The Role of Evidence in Technology Approval and Coverage Decisions

Jennifer Erickstad

February 2011, Vol 2, No 1 -


San Diego, CA—The “real problem” leading to escalating healthcare costs is the “rapidly uncontrolled manner of the introduction of new treatments before their effectiveness, cost, and comparative value are satisfactorily evaluated,” said Michael L. Steinberg, MD, professor and chair, UCLA Department of Radiation Oncology, at the Presidential Symposium at the ASTRO annual meeting.

Dr Steinberg noted that 40% to 60% of healthcare cost increases can be attributed to the introduction of new technology, and that oncology has “become a target” for cost-cutting, because the specialty’s inflationadjusted direct medical spending has exceeded inflation for care provided by other specialties by 50% year after year across the past 2 decades.

Dr Steinberg detailed how evidence influences the entry of new technologies into the market and how technology assessment leads to coverage.

As he explained the “convoluted pathway of incorporating new treatments” into the US healthcare system, Dr Steinberg emphasized that although the US Food and Drug Administration (FDA) tests drugs for safety and effectiveness (which “invariably means a clinical trial”), devices—such as those used to deliver radiation therapy—can enter the market by either a premarket approval or the 510(k) process.

The device must only prove it is the potential equivalent to a so-called predicate device that entered the market before the regulation was enacted in 1976, and that it delivers the treatment in a safe manner, without further proof of efficacy.

Dr Steinberg said that radiation oncologists have already seen this type of escalation occur with the coding process. He explained that the Current Procedural Terminology (CPT) panel previously required 5 articles from US journals to award a code.

Now, however, they have specified that at least 1 article must be level III evidence, and that the applicant must submit any articles with opposing views. In addition, the CPT panel also requires that the applicant provide a much more detailed summary of the evidence.

Accord ing to Dr Steinberg, the panel’s requirements were significantly higher than when a code was assigned for intensity-modulated radiation therapy back in 2000. The panel wanted “outcome data that showed the intervention yielded a meaningful outcome, not simply a technical enhancement,” he said.

Even as he advocated for evidencebased medicine (EBM) as part of the coverage process, Dr Steinberg noted that using it as the sole method of coverage determination “also has its problems.”

Payers have used EBM to “control spending and protect their profits,” and at the same time been insensitive to the real barriers of clinical trials, he said.

Despite these potential pitfalls, Dr Steinberg concluded that policies should be established to make sure new technology is quickly available, while still embracing the use of evidence- based assessment to ensure solvency of the system, finding a balance between what he calls the “evidencebased medicine Taliban” and the “professors of anecdotal evidence.”