NICE judges Tarceva too expensive for NHS
pharmafile | March 9, 2007 | News story | Sales and Marketing |Â Â Tarceva, lung cancerÂ
Roche's cancer drug Tarceva has been rejected by NICE for use against the most common form of lung cancer.
The watchdog decided the drug was not a cost-effective treatment for non-small cell lung cancer, but recommended further research into its use in certain subgroups of patients.
Roche immediately announced its intention to appeal the Final Appraisal Determination on which NICE's final guidance will be based – and stressed clinicians could still prescribe the treatment while the appraisal was ongoing.
John Melville, general manager, Roche Products Ltd, said: "It is particularly disappointing that the evidence submitted has been assessed neither fairly nor appropriately by NICE.
"The proposed guidance as it stands is perverse in the light of the evidence made available to the NICE Appraisal Committee. We do not take the decision to appeal lightly and only do so when we believe that the determination is incorrect based on the evidence made available during the appraisal."
Roche will appeal on the basis that the evidence submitted was not assessed fairly or appropriately and that the proposed guidance is perverse in the light of the evidence made available to the NICE Appraisal Committee.
Cancer charities and groups have also voiced their displeasure at NICE's decision.
Christine Akilade, a senior nurse at Cancerbackup, said: "Today's decision by NICE is disappointing in that Tarceva provides another treatment option for people with non-small cell lung cancer. It can give some patients with lung cancer extra time, which can be extremely valuable to patients and their families.
"Until the NICE guidance is final, clinicians should continue to prescribe this treatment, as clearly stated by the Health Service Circular 1999/176."
The UK Lung Cancer Coalition is a group of leading lung cancer experts, senior NHS and Department of Health professionals, charities and healthcare companies. Responding to NICE's decision, it said: "For far too long, lung cancer has been treated as the poor relation when compared to other cancers.
"It is time that we worked together to increase survival for UK patients suffering from this terrible disease and give this group of patients as many chances at life as possible."
NICE's decision contrasts sharply with one from the SMC, which accepted Tarceva (erlotinib) as clinically and cost-effective in June 2006.
The typical cost of a course of treatment with Roche's once-a-day pill is £6,800.
NICE's assessment of Tarceva in locally advanced or metastatic NSCLC after the failure of a least one-prior chemotherapy regimen compares it to either Sanofi-Aventis' Taxotere (docetaxel) or best supportive care.
Tarceva was approved for NSCLC in Europe in September 2005, making it the only treatment of its kind to be approved for the indication.
It is one of the new EGFR-inhibitor class of drugs that target genetic mutations which allow cancer cells to multiply, and is designed to bypass many of the unpleasant side-effects associated with traditional chemotherapy.
Clinical specialists and patient experts told NICE during its deliberations that the drug was a potential breakthrough for patients for whom no other treatment is available. They also emphasised Tarcevas favourable toxicity profile, with fewer serious adverse events being reported during treatment than with Taxotere.
NICE's Appraisal Committee recommended Tarceva be considered for early review in February 2008, because of its rapidly changing evidence base.
Further research was recommended into female patients who were non-smokers and of South Asian ethnicity, presenting with adenocarcinoma (a cancer of glandular tissue) and a further possible subgroup, based on EGFR status.
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