Accelerated approval speed bump will limit access, disincentivize orphan drug development
Penn.-based commercial payer using accelerated approval to justify coverage denials of non-oncology products for 18 months
While the impact of a small commercial payer’s decision to restrict access to accelerated approval drugs will be limited, if the strategy is adopted by larger payers, it could block access to life-sustaining medicines and disincentivize development of drugs. The effects of barring access to certain drugs for the first 18 months following accelerated approval could be especially troubling for patients with rare diseases, and for companies developing orphan products.
Independence Blue Cross, a Blue Cross affiliate covering about three million patients in Philadelphia and southeastern Pennsylvania, announced in December a new policy, which was highlighted by Tufts Medical Center Senior Fellow Brian Reid, under which products granted accelerated approval would be excluded from coverage for a period of 18 months...