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NICE backs Xalkori for lung cancer, but may cut two others from CDF

Preliminary verdict could lead to removal of Novartis' Afinitor and Janssen's Imbruvica from the Fund

Pfizer HQ building 

New draft guidance in the UK means that some patients with lung cancer will be eligible for treatment with Pfizer's Xalkori, reversing an earlier rejection.

The National Institute for Health and Care Excellence (NICE) recommends ALK inhibitor Xalkori (crizotinib) for NHS use after Pfizer agreed to a further discount on the drug's price for the second time. An earlier reduction from its £51,000-a-year UK list price was not enough to win over NICE when it last issued draft guidance on the drug in 2013.

Now, Xalkori can be used as a first-line treatment for patients with ALK-positive advanced non-small cell lung cancer (NSCLC), and is the first oral alternative to intravenous chemotherapy in this patient group.

Prof Carole Longson, director of the health technology evaluation centre at NICE, said the agency was pleased to have agreed a deal with Pfizer that would allow NHS patients to have access to the drug.

"As the only oral treatment available for people with untreated lung cancer, crizotinib is a really valuable option that will now be routinely available on the NHS," she said.

Around 459 patients are expected to be eligible for first-line treatment with crizotinib in England and Wales, and the drug has also been recommended for use in this setting by the Scottish Medicines Consortium (SMC).

Reacting to the news, the chief executive of the Roy Castle Lung Cancer Foundation, Paula Chadwick, said the drug represents a "clear advance" in the treatment of patients living with advanced lung cancer.

"Today's decision is a positive endorsement of this campaign and we applaud the NHS, NICE and Pfizer," she added. "We hope to see many more positive decisions and continued investment as we move one step closer to beating the UK's biggest cancer killer."

Afinitor and Imbruvica out?

The good news on Xalkori was overshadowed by NICE's decision on two other Cancer Drugs Fund (CDF) drugs - Novartis' breast cancer therapy Afinitor (everolimus) and Janssen's Imbruvica (ibrutinib) for mantle cell lymphoma.

Although NICE said it is not recommending these drugs are removed from the new version of the CDF, it “is advising two drugs are not cost effective, which means they may be removed from the CDF list”.

The verdict on both treatments is, so far, just a preliminary one and still open for consultation, with the Institute likely hoping to stimulate negotiations on further pricing reductions. Novartis and Janssen had already offered a discount in patient access schemes for the two medicines.

Three other manufacturers facing the possible expulsion of their drugs from the CDF have cut prices during the re-appraisal process in order to win NICE backing for routine NHS use, according to a report in The Guardian. The three drugs are Pfizer's Bosulif (bosutinib) for chronic myeloid leukaemia, Eli Lilly's Alimta (pemetrexed) for NSCLC and Sanofi's Jevtana (cabazitaxel) for advanced prostate cancer, it says.

Meanwhile, the uncertainty about Afinitor's place within the CDF has been met with consternation from the Breast Cancer NOW charity, which said it meant patients in England would be denied access to a drug that is available in Wales and Scotland.

"This is a huge blow to many breast cancer patients and we fear this decision could be just a taste of what's to come for innovative breast cancer drugs in England," said the charity's chief executive Baroness Delyth Morgan.

"Our worst fears about the re-launched CDF are being realised. Without further reform to NICE's appraisal process, we are deeply concerned that Afinitor will be the first of many breast cancer drugs to which patients in England will be cruelly denied access," she asserted.

Article by
Phil Taylor

23rd August 2016

From: Regulatory

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