Comments on Washington PDAB affordability reviews of HIV medications

May 19, 2025
Washington Prescription Drug Affordability Board
Washington Health Care Authority
PO Box 42716
Olympia, Washington 98504-2716

Re: Public Comment for May 21, 2025 Board Meeting

Dear Members of the Washington Prescription Drug Affordability Board:

The HIV+Hepatitis Policy Institute is a leading national HIV and hepatitis policy organization promoting quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions. As the Board finalizes its list of prescription drugs to review, we want to reiterate our concerns about the inclusion of HIV and hepatitis medications and encourage the Board to reconsider their inclusion.

Affordability Reviews of HIV Medications
We believe that affordability reviews of HIV medications fail to fully account for the intricacies of the existing HIV safety net, which makes lifesaving HIV treatments affordable for most people. We also want to highlight numerous factors in the global HIV drug ecosystem that would be difficult for a state to effectively consider.

Since the onset of the AIDS crisis in the 1980s, our community has tirelessly fought for access to effective treatments, leading to the establishment of vital safety net programs that ensure HIV care and medications remain affordable. Programs such as the Ryan White HIV/AIDS Program, funded by Congress at $2.5 billion annually, ensures access to HIV treatments and care to low-income people living with HIV.[i] The Ryan White Programs generates $2.8 billion in drug purchases through the 340B program[ii] enabling crucial wraparound services and provide care and treatment to those who cannot afford it. Additionally, drug manufacturers contribute over $1 billion in rebates directly to state AIDS Drug Assistance Programs (ADAPs) all to help with affordability of HIV drugs.[iii]

For example, Washington’s ADAP, known as the Early Intervention Program (EIP), operates with a diverse funding stream that includes federal Part B Ryan White funding, pharmaceutical rebates, and program income. In the 2023–2025 biennium, Washington projected expenditures of approximately $100.7 million for EIP, with anticipated revenues of about $130.7 million, largely driven by manufacturer rebates.[iv] This funding supports access to essential HIV medications and insurance assistance for eligible residents. Further affordability is achieved through additional rebate programs, such as Medicaid drug rebates, which help reduce the financial burden on public programs.

Pharmaceutical manufacturers also play a key role, contributing billions through copay assistance, free medication programs, and global initiatives like PEPFAR, which expand access to affordable HIV treatments worldwide. While gaps in coverage remain, this robust safety net has been instrumental in ensuring people living with HIV receive the care and medications they need at an affordable rate.

Federal policies have further reinforced this safety net, helping to expand access to preventive care. For instance, the Affordable Care Act (ACA) and recommendations from the U.S. Preventive Services Task Force (USPSTF) have eliminated financial barriers by mandating that PrEP (pre-exposure prophylaxis) be available at no cost to most insured individuals. This policy ensures that those vulnerable to HIV can access lifesaving preventive treatments, complementing safety net programs and helping to reduce the spread of the virus for free.

In recent months, the federal government has taken steps to suspend or restructure key HIV programs, contracts, and personnel. These interruptions jeopardize more than three decades of progress in treatment access and prevention. They have introduced uncertainty into the funding streams and service networks that people with HIV rely on every day. At a time when this national infrastructure is already under strain, additional state-level interventions, such as affordability reviews or upper payment limits, could compound that disruption and make it harder for individuals to stay in care, adhere to treatment, and achieve viral suppression. Especially for low-income and marginalized populations, continuity of care is not optional; it is lifesaving.

Affordability reviews of HIV medications may fail to fully capture the complexity and interdependence of safety net programs, which not only ensure affordability for patients but also sustain the broader HIV care infrastructure. Pricing interventions, such as the imposition of upper payment limits (UPLs), could destabilize this ecosystem, jeopardizing access to care and disincentivizing pharmaceutical manufacturers from continuing the research and development that has driven remarkable progress. The transformative innovations enabled by this investment, including longer-acting treatments, preventive therapies, vaccines, and the hope of an eventual cure, could be at risk if the delicate balance of these systems is disrupted.

Importantly, high out-of-pocket costs for patients often stem from systemic issues unrelated to drug pricing, such as insurer practices and pharmacy benefit manager (PBM) strategies. Policymakers should focus on addressing these barriers through targeted reforms, such as regulating PBMs, capping out-of-pocket expenses, and ensuring that copay assistance counts toward deductibles. These solutions can improve affordability for patients without undermining the infrastructure and progress that have revolutionized HIV care.

We strongly believe that affordability reviews of HIV medications are unnecessary, given the comprehensive safety net programs that effectively ensure access to lifesaving treatments. Any future pricing interventions, such as the imposition of UPLs, could destabilize this well-established network, threatening access to care for people living with HIV. Programs like the Ryan White HIV/AIDS Program, the 340B program, and manufacturer copay assistance are critical to sustaining the progress and innovation that have transformed HIV treatment.

Affordability Reviews of Hepatitis C Medications
Similar to HIV treatments, Hepatitis C (HCV) medications have undergone transformative advancements over the past decade, dramatically improving cure rates and reducing treatment duration. The introduction of direct-acting antivirals has revolutionized HCV care, offering cure rates exceeding 95% often within eight to twelve weeks. Competition and negotiated pricing have significantly reduced the costs of these drugs over time, making them much more accessible to those who need them.

The Hepatitis C safety net includes a variety of public and private programs that ensure affordability for most patients. Medicaid programs, the 340B Drug Pricing Program, and pharmaceutical manufacturer assistance programs all play a critical role in expanding access to treatment.

Washington State’s Medicaid program, for example, has implemented an innovative subscription-based payment model for HCV treatments. This approach, sometimes referred to as the “Netflix model,” allows the state to pay a fixed amount for unlimited access to certain Hepatitis C medications over a set period. By lowering the cost per patient and expanding access without imposing price controls, the model shows how states can use innovative purchasing strategies to address affordability concerns within existing systems, making additional pricing interventions like affordability reviews or upper payment limits unnecessary.

Moreover, the financial benefits of curing Hepatitis C far outweigh the costs of treatment. Cures for Hepatitis C have been so effective that by 2026, the cumulative savings will reach $43 billion for the federal government and states.[v] These savings result from reduced healthcare costs associated with liver disease, liver transplants, and other complications of untreated Hepatitis C. Recent analyses estimate that patients with chronic HCV may incur annual healthcare costs of $15,000 to $20,000, which can exceed $60,000 per year if liver disease advances to decompensated cirrhosis or liver cancer. These expenses are disproportionately absorbed by public programs like Medicaid, compounding the financial strain on state health systems. Investing in curative therapies not only improves patient outcomes but prevents these escalating costs.

For these reasons, we strongly believe that affordability reviews of Hepatitis C medications are unnecessary. The existing safety net programs and strategic pricing models already facilitate broad access to curative therapies, and any pricing interventions could undermine ongoing progress toward Hepatitis C elimination.

As we look ahead, it is critical to protect and strengthen the programs that have made HIV and Hepatitis C treatments accessible and affordable. Policymakers should focus on targeted solutions that address out-of-pocket costs and insurance barriers, rather than implementing pricing interventions that could undermine existing safety nets. By preserving and enhancing these frameworks, we can continue to advance toward the ultimate goal of eliminating HIV and Hepatitis C as public health challenges.

Thank you for your consideration of these comments. We welcome the opportunity to serve as a resource as the Board continues its important work to advance affordable and equitable healthcare for all Washingtonians. If you have any questions or need any additional information, please do not hesitate to reach out to our Government Affairs Manager, Zach Lynkiewicz, at zlynkiewicz@hivhep.org.

Sincerely,

Carl E. Schmid II
Executive Director

[i] Ryan White HIV/AIDS Program Funding: FY 2015–FY 2024 appropriations by program

[ii] 2023 340B Covered Entity Purchases

[iii] 2024 National RWHA Part B ADAP Monitoring Project Annual Report

[iv] Washington State Department of Health

[v] American Journal of Managed Care. Impact of Direct-Acting Antiviral Use for Chronic Hepatitis C on Health Care Costs in Medicaid: Economic Model Update. December 2022.

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