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Pharmacist Group Sees Value in Offering Assurex PGx Tests for Mental Health, Pain Rx Personalization

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Originally published Oct. 28.

NEW YORK (GenomeWeb) – A deal between Skilled Care Pharmacy and Assurex Health will utilize the central role pharmacists play in managing prescriptions for patients to drive physician adoption of pharmacogenetic testing for behavioral health and chronic pain patients.

Mason, Ohio-based Skilled Care – a firm that provides medications and consulting pharmacists services to healthcare providers and long-term care facilities – announced last week it would offer doctors in three Midwestern US states the opportunity to assess certain patients on mental health and pain medications with Assurex's pharmacogenetic tests. The deal may signal a re-entrance of pharmacists into the personalized medicine space.

Assurex markets two types of PGx tests under the GeneSight brand. GeneSight Psychotropic analyzes genomic variants in mental health patients associated with their ability to respond to more than 30 drugs for depression, anxiety, bipolar disorder, schizophrenia, and other neuropsychiatric conditions. GeneSight Analgesic is a test that personalizes treatments for people taking drugs for chronic pain.

For Assurex, the deal with Skilled Care marks yet another positive milestone in its commercialization push for its GeneSight PGx tests, on which 100,000 patients have been tested to date as of an August statement. Skilled Care serves more than 10,000 residents working at more than 100 facilities in Indiana, Kentucky, and Ohio.

"The overarching philosophy on which Skilled Care was built is to make sure people receive the right medications at the right time in the right dose," Kathy Wolf, marketing director at Skilled Care, told PGx Reporter. "It is our culture to make sure we reduce unnecessary medications and make sure residents are taking the right medications."

Generally, doctors who have used PGx testing to guide treatment strategies for mental health or chronic pain patients have chosen to do so for those who have been on multiple medications and have poor compliance. According to Wolf, since Skilled Care's consultant pharmacists can see what drugs are being prescribed and when scripts are being changed, they are in a unique position to advise doctors when GeneSight testing might be appropriate for a particular patient, and these pharmacists have been trained to assess such opportunities. "Working closely with the patient, nursing staff, and physicians, the consultant pharmacist knows when the team is struggling to find the appropriate therapy for the patient, and is involved in the process," she said.

In particular, Skilled Care believes Assurex's tests could benefit elderly patients in long-term care, who often suffer from a litany of health issues for which they are taking a slew of medications. The Geriatric Mental Health Foundation estimates that close to 15 percent of people in the over 65 age bracket and nearly half of the patients enrolled in nursing homes suffer from depression. Many times, these senior citizens are prescribed drugs from which they are at high risk of experiencing adverse reactions, which in turn adds to their cost of care.

Outside of the senior citizen group, Assurex estimates that last year doctors wrote 400 million prescriptions for behavioral health conditions and 280 million for chronic pain. When patients misuse these drugs or aren't adherent to the treatments mainly due to adverse events, it costs the healthcare system $140 billion each year. According to clinical utility studies performed by Assurex, testing patients on GeneSight to personalize treatment strategies can lead to per-person savings of more than $1,000 in prescription drug costs and $1,500 in prescription utilization costs.

The list price of GeneSight is between $3,000 and $4,000. According to Assurex, the test is covered by Medicare, Medicaid, and some private payors. When the test isn't reimbursed by insurance, the company offers financial assistance programs for certain qualifying patients. Skilled Care pharmacists, while they will be able to help doctors get information on GeneSight, will not bill insurers on behalf of patients. "The test is ordered by a prescribing health care provider with Assurex Health handling the billing to the appropriate insurer," a company spokesperson said.

Meanwhile, this deal with Assurex marks Skilled Care's first foray into the genetic testing space, and the group's efforts are reminiscent of pharmacy benefit manager Medco's strategy for driving adoption of PGx in the healthcare system. Several years ago, under a short-lived but innovative personalized medicine program, Medco was conducting research to gather clinical utility data on genetic interventions in partnership with diagnostics developers and drug companies. For example, the Medco Research Institute and Assurex in 2011 announced they would launch a pilot program to evaluate psychotropic drug adherence and medical care utilization among Medco members after they've been genotyped using the GeneSight PGx test.

The idea behind this and other similar projects was that once clinical utility data had been gathered supporting the use of PGx testing in a particular setting, Medco's pharmacists would reach out to doctors and recommend where it could improve patients' outcomes and lower healthcare costs. Medco's personalized medicine efforts were a small part of its overall business, but after Medco was acquired by Express Scripts two years ago, the clinical utility research efforts for genetics were cut, industry observers have said. Based on the information on Express Scripts' website, it is still offering PGx testing services through specialty pharmacists, but for a very limited list of drug/gene pairs.

Along with the loss of Medco's research support in the personalized medicine space, the interest in gauging whether pharmacists could drive adoption of PGx testing in a way that improved patient outcomes and lowered costs, also waned. However, if molecular diagnostics shops ink deals with pharmacy groups, such as the one Assurex has with Skilled Pharmacy, pharmacists can step into a critical and yet unfilled role in helping doctors identify genetic testing opportunities in a cost-effective manner.

Outside the US there are signs that healthcare providers are interested in exploring the role pharmacists can play in delivering personalized medicine. For example, Genome British Columbia (BC) in Canada and the BC Pharmacy Association announced this week that they would fund a project to study whether pharmacists can effectively facilitate genetic testing so that doctors can use the information to personalize their patients' dose of the commonly prescribed and highly variable anticoagulant warfarin. If this first phase proves successful, then the researchers are hoping to expand the project to the broader community of pharmacists in BC (see related story, in this issue).

Skilled Care believes that the PGx testing recommendations from its pharmacists will be well accepted by doctors. The group pointed out, for example, that when its pharmacists recommend a drug for a particular patient, doctors take their advice 90 percent of the time. "The recommendations made by the consultant pharmacist are based on the clinical data, as well as the individual patient," Wolf explained. "The chart is reviewed, laboratory values are assessed, regulatory guidelines and issues are considered."

That Assurex would target pharmacist groups as part of the commercialization strategy for its GeneSight tests is no surprise, since former Medco employee and personalized medicine proponent Bryan Dechairo is leading the company's medical efforts. Formerly the head of diagnostic reimbursement evaluation and extramural R&D for Medco Health Solutions, Dechairo joined Assurex in 2012 as senior VP of medical affairs and clinical development.

"We believe the new strategic partnership with Skilled Care Pharmacy will help us to continue to amplify the true potential of combinatorial pharmacogenomics, [which is] the study of how variations in multiple genes influence an individual’s response to medications, as well as evidence-based medicine and clinical pharmacology," a spokesperson for Assurex told PGx Reporter.

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