From Specialty Pharmacy News - In the latest in a long list of dustups over new hepatitis C drugs, two public health advocacy groups are suing the FDA and HHS in an effort to force the FDA to release raw clinical trial data for Gilead Sciences Inc.’s Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir), which were given priority review and breakthrough-therapy designation. The organizations are seeking the data because information “suggest[s] that the drugs have been widely used” to treat people with hepatitis C “who face variants of the virus or other circumstances that were little-studied during the clinical trials.” However, it sounds like the groups are… Read more
From Specialty Pharmacy News - As guidance on the 340B Drug Pricing Program enters its third month at the Office of Management and Budget (OMB), yet another report has been released that calls into question an aspect of the program. Issued in June, the Government Accountability Office (GAO) report (GAO-15-442) recommends modifying the program so providers are not incentivized to prescribe more or more expensive drugs to Medicare Part B beneficiaries treated at 340B hospitals. Read more
From Drug Benefit News - While specialty drug expenditures for members of public exchange plans rose considerably in the last year, a new analysis from Express Scripts Holding Co. suggests there may be a silver lining for exchange plan sponsors: New enrollees in the first quarter of 2015 were healthier and spent less on medications than those who were new to exchanges in the year-ago quarter, which should help plans better manage their risk. Read more
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