By InformedDNA
Clinical genomics guidance

Appropriate clinical guidance is the cornerstone of any health plan benefits management program when it comes to genomics in healthcare. However, writing and maintaining appropriate genomic coverage policies in-house poses unique challenges for most health plans. Genomic coverage guidelines must address many factors in the face of rapidly changing genomic science and a rapidly expanding test landscape.

This is further complicated by the multi-specialty relevance of genetic testing. Adopting a clinical specialty-based — rather than a gene- or test-based — approach to policy development represents a paradigm shift for most health plans.

Personalized Clinical Guidance Development for Precision Medicine

Traditional clinical utility frameworks are difficult to apply to genomics because they focus only on the amount and strength of traditional research-based evidence — which is often limited in genomics due to the rapidity with which new tests and gene discoveries are being introduced to the market. To address the scarcity of outcomes evidence, a genomics-centric approach must incorporate additional clinically important factors along with the most current evidence. These additional factors include available professional society guidance and expert opinion statements, clinical availability of comparable alternatives, downstream costs, risk of overutilization, and risk of harm, all of which impact appropriate coverage decision-making in precision medicine

Once clinical specialty-based guidelines are written, they must be deployed in a systematic way that ensures consistent use for internal clinical reviews and that the policies can evolve based on changing science and with real-world applications in mind.

Precision Drug Management 

Another area growing in the era of precision medicine is the intersection of pharmaceuticals and genomics. FDA approvals of specialty drugs have accelerated in recent years, with more new specialty drugs being approved than traditional drugs in the past 10 years. Just like medical coverage policy development for genomics, health plans must be able to quickly evaluate and create pharmacy and therapeutics policy criteria for coverage of new genomics-based therapeutics. Access to genomics expertise to support the creation of evidence-based coverage criteria for precision drug management is an efficient way to ensure medically necessary coverage of specialty drugs. Utilizing the same approach to clinical guidance as in medical coverage policy development, precision drug coverage criteria should be developed with insights from genomic experts and allow for a flexible and dynamic approach, based on the latest evidence from genomic-based clinical trials.

Benefits of Rigorous, Evidence-Based Clinical Guidance 

Providing clinical guidance through a dynamic, flexible model ensures guidelines and coverage policies are equipped to encompass the breadth of all relevant conditions and factors. With the fast-changing world of genomics, coverage policies need to be flexible enough to apply to new tests that enter the market, without necessitating constant out-of-cycle updates. With a clinical specialty-based approach, health plans can close the gap between the traditional utility framework and the real-world application of genomics in clinical practice. Ultimately, it enables policy consolidation, not only making it simpler for providers to navigate, understand, and utilize but for health plans to deploy.

At InformedDNA, we leverage the expertise of the most experienced full-time staff of lab-independent, board-certified genetics specialists in the U.S. to help ensure that patientshealth planshealth systems and hospitals, pharmaceutical companies, and healthcare providers have access to the highest quality genetics services. If you’d like to learn more about InformedDNA and the expert genetics services we offer, please get in touch – just fill out the short form below, or give us a call: 844-846-3763.


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