Naltrexone / bupropion (Mysimba®)

Assessment Status Assessment Process Complete
Drug Naltrexone / bupropion
Brand Mysimba®
Indication Is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥ 18 years) with a BMI of ≥30 kg/m2 (obese) or ≥27 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities.
Assessment Process
Rapid review commissioned 12/03/2017
Rapid review completed 28/03/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 29/03/2017
Pre-submission consultation with Applicant 29/05/2017
Full submission received from Applicant 06/11/2017
Preliminary review sent to Applicant 05/01/2018
NCPE assessment re-commenced 01/02/2018
Factual accuracy sent to Applicant 24/04/2018
NCPE assessment re-commenced 01/05/2018
NCPE assessment completed 09/05/2018
NCPE assessment outcome The NCPE recommends that naltrexone/bupropion (Mysimba ®) should not be considered for reimbursement.

Technical Summary

This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.