Overcoming barriers to PGx Adoption

At AltheaDx, we know the key to PGx adoption in mental health is understanding the barriers so they can be addressed.

Today, we want to share some of our favorite quotations and insights from the review article “Barriers to clinical adoption of pharmacogenomic testing in psychiatry: a critical analysis.” The article here was published In Nature’s Translational Psychiatry this past October and provides much-needed clarity on opportunities and challenges facing PGx adoption in mental health.  The authors conducted a comprehensive review of the literature using PubMed, Cochrane, Scopus, and OVID databases.  

Early indications of HCP satisfaction with PGx testing

As a starting point, a 2015 survey reporting four out of five psychiatrists with recent experience ordering pharmacogenomic tests were satisfied or very satisfied with the genetic information provided by the tests.

Yet adoption has remained tempered – why?

Despite mounting clinical evidence and significant unmet patient need in achieving clinical remission, PGx testing still is not a mainstay in mental health treatment. However, several fault lines have been exposed suggesting healthcare providers have a much greater potential to successfully onboard PGx. Each barrier highlighted in the article is now a focal point for building a unique PGx experience, not least of which is to close gaps in high-quality, published evidence for the clinical efficacy and utility of PGx testing. You can read about the IDgenetix® randomized controlled trial here. 

Key barriers must be addressed to support adoption:

  • Evidence for the clinical utility of PGx testing
  • Evidence for the cost-effectiveness of PGx testing 
  • Physician education regarding PGx testing

Inadequate education remains a key barrier

The article highlights: 

“Genetic testing can be difficult to learn and lack of education on the subject is another significant barrier. For example, Green et al. surveyed 90 department chairs from medical schools in the US and Canada to assess the extent of PGx education in their Respective institutions. A dedicated PGx course was available in only two medical schools. PGx education most often took place in second-year pharmacology courses, and 71.6% of respondents estimated that required teaching of curricular PGx content would take less than 4 hours.”

Based on our experience, completion of the first test requires a well-orchestrated welcome and onboarding, but after a clinician has established their account to our online portal and run a few tests, they can be completed and processed easily and quickly, and are not an undue burden on practice workflow. Making the steps as easy as possible for all audiences has been our focus. Meanwhile training on the interpretation of the test results is where the value is fully realized for patients. That’s why our MSL and sales teams are immediately available to help the clinician understand the test report.

Action changes attitude

The article cites:

“Even a relatively small amount of PGx education can have significant influences on physicians’ perceptions of clinical utility. At least three studies reviewed have shown strong associations between education in PGx, or self-reported knowledge thereof, and increased positive attitudes toward utility of PGx testing. The act of reading the test instructions, and acting on the information provided, may provide significant educational benefit.”

Evidence of Clinical Utility with a Randomized Controlled Trial

The most important driver of adoption of PGx is clinical evidence. The basis for IDgenetix® is the combination of drug-gene interactions, drug-drug interactions, and lifestyle factors – all in one test. Using the test to help select treatment choices may then help lift response and remission rates as demonstrated in our peer-reviewed, published randomized controlled trial.

The Nature article also reports: 

“IDgenetix (formerly NeuroIDgenetix; Althea Dx) The effects of PGx testing using the IDgenetix test have been assessed in one US clinical trial. The participant sample included 685 clients with a diagnosis of major depression, anxiety disorder (independent of depression), or major depression comorbid with anxiety disorder, respectively [17]. In this trial, clients with severe depression (i.e., HAMD score > 24; n = 40) whose physicians used the IDgenetix PGx test showed greater improvements in response (p = 0.001) and remission (p = 0.02) relative to TAU, per HAM-D scores, at 12-week follow-up. This clinical trial also showed significant reductions in anxiety symptoms, at all data collection points, for participants who received PGx testing.”

Evidence of Cost Savings can also reinforce value 

The author’s note:

“Many, but not all, studies identify PGx testing as cost-effective or cost-saving relative to treatment-as-usual. In the case of IDgenetix, (formerly NeuroIDgenetix; Althea Dx) Groessl et al. developed an economic model of savings from PGx guided treatment using the IDGenetix test. The total direct medical costs over three years were lower for participants with moderate to severe depression whose clinicians had used the IDGenetix test to guide their treatment ($44,697 USD vs. $47,295, respectively; OR ~ 0.94). 

Primary Care can also serve as a beachhead

As physicians, and especially primary care providers, manage the health of many prospective PGx end users, they are among the most capable and important of all PGx stakeholders. They are the ones who engage critically in the implementation discourse, regardless of whether they choose to adopt testing in their clinic. 

The category needs strong leadership

The article reinforces:

“Lobbying policymakers to develop regulations for new partnerships and improve upon existing ones is critical. Such improvements could include protocols for maintaining user confidentiality, optimal data storage, and ensuring open access to RCT and economic assessment data, among others. Indeed, progress on this front has already begun. Several adoptees should collaborate with local content experts, key opinion leaders, genetic counselors, genomics researchers, and community members of non-European ancestry to develop protocols for the safe and responsible engagement of individuals in these communities in PGx research”

“Overall, there appears to be great promise in the application of PGx testing in mental health care. Progress in addressing barriers identified in this review, should assist with clinical adoption, actualizing the benefits of this innovation and advancing the potential of personalized medicine — all to reach our united end goal of improving healthcare systems worldwide.”

In closing, we appreciate the authors for bringing necessary attention on the barriers-to-entry, which are now being tackled by AltheaDx and others. We are seeing more adoption, and with continued gains of new insurance coverage, we are at the tip of the iceberg; there is no reason why not to perform these tests for diagnosed patients to help guide treatment!