Exclusivity deals for hepatitis C drugs by pharmacy benefit managers and a major health plan have raised concerns that the decision of which drug is best for a patient is being taken away from clinicians.
Last week Anthem became the first payer to announce an exclusivity deal for a hepatitis C drug. As part of the pact, beneficiaries must try Gilead Sciences' Harvoni before trying any other treatment for hepatitis C genotype 1, which accounts for up to 75% of all U.S. cases.
The decision came just days after CVS Health announced its own deal with Gilead.
Both decisions were preceded by Express Scripts' announcement that AbbVie's Viekira Pak would be its preferred hepatitis C drug.
While thankful that the companies are ensuring access to treatment, some patient advocates find the trend unsettling.
“Hepatitis C does not act the same in every individual,” said Lorren Sandt, executive director at the Caring Ambassadors Program. “This is an infectious disease that mutates and it should be the doctor's decision, not the insurance company's, which drug a person receives.”
Alan Franciscus, executive director of the Hepatitis C Support Project, called the agreements “a scary precedent.” “The insurance companies and dispensing companies like CVS and Express Scripts are deciding what drugs hepatitis C patients are being prescribed instead of physicians making medical decisions based on solid science,” Franciscus said.
Both the Caring Ambassadors Program and the Hepatitis C Support Project receive financial support from Gilead and AbbVie.
A trade group for clinicians and researchers specializing in liver disease echoed the concerns of the patient advocates. “All patients who receive advice from their doctor to take newest medications should not be denied,” said Greg Bologna a spokesman for Association for the Study of Liver Diseases.
Representatives of Express Scripts and CVS counter that the deals make it more affordable for more people to get the new breed of treatment and disagree that they present roadblocks to patients getting the most appropriate drug.
“We have driven the cost of cure down to a point where we are now able to treat all patients with hepatitis C genotype 1 instead of just the sickest,” Brian Henry, a spokesman for Express Scripts. “That is an advance that physicians welcome, that advocates welcome, and that patients welcome.”
Henry added that there are pathways for physicians to appeal a coverage decision and to make sure a patient gets the treatment they need if for some reason they are not responding well to Viekira Pak.
CVS spokeswoman Christine Cramer said “the strategy meets patient needs while delivering excellent value and clinical options to both clients and plan members.”
Another PBM, Prime Therapeutics, is taking a different approach to providing access to hepatitis C drugs. The company, which serves more than 25 million people and is collectively owned by 13 Blue Cross and Blue Shield Plans, announced Monday that it reached agreements with both Gilead Sciences and AbbVie.
“There has been a substantial reduction in the net price of both of these drugs just in the past few weeks, so sometimes it pays not to go first,” Peter Wickersham, senior vice president of integrated care and specialty at Prime said in a statement. David Lassen, chief clinical officer at Prime added that "it was clear that neither Gilead nor AbbVie wanted to be left off our formulary and the result proved to be significantly better than taking an exclusive position.”
Anthem, like CVS and Express Scripts, emphasized that its Harvoni agreement does not preclude a doctor from prescribing another hepatitis C drug for clinical reasons. However, the population of patients who would need a different drug is expected to be small, a spokeswoman said.
So far, it appears that Anthem is the only payer to enter an exclusivity agreement.
One plan with no interest in such an agreement is Geisinger Health Plan, a subsidiary of Danville, Pa.-based Geisinger Health System. “[We] do not plan to select an exclusive hepatitis C treatment manufacturer or agent. Our members have access to the drug that will provide the best outcome as determined by the treating hepatologist,” said Dr. Ray Roth, chief medical officer for the plan.
A Cigna Corp. executive said the company expects price competition to address the cost of the drugs, which has become a source of consternation for health insurers. Harvoni, approved by the FDA on Oct. 10, costs $94,500 for a 12-week regimen. Viekira Pak costs $83,320 for 12 weeks of treatment. Cigna is currently negotiating with Gilead and AbbVie. “We are seeing real competition between the two manufacturers which will benefit our customers and clients,” said Christopher Bradbury, vice president of integrated clinical and specialty drug solutions for Cigna Pharmacy Management.
But there is little doubt that other insurers will follow Anthem's lead.
“The savings to payers in these hepatitis C examples should be considerable, and the hope is that consumer benefit will exceed the loss of convenience,” said Katherine Hempstead, a health insurance policy director at the Robert Wood Johnson Foundation. “While these are the biggest examples thus far, I think we should expect specialty formulary exclusions to be a growing part of the future of drug contracting.”
Follow Virgil Dickson on Twitter: @MHvdickson