TABLE 28Characteristics of submitted economic evaluations

AuthorNovartis 20104BMS3PenTAG AR2
Study populationPatients with standard-dose imatinib-resistant CP-CMLPatients with CML who are resistant to imatinibPatients resistant to imatinib with CP-CML
Intervention(s)Nilotinib: 800 mg/day

HDI: 800 mg/day

SCT: Allo-SCT as third-line therapy if appropriate

HU: 2 g/day as third-line therapy

SCT/HU: second-line exploratory analysis
Dasatinib: CP 100 mg/day

AP/BC 140 mg/day

Nilotinib: 800 mg/day

Imatinib: doses increased to 800 mg per day in the absence of SAE
Dasatinib: CP 100 mg/day

Nilotinib: 800 mg/day

Imatinib: doses increased to 800 mg/day in the absence of SAE

IFN-α: 8.65 MU/day
Intervention effectOS and TTD

Nilotinib: 24-month OS 86%; duration of treatment: not stated

HDI: 12-month OS 96%; 24-month OS 84%; duration of treatment 14 months

SCT: 5-year OS 34%

HU: 5-year OS 16%; survival in AP, 9.14 months; survival in BC, 9.89 months
Dasatinib: 8.1% NR, 33.1% CHR, 15.3% PCyR, 43.5% CCyR

Imatinib 400 mg: 100% NR

Imatinib 600 mg: 56.4% NR, 15.4% CHR, 28.2% PCyR, 0% CCyR

Imatinib 800 mg: 32.1% NR, 13.3% CHR, 14.2% PCyR, 40.5% CCyR

Nilotinib: 6.0% NR, 35.0% CHR, 18.0% PCyR, 41.0% CCyR

IFN-α: 100% NR. SCT: 100% NR
MCyR

Dasatinib: 58.1%

Nilotinib: 52.4%

HDI: 44%

IFN-α: 22%

PFS

Dasatinib: 0.77 at 24 months

Nilotinib: 0.864, 0.769, and 0.632 at 6, 12 and 18 months

HDI: 0.81, 0.57, 0.29 at 12, 24 and 48 months

Survival in AP: 9.64 months

Survival in BC: 13.12 months
Intervention costQuarterly costs

Nilotinib: £7928

HDI: £10,490

HU (2 g daily): £38.00

Allo-SCT (first 100 days) £79,380
Monthly costs

Dasatinib: £2,504.96

Imatinib 400 mg: £1604.08

Imatinib 600 mg: £2406.12

Imatinib 800 mg: £3208.16

Nilotinib: £2613.05
Two-month cycle

Dasatinib: £5080

Imatinib: £6505

Nilotinib: £5286

IFN-α: £1486
Model typeMarkov model to simulate the transition of a hypothetical cohort of 1000 patients in CP who progress to AP, then BC, then deathMarkov model to predict the health changes and resulting costs for patients starting dasatinib treatment in each of the three phases of CML: CP, AP and BCSurvival model to predict duration, QALYs and costs, in CP (on or off treatment), AP and BC, and OS in hypothetical cohort of 1000 patients in CP
Baseline cohortAn equal number of male and female patients aged 57 yearsPatients starting in CP: age 56 years, 50% male

Patients starting in AP: age 56 years, 56% male

Patients starting in BC: age 48 years (myeloid), 49 years (lymphoid)
A cohort of 1000 patients with an assumed age of 56 years
Base-case resultsNilotinib dominates HDI (i.e. is less costly and more effective than HDI)

ICER for nilotinib vs SCT/HU is £44,028
Dasatinib dominates HDI, nilotinib and SCTICER for nilotinib vs IFN-α is £44,616

Nilotinib dominates HDI

ICER for dasatinib vs nilotinib is £277,698

AP, accelerated phase; BC, blast crisis; CCyR, complete cytogenetic response; CP, chronic phase; CP-CML, chronic-phase chronic myeloid leukaemia; HDI, high-dose; imatinib; HU, hydroxycarbamide; ICER, incremental cost-effectiveness ratio; IFN-α, interferon alfa; MCyR, major cytogenetic response; MU/day, million units per day; NR, no response (manufacturer's definition); OS, overall survival; PCyR, partial cytogenetic response; SAE, serious adverse event; SCT, stem cell transplantation.

CCyR typically defined as no Philadelphia-positive (Ph+) chromosomes in metaphase in bone marrow; PCyR typically defined as between 1% and 35% of Ph+ chromosomes in metaphase in bone marrow; MCyR typically defined as ≤ 35% Ph+ chromosomes in metaphase in bone marrow (study definitions may vary).

Exploratory analyses are shown in italic text.

From: 4, Economic analysis

Cover of Dasatinib, High-Dose Imatinib and Nilotinib for the Treatment of Imatinib-Resistant Chronic Myeloid Leukaemia: A Systematic Review and Economic Evaluation
Dasatinib, High-Dose Imatinib and Nilotinib for the Treatment of Imatinib-Resistant Chronic Myeloid Leukaemia: A Systematic Review and Economic Evaluation.
Health Technology Assessment, No. 16.23.
Loveman E, Cooper K, Bryant J, et al.
Southampton (UK): NIHR Journals Library; 2012 May.
© 2012, Crown Copyright.

Included under terms of UK Non-commercial Government License.

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