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Published in: PharmacoEconomics 3/2013

01-03-2013 | Review Article

Trastuzumab for the Treatment of HER2-Positive Metastatic Gastric Cancer

A NICE Single Technology Appraisal

Authors: Eldon Spackman, Stephen Rice, Gill Norman, Dong-Churl Suh, Alison Eastwood, Stephen Palmer

Published in: PharmacoEconomics | Issue 3/2013

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Abstract

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of trastuzumab, Roche Pharmaceuticals, to submit evidence for the clinical and cost effectiveness of this drug for the treatment of advanced gastric cancer (aGC), as part of the Institute’s single technology appraisal (STA) process. The Centre for Reviews and Dissemination (CRD) and the Centre for Health Economics (CHE) Technology Appraisal Group at the University of York was commissioned to act as the evidence review group (ERG). This article provides a description of the company submission, the ERG report and NICE’s subsequent decisions. In the initial appraisal by NICE, trastuzumab was rejected for use in the licensed population. Given this result, the manufacturer submitted additional evidence. In the final appraisal decision, trastuzumab was approved, in accordance with supplementary guidance issued by NICE on appraising life-extending, end-of-life treatments, for patients whose human epidermal growth factor receptor 2 (HER2) status was defined by an immunohistochemistry 3 positive (IHC3+) result. This appraisal highlights the need to fully assess the impact of different approaches to diagnostic testing on the cost effectiveness of targeted treatments. In this appraisal, it was found that the diagnostic strategy influenced the effectiveness and cost of trastuzumab. In the future, different diagnostic strategies should be compared in the incremental cost-effectiveness analysis.
Literature
1.
go back to reference Sculpher M. Single technology appraisal at the UK National Institute for Health and Clinical Excellence: a source of evidence and analysis for decision making internationally. Pharmacoeconomics. 2010;28(5):347–9.PubMedCrossRef Sculpher M. Single technology appraisal at the UK National Institute for Health and Clinical Excellence: a source of evidence and analysis for decision making internationally. Pharmacoeconomics. 2010;28(5):347–9.PubMedCrossRef
2.
go back to reference Rodgers M, Griffin S, Paulden M, et al. Alitretinoin for severe chronic hand eczema: a NICE single technology appraisal. Pharmacoeconomics. 2010;28(5):351–62.PubMedCrossRef Rodgers M, Griffin S, Paulden M, et al. Alitretinoin for severe chronic hand eczema: a NICE single technology appraisal. Pharmacoeconomics. 2010;28(5):351–62.PubMedCrossRef
3.
go back to reference Bagust A, Greenhalgh J, Boland A, et al. Cetuximab for recurrent and/or metastatic squamous cell carcinoma of the head and neck: a NICE single technology appraisal. Pharmacoeconomics. 2010;28(6):439–48.PubMedCrossRef Bagust A, Greenhalgh J, Boland A, et al. Cetuximab for recurrent and/or metastatic squamous cell carcinoma of the head and neck: a NICE single technology appraisal. Pharmacoeconomics. 2010;28(6):439–48.PubMedCrossRef
4.
go back to reference Stevenson M, Pandor A. Febuxostat for the management of hyperuricaemia in patients with gout: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(2):133–40.PubMedCrossRef Stevenson M, Pandor A. Febuxostat for the management of hyperuricaemia in patients with gout: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(2):133–40.PubMedCrossRef
5.
go back to reference Scotland G, Waugh N, Royle P, et al. Denosumab for the prevention of osteoporotic fractures in post-menopausal women: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(11):951–61.PubMedCrossRef Scotland G, Waugh N, Royle P, et al. Denosumab for the prevention of osteoporotic fractures in post-menopausal women: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(11):951–61.PubMedCrossRef
6.
go back to reference Dickson R, Bagust A, Boland A, et al. Erlotinib monotherapy for the maintenance treatment of non-small cell lung cancer after previous platinum-containing chemotherapy: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(12):1051–62.PubMedCrossRef Dickson R, Bagust A, Boland A, et al. Erlotinib monotherapy for the maintenance treatment of non-small cell lung cancer after previous platinum-containing chemotherapy: a NICE single technology appraisal. Pharmacoeconomics. 2011;29(12):1051–62.PubMedCrossRef
7.
go back to reference McKenna C, Maund E, Sarowar M, et al. Dronedarone for the treatment of atrial fibrillation: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(1):35–46.PubMedCrossRef McKenna C, Maund E, Sarowar M, et al. Dronedarone for the treatment of atrial fibrillation: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(1):35–46.PubMedCrossRef
8.
go back to reference Holmes M, Carroll C, Papaioannou D. Dabigatran etexilate for the prevention of venous thromboembolism in patients undergoing elective hip and knee surgery: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(2):137–46.PubMedCrossRef Holmes M, Carroll C, Papaioannou D. Dabigatran etexilate for the prevention of venous thromboembolism in patients undergoing elective hip and knee surgery: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(2):137–46.PubMedCrossRef
9.
go back to reference Yang H, Craig D, Epstein D, et al. Golimumab for the treatment of psoriatic arthritis: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(4):257–70.PubMedCrossRef Yang H, Craig D, Epstein D, et al. Golimumab for the treatment of psoriatic arthritis: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(4):257–70.PubMedCrossRef
10.
go back to reference Boyers D, Jia X, Jenkinson D, et al. Eltrombopag for the treatment of chronic immune or idiopathic thrombocytopenic purpura: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(6):483–95.PubMedCrossRef Boyers D, Jia X, Jenkinson D, et al. Eltrombopag for the treatment of chronic immune or idiopathic thrombocytopenic purpura: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(6):483–95.PubMedCrossRef
11.
go back to reference Burch J, Griffin S, McKenna C, Walker S, Paton J, Wright K, et al. Omalizumab for severe persistent asthma in children aged 6–11 years: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(11):991–1004.PubMedCrossRef Burch J, Griffin S, McKenna C, Walker S, Paton J, Wright K, et al. Omalizumab for severe persistent asthma in children aged 6–11 years: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(11):991–1004.PubMedCrossRef
12.
go back to reference Whyte S, Pandor A, Stevenson M. Bevacizumab for metastatic colorectal cancer: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(12):1119–32.PubMedCrossRef Whyte S, Pandor A, Stevenson M. Bevacizumab for metastatic colorectal cancer: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(12):1119–32.PubMedCrossRef
13.
go back to reference Kilonzo M, Hislop J, Elders A, et al. Pazopanib for the first-line treatment of patients with advanced and/or metastatic renal cell carcinoma: a NICE single technology appraisal. Pharmacoeconomics. 2013;31(1):15–24.PubMedCrossRef Kilonzo M, Hislop J, Elders A, et al. Pazopanib for the first-line treatment of patients with advanced and/or metastatic renal cell carcinoma: a NICE single technology appraisal. Pharmacoeconomics. 2013;31(1):15–24.PubMedCrossRef
14.
go back to reference Craig D, Rice S, Paton F, et al. Retigabine for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation: a NICE single technology appraisal. Pharmacoeconomics. 2013. doi:10.1007/s40273-012-0018-1. Craig D, Rice S, Paton F, et al. Retigabine for the adjunctive treatment of adults with partial onset seizures in epilepsy with and without secondary generalisation: a NICE single technology appraisal. Pharmacoeconomics. 2013. doi:10.​1007/​s40273-012-0018-1.
15.
go back to reference Rafia R, Simpson E, Stevenson M, Papaioannou D. Trabectedin for the treatment of advanced metastatic soft tissue sarcoma: a NICE single technology appraisal. Pharmacoeconomics (in press). Rafia R, Simpson E, Stevenson M, Papaioannou D. Trabectedin for the treatment of advanced metastatic soft tissue sarcoma: a NICE single technology appraisal. Pharmacoeconomics (in press).
16.
go back to reference Simpson EL, Fitzgerald P, Evans P, et al. Bivalirudin for the treatment of ST-segment elevation myocardial infarction: a NICE single technology appraisal. Pharmacoeconomics (in press). Simpson EL, Fitzgerald P, Evans P, et al. Bivalirudin for the treatment of ST-segment elevation myocardial infarction: a NICE single technology appraisal. Pharmacoeconomics (in press).
17.
go back to reference Greenhalgh J, Bagust A, Boland A, Blundell M, Oyee J, Beale S, Dundar Y, Hockenhull J, Proudlove C, Chu P. Rituximab for the first-line maintenance treatment of follicular non-Hodgkin’s lymphoma: a NICE single technology appraisal. Pharmacoeconomics (in press). Greenhalgh J, Bagust A, Boland A, Blundell M, Oyee J, Beale S, Dundar Y, Hockenhull J, Proudlove C, Chu P. Rituximab for the first-line maintenance treatment of follicular non-Hodgkin’s lymphoma: a NICE single technology appraisal. Pharmacoeconomics (in press).
18.
go back to reference Armstrong N, Manuela J, van Asselt T, et al. Golimumab for the treatment of ankylosing spondylitis: a NICE single technology appraisal. Pharmacoeconomics (in press). Armstrong N, Manuela J, van Asselt T, et al. Golimumab for the treatment of ankylosing spondylitis: a NICE single technology appraisal. Pharmacoeconomics (in press).
19.
go back to reference Tosh J, Archer R, Davis S, et al. Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying anti-rheumatic drugs: a NICE single technology appraisal. Pharmacoeconomics (in press). Tosh J, Archer R, Davis S, et al. Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying anti-rheumatic drugs: a NICE single technology appraisal. Pharmacoeconomics (in press).
20.
go back to reference Kearns B, Lloyd-Jones M, Stevenson M, Littlewood C. Cabazitaxel for the second-line treatment of metastatic hormone refractory prostate cancer: a NICE single technology appraisal. Pharmacoeconomics (in press). Kearns B, Lloyd-Jones M, Stevenson M, Littlewood C. Cabazitaxel for the second-line treatment of metastatic hormone refractory prostate cancer: a NICE single technology appraisal. Pharmacoeconomics (in press).
24.
go back to reference Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358(1):36–46.PubMedCrossRef Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358(1):36–46.PubMedCrossRef
25.
go back to reference Okines AFC, Norman AR, McCloud P, Kang YK, Cunningham D. Meta-analysis of the REAL-2 and ML17032 trials: evaluating capecitabine-based combination chemotherapy and infused 5-fluorouracil-based combination chemotherapy for the treatment of advanced oesophago-gastric cancer. Ann Oncol. 2009;20(9):1529–34.PubMedCrossRef Okines AFC, Norman AR, McCloud P, Kang YK, Cunningham D. Meta-analysis of the REAL-2 and ML17032 trials: evaluating capecitabine-based combination chemotherapy and infused 5-fluorouracil-based combination chemotherapy for the treatment of advanced oesophago-gastric cancer. Ann Oncol. 2009;20(9):1529–34.PubMedCrossRef
26.
go back to reference Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376(9742):687–97.PubMedCrossRef Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376(9742):687–97.PubMedCrossRef
27.
go back to reference Aaronson N, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez N, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76.PubMedCrossRef Aaronson N, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez N, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76.PubMedCrossRef
28.
go back to reference Satoh T, Leon J, Lopez RI, Ferry DR, Bang Y, Van Cutsem E, et al. Quality of life results from a phase III trial of trastuzumab plus chemotherapy in first-line HER2-positive advanced gastric and GE junction cancer [abstract no. 7]. Gastrointestinal Cancers Symposium; 22–24 Jan 2010; Orlando. Satoh T, Leon J, Lopez RI, Ferry DR, Bang Y, Van Cutsem E, et al. Quality of life results from a phase III trial of trastuzumab plus chemotherapy in first-line HER2-positive advanced gastric and GE junction cancer [abstract no. 7]. Gastrointestinal Cancers Symposium; 22–24 Jan 2010; Orlando.
29.
go back to reference Yun J, Lee J, Park SH, Park JO, Park YS, Lim HY, et al. A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer. 2010;46(5):885–91.PubMedCrossRef Yun J, Lee J, Park SH, Park JO, Park YS, Lim HY, et al. A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer. 2010;46(5):885–91.PubMedCrossRef
30.
go back to reference Kim TW, Choi SJ, Ahn JH, et al. A prospective randomized phase III trial of 5-fluorouracil and cisplatin (FP) versus epirubicin, cisplatin, and 5-FU (ECF) in the treatment of patients with previously untreated advanced gastric cancer (AGC). Eur J Cancer. 2001;37(Suppl. 6):S314.CrossRef Kim TW, Choi SJ, Ahn JH, et al. A prospective randomized phase III trial of 5-fluorouracil and cisplatin (FP) versus epirubicin, cisplatin, and 5-FU (ECF) in the treatment of patients with previously untreated advanced gastric cancer (AGC). Eur J Cancer. 2001;37(Suppl. 6):S314.CrossRef
31.
go back to reference Tobe T, Nio Y, Tseng CC, et al. A randomized, comparative-study of combination chemotherapies in advanced gastric-cancer—5-fluorouracil and cisplatin (FP) versus 5-fluorouracil, cisplatin, and 4′-epirubicin (FPEPIR). Anticancer Res. 1992;12(6B):1983-8. Tobe T, Nio Y, Tseng CC, et al. A randomized, comparative-study of combination chemotherapies in advanced gastric-cancer—5-fluorouracil and cisplatin (FP) versus 5-fluorouracil, cisplatin, and 4′-epirubicin (FPEPIR). Anticancer Res. 1992;12(6B):1983-8.
32.
go back to reference Wagner AD, Unverzagt S, Grothe W, Kleber G, Grothey A, Haerting J, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev. 2010;3:CD004064. Wagner AD, Unverzagt S, Grothe W, Kleber G, Grothey A, Haerting J, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev. 2010;3:CD004064.
33.
go back to reference Ross P, Nicolson M, Cunningham D, Valle J, Seymour M, Harper P, et al. Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) with epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. J Clin Oncol. 2002;20(8):1996–2004.PubMedCrossRef Ross P, Nicolson M, Cunningham D, Valle J, Seymour M, Harper P, et al. Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) with epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. J Clin Oncol. 2002;20(8):1996–2004.PubMedCrossRef
34.
go back to reference National Institute for Health and Clinical Excellence. Sunitinib for the treatment of gastrointestinal stromal tumours [guidance no. 179]. London: NICE; 2009. National Institute for Health and Clinical Excellence. Sunitinib for the treatment of gastrointestinal stromal tumours [guidance no. 179]. London: NICE; 2009.
36.
go back to reference Norman G, Rice S, Spackman E, Stirk L, Danso-Appiah A, Suh D; CRD and CHE Technology Assessment Group, et al. Trastuzumab for the treatment of HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. Southampton: Health Technology Assessment Programme; 2010. Norman G, Rice S, Spackman E, Stirk L, Danso-Appiah A, Suh D; CRD and CHE Technology Assessment Group, et al. Trastuzumab for the treatment of HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. Southampton: Health Technology Assessment Programme; 2010.
37.
go back to reference Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, et al. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009;20(4):666–73.PubMedCrossRef Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, et al. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009;20(4):666–73.PubMedCrossRef
Metadata
Title
Trastuzumab for the Treatment of HER2-Positive Metastatic Gastric Cancer
A NICE Single Technology Appraisal
Authors
Eldon Spackman
Stephen Rice
Gill Norman
Dong-Churl Suh
Alison Eastwood
Stephen Palmer
Publication date
01-03-2013
Publisher
Springer International Publishing AG
Published in
PharmacoEconomics / Issue 3/2013
Print ISSN: 1170-7690
Electronic ISSN: 1179-2027
DOI
https://doi.org/10.1007/s40273-013-0023-z

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