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 to the doses. 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 cheek swab that collects DNA from the cells on the inside of a person’s mouth. The specimen collection can be performed by an appropriately trained individual and the report results available in 1-2 weeks. A cheek swab is one of the most common ways to do DNA tests. 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.

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."

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.

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 2015/2016 White House initiative to improve precision medicine. The mission is 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.

Personalized Medicine Coalition PMC 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.

Department of Health and Human Services Grants Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33)

Medicare is the most reliable payer and the commercial carriers range in reliability of payment. Few Medicaid carriers are currently paying for these tests today but with the significant 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.

Available Tools and Resources

Genetic Testing and Precision Medicine- A personalized medical approach to improve outcomes.

Personalized Medicine Coalition- Personalized Medicine Report

Therapeutic drug monitoring: A patient management tool for precision medicine

Therapeutic drug monitoring in the era of precision medicine

Premier DNA is a genetics testing company that has created a integrated care model combining genetic testing, interactive genetic reporting, and pharmacy consultation. They offer this program under the registered trade name Med Op Rx. This service becomes a useful tool to guide the physician in terms of implementing the most precise MAT program given the individual patient's genetic makeup.

Promising Practices

Precision Medicine's value - Includes promising practices and developments in the field of precision medicine and therapies.

GIGA Precision Medicine & Global Mental Health.

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