OBJECTIVES: Biomarker-driven prescribing is paramount in oncology indications. Although preferred for targeted treatment, these therapies are premium-priced and often subject to payer restrictions and cost-containment strategies constraining their uptake. Focusing on key oncology indications, this research explored the drivers and barriers to use these agents and how reimbursement impacts drug selection and prescribing.

METHODS: In August 2019, 100 medical oncologists across the United States were surveyed regarding the role cost and reimbursement play in their decisions for prescribing of biomarker-driven therapies and 30 payers who influence pricing and reimbursement in their commercial plans were surveyed. Additionally, data was analyzed from DRG’s Fingertip Analytics, a nationwide database of formulary coverage.

RESULTS: Although most payers (67%) believe that premium pricing for biomarker-driven therapies is justified, these therapies present a significant financial burden for U.S. payers; leading to various contracting agreements and management strategies to control the costs of biomarker-driven therapies. Most surveyed payers indicated their MCOs are using indication-based formulary approaches for oncology therapies that treat multiple indications (83%) and have received health economic outcomes data to support their value assessment (70%). Furthermore, payers indicated that companion diagnostics tests (67% of payers) and the company pharmacoeconomic submissions with compelling data (63%) have positive influence for tier placement on coverage decisions. For many surveyed oncologists, changes in payer policies would not change their prescribing. However, clinical pathway programs including biomarker tests (64-77%) and utilization management controls are increasingly popular measures for curbing treatment costs.

CONCLUSIONS: Evaluating drugs for overall benefit versus overall cost to the system is the new norm and providing robust pharmacoeconomic data is crucial to demonstrate a biomarker-driven therapy’s value and achieve optimal market access. Compelling efficacy and cost-effectiveness data in a real-world setting over standard therapies support more favourable value assessment, pricing and reimbursement negotiations, and prescribing overall.