Economic evaluation of the NIHR PAX-BD study

Over a lifetime, 2.5% of people will suffer from bipolar disorder (BD) which has significant impact on patients’ quality of life and is associated with a 10 year reduction in life expectancy. NICE recommends ‘mood stabiliser’ treatments, however, treatment resistance and side effects, such as sedation and weight gain, are common problems for patients. Pramipexole is currently used as a treatment for Parkinson’s disease, and there is some evidence suggesting that it can help in the treatment of BD. Its safety and side effects are well known, in particular, it is less likely to cause weight gain than current NICE recommended treatments. The economic evaluation of the NIHR PAX-BD study (RCT of Pramipexole addition to mood stabilisers for treatment resistant bipolar depression) aims to determine whether pramipexole, added on to mood stabilisers, is a cost effective treatment for patients with BD whose depression has not responded to NICE recommended treatment.

The economic evaluation will use the NHS/Personal Social Services perspective preferred by the UK NICE with secondary analyses incorporating wider societal costs. Outcome measures from a health economics perspective will include the health-focused EQ-5D, as well as the ICECAP-A and OxCAP-MH instruments to move beyond the QALYs framework and incorporate relevant non-health outcomes based on the capabilities approach.

Dates: April 2018 – March 2022

Funding: National Institute for Health Research (NIHR), UK

Collaborator(s): University of Newcastle upon Tyne

Information: Judit Simon, Timea Helter

Publication(s):

• Azim L, Hindmarch P, Browne G, Chadwick T, Clare E, Courtney P, et al. Study protocol for a randomised placebo-controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression (the PAX-BD study). BMC Psychiatry. 2021 Dec;21:334. DOI: 10.1186/s12888-021-03322-y