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Interesting Blog: Nice says NO!

The IN VIVO Blog: "No!" says NICE, to Sprycel, Tasigna

"No!" says NICE, to Sprycel, Tasigna
Posted: 09 Feb 2010 10:23 AM PST

The UK cost-effectiveness watchdog NICE today delivered a resounding "no" to the use on the National Health Service of Bristol's dasatinib (Sprycel) and Novartis' nilotinib (Tasigna) in chronic myeloid leukemia patients intolerant to imatinib (Glivec).

"The evidence available to support [the clinical effectiveness] of dasatinib and nilotinib was very poor," declared Professor Peter Littlejohns, clinical and public health director at NICE. "The drugs' cost is also very high," he added, in a press release announcing the latest draft guidance.

Sprycel costs about £30,477 per year, and nilotinib about £31,711, according to appraisal documents on NICE's website. And the drugs are taken for several years, with no evidence-based 'cut-off' point currently in use.

It doesn't even look as if the drugs came close, in other words. And Bristol and Novartis can't even consider one of the loopholes now available to companies, the end-of-life guidance issued in late-2008, which permits a somewhat higher cost-per-QALY (quality-adjusted life year) than usual for drugs that extend life in niche yet terminal diseases. (This, you will recall, is what allowed Celgene's multiple myeloma drug Revlimid to slip past the agency.)

The available evidence on the drugs' extension of life--typically required to be of at least three months--"is too weak", declares the NICE PR in yet another blow to the products' manufacturers. That the drugs, both second-generation tyrosine kinase inhibitors, offer such an extension, documents declare, "is plausible, but definitely not proven."

But at the end of this rather damning announcement came an olive branch. "It would be heartening to hear that pharmaceutical company manufacturers are prepared to share some of the very high cost of these drugs with the NHS," suggested Littlejohns.

Now if that isn't a call for a cost-share (or should we say 'patient-access') scheme, then I don't know what is. Recall that such schemes have allowed NICE to green-light a good handful of expensive drugs that likely would not have otherwise made the cut--including most recently UCB's RA drug certolizumab (Cimzia). (Interestingly, although Celgene also put forward such a plan for Revlimid, this wasn't what tipped the decision in its favor.)

So we understand NICE's call for companies to make an effort on the cost-share front--indeed, the agency's CEO Andrew Dillon has told us clearly that he'd prefer if manufacturers simply submitted such schemes up front rather than waiting for a rejection in order to fish one out.

But is Littlejohns implying that a cost-share proposal would simply eliminate all the problems that the appraisal committee identified in the submission, around trial data and design? These seemed considerable: no studies submitted assessed either drug against relevant comparator; trials were 'heterogenous in terms of design, population, implementation and analysis'.

We put this question to NICE. Their reply:

Although there is some evidence to suggest that dasatinib and nilotinib could be considered clinically effective in cases of chronic myeloid leukaemia (CML), the quality of that evidence was extremely poor. This, coupled with the very high cost of the drugs, meant that the independent appraisal committee could not recommend them as an appropriate use of NHS resources.

During the public consultation on the draft recommendations manufacturers will have the opportunity to propose a patient access scheme, to make it easier for the NHS to afford expensive new treatments. We would be happy to look at such a scheme.

The answer is still not entirely clear (to me anyway; and I'm pushing for further clarification). But it sure looks as if patient access schemes will trump poor data.

If that's true, we're not sure that will do anyone any good--the NHS (paying, if a reduced price, for drugs that aren't effective), companies (forced to submit access schemes above all else), or patients (potentially receiving an ineffective drug and, as a group, perhaps not getting something else as a result).

We hope, then, that we're wrong.

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Sandy, who is running the health service - NICE or the government?

If you read NICE's comments, the clinical effectiveness of these two drugs are conceded. However, NICE move more and more towards being in charge of cash provision and becoming the negotiating body between patients and drug companies, rather than being what they were set up to be - advisors.

Are they qualified to do this? Is this their remit? Can they do this and remain independent? I reckon the government needs to re-evaluate the whole drugs provision system. They need to look at how they will get the effective, life saving drugs to the patients, rather than how they can stop them getting to the patients.

Sorry for the lack of suggestions as to what can be done, but the whole system has to be changed. This is totally the wrong way to advance the cancer services of the NHS.

Livid at this.

Hello
Not posted for some time, but I find that I amtoo incensed at what I read about yet another debacle of a decision made by the keepers of the nation's health, i.e. NICE. I was party to the NICE evaluation of Glivec, and did produce written comments on the report as prepared by Exeter University. Then as obviously now, all of these comments were ignored and the reported damned Glivec as in-effective and too costly. How wrong they were!
Here we are 2010 and history repeating itself, courtesy of NICE! Once again Exeter University have produced the report, and again the same fatuous comments. Full of inaccucies, and 'accountant speak'.
I personally graduated from Glivec to Dasatinib, some three years ago, so according to NICE I should have been dead within three months !! No, I am not,in fact at my last FBC at Hammersmith, I had achieved almost 'normal' blood values, along with, what was called 'an exciting PCR', the letters CMR were mentioned at the time The only reasons for achieving this has been a half dose of 50mg Dasatinib daily !!. So where does this leave us as end users of Dasatinib ? Well, as far as we know, we users are 'safe', but why oh why should these so called experts within NICE deliberatley mislead the nation with such eroneous facts and figures. The time has long passed for pleasant words etc. the time is right for concerted action to make the general public aware that they are being deliberately being fed information that is just not true.
Comments ?
Keep smiling
Keith

Hi Keith
Great to hear from you old timer ! So pleased for you that your results on Dasatinib are so good, this is fantastic news.

Like you I am incensed almost beyond words. It feels so impossible to make any comment that will be valued by 'the powers that be' who ever these nameless faceless bean counters are. Frustration has moved me to tears this time, and I feel totally impotent against the monolith of NICE. Like you I am on a second generation drug - Tasigna, half dose for 2 years and at PCR 0.002 WOW. Plus I feel fantastic, the side effects are bearable and my energy levels good most of the time. Why do these bits of information from people like you and I get ignored and side lined.
ATB
Pennie

Good to hear from you. We have come a long way from our first telephone call all those years ago when you were enquiring about STI 571, and then your fight to get it! He ho, time does pass quickly especially when you are having such fun. PCR eventually at 0.049, thanks to Dasatinib !!!! on three monthly visits to HH.,Good fun, only have to get extra early four times a year!!!!
Still we are both still here in 2010, especially when I was given 2 months in Oct 1996, stubborn old sod or what ??
Have fun Pennie, and remember if you or the charity need a re-enactment at any of your fundraisers, let me know. One thing I can assure, is that it will be totally and utterly politically incorrect. !!
Keith