Literature DB >> 28914440

Olaratumab in Combination with Doxorubicin for the Treatment of Advanced Soft Tissue Sarcoma: An Evidence Review Group Perspective of a National Institute for Health and Care Excellence Single Technology Appraisal.

Irina A Tikhonova1, Tracey Jones-Hughes2, James Dunham2, Fiona C Warren2, Sophie Robinson2, Peter Stephens3, Martin Hoyle2.   

Abstract

The manufacturer of olaratumab (Lartruvo®), Eli Lilly & Company Limited, submitted evidence for the clinical and cost effectiveness of this drug, in combination with doxorubicin, for untreated advanced soft tissue sarcoma (STS) not amenable to surgery or radiotherapy, as part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal process. The Peninsula Technology Assessment Group, commissioned to act as the Evidence Review Group (ERG), critically reviewed the company's submission. Clinical effectiveness evidence for the company's analysis was derived from an open-label, randomised controlled trial, JGDG. The analysis was based on a partitioned survival model with a time horizon of 25 years, and the perspective was of the UK National Health Service (NHS) and Personal Social Services. Costs and benefits were discounted at 3.5% per year. Given the available evidence, olaratumab is likely to meet NICE's end-of-life criteria. To improve the cost effectiveness of olaratumab, the company offered a discount through a Commercial Access Agreement (CAA) with the NHS England. When the discount was applied, the mean base-case and probabilistic incremental cost-effectiveness ratios (ICERs) for olaratumab plus doxorubicin versus the standard-of-care doxorubicin were £46,076 and £47,127 per quality-adjusted life-year (QALY) gained, respectively; the probability of this treatment being cost effective at the willingness-to-pay threshold of £50,000 per QALY gained, applicable to end-of-life treatments, was 0.54. The respective ICERs from the ERG's analysis were approximately £60,000/QALY gained, and the probability of the treatment being cost effective was 0.21. In August 2017, the NICE Appraisal Committee recommended olaratumab in combination with doxorubicin for this indication for use via the UK Cancer Drugs Fund under the agreed CAA until further evidence being collected in the ongoing phase III trial-ANNOUNCE-becomes available in December 2020.

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Year:  2018        PMID: 28914440     DOI: 10.1007/s40273-017-0568-3

Source DB:  PubMed          Journal:  Pharmacoeconomics        ISSN: 1170-7690            Impact factor:   4.981


  12 in total

1.  Prognostic factors for the outcome of chemotherapy in advanced soft tissue sarcoma: an analysis of 2,185 patients treated with anthracycline-containing first-line regimens--a European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study.

Authors:  M Van Glabbeke; A T van Oosterom; J W Oosterhuis; H Mouridsen; D Crowther; R Somers; J Verweij; A Santoro; J Buesa; T Tursz
Journal:  J Clin Oncol       Date:  1999-01       Impact factor: 44.544

2.  Randomized phase III study comparing conventional-dose doxorubicin plus ifosfamide versus high-dose doxorubicin plus ifosfamide plus recombinant human granulocyte-macrophage colony-stimulating factor in advanced soft tissue sarcomas: A trial of the European Organization for Research and Treatment of Cancer/Soft Tissue and Bone Sarcoma Group.

Authors:  A Le Cesne; I Judson; D Crowther; S Rodenhuis; H J Keizer; Q Van Hoesel; J Y Blay; J Frisch; M Van Glabbeke; C Hermans; A Van Oosterom; T Tursz; J Verweij
Journal:  J Clin Oncol       Date:  2000-07       Impact factor: 44.544

3.  Comparative study of the National Cancer Institute and French Federation of Cancer Centers Sarcoma Group grading systems in a population of 410 adult patients with soft tissue sarcoma.

Authors:  L Guillou; J M Coindre; F Bonichon; B B Nguyen; P Terrier; F Collin; M O Vilain; A M Mandard; V Le Doussal; A Leroux; J Jacquemier; H Duplay; X Sastre-Garau; J Costa
Journal:  J Clin Oncol       Date:  1997-01       Impact factor: 44.544

4.  Efficacy of sequential high-dose doxorubicin and ifosfamide compared with standard-dose doxorubicin in patients with advanced soft tissue sarcoma: an open-label randomized phase II study of the Spanish group for research on sarcomas.

Authors:  Joan Maurel; Antonio López-Pousa; Ramón de Las Peñas; Joaquín Fra; Javier Martín; Josefina Cruz; Antonio Casado; Andrés Poveda; Javier Martínez-Trufero; Carmen Balañá; María Auxiliadora Gómez; Ricardo Cubedo; Oscar Gallego; Belen Rubio-Viqueira; Jordi Rubió; Raquel Andrés; Isabel Sevilla; Juan Jose de la Cruz; Xavier García Del Muro; Jose María Buesa
Journal:  J Clin Oncol       Date:  2009-03-09       Impact factor: 44.544

5.  The grading of soft tissue sarcomas. Results of a clinicohistopathologic correlation in a series of 163 cases.

Authors:  J Costa; R A Wesley; E Glatstein; S A Rosenberg
Journal:  Cancer       Date:  1984-02-01       Impact factor: 6.860

6.  Soft-tissue sarcomas of adults; study of pathological prognostic variables and definition of a histopathological grading system.

Authors:  M Trojani; G Contesso; J M Coindre; J Rouesse; N B Bui; A de Mascarel; J F Goussot; M David; F Bonichon; C Lagarde
Journal:  Int J Cancer       Date:  1984-01-15       Impact factor: 7.396

7.  Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial.

Authors:  William D Tap; Robin L Jones; Brian A Van Tine; Bartosz Chmielowski; Anthony D Elias; Douglas Adkins; Mark Agulnik; Matthew M Cooney; Michael B Livingston; Gregory Pennock; Meera R Hameed; Gaurav D Shah; Amy Qin; Ashwin Shahir; Damien M Cronier; Robert Ilaria; Ilaria Conti; Jan Cosaert; Gary K Schwartz
Journal:  Lancet       Date:  2016-06-09       Impact factor: 79.321

8.  Quality of Life and Utility in Patients with Metastatic Soft Tissue and Bone Sarcoma: The Sarcoma Treatment and Burden of Illness in North America and Europe (SABINE) Study.

Authors:  Peter Reichardt; Michael Leahy; Xavier Garcia Del Muro; Stefano Ferrari; Javier Martin; Hans Gelderblom; Jingshu Wang; Arun Krishna; Jennifer Eriksson; Arthur Staddon; Jean-Yves Blay
Journal:  Sarcoma       Date:  2012-03-20

9.  Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves.

Authors:  Patricia Guyot; A E Ades; Mario J N M Ouwens; Nicky J Welton
Journal:  BMC Med Res Methodol       Date:  2012-02-01       Impact factor: 4.615

Review 10.  UK guidelines for the management of soft tissue sarcomas.

Authors:  Adam Dangoor; Beatrice Seddon; Craig Gerrand; Robert Grimer; Jeremy Whelan; Ian Judson
Journal:  Clin Sarcoma Res       Date:  2016-11-15
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