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12:00 AM
Jul 28, 2008
 |  BioCentury  |  Politics, Policy & Law

Refusing to play NICEly

The U.K.'sNational Institute for Health and Clinical Excellence recently terminated four technology appraisals because manufacturers failed to submit evidence the agency needed to issue a positive or negative recommendation. Given the growing influence of NICE's decisions on the uptake of technologies both in the U.K. and other countries, avoiding a negative recommendation conceivably could be considered a viable regulatory strategy by some companies. But not everyone agrees.

NICE influences whether drugs will be available to NHS patients in England and Wales but does not have the authority to compel companies to submit evidence necessary for an appraisal. The agency can appraise a technology without a manufacturer's submission if it is able to obtain the data it wants from publicly available information. But the data are not always available for newer technologies, according to Pippa Anderson, a senior principal in the Pricing and Market Access practice at healthcare consultancy IMS Health.

The terminated appraisals include two for Avastin bevacizumab from Roche, both in combination with paclitaxel for first-line metastatic breast cancer, and in addition to platinum-based chemotherapy for first-line, inoperable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC); one for Erbitux cetuximab from Merck KGaA to treat colorectal cancer following failure of oxaliplatin-containing chemotherapy; and one for Gliadel carmustine implant from Archimedes Pharma Ltd. as an adjunct to surgery in patients with recurrent glioblastoma multiforme (GBM)(see BioCentury Extra, Wednesday, June 25).

According to NICE, the companies did not submit the evidence for Erbitux in colorectal cancer and Avastin in breast cancer because they concluded the drugs would not meet the agency's cost-effectiveness thresholds. Generally, a technology must have an incremental cost less than or equal to £20,000-£30,000 ($40,074-$60,111) per quality adjusted life year (QALY) for NICE to consider it cost-effective.

NICE also issued a document stating Roche did not submit evidence to support the appraisal of Avastin in NSCLC because the company did not plan...

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