FDA Panelist Questions Marketing Benefits From Soliris REMS

Cleveland Clinic hematologist suggests eculizumab risk management plan provides Alexion with an opportunity for direct-to-consumer marketing.

Alexion Pharmaceuticals Inc.’s support for maintaining the current Risk Evaluation and Mitigation Strategy for its rare disease drug Soliris (eculizumab) prompted an FDA advisory committee member to question the program’s utility as a marketing tool.

At the Drug Safety and Risk Management Advisory Committee’s Nov. 18 meeting, Cleveland Clinic hematologist Mikkael Sekeres said he was trying to understand why the company was so vested in keeping the current REMs with elements to assure safe use.

The REMS requires certification and enrollment of prescribing physicians and provision of various educational materials to physicians and their patients. The committee met to consider whether the program should be redesigned to be less burdensome, kept intact or eliminated (see related story, (Also see "When To End A REMS? Soliris Review Stirs Debate On How To Scale Back" - Pink Sheet, 24 Nov, 2014.)).

Alexion also runs the OneSource Patient Support Program, which began prior to implementation of the REMS. Patients who voluntarily enroll in OneSource receive monthly phone calls to ensure that they have a copy of the Soliris Patient Safety Card and to review the signs and symptoms of meningococcal infection.

“Why are you so pro keeping the REMS and maintaining the resources to reach out to patients, 2,500 or 3,000 patients every single month for years,” Sekeres asked the company.

Pamela Williamson, Alexion’s senior vice-president for global regulatory affairs and patient safety, said OneSource provides a number of different supports for patients, including reinforcement of REMS educational messages and assistance with securing access to the drug.

“These types of services can and could and would be provided to the patients as a service and those could be provided outside the scope of the REMS,” she said.

“We believe the REMS is important because of the totality of the elements to assure safe use which have been described here today. The overarching objective and the overarching importance is to ensure that the signs and symptoms of meningococcal infection are recognized as early as possible and ensure quick treatment,” Williamson said. “Whether that would be a requirement for REMS or something that the company would do because we’ve been diligent to ensure the safe use of our product, that’s something we could certainly discuss.”

Sekeres said that while he agreed with Williamson’s characterization of the REMS’ focus, he nevertheless questioned whether the company was gaining a marketing benefit from the FDA-required risk management plan.

The notion that REMS provide companies with a marketing safe harbor – in the form of government-sanctioned communications and educational materials about a drug – is not entirely novel (Also see "Waking Up to REMS (Part 3): Redefining Marketing" - Pink Sheet, 1 Sep, 2009.).

“We have to also be cognizant of the salutary benefit of maintaining the REMS and that is getting patients this drug, making it easy for them, making it easy for the nurses I work with to get this drug,” said Sekeres, who supported eliminating the program entirely.

“There is some direct-to-consumer marketing that concerns me about this.”