New York Attorney General Eric Schneiderman has subpoenaed 16 insurers to determine whether they are inappropriately denying patients access to new hepatitis C drugs. People familiar with the matter noted that the initial two subpoenas specifically requested documentation regarding coverage of Gilead Sciences' Harvoni (ledipasvir/sofosbuvir), while the remaining subpoenas did not mention a specific drug.
The attorney general's office has found that many insurance plans have restricted access to Harvoni until liver damage occurs. The office added that between 50 percent and 90 percent of patients who were prescribed Gilead's product were denied coverage by insurers. According to the attorney general's office, the probe centres on whether the insurance companies are engaging in misleading and deceptive practices, as the law requires accurate disclosure of what they cover and consider medically necessary.
Harvoni, which was granted expanded approval by the FDA in November last year, is priced at $94 500 for a 12-week course of treatment, although Gilead noted that it provides large discounts to insurers, including a discount in excess of 50 percent to Medicare. Other newer hepatitis C drugs include Gilead's Sovaldi (sofosbuvir), AbbVie's Viekira Pak, which combines Viekira (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir), and Merck & Co.'s Zepatier (elbasvir/grazoprevir), which was recently launched at a list price of $54 600 for a 12-week course of treatment (for related analysis, see ViewPoints: One, two, three (four), Merck & Co. declares another HCV price war).
Insurers reportedly contacted as part of the investigation include Aetna, Anthem, CareConnect and EmblemHealth. Anthem, which operates the Empire Blue Cross Blue Shield insurance company, said it recently expanded coverage for hepatitis C drugs. "After several months of ongoing clinical review of the medical evidence and safety concerns surrounding hepatitis C treatments, coverage for Empire Blue Cross Blue Shield employer and individual health insurance plans was expanded for six of the newer oral treatments effective December 7, 2015," Anthem spokeswoman Jill Becher noted.
Commenting on the news, Leslie Moran, spokeswoman for the New York Health Plan Association, remarked "we feel the attorney general's subpoena is overly broad and does not take into account evolving guidance related to these new therapeutic classes of drugs." Moran continued "moreover, it does not take into consideration the impact of excessive and unsupported pricing of these drugs -- which has a negative impact on affordability of coverage."
Pharmacy benefit manager Express Scripts previously announced that Viekira Pak would be awarded preferred status in its formulary after receiving an undisclosed discount from AbbVie. Conversely, Harvoni and Sovaldi were granted preferred status by CVS Health, while Harvoni was selected as the primary treatment option for patients with genotype 1 hepatitis C infection by Anthem.
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