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Solving Access Barriers in Biomarker Testing: 5 Tips for Manufacturers

By Hannah Baxter, Jen Klarer and Carolyn Zele

Despite the rapid evolution of personalized medicine, access to genetic testing and next-generation sequencing (NGS) is a challenge—due in no small part to coverage confusion. Physicians struggle to navigate poorly defined testing coverage policies and a fragmentated payer and vendor ecosystem, resulting in delayed care for patients requiring precision therapies.

While biomarker testing and NGS are more likely to be covered by payers if markers are associated with targeted therapies (i.e., biomarker-specific language in a drug’s indication statement), challenges persist for providers and patients to ensure coverage.

Let’s take a look at the existing access barriers—and how manufacturers can circumvent them.

Vague coverage policies and unstated criteria

For most health plans, coverage criteria for biomarker tests are neither explicit nor well understood. Given the pace of innovation, payers and laboratory benefit managers (LBMs) who develop testing coverage often default to generalized policies.

When biomarker testing policies are well-defined (e.g., criteria for eligibility, codes relevant to disease state), it is largely due to the availability of multiple or long-established products approved for treatment.

As a result, physicians are often unclear about test coverage, eligibility requirements, and which codes facilitate reimbursement. If the submission is incomplete or coding incorrect, the claim could be denied.


Read the full article at Drug Channels for tips on how to improve access to biomarker testing. For more expert guidance, learn about MMIT and The Dedham Group’s premier advisory services for oncology clients.

© 2024 MMIT
Hannah Baxter

Hannah Baxter

Hannah Baxter is an associate partner at The Dedham Group.

Jen Klarer

Jen Klarer, partner and head of Cell & Gene Therapy at The Dedham Group, has more than a decade of experience in multi-channel market analysis and strategic access optimization, spanning specialty therapeutic categories including cell and gene therapy, oncology, immunology, and rare disease. Jen’s expertise includes coverage and reimbursement modeling, provider site activation planning, and commercial operations configuration. Jen previously conducted six years of academic research, including pre-clinical study of an autologous cell therapy for critical limb ischemia. She holds a Master of Science degree in biomedical engineering from Columbia University.

Carolyn Zele

As a solution consultant for MMIT, Carolyn Zele helps pharmaceutical manufacturers simplify market access and prepare for launch success. Prior to MMIT, Carolyn spent numerous years in the payer/PBM space managing formulary teams and technology across both regulated and non-regulated lines of business.

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