about a new proposed mandatory pricing model—the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model—that would assess the inflation rebate amounts paid for certain medications covered under Medicare Part D using a benchmark derived from international pricing information rather than using current domestic benchmarks (CMS, 2025).

Centers for Medicare and Medicaid Services
Photo Source: CMS

The GUARD model is one of two pricing models being proposed by the Trump Administration—the other being the Global Benchmark for Efficient Drug Pricing (GLOBE), which would assess inflation rebates for drugs covered under Medicare Part B.

In both models, the Trump Administration plans to use modeling to employ drug “rebate models,” which are payment models ostensibly intended to lower the cost of medications by having drug manufacturers return a percentage of the purchase price to the buyers. These rebates are generally negotiated behind closed doors between payors, including pharmacy benefit managers (PBMs), insurers, and government programs, with drug manufacturers. Once those rebate amounts are set, drug manufacturers remit rebate payments to payors only after the drugs have been purchased and dispensed (SmithRx, 2025).

CMS's GUARD Model would attempt to reduce Medicare drug spending by tying prices to international benchmarks and collecting rebates from manufacturers when prices exceed those. 

Rebates, such as the proposed 340B Drug Pricing Program rebate model, can be an effective means of introducing cost savings into health care systems and indirectly helping patients, because they bring added transparency. In the case of the GUARD Model, they can also disadvantage patients. That is because the rebated price is not known at the time that the patient is dispensed the medication. Accordingly, out-of-pocket costs are calculated based on the higher "list" prices of drugs, forcing patients to pay more in deductibles, coinsurance, and copayments at the pharmacy counter.

In essence, the wider health care system may benefit from a rebate, but the patient may see no reduction in their costs. The 340B rebates differ from GUARD/GLOBE in that 340B rebates are specifically designed to be passed onto the consumer in the form of increased investment in/access to/savings for healthcare services. GUARD/GLOBE rebates are specifically designed to go to payors, with no requirements whatsoever that those revenues be reinvested or savings passed on.

Drug rebate models have been in place in the U.S. since the 1990s, with the creation of the Medicaid Prescription Drug Rebate Program (MDRP) under the Omnibus Reconciliation Act. They are also actively used in at least 31 European countries, including Italy, Portugal, Spain, France, Germany, and the United Kingdom (Vogler et al., 2012).

REBATE
Photo Source: ADAP Advocacy | iStock

The primary rationale behind these rebate models is that requiring manufacturers to pay rebates to payors incentivizes drug manufacturers to keep drug prices lower. While this might be true in nations where this is a single payor, such as those listed above, rebate models in the U.S. have objectively poorer outcomes.

Recent research from the Leonard D. Schaeffer Institute for Public Policy & Government Service out of the University of Southern California found that, on average, every $1 increase in rebates was associated with $1.17 increase in list prices, particularly for single-source drugs—a Food and Drug Administration (FDA)-approved medication available from only one manufacturer, often lacking a generic equivalent, and specifically the types of drugs that will be evaluated under both the GUARD and GLOBE models being proposed (Sood et al, 2020).

Another study examined rebates for 444 unique branded medications and found that, while drug manufacturers may increase list prices in order to offer larger rebates to payors, consumers—particularly those lacking health insurance coverage—experienced statistically significant increases in out-of-pocket costs for those medications (Yeung et al., 2021).

Decades of research confirm what people living with HIV/AIDS already know: out-of-pocket costs lead to skipped doses, delayed refills, or complete abandonment of prescriptions. 

Public health data from the Centers for Disease Control show that a significant share of people living with HIV/AIDS (PLWHA) report cost-related non-adherence. A 2019 study found that 7% of PLWHA in the U.S. reported non-adherence to prescribed dosing due to cost-related concerns, with another 4% reporting skipping doses, 4% reporting taking less medicine, and 6% reporting delaying medication purchases (Beer et al., 2019).

Sadly, PLWHA facing affordability challenges may delay or abandon medications because they are unable to afford out-of-pocket costs.  These cost-saving behaviors are directly associated with lower rates of viral suppression, poorer health outcomes, and increased strain on the healthcare system.

Research has also demonstrated that very small cost-sharing amounts can have outsized effects. Studies examining HIV prevention and treatment medications have found that prescription abandonment rates rise sharply when out-of-pocket costs increase from $0 to even $10 (Dean et al., 2024). Persistence on therapy drops as costs rise—a finding that should concern everyone.

Patient cost-sharing
Photo Source: ADAP Advocacy | iStock

Put simply, when patients pay more, adherence suffers, and people's health suffers.

In order for rebates to truly result in lower costs for consumers, the U.S. would need to do away entirely with our multi-payor healthcare model, which requires different payors (both for-profit and government-based) each have to enter into pricing and rebate negotiations with drug manufacturers to set prices and rebate amounts.

Pressure campaigns are effective only when pressure is applied from all sides. While drug manufacturers are unlikely to abandon a revenue cash cow like the Medicare program, they still have non-Medicare-enrolled consumers onto whom they can push increased drug prices with few to no negative outcomes. Consumers have come to not only accept but also expect medication price inflation, especially when there are few, if any, viable comparable alternative therapies available to them.

What the GUARD and GLOBE programs are intended to do is force manufacturers to provide higher rebates for medications that CMS deems “too expensive.” This, they posit, will result in lower drug costs for seniors and those non-seniors who rely on Medicare for drug coverage. The reality is that those consumers will likely realize few, if any, net savings from these programs, so long as there are multiple payors willing to pay whatever price is needed to move medications to their customers.

Although the GUARD proposal may seem promising to some, it does not require that these rebates be automatically passed on to patients in the form of lower out-of-pocket costs. That central problem needs to be addressed before the proposal is finalized and implemented.

The proposal states that it hopes that lower GUARD prices will benefit patients. The proposal says that "[i]t is possible that in response to the alternative payments]" GUARD creates manufacturers might "reduce their net price" in an effort to reduce the GUARD Model rebate payments. If so, then there might be some chance that patients would benefit from the GUARD prices. 

But the "possibility" that GUARD "might" help patients at the pharmacy counter just is not good enough. ADAP Advocacy plans to submit public comment in response to these proposals that address the patient perspective.

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] Beer, L., Tie, Y., Weiser, J., & Shouse, R. L. (2019, December 13). Nonadherence to Any Prescribed Medication Due to Costs Among Adults with HIV Infection — United States, 2016–2017. Morbidity and Mortality Weekly Report, 68(49): 1,129-1,133 http://dx.doi.org/10.15585/mmwr.mm6849a1

[2] Centers for Medicare and Medicaid Services. (2025, December 29). GUARD (Guarding U.S. Medicare Against Rising Drug Costs) Model. United States Department of Health and Human Services: Centers for Medicare and Medicaid Services: Priorities: Overview: Innovation Models. https://www.cms.gov/priorities/innovation/innovation-models/guard

[3] Dean, L. T., Nunn, A. S., Chang, H. Y., Bakre, S., Goedel, W. C., Dawit, R., Saberi, P., Chan, P. A., & Doshi, J. A. (2024). Estimating The Impact Of Out-Of-Pocket Cost Changes On Abandonment Of HIV Pre-Exposure Prophylaxis. Health affairs (Project Hope), 43(1), 36–45. https://doi.org/10.1377/hlthaff.2023.00808

[4] SmithRx. (2025, March 21). How Drug Rebates Influence Prescription Costs for Employers. San Francisco, CA: SmithRx. https://smithrx.com/blog/how-drug-rebates-influence-prescription-costs-for-employers

[5] Sood, N., Ribero, R., Ryan, M., & Van Nuys, K. (2020, February 11). The Association Between Drug Rebates and List Prices. Los Angeles, CA: University of Southern California: Leonard D. Schaeffer Institute for Public Policy & Government Service. https://schaeffer.usc.edu/research/the-association-between-drug-rebates-and-list-prices/