Fair Pricing Coalition Recognizes Merck’s Lower Price for Curative Hepatitis C Treatment, Calls for Manufacturers to Reduce Excessive Prices and Increase Patient Assistance

The Fair Pricing Coalition (FPC) today expressed appreciation for Merck’s & Co. Inc.’s decision to launch its new curative hepatitis C (HCV) treatment, Zepatier, at a price below existing HCV treatments in a tacit acknowledgement that existing high prices have hurt patients and are untenable for the market. Zepatier’s $54,600 list price is lower than the egregious prices for Gilead Sciences’ Harvoni ($94,500) and AbbVie’s Viekira Pak ($83,319), and represents a step in the right direction. Even at this price, however, the FPC is still concerned that patients may not be able to afford to cure their HCV – preventing the U.S. from ending the HCV epidemic and increasing system-wide healthcare costs.

Merck’s lower price follows substantial public and Congressional scrutiny of HCV treatments. After an exhaustive investigation, the Wyden-Grassley Senate Finance Committee report concluded that Gilead Sciences’ HCV pricing was focused on “maximizing revenue,” not “fostering broad, affordable access.” While Merck’s lower price may increase patient access to HCV treatments, we hope that Merck will work to ensure that prior approval restrictions instituted by public and private payers will be eliminated once and for all.

“High costs of treatment have led insurers to severely restrict patient access to curative HCV treatment,” said FPC Co-Chair Lynda Dee. “While companies insist that patients will not bear the full cost of treatment, many patients are not receiving any treatment at all because insurers refuse to pay these exorbitant prices. Merck’s willingness to set Zepatier’s initial price lower than the competition must be followed with negotiated insurer discounts that allow patients easy access with minimal cost-sharing.”

As the population with HCV ages, public programs like Medicare are facing unprecedented costs from curative treatments. “Because Medicare is not allowed to negotiate for lower drug prices, Medicare spending exists at the whim of drug manufacturers,” explained FPC member Emalie Huriaux. “These costs are passed on, in part, to patients, who must pay a percentage of the drug’s cost as co-insurance. Merck’s lower price may reduce some Medicare costs, but patients will still face massive cost-sharing, hurting their ability to access necessary treatment.” We hope Merck will offer Medicare and Medicaid programs additional rebates so that very needy patients will be able to access this exciting new HCV regimen.

Excessive HCV prices have led insurers to routinely deny patient access to lifesaving HCV treatment, including refusing treatment to patients without advanced fibrosis or those who have recent histories of substance use. These practices have no medical basis. The FPC commends Merck for studying the efficacy of Zepatier in patients who use drugs. For any denials by insurers, HCV drug manufacturers must ensure broad patient assistance programs are available to fill in the gaps, guaranteeing that patients receive necessary treatment.

“Recently, Gilead Sciences changed its patient assistance program to refuse free treatment to individuals denied access by their insurer,” said FPC member Tim Horn. “We hope that Merck’s lower pricing means they will reject this deplorable practice and provide free access to patients denied by public and private payers.”

“We will be watching closely to ensure that Merck has robust patient assistance and co-pay assistance programs,” added FPC co-chair Murray Penner. “Merck must ensure that all patients, including Medicaid patients, often the most financially needy of all, have access to Zepatier.”

Contact: Lynda Dee
(410) 332-1170
lyndamdee@aol.com

Fair Pricing Coalition Disappointed by the High Price of New Janssen Hepatitis C Drug Olysio (simeprevir)

The Fair Pricing Coalition (FPC) today expressed disappointment at the price Janssen Therapeutics set for Olysio (simeprevir), a second generation protease inhibitor (PI) approved by the U.S. Food and Drug Administration on November 22, 2013 for the treatment of chronic hepatitis C (HCV) in genotype 1 patients.  Janssen has set the wholesale acquisition cost, (WAC) for a single 12-week course of Olysio at $66,360.  Though this is in parity with current HCV PIs, the FPC believes that all HCV drugs are priced too high. The WAC price of Olysio represents only part of the cost of an anti-HCV regimen, including at least $18,000 in WAC costs of interferon and ribavirin, plus the additional cost of the NS3 Q80K polymorphism screening test recommended by the FDA for all patients before initiating Olysio therapy.

“While we are very excited to have more effective and more tolerable treatment options for people living with hepatitis C, we are concerned about the overall cost of treatment,” said FPC HCV Co-Chair Lorren Sandt. “Janssen did price Olysio comparatively with other HCV PIs, but the bar previously had been set too high.  We strongly urged Janssen to price Olysio lower than current regimens to help address the overall cost of therapy, which continues to spiral out of control.”

The FPC is gravely concerned about the continued precedent this pricing has on the future of HCV therapy.  Industry experts have stated their expectations that Gilead Sciences’ new direct acting antiviral, sofosbuvir, will be approved by the FDA in the next few weeks.  While the cost of sofosbuvir is not yet known, patients and doctors may look to combine these therapies (off label), resulting in an expected doubling of the current price of therapy.

“We know that this is just the initial price,” said Sandt.  “Other HCV protease inhibitor manufacturers quickly increased prices after their initial 2011 launch. For example, a 12-week course of Vertex’s PI Incivek (telaprevir) had a WAC price of $49,000 at launch, but is now priced at $66,155.  We caution Janssen not to continue this unacceptable trend. Treatment is just too costly for the majority of people living with chronic HCV,” concluded Sandt, “and we fear that barriers to patient access will be inevitable as a result.”

Anticipating the price of Olysio, the FPC urged Janssen to expand their access programs to ease the fiscal challenges that patients will face when trying to purchase Olysio. The FPC acknowledges that the Johnson & Johnson Patient Assistance Foundation agreed to expand the eligibility criteria for Olysio from 200% to 500% of the Federal Poverty Level (FPL). While this is a step in the right direction, it is not as generous as the program Vertex established for their PI, which is a maximum household income of $100,000 per year. The FPC also applauds Janssen’s intent to initiate a $25,000 per course of treatment co-pay program for Olysio.  Unfortunately, the legal status of such programs for the Qualified Health Plans in the new Affordable Care Act Exchanges remains in question, possibly making Olysio access out of reach for many ACA patients.

“We thank Janssen for responding to our requests to increase the eligibility level of their PAP for Olysio and for developing a generous co-pay assistance program,” said Murray Penner, a member of the FPC.  “We know that co-insurance costs will be very high for patients.  Despite the access programs Janssen has in place, we are very concerned that the high price of Olysio, coupled with high co-insurance costs for patients, will result in limited access to Olysio.”