It has been more than a year since President Barack Obama unveiled the Precision Medicine Initiative (PMI).
In response to the initiative, the FDA began considering regulating practices to use, market, and analyze genetic information. Currently, the FDA is seeking public input regarding the use and implications of genetic testing.
A few of the following uses of genetic testing are being considered: tests that determine the risk of developing a condition, tests that diagnose hereditary genetic disorders, and tests that can guide treatment or therapeutic interventions1. Therapeutic intervention is the consideration where pharmacists can have the most impact.
In June 2015, Medicare made a decision that seemed in misalignment with the president’s message of innovation with the PMI. Due to some abuses in the pharmacogenomic testing marketplace, Centers for Medicare & Medicaid Services (CMS) decided they would only pay for genetic tests in 2 evidenced-based instances:
- Genetic testing of the CYP2C19 gene is considered medically necessary for patients with acute coronary syndrome undergoing percutaneous coronary intervention who are initiating or reinitiating clopidogrel (Plavix) therapy.
- Genetic testing of the CYP2D6 gene is considered medically necessary to guide medical treatment and/or dosing for individuals for whom initial therapy is planned with: amitriptyline or nortriptyline for treatment of depressive disorders or tetrabenazine doses greater than 50 mg/day, or re-initiation of therapy with doses greater than 50 mg/day2.
The tide of favor seemed to have turned back toward acceptance of genetic testing in February 2016, when the White House, along with more than 40 private-sector organizations made “commitments that will accelerate precision medicine, in alignment with the key principles of the Precision Medicine Initiative.” Some of these goals were to:
- Make it easier for patients to access, understand, and share their own digital health data, including donating it for research
- Engage participants as partners in research, including returning results to them in dynamic, user-centered ways
- Bring the promise of precision medicine to everyone
- Open up data and technology tools to invite citizen participation, unleash new discoveries, and bring together diverse collaborators to share their unique skills
- Adhere to strong privacy and data security principles
- Advance and scale precision medicine approaches in clinical practice3
The actions included various commitments from big players in pharmacy and electronic medical record (EMR) marketplaces, such as McKesson, Cerner, Allscripts, Surescripts and Epic. Lack of integration into EMR systems has been a cited as barrier for implementation for many pharmacogenomic programs.
The University of Florida, in conjunction with its college of pharmacy, recently hosted its first annual precision medicine conference. The objectives included training pharmacists on how to be proficient in targeting patients, what the best practices are, and how to use genomic data in clinical decision making.
A representatives of one independent community pharmacy in North Carolina was in attendance at the inaugural conference. The pharmacy has implemented the Rxight Direct-to-Pharmacist Pharmacogenetic program from MD Labs for integrating pharmacogenetic testing and medication therapy management (MTM). Having pioneered a model that combines genetic test results and clinical recommendations, the pharmacy is making waves on Capitol Hill.
Amina Abubakar and Olivia Bentley, of Rx Clinic Pharmacy in Charlotte, North Carolina, have created the model that integrates MTM services and pharmacogenomic (PGx) testing. Abubakar and a friend were the only 2 pharmacists represented at the FDA open forum called Patient and Medical Professional Perspectives on the Return of Genetic Test Results.
Abubakar courageously voiced her opinion on how pharmacists can impact patient outcomes and create acceptable models that ensure PGx testing is optimized.
Also in attendance was Jo Handelsman, associate director for science at the White House Office of Science and Technology Policy. She was so impressed by the idea that pharmacists could help alleviate 2 of the main concerns regarding widespread genetic testing—lack of physician time and lack of certified genetic counselors—that they invited MD Labs and Abubakar back to the White House in April.
“The model we are presenting to the FDA incorporates patient counseling, MTM, and pharmacogenomic testing,” Bentley said, as she shared some information about their innovative program. “Our pharmacists are trained in administering these tests and incorporating them within an MTM appointment. We are committed to focusing the report on drug-drug and drug-gene interactions that the patient and provider can use each time a new therapy is initiated.”
When asked about the biggest barriers to pharmacogenomic testing in community pharmacies Bentley and I agree.
“The biggest barrier for many community pharmacies is creating a model that fits into their workflow and reimburses the pharmacist for their time,” Bentley said. “The Rxight model addresses both of these issues. They also provide training and support for the participating pharmacists who want to begin offering the tests.”
Training and proper utilization of pharmacogenomic testing data is the missing piece of the puzzle and why, I believe, the FDA sees value in pharmacist-managed genetic testing. If you are interested in supporting pharmacy’s pharmacogenomic efforts, you can get involved by commenting on the FDA document (www.regulations.gov) before the March 31, 2016 deadline.
Let’s not allow ourselves to be overlooked as providers, and support Abubakar in giving a voice to pharmacists who wish to offer pharmacogenomics as part of their clinical consulting services.
1. Patient and medical professional perspectives on the return of genetic test results and interpretations; public workshop; request for comments. Regulations.gov. Accessed March 28, 2016.
2. License for use of physicians’ current procedural terminology, fourth edition (CPT). Centers for Medicare & Medicaid Services. https://www.cms.gov/medicare-coverage-database/license/cpt-license.aspx?from=~/overview-and-quick-search.aspx. Accessed March 28, 2015.
3. Obama administration announces key actions to accelerate precision medicine initiative. WhiteHouse.gov. https://www.whitehouse.gov/the-press-office/2016/02/25/fact-sheet-obama-administration-announces-key-actions-accelerate. Published February 25, 2016. Accessed March 28, 2016.
Blair Thielemier, PharmD
Blair Green Thielemier, PharmD is an independent consultant pharmacist living in Arkansas with her husband and daughter. Her latest project is the first-ever virtual pharmacy conference, the Elevate Pharmacy Virtual Summit. She is also the founder of Pharmapreneur Academy, an online e-Course and Community where she guides pharmacist-entrepreneurs through the process and barriers of building a pharmacy consulting business. She is the author of How to Build a Pharmacy Consulting Business, a contributing author for Pharmacy Times and guest host on the Pharmacy Podcast. More information about Dr. Thielemier can be found on her website.