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National Institute for Health and Clinical Excellence (NICE) hears appeal on Alimta drug

In July 2007, following an appeal by the drug company, Eli Lilly, who manufacture Alimta, the National Institute for Health and Clinical Excellence (NICE) reversed its previous decision and recommended the use of the drug for mesothelioma sufferers.  (Click here to read our previous article).

However, following its decision in July, NICE received 2 appeals which were heard at the end of November 2007. (Click here to read previous article).

The appeals came from the Birmingham East and North Primary Care Trust and a joint appeal from the Royal College of Physicians and the Association of Cancer Physicians.  The reasons for the two appeals were very different.  The Primary Care Trust appealed the decision on the basis of cost whilst the College of Physicians and the Association of Cancer Physicians appealed on the ground that the guidance given by NICE on the use of Alimta may significantly restrict the number of sufferers who can receive the drug. 

The College of Physicians and the Association of Cancer Physicians

The College of Physicians and the Association of Cancer Physicians appealed the decision on the grounds that the guidance provided by NICE could potentially mean that many mesothelioma sufferers would not be eligible for Alimta because they had undergone some form of surgical intervention. 

The guidance stated that Alimta should be available to those in ‘the advanced stage of the disease for whom surgical intervention is inappropriate.’ 

The College pointed out that many mesothelioma sufferers have some form of surgical intervention in the early stages.  They argued that as one example, many patients as part of their treatment have a procedure called a VAT’s pleurodesis, a procedure where talc is placed between the lung and the chest wall to prevent fluid from building up, one symptom of mesothelioma.  Without further guidance from NICE, these sufferers may not be able to have Alimta. They would not therefore have the possibility of obtaining relief from their other symptoms or the possibility of extending their life.

Birmingham East and North Primary Care Trust

The focus of the Primary Care Trust’s (PCT) argument was on cost.  They believed that in doing its cost benefit analysis, NICE was mistaken and that the cost of the treatment would potentially be higher.  They argued that it was not clear whether the cost had been calculated on the basis of the sufferer receiving 4, 5, or 6 cycles and that each dose prescribed was to be a 100mg.  In England, they said the only licence currently available for Alimta was a 500mg dose, which is more expensive, and that by issuing guidance on the use of the drug as they had, there was no incentive for the manufacturer to provide the drug in a smaller dose.  Further, they said there was no actual guidance on whether the treatment should be stopped after 4 cycles if the sufferer was not responding. Therefore, in practice, they may receive a higher number of cycles which again would be more expensive. 

The PCT argued that when considering whether to allow the treatment, NICE had used the wrong comparison.  NICE considered the cost of prescribing the drug Cisplatin, another chemotherapy drug, in comparison to the cost of Cisplatin and Alimta together. The PCT argued that in practice, doctors did not prescribe Cisplatin to mesothelioma sufferers and therefore, the correct comparison was between the use of Cisplatin and Alimta together, compared with the cost of simply managing a sufferer’s symptoms.  Furthermore, they argued that there was insufficient evidence to suggest that using Alimta was better than simply actively managing the symptoms.

Finally, they suggested that if a sufferer can bring a compensation claim then they have the right to claim the cost of private medical treatment without needing to rely on the NHS.  This of course is only the case where a sufferer can bring a civil claim, those who for whatever reason cannot pursue a claim would not, on the basis of this argument, be able to receive the drug.

Dr Jeremy Steele, a Consultant oncologist said of the appeals “It's a great shame that a small issue around cost will now delay patients' access to the drug further. This has been such a slow and frustrating process.

"The appeal panel was very fair and pointed out that the grounds of the appeals were not based on anything fundamental.

"I'm confident that the drug will still be recommended by NICE , but access for patients will now be at least several months away." Click here for link to Guardian article.

The National Institute for Health and Clinical Excellence’s decision is expected shortly.

Article posted by Helen Wilson, solicitor.

Tel: 0161 832 1251, email: hw@johnpickering.co.uk           

Background

Mesothelioma is an asbestos-related cancer that affects the lining around the lungs (the pleura) and certain other organs such as the peritoneum. There is no cure for mesothelioma.  Radical surgery is available to a limited number of eligible patients. The condition can be difficult to diagnose and patients generally survive less than 18 months from diagnosis.  The only known cause of mesothelioma is asbestos. Mesothelioma often occurs 30 to 40 years after asbestos exposure, with no upper time limit.  Although mesothelioma is an occupational disease, victims include teachers, nurses, doctors, shop workers and family members of people who have worked with asbestos.

John Pickering and Partners LLP

John Pickering and Partners LLP is a specialist legal practice that has represented Claimants in the leading asbestos "test cases" in the last ten years. The firm represented Sylvia Barker in Barker v Corus (UK) Plc, a case that highlighted the legal tactics of employers and insurers trying to cut back their compensation liabilities to mesothelioma sufferers, and which prompted the amendment of the Compensation Act 2006 to ensure full compensation for mesothelioma claims. The firm represented two of the three Claimants in the Fairchild appeal, in which the insurance industry tried unsuccessfully to block compensation altogether for mesothelioma sufferers unable to identify which of two or more sources of asbestos exposure had caused their illness.

The firm represented Alice Jefferson, a mesothelioma sufferer, whose illness and compensation claim against Cape Asbestos were featured in the important documentary "Alice: A Fight For Life."   Shown by Yorkshire Television in July 1982, the programme was an important catalyst for legal change and public awareness of the plight of the victims of asbestos.

If you need advice about an asbestos related illness, contact us now for information about making a claim for compensation.

Further information:
Kevin Johnson, Partner
John Pickering and Partners LLP
19 Castle Street
Liverpool
L2 4SX

Telephone: 0151 227 1214

E-mail: kj@johnpickering.co.uk
Website: www.johnpickering.co.uk

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