Replies to post #143225 on Biotech Values

[DewDiligence]

The safety hurdles are much lower than in virtually any other space, and reimbursement is also pretty clear.

There are still only so many reimbursement dollars in the aggregate available for cancer drugs, no matter how impressive their efficacy and tolerability may be by historical standards.

In short, there simply aren’t going to be that many Ponatinibs.

[DewDiligence]

The safety hurdles [for cancer drugs] are much lower than in virtually any other space, and reimbursement is also pretty clear.

Well, UK’s NICE just rejected Zelboraf:

http://in.reuters.com/article/2012/06/14/us-roche-britain-idINBRE85D1RJ20120614

The National Institute for Health and Clinical Excellence said on Friday that while Zelboraf was effective for melanoma patients with a particular genetic mutation, its longer-term effect on survival was uncertain.

NICE said that, as a result, it could not recommend the drug as a cost-effective treatment for the deadliest form of skin cancer within the state-run National Health Service (NHS), even after an undisclosed price discount offered by Roche.

This sentence should worry other cancer-drug companies:

NICE said the longer-term survival benefits from using Zelboraf were uncertain because many patients in a key trial switched treatment as their disease progressed.

In other words, Zelboraf is being penalized for having its pivotal trial halted early due to strong efficacy.