Expand DNA Testing to Improve Precision MAT/MAR Therapies

Introductory Paragraph

Genetics and genetic makeup impact how individuals respond to medications. With today's more refined analysis of the human genome map, there is a growing understanding of how DNA accounts for changes in drug metabolism. This means that DNA testing can enhance personalized medicine to improve Medication-Assisted Therapy (MAT).

Key Information

Individuals all process and metabolize drugs in differing ways. Someone's genetic makeup, the amount of enzymes, and specific receptors they have contribute to how a person can metabolize medicine. Genetic testing reveals information that can help us accurately tailor medications on a patient-to-patient basis. This is called Precision or Personalized Medicine and "focuses on providing health care with increased resolution, accounting for aspects that are unique to the individual and their disease. By definition, precision medicine involves all phases of care: prevention, diagnosis, and treatment."

In the past, physicians had limited tools to evaluate dosages for MAT Plans, and they relied on a series of "trial and error" doses that were adjusted, based on patient response. When the dose of medication was not ideal, the patient either received insufficient benefit from the medication or had side effects or adverse drug reactions. The inconsistent impact of medication used in MAT has been a contributing factor to the relapse rates in opioid addicted patients. Now, MAT can be used with insights from genetic tests to optimize the plan for each patient. A clinical genomic test can display the expected benefits and risks if the patient receives any one of over two hundred medications. When the focus is on the drugs being used to treat opioid addiction, such interactive reports can then be used by physicians, pharmacists, therapists, dietitians, and social service professionals to develop more precise and personalized treatment plans. DNA testing can also be used to inform how the patient's dietary regimen can affect their use of specific medications.

A genetic test is performed by obtaining a simple procedure which collects DNA from the cells on the inside of a person’s mouth. A cheek swab is one of the most common ways to do DNA tests, and the specimen collection can be performed by an appropriately trained individual. The report results are available in 1-2 weeks. Insurance coverage varies for this test which costs approximates between $500 and $1,200 based on whether annual pharmacy consultative services are included.

Relevant Research

This study showed that more precise dosing in MAT, based on more accurate analysis of gene allele variability has decreased relapse rates in opioid addicted patients by 25% over an 18-month tracking period.

This article documents the complexity of pharmacogenetic testing and concludes that the success of testing depends on the physician’s ability to understand the obtained results in a standardized way for each particular patient.

The U.S. Department of Veteran Affairs Office of Research & Development has initiated funding of research for genomics and mental health, but does not yet have results. For example, the PRIME Care Trial is an ongoing study with 2000 veterans to determine the efficacy of precision medicine in addressing Major Depressive Disorder.

This research editorial states that "Despite its conceptual elegance and dominance as a research framework ... precision medicine has a very limited track record of demonstrable success thus far for mental illnesses."

McKinsey & Company performed a market analysis and reported the following trends:

• Data integration and analytics to realize the value of data have become increasingly important for the healthcare-delivery value chain.
• Payers are facing increasing pressure on costs and looking for new opportunities to control them.
• The US reimbursement landscape, which drives the profitability of most diagnostics players, is gradually evolving.

Impactful Federal, State, and Local Policies

Precision Medicine Initiative. In 2015, the White House launched an initiative to improve precision medicine. The mission was to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care. As part of this effort, the National Institutes of Health (NIH) formed the Precision Medicine Initiative Working Group of the Advisory Committee to the Director which generated a final report. The report provided a framework for setting up the All of Us Research Program at NIH which includes a focus on precision medicine. NIH also launched a grant program titled "Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33)."

Medicare. Commercial insurance carriers range in the reliability of payment, so Medicare is the most reliable payer. Few Medicaid carriers are currently paying for these tests, but with the additional funding being made available to individual states to address the opioid addiction crisis, the anticipation is that the state-based Medicaid plans will begin to address this coverage gap.

The Personalized Medicine Coalition engages on a number of key priorities in public and science policy to advance its mission of promoting innovation and delivery of cell and gene therapies.

Available Tools and Resources

• The American Society for Clinical Pharmacology and Therapeutics has published "Therapeutic drug monitoring: A patient management tool for precision medicine."

• The British Pharmacological Society has published "Therapeutic drug monitoring in the era of precision." medicine

• The Personalized Medicine Coalition has published the "Personalized Medicine Report' which outlines opportunities, challenges, and a prognosis on the future of the field.

• Health IT Analytics provides a newsletter dedicated to precision medicine.

Promising Practices

The Global Imaging Genetics Initiative in Adolescence (GIGA) is a consortium of several groups in China, India, Europe, and the USA that investigate mental health outcomes in children and adolescents in different cultures, environments, and ethnic groups using behavioral and brain imaging genetic studies. It is working towards data acquisition, retrieval, and analysis of more than 195,000 individuals. GIGA is built on the potential for precision medicine to revolutionize the prevention and treatment of mental illness. It aspires to establish relevant risk and resilience factors and to define methods for earlier and more targeted prevention and to to reduce stigma, which it recognizes as an obstacle to mental health care access.

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