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Published: November 17, 2015

Biopharmaceutical Manufacturers' At-Risk Day Is Here

November 17, 2015 - Curant COO, Marc O'Connor, in Specialty Pharmacy Times - During a strategy session in June, my colleagues at Curant Health and I identified the need for biopharmaceutical manufacturers to go “at risk” in negotiations with payers and PBMs for new high cost specialty therapies as a near-term industry trend.

“At risk” describes the nascent requirement for manufacturers to accept lower payment, or in some cases no payment at all, if high cost drugs are shown ineffective in real-world conditions. For Amgen, at-risk actually arrived last week with the announcement of the Harvard Pilgrim health plan deal for the PCSK9 inhibitor, Repatha.

According to several reports, Harvard Pilgrim will recoup additional rebates from Amgen if patients on Repatha do not achieve specific cholesterol targets for various patient groups.

The writing has been on the wall for some time as payers’ prior authorization requirements have become so stringent and complex that access to therapies has become a hurdle many patients are not able to overcome.

In cases where curative therapies like Gilead’s Harvoni for hepatitis C are involved, these hurdles are often detrimental to the payers who establish them.

A $94,500 course of Harvoni that cures hepatitis C is a better value for the payers than a $577,000 liver transplant, and better for the patient as well. Go figure.

It appears that Harvoni's actual hepatitis C cure rates in real world conditions may fall short of the expectations set by its clinical trial results and advertising campaign.

However, a 30% improvement in cure rates remains an astonishing advancement over the previous therapeutic courses that involved multiple medications, complex regimens and a horde of negative side effects.

As the health care industry continues to grind its way through the growing pains associated with the shift to value-based care, we expect at-risk contracts between payers and manufacturers on new high-cost therapies to become more and more common.

There are strategies and tools available that place improvements in patient outcomes firmly at the center that also align the entire industry.

As I wrote in Specialty Pharmacy Times last month, “Manufacturers want top dollar for their therapies to ensure they recoup research and development spending while payers want to keep spending low and demand evidence-based value.

Stuck in no man’s land are the prescribers and patients who need clarification on the requirements and pathway to approval for ultra high-cost maintenance drugs like PCSK9 inhibitors.

“Focusing on patient outcomes and additional services by specialty pharmacies mirrors the move Medicare is making toward value-based care for reimbursements. As these forces grow in influencing the health care system, the beneficiaries will be patients whose lives improve, the manufacturers who can more effectively account for the value their therapies provide, and the payers whose highly adherent patients experience fewer instances of more costly acute care.”

Pharmaceutical manufacturers’ day at-risk has arrived.

Negotiated “at risk” contracts that include the engagement of pharmacy partners with medication management protocols proven to improve adherence and outcomes, agreed upon up-front data sharing and outcomes measurement, and neutral arbiters of that data have the capability of making this development an industry-wide win.

Read Marc's article in Specialty Pharmacy Times.

To learn more about Curant Health, contact Kristin Lindsey, Marketing Director, at

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