Medicaid programs in Delaware, Maryland, New Jersey, and Pennsylvania denied nearly half of all claims in the past year for direct-acting antiviral (DAA) hepatitis C drugs, according to an analysis of pharmacy data presented at the American Association for the Study of Liver Diseases 2015 Liver Meeting.
The finding confirms anecdotal reports from physicians that they are unable to provide the drugs to some of their most impoverished patients, said the presenter, Vincent Lo Re (University of Pennsylvania).
Lo Re et al analyzed the prescriptions for hepatitis C drugs given to 2350 patients. The prescriptions were submitted between November 2014 and April 2015 to a large specialty pharmacy that serves the mid-Atlantic region, wrote Kaiser Health News. Of the patients, 504 were covered by Medicaid, 810 by Medicare, and 1036 by commercial insurance.
The researchers found that 377 patients received an absolute denial (16.0%). In the Medicaid group, 46% of patients received a denial, whereas 5% of patients with Medicare and 10% with private insurance were denied.
“The only thing that that was surprising was the magnitude of the denial rate,” Lo Re told Medscape Medical News.
Furthermore, the median wait for prescriptions to be filled was longer for Medicaid patients (21 days) than for those covered by Medicare or commercial insurance (each 14 days).
The most common reasons for absolute denial were insufficient information to assess medical need (133 patients, 35.5%), lack of medical necessity (125 patients, 33.3%), and positive results from an alcohol or drug test (15 patients, 4.0%).
In the overall cohort, Medicaid coverage (odds ratio, 8.97) absence of cirrhosis (odds ratio, 3.70), and HIV coinfection (odds ratio, 3.31) were independently associated with claim denial.
Prescriptions that required prior authorization by outside pharmacies were excluded from the analysis, as were patients covered by insurers that mandated the use of a different pharmacy. Patients with no health insurance were also excluded.
Lo Re et al found no significant difference in age, race, or history of treatment for hepatitis C between the Medicaid, Medicare, and commercially insured patients. In each insurance group, at least 80% of the prescriptions were for ledipasvir, sofosbuvir, plus ribavirin; prescriptions for sofosbuvir plus ribavirin were a distant second.
The authors conclude that Medicaid programs should seek to increase access to DAA agents for patients with chronic HCV infection.
This was the first analysis of denial of prescriptions for DAAs in this group of patients, wrote the University of Pennsylvania in a Press Release. DAAs cure most patients but are expensive—the costs to treat 1 patient for a 12-week course at a cost of more than $90,000.
A study published last August examined Medicaid reimbursement criteria in 42 states for sofosbuvir. It found that three quarters of those states limited access to people with advanced liver disease, and half the states required people to be drug or alcohol-free for a period of time before hepatitis C drug prescriptions could be filled.
However, these studies are limited as they are not nationwide—there is great variation in requirements among states.
The Philly.com blog wrote that the U.S. Department of Health and Human Services sent letters of concern to state programs nationwide 2 weeks ago, and also asked drug manufacturers what they are doing to make the treatments more affordable.
Based on 20,000 pages of internal company documents, interviews with health care experts, data from Medicaid programs in 50 states and the District of Columbia, the investigation found that the company pursued a marketing strategy and final wholesale price of Sovaldi (sofosbuvir)—$1000 per pill, or $84,000 for a single course of treatment—that it believed would maximize revenue. Building on that price, Gilead later introduced Harvoni (ledipasvir and sofosbuvir) at $94,500.
The Senate committee report concluded that promoting broad, affordable access was not a key consideration in the process of setting the wholesale prices.
The Wall Street Journal wrote that, based on the Senate report, Gilead knew the $1000-a-pill launch price for the drugs would be out of reach for many patients and cause “extraordinary problems” for government health programs.