The National Institute for Health and Clinical Excellence (NICE) issued guidance on Alimta(R) (pemetrexed), the only licensed treatment for malignant pleural mesothelioma - a form of lung cancer resulting from exposure to asbestos. Alimta is recommended only in patients who have WHO performance status of 0 or 1, who are considered to have advanced disease and for whom surgical resection is considered inappropriate.

Following a two-and-a-half year approval process, which included two appeals, the guidance means that primary care trusts (PCTs) will be able and obliged to fund pemetrexed for all NHS patients with mesothelioma for whom the treatment is suitable. The most recent appeal has been dismissed on all counts.

It was hoped that access to this treatment across England, Wales and Northern Ireland would consistently be available last year when, following a lengthy review process, NICE made a landmark decision to change its position and recommend Alimta for the treatment of malignant pleural mesothelioma[1] . However, appeals were submitted against the NICE recommendation and the process was subsequently further delayed by several months. Such delays are significant for patients with mesothelioma who have a life expectancy of between only 8 and 18 months[2]. Although there is no cure for mesothelioma, Alimta can increase life expectancy and bring symptom relief and improved quality of life.[3]

Dr Gary Middleton, a Consultant Medical Oncologist at Royal Surrey County Hospital welcomed the decision. "Patients suffering with this disease have always deserved a decision based on need and not cost and NICE have now granted that. However, the time taken to arrive at this decision has added more mental and physical pain for many and for some it has simply come too late. To place treatment choices at the mercy of a ponderously slow system geared towards cost will inevitably mean that outcomes for cancer patients in the UK will lag behind those in the rest of the developed world."

People affected by mesothelioma in the UK are primarily those who have worked in manufacturing industries such as shipbuilding, construction work and railway engineering. Incidence of the disease is therefore concentrated in areas such as Glasgow, the North East, the North West, Belfast, London, Plymouth, Portsmouth and Southampton.[7] A number of teachers working in schools built using asbestos have also contracted the disease. Asbestos affects not only those who are directly exposed to it but other family members who have come into contact with the deadly fibres on clothing worn at the place of work.

Mick Clapham MP, chair of the All-Party Parliamentary Group on Occupational Safety and Health comments "I welcome confirmation of the NICE decision to recommend Alimta, as the only licensed treatment for malignant pleural mesothelioma. The Government must now ensure a level playing field of access to Alimta across the UK for workers suffering from mesothelioma."

After a review of efficacy and safety data, Alimta (+ cisplatin) received a licence for the treatment of malignant pleural mesothelioma in the UK in November 2004. It was accepted for use by the Scottish Medicines Consortium in July 2005.[4]

Tony Whitston, Chair of The Asbestos Support Groups' Forum commented, "At last this means an end to the postcode lottery which has meant that some patients have received the treatment while those in neighbouring PCT areas have not. We urge PCTs to address the needs of mesothelioma patients who have waited so long for this decision and to allow funding straight away and not to wait until the three-month implementation period is over before they allow access to this treatment."

Note:

It takes between 20 and 40 years for mesothelioma to develop and people exposed to asbestos before its gradual withdrawal from the 1970s onwards are only now beginning to show symptoms of the disease. In 2004 over 1,600 people died from mesothelioma in the UK[5] but the peak in numbers won't be reached until around 2015 when 2,500 new cases are expected[6] .

Details of the NICE appraisal process for Alimta (pemetrexed disodium) can be seen on the NICE website: nice/

Prepared January 2008, item code AT277

References

[1] National Institute of Health and Clinical Excellence .Pemetrexed in the treatment of malignant pleural mesothelioma. FAD published 9th July 2007: click here toview article January 2008.

"NICE has recommended pemetrexed (Alimta) as a treatment option for malignant pleural mesothelioma only in people who have a World Health Organization (WHO) performance status of 0 or 1, who are considered to have advanced disease and for whom surgical intervention is considered inappropriate. Patients currently receiving pemetrexed who do not fall into the patient population defined in section 1.1 should have the option to continue therapy until they and their clinicians consider it appropriate to stop."

[2] Pass H. Malignant pleural mesothelioma: surgical roles and novel therapies. Clin Lung Cancer. 2001;3:102-17. Medline.

[3] Green J et al. The Cochrane Collaboration. Pemetrexed disodium in combination with cisplatin versus other cytotoxic agents or supportive care for the treatment of malignant pleural mesothelioma (Review). The Cochrane Library 2007, Issue 1.

[4] Scottish Medicines Consortium. Detailed advice document. Pemetrexed 500mg infusion (Alimta®) Drug No (192/05) July 2005 click here to view article Accessed 21 January 2008.

[5] Cancer Research UK

[6] Health & Safety Executive. Mesothelioma mortality in Great Britain: estimating the future burden. National Statistics 2003. Click here to view article

[7] Health & Safety Executive. Mesothelioma Area Statistics: Counties (included local authorities) and unitary authorities in Great Britain. 1976-1991.

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