Lung cancer (non-small-cell, first line treatment) - pemetrexed: appraisal consultation document
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Pemetrexed for the first-line treatment of non-small-cell lung cancer
Appraisal Committee's preliminary recommendations
The manufacturer's submission
Consideration of the evidence
Proposed date for review of guidance
Appendix A: Appraisal Committee members and NICE project team
Appendix B: Sources of evidence considered by the Committee
The Department of Health has asked the National Institute for Health and Clinical Excellence (NICE or the Institute) to conduct a single technology appraisal (STA) of pemetrexed for the first-line treatment of non-small-cell lung cancer (NSCLC) and provide guidance on its use to the NHS in England and Wales. The Appraisal Committee has had its first meeting to consider both the evidence submitted by the manufacturer and the views put forward by non-manufacturer consultees and commentators, and by the clinical specialist and patient expert representatives nominated for this appraisal by non-manufacturer consultees and commentators. The Committee has developed preliminary recommendations on the use of pemetrexed for the first-line treatment of advanced NSCLC.
This document has been prepared for consultation with the formal consultees. It summarises the evidence and views that have been considered and sets out the preliminary recommendations developed by the Committee. The Institute is now inviting comments from the formal consultees in the appraisal process (the consultees for this appraisal are listed on the NICE website, www.nice.org.uk). This document should be read in conjunction with the evidence base for this appraisal (the evaluation report) which is available from www.nice.org.uk
The process the Institute will follow after the consultation period is summarised below. For further details, see the ‘Guide to the single technology appraisal process’ (this document is available on the Institute’s website, www.nice.org.uk).
- The Appraisal Committee will meet again to consider the original evidence and this appraisal consultation document in the light of the views of the formal consultees.
- At that meeting, the Committee will also consider comments made on the document by people who are not formal consultees in the appraisal process.
- After considering feedback from the consultation process, the Committee will prepare the final appraisal determination (FAD) and submit it to the Institute.
- Subject to any appeal by consultees, the FAD may be used as the basis for the Institute’s guidance on the use of the appraised technology in the NHS in England and Wales.
The key dates for this appraisal are:
Closing date for comments: 06 May 2009
Second Appraisal Committee meeting: 24 June 2009
Details of membership of the Appraisal Committee are given in appendix A, and a list of the sources of evidence used in the preparation of this document is given in appendix B.
Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation.
|1||Appraisal Committee's preliminary recommendations|
|1.1||The Committee is minded not to recommend pemetrexed, within its licensed indication, for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer.|
|1.2||The Committee recommends that NICE requests further clarification on the cost effectiveness analysis from the manufacturer as described in 1.3-1.5. This should be made available for the next Appraisal Committee meeting.|
|1.3||A cost effectiveness analysis comparing pemetrexed/cisplatin with gemcitabine/cisplatin which accurately represents the outcomes of the JMDB trial.|
|1.4||A separate analysis based on the JMDB clinical trial where event data from the clinical trial should be used to estimate its costs effectiveness.|
|1.5||All new analyses should be comprehensively quality assured.|
|2.1||Pemetrexed disodium (Alimta, Eli Lilly and Company Limited) in combination with cisplatin has a marketing authorisation for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) other than predominantly squamous cell histology.|
|2.2||Pemetrexed is an antifolate agent that works by disrupting folate-dependent metabolic processes essential for cancer cell replication and survival. Cisplatin is a platinum-based chemotherapeutic agent that has antitumour activity in a number of different cancers.|
|2.3||The licensed dose is 500 mg/m2 body surface area, administered as a 10-minute intravenous infusion on the first day of each 21-day cycle. It is followed approximately 30 minutes later by 75 mg/m2 cisplatin infused over 2 hours. To reduce toxicity, patients treated with pemetrexed should receive folic acid and vitamin B12 supplements. To reduce the incidence and severity of skin reactions, premedication with a corticosteroid is recommended.|
|3||The manufacturer's submission|
|The Appraisal Committee (appendix A) considered evidence submitted by the manufacturer of pemetrexed and a review of this submission by the Evidence Review Group (ERG; appendix B).|
|3.1||In the submission the manufacturer compared pemetrexed combined with cisplatin (pemetrexed/cisplatin) with gemcitabine combined with cisplatin (gemcitabine/cisplatin). The manufacturer justified this choice of comparator with marketing data that suggest gemcitabine plus a platinum drug account for 80% of first-line NSCLC treatment, and the fact that according to a meta-analysis and clinical opinion cisplatin is the preferred platinum drug. The manufacturer identified gemcitabine combined with carboplatin (gemcitabine/carboplatin) and docetaxel combined with cisplatin (docetaxel/cisplatin) as additional comparators. The manufacturer stated that carboplatin is still commonly used in the UK because patients do not need the same hydration that is necessary with cisplatin. It also stated that docetaxel is used occasionally because it requires fewer infusions than gemcitabine.|
|3.2||For the comparison of pemetrexed/cisplatin with gemcitabine/cisplatin the manufacturer identified one phase III, open-label, non-inferiority randomised controlled trial (RCT). This trial (known as JMDB; n = 1725) compared 862 patients given pemetrexed/cisplatin with 863 patients given gemcitabine/cisplatin. It included patients with either squamous or non-squamous NSCLC and subgroups were defined by histology type, including adenocarcinoma, large-cell carcinoma and 'not otherwise specified'. Patients received up to six cycles of chemotherapy and were followed for 2.5 years. The trial results demonstrated overall survival of 10.3 months for both the pemetrexed and gemcitabine arms in all randomised patients (hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.84 to 1.05, p = 0.259). People with NSCLC of non-squamous histology had greater overall survival in the pemetrexed arm than the gemcitabine arm, based on median values (11 months versus 10.1 months, respectively; HR: 0.84, 95% CI 0.74 to 0.96, p = 0.011). A subgroup analysis based on median values showed that in the group including patients with adenocarcinoma and large cell carcinoma the overall survival was 11.8 months for pemetrexed/cisplatin compared with 10.4 months for gemcitabine/cisplatin (HR 0.81, 95% CI 0.70 to 0.94, p = 0.005). The manufacturer concluded that these results proved the hypothesis that pemetrexed/cisplatin was non-inferior to gemcitabine/cisplatin for overall survival in the overall JMDB trial population. The manufacturer also stated that survival benefit is greatest in the subgroup of patients with adenocarcinoma and large cell carcinoma and that therefore this subgroup should be the target population for pemetrexed treatment.|
|3.3||The difference in median progression-free survival between patients receiving pemetrexed/cisplatin and gemcitabine/cisplatin in all randomised patients was not significant: 4.8 and 5.1 months, respectively (HR 1.04, 95% CI 0.94 to 1.15). In patients with non-squamous histology, median progression-free survival was 5.3 for pemetrexed/cisplatin and 5.0 months for gemcitabine/cisplatin (HR 0.95, 95% CI 0.84 to 1.06). For the target group of adenocarcinoma and large cell carcinoma the progression-free survival was 5.3 for pemetrexed/cisplatin and 4.7 months for gemcitabine/cisplatin (HR 0.95, 95% CI 0.79 to 1.02).|
|3.4||Pemetrexed was associated with statistically significantly fewer grade 3 and 4 adverse events, specifically neutropenia, febrile neutropenia, thrombocytopenia, anaemia and alopecia. Patients in the pemetrexed arm received fewer red blood cell transfusions, and less granulocyte colony stimulating factor and erythropoietin. Patients randomised to pemetrexed experienced statistically significantly more nausea. No quality of life data was measured in the JMDB clinical trial.|
|3.5||The manufacturer carried out an indirect comparison of pemetrexed/cisplatin with other comparators (gemcitabine/carboplatin and docetaxel/cisplatin). The manufacturer identified two phase II, open-label RCTs that could be mapped to the treatment arms of JMDB: Zatloukal et al. (2003), which compared gemcitabine/cisplatin (n = 87) with gemcitabine/carboplatin (n = 89) and Schiller et al. (2002), which compared gemcitabine/cisplatin (n = 301) with docetaxel/cisplatin (n = 304). All treatments were administered within their licensed indications. The trials were relatively homogenous in terms of patient population and when compared with the JMDB trial. The manufacturer noted that the unadjusted comparison suggested that median overall survival and progression-free survival were improved for pemetrexed/cisplatin in patients with squamous and non-squamous NSCLC relative to the other comparators.|
|3.6||The manufacturer's indirect comparison methodology involved calculating hazard ratios for each of gemcitabine/carboplatin and docetaxel/cisplatin, compared with gemcitabine/cisplatin. The hazard ratios were based on median overall survival and were applied to the hazard rate of the gemcitabine/cisplatin arm in the JMDB trial to produce hazard rates for gemcitabine/carboplatin and docetaxel/cisplatin, adjusted for the JMDB population. This was then used to calculate adjusted median overall survival estimates for the JMDB population. The manufacturer used this method to adjust the hazard rates for the subgroups by using the corresponding hazard rates in JMDB (such as for non-squamous NSCLC). The results of this analysis for the target population of patients with adenocarcinoma and large cell carcinoma suggested an overall survival advantage for pemetrexed/cisplatin (11.8 months, 95% CI 10.4 to 13.2) versus gemcitabine/carboplatin (9.5 months, 95% CI 8.10 to 13.38) and docetaxel/cisplatin (9.8 months, 95% CI 8.61 to 11.48). Pemetrexed also had an advantage in terms of progression-free survival: 5.32 months for pemetrexed/cisplatin compared with 3.77 for gemcitabine/carboplatin and 4.06 months for docetaxel/cisplatin(no confidence intervals were reported).|
|3.7||The manufacturer developed a Markov model with a 6-year time horizon that compared pemetrexed/cisplatin, gemcitabine/cisplatin, gemcitabine/carboplatin and docetaxel/cisplatin. The estimates of efficacy used in the economic model were based on a direct comparison of overall survival between pemetrexed/cisplatin and gemcitabine/cisplatin. All clinical events were modelled via transition probabilities. Treatment effects considered included overall survival, progression-free survival, response rates, adverse events and HRQoL. All effectiveness data used in the model, apart from HRQoL, were trial based. The JMDB trial was used for the direct comparison, and the results of the indirect comparison were used for the other comparators. The adverse event states were built into the model as separate mutually exclusive health states.|
|3.8||In the model patients were given a maximum of four cycles. A continuation rule stipulated that only patients whose disease had responded to pemetrexed after three cycles continued treatment. To reflect treatment discontinuation after the third cycle for patients whose disease did not respond, all chemotherapy costs for the following cycles were removed.|
|3.9||A literature review of the utility data for patients with NSCLC identified a number of studies, but the manufacturer considered that none were suitable for inclusion. Instead, a study by Nafees et al. (2008) was used. This study was commissioned for second-line treatment of NSCLC by the manufacturer, but was assumed by the manufacturer to apply to the first-line setting. The study involved 100 members of the public interviewed with visual analogue scale and standard gamble techniques to elicit societal values on utilities in lung cancer.|
|3.10||The base-case analysis compared pemetrexed/cisplatin with gemcitabine/cisplatin. In the population with non-squamous NSCLC, the analysis resulted in an incremental cost-effectiveness ratio (ICER) for pemetrexed/cisplatin compared with gemcitabine/cisplatin of £33,065 per quality-adjusted life year (QALY) gained without the continuation rule (see 3.8), and £25,967 per QALY gained using the continuation rule. When subgroups according to histology were analysed using the continuation rule, pemetrexed/cisplatin compared with gemcitabine/cisplatin in the adenocarcinoma subgroup gave an ICER of £18,442 per QALY gained, and large cell carcinoma gave an ICER of £8,056 per QALY gained.|
|3.11||The ERG reviewed the evidence submitted for clinical and cost effectiveness. The ERG report concentrated on the exclusion of vinorelbine, the indirect comparison and the suitability of the chosen cost-effectiveness analysis.|
|3.12||The ERG noted that vinorelbine had been excluded from the analysis even though the marketing data presented by the manufacturer suggested it accounted for 11% of first-line NSCLC treatment, which was greater than the 4% usage of docetaxel. The ERG considered that vinorelbine should have been included in the manufacturer's decision problem to allow a full assessment of pemetrexed against relevant comparators.|
|3.13||The ERG noted that in the JMDB trial baseline characteristics were well balanced between treatment arms and between histological subgroups. The ERG noted that the findings from the per-protocol analysis requested from the manufacturer did not differ much from the findings from the intention-to-treat analysis. The ERG considered that this made the JMDB trial results considerably more robust. On request, the manufacturer reported the p values for the test for interaction as p = 0.0024 for squamous NSCLC compared with non-squamous NSCLC, and p = 0.0059 across all other subgroups. This makes it more likely that there were real differences between the histological subgroups.|
|3.14||The ERG commented that it had concerns over the trial selection for the indirect comparison. The ERG believed that all the comparators specified in the scope (pemetrexed, docetaxel, gemcitabine, paclitaxel and vinorelbine) should have been included in the indirect comparison analyses. This would have identified five further phase III RCTs for consideration, and improved the subsequent power and validity of the indirect comparison. The ERG also noted that the manufacturer did not assess validity of the included RCTs.|
|3.15||The ERG also expressed concern over the statistical approach used in the indirect comparison. It noted that the manufacturer's method may result in under or overestimation of treatment effects, and loss of statistical power. It also noted that the manufacturer's submission suggested that the treatment-arm-level hazard rates were used; the ERG stated that indirect comparisons should be based on a comparison of relative effects rather than a comparison of single arm estimates, as the former maintains randomisation within a trial. The ERG stated that the key assumption of an indirect comparison is that the relative effects are exchangeable across the trial settings, that is, there are no treatment effect modifiers. Within the JMDB trial, histology is an effect modifier, and this should be accounted for in the indirect comparison. The ERG concluded that, because key comparators were excluded from the indirect comparison analysis, and because of the assumptions underlying the statistical approach employed, the findings from this analysis should be interpreted with caution.|
|3.16||The ERG commented on the submitted cost-effectiveness analysis. It noted that the chosen Markov model structure does not seem to be appropriate because it does not replicate the trial data used to calibrate the model to an acceptable level of accuracy. The ERG commented that this was noticeable when calculating response and survival. The ERG considered that because overall survival and progression-free survival are the primary outcomes in the JMDB trial, they should be accurately replicated in the economic model for each of the subgroups for the trial period. It noted that the manufacturer's model appears to overestimate overall survival in both arms and almost all patient groups. For progression-free survival, the ERG commented that the model tends to underestimate in the first 6 months and to overestimate thereafter. In addition, the ERG noted that some survival estimates suggested an error in the model's logic.|
|3.17||The ERG commented on the use of response to treatment in the model structure. It is commonly assumed that response leads to a delay in disease progression and therefore to progression-free survival, this becoming the source of survival gain. Following disease progression it is usually assumed that the natural course of the disease will continue. The JMDB trial data suggested that all the reported survival gain occurred after disease progression, with progression-free survival effectively identical between the pemetrexed/cisplatin and gemcitabine/cisplatin arms. The ERG stated that it was not clear whether objective response determined the extent of health gain and whether the survival gain was restricted to patients whose disease has responded to treatment, or to all patients who had treatment. The ERG considered that this had implications for the design of the model; if response doesn't predict progression-free survival or post-progression survival, then its use as a distinct health state is potentially irrelevant, and could generate misleading results.|
The ERG identified a number of additional concerns with the cost-effectiveness analysis, including the following:
|3.19||The ERG stated that the evidence submitted by the manufacturer was not sufficiently convincing or robust for it to determine the cost effectiveness of pemetrexed.|
|3.20||Full details of all the evidence are in the manufacturer's submission and the ERG report, which are available from www.nice.org.uk/TAxxx|
|4||Consideration of the evidence|
|4.1||The Appraisal Committee (appendix A) reviewed the data available on the clinical and cost effectiveness of pemetrexed for the treatment of NSCLC, having considered evidence on the nature of the condition and the value placed on the benefits of pemetrexed by people with NSCLC, those who represent them, and clinical specialists. It was also mindful of the need to take account of the effective use of NHS resources.|
|4.2||The Committee discussed current UK clinical practice for the treatment of NSCLC. It noted that the manufacturer had limited its analysis to comparisons with gemcitabine/cisplatin, gemcitabine/carboplatin and docetaxel/cisplatin. The Committee heard from clinical specialists that current UK clinical practice was to combine gemcitabine with a platinum drug (usually cisplatin) in the majority of cases. The Committee heard from clinical specialists that there were still some centres that used carboplatin as they could not administer cisplatin because of the hydration required.|
|4.3||The Committee discussed the additional comparator presented by the manufacturer (docetaxel/cisplatin) and the ERG's concern that vinorelbine had been excluded. The Committee heard from clinical specialists that docetaxel and vinorelbine are not widely used in the UK because of their adverse-event profiles, in particular the higher rates of febrile neutropenia compared with those seen with pemetrexed and gemcitabine. However, the Committee heard from clinical specialists that docetaxel requires fewer hospital visits than gemcitabine, and so it is occasionally used in areas where transport to hospital is difficult. The Committee noted market research data presented by the manufacturer that confirmed that gemcitabine was the main treatment regimen used in the UK, with an 85% market share. Vinorelbine was in second place with an 11% market share. The Committee heard from clinical specialists that the 11% market share of vinorelbine could be an overestimate because it could include use in other indications. The Committee concluded that the gemcitabine/cisplatin combination was the principle comparator in UK clinical practice for the first-line treatment of NSCLC.|
|4.4||The Committee considered the evidence on the clinical effectiveness of pemetrexed/cisplatin compared with gemcitabine/cisplatin. It noted that the JMDB trial was well conducted and considered its results to be robust. The Committee heard from the clinical specialists that the histological subtyping was an important factor in predicting response to pemetrexed. It also heard that the improved overall survival with pemetrexed seen in the JMDB trial in the adenocarcinoma and large cell carcinoma subgroups has been replicated in other studies. The Committee concluded that there is evidence to support a true difference in response to pemetrexed between histological subtypes, although the pathophysiological basis for this is not known.|
|4.5||The Committee then discussed whether the results of the JMDB trial were generalisable to UK clinical practice, with particular reference to routine identification of histological subtypes and numbers of treatment cycles recommended. It heard from clinical specialists that histological identification of patients with non-squamous disease to determine whether they have adenocarcinoma or large cell carcinoma was not common practice in the UK. However the Committee was persuaded that there would not be problems with implementation in practice because pathology services in the UK can perform such histological diagnoses.|
|4.6||The Committee noted that four cycles of chemotherapy was considered standard UK clinical practice, whereas the trial had allowed up to six, with an average of 4.4 actually being administered. The clinical specialists stated that a reduction in the number of cycles from 4.4 to four was unlikely to affect the clinical outcomes of the trial. The Committee concluded that pemetrexed/cisplatin was more clinically effective than gemcitabine/cisplatin.|
|4.7||The Committee considered the indirect comparison of pemetrexed/cisplatin with gemcitabine/carboplatin and docetaxel/cisplatin. It noted the manufacturer's exclusion of comparators such as vinorelbine. It considered that even though its use in the UK was low, the omission was inappropriate because it excluded additional information and data from the analysis. The Committee was also mindful of the concerns of the ERG over the methodology used by the manufacturer, and of the fact that the indirect comparisons presented in the manufacturer's submission were potentially flawed because of the exclusion of relevant comparators and the chosen statistical method. However, the Committee noted that the gemcitabine/cisplatin combination was the principle comparator in UK clinical practice for the first-line treatment of NSCLC. It also noted evidence from the clinical specialists and patient experts that suggested that gemcitabine/cisplatin was as effective or more effective than gemcitabine/carboplatin or docetaxel/cisplatin. The Committee concluded that its concerns around the indirect comparison did not prevent it from concluding that pemetrexed is clinically effective in UK clinical practice.|
|4.8||The Committee heard from patient experts and clinical specialists that pemetrexed was valued by patients because of its favourable adverse-event profile, in particular the lower incidences of febrile neutropenia and alopecia. In addition, patients preferred pemetrexed's shorter infusion time and the fewer hospital visits needed for treatment compared with gemcitabine The Committee concluded that the increased survival and lower toxicity demonstrated in the JMDB trial for pemetrexed/cisplatin was clinically significant when compared with gemcitabine/cisplatin, especially when taking into account the overall low survival rates for NSCLC.|
|4.9||The Committee considered the manufacturer's submitted cost-effectiveness analysis and the ERG's critique. The Committee noted that the model did not replicate the results of the JMDB trial, especially with respect to the three primary clinical outcomes (overall survival, progression-free survival and response rate). The Committee agreed with the ERG that, as the JMDB trial data are the primary source of clinical data used in the model, the model should be able to reproduce its results. The Committee also noted the other problems identified by the ERG and was concerned that the submitted model had not been adequately quality assured. The Committee concluded that on the basis of the evidence presented, the cost effectiveness of pemetrexed in combination with cisplatin had not been proven despite the apparently favourable ICERs in the manufacturer's submission.|
|4.10||The Committee considered that pemetrexed was potentially an important treatment for NSCLC given its clinical effectiveness and lower incidence of grade 3 and 4 adverse events. The Committee recommended that further additional analyses be requested from the manufacturer to address the concerns of the ERG about the cost-effectiveness model. The Committee considered that the additional analyses should produce clinically consistent deterministic results with the JMDB trial for the trial period, such as for overall survival and progression free survival. These additional analyses should resolve the issues identified in section 3.17 and 3.18. In addition, the Committee considered that a separate validation analysis based only on the JMDB trial data should be presented. This separate analysis should present the health outcomes and costs associated with pemetrexed/cisplatin compared with gemcitabine/cisplatin for the trial period based on the JMDB event and patient-level data. The Committee considered that any analysis should be presented with a comprehensive quality assurance.|
|5.1||The Healthcare Commission assesses the performance of NHS organisations in meeting core and developmental standards set by the Department of Health in ‘Standards for better health’ issued in July 2004. The Secretary of State has directed that the NHS provides funding and resources for medicines and treatments that have been recommended by NICE technology appraisals normally within 3 months from the date that NICE publishes the guidance. Core standard C5 states that healthcare organisations should ensure they conform to NICE technology appraisals.|
|5.2||'Healthcare standards for Wales' was issued by the Welsh Assembly Government in May 2005 and provides a framework both for self-assessment by healthcare organisations and for external review and investigation by Healthcare Inspectorate Wales. Standard 12a requires healthcare organisations to ensure that patients and service users are provided with effective treatment and care that conforms to NICE technology appraisal guidance. The Assembly Minister for Health and Social Services issued a Direction in October 2003 that requires local health boards and NHS trusts to make funding available to enable the implementation of NICE technology appraisal guidance, normally within 3 months.|
NICE has developed tools to help organisations implement this guidance (listed below). These are available on our website (www.nice.org.uk/TAXXX). [NICE to amend list as needed at time of publication]
NICE is developing the following guidance (details available from www.nice.org.uk):
|7||Proposed date for review of guidance|
|7.1||The review date for a technology appraisal refers to the month and year in which the Guidance Executive will consider whether the technology should be reviewed. This decision will be taken in the light of information gathered by the Institute, and in consultation with consultees and commentators.|
|7.2||It is proposed that the guidance on this technology is considered for review in April 2012. The Institute would particularly welcome comment on this proposed date.|
|Appendix A. Appraisal Committee members and NICE project team|
|A. Appraisal Committee members|
The Appraisal Committee is a standing advisory committee of the Institute. Its members are appointed for a 3-year term. A list of the Committee members who took part in the discussions for this appraisal appears below. The Appraisal Committee meets three times a month except in December, when there are no meetings. The Committee membership is split into three branches, each with a chair and vice chair. Each branch considers its own list of technologies, and ongoing topics are not moved between the branches.
Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.
The minutes of each Appraisal Committee meeting, which include the names of the members who attended and their declarations of interests, are posted on the NICE website.
Professor David Barnett (Chair)
Professor Philip Home (Vice Chair)
Professor A E Ades
Mrs Elizabeth Brain
Dr Robin Carlisle
Mrs Fiona Duncan
Dr Paul Ewings
Mr John Goulston
Mr Adrian Griffin
Dr Richard Harling
Dr Vincent Kirkbride
Dr Alec Miners
Dr Ann Richardson
Mrs Angela Schofield
Mr David Thomson
Dr William Turner
Dr Luke Twelves
Mr Mike Spencer
Dr Jane Adam
Dr David Newsham
Professor Iain Squire
Dr James Moon
Dr Peter Heywood
Dr Ian Lewin
Mr Christopher Earl
|B. NICE Project Team|
Each technology appraisal is assigned to a team consisting of one or more health technology analysts (who act as technical leads for the appraisal), a technical adviser and a project manager.
Dr Andres Roman
|Appendix B. Sources of evidence considered by the Committee|
The Evidence Review Group (ERG) report for this appraisal was prepared by Liverpool Reviews and Implementation Group, The University of Liverpool:
The following organisations accepted the invitation to participate in this appraisal. They were invited to comment on the draft scope, the ERG report and the appraisal consultation document (ACD). Organisations listed in I were also invited to make written submissions. Organisations listed in II and III had the opportunity to give their expert views. Organisations listed in I II and III also have the opportunity to appeal against the final appraisal determination.
II Professional/specialist and patient/carer groups:
III Other consultees
IV Commentator organisations (did not provide written evidence and without the right of appeal)
The following individuals were selected from clinical specialist and patient advocate nominations from the non-manufacturer/sponsor consultees and commentators. They gave their expert personal view onpemetrexed for NSCLC by attending the initial Committee discussion and providing written evidence to the Committee. They are invited to comment on the ACD.
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