Featuring Public Policy Ph.D. Candidate Zippora Kiptanui presenting her research:
“Evidence-base for Novel Drug Approval, Coverage and Cost-Control Strategies”
Dr. Judith Ann “Judy” Shinogle was a former Senior Research Scientist with the Maryland Institute for Policy Analysis and Research and Adjunct Associate Professor of Public Policy, who passed away in May 2012. Judy’s work for MIPAR included studies on gambling, childhood obesity, and wellness initiatives. Her published work includes articles on the effects of mental health insurance coverage on employees’ disabilities, mental health parity in insurance, economic costs of obesity, and pharmaceutical use among persons with disabilities.
The Judith A. Shinogle Memorial Fellowship is chosen by a faculty panel and awarded each year to a Health Policy doctoral student for their notable contribution to research in Health Policy. Each year in November, the student recipient presents their work at the Judith A. Shinogle Memorial Award Lecture.
The 2021 Shinogle Memorial Fellowship Awardee and Lecture presenter is Public Policy Ph.D. Candidate Zippora Kiptanui, and she presented her research titled “Evidence-base for Novel Drug Approval, Coverage and Cost-Control Strategies.”
In her research, Ms. Kiptanui examines the novel drug approval process – where drugs are innovative products developed to respond to an unmet medical need, and often face fast-tracked approval by the FDA. They are often very expensive treatments, but treat conditions that have never been treated effectively before, like Alzheimer’s or Spinal muscular atrophy in children. These high-cost treatments and their expedited approval path can drive up costs for payer systems like Medicare and Medicaid, and also face ongoing debate about side effects or drug effectiveness.
Ms. Kiptanui’s research focuses on two main questions:
- Does evidence in the real world of use align with outcomes from clinical trials?
- What evidence supports cost-containment strategies some states have started?
The first question aims at drug effectiveness, and the second looks at state-based cost control measures. States are purchasers of large amounts of health care, including prescription drugs or health coverage for large groups of people like Medicaid recipients, prison inmates, and public employees.
States therefore have concerns about the high cost of these novel drugs. They have sought alternative payment arrangements including Value-based purchasing strategies, which tie payments for drugs to patient care metrics. Traditional payment method might just take into account the cost of manufacturing the drug + profits, and the alternative arrangement incorporates value to the patient, not just supply-side numbers. States are trying the alternative payment arrangement out with their state Medicaid programs, and Ms. Kiptanui is examining the evidence that supports these alternative arrangements.