New Ruling a Setback for Promise of Personalized Medicine
Seattle, WA (June 3, 2015) — On June 22, 2015, Medicare will begin denying coverage for the majority of genetic drug sensitivity (pharmacogenetic) testing that it has reimbursed since 2009.
Payment denial is expected to impact as many as 19 million of the 49 million Medicare beneficiaries in the U.S. who are at special risk of costly and life-threatening adverse drug events.1 Sadly, if it became a standard of care, this testing could save Medicare millions.
Precision Medicine, the use of an individual’s genetic information to tailor treatment, is by all accounts the future of healthcare. Despite the large body of clinical research supporting the utility of this testing – 17,000 pieces of clinical literature and counting – Medicare’s judgement that there is insufficient evidence to demonstrate that genetic testing improves clinical outcomes could set back adoption of this life-saving test by years.
What is Pharmacogenetic Testing?
Pharmacogenetic (PGx) testing reveals genetic variations that determine how the body metabolizes many of the most commonly prescribed medications. The testing reduces “trial-and-error” prescribing by enabling doctors to prescribe the most effective drug and dose the first time, potentially reducing side effects while saving both the patient and the healthcare system as a whole time and money.
Why is Pharmacogenetic Testing Important?
Research has shown that three out of four people have a genetic variation affecting their response to drugs. Genetically determined variation in drug response is so common that the FDA has included information about drug-gene interactions on more than 130 medication product inserts.
The potential cost-savings of widespread pharmacogenetic testing is huge. According to the CDC, adverse drug events cost the U.S. health system approximately $3.5 billion annually.2 More than a third of potential clinically significant drug interactions, a potential cause of adverse drug events, have been shown to involve genetics.3 Recent analysis of the recently released CMS Medicare Part D prescription drug data from 2013 suggests:
- $1.5 billion and 38,000 lives — that’s what genetic testing could potentially save for acute coronary syndrome (ACS) patients receiving percutaneous coronary intervention (PCI), who are on the heart medications clopidogrel (Plavix), prasugrel, and ticragelor. In total, 2.9 million Medicare recipients were on at least one of these medications. Medicare spent $894 million on these drugs combined, with Plavix/clopidogrel costs representing 80 percent of that figure.4
- Between 560,000 and 1.1 million Medicare recipients could be experiencing ineffective pain relief due to genetic variability while taking hydrocodone-acetaminophen, the prescription painkiller taken by the highest number of Medicare patients. In 2013, Medicare spent roughly $567 million on this drug for 8 million individual beneficiaries (about $70 per person). This is even more alarming considering untreated pain is a leading cause for falls, leading to hospitalization in the elderly.
Impact on the Elderly
Statistics show that adverse drug reactions, a specific subset of adverse drug events, cause 1 in 8 hospitalizations, with the elderly being twice as likely to be hospitalized by an adverse drug reaction compared to the non-elderly.5,6 Though it’s unclear how many of these are caused by drug-gene interactions, many Medicare patients are at particularly high risk, since 44 percent of men and 57 percent of women over 65 take five or more medications per week.7 Additionally, the metabolism of six of the top 10 drugs by Medicare claim count is potentially affected by genetics.
“Pharmacogenetic testing has been a covered benefit since 2009. Denying payment for these medically necessary tests is counter to the Triple Aim. Use of these tests could help doctors avoid unnecessary treatment failures and dangerous side effects; plus could reduce the more than $2000 per patient per year Medicare spends on adverse drug events,” said Kristine Ashcraft, Chief Operating Officer at Genelex. “This testing is the underpinning of precision medicine that President Obama recently called out as a national priority, and is required for better patient care.”
The potential for improvements in patient care and costs are not lost on physicians, whose use of PGx testing continues to be on the rise. A 2012 survey published in Clinical Pharmacology and Therapeutics reports that 12 percent of physicians have ordered PGx testing in the last six months, and 26 percent anticipate ordering a test in the next six months.8 A survey completed in 2014, published in the journal Pharmacogenomics and Personalized Medicine, found that 20 percent of surveyed physicians had ordered a PGx test in the last year.9
Drug sensitivity tests remain available after June 22 from Genelex and other laboratories. Medicare patients talking multiple medications, experiencing treatment failures or unwanted side effects are encouraged to request this testing before the cut-off date (the public is encouraged to visit this patient information site: http://genelex.com/seniors). See links below for further information about Medicare and pharmacogenetic testing.
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Genelex is a pioneer in comprehensive medication management, pharmacogenetic testing and analysis. Its patented YouScript® Personalized Prescribing Software is the only commercially-available medication management system to assess the cumulative effect of a patient’s genetics and entire drug regimen. YouScript is an Allscripts Developer Program Approved Application and is used by healthcare providers, clinical researchers and managed and accountable care organizations. Founded in 1987, Genelex is based in Seattle and was one of the first labs to provide pharmacogenetic testing and interpretation. For more information, please go to: www.genelex.com or www.youscript.com.
- Based on current figures from the Kaiser Foundation in a recent study about the incidence of high-risk medications in patients 65 and over, and phenotype frequency data.
- Verbeurgt P, Mamiya T, Oesterheld J. How common are drug and gene interactions? Prevalence in a sample of 1143 patients with CYP2C9, CYP2C19 and CYP2D6 genotyping. Pharmacogenomics. 2014;15(5):655-65. Epub 2014/05/07. doi: 10.2217/pgs.14.6. PubMed PMID: 24798722.
- Figures are based on an economic model created to show the possible positive impact of pharmacogenetic testing on ACS/PCI patients, using recently released CMS Medicare Part D prescription drug data that detailed how many Medicare patients were prescribed clopidogrel (also known as Plavix), prasugrel, and ticragelor in 2013.
- Jansen PA, Brouwers JR. Clinical pharmacology in old persons. Scientifica. 2012;2012:723678. PubMed PMID: 24278735
- Beijer HJ, de Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharmacy world & science : PWS. 2002;24(2):46-54.
- Woodruff B. Preventing polypharmacy in older adults. American Nursing Today. 2010; 5(10). Available from: http://www.americannursetoday.com/preventing-polypharmacy-in-older-adults/
- Stanek EJ, Sanders CL, Taber KA, Khalid M, Patel A, Verbrugge RR, et al. Adoption of pharmacogenomic testing by US physicians: results of a nationwide survey. Clin Pharmacol Ther. 2012;91(3):450-8. PubMed PMID: 22278335.
- Johansen Taber KA, Dickinson BD. Pharmacogenomic knowledge gaps and educational resource needs among physicians in selected specialties. Pharmgenomics Pers Med. 2014;7:145-62. PubMed PMID: 25045280.