REMS Review: Barriers to Actionable Data Collection

Manufacturers often select their specialty drug distribution strategy based on the level of REMS reporting required by the FDA. What are some things keeping specialty pharmacies and manufacturers from collecting the data they truly want?

Manufacturers often select their specialty drug distribution strategy based on the level of REMS reporting required by the FDA. What are some things keeping specialty pharmacies and manufacturers from collecting the data they truly want?

Risk evaluation and mitigation strategies (REMS) data on specialty drugs can be required for many reasons: they can be mandated by the FDA, required for drug approval, or used to help protect an expensive drug against risk.

Although some believe in the tenet that “all drugs should be available to all patients at all times,” and all pharmacists, including retail pharmacists, should have equal access to all products approved by the FDA, the reality is that many manufacturers restrict access because they are required to report certain compliance data to the FDA. Often, retail pharmacies are not equipped to provide manufacturers with the level of data that are needed for specialty products. Manufacturers also have to be able to provide an appropriate level of patient care and have to prove their ability to be a trustworthy partner by ensuring their product stays in a legitimate distribution channel.

Earlier this year, the Office of the Inspector General for the Department of Health and Human Services reported that the FDA lacks reliable methods to assess the effectiveness of REMS, even though many REMS programs are required by the agency. Nearly half of sponsor assessments for the 49 REMS programs reviewed did not include all data requested in FDA assessment plans, and 10 were not submitted on time. In 2011, the FDA created the REMS Integration Initiative to evaluate REMS, and on September 30, 2013, the FDA is expected to publish further guidance on methodologies for assessing REMS.

According to Letitia Snyder, national oncology account manager at Pfizer Inc, it is best to be “channel agnostic”: the most important thing specialty manufacturers can do is to make sure the appropriate processes are in place. They may have to be creative when it comes to building the right REMS strategy and choosing the optimum distribution model for their product, she noted during a presentation at CBI’s 4th Annual Forum on Strategic Distribution Planning for Specialty Products.

at CBI’s 4th Annual Forum on Strategic Distribution Planning for Specialty Products. - See more at: http://www.specialtypharmacytimes.com/news/The-Evolving-Specialty-Market#sthash.Liyvq4Gh.dpuf

A good REMS strategy has to be executable, Snyder insisted, and all of the REMS components have to be harmonious. “Brand teams have to be aligned to what the industry can bear,” Snyder noted. Although a product can be launched in a range of ways, such as through an exclusive, limited, or broad distribution channel, “[T]he needs may change over a product’s lifecycle.”

Problems with Data Sharing

Specialty pharmacies provide manufacturers with patient data, and sometimes there is a need to see extended fields that are not included in primary reports sent to drug developers. Snyder noted that while most data can provide certain insight, manufacturers don’t always leverage the data they are given in the most optimal way. There can be over 200 additional fields of secondary information handed over to the drug manufacturer, but these data are not always used (or necessary) to form conclusions about the utilization of a specialty drug.

Specialty pharmacy providers (SPPs) also may face some difficulties with payers related to data reporting, the forum’s audience members pointed out. Even though “primary insurance copay” is often a required data field, one which tells how much the payer is reimbursing, some payers report this number in a range, whereas others say they can’t capture this data point. Additionally, some payers will be resistant to share data, telling the SPPs that they don’t want them to share their benefit design with outside parties. Another data collection barrier occurs when the pharmacy benefit manager is listed as the payer, instead of the actual insurance company. The SPP is often in a conundrum, remarked another attendee, because although SPPs are tasked to provide the best data possible to the manufacturer, payer contracts they have signed may restrict them from providing the requested information.

Yet another data capture nightmare can occur when it comes down to naming conventions, noted David MacLeod, vice president, program development, patient access solutions, and executive advisor, Campbell Alliance at inVentiv Health. Fields in a data report can be referenced in different ways, even within the same system, he pointed out.

In order to capture what is truly needed in terms of data, manufacturers and specialty pharmacies should explicate their explicit data needs in their distribution contracts, Snyder concluded. These data requirements should be formed based on the question, “Which fields generate actionable intelligence?,” added Ken Visser, national account manager, business development, Diplomat Specialty Pharmacy.