Other articles in this issue discuss drug development, treatment for opioid use disorder, and more.
Pharmaceuticals
The Orphan Drug Act of 1983 introduced financial incentives to encourage the development of drugs for rare diseases.
Kathleen Miller and Michael Lanthier examine the approval of orphan drugs and find that of the 491 novel approvals between 1990 and 2022, 65 percent of orphan drugs have been approved for a single rare disease, 15 percent for multiple rare diseases, and 20 percent for both rare and common diseases.
The latter group “represented an outsize share of the top-selling orphan drugs in 2021.”
Sanket Dhruva and coauthors survey physicians about the Food and Drug Administration (FDA)drug and medical devices approval processes and find that “many physicians lacked understanding of the level of evidence required for FDA approval and that they expect (or believe) it to be more rigorous than it is.”
Physicians believe that the FDA should require higher-quality evidence standards and conduct more follow-up after expedited approval processes.
With no-cost coverage of preventive services under legal challenge, Lorraine Dean and coauthors estimate how the use of oral HIV pre-exposure prophylaxis (PrEP) would change in the face of patient cost sharing.
They conclude that about one-third of commercially insured patients receiving PrEP could abandon their prescriptions if they faced cost sharing between $100 and $500.
The authors conclude, “The combination of policy tools enacted during [this period] was likely a potent contributor to this change.”
Despite the improvement, disparities in MOUD persisted, with use highest among enrollees who were White, were older, had comorbidities, and lived in a metropolitan area.
Medicaid managed care plans vary widely in their requirements for prior authorization of buprenorphine, which providers often cite as a barrier to appropriate OUD care.
Analyzing plan coverage documents, Christina Andrews and coauthors find higher rates of prior authorization requirements among plans operating in states with a Republican-leaning electorate and among for-profit plans relative to nonprofit plans.
Using federal treatment locator data, Caroline King and coauthors identify 160 residential addiction treatment facilities nationwide that serve adolescents with OUD.
Of these, a little more than half had a bed immediately available at the time of inquiry. Four-fifths of nonprofit facilities and one-fifth of for-profit facilities accepted Medicaid.
Overall, “only seven states had a facility that accepted Medicaid, had a bed open the same day, and offered buprenorphine.”
Adrianna McIntyre and colleagues examine the effects of a natural experiment when some enrollees in the Massachusetts Health Connector (the state’s Affordable Care Act Marketplace) faced new nominal monthly premiums of less than $10 in 2017.
The authors find that plans with new premiums saw enrollment fall 14 percent over the following year, suggesting that premiums create both financial and administrative burdens for enrollees.
Lauren Taylor and Len Nichols describe their experience in three cities seeking to implement the Collaborative Approach to Public Good Investments (CAPGI) model, which aims to align financing among multiple stakeholders to support investment in programs that address social determinants of health.
Among the essential ingredients: “clearly bounded coalitions whose membership was well understood and roles that were clearly specified.”
Amy Finkelstein and coauthors present follow-up analysis of their 2020 experiment, which concluded that the Camden Coalition’s care coordination model, targeting people in Camden, New Jersey, with complex medical and social needs, did not reduce hospital readmission rates or other related outcomes.
Seeking to understand the earlier disappointing results, they find that the program increased ambulatory care visits after hospitalization, suggesting that more than care coordination is needed to generate measurable effects for this high-need population.
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About Health Affairs
Health Affairs is the leading peer-reviewed journal at the intersection of health, health care, and policy. Published monthly by Project HOPE, the journal is available in print and online.
Project HOPE is a global health and humanitarian relief organization that places power in the hands of local health care workers to save lives across the globe. Project HOPE has published Health Affairs since 1981.
