Cost-Effectiveness Analysis of Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukaemia in Portuguese Patients who are Unsuitable for Full-Dose Fludarabine-Based Therapy.
BACKGROUND
Chronic lymphocytic leukaemia (CLL) mostly affects patients with comorbidities and limited therapeutic options. Obinutuzumab in combination with chlorambucil (GClb) is a new therapeutic option for previously untreated CLL patients who are unsuitable for full-dose fludarabine-based therapy. This combination delays disease progression but incurs additional costs; thus, an assessment of its value for money is relevant.


OBJECTIVE
To estimate the incremental cost-utility ratio of GClb in comparison with (i) rituximab in combination with chlorambucil (RClb), and (ii) chlorambucil alone (Clb) from the perspective of the Portuguese National Health Service (NHS).


METHODS
A Markov model was used to predict disease progression. Pre-progression clinical data were based on the latest CLL11 trial data, and post-progression clinical data were obtained from CLL5 trial data. Utility values are from Kosmas et al. (Leuk Lymphoma 56:1320-1326, 14). Only direct medical costs were included. The resource consumption was estimated by a panel of Portuguese experts, and the unit costs were obtained from official sources. A discount rate of 5% was applied to costs and consequences.


RESULTS
GClb and RClb were associated with an increase of 1.06 and 0.39 quality-adjusted life-years (QALY) at an additional cost of €21,720 and €9836 when compared to Clb, respectively. The cost-utility ratio of GClb versus Clb was €20,397/QALY, while RClb was extendedly dominated.


CONCLUSIONS
The use of GClb for previously untreated CLL patients who are unsuitable for full-dose fludarabine-based therapy incurs an incremental cost per QALY that is generally accepted in Portugal. Therefore, although there is some uncertainty, obinutuzumab is probably a cost-effective therapy in the Portuguese setting.
CISEP - Research Centre on the Portuguese Economy, ISEG, Universidade de Lisboa, Lisbon, Portugal. ana.paquete@medicina.ulisboa.pt.
Ana Teresa
http://orcid.org/0000-0001-7162-1400
AT
Paquete
CISEP - Research Centre on the Portuguese Economy, ISEG, Universidade de Lisboa, Lisbon, Portugal.
Luís Silva
LS
Miguel
F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Ursula
U
Becker
Roche Farmacêutica Química, Lda., Lisbon, Portugal.
Catarina
C
Pereira
CISEP - Research Centre on the Portuguese Economy, ISEG, Universidade de Lisboa, Lisbon, Portugal.|ISEG - Lisbon School of Economics and Management, Universidade de Lisboa, Lisbon, Portugal.
Carlos Gouveia
CG
Pinto
D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000191:economics / Q000627:therapeutic use*; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D002699:Chlorambucil / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D004359:Drug Therapy, Combination; D017048:Health Care Costs; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy*; D008390:Markov Chains; D019057:Quality-Adjusted Life Years; D000069283:Rituximab / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D014740:Vidarabine / Q000031:analogs & derivatives* / Q000627:therapeutic use
D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D018906:Antineoplastic Agents, Alkylating; D002699:Chlorambucil; D000069283:Rituximab; D014740:Vidarabine; C543332:obinutuzumab; C024352:fludarabine