Orphan drugs revisited: cost-effectiveness analysis of the addition of mifamurtide to the conventional treatment of osteosarcoma.
Expert Rev Pharmacoecon Outcomes Res
; 15(2): 331-40, 2015 Apr.
Article
en En
| MEDLINE
| ID: mdl-25354299
ABSTRACT
INTRODUCTION:
Mepact(®) (mifamurtide) is the first drug approved for the treatment of high-grade resectable non-metastatic osteosarcoma in patients aged 2-30 in the last 20 years. It follows a randomized clinical trial showing a statistically-significant and clinically-relevant decrease in the risk of death without compromising safety.AIM:
This study assessed the cost-effectiveness and budget impact of mifamurtide.METHODS:
The economic evaluation was done on a hypothetical cohort of young patients under the age of 30 with high-grade, non-metastatic, resectable osteosarcoma. Standard chemotherapy without mifamurtide was used as comparator. A Markov model was adapted using Spanish costs and the results of the INT-0133 Phase III study. The analysis has been carried out from the perspective of the Spanish National Health Service, with a time horizon of up to 60 years in the base analysis.RESULTS:
The observed greater efficacy of mifamurtide in the trial translates into a gain of 3.03 (undiscounted) and 1.33 (discounted) quality-adjusted life years at an additional cost of 102,000. The estimated budgetary impact of using mifamurtide in 10-100% of the potential population would cost 671,000 and 6.7 million respectively.CONCLUSION:
The cost per quality-adjusted life years gained with mifamurtide in Spain is in the low band (<100,000) of the iCERs obtained by other orphan drugs and would have a limited and affordable cost in Spain.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Fosfatidiletanolaminas
/
Neoplasias Óseas
/
Protocolos de Quimioterapia Combinada Antineoplásica
/
Osteosarcoma
/
Acetilmuramil-Alanil-Isoglutamina
Tipo de estudio:
Clinical_trials
/
Health_economic_evaluation
Aspecto:
Patient_preference
Límite:
Adolescent
/
Adult
/
Child
/
Child, preschool
/
Female
/
Humans
/
Infant
/
Male
País/Región como asunto:
Europa
Idioma:
En
Revista:
Expert Rev Pharmacoecon Outcomes Res
Asunto de la revista:
FARMACOLOGIA
Año:
2015
Tipo del documento:
Article
País de afiliación:
España