Patient services programs have helped countless consumers gain access to new high-priced specialty drugs.
But these programs, present a number of new risks and challenges to drug manufacturers, since they position the company within the patient, provider, and insurer relationship. They also often involve complex and expensive arrangements with third-party intermediaries, such as HUB vendors and specialty pharmacies.
These initiatives have raised compliance concerns around drug pricing and the potential for undue influence, product promotion, and clinical interference. Moreover, a recent string of settlements and subpoenas has demonstrated an increase in regulatory scrutiny around patient services programs.
KPMG LLP Life Sciences Advisory team assists pharmaceutical manufacturers with managing and mitigating the operational, financial, and regulatory risks associated with administering patient services programs.