A Comprehensive Launch Strategy Leads to Broad Access

The Challenge

The Challenge

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.

The IP Solution

The IP Solution

After working with the company to evaluate their internal competencies and identify gaps in their commercialization strategy, IP engaged in an assessment of the oncology clinical pathways climate in relation to this new therapy.

Following this in-depth market analysis, we developed a strategy to support their coding and reimbursement needs—including an extremely quick turnaround to identify the viability of an NTAP designation, and later, the development and submission of an application to CMS.

Additionally, in collaboration with the Market Access and Medical Affairs teams, IP supported the development and submission of applications for the product’s inclusion in the five major oncology clinical compendia and several major pathways organizations. We also provided support for outreach and engagement with the major pathways vendors, EMR vendors, and payers.

The IP team are great partners. They are very knowledgeable and easy to work with. They are solutions oriented.
VP, Market Access, Pharma/Biotech Company
The Result

The Results

In fewer than 18 months following the commencement of their partnership with IP, the company received FDA approval and was subsequently recognized across all major oncology clinical compendia. IP’s work with the company continues as they seek supplemental indications and release incremental data in support of broad access for their product.

Related Case Studies

Clinical Guideline Strategy

IP leveraged its Medical Affairs expertise and experience supporting more than 70 submissions to key oncology clinical practice guidelines to advocate for the inclusion of a test that predicts the benefit of therapy, resulting in broad and appropriate access for patients. 

Healthcare Policy Changes Interpreted in Real-Time

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.