An expert discusses how the biggest barriers to incorporating antibody-drug conjugates (ADCs) include lacking biomarker knowledge and how payer restrictions can be overcome through early biomarker testing, proper documentation of target expression levels, and following FDA or National Comprehensive Cancer Network (NCCN) guidelines to ensure patient access to appropriate therapies.
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ADC therapies represent a breakthrough in ovarian cancer treatment, but incorporating these targeted therapies into clinical practice faces significant barriers. The primary obstacle is biomarker testing, as all ADC therapies require specific molecular targets for effectiveness. Clinicians must test patients early for key biomarkers including HER2 and folate receptor α, which are essential for determining treatment eligibility. Next-generation sequencing panels often include immunohistochemistry testing for these common targets, though local hospital pathology departments may provide faster turnaround times for established markers like HER2.
Payer restrictions create additional challenges in accessing ADC therapies for ovarian cancer patients. Insurance approval requires documented evidence of specific biomarker expression levels, such as HER2 3+ staining or folate receptor α positivity in greater than 75% of tumor cells. These expression thresholds align with FDA accelerated approval criteria and must be validated through Clinical Laboratory Improvement Amendments–certified laboratory testing. Health care providers must follow both FDA guidelines and NCCN recommendations, which may be less restrictive but remain evidence-based, to justify treatment access to insurance companies.
Overcoming payer-related barriers requires comprehensive documentation and strategic biomarker testing approaches. Physicians should utilize next-generation sequencing panels that include immunohistochemistry components to provide robust evidence for insurance approval. Early biomarker testing, proper documentation of expression levels, and adherence to established guidelines help clinicians navigate payer restrictions effectively. This systematic approach ensures that eligible ovarian cancer patients can access potentially lifesaving ADC therapies without unnecessary delays in their treatment journey.
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