Trusts paying over the odds for ‘innovative’ devices

NICE’s chief medical officer, Professor Jonathan Benger, told HSJ the agency could not find evidence to support the variation in prices being charged for the synthetic devices used to replace heart valves in some cardio-vascular patients.

There are several such devices used by the NHS at different price points, which were examined by NICE’s clinical experts. Their draft guidance published this month found there is a “wealth of evidence” on how they perform compared to open heart surgery.

But they concluded more evidence is needed comparing the devices themselves. NICE is currently consulting on these conclusions and will publish the final report in early January 2025.

This was the first of eight “late-stage assessments” of well-established medical technologies. This is a new area of work for NICE – it has historically focused on examining novel technologies or those that are yet to be in widespread use by the NHS, Professor Benger said.

LSAs will focus on medical technology products already in wide use by the NHS. They will address more mature areas of MedTech available to trusts to help providers and commissioners choose between a multitude of competing products, he explained.

“The market proliferates, more people come along, people innovate, they drive innovation, they make different valves, better valves, bigger valves, smaller valves,” he said. Then the market gets quite saturated and then the question is, ‘there was one valve in the beginning, now they were 14, I’m not quite sure which one to buy’”.

NICE’s LSAs are intended to give commissioners independent analyses to determine which product provides the best value for money, not just relying on the competing claims of manufacturers, he said.

To do this NICE will need more comparative data to properly understand which products are providing value for money. This means clinicians and trusts need to contribute clinical outcomes data to outcomes registries, and the cardiac outcome registry will need updating, he explained.

Additionally, “there’s an onus on manufacturers” to provide the data to back up claims of superiority for their products, “particularly where they’re using that as the basis of an increasing price”.

He denied that LSAs were a means to cut costs, however. NICE’s analysis is to find the best value for money and that may include highlighting a device that costs more but provides sufficiently improved performance that it justifies the higher price.

“I think innovation will be stimulated if there’s confidence in the industry. So, if you’re a manufacturer of [heart] valves the reality is that if you innovate and you demonstrate that you’ve innovated and it leads to patient improvements, NICE will endorse your valve,” he said.

“We will say that’s a cost-effective use of NHS resources because the outcomes are better.”

There will be eight LSAs in total, including the analysis of atrial valves. They are:

1. Transcatheter heart valves for transcatheter aortic valve implantation to treat aortic stenosis – due to be published 8 January 2025
2. One-piece closed bags for adults with a colostomy – due to be published 21 January 2025
3. Topical Antimicrobial dressings for wound care – due to be published 27 March 2025
4. Drug-eluting coronary stents for treating coronary artery disease due to be published – 28 March 2025
5. Compression products for wound care – due to be published 29 April 2025
6. Bed frames for patient care and recovery in acute clinical settings (provisional title) – due to be published 28 May 2025
7. Slide sheets for repositioning or moving a person on or from a bed – due to be published 28 May 2025
8. Intermittent urethral catheters for urinary management in adults – publication TBC

This will require a shift in how data is collected. “We [have] put a lot of emphasis at the beginning of the pipeline, and we not necessarily put the same degree of emphasis later in the pipeline,” he explained.

But this will be necessary to help foster innovation, ensuring the most effective technologies are available to the NHS. “If we’re going to keep recommending new health technologies to enter the market, we also have a responsibility to continue to support evaluation and decision making and ultimately retire technologies that are no longer suitable, that have been superseded by more innovative developments.”