Employers’ Guide to Precision Medicine: Genetic Testing, Treatments and Implications for Coverage

Precision medicine has great potential to improve patient care and outcomes. The speed of clinical progress has been unprecedented, most notably benefiting patients at risk for, or affected by, genetic conditions.

December 11, 2020

Precision medicine has great potential to improve patient care and outcomes. The speed of clinical progress has been unprecedented, most notably benefiting patients at risk for, or affected by, genetic conditions.

While precision medicine itself is not new, the relatively recent advancements in gene science have put the spotlight both on its clinical potential and rising cost. Since the Human Genome Project succeeded in  mapping the human genome in 2003, innovation in genetic testing and development of new gene therapies accelerated.

The term “precision medicine” refers to a broad range of medical treatments that are based on the individual characteristics of the patient. It recognizes that individuals’ traits, including their genetic profile, may determine their likelihood of disease development, as well as the likelihood of successful response to treatment. Precision medicine also allows doctors to customize preventive and therapeutic protocols to target those patients who will benefit most. Companion testing can reduce waste by avoiding the administration of expensive treatments to patients whose gene mutation does not match the one targeted by the drug. The expense and negative side effects also can be avoided for those who will not benefit. The advancements in genetic science have simply made medicine more…precise!

The field of genetics is not particularly new. Chromosomes (molecules that contain genetic information) were linked to inherited diseases in the early 1900s, and the first tests to identify genetic conditions, like Down syndrome and cystic fibrosis, were developed in the 1950s.1

Today, there are more than 75,000 genetic tests, with several entering the market every day. Gene therapies with unprecedented price tags are also becoming available. Since the first approval in 2017, the Food and Drug Administration (FDA) has approved a total of 17 cell and gene therapies for various cancers, viral infections and inherited disorders. Some 362 other gene therapies are in clinical development in the U.S. alone2

What Should Employers Be Aware Of?

As the science rapidly evolves, regulators and other industry players are having trouble keeping up with oversight and guidance. The complexity, scope and relative novelty of many of these tests and treatments also mean that patients, health benefit professionals and even providers don’t have the expertise to effectively navigate all available testing and treatment options. The promise of genetic tests, simple human curiosity and, in some cases, marketing efforts, can also lead to waste and fraud.

This Guide is designed to help employers sort through the essential information related to precision medicine and genetics by providing information on the following:

  • The types and utility of genetic tests and their applications;
  • Genetic therapies currently on the market, the pipeline and the related price challenges; and
  • The impact of this innovation on health benefit strategy, implications for coverage, programmatic design, cost, and vendor partnerships.

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