Navigating access and reimbursement dynamics in precision medicine

Precision medicine offers significant promise in enabling targeted therapies for complex illnesses. But unlike the more predictable path of traditional drug coverage and reimbursement, the process of facilitating access and reimbursement for these therapies presents unique challenges. 

The pharmaceutical pipeline is rich with biomarker-driven therapies aimed at improving patient outcomes through targeted treatment options. Precision medicine enhances treatment outcomes by developing therapies for specific patient populations most likely to benefit. Detection methods vary widely, from identifying mutations that signal treatment resistance to biomarkers that monitor therapy response. 

Today, biomarkers can be detected using various laboratory techniques, ranging from cost-effective in-house PCR testing to more complex next generation sequencing (NGS) tests. As treatment paradigms evolve, so do testing protocols, with some biomarkers requiring close monitoring throughout a patient’s treatment journey. This necessitates careful commercial planning for both pharmaceutical and diagnostic manufacturers. This variety of test methods and uses can have a significant impact on operational workflows in physician offices, hospitals, and laboratories, affecting reimbursement and access.

Aligning stakeholders and streamlining patient access

Pharmaceutical manufacturers must consider multiple stakeholders when assessing their commercial and market access strategies for biomarker-driven therapies. 

Early planning with diagnostic testing partners to align on go-to-market plans is crucial. Whether tests are performed through sole-source third-party labs or distributed via in vitro diagnostic kits, smooth partnerships with diagnostic partners are key when integrating novel testing paradigms into treatment workflows. 

Payer partnerships are also essential. As new biomarkers and testing protocols emerge, payers are re-evaluating their approach to diagnostic testing and screening coverage. Several commercial payers have implemented stringent requirements, such as DEX Z-codes or automated denials, to manage testing and address code specificity challenges. Some health plans are negotiating test prices, especially for higher-cost options like NGS in high-priority therapeutic areas such as oncology. The fragmented flow of diagnostic testing referral, administration, interpretation, as well as associated coverage and medical decision-making continues to challenge test deployment—requiring tailored customer education and resource support. With these challenges in mind, laboratory benefit managers have emerged as critical access players, overseeing laboratory utilization management, claims adjudication, lab network negotiations, and contracting. 

Public policy also impacts diagnostic access. Many states are considering or have mandated coverage of biomarker testing in certain therapeutic areas. At the federal level, increased regulation of laboratory-developed tests (LDTs) may require more time for approvals. The FDA recently issued a final rule to provide greater oversight over LDTs, historically under the purview of the Centers for Medicare & Medicaid Services. 

Given the many players and roles, life sciences firms must carefully develop their go-to-market position and engagement tactics. 

Best practices for a successful launch

1. Articulate the clinical value of diagnostic tests: Define diagnostic positioning and medical necessity, linking the marker to physician decision-making and improved patient outcomes.
2. Differentiate evidence to secure coverage: Involve market access team members early in evidence generation plans and payer positioning, using data to demonstrate medical necessity through clinical utility and validity. This can ultimately help minimize barriers like prior authorization. 
3. Manage stakeholders effectively: Develop engagement strategies for access decision-makers, including managed care organizations, laboratory benefit managers, specialty societies, policymakers, and customers.
4. Evaluate claims processing and reimbursement infrastructure: Assess current coding infrastructure, evaluate sufficiency of anticipated provider economics, and the path to price-setting under Medicare payment rules for establishing the Clinical Lab Fee Schedule. If codes or fee schedules are required, determine strategy, pathway, and timing for labs versus providers based on your testing ecosystem.
5. Develop alliances: Identify compliant approaches to engaging, educating, and partnering with diagnostic manufacturers and laboratories to support test launch strategy and execution across key markets.

Precision medicine therapies face unique market access considerations and require early understanding and planning for successful adoption. Manufacturers that adopt proactive and collaborative strategies that anticipate diagnostic, reimbursement, and regulatory headwinds will be best positioned to achieve their goals.