Use of Systematic Literature Reviews (SLRs) and Meta-Analyses (MA) to Support HTA Submissions: An Application in Pancreatic Cancer

Speaker(s)

Aksomaityte A1, Amonkar M2, Frederickson AM3, Lang BM4, Dheban S5, Malbecq W6, Mojebi A7, Wu P7, Hale B7, Kalyvas C6, Abderhalden LA5
1MSD (UK) Limited, London, UK, 2Merck & Co., Inc., North Wales, PA, USA, 3PRECISIONheor, New York, NY, USA, 4MSD, Flughafen, ZH, Switzerland, 5MSD, Zurich, ZH, Switzerland, 6MSD, Brussels, Belgium, 7PRECISIONheor, Vancouver, BC, Canada

Presentation Documents

OBJECTIVES: Systematic literature reviews (SLR) and meta-analyses (MA) are evidence synthesis tools that can aid Health Technology Assessment (HTA) agencies in making evidence-based decisions. This research aims to (1) describe how SLRs and MA can support HTA submissions, and (2) provide SLR/MA applications to quantify the efficacy of the relevant historical chemotherapies for pancreatic cancer patients.

METHODS: A clinical trial based SLR was conducted for therapies, recommended in treatment guidelines and/or HTA assessments, among advanced, unresectable and/or metastatic pancreatic adenocarcinoma patients who had progressed on prior treatment (Jan. 2000 – July 2021 Embase, MEDLINE, Cochrane, and recent ASCO/ESMO conference database search). Published data (rates and survival curves) from the relevant chemotherapies were extracted and synthesized using random-effects MA. The outcomes of interest were objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). The ORR was estimated using the Freeman-Tukey double arcsine transformation. The OS/PFS survival curves were digitized to obtain pseudo-individual participant data and analyzed following the Combescure et al. (2014) methodology.

RESULTS: There were 1792 patients among 19 studies analyzed in the MA of ORR, with some studies evaluating more than one chemotherapy. Estimated ORR was 6.8% (95% CI 4.5-9.4%). Median PFS was 2.8 months (15 studies; 24 survival curves; 95% CI 2.4-3.3), and median OS was 6.2 months (21 studies; 27 survival curves; 95% CI 5.3-7.1).

CONCLUSIONS: HTA agencies rely on an array of tools to evaluate a new therapy including SLR/MA, indirect treatment comparisons, network meta-analysis, and others. For example, results from such MA applied in pancreatic cancer can be used to contextualize the comparative effectiveness of novel therapies evaluated in single-arm trials to support HTA submissions. With the vast number of therapies being developed/approved compounded with the expanding body of literature, HTA agencies increasingly rely upon synthesized evidence to inform decision making.

Code

SA2

Topic

Clinical Outcomes, Study Approaches

Topic Subcategory

Comparative Effectiveness or Efficacy, Literature Review & Synthesis, Meta-Analysis & Indirect Comparisons

Disease

SDC: Oncology