A select group of patient advocates, academic researchers, payers, pharmaceutical innovators, and policymakers were brought together in June 2017 to discuss how to accelerate getting new drugs to patients to both prevent and treat Alzheimer’s disease.
The goal of the meeting, which was hosted by the USC Schaeffer Center for Health Policy & Economics, Alzheimer’s Drug Discovery Foundation, and Center for the Evaluation of Value and Risk in Health at Tufts University, was to identify policies that might more efficiently and effectively move incremental drug innovations on AD and AD-related disorders from the research pipeline to patients.
Dana Goldman, Howard Fillit, and Peter Neumann outlined the findings from this meeting in a perspective published in Alzheimer’s & Dementia.
Three critical issues came to light and need to be addressed to effectively move innovation forward:
- We need a more robust pipeline
- There is a high price to drug development failure
- We need create financing mechanisms
Goldman, Fillit, and Neumann discuss each of these areas and note a number of key policy levers that could be employed to ensure progress in developing effective drugs and getting them to patients:
- Deploying a postmarket surveillance study system, linking claims and electronic health records to clinical and patient-reported outcome data, to measure longer term utilization and other outcomes.
- Fostering collaboration between industry and the academic and clinical fields, both in financing and conducting experimental trials and establishing disease registries to store large quantities of relevant clinical data, that is, biomarkers, neuropsychiatric assessments, and patient-reported outcomes, which could be used in phase 4 follow-ups and inform future risk-sharing cost models.
- Developing innovative payment approaches that share risk between manufacturers and payers.
- Harmonizing policies at the Food and Drug Administration and Medicare requirements through, for example, parallel review for drug approval and coverage or the use of aligned metrics for regulatory coverage, quality reporting, and payment.
- Adopting “coverage with evidence development” policies to allow conditional coverage for drugs while additional data are collected.
- Adding flexibility for drug companies to communicate with payers about data and outcomes in diverse clinical settings.
Citation: Goldman, D.P., Fillit, H., & Neumann, P. (2018). Accelerating Alzheimer’s Disease Drug Innovations from the Research Pipeline to Patients. Alzheimer’s & Dementia, Article in Press (1-4).