HJBR May/Jun 2019
Healthcare Journal of BATON ROUGE I MAY / JUN 2019 45 Rebekah E. Gee, MD, MPH Secretary, Louisiana LDH law (28 U.S.C. Section 1498) to help obtain affordable drugs, as there was precedent for the federal government to unilaterally license and provide reasonable compensa- tion for intellectual property in instances of compelling national interests (for exam- ple, night vision goggles). To explore the idea further, Sharfstein convened a confer- ence of advocates and legal and policy ex- perts inApril 2017 to discuss the viability of this option for Louisiana, should voluntary approaches not be successful. The Depart- ment of Health of Louisiana then received public comments on this concept, and the overwhelming majority of the 102 com- ments received were supportive. However, the pharmaceutical industry was less than enthusiastic about this possibility and reg- istered its reservations. The Subscription Model To continue the work, I assembled a team of economists and policy experts from across the country. In 2017, our focus shifted to the idea of a voluntary subscrip- tion model. This idea was a variant of Aus- tralia’s approach to hepatitis C and was put forward as the Netflix approach by Peter Bach, Louisiana Senator Bill Cassidy (R), and Mark Trusheim, and informed by the recommendations of the National Acade- my of Sciences Engineering andMedicine’s hepatitis elimination committee. The idea seemed to have real potential. Here’s how a subscription-based pay- ment model works: At its foundation, it is an agreement between the state and a pharmaceutical manufacturer in which the state commits to contracting with a pharmaceutical manufacturer and spend- ing a capped amount on that manufactur- er’s hepatitis Cmedication, in exchange for universal access to the drug for a particu- lar population. In effect, Louisiana would gain access to needed medications, while the selected drug manufacturer would be guaranteed a set level of revenue. The medications would then be used to treat those infected in the state’s Medicaid and incarcerated populations. With Governor Edwards’ endorsement, I asked the National Governor’s Association (NGA) if it would be interested in conven- ing other states to discuss policy solutions, to ensure that we weren’t alone in our jour- ney. With the generous support of the Lau- ra and John Arnold Foundation, the NGA convened 11 states to explore meaningful change and, in August 2018, published the report cataloging several ideas—the sub- scription model among them. Meanwhile, we contacted CMS to make sure we did not get too far down the road toward implementation, to avoid hitting an unanticipated roadblock. We initially thought we would need a Medicaid waiver, but expert CMS staff helped us to develop a model that uses existing mechanisms of the supplemental rebate program to ensure access for the state’s Medicaid population and the 340B drug discount program to ensure access to the state’s corrections population. Engaging The Pharmaceutical Indus- try Our discussion with the pharmaceuti- cal industry became more positive as the market for hepatitis C drugs became more competitive. In August 2018, we released a Request for Information on the subscrip- tion-based payment model, which result- ed in positive responses from PhRMA and several other entities. We also met with Sen. Bill Cassidy, one of the state’s few hepatologists, who was very supportive of the unique approach the state was taking. Based on the feedback and responses re- ceived, we drafted a Solicitation for Offers for a subscription model for hepatitis C medications. Access to medication is only the first step in eliminating hepatitis C. In addi- tion to pursuing the subscription model to procure DAAs, we are also building out the other key strategies necessary to reach our goal of eliminating hepatitis C. We are working with partners at the Centers for Disease Control and Prevention, the National Institutes for Health, and Johns Hopkins University, and in January 2019, were awarded additional funding from the Laura and John Arnold Foundation to plan and pursue a comprehensive public health strategy that will result in the elimination of hepatitis C in Louisiana. The journey began years ago, and on February 28, we received responses to our Solicitation for Offers from all three man- ufacturers of DAAs. On March 26, we an- nounced our intent to sign a contract with Gilead’s Asegua Therapeutics as our hepa- titis C subscription model pharmaceutical partner by June 1, 2019. I am optimistic that Louisiana has found a win-win approach to pharmaceutical pricing that is different from the typical price-per-cure approach. Our journey has included unprecedented collaboration and contributions from governors, other state and federal government partners, the pharmaceutical industry, nonprofits, phil- anthropic organizations, policy experts, advocates, and academia. If successful, it could inform pharmaceutical purchasing in the setting of public health crises. We hope this new model will make hepatitis C elimination a reality not just for Louisiana, but also for our nation. n *This column by Dr. Rebekah Gee originally ran in the HealthAffairs Blog, www.healthaf- fairs.org .
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