Budget impact analysis of a bioprosthetic valve with a novel tissue versus mechanical aortic valve replacement in patients older than 65 years with aortic stenosis in Saudi Arabia

Abstract

Aims

A budget impact analysis (BIA) comparing bioprosthetic valves with RESILIA tissue and mechanical valves in aortic stenosis (AS) patients > 65 years in the public and private sectors of Saudi Arabia.

Materials and methods

A decision-tree with a partitioned survival model was adapted to estimate the financial consequences of either a RESILIA tissue valve or a mechanical valve in aortic valve replacement (AVR) procedures up to 5 years. The budget impact of resource consumption for both valve types was compared and included disabling strokes, reoperations, minor thromboembolic events, major bleeding, endocarditis, anticoagulation treatment and monitoring, and echocardiogram assessments. One-way sensitivity analyses (OWSA) were performed on cost and probability inputs.

Results

RESILIA tissue valves versus mechanical valves are overall budget saving commencing in Year 1 and savings gradually increase year-on-year. The higher costs of the initial procedure, reoperation, and additional monitoring (echocardiogram tests and visits) associated with RESILIA tissue valves are offset by savings in warfarin use, disabling strokes, major bleeding, and anticoagulation complications. The cost per initial procedure per patient is SAR795 higher for a RESILIA tissue valve reflecting the higher valve acquisition cost, which is partially offset by a shorter hospital stay. The OWSA suggests that total procedure costs of each valve, including the hospital stay, are the main cost drivers in the model.

Limitations

The variability of cost inputs and the presence of multiple payers with multiple costing data is a key challenge in Saudi Arabia. Budget impact results may, therefore, change if repeated per AVR center and may also be impacted by the long-term durability of RESILIA tissue valves.

Conclusions

An AVR in patients > 65 years with a RESILIA tissue valve is budget-saving from the first year in Saudi Arabia. Patients, payers, providers and policymakers may benefit economically from increased implantation of RESILIA tissue valves.

Keywords:

• Budget impact analysis
• Saudi Arabia
• aortic stenosis
• RESILIA tissue valve
• surgical aortic valve replacement

JEL CLASSIFICATION CODES:

• D81
• D8
• D
• E37
• E3
• E

Transparency

Declaration of financial/other interests

JLC is a consultant for Edwards Lifesciences. HAA, UA, TA, and AA are supported by their employing institutions. BM is an employee at Edwards Lifesciences.

Acknowledgements

None reported.

Author contributions

JLC and BM: Study concept and design.

JLC, HAA, UA, TA, AA, KA, and BM: Data collection and data interpretation.

JLC primarily wrote the manuscript along with PC, HAA, UA, TA, AA, KA, and BM.

JLC, HAA, UA, TA, AA, KA, and BM revised the manuscript.

Reviewer disclosures

Peer reviewers on this manuscript have received an honorarium from JME for their review work but have no other relevant financial relationships to disclose.

Notes

i RESILIA is a registered trademark of Edwards Lifesciences Corporation, Irvine, CA, USA.

Additional information

Funding

This work was supported by a grant from Edwards Lifesciences.