Case Studies

A European-based pharmaceutical company with several products in the US market was under pressure to interpret and respond to rapidly changing US healthcare policies which could potentially impact access for their portfolio of oncology products.

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.

A mid-sized pharmaceutical company was looking to enter the European market through a compassionate use/early access pathway but lacked an understanding of the requirements specific to each country that would lead to broad access and reimbursement for their product across Europe.

A precision therapies-focused biopharmaceutical company was bringing their second product to market. In order to support product access at the provider level and drive market share and utilization, it was critical they understood the oncology clinical pathway landscape within two distinct therapeutic classes.

A large, multinational pharmaceutical company was looking to incorporate the patient voice across all stages of product development for their entire portfolio of oncology/hematology products. Their team needed support from a partner with the expertise to reach patients and advocacy organizations, and to develop an overall strategy for their advocacy relations team.

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.