Off-Label Coverage of High-Cost Drugs by Independent Charity Patient Assistance Programs

Excerpt

Independent charity patient assistance programs are funded by pharmaceutical companies to help eligible patients cover their out-of-pocket costs for prescription drugs.¹ Pharmaceutical companies are prohibited from advertising or distributing information about off-label uses of their products but commonly suggest off-label uses in their direct-to-consumer advertisements for certain drugs.^{2, 3} Independent charity patient assistance programs had been prohibited from offering financial assistance for off-label uses until 2014,⁴ when the US Department of Health and Human Services relaxed the guidelines to allow these programs to cover less expensive drugs for off-label uses.⁵ The extent to which independent charity patient assistance programs have covered off-label uses of prescription drugs and the types of these covered drugs have not been examined. …