Road Map for REMS - Pharmaceutical Executive

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Road Map for REMS


Pharmaceutical Executive


The First Two Years

Since the inception of the REMS program in March 2008, a total of 125 drug products have had risk-reduction strategies developed to enhance their safety. In its first 12 months there were 40 REMS; by March 2010 that number had tripled (see figure 1). Yet the proportion of REMS that have required only the minimal category of medication guide has remained constant at 60 percent. A breakdown of the remaining 40 percent that consist of the more complex categories—communication plans, ETASUs, and implementation plans—shows a similar consistency. Still, it is safe to assume that the number of REMS will continue to rise, depending on the rate at which new drugs are approved.

Certain therapeutic areas are red-flagged for REMS. A new drug developed to treat any of the following eight diseases has a high probability—between 5.5 and 8 percent—of requiring REMS as a condition of approval: diabetes; asthma/allergy/COPD; antibiotics for infections; epilepsy; depression; HIV; arthritis; and opioids for pain (see figure 2). Yet no drug or disease is automatically exempt, and the 125 products with approved REMS span the entire spectrum of medical conditions. Complex REMS programs involving ETASUs and implementation plans are typically sparked by risks related to tetrogenicity, cardiac problems, hematological risks, liver dysfunction, and new or worsened malignancies.

The View From Here

It's common for drugmakers to rue REMS because they add extra work and cost. In addition, certain REMS can circumscribe a drug's potential market by specifying an appropriate patient profile, with the result that the large-scale prescribing that can turn an arthritis painkiller like Vioxx into a megablockbuster will be far less common.

Yet REMS can also play a beneficial role in the marketing of a new drug. In that sense, REMS are not just a regulatory requirement. They can also be a strategic driver of change for the commercialization of a drug. While much grumbling has already been heard about the challenges in developing and managing REMS programs, it's worth noting how REMS can not only maximize brand value but help meet the drug development needs of the future. Gradually, the industry is recognizing that in the long run the REMS system can burnish its own value in terms of public trust.

Physicians, however, are not looking forward to the additional load of paperwork that REMS will entail. Pharma will have to labor to educate doctors about not only the implementation but the potential upside of REMS. The best possible risk-mitigation strategy for a pharma to develop will be one that is the least onerous for physicians, so involving doctors early in the process pays dividends. If successfully executed by the drugmaker and the physician, REMS are likely to ultimately reduce legal liabilities—less harm to patients means fewer lawsuits.

The High Cost of REMSing

The most aggravating irritation posed by REMS is predictably that of cost. Maintaining registries as well as data tracking and analysis demand a substantial investment. Failure to plan ahead for the early signal detection of a drug's potential adverse event—and the appropriate follow-up in a detailed submission to FDA for REMS—is likely to result in a delay of approval and a loss of revenue. It also may force the drugmaker to rack up costs as it hurries to ramp up its complex REMS program.

A post-marketing REMS commitment runs what many may consider an excessive length of time. All REMS programs must include a timetable for submission of assessment at 18 months, at three years, and at seven years. (The timetable to ensure that the REMS is working for drugs granted fast-track approval is still a work in progress.) With the first set of REMS assessments currently coming back to FDA, it behooves pharma to closely watch how the agency handles its reviews. Whether officials will determine that the system is over- or underperforming remains to be seen.

The length of time of some REMS may rival a drug's patent life. For example, the Novo Nordisk's Victoza, the first once-daily GLP-1 for type-2 diabetes, was approved based on the Danish firm's maintaining a post-marketing registry for 15 years—not an especially promising sign for makers of diabetes drugs. Faced with such burdens, companies will have to weigh the expense involved in the commercialization of a new drug before making the go/no-go decision. The ultimate effect may be to stifle innovation.


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