Comments on Draft COMAR 14.01.04 Revisions

HealthHIV supports the Board’s goal of improving affordability and continues to weigh in through the lens of our work with Maryland partners to strengthen HIV treatment and prevention access.

That matters in Maryland because the state’s Integrated HIV Prevention and Care Plan depends on people being able to start and consistently stay connected to affordable HIV treatment and prevention services. As stakeholders and contributors to the state’s HIV planning body and its vision, HealthHIV has seen how decisions can affect progress toward Ending the HIV Epidemic in the U.S. goals, Ryan White implementation efforts and the safety-net programs that help people remain engaged in care.

Although the draft regulations do not specifically identify HIV medications, they establish a process for identifying, referring and selecting prescription drug products for cost review that could include HIV treatment and prevention medications. If cost review focuses too narrowly on price or payer cost, it can create different costs, unmet needs and access barriers elsewhere in the system. Recent examples involving formulary restrictions and dispensing models in Florida’s AIDS Drug Assistance Program (ADAP) have shown how state payer changes can affect HIV coverage, prior authorization, utilization management and access to widely used HIV medications. So, too, Colorado’s Department of Health Care Policy and Financing (HCPF) has proposed reinstating prior authorization determination processes for HIV medications under Medicaid. Each example raises the same practical concern: state-level affordability, coverage or utilization management decisions can affect access to widely used HIV medications. 

The draft uses therapeutic class, therapeutic equivalents, NDCs, active moiety and active ingredient as part of the review process. For HIV medications, those categories do not tell the full clinical or access context. Treatment decisions depend on resistance history, prior treatment experience, drug-drug interactions, tolerability, hepatitis B status, renal and metabolic considerations, adherence needs and patient-provider decision-making. A regimen that appears comparable in a dashboard may not be comparable for the person taking it every day, especially when resistance history is not fully captured across counties, states and care systems.

Therapeutic equivalence may look clean on paper, but in HIV it can hide costs the system has not examined when benefit design or access decisions lead to non-medical switching, unmet medical need, adherence disruption, additional monitoring or resistance testing, or increased transmission risk tied to avoidable access instability. For people who rely on lifelong HIV treatment or prevention medications, access is then further and repeatedly re-tested by annualized plan design, pharmacy access to specific or preferred sites, carrier rules, eligibility processes, refill cycles, benefit changes and consultation requirements. Those recurring checks can turn stable treatment or prevention into an ongoing administrative burden, including through Ryan White and Medicaid eligibility determinations, and can shape both the person’s HIV care continuum and the payer and provider systems expected to support it. Coverage disruption is not a single event; it can become the monthly and annual grind of staying on HIV treatment or prevention.

Single-tablet regimens and regimen stability also matter as a matter of practice, especially for people with complex health needs, polypharmacy and multiple medications, unstable coverage or long treatment histories. For many people with HIV, the question is not whether another regimen exists on paper, but whether a change disrupts adherence, pharmacy access or long-standing treatment stability. Cost review should therefore account for regimen simplicity and stability, not only gross spending, WAC, payer cost or patient out-of-pocket cost.

Small disruptions in HIV medication access are not clinically neutral. Coverage changes, formulary movement, prior authorization, pharmacy access problems or pressure to switch regimens can affect viral suppression, resistance risk and continued engagement across the HIV care continuum.

With that, HealthHIV’s concern continues to be straightforward: if HIV treatment or prevention medications are considered for cost review, affordability decisions have to be evaluated by how they affect patient access, adherence, viral suppression, PrEP use and the programs that help people stay connected to care and prevention. Within HIV care, affordability is not experienced in one uniform way across the state. Across populations, communities and even ZIP codes, adherence shapes health outcomes, longevity and onward transmission risk across a lifetime. Changes that disrupt access can affect the long arc of treatment stability and HIV prevention.

HealthHIV also appreciates that the draft provides a 30-day comment window for public input on staff-developed therapeutic alternatives. That opportunity matters. But for HIV treatment and prevention medications, determining whether a proposed therapeutic alternative is meaningful in real life is not a simple paper review. It requires more than comparing products by therapeutic class, price or formulary placement. The Board would need to evaluate whether the alternative is clinically appropriate, whether it addresses the same clinical need, whether people can access it through their coverage or pharmacy, and whether changes would affect ADAP, Ryan White providers, Medicaid programs or other safety-net systems that help sustain HIV care. That access question is not simple in HIV, because the system determining who is affected is fragmented across payers, pharmacies, public programs and safety-net providers.

Much of that information is not available in one place and may require targeted outreach, provider and patient input, payer context and some level of qualitative or quantitative data collection. A 30-day window may allow organizations to flag concerns, but it may not be enough time to produce the condition-specific, real-world evidence the Board would need to understand whether a listed therapeutic alternative is actually workable for HIV treatment or prevention.

Cost review should account for outcomes that are central to HIV care and prevention, including adherence, viral suppression, PrEP use, prevention value, treatment stability and uninterrupted access. These outcomes may not be fully captured by price, rebate, claims or gross spending data. In HIV, affordability cannot be separated from whether people can start, stay on and continue the medications that support individual health and prevent new infections.

HealthHIV recommends that the final regulations make clear that therapeutic alternatives and future affordability actions will be evaluated for clinical context, patient access and safety-net impact. Maryland can pursue prescription drug affordability while protecting the treatment stability and public health gains that sustained HIV treatment and prevention make possible.