AMCP: Performance-based Risk-sharing Agreement Data Benefits Payers and Drug Makers

The development and launch of a new drug is filled with uncertainty. Historically, the pharmaceuti­cal manufacturer has no guarantee of success when investing in research and development, so, upon launch, it tends to seek the highest justifiable price possible to recoup its investment, yet also make a profit. This leaves the payer with a significant risk of its own, as it attempts to negotiate fair pricing for an expensive drug with no established history of real-world effectiveness or meaningful benefit for enrollees. Thus, a risk-sharing “equilibrium” is created.

Enter performance-based risk-sharing agree­ments. A concept that goes by a variety of names— including managed entry agreements, patient access schemes, and pay-for-performance programs—risk-sharing agreements are arrangements between payers and drug makers that can ease some of the risk payers assume when a new product hits the market.

Lou Garrison, PhD, professor, pharmaceutical outcomes research and policy program, department of pharmacy, University of Washington, and Zoltan Kalo, PhD, professor of health economics, Eotvos Lorand University, discussed risk-sharing agreements during a session at AMCP Nexus.

Although managed entry agreements are widely used in Europe, such arrangements are less common in the United States. Between 1997 and 2012, there were just 17 risk-sharing agreements in the United States. Still, interest is growing among both payers and drug makers. Dr Garrison and Dr Kalo believe improved data collecting systems may facilitate an increase in such arrangements in the future.

Risk-sharing agreements usually link a drug’s price, reimbursement, and/or revenue to patient outcomes. As a result, data collection is a key ele­ment of risk-sharing agreements and usually begins after a drug receives approval from the US Food and Drug Administration. Payers typically assume the data-gathering responsibilities.

There are several examples of actual risk-sharing agreements currently carried out in the United States.

Merck and Cigna entered into a risk-sharing agreement that centered on a diabetes support program involving Januvia (sitagliptin) and Janumet (sitagliptin-metformin HCL).

There were 3 main components of the deal: (1) Cigna assesses blood sugar levels for patients on any oral antidiabetics with the understanding that if collective A1C values improve, Merck increases discounts for sitagliptin and sitagliptin-metformin HCL; (2) Merck further increases discounts in return for Cigna’s evaluating claims data to de­termine whether patients take sitagliptin and sitagliptin-metformin HCL as prescribed; and (3) sitagliptin and sitagliptin-metformin HCL receive better placement on Cigna’s formulary and a lower copayment than other branded drugs.

The evidence collected for the agreement revealed a more than 5% drop in patients’ blood sugar levels. Those who participated in the support program were also more likely to control their blood sugar than those who did not.

Further, Cigna found that 87% of patients who took sitagliptin and sitagliptin-metformin HCL took the drugs correctly.

Health Alliance Medical Plans and Proctor & Gamble and Sanofi-Aventis, maker of Actonel (risedronate), are also involved in a risk-sharing agreement. Because clinical trials of risedronate had failed to show a statistically significant drop in non-spinal fractures (while trials involving competitor drugs had), the manufacturers agreed to reimburse the insurer for the costs of treating non-spinal fractures in patients who consistently took their medication.

This agreement is the first published example of a manufacturer agreeing to cover the cost of disease-related sequelae as opposed to discounting or refunding the cost of a drug, Dr Garrison and Dr Kalo explained.

BENEFICIAL RESULTS

Evidence collected through risk-sharing agree-ments not only benefits payers and manufactur-ers, but also the public good. For that reason, Dr Garrison and Dr Kalo recommended public authorities incentivize the use of risk-sharing agreements as well as the proper dissemination of subsequent research results, for the benefit of all.—Jolynn Tumolo