Abstract
Background: Peripheral arterial disease (PAD) with severe manifestations, including critical limb
ischemia (CLI), affecting quality of life and increasing healthcare costs. Currently, the use of
drug-eluting stents (DES) for endovascular interventions is not covered by the Thai healthcare
system.
Objectives: To develop a comprehensive reimbursement proposal for DES in the treatment
of severe PAD in Thailand. This includes evaluating the economic value of using drug-coated
balloons (DCB), bare-metal stents (BMS), and open surgery as alternative treatment options.
Additionally, assessing budget impact and service provision feasibility are necessary.
Methods: A cost-effectiveness study comparing DES with other endovascular interventions,
such as percutaneous transluminal angioplasty (PTA) with a plain balloon, BMS, and open
surgery, was conducted. A Markov model was used to incorporate social perspectives and
provider viewpoints. The cost was referred to the standard cost for health technology
assessment. The utility was obtained through primary data and previous literature. The budget
impact analysis was conducted from the perspective of the National Health Security Office
(NHSO), predicting the budget impact for five years. The feasibility of service provision is also
studied from the perspectives of practicing physicians and stakeholders using qualitative
methods, including semi-structured interviews.
Results: DES required additional costs to gain QALYs, with an ICER of 78,359 baht per QALY,
which is cost-effective under Thailand's willingness-to-pay threshold of 160,000 baht per QALY.
Conversely, BMS and bypass are not cost-effective as their ICERs exceed the threshold.
Scenario analysis showed that if only one stent is used, both DES and BMS become cost-saving.
Assuming 90% of CLI patients need endovascular intervention and service coverage by
specialists and equipped hospitals is 20%, the first-year budgetary impact of DES treatment is
estimated at 489.78 million baht for total treatment costs. However, the availability of catheter
and stent procedures remains limited to regional and university hospitals.
Conclusion: The use of DES for CLI patients in Thailand is considered cost-effective as it falls
within the country's willingness-to-pay threshold and yields higher QALY compared to BMS.
However, cost-saving is achievable with BMS when two stents are used. Furthermore, current
service provision coverage is limited, highlighting the need for improved support and expanded
coverage.
