As advancement in pharmacogenomics testing gains wider traction within the healthcare industry, and as the U.S. Food and Drug Administration continue to further classify additional PGx Biomarkers moving forward, the strength of PGx testing for laboratories as a growth opportunity in 2023 and beyond cannot be ignored. The global Pharmacogenomics market is projected to reach $11.63 billion by the year 2028. That’s a CAGR growth of 7% during the period between 2021 and 2028, and by the end of the decade, it is expected to grow at a CAGR of 8.47%.
While that is an impressive growth compared to the laboratory market overall, the primary driver behind the growth of PGx in the next 5 years is going to depend heavily on the aging population and the effects of chronic diseases, and how patient outcome in treating said chronic diseases are more and more dependent on modern precision medicine.
In this article by TechBullion, the first restraint that was listed for limiting global PGx market growth is the LACK OF AWARENESS of PGx. The majority of healthcare providers and patients today are unaware of the benefits of PGx and how it improves patient outcome. Without sufficient understanding and awareness of the technology, it is difficult to gain a wider acceptance of the application across the care continuum.
The problems Impacting patient outcome today
A simple statistic is this. Nearly 3 in every 5 American adults have chronic illnesses and are on prescription medication daily. That’s over 100 million adults 18 and over. And a high percentage of these prescriptions don’t work as doctors prescribe or intended due to several factors, including genetic variations that affect the efficacies of commonly prescribed medication.
Approximately 7 percent of FDA-approved medications have been shown to have implications related to genetic variants commonly found within the population. Those 7 percent of medications represent over 18% of the nearly 4 billion prescriptions written in the United States. While certain genetic variations may be rare, the dangers of interaction with the prescribed medication or the lack of efficacy can have a wide range of ramifications for the treatment of the patient.
Again, the key to improving patient outcome in 2023 lies in improving the understanding of PGx amongst physicians and caretakers, and increasing the use of PGx testing to increase the efficacies and/or decrease the risk of these following patient events:
• Improve Antidepressant Efficacy
According to the World Health Organization, depression affects up to 3.8% of the world’s population. That includes up to 280 million people whose lives are affected by depression daily. In the United States, it is estimated that 21.0 million adults may be suffering from one form of depression or have had a depressive episode. This represents 8.4% of all U.S. adults.
As the cost to treat depression continues to increase, escalating 35% from 2010 to 2018 to $236 billion, many of the patients suffering from depression or depressive episodes fail to get proper treatment due to a variety of reasons. One of which is that anti-depressants may take a delayed treatment period to reach full efficacy. For many more, the side effects are not worth the effort. According to the Mayo Clinic, “[i]f a family member has responded well to an antidepressant, it may be one that could help you. Or you may need to try several medications or a combination of medications before you find one that works. This requires patience, as some medications need several weeks or longer to take full effect and for side effects to ease as your body adjusts.”
This could mean weeks of trial-and-error and dozens of medications to go through to find an effective treatment for the patient, which is time-consuming and a potential waste of money in medication for the patient. PGx testing allows for genetics-based testing to rule out certain medications that may not be effective, or search for specific genes that are linked to improved efficacy and outcome for treatment response. A double-blind, randomized, controlled trial conducted in 2013 has shown a 33.1% improvement in the PGx guided test subjects.
• Decrease the Risk of Hematological Toxicity
Hematological Toxicity is a decrease in the bone marrow and blood cells, which may lead to other symptoms such as infections, bleeding, or anemia. It is a life-threatening condition and a common cause of prematurely ending anticancer chemotherapies.
A 2016 study in correlation between gene-marker DPYD*2A and popular chemotherapy using Fluoropyrimidine concludes that the gene is strongly associated with severe and life-threatening hematological toxicity. According to the study, “genotype-guided dosing results in adequate systemic drug exposure and significantly improves the safety of fluoropyrimidine therapy for the individual patient.” Furthermore, the study states “average total treatment cost per patient was lower for screening (€2,772 [$3,767]) than for non-screening (€2,817 [$3,828]), outweighing screening costs.”
Furthermore, Irinotecan, a common anticancer agent used to treat solid tumors for colorectal and pancreatic cancers, has been shown to have direct correlation to genetic marker UGT1A1*28. In 2005, FDA revised the drug’s label to indicate a reduced dosage should be considered for patients with UGT1A1*28 polymorphism. The resulting toxicity interaction can result in severe neutropenia and diarrhea. In 2021, about 150,000 people in the United States are likely to be diagnosed with colorectal cancer, and approximately 22% are candidates for irinotecan therapy. Advanced PGx screening can offer a guided treatment that will lead to reduced toxicity and side effects.
• Decrease the Risk of Cardiovascular Events
According to the Center for Disease Control and Prevention, “heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States.” Before the COVID pandemic, heart disease accounted for 1 in every 5 deaths in America. Anticoagulant medications, NSAIDs, and antiplatelet therapies are common treatments for a common ailment. Yet even some of the most commonly prescribed medicine to treat heart disease like Warfarin can result in adverse cardiovascular events in certain groups with specific genetic markers.
In a 2012 study, CYP2C9 and VKORC1 are shown to be responsible for why warfarin is often markedly less effective in users of non-European descent. Due to genetic variations, fixed-dosing regimens can often result in over-anticoagulation in up to 35% of the patients, and prolonged hospitalization in under-anticoagulated. A better course of treatment using adjusted-dosage measures requires constant monitoring and measurement of each patient’s changing diet, other medication and their dosages, and changes in their health, resulting in an expensive and time-intensive process and still with varied results, placing an undue burden on the patient.
Warfarin dosing guided by PGX testing can reduce the risk of over-anticoagulation and also reduce the length of hospitalization.
These factors, combined with other benefits of PGx screening, can result in improved patient outcomes from a variety of treatments, for chronic illnesses, and population health. Reducing rehospitalization risks, improving drug efficacy, and reducing the likelihood of harmful drug side effects will result in better treatment and outcomes.
To improve PGx market share in 2023 and beyond, laboratories will need to take a leadership role
It’s been established that a successful PGx testing strategy is crucial to improving patient outcomes in a variety of care scenarios. However, the statistics shared in this blog still aren’t widely understood by the healthcare community, despite the numerous studies cited. For PGx to reach the promised growth and beyond, laboratories that have launched a PGx testing program, or are in the process of planning a PGx product offering must take the next steps to improve the PGx outlook outlined below:
Communicate and Educate
Being at the forefront of modern precision medicine means laboratories providing PGx testing services are breaching a relatively new frontier. Both physicians and patients who may be tangentially aware of the benefit of precision medicine, may not be aware of the role PGx testing plays in the larger framework.
Especially with a typical healthcare provider working more than 60 hours a week, facing mounting administrative and documentation tasks outside of providing care, and pressure from all fronts as part of a stressed and burnt-out workforce, most doctors won’t have the time or resources to research and understand the key benefits provided by PGx screening to their patients. Focus on providing viable clinical research results specific to their area of practice, include patient outcome impact and cost-benefit analysis, and provide direct links to studies that bolster the argument for PGx screening.
In addition, laboratories large and small need to take a page out of the pharmaceutical industry playbook. Patient-driven demand for PGx screening can lead to wider adaptation and acceptance of PGx testing as a way to save money, reduce risk, and decrease the time and resources spent finding the right dosage. The “ask your doctor” marketing campaign has worked wonders for the pharmaceutical industry, and educating patients about the benefit of PGx testing, in combination with communicating and educating providers, will accelerate the growth of PGx testing.
Work with Payors to Recognize and Reimburse for PGx Tests
We’ve also addressed the issues with regard to revenue flow and reimbursement in this blog. And another big hurdle for wider acceptance of PGx testing and growth for 2023 and beyond, is coverage for PGx tests by commercial insurance payors. Despite the evidence stated above in this blog, and wider acceptance by the scientific and healthcare community, most insurance carriers still consider PGx tests experimental, and therefore do not offer reimbursement of cost.
When the burden or cost of PGx testing is shifted back to the patient, the uptake rate is significantly reduced. As part of the communication and education process, consumers and healthcare providers alike should be made aware that some high-deductible insurance and PPOs may offer coverage for specific PGx tests, and the list of participating networks for each laboratory work with be made available.
Speaking of payors, the biggest payor, Medicare, has Medicare Administrative Contractor (MAC) established independent reimbursement policies in states and regions they cover. Network with service providers and form action committees with other laboratories to lobby for wider acceptance and reimbursement of PGx testing should be a priority for 2023 and beyond.
Exciting News Abound for PGx in 2023
There are plenty to be excited about in PGx in 2023 and beyond. Multiple news outlets are now starting to pick up topics related to cancer screening using genetic markers, such as this recent NPR article. Recent news about the success in Guardant’s DNA test has the industry abuzz and at the forefront of the medical community. Advancements in precision medicine are now affecting not just the treatment of the body, but of the mind as well. These exciting news are now being picked up and disseminated via national and local news outlets, and at 1health.io we can’t help but be excited about the outlook for PGx testing and the laboratories that perform them in the near future. Take this opportunity to share the research cited in this article with your patients and providers to further help the PGx market to grow in the next 5 years.
With the recent impact on consumer behavior due to COVID-19 that we referenced in this blog entry, and with modern precision medicine shifting focus of value-based care from a one-size-fits-all approach to more personalized treatment, opportunities now present themselves for laboratories capable of sample intake and PGx testing to be at the forefront of improving patient outcomes in the 21st century.
1health is driving healthcare innovation by empowering our laboratory partners to make modern diagnostic testing more accessible, affordable and simple in the healthcare industry. 1health provides laboratories with a modern, secure, and easy-to-use software platform that makes it easy to launch new test products, onboard new clinical customers, and compete in the growing at-home and online commerce markets. The result is stronger, more-trusted relationships between laboratories and their customers, better healthcare outcomes for consumers, and ultimately more lives saved. Additionally, 1health provides marketing know-how and go-to-market strategies to reduce time-to-market for laboratories with PGx capacities large and small.
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