Originally published in STAT

By John Kuelper 

Health care luminaries met to discuss the promise of precision medicine at a panel in Davos last month. As is typical for discussions at the World Economic Forum, the participants explored big issues — global diversity, artificial intelligence, and the ethical complexities of modern medicine.

Hearing these leaders assess the potential of data-driven medicine, I was struck by a simple fact: Mundane and subtle obstacles like insurance models, legacy processes, and siloed data are defining the on-the-ground reality for precision medicine. All of those are issues that community providers are well-positioned to address.

The science of precision medicine is already here: There are currently tens of thousands of commercially available genetic and genomic tests, plus more than 300 FDA-approved drugs tied to genetic markers. Physicians now have access to entirely new classes of personalized therapies that can engineer a patient’s own immune cells and turn them into treatments unique to them.

Despite the availability of these breakthroughs, only a fraction of the patients who could benefit from precision diagnostics and targeted therapeutics have access to them. Availability isn’t the problem. Instead, practical challenges are preventing them from reaching patients.

These practical challenges include:

Lack of access at scale. Now that the technical barriers to delivering precision medicine have largely been solved, the challenge for targeted treatments and tests is making them more accessible to physicians and their patients. Most health systems lack common processes for ordering genetic and specialized diagnostic tests. Physicians must follow complex, manual protocols that vary from insurer to insurer, which presents a barrier to their wider use. The lack of industry-standard reporting and infrastructure make it difficult to access test results or compare one lab’s results to another’s, even for the same gene. Overall, there has been a lack of collaboration between clinicians and the manufacturers that control the supply of these targeted therapies.

Untapped data. One of the biggest current criticisms of precision medicine is the lack of data on its long-term clinical and cost effectiveness. It’s not that this data doesn’t exist — it does — but laboratory, clinical, and cost data are trapped in silos and not easily connected. That is compounded by an overall sense of information overload. Clinicians have access to more data than they could possibly digest. They need a way to cut through the noise and home in on what’s relevant to the patient in front of them.

Lagging insurance models. Precision medicine therapies are fundamentally different from those that have come before. They’re more expensive to make and their effect is more binary — they can provide cures for patients with particular molecular profiles but be completely ineffective for others. As a result, standard insurance models aren’t designed to support these types of therapies.

Today’s insurance models are designed around the “average” patient. It works something like this: If every patient with X type of cancer gets Y drug, we will see better outcomes on average, so we encourage all patients with X type of cancer to get Y drug. That approach doesn’t make sense for targeted, personalized treatments. The premise of precision medicine is to deliberately design for the outlier, not the average patient. So even if 95 percent of patients would see no improvement with the drug, identifying the 5 percent who would have a profoundly beneficial response makes it possible to economically justify a price point that looks high on its surface.

The insurance concept called outcomes-based contracting, which ties prices to how effective a treatment is for a specific patient, is a start. However, it hasn’t yet been widely adopted and requires significantly more collaboration between providers, payers, and manufacturers than exists in the current environment.

Addressing the shortcomings

We know why targeted treatments are not getting to the patients who need them. It’s now time to fix the system. Community providers are best positioned to address these challenges and they are beginning to lead the charge.

Provider collaborations like the Precision Medicine Alliance are developing best-practice clinical programs and common contracting and procurement processes to enable access at scale, while initiatives like the American Society of Clinical Oncology’s TAPUR study are validating new use cases for existing targeted drugs.

Efforts to improve data sharing include the formation of large-scale consortia like the Oncology Precision Network that pool longitudinal clinical-genomic data to address specific unmet clinical needs. These demonstrate that such collaborations can work. It is also important to develop practice guidelines for precision medicine, like those produced by the National Comprehensive Cancer Network, to validate data collected by different stakeholders.

For insurers, projects like Intermountain Healthcare’s work validating the impact of precision medicine on the total cost of care are helping payers better understand and plan for these treatments, as is Roche’s commitment to funding large-scale health economic research to help push forward value-based programs. We need more collaboration like this between providers and therapeutic manufacturers to lay the groundwork for more innovative reimbursement structures.

Next steps

Precision diagnostics and targeted medicines are here today, but more needs to be done to bridge the gap between availability and access.

By adjusting the market forces that currently limit the growth of this game-changing approach to disease, the health care system will soon be able to get these treatments to the patients who need them, changing lives while potentially reinventing what medical care can achieve. Community providers hold the key to making this happen.

John Kuelper is an investment director of Ascension Ventures, a strategic health care venture firm that invests on behalf of 13 health system limited partners that collaborate to identify, invest in, and grow transformative health care companies. Intermountain Healthcare and the two health systems that founded the Precision Medicine Alliance (Catholic Health Initiatives and Dignity Health) are investors in Ascension Ventures capital funds. Ascension also invests in other precision medicine companies.