Lack Of MS Clinical Guidelines Presents Challenge To Payers

Multiple sclerosis is one of the fastest growing areas of specialty drug spend, along with oncology and autoimmune disease. In oncology, the National Comprehensive Cancer Network Clinical Practice Guidelines have become a peg for payers to hang reimbursement decisions on (Also see "How To Withdraw A Drug: FDA’s Final Decision on Avastin" - In Vivo, 27 Dec, 2011.). In autoimmune disease, key treatments work through the same mechanism of action, making payers more comfortable with reimbursement decisions. However, in MS, some drugs work through different mechanisms of action and increasingly so as more drugs reach the market. At the same time, updated third-party clinical guidelines for payers to use as a reference don’t exist. That leaves payers weighing safety and efficacy data and in the absence of comparative data, leaving over-dependence for some reimbursement decisions on rebates and price.

The American Academy of Neurology has guidelines on the use of disease-modifying therapies in MS, but they date from 2002. Although the academy reaffirmed them in 2008, they do not address recent launches like Gilenya and Ampyra. The AAN has no plans to update the guideline in the next year, the association said.

“Part of the reason there aren’t good guidelines is because there are not a lot of supportive data to be able to create evidence-based guidelines,” said Gary Owens, a managed care consultant and former VP at Independence Blue Cross. “There have been a lot of studies. There’s lots of data, but the data doesn’t help you find a clear pathway through the woods.”

Owens was the moderator for a panel of managed care experts that met last year with the goal of developing a series of consensus statements payers could use as a resource for MS. Following two rounds of Web-based surveys, the group held a live panel discussion in December 2011, involving eight pharmacy directors and six medical directors from 12 health plans, one specialty pharmacy, and one consulting company, Xcenda, the consulting arm of wholesaler AmerisourceBergen Corporation. The results were published in the January/February issue of the Journal of Managed Care Pharmacy.

The panel reached 25 “consensus statements” to address the management of patients with MS. One key decision was that health plans should include preferred access to Copaxone and at least one interferon, though the group did not reach consensus on which interferon should be preferred. The panel also agreed that access to Gilenya and Ampyra should be managed by prior authorization.

“The biggest underpinning challenge is that there isn’t a clear and comprehensive guideline that physicians have put forth for payers to follow, so in the absence of guidelines, payers have to make management decisions without the information it would be ideal for them to have,” said one of the study’s authors, Laura Happe, Associate Professor of Pharmacy Administration at Presbyterian College School of Pharmacy.

Ultimately the consensus statements are in line with many of the steps payers are already taking. The panel agreed that if efficacy and safety are determined to be comparable among interferon agents, then cost and contracting should be weighed.