Last month, the announcement of aggressive plans to move the Medicare fee-for-service plan to a value-based payment system (see Medicare Bets Big On Pay-For-Value) received lots of media and industry attention. But at the same time, the Obama Administration announced a $215 million “precision medicine” initiative (see President Obama’s Precision Medicine Initiative). “Precision medicine” in this context is synonymous with “personalized medicine,” – using an individual’s genetic profile to guide decisions made in regard to the prevention, diagnosis, and treatment of disease.
The Obama Precision Medicine Initiative, has four components:
- $130 million to the National Institutes of Health NIH, which will combine existing genomic databases
- $70 million to the National Cancer Institute (NCI), part of NIH, to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development treatments
- $10 million to the Food and Drug Administration (FDA) to hire additional expertise and advance the development of high quality, curated databases to support the regulatory structure needed to advance precision medicine
- $5 million to the Office of the National Coordinator for Health Information Technology (ONC) to develop interoperability standards and enable secure exchange of data
The initiative appears to build on the 13-year, 3.8 billion Human Genome Project initiative – a sort of “big data” meets “big genome” approach to moving genetic information to practice. The proposal has mixed reviews, from critical to glowing – Hospitals, Doctors Cheer Obama’s Call For Personalized Medicine, Personalized Medicine: Government Is The Problem, Not The Solution, Commentary: Personalized Medicine Offers Huge Promise, and In Retrospect, Obama’s Personalized Medicine Initiative Is Nothing New.
Regardless of whether the initiative makes it through the upcoming and contentious budget process, it has raised the profile of the current possibilities for personalized medicine. A quick Google search of “genetic testing” services reveals a long list of early market entrants with direct-to-consumer strategies. Here are just a few:
- 23andMe’s Personal Genome Service – Direct-to-consumer genetic testing providing DNA analysis technologies and web-based interactive tools.
- Natera’s Horizon Multi-Disease Carrier Screening – A panel of genetic prenatal tests, from preimplantation genetic diagnosis for IVF, to non-invasive prenatal testing.
- Emory University’s JScreen – Specific preimplantation genetic testing for 19 genetic diseases, for IVF candidates.
- Personalis’ ACE Clinical Exome Test – A Next–Generation Sequencing (NGS)-based test that provides a molecular genetic diagnosis for patients with relevant disorders.
- Gentrace DNA Family Check – Genetic testing to determine biological parenthood, sibling relations, family relations (aunts and uncles), twin relations (identical or fraternal) and grandparent relations.
And we’re just starting to see the application of genetic knowledge to clinical practice in a more structured way. One example is the use of genetic information to help consumers and professionals determine the best match with available psychotropic medications. This includes Genomind’s Genecept Assay, AssureRX’s Genesight, and Pathway Genomics’ Mental Health DNA Insight. And, we’re starting to see payers issue clinical and reimbursement policies related to genetic testing like the Genetic Testing For Mental Health Conditions, from BlueCross BlueShield of Western New York, and Corporate Medical Policy: Genetic Testing for Mental Health Conditions, of BlueCross BlueShield of North Carolina.
For even more, check out these resources in the OPEN MINDS Industry Library:
- Genetic Research Finds Schizophrenia Is Eight Distinct Disorders
- Medicare To Cover Assurex Health Genetic Test
- Genetics & Neuroscience Will Transform Mental Health Treatment Within 10 Years
- Genetic Biomarkers Predict Antidepressant Response; Genetic Switch May Cause Depression Brain Changes
- Priorities for Personalized Medicine
- Personalized Medicine – Ready Or Not?
- The End Of Symptomatic Psychiatry?
- Behavioral Health Moves Toward Personalized Medicine: How Genetics Are Changing Treatment For Provider Organizations & Consumers
- Personalized Medicine: Relative Vs. Actual Risk
- Medicine In Denial
Like most issues in the U.S. health care system, the personalized medicine phenomenon will be addressed by a confluence of activities from private sector investors, the consumer health care market, health plan policies, regulation, and government investment. We’ll keep our readers up-to-date on the emerging developments – and its effect on serving consumers.