The GIRS Value Pointer Clinical Outcomes Strategies™ Team conducted an evidence review for a drug that resulted in integrated clinical outcomes and reimbursement strategies. We performed a literature search for the class of drug and reviewed six studies. Four of the studies were Randomized Control Trials (RCTs) and two were prospective clinical studies. Three studies were based in Europe and three were conducted in the U.S. This review resulted in two main studies being selected for the Evidence Table to be included in the payer dossier for coverage. These studies were selected because they met payer desired criteria for study design and evaluated the drug in the target population.
The remaining four studies were not selected because they did not evaluate the medical therapy in the target population. It is unlikely that payers would consider these four studies generalizable or relevant in a coverage determination for the drug.
The value story for the drug was developed based on current data: The drug is a safe and effective product for the approved indications as an alternative to surgical procedure. It significantly reduces the need for and the extent of surgery compared to SOC while achieving comparable long-term results and reducing costs of the specific therapy.
A payer dossier was developed combining US and International data based on payer-specific criteria for coverage. The stage has been set to implement payer education and coverage support with our Payer Advocacy Compass™ (PAC) team in 2017. Please contact us at http://girsinc.com/contact/ to review your Clinical Outcomes Strategies and to plan your 2017 Payer Advocacy work so that you can achieve the best market access outcomes expediently.