Comparing More Than Medicines

Comparing More Than Medicines

05.06.11 | By Kate Connors

A recent study in the Journal of the American Medical Association raises notable points about the current presence of comparative effectiveness research (CER) in the health care system.

Excluding orphan drugs and first-in-class medicines, a majority of new medicines (defined as new molecular entities) approved by the FDA between 2000 and 2010 had CER data available at the time of approval.

Overall, "we found that publicly available documents include results of at least one head-to-head trial with an approved alternative for approximately half of all newly approved NMEs," the study by Nikolas H. Goldberg and colleagues from Brigham and Women's Hospital and Harvard Medical School concludes.

Given the many considerations for biopharmaceutical research companies to evaluate when creating a clinical trial program for a potential new medicine, this demonstrates sizable dedication to CER on the part of the private sector.

This proven commitment to CER means that physicians have more information available to them when making their prescribing decisions, thereby helping them tailor the best care possible to each patient.

However, in a system in which medicines account for 10 cents out of every health care dollar, what is being done to better understand how effectively the other components of the system are working?

Biopharmaceutical research companies, and PhRMA, support comparative effectiveness research that better serves health care providers and patients by providing information while maintaining patient access, recognizing that individual patients respond to therapies in different ways.

But we also feel that all aspects of patient care should be similarly supported by good evidence.

The Los Angeles Times quotes an FDA official who agrees that the JAMA article demonstrates a step forward for CER:
"Dr. Robert Temple, who directs FDA's Office of Medical Policy at the Center for Drug Evaluation and Research, said he was surprised by how many drugmakers had provided some comparative data, despite not being required to do so.
"'Considering that there is absolutely no requirement, it is pretty impressive,' he said in a phone interview."

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