CLN - Focus on Molecular Diagnostics
Supported by
As demand for personalized medicine grows, pharmacogenomics (PGX) has become an increasingly common — and critical — part of clinical care. Specialists from all over the healthcare sector are working to make sure PGX tests are not only accurate, but that they’ll be paid for.
Becky Winslow, PharmD, is the founder and lead consultant of inGENEious RX Incorporated, a boutique in vitro diagnostic consulting firm best known for their work in advancing pharmacogenomics to become a standard-of-care laboratory test. We spoke to Winslow about her career path, which took her from being a clinical pharmacist and pharmacy operations director to an expert PGX strategist, and what clinical laboratorians need to know about the financial aspect of this vital technology.
Having worked as a pharmacist and laboratorian, I have a comprehensive understanding of the factors that influence PGX’s successful journey from the boardroom to the bedside.
I label inGENEious RX services as fractional medical affairs services. Having witnessed firsthand throughout my career the disconnect between clinical and commercial, I built this firm to focus on the business of clinical diagnostics. We specialize in supporting molecular, genetic, and other complex testing companies with the operational and strategic expertise they need to thrive — without the cost or overhead of a full-time internal team. While traditional medical affairs groups lean heavily on publications and key opinion leader engagement, we’re heavy on the “affairs”: the often-neglected but mission-critical functions that tie clinical value to financial performance. Our work sits at the intersection of clinical relevance, payer expectations, utilization strategy, and reimbursement enablement. In short: we exist to make sure payers reimburse tests with proven clinical utility — and the tests stay in the market. Because clinical impact doesn’t matter if the business can’t sustain it.
Twelve years ago, a clinical laboratory recruited me to serve as a clinical science liaison between the laboratory and their physician clients. I helped physicians to clinically implement PGX testing into their workflows and apply the results to medication-therapy management. Prior to my intervention, the prescribers signed contracts with the lab, but didn’t order tests because they didn’t know for which patients the tests were medically necessary nor how to act on the results. My work grew from there.
I graduated as a Doctor of Clinical Pharmacy (PharmD) in 1998. If you had told me then that I would wind up working with life-science companies and laboratories, I probably would have laughed; I had no idea a PharmD could do that or that those entities would value my clinical expertise.
At the start of my career, I worked as a clinical pharmacist — which is pretty much what I envisioned doing with my degree. I provided direct patient care and directed clinical pharmacy programs in community, hospital, public health, and long-term care pharmacies. This is where I mastered convincing stakeholders to implement new-to-us products and services with proven clinical utility. I also mastered clinical implementation science because I had to drive the products’ implementation into patient care once I secured approval. Commercial teams engaged me as an internal champion for their clinical products based on my advocacy and implementation success.
The biggest change is that it’s advanced outside of academia. Before, PGX was siloed mostly at academic institutions, but recently it’s really flowed out into the community. Community stakeholders are championing its use — which is impressive, especially considering that there was no gold standard on how to do this. We’ve been paving that yellow brick road for the last 12 years to help PGX reach its potential.
Payer reimbursement used to be a major issue, but that brick is halfway established. Medicare, for example, reimburses testing, but commercial payers are not fully on board yet. For that to happen, the payers are demanding clinical-economic-utility research and evidence. That’s a brick.
Professional society endorsement and inclusion in official drug-dosing or monitoring guidelines is a critical brick that has proven difficult to secure. This brick will ultimately compel prescribers to order the test. Despite the Clinical Pharmacogenetics Implementation Society authoring clinical implementation guidelines, FDA mention in drug labels, and payer endorsement, professional societies such as the American Psychiatric Association have not yet endorsed PGx testing. Only recently has the National Comprehensive Cancer Network (NCCN) updated its guidelines to recommend considering DPYD genetic testing before initiating fluoropyrimidine-based chemotherapy.
And then the other brick, which I’d say we’ve smoothed out the dirt for, is to increase healthcare professionals’ knowledge of which tests are clinically useful, which patients need testing, and how to fit PGX into workflows and apply the results to patient care. Embedded training in medical education will decrease knowledge gaps and tests inclusion in order sets, clinical decision support systems, and electronic health record defaults, will boost clinician confidence.
Clinical laboratories must do the heavy lifting. Applying standard of care lab test strategy to PGx testing is a formula for failure. Unlike COVID and other standard of care tests such as hemoglobin A1Cs, PGX tests aren’t selling themselves. COVID had urgency, mandates, and reimbursements baked in. Providers aren’t required to order PGx, and most patients aren’t asking for it. Payers want more than a CPT code — they want proof prescribers are using the test correctly. I cannot stress this enough: Labs must understand two factors that will make or break their success before they design and commercialize their test. First, what compels payers to reimburse tests and the medical necessity documentation payers require for the lab to keep the reimbursement. Second, the clinical end user support essential to generate and maintain financially sustainable test volume.
Initially, as a pharmacist, I did not feel confidant talking about the financial case for clinically utile products and services. Pharmacy school didn’t prepare me for the business side of patient care. I didn’t learn to talk about costs; I learned we should just do what’s right for our patients. But over time I came to realize that even the best clinical product with the best clinical outcomes can’t help a single patient if nobody is willing to pay for it.
In other words, without sustainable reimbursement, PGX stakeholders don’t have a test — which means patients can’t benefit from it. While I’m not actually applying test results to patients’ medication therapy management anymore, I now work on the other side of the coin, where I'm making the test possible. So that’s how I’m contributing to overall healthcare impact — by improving patient access.
Laboratories, clinical decision-support software vendors, and — most recently — life-science companies.
The cost for consulting is less than the costs associated with trial and error. I have examples I can share. And, honestly, the best time to call is before they’ve already planned a test. That way, they haven’t had to contend with coverage and reimbursement yet, or with payers denying them. Or worse, a payer audit and recoupment of reimbursement.
Without sustainable reimbursement, PGX stakeholders cannot execute PGX’s promise to improve patients’ medication and health outcomes. I support PGX stakeholders with all of the elements needed for the sustainable provision of PGX testing. That includes coverage, reimbursement, and reimbursement retention for both the test and the patient-care services required to optimize its impact.
All signs indicate, in 10 years, PGX will be a standard of care test. I believe it will follow the same trajectory as lab tests clinicians currently demand to avoid toxicity, ensure efficacy, and personalize dosing when managing medication therapy. Organ function monitoring such as liver function tests and therapeutic drug monitoring such as lithium levels were not always a standard of care. Non-PGx lab tests became standard of care by proving their value over time — they showed that clinical decisions based on these results lead to better safety, efficacy, and efficiency in medication management. Their success provides a roadmap for PGx tests aiming to reach similar levels of adoption. Today, we simply don’t prescribe certain drugs unless we know a patient’s kidney function. Likewise, in the future, we will not prescribe certain drugs unless we know the patient’s pharmacogene phenotype.
Jen A. Miller is a freelance journalist who lives in Audubon, New Jersey. +Bluesky: @byjenamiller.bsky.social