Emerging Innovations Within the Field of Precision Medicine

For science and medicine, the Covid-19 pandemic has taught us that fighting disease and protecting the future of medical progress both hinge on innovation and personalized treatments in the healthcare sector. Bureaucratic roadblocks and unnecessary government interference threaten medical progress and put our medical future in jeopardy. We would be defenseless in combating the next pandemic, treating the disease that is still unknown, or curing cancer without a firm foundation of personalized health.

An ethos of ‘the right treatment at the right time for the right patient at the right cost’ must instruct government policy and private sector action on medical progress. Here the editors of RealClearHealth endorse the push to “prioritize access to emerging precision medicine tools for autoimmune diseases, including predictive drug response tests that steer patients toward appropriate medication therapies to manage their illness.”

The following is a Congressional letter from a group of healthcare and patient advocacy organizations asking Senate and House Leadership to “prioritize access to emerging precision medicine tools for autoimmune diseases. Emerging innovations within the field of precision medicine, including predictive drug response tests, aim to address this challenge by using the patient’s unique biology to drive treatment decisions.”

We agree. Personalized care is the future of medical progress. All those who impact healthcare policy and health systems in the United States – from elected officials to researchers to doctors and nurses – must put patient care and access above all other considerations if we are to advance medical progress.

The Congressional Letter reads as follows:

Dear Chairman Wyden, Chairwoman Murray, Ranking Member Crapo, Ranking Member Burr, Chairman Pallone, Chairman Neal, Ranking Member Rodgers, and Ranking Member Brady

On behalf of the undersigned groups, we urge you to prioritize access to emerging precision medicine tools for autoimmune diseases, including predictive drug response tests that steer patients toward appropriate medication therapies to manage their illness.

Autoimmune diseases, such as rheumatoid arthritis (RA), psoriatic arthritis and ulcerative colitis, are debilitating, life-long illnesses – and research shows they are on the rise. Many autoimmune diseases, including those listed above, have a disproportionate impact on women – nearly three-quarters – and are more common in minority populations. Regrettably, many of these diseases go undiagnosed until they are in an advanced stage, when major symptoms begin to appear.

Once a diagnosis is made, clinicians work with their patients to identify a treatment pathway that balances available clinical evidence and the patient’s values and lifestyle. With autoimmune diseases, the options for treatment are relatively narrow and largely dependent on targeted therapeutics, or biologics. However, most insurers – including Medicare Advantage plans – impose strict utilization management protocols (e.g., step therapy or “fail first”) that ultimately force patients to try-and-fail drugs on the plan’s formulary. As outlined in a 2017 Health Affairs article, formularies present challenges for targeted therapeutics:

The trend toward very specific, targeted therapeutics for well-defined subsets of patients may change the effectiveness of formularies as a product selection tool in the future. It is a different exercise for plans to try to make substitutions among highly selective tumor-specific oncology products, for example, than to make old-style choices among a group of similar statins or even among tumor necrosis factor inhibitors.

Emerging innovations within the field of precision medicine, including predictive drug response tests, aim to address this challenge by using the patient’s unique biology to drive treatment decisions. Indeed, access to predictive drug response tests are important to overcoming the challenges with utilization management, and more importantly, helping patients receive the therapy most likely to effectively manage their condition.

Several states are already introducing legislation aimed and requiring similar tests as part of utilization management protocols, including step therapy and prior authorization. Therefore, we urge you to expend every effort toward ensuring that predictive drug response testing, specifically within the autoimmune treatment arena, is made available as soon as possible.

Association of Women in Rheumatology
Florida Society of Rheumatology
Kentuckiana (Kentucky/Indiana) Rheumatology Alliance
Michigan Rheumatism Society
National Organization of Rheumatology Managers
New York State Rheumatology Society
North Carolina Rheumatology Association
Rheumatology Nurses Society
Rheumatology Society of New Mexico
South Carolina Rheumatism Society
State of Texas Association of Rheumatology
Tennessee Rheumatology Society