More NICE debate over cancer meds

Tracy Staton — Fri, 27 Jun 2008 09:16:33 -0400

It's not just Roche that refused to fork over cost-effectiveness info on its cancer med to the U.K.'s National Institution for Clinical Health and Excellence. So, too, has Merck Serono. Yesterday, you'll recall, NICE said it was rejecting Roche's Avastin for National Health Service use because it lacked that data. Merck Serono's Erbitux is in the same boat. And given the fact that NICE is increasingly skeptical of high-priced cancer meds, there's likely to be more wrangling among the regulators and pharma.

Merck Serono's U.K. oncology chief Denise Richard maintains that NICE needs to change its criteria and procedures--and needs to speed up its reviews, too. For instance, NICE doesn't allow drugmakers to update their applications even during long appeals, she told the Financial Times, even though efficacy data often changes quickly.

Richard also thinks NICE should change its requirements for cost-effectiveness for patients with late-stage cancer. One of the regulators' gripes is that some of these expensive meds only extend life by months rather than years; Richard says late-stage patients rarely live more than a few months. So that extra time can be precious.

Interestingly, the FT posits that the best value might lie in using these high-tech meds earlier in the cancer-fighting game--but at lower prices, so that drugmakers would make up the price difference by selling a higher volume.

- see the FT article

ALSO NOTED: Rebif gets EU nod; Bayer buys Citracal;

Thu, 30 Aug 2007 06:59:50 -0400

> Merck Serono got the EU nod to market a new version of the relapsing multiple sclerosis med Rebif. The new formulation, designed to be better tolerated when injected, will launch next month; the company is authorized to sell it in all 27 E.U. countries, plus Iceland, Liechtenstein and Norway. Release

> Bayer is buying the over-the-counter calcium supplement Citracal from Mission Pharmacal. The financial terms weren't disclosed, but the product sold some $47 million last year. Report

> Roche lost its bid to overturn an Australian ban on advertising the weight-loss drug Xenical. Report

> Contract manufacturer Catalent Pharma has signed a deal to increase production of Danish drug maker ALK-Abelló's tablet-based allergy vaccine Grazax, using a newly built production line funded by the drug company. Report

And Finally... Why aren't markets moved by government investigations of Big Pharma shenanigans? The Financial Times wants to know--especially when almost every major drug maker is under scrutiny, and a few have even pleaded guilty to corporate criminal charges. Report (sub. req.)