Botulinum toxin type A for the treatment of patients with post-stroke spasticity in Thailand: cost-utility and budget impact analysis.

OBJECTIVES

To evaluate the cost-utility of botulinum toxin A (BoNT-A) for treating upper limb (UL) and lower limb (LL) post-stroke spasticity.

DESIGN

Using a Markov model, adopting a societal perspective and a lifetime horizon with a 3% annual discount rate, the cost-utility analysis was conducted to compare BoNT-A combined with standard of care (SoC) with SoC alone. Costs, utilities, transitional probabilities and treatment efficacy were derived from 5-year retrospective data from tertiary hospitals and meta-analysis. Uncertainty analyses were performed.

SETTING

Tertiary hospitals in Thailand.

PARTICIPANTS

Cohort of post-stroke patients aged 55 years with UL or LL spasticity and a Modified Ashworth Scale score ≥1+.

INTERVENTIONS

BoNT-A (abobotulinumtoxinA: aboBoNT-A, onabotulinumtoxinA: onaBoNT-A or prabotulinumtoxinA: praBoNT-A) combined with SoC versus SoC alone.

PRIMARY OUTCOME MEASURES

Expected life years, quality-adjusted life years (QALYs), costs and incremental cost-effectiveness ratios (ICERs), considering a cost-effectiveness threshold of 160 000 THB (US$4468) per QALY gained.

RESULTS

The combination of aboBoNT-A and SoC yielded the highest QALYs gained (0.013 for UL and 0.11 for LL), followed by onaBoNT-A and SoC and praBoNT-A and SoC. The additional costs for treating UL and LL cases were highest for onaBoNT-A US$75 and US$95, respectively, followed by aboBoNT-A and praBoNT-A. ICER values for treating UL with aboBoNT-A, onaBoNT-A and praBoNT-A ranged from US$4669 to US$7541 per QALY. For LL treatments, aboBoNT-A and onaBoNT-A had ICER values ranging from US$7072 to US$15 182 per QALY. Integrating BoNT-A treatment delivery into the healthcare system would require a budget outlay of approximately US$413 246-US$966 103 that may vary annually by an additional US$50 260-US$335 064.

CONCLUSION

BoNT-A effectively reduces focal spasticity and improves quality of life in post-stroke patients. However, its cost-effectiveness in Thailand necessitates price negotiations as a condition for inclusion in the pharmaceutical reimbursement list.