The variation in price the NHS is paying for valves used in
keyhole heart procedures is not supported by reliable evidence,
NICE has said in draft guidance.
Over time the price of the 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.
More than £100m is spent each year in England on heart valves for
transcatheter aortic valve implantation (TAVI) in people with
aortic stenosis. Savings made by using the most appropriate
cost-effective value could be used by the NHS to fund more
procedures and therefore cut the waiting lists.
These artificial valves are used to replace the native heart
valve that becomes stiffened and narrowed over time. The
replacement valve is passed into position along a blood vessel
and improves normal blood flow out of the heart. Most TAVI
procedures are carried out in day surgery by interventional
cardiologists and the average age of patients is 82 years[i].
There were 7,669 TAVI procedures performed in 32 NHS centres in
England, Wales and Northern Ireland in the latest year for
which data was
published (2022/23). This figure 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.
NICE's medical technologies advisory committee heard from
professionals that many people are suitable for any one of the
valves currently available.
The independent committee noted that using cost-effective valves
could allow the NHS to treat more patients using the money saved
but emphasised that hospitals should have a range of valves, so
the most clinically appropriate device is always available to
meet an individual patient's requirements.
The committee reviewed the price paid by the NHS in England for
the 11 different valves available, but the individual prices
cannot be reported as they are commercial in confidence. The
difference between the cheapest and most expensive valve paid for
by the NHS was several thousand pounds.
This is the first technology evaluated by NICE in
its late-stage assessment (LSA)
programme. The process was developed to consider technologies
already in widespread use in the NHS to determine if price
variation is justified based on innovations and improvements, and
thus inform future procurement decisions.
The Department of Health and Social Care has asked NICE to carry
out eight LSAs on a wide range of products and innovations in a
way that examines clinical effectiveness and value for
money. The chosen topics cover categories where there is price
variation across a range of similar devices. NICE committees will
look for evidence that innovation and incremental improvements in
the products available are providing value to the taxpayer.
Professor Jonathan Benger, chief medical officer and
deputy chief executive at NICE, said: “Thousands of
people each year require TAVI procedures. These are highly
effective but cost millions of pounds from the finite NHS budget.
“We have looked for evidence to determine whether differences in
innovation and performance between these valves can justify their
range in price, but the information we have seen does not support
the current variation in cost.
“We hope this evidence-based guidance will provide commissioners
with the confidence to agree a cost-effective price and allow the
NHS to reinvest the money saved to treat more
patients as a result.”
Our guideline committee on the investigation and management of
heart valve disease presenting in adults considered the price of
valves[ii] in November
2021.
It found that TAVI is not cost effective for people in a
high-risk population when the price is above £18,000. The cost of
open-heart surgery is highest in this population, so the benefit
of a much less invasive TAVI procedure is maximised. For people
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 or less 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.
Our guideline committee noted that NHS Supply Chain reported the
average cost of a TAVI device was £17,500 in November 2021.
The alternative to TAVI is to use more invasive surgery where the
chest is opened. Comparison between the two procedures (TAVI and
open surgery) was beyond the scope of this committee who were
tasked with assessing the incremental clinical, economic and
non-clinical benefits of transcatheter aortic valve implantation
devices for people with severe aortic stenosis to consider
whether price variation is warranted and inform future
procurement decisions.
A consultation on our committee's recommendations has now begun
at nice.org.uk and closes on Monday 2 September 2024.
ENDS
About the guidance
- The draft guidance/guidance will be available
at https://www.nice.org.uk/guidance/indevelopment/gid-hte10027/documents from
Friday 9 August 2024.
- An embargoed copy can be downloaded here: https://dmscdn.vuelio.co.uk/publicitem/39a2ed9e-2049-412d-a17f-f1f912b6e7ce
