Biotech Manufacturers Anticipate CER Challenges - Comparative effectiveness poses challenges for drug manufacturers. - BioPharm International

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Biotech Manufacturers Anticipate CER Challenges
Comparative effectiveness poses challenges for drug manufacturers.


BioPharm International
Volume 23, Issue 11

CONSIDERING COSTS


More on CER
Whether more comparative research will actually limit healthcare spending remains to be seen. Analysts project that PCORI will reduce federal healthcare spending by about $3 billion over 10 years—just about what the government will spend on the CER program. And that calculation assumes that more comparative information will lead to changes in physician practice and patient choice.

Potential savings are limited, moreover, by Congress's stipulation that Medicare cannot use CER to establish cost-effectiveness thresholds, set practice guidelines, or make coverage or payment recommendations, as done by NICE. Even so, private insurers and payers are free to tap CER evidence in their coverage decisions, as they have done for years, and more outcomes studies will support efforts by payers to negotiate lower rates and steer consumers to more high-value care options. At a CER briefing last month sponsored by Health Affairs, Harvard researcher and former Medicare official Steven Pearson proposed that Medicare reward innovation by paying higher prices for medical products that can document superiority, but only a comparable or "reference" price for those that demonstrate comparable clinical effectiveness.

At the same time, efforts to limit or curtail treatment choices will remain difficult and will require a very high threshold of evidence. "CER is not a panacea or a silver bullet," stated Kavita Patel, director of health policy at the New American Foundation, at a CER summit in September. Gail Wilensky, senior fellow at Project Hope, said she's "cautiously optimistic" about the progress so far, but acknowledged that CER remains a "very fragile concept" that "a lot of people still want to torpedo."

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,


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