27/08/2009 by admin.

The National Institute for Health and Clinical Excellence’s decision to reject an appeal to make Roche’s Avastin, Bayer’s Nexavar and Wyeth’s Torisel available on the National Health Service for renal cancer patients has unsurprisingly led to protests from the drugmakers and patient groups.

NICE has this morning issued guidance saying that Avastin (bevacizumab), Nexavar (sorafenib) and Torisel (temsirolimus) are not recommended as first-line treatment options for advanced and/or metastatic renal cell carcinoma. In addition, the agency has turned down the use of Nexavar andPfizer’s Sutent (sunitinib) as secondary treatment options for people with either form of the disease, adding that those patients who are currently receiving these treatments should have the option to continue their therapy until they and their clinicians consider it appropriate to stop.

A year ago, NICE turned down all four drugs for first-line use but then changed its guidance to recommend Sutent at the beginning of 2009. However an appeal against that Final Appraisal Determination brought by Roche, Wyeth the James Whale Fund for Kidney Cancer and a joint appeal from Rarers Cancer Forum and Macmillan Cancer Support, have not been upheld.

Peter Littlejohns, NICE’s clinical and public health director, noted that “we are very aware that renal cancer is a devastating disease for the individual and their family” and following the about-turn over Sutent in March, “one of these new treatments is now available”. However, he added that the evidence to support the use of the other first and second line treatments “isn’t strong enough to justify using NHS funds, which could be used for other cancer treatment programmes or in other treatment areas”.

Prof Littlejohns concluded that “our advisory committee used the additional flexibility we have recently given them to give special weight to drugs that extend life, at the end of life, but the benefit was still too small set against their cost”.

Roche has responded to the guidance by saying that it is “fundamentally flawed” and serves only to reduce treatment access and options “for those UK patients who are sadly dying from this disease whilst being available to other patients in comparable countries”. The company adds that the appraisal committee accepted Avastin in combination with interferon has a similar clinical and cost-effectiveness profile to the already-approved Sutent “but turned it down simply because it has a licence in other indications - despite the fact that these indications are not currently routinely reimbursed on the NHS”.

The implication of this guidance, Roche claims, is that patients who are unsuitable for sunitinib “may be condemned to faster disease progression of their terminal cancer”. John Melville, general manager of Roche UK, said the decision is “entirely illogical and neither addresses the needs of patients with renal cancer, nor advances the innovation agenda”.

He added that Avastin “demonstrates the same value to the NHS as sunitinib and this guidance goes against the spirit of end-of-life criteria which were devised for this very setting”. The company stated that it is “considering all options”.

Stella Pendleton, executive director of the Rarer Cancers Forum, said “this is a deeply disappointing decision and a bitter blow. It is “harrowing” for patients “to know that effective treatments are available but they can’t get them on the NHS”, she added.

Ms Pendleton went on to note that the guidance will be considered for review by June 2011 and that review and “reversal of this decision cannot come fast enough”.

By Kevin Grogan

PharmaTimes

Posted in EBM updates | Print | No Comments »

20/08/2009 by admin.

Ugandan government ministers have warned that the country is running out of AIDS drugs, blaming the global financial crisis and a successful testing policy. The health ministry says that only 190 000 patients are receiving antiretroviral drugs out of the 357 000 who qualify for them. The health minister, Stephen Malinga, blames the shortages on the global economic crunch; a successful testing regime that has led to a rise in the numbers of people with access to the drugs; and policy changes that have increased the number of people who qualify for the drug.BMJ , vol 339, 15/8/9, p364http://www.bmj.com/cgi/section_pdf/339/aug12_1/b3278.pdf

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20/08/2009 by admin.

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have will work together to ensure that clinical trials related to drug marketing applications in the USA and Europe are conducted “uniformly, appropriately, and ethically.”  

The “good clinical practices initiative” is expected to strengthen safeguards for partici­pants in clinical studies. In a joint statement the EMEA and the FDA said that in most cases the same clini­cal trials are used to support applications to both agencies for approvals of new drugs. Many of the people participating in these clinical trials are recruited in