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NICE forced to look again at Alimta

Procedural error forces watchdog to reconsider rejection of Lilly's lung cancer

Eli Lilly HQ

The UK's National Institute for Health and Clinical Excellence (NICE) has to take another look at Eli Lilly's Alimta as a treatment for certain lung cancer patients after rejecting the drug earlier this year.

The cost-effectiveness watchdog says it kicked off another appraisal of Alimta (pemetrexed) after a procedural error was uncovered during Lilly's appeal of the June verdict.

NICE's original decision was not to recommend the drug as a maintenance treatment of non-squamous non-small cell lung cancer (NSCLC) after induction therapy with Alimta and chemotherapy drug cisplatin. 

Previously NICE backed the drug as a first-line treatment for locally advanced or metastatic NSCLC and as a maintenance treatment option following platinum-based chemotherapy in combination with gemcitabine, paclitaxel or docetaxel.

The procedural error relates to the "handling of the technology appraisal" for pemetrexed, says NICE, and specifically the "release of the evidence review group's exploratory amendments to the manufacturer's model".

The upshot is that the original Final Appraisal Document (FAD) for Alimta has been retracted and a new Appraisal Consultation Document (ACD) published for comment.

The ACD will also be accompanied by a document that describes the technical detail of the exploratory analyses by the evidence review group, and NICE is scheduled to review responses to the package at a meeting on September 25.

Despite the procedural error, NICE continues to maintain in its ACD that Alimta's cost of around £11,520 for an average eight treatment cycles is too expensive.

Although Alimta is already approved for maintenance therapy after a different chemotherapy regimen "in this case … although effective, the benefits did not justify the costs", said NICE chief executive Sir Andrew Dillon.

The ACD continues to set the Quality Adjusted Life Year (QALY) for Alimta at £82,000, well above NICE's usual threshold of £30,000

The goals of maintenance treatment - which is a relatively new concept in NSCLC treatment - are to prolong the period of remission after first-line chemotherapy and increase the likelihood of being able to receive second-line chemotherapy. 

Traditionally, responding patients would generally come off treatment and only re-start it if the cancer recurred.

Alimta is a huge seller for Lilly with revenues of $2.6bn last year and is expected to reach turnover of $3.5bn-plus at peak, although it has suffered some setbacks with the drug of late.

These included disappointing phase III data last year in a trial looking at its combination with Roche's Avastin (bevacizumab) and carboplatin in patients with non-squamous NSCLC.

22nd August 2013

From: Sales, Regulatory



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