Gilead Sciences continues battling with insurers over hep C reimbursement

Company's patient-assistance program becomes a weapon; meanwhile cure rates as high as 98.4% are being claimed


Gilead Sciences’ treatment for hepatitis C, Solvaldi (sofosbuvir) created a stir when it came on the market in late 2013; the 12-week, $84,000 regimen punched holes in insurer and health-plan budgets throughout 2014 while raking in some $11 billion for the company during that year. Gilead followed Sovaldi with Harvoni, a combination drug with higher efficacy and higher cost in some instances, while AbbVie entered the market in late 2014 with the Viekira Pak, a three-drug combination; AbbVie also negotiated a significant discount with some payers and PBMs, notably Express Scripts which offers Viekira exclusively to some of its clients.
 
Now, Gilead, which had negotiated its own discounts with payers, reportedly in the 45% range, is stepping up its competitive position by restricting the patient assistance program (PAP) it has offered to underinsured patients. As reported by FiercePharma, Gilead has issued a letter stating that “Our PAP criteria enabled continued restrictions by some payers by providing a generous route for them to deny access and refer patients they have chosen not to cover. While we have approved many of these patients in the past, we feel it is necessary to establish more specific guidelines for patient eligibility” in the PAP programs. In effect, Gilead is saying, if your insurer puts barriers between you and our drugs, don’t blame us; arguably, it is also conserving its PAP dollars for needier patients.
 
The contrasting view is offered by a news release just issued by Cigna, the health insurer. It announced that it has achieved 98.4% success in “sustained virologic response (SVR12)” of patients (meaning that they are cured) treated with Harvoni under what it calls its Connected Care program. Cigna has an incentive program with Gilead which, presumably, rewards Cigna with a discount for expanded use of Harvoni. Cigna’s program fits many of the criteria of a hub-based patient-support program, with its own specialty pharmacy, comprehensive clinical counseling and physician access. Given that the drug is so expensive, and that it requires a sustained, multiple-month regimen to be successful, payers have their own incentive to ensure that the regimen is followed rigorously. And while Solvaldi/Harvoni were introduced with clinical data showing near-complete cure rates, to achieve this in real-world settings is notable.
 
“Our specialty approach focuses on delivering better clinical outcomes and affordability. We focus on the whole customer, collaboration with physicians, and comprehensive customer engagement. This approach goes well beyond just negotiating competitive drug price rates by creating real incentive alignment with drug manufacturers to meet or exceed expected clinical outcomes,” said Christopher Bradbury, SVP, integrated clinical and specialty drug solutions for Cigna Pharmacy Management, in a statement. “Our connected care approach drives meaningful improvement in clinical results and affordability and — as we see with hepatitis C — delivers powerful, real-world benefits for customers and clients.”
 
Gilead says that its restrictions will affect “a very small number” of patients; still, it puts those patients in the position of being bargaining chips between Gilead and payers. There are other hep C treatments expected to come to market, notably from Merck and Bristol Myers-Squibb; and already, Gilead has both set up licensing agreements with developing-world pharma suppliers to provide low-cost versions of its drugs, and has seen a nonlicensed provider, Bangladesh-based Incepta Pharmaceuticals, bring out a version. So far, however, Gilead continues to generate massive revenue, reportedly over $4.5 billion in Q1 2015 alone, from its hep C franchise.