11.30.18

World AIDS Day: Spotlight on Scientific and Policy Innovation

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Tomorrow is World AIDS Day. The first-ever global health day, World AIDS Day has been observed on December 1st since 1988. It is an opportunity to remember the history of HIV and those we have lost, to reflect on the worldwide effort to end the HIV epidemic, to show support for those living with HIV, and to look forward to advancements and progress ahead.

One exciting area of innovation is long-acting HIV treatment and prevention. Long-acting products (injections, implants or oral medications) have enormous potential in transforming HIV treatment. They are drugs that do not require daily dosing—possibly only requiring a few administrations a year. These drugs would go a long ways towards helping those who face challenges with adherence and maintaining methods of prevention.

These are exciting developments in HIV treatment and prevention, however, there is still significant work to accomplish to ensure these drugs reach those who need them. Complex issues that lay ahead: Food and Drug Administration (FDA) approval for safe and effective use, defining the intended market, payer coverage and access, and other policy issues that affect drug pricing. These drugs can be quite costly—a recently FDA approved long-acting product, ibalizumab (Trogarzo), an intravenous injection administered every 14 days, has an estimated wholesale cost of $118,000 per year. To achieve the benefits of innovative products, policy shapers, federal agencies, community partners, medical providers, and researchers must all be jointly engaged in considering how best to supply them to consumers.

Some suggest implementation of transparency legislation to hold drug manufacturers accountable, which would require manufacturers to justify price increases above a certain threshold. Annual reporting would also be required on production costs, profits, and marketing spending. Others suggest increased state negotiation power, which would allow states greater leverage in obtaining supplemental rebates for costly drugs. The Trump Administration on October 25, 2018 proposed  “International Pricing Index Model for Medicare Part B Drugs,” which is meant to cut costs of drugs by aligning them with international prices. This may have an impact on the new long-acting drugs if they fall under in-patient and preventative service benefits under Medicare Part B.

World AIDS Day is tomorrow, and we eagerly look forward to the positive impacts of scientific and policy innovation. However as we do so, we must not forget the issues that are still persisting. HIV disproportionately impacts communities of color, and undocumented individuals particularly face increased health challenges and healthcare access. We must continue to use the tools we have and advocate for sound policies that promote and protect healthy lives.

  • For more information regarding long-acting products, the O’Neill Institute and amfAR have jointly produced four briefs on this topic and an expert panel discussion is available
  • Concerned about health access? Consider submitting a comment on the Trump Administrations Public Charge policy, “Inadmissibility on Public Charge Grounds”. The formal Public Charge Notice of Proposed Rulemaking has been issued; there are 60 days to commentwith a deadline of December 10, 2018.

This blog post was co-authored by Airin Chen, a second-year law student at Georgetown Law and a research assistant at the O’Neill Institute.

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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