Could Internet Be Path To Simplifying Participation In REMS?

Suggestions to FDA on improving REMS assessments include providing access to patient and physician surveys through a single website and timing assessments based on product launch, not REMS approval.

The Internet could be a useful tool in facilitating assessment of the effectiveness of Risk Evaluation and Mitigation Strategies in imparting safety information to physicians and patients, Amgen Inc. suggested to FDA in comments on an agency initiative to improve the REMS assessment process.

“A centralized website where physicians and patients could electronically access and complete surveys for any products that have a REMS would help systematize the completion of these assessments and minimize the current challenges to participation,” Amgen says.

The company’s comments respond to FDA questions about the best ways to conduct physician and patient knowledge surveys about safety messages delivered by a REMS, the topic of discussion during a public workshop in June (Also see "REMS Clock Ticking: Sponsors Grapple With Assessment Time Constraints" - Pink Sheet, 9 Jul, 2012.).

The suggestion to centrally locate REMS surveys fits with industry and FDA efforts to standardize REMS as much as possible and reduce the safety program’s burden on sponsors and the health care system. Several provisions of the prescription drug user fee agreement that takes effect Oct. 1 pursue that goal (Also see "PDUFA Commitment Letter Formalizes REMS Standardization Schedule" - Pink Sheet, 1 Sep, 2011.).

A centralized approach to prescriber enrollment in REMS received support during a 2011 advisory committee to discuss the impact of REMS with elements to assure safe use on patient access, the health care delivery system and safe drug use. Several members backed the creation of a single system that would allow physicians to register for any REMS (Also see "FDA Standardizing REMS Re-Enrollment Procedures" - Pink Sheet, 2 Dec, 2011.).

Enhancing Survey Participation

Having a single website for surveys would simplify access to the questionnaires for physicians who prescribe, and patients who take, multiple drugs with REMS, making it more likely they would respond, Amgen told FDA. “Creating a more direct interface with patients and physicians, under the auspices of a centralized website, could yield more meaningful participation rates,” the firm maintained.

It also could result in a reasonable compensation rate to encourage physician and patient participation in surveys, Amgen added. REMS sponsors typically go through physicians to identify and recruit participants for patient surveys and each company must determine how to compensate physicians for their time.

A single site would allow a single incentive system, Amgen pointed out. “A vendor with experience in survey design and fair market value rules should be able to make that determination,” the firm noted, and “the one-stop-shop approach would allow for a set of agreed-upon incentives for any patient and physician who participates.”

Amgen also suggested that a single website be considered for more than just REMS assessments. “As part of the next PDUFA reauthorization, it may be worthwhile for FDA and industry to discuss how to support a more streamlined, centralized, and consistent program of education, communication, assessment, and implementation of elements of safe use through an FDA website or through vendors funded by the FDA,” Amgen said.

To spur physicians to take surveys, Novartis AG proposed offering health care providers the “opportunity for CME [continuing medical education] to encourage participation in on-line surveys.”

The American Pharmacists Association supported that approach. “Accredited CE program providers could provide overall program assessment and provide assessment based on follow-up outreach to participants, for example, on how participants used program information in their practice settings,” the group said.

Amgen agreed that CME providers would be an appropriate route for assessing the impact of REMS on prescribers. “Having an independent organization conduct such assessments is preferable,” the company said. Medical specialty organizations also could be involved, “particularly if their members are prescribing multiple products with REMS from many different sponsors.”

Timing Of Assessments

Several companies submitted comments urging FDA to consider the timing of drug availability when setting the assessment schedule. Novartis noted that with one of its drugs, the assessment was due one year following approval, but the product was available only three weeks prior to the survey and drug use pattern analysis. As a result, the firm noted, assessment conclusions were based on a small sample size and short duration of follow-up.

United Biosource Corp., which has developed REMS for several sponsors, pointed out that commercialization of some products may occur months after REMS approval. “This does not provide enough penetration of the product into the marketplace to easily identify patients who have received prescriptions and [health care providers] who are prescribing the product.”

To address the problem, Novartis recommended that FDA put in place “a mechanism for a sponsor to request and receive approval for a revised date based on product launch date or other extenuating circumstances.”

FDA has indicated it is aware that the timing of assessments determines the information that can be gathered. The assessment plan for the class-wide opioid REMS reflects the large number of drugs, prescribers and patients involved in that risk management program and the time needed to put all its components in place. The first assessment is due six months after the REMS’ approval, but prescriber knowledge will not be part of the assessment until three years after the REMS has been in place, when 25% of prescribers are expected to have received training (Also see "Opioid Prescriber Knowledge Assessment Due Year After Patient Assessment" - Pink Sheet, 16 Jul, 2012.).