21st Century Cures: Patients must be the focus

Last week, the House Energy & Commerce Committee unanimously passed H.R. 6, the 21st Century Cures Act.  Intended to modernize the nation’s biomedical innovation infrastructure and hasten the pace of cures, this bill comes after almost a year of fact-finding and will quickly be scheduled for consideration by the entire House. Depending on the outcome, this legislation could change the detection, treatment and management of cancer and other devastating diseases for decades to come.

As Congress starts to take up this legislation, the American Society of Clinical Oncology (ASCO) will host its annual meeting in Chicago   At this forum, 30,000 oncology professionals will learn about the latest advances in treating cancer, including immunotherapy and molecular therapies that precisely target tumor cells block their growth or destroy them entirely. 

{mosads}Thus, the confluence of the ASCO meeting and the proposed “cures” legislation underscores both the promise and challenges of bringing more promising treatments to patients. On the plus side, innovation is largely responsible for almost 70 percent of patients surviving at least five years after a diagnosis and a 20 percent drop in cancer deaths.  Yet, it takes nine or more years for a new cancer therapy to reach the market compared to an average time of two years from discovery to approval for HIV drugs.

Because cancer is the nation’s most costly disease and the second most common cause of death, more progress is needed and at an even faster pace. This is why a coalition of stakeholder organizations called the Cancer Innovation Coalition released a policy blueprint, Securing the Future of Innovation in Cancer Treatment, as a call-to-action in May 2014. The paper identified priorities for addressing the institutional, regulatory and funding hurdles that drive up the costs and delay the development of new cancer therapies – factors that ultimately limit patient access to much needed treatment.

The 21^st Century Cures Act is an important step in addressing these obstacles and the Cancer Innovation Coalition looks forward to a continued voice in the process.  However, one of the greatest challenges cancer patients face – having access to new therapies once they are approved – needs additional attention.

Consider that some insurance companies don’t cover the routine costs of clinical trials due to liability concerns about the added costs of research-related complications. In this situation, patients are often left with a choice between paying out of pocket for the clinical trial or forgoing the trial altogether.

Patients also face barriers to genomic testing due to differences in how these tests are regulated. Compounding the problem, the promise of using biomarkers in cancer trials has gotten ahead of laboratories being able to prove “clinical validity” to Medicare and commercial payers.

Especially disturbing are the cost-containment practices of many health plans, including Medicare, that limit patient access to innovative cancer treatments. These practices include moving newer cancer therapies into the highest “specialty tier” and charging patients a percentage of the drug’s cost, from 25 percent up to 71 percent, according to recent estimates.

Because the goal of the 21^stCentury Cures Act is to deliver more innovative treatments to patients, addressing these access barriers is the right thing to do.  This can be accomplished through legislative provisions that:

• Ensure coverage of medically appropriate and clinically validated genomic tests for patients enrolled in Medicare Part B and QHPs
• Require health plans to provide adequate coverage for innovative cancer therapies and the routine costs associated with clinical trials
• Direct health plans to provide transparent and readily accessible information to patients and clinicians on the clinical pathways used to determine which treatments will be reimbursed

If the benefits of innovation are to be realized, policies that ensure patients have access to novel medicines must be part of the equation. Otherwise, Congress will be successful in bringing more breakthrough medicines to market but many patients won’t be able to take them.

Balch is chief executive officer of the National Patient Advocate Foundation.