US bill proposes Comparative-Effectiveness Research Centre

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Mr Randall Stafford of the Stanford Prevention Research Center and Mr Caleb Alexander of the University of Chicago, USA have published several challenges that must be met if comparative-effectiveness research (CER) is to be useful in significantly improving the quality and affordability of US health care. In the 17 June 2009 issue of the Journal of the American Medical Association they write, “Researchers, policy makers, insurers, and other stakeholders have voiced enthusiasm about the value of CER that rigorously evaluates two or more drugs or devices. The most recent boost for these efforts has been the US congressional financial stimulus package that contains provisions for US$1.1 billion (Euros 787.4 million) to be devoted to this effort. The appeal of CER is undeniable. If there is one issue that stakeholders agree about, it is that increasing healthcare costs are ultimately unsustainable and society needs more value for its money. However, it is not clear whether CER, as it is commonly framed, has a comparative advantage when it comes to improving the US healthcare system. If CER is to succeed, future initiatives will need to generate data prior to the widespread adoption of a drug or device.”

They outline five ways to put more meat on the bones of the discussions surrounding CER. Firstly, the data should be generated more rapidly; obtaining comparative-effectiveness information earlier in the life of a new drug or device is a priority. Secondly, the evidence should be linked to strategies proven to modify how physicians practice medicine; simply making the data available to physicians and patients is not enough. Thirdly, the agenda beyond drugs and devices should be broadened. Researchers should focus on comparisons that include lifestyle modifications, such as diet and exercise, as well as alternative therapies that patients often implement on their own. In addition, research is needed on the most effective ways of delivering care. Fourthly, the regulatory environment should be altered. “Comparing a new drug against placebo does not make much sense if our goal is to compare different clinical strategies,” said Mr Stafford, noting that placebo-controlled trials are the standard for drug approval by the US FDA. “The threshold must be raised for comparative-effectiveness to work,” he said. Mr Stafford and Mr Alexander suggested that if a new medication is not tested head-to-head against similar drugs, its labelling could be changed to say, for instance, this drug has not been found to be superior to the other calcium-channel blockers in the treatment of hypertension. This requirement would provide useful information to patients and physicians, as well as give manufacturers an incentive to perform more drug versus drug clinical trials. Fifthly, the cost implications should be considered. This is controversial because many fear that it may lead to restrictions on higher-cost treatments, regardless of the treatment's effectiveness. Some proponents of CER have suggested not including cost as a factor. But as Mr Stafford and Mr Alexander write in their commentary, “what good is comparative-effectiveness if it cannot be used to discern anything about value to clinicians, insurers, patients and society?”

The discussions surrounding how to implement CER data into the healthcare reform effort are still in the early stages, which is why Mr Stafford and Mr Alexander hope their commentary will prod policymakers to ensure that the discussions are as comprehensive as possible.

Mr Stafford and Mr Alexander support efforts to help physicians and patients make better use of research results in determining which drugs, devices and other treatment options are the most effective. “The drive for comparative-effectiveness has tremendous appeal. Who could argue against the idea of generating knowledge about what works and what does not?” said Mr Alexander. But they say broader changes are needed in the healthcare system — including the FDA's process for approving new medications and devices — to yield the right kind of data for such comparisons, and to ensure that patients, physicians and medical organisations make the wisest possible use of their healthcare dollars.

In the mean time, FDA News reported that US House Democrats unveiled draft healthcare legislation that would establish an HHS Center for CER as the Senate debate over the issue of weighing treatments against each other stalls another healthcare bill. The centre would conduct research across the full spectrum of healthcare items and services including drugs, devices, surgical procedures and other medical interventions, according to the House draft.

Source: FDA News/Drug Industry Daily, JAMA 2009;301(23):2488-90, ScienceDaily