- Janine Morales, PhD
Finding ‘The Easy Button’ In Precision Medicine
In this Q&A, Janine Morales, Ph.D., Senior Director Clinical Knowledge Systems and Clynt Taylor, Chief Executive Officer, Trapelo Health share how Trapelo is transforming clinical practices and oncology patient care.
Background: Trapelo offers an interoperable, shared, precision medicine platform that enables real‑time, actionable decision support, treatment selection, and reimbursement assurance. The platform:
Connects oncologists, labs and payers in real time through a single platform to realize the promise of precision medicine;
Identifies the evidence‑based biomarkers that should be tested for each patient;
Presents practice‑preferred testing options covered by the patient’s insurance;
Receives digital results from labs, presents evidence‑based treatment options, and streamlines prior‑authorization of testing and treatment; and
Increases adoption of biomarker testing to give patients greater access to the latest therapies including clinical
The platform is continuously updated by a dedicated team of molecular scientists and oncology specialists.
Actionable Data for Testing Decisions
Q. What constitutes actionable data, and how is it used for testing decisions?
A. Clinically actionable data is information that supports a care decision and is made available when the decision is being made. In terms of testing, actionable data starts with the most current clinical evidence on test performance characteristics and whether the test results lead to better treatment decisions. It is important to note that the quality and quantity of actionable data can vary widely from one test to another and from one disease type to another. Having insight into the breadth and depth of the available data and its applicability to a patient’s specific clinical features is essential. Of course, the reality is that multiple stakeholders and processes must work together to operationalize the use of clinical information. Actionable data, including available laboratory tests, institutional best practices, payer policies, and clinical guidelines, must also be made available within the clinical workflow as testing and therapy decisions are being made.
Q. Why not just test everyone using large panels?
A. This is certainly an option, however, ensuring that patients receive clinically necessary testing in a timely manner and with minimal financial burden requires a more nuanced approach for the following reasons:
Many physicians find large panel testing practical because they don’t have to spend precious time thinking about what test to order, but not all panels include the all‑necessary genomic Additionally, not all predictive markers are genomic in nature. Other methodologies such as IHC, FISH or PCR are the gold standard for some markers and not all laboratories offer the full range of tests.
For cancer types with a limited number of clinically relevant markers, targeted testing might be the quickest way to get to a treatment
There is a cost to testing everyone using large panels, and there’s the question of who Most payers don’t see the value in testing all patients with large panels but do see the value in testing the specific biomarkers that inform an evidence‑based treatment for every patient who needs testing.
A 2019 study published in ASCO revealed that many oncologists have difficulty picking out the appropriate treatment options from a large panel lab Additional tests and treatment choices may add to the already confusing challenge of knowing how to treat patients appropriately based on the most current clinical evidence.
Q. There is a lag in the adoption of new biomarkers in clinical practice. Why?
A. We recognize that it can take years for the introduction of a new biomarker to reach 90% adoption by doctors, meaning patients could be missing their chances at the best outcome. Data are changing rapidly, making it challenging for busy oncologists to keep up with all the new research and indications. Additionally, the process of placing test orders and getting prior authorization for the tests is disjointed and cumbersome. The assistance of technology applications that provide clinical decision support and align the important stakeholders within the clinical workflow will close the adoption gap in testing of biomarkers.
Q. You have a patent pending on your testing approach. How is your approach novel and different?
A. Many solutions focus on utilization management (i.e., policies around who can be tested) or the price of the product (i.e., how much to pay for a lab test panel). The core of the Trapelo solution is our configurable technology platform that brings information from our deep knowledgebase and from other stakeholders, such as payers and laboratories, and presents it in a single view to ensure that appropriate testing is performed accurately and efficiently for each patient.
“Testing is becoming inextricably intertwined with treatment decisions, meaning it has become increasingly important to know what was tested to ensure that the best treatment decision is made.”
Q. What impact does the use of actionable data have on testing results and decisions?
A. Payers require that treatments are supported by clinical evidence. Oncologists look for treatment options that are efficacious and safe for their patients, and they want immediate assurance that those will be reimbursed without the unnecessary burdens that can accompany the traditional prior authorization process. By marrying actionable data (information supported by clinical evidence) with test results, doctors can see which treatments are supported by clinical evidence, meet NCCN guidelines and FDA approvals, and have a payer’s FastPath, indicating streamlined prior authorization. This actionable data aligns the priorities of the practice and the payer in real-time.
Q. How do you see health plans evolving policies to pay for molecular testing?
A. Testing is becoming inextricably intertwined with treatment decisions, meaning it has become increasingly important to know what was tested to ensure that the best treatment decision is made. While the cost of testing is a consideration, it pales in comparison to the cost of therapies or managing the toxicities associated with the wrong treatment. So, we think it is incumbent on health plans to maintain policies that keep pace with the latest, best evidence on test utility. Additionally, the coverage framework should adapt to meet the realities of multigene testing. It doesn’t make sense for a payer to deny authorization of a 15‑gene panel if only eight of those genes are medically necessary and an eight‑gene panel doesn’t exist. Panels are designed to meet both current, future and investigational needs, and coverage policies should try to meet this reality while ensuring that tests are only reimbursed for the value that they provide to a given patient. The transparency delivered by Trapelo makes this achievable.
Q. How will that impact how physicians order molecular testing?
A. As precision medicine becomes more complex and as policies evolve and become more nuanced to manage the complexity, it will become increasingly important for technology solutions to support clinicians in decision‑making. The new era of precision oncology requires systems that manage and integrate all this information for the physician and guide them to the best testing option, and then process test orders from any laboratory quickly and easily through a single resource.
Q. There are other systems that help physicians interpret results. How is Trapelo different?
A. We pull test results into an actionable‑results viewer that displays which treatment options have the highest level of evidence to support them, while also showing toxicity, efficacy and costs. And when payers participate, Trapelo shows which treatments meet the clinical and policy guidelines for automated or expedited prior authorization. Finally, once treatments are selected, we show resources for these treatments that can help patients gain access.
Actionable Data for Streamlined Operations
Practices now have access to more actionable, decision‑making technologies, but not every practice may use these technologies to the full extent of their capabilities. In this regard, consider the following questions:
Q. How does Trapelo ensure the utilization of these technologies? A. We made it easier to place orders through Trapelo than to order manually or even through other portals. We took the administrative burden out of the process, which shortens turnaround times for results. Trapelo also gives practices unprecedented insights into their own pathways for ordering molecular testing, just a few ways we ensure utilization.
Q. How does Trapelo avoid overwhelming users with too much information?
A. We worked hard to minimize clicks and to only ask what’s needed to provide a straightforward result. For example, it takes only a few clicks to show what markers are important to test; one more click shows which labs can do the tests and the last click sends it on its way.
Q. Do physicians tend to follow a “golden path” once they find a way to a solution or do you find that physicians have started to adapt and explore? A. By design, FastPath is intended to present the pathways that comply with clinical evidence and provider‑ and payer‑preferences, but some doctors still prefer to configure their own tests. Trapelo alerts them to biomarkers that have evidence to support their inclusion, so nothing gets overlooked.
“Trapelo is an interoperable, precision-medicine platform that supports other applications like tumor boards, real-world evidence, and other sources of information (such as clinical trials within a practice network).”
Q. Can physicians interact with the system to delve deeper for a given output? For example, to what extent can physicians explore hypotheses? Can a practice customize a system to integrate its proprietary databases? A. Trapelo is an interoperable, precision‑ medicine platform that supports other applications like tumor boards, real‑world evidence, and other sources of information (such as clinical trials within a practice network). Trapelo has been designed to solve existing impediments to the practical use of precision medicine by automating processes and streamlining practice operations to make testing and therapy decisions more accurate and to give patients timely access to the most efficacious treatments.
Q. How do you envision Trapelo impacting the overall use of precision medicine?
A. Our vision for Trapelo is to become the most trusted resource in the use of precision oncology, making life easier for doctors and labs by removing cumbersome administrative hurdles while giving payers unprecedented insights and assurance in the treatments being prescribed. Ultimately, our mission is to give every patient a better chance at the best outcome.
Q. What are Trapelo’s plans for databases beyond genomics and cancer? For example, will databases include multi-omics data to build out its capabilities for outcomes research and evidence-based decisions?
A. Yes. Trapelo keeps up with the latest treatment options. While in use, it captures a unique data set that is important in outcomes research and evidence‑based decisions.
Q. Does Trapelo integrate (or plan to integrate) an augmented intelligence capability?
A. Trapelo currently leverages augmented technology as part of its curation process to comb the vast amount of clinical information released daily. Trapelo’s systems prioritize relevant content based on an evolving set of clinical data attributes for our team of scientists who curate and contextualize the information. These systems have allowed us to scale the vast amount of content we process every day. Additionally, the Trapelo testing solution is based on a set of algorithms that derive and present the best testing options at that point in time based on the clinical information entered and on the patient’s insurance policy (when available). Trapelo has begun to integrate similar functionality to help in the results‑interpretation/treatment‑ selection process.
Actionable Data for Reimbursement Assessment and Decisions
Q. What other therapeutics are on the horizon?
A. Although the platform is disease agnostic, we’re focused on oncology for now and are exploring the next diseases to move into.
Q. Can you describe the relationship that Trapelo has with payers? What is the nature of the engagement? For example, are payer engagements periodic interactions or is the relationship more transactional and event-driven?
A. Trapelo replaces what is traditionally known as a “mother‑may‑I” prior authorization process with a real‑time, decision‑support process that tracks the oncologist’s selection of testing and treatment options that are supported by the most current published clinical evidence. This creates alignment between oncologists and payers in real time without requiring the practice to submit treatment plans and wait for approvals. This approach can be compared with Gold‑carding those decisions that meet clinical and policy guidelines. Since it’s all executed in real time, payers have greater visibility into the treatments and testing options presented and the ones selected.
Q. Does Trapelo take a role in filing for coverage determination for reimbursement?
A. Trapelo does help payers and labs automate prior authorization and billing for testing, but it does not take on the role of filing for coverage determination. However, we feel that our knowledgebase and usage analytics inform this process, and we are exploring how best to approach this.
Q. How does Trapelo gain access information from different and various payers in a timely manner?
A. Trapelo connects to the practice information systems, labs and payers in real time. This reduces turnaround times in lab orders and shortens wait times for patients to receive treatment.
Q. How often are the reimbursement data refreshed?
A. The precision medicine knowledgebase is continuously updated. Since the Trapelo system operates in real time, doctors, labs, and payers can be confident that it is keeping all stakeholders aligned and up to date.
Q. Is the reimbursement database linked with the administrative staff or the billing systems of the cancer centers and community oncology groups?
A. The Trapelo platform coordinates prior authorization of molecular testing and targeted therapies. Depending on the oncology practice’s billing workflow, Trapelo can provide the necessary documentation for reimbursement.
Q. What feedback has Trapelo received from physicians? From the administrative staff of the cancer centers and groups?
A. One customer described Trapelo as the “Easy Button” for ordering the right molecular testing for the right patients. A nurse said, “It used to take 15‑20 minutes to place a test order; now it takes two.” The impact of reducing the burdens of prior authorization is still being documented, but initial projections are that it will be a huge benefit for patients, doctors, labs and payers.
“The sharp increase in the cost of new therapies has caused oncologists to become increasingly aware of the financial impact or toxicity of certain treatment options for patients.”
Q. How, and to what extent, do physicians use reimbursement data when weighing information for actionable decision-making?
A. The sharp increase in the cost of new therapies has caused oncologists to become increasingly aware of the financial impact or toxicity of certain treatment options for patients. Consequently, the more information a doctor has at the point of treatment decision‑making, the easier it is to communicate to their patients.
Q. Is there anything you’d like to add about on the future direction of Trapelo that we have not yet covered?
A. For years, payers have worked to eliminate unwarranted variability in cancer care. In the new era of personalized medicine, variability is unavoidable. By nature, precision medicine is variable by patient, and each case is increasingly dependent on specific biomarker test results to help inform treatment. This shift requires a new approach to managing the growing complexity and cost. Trapelo is designed specifically for this new era of oncology care.
To learn, see TrapeloHealth.com/demo. You can also tune in to The Precision Medicine Podcast which brings together industry leaders to help accelerate the effective use of precision medicine for cancer care. For more with Clynt Taylor, listen to Episode 11, “Is Collaboration the Key to Easing the Burdens of Prior Authorization in Precision Medicine Today?”
ABOUT THE AUTHORS Clynt Taylor, President, Trapelo Health
Clynt Taylor is the President of Trapelo Health and a member of the company’s board of directors. He joined the company in 2017 and brings over 20 years of experience in healthcare technology innovation, both as an entrepreneur and senior executive with startup and growing companies
Since beginning his career at IBM, he’s held leadership roles at healthcare technology companies like NextGen, where he led sales and marketing teams; HealthVision as General Manager of its fastest-growing division (purchased by Lawson) and Galvanon as Co-founder and CEO Healthcare Solutions (purchased by NCR). Most recently, he held various senior executive roles with NantHealth – including leading the innovation, launch and commercialization of eviti, Inc., recognized today as one of the nation’s premier oncology decision-support solutions.
Janine Morales, Ph.D., Senior Director Clinical Knowledge Systems, Trapelo Health
Janine Morales joined the Trapelo Health team in 2011 and oversees a team of editors and curators with deep expertise in molecular oncology. Her group is responsible for maintaining the company’s clinical information asset, a comprehensive knowledge-base summarizing published data pertaining to molecular biomarkers as predictors of response to targeted therapies in oncology. Janine also led the development of the company’s framework for the systematic evaluation and synthesis of molecular clinical evidence as well as the principles guiding the presentation of molecular evidence in patient-specific reports.
She brings 15 years of editorial and information management experience in the biotech and medical sectors and was a member of research and development teams at Elan Corp. and DNAX Research Institute (acquired by Merck & Co). Janine received a BS in Biochemistry from the University of Rochester and earned her Ph.D. in Pharmacology from the University of California, San Francisco.