NEW YORK – Precision medicine experts are calling for the better integration of precision medicine into clinical care for non-small cell lung cancer and recommend new strategies for creating guidelines and policies as well as for handling reimbursement of precision oncology care in a white paper published by health technology firm Diaceutics this week.
The five recommendations were developed by Diaceutics' Health and Economic Forum, a group of multidisciplinary experts. The forum first created preliminary recommendations that were then presented to healthcare industry attendees for feedback at Diaceutics' Health and Economic Forum Summit earlier this year. The white paper recommendations are a compilation of the forum's discussions and real-world feedback.
Susanne Munksted, chief precision medicine officer at Diaceutics, noted the recommendations come on the heels of the firm's clinical practice gaps research in NSCLC, which in 2022 identified seven gaps along the care pathway that were contributing to approximately 64 percent of potentially eligible patients with advanced NSCLC not receiving precision oncology therapies.
"We chose newly diagnosed NSCLC [for these reports] because it's so well investigated," Munksted said. "There are a number of drugs available for known biomarkers, and there have been guidelines on precision medicine in that space for many years. It's almost like the poster child of precision medicine. It was a realization [from the clinical practice gaps study] that if we can't get it right there, that doesn't really bode well for [other less-studied tumor types] in the future."
Clinical recommendations
The first two recommendations from the expert panel addressed challenges in integrating precision medicine into the care pathway and ensuring NSCLC patients receive genomic profiling early in the diagnostic and treatment process.
To better combine precision medicine approaches with clinical care, the experts recommended generating more evidence-based data to support the use of biomarker testing and precision oncology drugs that will incentivize physicians and health systems to use these approaches. They suggested using evidence- and value-based care payment programs, which typically prioritize quality of life alongside medical care, to incentivize clinicians and health systems to implement genetic testing prior to making a treatment decision.
The experts further encouraged the industry to build evidence surrounding the impact of biomarker testing on clinical decision-making, specifically aiming to demonstrate that it plays a role in improving the quality of care and avoiding waste in treatment. Experts also urged the development of Healthcare Effectiveness Data and Information Set (HEDIS) measures, the metric by which health plans measure their performance, that specifically include biomarker testing in eligible patients to generate even more evidence regarding the utility of biomarker testing. Finally, the group encouraged the industry to incentivize physicians and health plans to implement biomarker testing before making treatment decisions through evidence- and value-based care payment programs.
Munksted noted that, in the Forum's market research prior to developing these recommendations, Diaceutics found that close to half of oncologists typically won't wait for results from genetic testing to come back before starting treatment in the first-line setting. This additional data that proves the value of genomic profiling earlier in the disease may help more oncologists understand the importance of these results.
"That finding indicates that more comprehensive testing earlier on is needed, but there also is a resistance to doing comprehensive testing [from payors] because if it doesn't drive a clinical decision, is it worth the investment to do comprehensive testing early on?" Munksted said. "There's so many layers of this that it almost needs a complete redefining of how we think about medicine and how we integrate it in the whole operational system."
The group also recommended that healthcare providers who have successful strategies implementing precision oncology approaches in NSCLC should publicly share their best practices and operational implementation plans for other health systems to follow.
The second clinical recommendation in the white paper focused on implementing comprehensive genomic profiling in early-stage NSCLC. There, the experts similarly recommended the development of value-based evidence supporting the use of genomic testing earlier in the treatment process.
They also recommended encouraging pathologists to initiate biomarker testing and reflex testing for prespecified biomarkers, even without a formal request from the treating oncologist.
Currently, oncologists still drive most orders for biomarker testing, according to Pranil Chandra, chief genomics officer at PathGroup and member of the forum panel, but he believes that pathologists have an important role to play in the testing and treatment process.
The expert panel recommended that the multidisciplinary care team, including oncologists and pathologists, could establish a prespecified set of biomarker tests for certain tumor types. They noted that this approach could help standardize and speed up the process of biomarker testing, which can sometimes take weeks or months, and potentially allow for more patients to start biomarker-driven treatments earlier in the disease.
As the landscape for biomarker testing becomes more complex, Chandra argued that selecting the correct test for patients is extremely important from a patient equity and a cost-effectiveness perspective.
"We have to be able to act on the information from a precision diagnostic, and that requires a very granular level of understanding of the information that comes out of the report," Chandra said. "That's really where pathologists and laboratorians have just such a critically important role to play."
Guideline, policy recommendations
To address gaps in the guidelines for NSCLC treatment, the experts recommended two changes: redesigning how guidelines are created to keep pace with the rapid advancements in precision medicine and including more diverse stakeholders in the development of precision oncology guidelines and policy, such as patients and other healthcare professionals.
In particular, the group proposed using a new approach to guideline creation and updates that incorporates parallel pathways. One track would include biomarker testing guidelines that are considered the minimum testing required for adequate care, while the other would include the biomarker testing recommended for optimal care, such as newer testing modalities and biomarkers.
"For some of the academic clinics, it's easier for them to do more comprehensive testing and they have the resources and skills to do it," Munksted said. "When you go to the community setting, it's not always [possible] to do comprehensive tests and understand what tests are needed with limited resources. For the guidelines to be more clear on defining what is adequate or minimum testing could help these clinics."
Chandra also noted that keeping guidelines as up to date as possible is crucial for the oncology care team. He noted that some guideline developers are more proactive than others but added that "there still needs to be an evolution of the guidelines to really update them as quickly as two weeks after any major publication that identifies clinically relevant biomarkers."
The experts also encouraged diagnostic companies and labs introducing novel tests to proactively identify where their new test fits into current guidelines, and if the test goes beyond what's outlined in current guidelines, the sponsors should bring forward improved health technology assessments (HTAs) to support their testing procedures.
However, Munksted noted there has been a lot of debate in the industry about who should pay for HTAs and other analyses of new genomic tests. Typically, most of the cost and reimbursement goes toward the drug and not the test, she said.
"Who should generate that evidence [for new tests]? The diagnostic companies are bringing products to market on a relatively low margin and often struggle to really cover the cost of building that evidence," Munksted continued. "Some will argue that pharma needs to do it because it is linked to their drug, but pharma will push back. That's a conundrum that hasn't been solved yet."
The experts also advocated for the inclusion of patients, patient advocacy groups, underserved populations, pathologists, genetic counselors, pharmacists, nurses, and other healthcare professionals in policy and guideline development processes to help address disparities in genomic profiling for NSCLC patients.
Including patient perspectives in the guideline development process may, for instance, help create guidelines and policies that allow patients to be more involved with their care and more effectively navigate the precision oncology treatment pathway.
The group recommended developing a metric that measures the "value of hope" in HTAs for genomic tests and precision therapies. They wrote that many patients value "the 'hope' of a large survival gain and preferred 'hopeful gamble' therapies over therapies considered as 'safe bets,'" citing research from the University of Southern California. The experts suggested developing a metric that captures this value of hope for precision medicine by exploring the financial, emotional, and societal benefits that are derived from precision medicine.
Terri Conneran, founder of patient advocacy group KRAS Kickers and a lung cancer survivor who was a member of the expert panel, said empowering patients with knowledge and information is critical to their care journey. In her experience, her doctors didn't share all of the information from genetic tests in an effort not to overwhelm her with data, but she wished she had known about her KRAS G12D mutation earlier in her treatment journey.
"I firmly believe that doctors and payors should recognize the crucial importance of sharing that information, even if it isn't going to give answers or it's not necessarily [pointing toward] a specific trajectory," Conneran said. "However, if [doctors] can be more intentional with their patient, the patient is going to have more confidence in them. We [as patients] are going to be able to research for ourselves and actually feel a sense of empowerment and ownership of our own journey."
Reimbursement recommendation
The experts had several recommendations to make the reimbursement system for precision testing and treatments in NSCLC more sustainable. The current system of reimbursement is designed to accommodate a very different type of drug, said Brenda Yanak, a member of the Diaceutics forum and founder of healthcare operations consulting firm Clinical Transformation Partners. She noted that the system needs to change from a blockbuster drug model, in which many patients receive the same drug, to a precision medicine model.
"The science is moving rapidly forward, the technology is moving rapidly forward, but the operations are stuck a couple decades ago," Yanak said.
"In the blockbuster model, the physician is the core of the healthcare decision-making, and in the precision model, it's more of a triangulation between the patient who's at the center, the physician, and the pathologists," she explained.
The first recommendation from the expert panel was to create a "dual system" for reimbursement, in which public payors cover the medically necessary tests and treatments while pharma/biotech, diagnostic companies, NGOs, patient advocacy groups, hospitals, and private payors bridge the gap for novel tests or treatments or provide funding to HTAs that will be used to update guidelines to include new biomarkers or tests.
This system would require creating tiers of tests that distinguish between those that are medically necessary and those recommended for optimal care, similar to the recommendations for guidelines.
Under this dual system, the experts recommended a few areas that could help alleviate the financial burden of new genomic tests. Public or private payors or diagnostics firms could consider supporting a new precision test with three years of automatic reimbursement post-launch, during which time additional research is conducted to optimize future reimbursement and collect quality metrics for the test. However, local regulations would vary for how this reimbursement would work in practice.
Yanak noted that the biggest gap in reimbursement is for the newly discovered exploratory biomarkers that have some evidence supporting their use but have not necessarily been included in guidelines yet.
"You can understand that payors would only want to pay for something that's approved, but that's not necessarily the optimal treatment pathway. So, you have to fill this gap and have the payors paying for what is medically known to be actionable in addition to these more exploratory biomarkers or for treatment being funded by other sources," she said. A combination of pharma sponsors, diagnostics developers, and patient advocacy groups could help address that gap.
The group also suggested bringing in venture capital groups, private equity investors, payors, and pharma companies to help financially support analyses demonstrating the value of novel tests prior to launch, which would, in turn, inform reimbursement once the test is on the market.
The experts said the proposed dual public-private reimbursement system should also ensure there is sufficient funding to demonstrate the clinical and economic value of precision testing, such as supporting pathology-oncology partnerships to illustrate the value of precision testing, exploring the cost of not testing in the context of avoiding waste for treatments that may not work for a patient due to certain biomarkers, and developing guidelines for what evidence payors need to prove the value of covering the cost of precision tests.
Ultimately, the experts concluded that implementing and using precision medicine in NSCLC will require constant review and updates as the science advances, so these recommendations aim to make that process simple and not resource intensive while also including all stakeholders in the design of that system.
Though the report focused on NSCLC, Munksted said the recommendations would help improve precision medicine use across all cancers.
"The industry really needed a broader systemic view on potential solutions to implement precision medicine that included a lot of different stakeholders," Munksted said. "We wanted to ensure [in our recommendations] that we had a broad representation of different viewpoints to look at some of the economic and operational barriers to why are we not succeeding with precision medicine."