AH109 - Unlocking PGx: Evidence, Use Cases, and Implementation

Finding the right medication can sometimes be a frustrating process of trial and error. Patients may experience side effects or fail to see a clinical benefit from the prescribed treatment. For decades, this approach was accepted as a standard part of patient care. It doesn’t need to be that way anymore, though.

Now, with genetic testing, patients can gain a more precise approach to their care. In this episode of the Astonishing Healthcare podcast, Houda Hachad, PharmD (VP, Clinical Operations, Aranscia) joined Judi Health's Caitlin Munro, PharmD (Clinical Partnerships Lead) and Haleh Campbell, PharmD (Clinical Programs Administration Manager) for a rich discussion about pharmacogenomics (PGx) and how it’s advancing and changing the landscape of medication therapy.

They also explore the clinical value of PGx, the importance of human intervention in interpreting test results, and some compelling data emerging from the Rx Helix program, which was recently presented at the Pharmacy Quality Alliance (PQA) annual meeting.

What Is Pharmacogenomics and How Does It Work?

PGx looks at how inherited genetic differences affect the way a person processes or responds to a medication. Revealing these genetic variations typically involves a cheek swap.

Why is revealing these variations important? As Houda explained, a patient may break down medication depending on specific genetic factors.

For example, a person may break down medic too slowly, which can increase side effects, another person might break it down too quickly, which can reduce benefit. So in some cases, genetics can also affect whether the medication needs a dose adjustment or closer monitoring or an alternative. So we can reveal these genetic differences by doing a very simple test. And that gives us results and can help actually guide treatments.” - Houda Hachad

However, as Houda clarifies, PGx doesn't replace a provider's expertise. It simply adds one more piece of information to help make medication decisions safer and more precise.

Why Is Pharmacogenomics Gaining Traction Now?

Pharmacogenomics is not a new concept, but a perfect storm of catalysts is pushing it into the mainstream. Houda highlights three main drivers for this recent surge in adoption.

“First of all, the cost of testing as mentioned has dropped,” she explains. “We have a lot of technologies that allow us to do rapid, efficient testing. We have also a large body of consortia and expert groups that came together to actually evaluate the evidence and issue evidence-based guidelines that are adopted by professional societies.”

Another factor is that expert groups and professional societies have established evidence-based guidelines for clinical application. Additionally, laboratories now offer affordable multi-gene panels to a wider range of constituents.

How Are FDA Guidelines Driving Genetic Testing?

The FDA has placed pharmacogenomic information into hundreds of drug prescribing labels. While some of this information simply notes that genetic variations do not impact a specific drug, other labels carry significant weight.

In some cases, the FDA recommends or requires genetic testing prior to starting a treatment.

“And in some cases, the label indicates if you know the pharmacogenomic results or the traits specific genes, you have to act differently, you have to deviate, and you cannot just prescribe a standard dose. For example, as you indicated, we see more and more information being generated by the sponsors, but we also see the FDA pushing forward in making that information available to providers,” Houda expanded.

This regulatory push forces prescribers to pay closer attention to genetic factors before writing a prescription.

Which Patients Benefit the Most from PGx Testing?

While anyone can learn from their genetic profile, specific clinical situations make PGx testing particularly valuable. Haleh notes several key groups that stand to gain the most from this targeted tool:

• Polypharmacy patients: Individuals taking three or more medications have a higher risk of drug-gene interactions.

• New therapy initiators: Testing at the beginning of a treatment plan helps personalize decisions right from the start.

• Patients with treatment challenges: Those who have experienced multiple treatment failures or unexpected side effects are prime candidates for testing.

There tends to be a lot of value with the most commonly used medication classes where responses can vary, Halls said. “For example, with drug classes like antidepressants or cardiovascular medications, or pain management therapies."

How Does Clinical Support Make PGx Actionable?

A common misconception is that the genetic test itself is the final intervention. In reality, handing a complex lab report directly to a patient or a busy prescriber often leads to confusion.

Caitlin recalls a classic philosophy from pharmacy school: do not treat a lab value, treat a patient. She argues that pharmacists are the ideal professionals to champion PGx implementation because they are uniquely trained as drug experts.

“Of course I'm biased; I'm a pharmacist. I think to myself, who better to be a part of the care team and championing this type of information than a pharmacist, that drug expert? So I think that's really important when it comes to looking at what kind of implementation or what kind of program around PGx that you want to implement. Who's going to be driving through or seeing through that change that we want to see in medication therapy.” - Caitlin Munro

Why Is Pharmacist Intervention Crucial?

Program’s like Rx Helix wrap genetic testing in comprehensive clinical support. In other words, when a test result comes back, a clinical pharmacist reviews the drug interactions, considers dosing adjustments, and looks at the patient’s specific plan design.

This human touch helps translate a dense laboratory report into an actionable insight. Pharmacists can educate the member, partner with the prescriber, and confirm that all recommendations are clinically sound and compliant with the formulary. Direct-to-consumer models rarely offer this level of ongoing, white-glove support.

What Did the Rx Helix Program Study Reveal About PGx?

The Judi Health team recently presented a poster on the impact of clinician-led telephonic education on PGx adoption at PQ. The findings from the Rx Helix program showcase exactly why targeted testing matters for chronic care management.

This study showed almost 100% of the program participants were polypharmacy patients. Furthermore, nearly 100% of those tested had an actionable phenotype.  

Most importantly, about 42% of patients had immediately actionable insights resulting from their tests. These findings confirm that PGx is not reserved for rare diseases; it directly impacts the commonly prescribed medications used by the general population every day.  

Click here to learn more about the study’s findings and Rx Helix generally.

Moving Toward Proactive Precision Medicine

The future of PGx lies in moving from reactive problem-solving to proactive medication management. By leveraging Unified Claims Processing™, organizations can identify patients based on their diagnoses before they even start a new therapy.  

“I see that the future state has really truly PGx-enabled medication management. So imagine a member prescribing medication and the system can seamlessly identify whether there is relevant drug-gene or drug-drug gene...interaction before that medication is dispensed or continued, and the pharmacist now has the opportunity to review the case and help determine whether action is needed. So I see an expansion of adoption for these types of interventions and hopefully getting us to really generate additional clinical outcomes as well as also cost avoidance outcomes.” - Houda Hachad

Want to learn more about Rx Helix and our approach to clinical programs? Contact our team today!

‍

Disclaimer

This podcast is for informational and entertainment purposes only. The views expressed are those of our guests, do not constitute professional advice, and may not represent Judi Health's/Capital Rx's position on any matters discussed. We make no representations or warranties regarding the accuracy or completeness of the content; information is subject to change and may not be updated.