The Budget Impact Analysis of Adopting Direct Oral Anticoagulants for Stroke Prevention in Nonvalvular Atrial Fibrillation Patients in Malawi.

OBJECTIVES: This study aimed to estimate the budget impact of adopting direct oral anticoagulants (DOACs) for stroke prevention in patients with nonvalvular atrial fibrillation in Malawi after the inclusion of DOACs in the World Health Organization's essential medicine list. METHODS: A model was developed in Microsoft Excel. An eligible population of 201 491 was adjusted with 0.05 % incidence rate and mortality rates yearly according to the treatments. The model estimated the implication of supplementing rivaroxaban or apixaban to the standard treatment mix (also the comparator), thus warfarin and aspirin. The current market share of 43% aspirin and 57% warfarin was adjusted proportionally with 10% DOAC uptake in the first year and 5% annually over the subsequent 4 years. Clinical events of stroke and major bleeding from the ROCKET-AF and ARISTOTLE trials were used because health outcome indicators affect resource utilization. The analysis was conducted solely from the Malawi Ministry of Health perspective and it considered direct costs over 5 years. The sensitivity analysis involved varying drug costs, population, and care costs from both public and private sectors. RESULTS: The research suggests that despite potential savings of $6 644 141 to $6 930 812 in stroke care because of fewer stroke events, the total Ministry of Health healthcare budget (approximately $260 400 000) may increase by between $42 488 342 to $101 633 644 in 5 years because drug acquisition costs are greater than savings. CONCLUSIONS: With a fixed budget and current DOACs prices, Malawi can consider using DOACs in patients at the highest risk while waiting for cheaper generic versions.

Single technology appraisals by NICE: are they delivering faster guidance to the NHS?

BACKGROUND: In 2005, a new technology appraisal process (the Single Technology Appraisal [STA]) was implemented by the National Institute for Health and Clinical Excellence (NICE), an independent agency that provides guidance to the UK NHS on the use of technology. The objective of STAs was to provide faster guidance to the NHS in order to help overcome the problems of 'NICE blight'. METHODS: Publicly available data from the NICE website and date of first marketing authorization (MA) from the Electronic Medicines Compendium were used to determine if STAs for cancer technologies have in fact been able to provide faster guidance than multiple technology appraisals (MTAs) for cancer interventions. RESULTS: STAs in cancer have, on average, taken 12.8 months from the date that NICE lists in the project history to guidance date. This compares with 20.7 months for MTAs in cancer. However, the time between the date of first MA and guidance is longer for cancer-related STAs than MTAs (95.1 months vs 74.6 months). The reasons for this are not clear; however, the STA programme includes examples of using an older product to treat a new cancer site, which may account for some of the differential. It may also reflect the timing that products are referred to NICE. CONCLUSIONS: The overall results suggest that STAs may be faster once NICE looks at the specific product, but that there is a greater delay in the referral of STA products to NICE than for MTA products. However, the time taken for STAs is still short of the target of 9.75 months (or 39 weeks) [assuming no appeals].