An Italian cost-effectiveness analysis of paclitaxel albumin (nab-paclitaxel) + gemcitabine vs gemcitabine alone for metastatic pancreatic cancer patients: the APICE study

ABSTRACT

Background: the APICE study evaluates the cost-effectiveness of nanoparticle albumin-bound paclitaxel (nab-paclitaxel – Nab-P) + gemcitabine (G) vs G alone in metastatic pancreatic cancer (MPC) from the Italian National Health Service (INHS) standpoint.

Research design and methods: A 4-year, 4 health states (progression-free; progressed; end of life; death) Markov model based on the MPACT trial was developed to estimate costs (Euro [€], 2017 values), and quality-adjusted life years (QALYs).

Patients were assumed to receive intravenously Nab-P 125 mg/m² + G 1000 mg/m² on days 1, 8, and 15 every 4 weeks or G alone 1000 mg/m² weekly for 7 out of 8 weeks (cycle 1) and then on days 1, 8, and 15 every 4 weeks (cycle 2 and subsequent cycles) until progression.

One-way and probabilistic sensitivity analyses explored the uncertainty surrounding the baseline incremental cost-utility ratio (ICUR).

Results: Nab-P + G totals 0.154 incremental QALYs and €7082.68 incremental costs vs G alone. ICUR (€46,021.58) is lower than the informal threshold value of €87,330 adopted by the Italian Medicines Agency during 2010–2013 for reimbursing oncological drugs.

Sensitivity analyses confirmed the robustness of the baseline findings.

Conclusions: Nab-P + G in MPC patients can be considered cost-effective for the INHS.

KEYWORDS:

• Cost-effectiveness analysis
• gemcitabine
• Italy
• metastatic pancreatic cancer
• nab-paclitaxel

Acknowledgments

A provisional version of the research reported in this manuscript has been presented at European Society for Medical Oncology (ESMO), Copenhagen, 7-11 October, 2016 (Lazzaro C, Barone C, Caprioni F, Cascinu S, Falcone A, Maiello E, Milella M, Pinto C, Reni M, Tortora G. An Italian cost-effectiveness analysis of paclitaxel albumin (nab®-paclitaxel) + gemcitabine vs gemcibatine alone for metastatic pancreatic cancer patients: the APICE study. (Poster 1045P)).

Clinical trial information:

NLM identifier: NCT00844649 available from https://clinicaltrials.gov/ct2/show/NCT00844649

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

All authors were involved in the conception and design, analysis, and interpretation of the data.

CL drafted the paper, that was revised by all authors, who also approved the final version to be submitted. All authors agree to be accountable for all aspects of the work.

Additional information

Funding

This study was funded by the Health Economics and Outcomes Research Unit of Celgene s.r.l