A Novel Therapy Seeks to Support Physician Reimbursement
The Challenge
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.
The IP Solution
Leveraging our extensive experience with the New Technology Add-On Payment (NTAP) application process, Innovation Partners successfully acquired an NTAP designation for the novel therapy.
Our success was the result of a proven process:
Using extensive analysis, we ensured that the therapy met CMS criteria for Newness, Cost Threshold, and Substantial Clinical Improvement.
We engaged in meetings with regulatory decision-makers and harnessed support from Key Opinion Leaders—including clinical experts, advocacy groups, and professional societies—in support of the NTAP. All leading to the development and submission of the application to the CMS.
What sets IP apart is knowledge of the oncology market and relationships with key players.
The Results
After the 18-month process, the therapy was awarded an NTAP designation, supporting in-patient prescribing and ensuring access for patients.
