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.

To ensure broad access for their supportive care technology, a European-based medical device company looking to enter the US market sought guidance and support in understanding the US payer system and how to gain buy-in from US healthcare providers.

A clinical-stage pharmaceutical company faced a unique barrier in bringing its first product to market—seeking pan-tumor approval based on a genetic marker, rather than a traditional approval based on cancer type. They subsequently sought recognition for the product across relevant clinical compendia.