GP practices are ‘under no obligation’ to prescribe cholesterol-lowering injection inclisiran without a local enhanced service (LES), local leaders have stressed.
LMCs across the country have reminded practices that prescribing or administering the drug is not part of the GP contract, and have said that ICBs should look into commissioning ‘an appropriately funded service’ for patients wishing to access it.
The BMA and RCGP have previously warned of ‘serious concerns’ around the rollout of the NICE-approved drug, including issues about ‘where the long-term responsibility lies when prescribing this drug’ and ‘the lack of clarity about where doctors and patients can turn if there are concerns or problems’.
In a briefing note updated in October, NHS England reiterated that the drug provides ‘an effective intervention’ for secondary prevention in patients who have not had their lipids effectively lowered through the use of statins or a combination of statins and ezetimibe.
NHS England said that inclisiran ‘has the potential to deliver significant population health gain’ but that achieving this requires ‘delivery at scale in primary care’ as deployment in secondary care alone will not deliver the reach and the level of impact that is needed to improve the health of at risk patients.
Until July this year, the commissioner is funding the drug centrally from a national NHS budget so that ‘local finances are not a barrier to access’.
Nationally, there was initially £10 available to practices, per patient, if ordered as a personally administered medication, and this was reduced to £5 in April.
Wessex LMC said that there are still ‘widespread concerns’ around the roll-out of the drug, which is injected twice-yearly and can be used on its own or in conjunction with statins or other cholesterol-lowering drugs.
In a newsletter, the LMC said: ‘We would like to remind practices that the prescription or administration of inclisiran is not part of the GMS/PMS contract (although in negotiation with the LMC it may be commissioned via a LES).
‘The onus lies with commissioners to commission an appropriately funded service if they wish patients to have access to this drug, either within general practice or via specialist services.’
Similarly Kernow LMC said that its position remains that GP practices ‘are under no obligation’ to prescribe or administer inclisiran ‘without being given the tools to do so’.
‘There is no commissioning planned for this until the ICB has undertaken a clinical review of its appropriateness,’ the LMC added.
Lincolnshire LMC also said that it does not currently recommend that practices prescribe and administer the drug without the provision of a LES, adding: ‘Should the Lincolnshire ICB decide they wish for this to be prescribed and administered outside of a secondary care setting and in general practice, we have highlighted that this would need to be an enhanced service at it is not core general practice work.’
It also added that ‘it seems unlikely’ that practices can administer inclisiran ‘without financial loss’.
Meanwhile, in December, NICE for the first time set a target for cholesterol levels in secondary prevention of cardiovascular disease.
Under the updated guidance, GPs are advised to keep patients’ LDL cholesterol levels at 2.0 mmol per litre or less, or non-HDL cholesterol levels of 2.6 mmol per litre or less.
READERS' COMMENTS [4]
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…Nor sign up to the LES either. We were offered £5 per patient, half of what we would get for an an adult vaccination. We haven’t signed.
No published long term safety data, no morbidity or mortality stats til 2026. First in class of a new group that secondary care haven’t rolled out first. £1900 per dose cost to NHS. I can fully understand why Novartis would want a rollout at scale at this price.
Honest question – if a patient understands the limitations of the medication with regards to the evidence base, but is suitable for treatment and makes an informed decision to proceed, can a private fee not be raised for the administration of the medication in practice?
The rush to roll this out is very, very strange.
The cost appears to be £6K in year one then £4K year two onwards; compared to peanuts for high dose statins. A surprising thing for the NHS to spend money on when it can’t fund GPs properly.
The evidence suggests that it lowers cholesterol, but there isn’t clinically-important end point data (no morbidity or mortality data). It is not a ‘game-changer’ drug. There are no studies directly comparing its benefits compared to high dose statins. Long term safety data is not there.
At best, this is a massive prospective, unblinded, uncontrolled experiment – and ethically any patients should be told that.
It is worth reflecting that rolling out drugs too quickly has led to significant problems in the past.
If it is being rolled out, surely secondary care is the place to deliver and monitor it initially?
Where is the pressure to prescribe this coming from? Isn’t this the sort of thing NICE would usually put the brakes on? Has NICE been politically influenced – and is NICE therefore no longer fit for purpose?
Once again – there is something *very, very* odd about this.
So weird that they can be pushy and keen to pay for a drug costing £1987/ injection…..
but won’t pay £2037/ injection with £50 going to the GP practice.
Is there something between 1987 and 2037 which makes it suddenly unaffordable?