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FDA Amendments Act of 2007 included provisions for sponsors to submit Risk Evaluation and Mitigation Strategies for select pharmaceuticals, if FDA considered it necessary to ensure that its benefits outweigh its risks.
FDA Amendments Act (FDAAA) of 2007 included provisions for sponsors to submit Risk Evaluation and Mitigation Strategies (REMS) for select pharmaceuticals, if FDA considered it necessary to ensure that its benefits outweigh its risks.
At last count there were 95 REMS programs available; about one-third are for new molecular entities (NMEs). With specialty drugs dominating the NME market, it is estimated that 75% of these newly approved drugs will have REMS.
Jennifer Restivo, vice president and managing director, managed markets, for Somerset, N.J.-based inVentiv Advance Insights, spoke at the 22nd annual meeting of the Academy of Managed Care Pharmacy in San Diego, and said, "developing and implementing REMS, especially those with ETASU can be daunting for all parties involved. The good news is that awareness around the need for payers and manufacturers to collaborate on such programs is increasing, though there are still significant hurdles to overcome."
CHALLENGES IN REMS PROGRAMS
All stakeholders face challenges in REMS programs, ranging from administrative to process hurdles. Providers are faced with time-consuming tasks associated with administering a product with REMS, including patient education, extra paperwork, and establishing procurement processes.
For manufacturers, the challenges include negotiations with the FDA, development of systems and process to collect data, and dealing with the negative perceptions often associated with a product facing a REMS. Payers must align the manufacturer's processes and procedures with their own-this is often tied to prior authorization and distribution.
REMS has the potential to improve adherence, on-label prescribing, and patient outcomes, which appeals to managed care payers. "A key to the successful design and development of any REMS is to consider the party that will ultimately be implementing the program. Experience with FDA audits, managing complex ETASU REMS programs, and the ability to integrate a full line of supply chain solutions are all vital when selecting a REMS administrator," said Kevin Cast, vice president, pharmaceutical sales at CuraScript, Orlando, Fla., an Express Scripts company.