- Genetic tests like one offered byMyriad Genetics claim to analyze a patient’s DNA and point them to the best depression drug for them.
- Myriad’s test is called GeneSight and costs $2,000. It’s covered for seniors on the government programMedicare, and by someprivate health plans, and brought in $125 million for Myriad in the company’s 2018 fiscal year. Analysts at Barclays believe the majority of that figure is from Medicare and Medicaid.
- Yet scientists and doctors haveraised concerns about these types of tests.
- Experts are set to discuss a range of these types of tests next week at a Medicare contractor advisory committee meeting, according to apublic announcement. The committee does not make coverage determinations, but provides advice and guidance.
- Myriad’s CEO, Mark Capone, downplayed the upcoming meeting at a conference last week, and said the Medicare advisory committee meeting could lead to new coverage opportunities for the test.
- Myriad said in a statement that “we believe the robust scientific body of knowledge supports the broad use of GeneSight for patients with depression.”
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For diseases like depression, finding medications that work well for patients can be a long, arduous journey.
Genetic tests now claim to speed it along by giving doctors more information about how patients’ bodies process different treatments. One prominent one, sold by the genetic-testing company Myriad Genetics, analyzes a patient’s DNA to point a doctor to the best options or doses of drugs like Zoloft and Paxil for an individual patient.
The test costs $2,000 and is covered for seniors on the government programMedicare, and by someprivate health plans. It brought in $125 million for Myriad in the company’s 2018 fiscal year, making it the company’s second-biggest product. The test accounted for 16% of Myriad’s total revenue that year.
Barclays analysts said that they believed a majority of the $125 million in revenue for GeneSight was from the government programs Medicare and Medicaid.
But lately, there’sgrowing scientific opinion that Myriad’s GeneSight and tests like it aren’t useful for patients. Myriad acquired the test as part of itsdeal to buy Assurex Health in 2016.
The Food and Drug Administration issued awarning last fall about tests that, like GeneSight, haven’t been approved or cleared by the regulator. The American College of Neuropsychopharmacology, a professional organization of brain scientists, put out astatement last year that such tests are “scientifically unsupportable for general clinical use.”
The concerns being raised by doctors and scientists could affect whether insurance companies and the federal Medicare program continue to pay for GeneSight. A Medicare contractor advisory committee isset to meet on June 26 to consider how strong the evidence is around these types of tests. These committeesadvise about whether Medicare should cover services for various areas in the US, but don’t make those determinations themselves.
GeneSight is mentioned specifically inpreliminary documents, representing a “meaningful step-up in risk,” Barclays analyst Jack Meehan and his team said in a recent research report. The analyst said “we continue to have concerns around the potential for reimbursement coverage for GeneSight, which we view as Myriad’s most important growth driver.”
A study of the GeneSight testpublished last fall and cited among documents for the upcoming meeting concluded that GeneSight’s results could be predicted without taking the test, and said that doctors could do that on their own based on information about the drug and their patient.
Myriad CEO Mark Capone, meanwhile, has downplayed the June meeting, saying that the Medicare advisory committee is taking a broad look at the space and that it could even lead to new coverage opportunities for the test.
Myriad said in a statement that “we believe the robust scientific body of knowledge supports the broad use of GeneSight for patients with depression. In our experience, physicians only continue to use tests that demonstrate clinical utility in their practices, and more than 37,000 doctors have used the GeneSight test with more than 1,000,000 of their patients with depression.”
The company says that the vast majority of patientspay less than $330 for the test out of pocket, once insurance is taken into account.
A leading genetic-testing company betting on a new type of test
Founded in 1991, Salt Lake City, Utah-based Myriad Genetics is best known for discovering the BRCA gene, which when mutated increase a person’s risk of breast cancer.
Myriad started selling tests for it, and its offerings have expanded over the years, including tests for risks of other cancers and diseases.
As competition from rival genetic-test makers increased, Myriad bet heavily on genetic tests for neuroscience drugs, buying the precision-medicine company Assurex and its GeneSight testin 2016.
The GeneSight test works like this: First, a patient gets a cheek swab taken. Later, a report comes back, breaking down various drugs into different, color-coded buckets.
GeneSight uses traffic-light colors for the reports. Green points to the medications that should be used; orange signals potential for “moderate” issues like dose changes or drugs working less well, and red for “significant” problems like side effects.
GeneSight makes those predictions by testing genes looking at how the body may break down medications and the potential responses to a given medication, according to Myriad.
Questions about the need for and use of genetic tests for depression drugs
When two researchers at the University of Kansas School of Medicine started looking at the GeneSight test, they compiled data for what the test recommended for 19 patients.
They found a trend. Of 22 antidepressant options, the same drugs were typically being recommended to patients, while another set were almost never recommended. They had similar findings when they looked at antipsychotic medications. In aresearch column published with those results last fall, the researchers questioned the basis for using these tests today.
“Although pharmacogenetic testing will almost undoubtedly prove critical in customizing treatment in psychiatry, the critical question is whether that time is now,” the study’s authors, Dr. Matthew Macaluso and Dr. Sheldon Preskorn,wrote.
The Barclays team said the study indicated that there’s limited reason to pay for the tests.
“If most patients have these three medications in the green bucket, patients could simply forgo the $2K test and begin taking one of these medications,” Barclays’s Meehan and team concluded.
Because the science of neuropsychiatric disorders, of which depression is one, along with diagnosing and treating them, isn’t well understood, this type of genetic testing is “scientifically unsupportable for general clinical use,” reads astatement from the American College of Neuropsychopharmacology last year.
The Food and Drug Administrationwarned about these types of “pharmacogenetic” tests last fall, and specifically pointed to ones being used for conditions like depression.
“However, the relationship between DNA variations and the effectiveness of antidepressant medications has never been established,” the FDA said, warning that doctors changing medications based on these types of test results could hurt patients.
PsychiatristDr. Charles Nemeroff, who haswritten that tests like GeneSight are “not ready for prime time,” says he’s seen that in practice. Nemeroff is the acting chair of the Department of Psychiatry at the University of Texas’s Dell Medical School.
“I have had depressed patients who responded well to an antidepressant show up in my office with the test results ordered by their primary care physician informing me that they has stopped taking their prescribed medication because it was classified at ‘red,'” he wrote in an email to Business Insider. “They subsequently and rapidly relapsed into another episode.”
Last year, an American Psychiatric Association workgroup that Nemeroff chairs also found that therewasn’t enough data to support widespread medical use, though it said such tests could be helpful for predicting things like side effects.
Myriad sees an opportunity to expand the number of doctors ordering its test
Myriad published alarge research study using GeneSight to help doctors pick depression treatments two months ago. The study did not show that using the test led to significant improvement in symptoms relative to usual types of treatment, which was the main goal of the trial. The study did show improved responses in patients and remission, which were secondary aims of the research, and which the company has emphasized.
A group of researchers from institutions like Kansas University School of Medicine and Mount Sinai Health Systemwrote after that they were troubled by the study’s conclusions, and criticized aspects of how the data were reported.
Such tests could be meaningfully helpful one day, but today busy doctors “could easily misconstrue the oversimplified findings from [the study] as evidence that a genetic test can now identify ‘which antidepressant will work,'” they said.
Read more: DNA tests that cost as much as $750 claim to tell you which antidepressant is best for you, but scientists say they’re not worth the money
Myriad CEO Capone meanwhile has said the Medicare advisory committee meeting could lead to new coverage opportunities for the test. Myriad asked for an expansion of GeneSight coverage, and the upcoming meeting is a first step towards that, the company said in a statement.
The idea is to get tests covered in primary care doctor offices, where it’s possible more testing might be done than in psychiatrists’ offices, “dramatically” expanding the number of doctors ordering the test, Capone said.
“Pharmacogenetics are used across hundreds and hundreds of drugs in many different disease states, and Medicare is thinking about writing a broad pharmacogenetic policy,” Capone said at a conference last week.
The upcoming committee meeting, which is scheduled for June 26, also mentions rivals likeIDgenetix andCNSDose. An updated decision about coverage could be published by the fall and come into effect by the end of the year, according to the Barclays analysts.
They now rate the risk for the Myriad test losing coverage at about 35%, but note that “as it currently stands, we believe the grounds for current GeneSight coverage remain weak.”
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