Comments urging the Pharmacy Quality Alliance to develop a new PrEP adherence measure

Submitted electronically via MyPQA

To whom it may concern:

The HIV+Hepatitis Policy Institute, a leading national policy organization promoting quality and affordable healthcare for people and communities affected by HIV, viral hepatitis, and other serious and chronic health conditions, thanks the Pharmacy Quality Alliance (PQA) for the opportunity to provide comments on PQA’s proposed measures and measure updates for the 2027 Measurement Year. Quality measurement in HIV care is a critical way to improve outcomes across the healthcare system and to support efforts to bring the HIV epidemic to an end. We thank PQA for its decision to establish this inaugural Annual Measure Public Comment period.

HIV Treatment
We support PQA’s proposed retirement of the Proportion of Days Covered: Antiretroviral Medications (PDC-ARV) measure, as long as PQA commits to the timely development of a new measure that reflects modern HIV treatments.

We agree with PQA’s assessment that HIV treatment has changed since the creation of the ARV measure. In 2011, all HIV treatment regimens consisted of a combination of three antiretroviral drugs, the vast majority of which were daily oral medications. Single-tablet regimens (STRs) were starting to become widely prescribed. Fifteen years later, a new long-acting injectable complete regimen is available and recommended in treatment guidelines, with further long-acting agents in the drug development pipeline. Two-drug regimens are also now available and one of the four current regimens recommended as preferred first-line treatments is a two-drug regimen.

Active measurement of HIV treatment adherence and persistence keeps the health system accountable for sustained viral suppression, which keeps the person on treatment healthy and prevents onward transmission. Given the ongoing importance of this measure, we support the timely development of a replacement measure that is better suited to present-day treatments and urge that the transition to a new measure take place without a gap in measurement after the retirement of the old measure.

As treatments have evolved, so have barriers to access. Prior authorization and step therapy requirements cause non-medical switching and harmful benefit designs like copay accumulators increasingly disrupt continuity of care for patients on effective, guideline-recommended regimens. Adherence measures should be able to take insurer-driven interruptions of care into account and distinguish them from gaps caused by a patient’s own choices.

HIV Prevention
We urge PQA to develop an adherence measure for HIV pre-exposure prophylaxis (PrEP).

PrEP has been available since 2012, transforming HIV prevention by giving people vulnerable to HIV a highly effective biomedical tool to prevent HIV acquisition. PrEP is now central to federal and local strategies to end the HIV epidemic, yet its uptake, while steadily improving, is still far too low in certain populations. Adherence and persistence are fundamental challenges to PrEP uptake. In addition to two daily oral regimens, there are now two provider-administered long-acting injectable PrEP medications with further long-acting formulations, including long-acting orals and ultra-long-acting injectables, in the drug development pipeline. We would note that provider-administered dosing means adherence within a given time interval is directly observed and necessarily complete.

With the increased availability of guideline-recommended long-acting injectable treatment and PrEP regimens, the complexity of measuring adherence to treatment and PrEP across the pharmacy and medical benefits has increased considerably.¹ We urge PQA to balance this complexity with the importance of maintaining continuous measurement of ARV adherence for treatment and beginning measurement for prevention.

Though all PrEP formulations are required to be available without cost-sharing or utilization management across a broad range of insurance types, access barriers continue and fall hardest on the populations most affected by HIV. A PrEP adherence measure should be designed to distinguish between patient disengagement and access delays imposed by insurers.

Thank you for your consideration of these comments. If you have any questions, comments, or would like to discuss these issues further, please contact Carl Schmid, Executive Director, HIV+Hepatitis Policy Institute, at cschmid@hivhep.org or (202) 462-3042; or Kevin Herwig, Health Policy Director, HIV+Hepatitis Policy Institute, at kherwig@hivhep.org or (617) 666-6634.

Sincerely,

Carl E. Schmid, II
Executive Director

¹ The complexity of present-day access to ARVs is detailed in a recent report: Pharmacv Benefit vs. Medical Benefit: Deciphering Coverage Pathways for HIV Medications, O’Neill Institute for National and Global Health Law, September 2026: https://oneill.law.georgetown.edu/wp-content/uploads/2026/09/IB-Pharmacy-vs-Medical-Killelea.pdf.