UK NICE Draft Guidance Reports No Evidence to Justify Price Variation of TAVI Devices in NHS

August 22, 2024—The United Kingdom’s National Institute for Health and Care Excellence (NICE) recently announced a Draft Guidance on heart valves used in transcatheter aortic valve implantation (TAVI) by the National Health Services (NHS). The committee drafting the guidance was tasked with assessing the incremental clinical, economic, and nonclinical benefits of TAVI devices for patients with severe aortic stenosis to consider whether price variation is warranted and inform future procurement decisions.

According to the guidance, which was reported by NICE on August 9, the price of valves has increased as companies have developed new versions; however, there is not enough evidence to determine whether differences between the available valves justify the price variations between them which can be thousands of pounds.

The guidance, “Transcatheter heart valves for transcatheter aortic valve implantation to treat aortic stenosis: Late-stage assessment” (GID-HTE10027), now in development, is expected to be published January 8, 2025.

NICE advised that a consultation on the committee’s draft recommendations has now begun and closes on September 2, 2024. Online commenting can be conducted via the NICE site here. After consultation, the committee may decide to maintain or amend their recommendations. A second committee meeting is scheduled to take place on Thursday, October 17, 2024.

According to NICE, more than £100 million is spent annually in England on heart valves for TAVI and savings made by using the most appropriate cost-effective valve could be used by the NHS to fund more procedures and therefore reduce waiting lists for procedures.

NICE stated that in 2022/2023 (the latest year for which data was published), there were 7,669 TAVI procedures performed at 32 NHS centers in England, Wales, and Northern Ireland. This was a 13% increase compared with 2021/22. NICE and NHS England are aware that cardiac surgery, for which TAVI is an alternative, is one of the areas where waiting times are longer than local targets, noted the guidance.

The committee reviewed the price paid by the NHS in England for the 11 different valves available. The difference between the cheapest and most expensive valve paid for by the NHS was several thousand pounds.

The guideline committee on the investigation and management of heart valve disease presenting in adults considered the price of valves, which was published November 2021 (here).

The committee found the following:

• TAVI is not cost effective for people in a high-risk population when the price of the TAVI valve is > £18,000. The cost of open heart surgery is highest in this population, so the benefit of a much less invasive TAVI procedure is maximized.
• For patients at lower surgical risk, the potential benefit is lower, so the price that is required to be cost-effective is also less.
• For the lowest-risk group, a price of ≤ £14,800 per TAVI valve was found to be cost effective.
• The price the NHS pays per valve does not change depending on which risk category the patient falls into. For the TAVI procedure to be cost-effective for everyone, the price would need to meet the lowest threshold of £14,800.

The guideline committee noted that NHS Supply Chain reported the average cost of a TAVI device was £17,500 in November 2021, reported NICE.