Impact of removing prescription charges on health outcomes: protocol for a randomised controlled trial

Abstract

IntroductionPrescription charges prevent many people from accessing the medicines they need to maintain or improve their health. In New Zealand, where most people pay $5 per prescription item, Māori and Pacific peoples, those living in most deprived areas and those with chronic health conditions are the most likely to report that cost prevents them from accessing medicines.Methods and analysisThis randomised controlled trial (RCT) will evaluate the effect of removing prescription charges on health outcomes and healthcare utilisation patterns of people with low income and high health needs. We will enrol 2000 participants: half will be allocated to the intervention group and we will pay for their prescription charges for 12 months. The other half will receive usual care. The primary outcome will be hospital bed-days. Secondary outcomes will be: all-cause and diabetes/mental health-specific hospitalisations, prescription medicines dispensed (number and type), deaths, emergency department visits and quality of life as measured by the 5-level EQ-5D version. Costs associated with these outcomes will be compared in an economic substudy. A qualitative substudy will also help understand the impact of free prescriptions on participant well-being using in-depth interviews.DiscussionBeing unable to afford prescription medicines is only one of many factors that influence adherence to medicines, but removing prescription charges is relatively simple and in New Zealand would be cheap compared with other policy changes. This RCT will help identify the extent of the impact of a simple intervention to improve access to medicines on health outcomes and health service utilisation.Ethics and disseminationThis study was approved by the Central Health and Disability Ethics Committee (NZ) in July 2019 (19/CEN/33). Findings will be reported in peer-reviewed publications, as well as in professional newsletters, mainstream media and through public meetings.Trial registration numberACTRN12618001486213p.

Impact of removing prescription co-payments on the use of costly health services: a pragmatic randomised controlled trial

“…The protocol for the study (known as the FreeMeds study) and the recruitment process are published elsewhere [ 28 , 29 ].…”

Preference-based measures of health-related quality of life in Indigenous people: a systematic review

“…Four condition-specific PBMs were reported in 6 publications—the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) (n = 1), the Functional Assessment of Cancer Therapy-General Population (FACT-GP) (n = 1), the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) (n = 3), and a newly proposed oral-specific health utility scale (n = 1). Only 14 reports clearly stated which value set was used [ 11 , 38 , 43 , 44 , 54 , 55 , 73 , 81 , 82 , 90 , 93 , 95 , 101 , 102 ], including value sets from Australia (n = 3), Canada (n = 1), New Zealand (n = 5), UK (n = 3), and USA (n = 2).…”

“…Nine of the included reports used a qualitative component or approach [ 30 , 60 , 64 , 73 , 78 , 90 , 102 – 105 ], with all but one [ 64 ] being part of a mixed methods study. Five reported using mixed methods, qualitative methods, or interviews but did not specify further the specific methodology used [ 60 , 72 , 78 , 102 , 103 ].…”

“…Nine of the included reports used a qualitative component or approach [ 30 , 60 , 64 , 73 , 78 , 90 , 102 – 105 ], with all but one [ 64 ] being part of a mixed methods study. Five reported using mixed methods, qualitative methods, or interviews but did not specify further the specific methodology used [ 60 , 72 , 78 , 102 , 103 ]. Of the remaining reports, one was a study protocol and described the plan to use phenomenological and collaborative storytelling to explore lived experience of injury-related disability [ 90 ].…”