August 29, the U.S. Food and Drug Administration announced a new program, Complex Innovative Designs Pilot Meeting Program or CIDPMP. FDA Commissioner Scott Gottlieb, M.D., stated in Wednesday’s address that the newly initiated pilot program is considered an “idea incubator to support another new effort” to accelerate biologics and drug product development in areas of unmet need. The program is intended to reinforce scientific evolution of clinical trials, allowing advancement in approach to overall clinical trial design.
This program is the sixth variant of the Prescription Drug User Fee Act (PDUFA), generally used to describe target action date for approval of drugs. Initially, the pilot was introduced in March and met with concern by various stakeholders, including Genentech and Biogen. Questions were raised surrounding the involvement of the FDA’s Center for Devices and Radiological Health (CDRH) and the level of data available to the public.
This innovative pilot will give sponsors—biopharma companies and those launching clinical trials—the opportunity to meet with the FDA’s Center for Drug Evaluation and Research (CBER) or Center for Biologics Evaluation and Research (CBER) twice within a 120-day span. Summaries will be expedited to 60 days after the second meeting, creating responsive trial results and the ability to “more quickly learn which patients are most likely to benefit from a treatment or experience a side effect.” Gottlieb continued, explaining that more extensive, timely feedback will “make it easier to target drugs based on the biological characteristics of their disease.”
The FDA will accept meeting submission requests electronically through June 30, 2022. Meetings will be conducted from now until fall of 2023. As per FDA statement, “Initial priority will be given to trial designs for which analytically derived properties may not be feasible and simulations are necessary to determine operating characteristics.” Proposals will be secondarily accepted based on relation to therapeutic need.
In his statement, Gottlieb concluded the pilot will “help advance the scientific community’s approach to designing clinical trials overall, while maintaining our gold standard for conducting high-quality, well-controlled clinical trials that produce reliable results to assess safety and efficacy.”
When determining your FDA strategies and pathway it is important to consider reimbursement implications in parallel. It is also important to incorporate payer desired clinical outcomes and clinical trial design when planning and implementing clinical studies. To implement successful market access strategies, the GIRS Value Discovery Landscape Assessment® team can conduct a Reimbursement Landscape Assessment to develop payer-desired strategies with clinical outcomes experts, coding experts, policy staff, reimbursement lawyers, and a panel of current insurer medical directors. We also can review the impact of the FDA strategies on the reimbursement of the medical device, drugs, biologic or diagnostic. This work will provide you with foundation reimbursement strategies that will influence and coordinate your clinical outcomes, marketing, and reimbursement strategies to result in the best market access outcomes. The PAC team can then implement these strategies to obtain positive coverage, appropriate payment, and innovative payer contracting arrangements to improve market uptake. Please contact us by email or call us at 1-844-514-4477. Also, follow our LinkedIn Company Page for more bi-weekly news on reimbursement trends, milestones, and achievements.