NICE set to take away standard of care for over 1,000 lung cancer patients in England and Wales ,

NICE set to take away standard of care for over 1,000 lung cancer patients in England and Wales

Patients with Britain's biggest cancer killer will be left with no active anticancer treatment option when first line therapy fails

Welwyn Garden City, Tuesday 4 February, 2014 – The National Institute for Health and Care Excellence (NICE) has recommended that relapsed (second line) non-small cell lung cancer (NSCLC) patients no longer have access to cancer pill Tarceva® (erlotinib) because it does not meet their criteria for clinical and cost-effectiveness.1 The decision will set lung cancer care in England and Wales backwards and over 1,000 patients a year will be left without an active treatment option after their first-line therapy has failed while patients in Scotland and the rest of Europe continue to benefit from erlotinib.2

Clinicians use erlotinib to treat six out of 10 patients receiving active anticancer therapy for relapsed NSCLC  but after re-reviewing its existing guidance, NICE will leave patients with access to only the chemotherapy, docetaxel, which many patients are too sick to tolerate.  This will effectively leave these less fit patients with no active treatment option to fight their cancer and goes against NHS England's policy which states that no patient will be without access to cancer treatment. 
Dr Mick Peake, Consultant Physician at the University Hospitals of Leicester NHS Trust and Clinical Lead, National Cancer Intelligence Network, (NCIN) said: "Lung cancer is one of the most difficult cancers to treat and the decision to remove what has become a standard of care will make our job as clinicians more difficult, particularly impacting on some of our sickest patients. Experienced clinicians need more freedom to be able to choose the treatment that they think is right for each patient."
It seems perverse that this NICE guidance will limit the treatment options available to only docetaxel, given that the independent evidence review shows the total NHS treatment costs of docetaxel to be higher than those of erlotinib.1 This difference arises because docetaxel needs to be given intravenously in hospital, whereas erlotinib is an oral treatment taken at home.1 The cost of managing treatment side effects is also greater with docetaxel, especially for life-threatening febrile neutropenia* which normally requires hospitalisation for antibiotic therapy.5,

International benchmarking studies show that the UK lags behind many other European countries in terms of lung cancer survival rates due to late diagnosis and poor treatment access, amongst other factors. ,  Lung cancer treatment rates in the UK are already low with less than 40% of patients receiving any kind of active treatment when their cancer relapses.2 The NICE decision would reduce this even further and impact treatment now and in the future, as a significant number of new lung cancer medicines currently in development are designed to be combined with erlotinib. 

Clinicians, patients and the public have until 24 February to respond to the preliminary NICE decision.  NICE will then publish its final decision in June.

Lung cancer by numbers:
• 35,184 people died of lung cancer in the UK in 2011 alone – this is equivalent to one death every 15 minutes3
• Over 1,000 patients will be affected by NICE's proposed decision2
• Less than 30% of UK lung cancer patients will be alive one year after diagnosis9
• In the UK, fewer than 9% of lung cancer patients will be alive five years after diagnosis9

The most common side effects of erlotinib are rash and diarrhoea, both of which are usually manageable.

*When a patient experiences a drop in the number of types of white blood cells needed to fight infections associated with fever and, often, other signs of infection

February 2014



Editor's Notes

About Lung Cancer
Lung cancer is responsible for 6% of all UK deaths and is the biggest cancer killer in Britain.3 Over 43,000 new cases of lung cancer are diagnosed in the UK each year,  resulting in over 35,000 deaths annually.3 This is the equivalent of one lung cancer death every 15 minutes in the UK.  The prognosis for lung cancer patients is often poor. Research shows that in the UK, only 8.8% of lung cancer patients will be alive five years after diagnosis.9

About erlotinib
Erlotinib is a once-daily, oral treatment for advanced or metastatic NSCLC. It has been shown to inhibit EGFR (epidermal growth factor receptor), a protein involved in the growth and development of cancers.11 Erlotinib is licenced as a first-line treatment in patients with locally advanced or metastatic NSCLC with activating EGFR mutations; as a maintenance treatment in patients with advanced NSCLC whose disease remains largely unchanged after four cycles of initial chemotherapy (known as stable disease); and as a second-line treatment for patients with locally advanced or metastatic NSCLC, whose cancer has worsened following at least one prior chemotherapy regime.11
For further information please see the Summary of Product Characteristics (SmPC) here:
NICE is not re-reviewing its guidance recommending first-line treatment with erlotinib.

About TA62
Erlotinib received regulatory approval and NICE endorsement (TA62) as a second line treatment for advanced NSCLC in November 2008, based on the results of the BR.21 study which found erlotinib plus best supportive care (BSC) to significantly improve both overall survival and progression-free survival compared with placebo plus BSC. The study also found erlotinib to relieve symptoms (e.g. cough, pain and shortness of breath) and provided an overall improvement in physical function and quality of life.

Adverse reaction reporting
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Roche is committed to the safety of its medicines. As such Roche encourages Adverse Events to be reported and hence the inclusion of this explanatory information. Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing [email protected] or calling +44(0)1707 367554.

About Roche in the UK
Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. For more information:

Contact details
Claire Jacques
Roche Communications
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Stephanie Coleman
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