Friday, May 10, 2024

Solving Access Barriers in Biomarker Testing: 5 Tips for Manufacturers

Today’s guest post comes from Hannah Baxter, Associate Partner at The Dedham Group; Jen Klarer, Partner, Head of Cell & Gene Therapy at The Dedham Group; and Carolyn Zele, Advisor, Solution Consulting at MMIT.

The authors discuss the access barriers facing patients who need biomarker testing. They discuss five ways manufacturers can prevent these barriers from affecting patients.

To learn more about navigating the complexities of market access, contact MMIT and its sister company, The Dedham Group.

Read on for their insights.

Solving Access Barriers in Biomarker Testing: 5 Tips for Manufacturers
By Hannah Baxter, Associate Partner, The Dedham Group, Jen Klarer, Partner, Head of Cell & Gene Therapy, The Dedham Group, and Carolyn Zele, Advisor, Solution Consulting, MMIT

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 fragmented payer and vendor ecosystem, resulting in delayed care for patients requiring precision therapies.

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

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


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 (eg, 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 the coding is incorrect, the claim could be denied.


The extent of testing policy ambiguity and differing submission requirements varies across payers. Provider sites struggle to amass enough test-specific experience per payer to master approval processes and significantly improve their claim acceptance rates.

In addition, there are often multiple stakeholders involved in the approval process, from payer to LBM to a third party. Some LBMs simply develop a testing policy’s structure, while others receive and adjudicate claims. As these relationships and responsibilities are often not public, a provider site may not know how to appropriately navigate barriers.


To complicate matters, providers might need to jump through additional hoops if a laboratory is out of network. Since laboratories have differing capabilities, determining which laboratories can identify patients and are considered in-network for a given biomarker test can be challenging and time-consuming.

Additionally, working with an unfamiliar laboratory can also limit physician awareness of which laboratory staff to coordinate with to ensure testing coverage (eg, patient medical history sharing).


If a physician orders a test that is initially denied by the payer—potentially because of missing eligibility information or the laboratory is out-of-network—the patient can incur steep out-of-pocket costs that can delay or prohibit treatment.

Manufacturers have a limited ability to help resolve these challenges. If a prospective patient has not yet been prescribed the therapy, manufacturer testing support requires a clear firewall between product marketing and prospective patients. Compliance teams may require additional steps to appropriately restrict test- or brand-specific messaging.


Ideally, when a new product requires biomarker testing, payers would work with LBMs to simultaneously create a product coverage policy alongside a clear, descriptive testing coverage policy. Alternatively, they could work to ensure that the test coverage policy captures targeted therapy candidates.

Here are 5 steps manufacturers can take to prevent access barriers for testing:
  1. Take the lead in promoting testing fluency. Manufacturers can educate payers, LBMs, and third parties on appropriate product test requirements and what constitutes eligibility. Additionally, pharmaceutical companies can clarify test requirements, support payers’ policy alignment, and prepare payer field teams to discuss test coverage.
  2. Establish engagement campaigns with specialists and prescribing physicians. Manufacturers can provide physicians with clear instructions on how to get biomarker tests covered and reimbursed (eg, sample clinical information within the initial prior authorization). Additionally, field teams can bolster submission education to improve coverage upon first submission.
  3. Educate providers on laboratory networks. Manufacturers can give providers a list of the laboratories that offer relevant tests. With web resources and payer collaboration, manufacturers can also map network relationships for top payers and share this information with providers.
  4. Provide public resources for patients and providers. On product websites, manufacturers can provide resources on how to identify eligible patients, including the test(s) needed, available vendors, proof of eligibility, and ordering instructions. Manufacturers could also post both product and testing coverage guidelines across payers on their brand website.
  5. Communicate changes in laboratory qualifications to payers. For some products, a laboratory must be qualified to run a particular test. Manufacturers could make public announcements to share the news about qualified laboratories, ensuring there are no delays when a laboratory becomes qualified and/or a laboratory is added to an in-network status.
Looking for expert guidance to help you navigate the complexities of market access? Learn how MMIT and its sister company, The Dedham Group can help.

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