A biopharmaceutical company was in the midst of bringing its first product to market with breakthrough therapy designation. The PDUFA date was fast approaching, and their small team needed guidance to steer them through the complicated access and reimbursement landscape.
An emerging pharmaceutical manufacturer sought FDA approval for a first-in-class therapy with potential to offer significant clinical improvement for patients with small cell lung cancer. However, there was concern about reimbursement. For a subset of patients, the therapy had to be administered in an in-patient setting, and current MS-DRG bundled payments were not priced to appropriately cover this type of administration. Without appropriate reimbursement, providers would be less likely to incur the risk in prescribing the novel therapy and access for patients would be severely limited.
A ground-breaking medical device, although recognized by major clinical compendia, was lacking the appropriate Current Procedural Terminology (CPT) codes. This created hesitancy among providers, who feared they would not be reimbursed or prescribing this supportive care technology for their patients.