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Use of Pemetrexed in Mesothelioma

Use of Pemetrexed in Mesothelioma. Citizen’s Council – November 2008. The Task. Provide Guidance to the NHS on the use of pemetrexed in for people with malignant pleural mesothelioma

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Use of Pemetrexed in Mesothelioma

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  1. Use of Pemetrexed in Mesothelioma Citizen’s Council – November 2008

  2. The Task • Provide Guidance to the NHS on the use of pemetrexed in for people with malignant pleural mesothelioma • Note that, in a nutshell, Pemetrexed confers about 3 months survival at an additional cost of £8000 plus the cost of managing greater toxicities

  3. Pleural Mesothelioma Cancer of lining of lung – pleura

  4. Pleural Mesothelioma 99% linked to asbestos exposure Can occur a long time after exposure: Age at presentation usually 60-80 yrs; Rising incidence: now 2000 patients/year Shortness of breath, chest pain, malaise, appetite loss, weight loss, sweats Almost always lethal over 6-18 months Prognostic factors: performance status [need to explain], stage [again may need to explain, age

  5. Treatment Surgery rarely possible Active symptom control very important Chemotherapy: no standard treatment. In UK Vinorelbine or MVP (mitomycin, vinblastine, cisplatin) often used, but only on the basis of non-RCT evidence

  6. The Evidence for Pemetrexed Randomised Controlled Trial of Cis+Pem vs Cisplatin alone % alive at 1 year: 38(Cis) 50(Pem-Cis) p=0.02

  7. Cis vs Cis+Pem Toxicity and QoL Quality of Life: Reported in abstract only Scores for global QOL, pain, dyspnoea and fatigue all significantly increased by week 15 in cis+pem arm QOL scores began to diverge by week 9

  8. ICER for Cis+Pem(and if 100mg vial of pem available)

  9. The Main Arguments – for (1) • Innovative drug • Now used elsewhere in Europe and the USA • Trials without including pemetrexed now unlikely/unethical • The only licensed treatment (MVP and vinorelbine are used “off license”) and in any case cisplatin is a good model for these treatments • The best ICER is plausible as many (if not most) patients even with advanced disease are of “good performance status”

  10. The Main Arguments – for Pem – Cis (2) (6) Rare disease (7)Time limited disease peak (the cohort of patients are now > 60) (8)Disadvantaged patients (those exposed to asbestos were usually asbestos factory workers and their families) (9) Societal responsibility for an industrial disease

  11. The Main Arguments – Against • Clinical evidence is limited to one trial • The comparator in the trial is not standard UK practice (and the manufacturer was not persuaded to enter Pemetrexed into a trial of the other comparators – “MS01”) – a trial is needed • The Pem Cis regime is moderately toxic (more so than comparators) • All analyses, even those searching for sub-groups show Pem-Cis to be not cost-effective by normal rules ie well above £20,000 - £30,000 per QALY. And the only sub-group at less than £40,000 was a slightly artificial one of high performance status patients

  12. Report Back Working in groups • Try to come up with an agreed answer/ majority • Did you all agree? • What problems did you face?

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