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‘Serious concerns’ over cholesterol-lowering injection rollout, warn GP leaders

cholesterol

The BMA and RCGP have warned of ‘serious concerns’ around the rollout of an injectable anti-cholesterol drug in general practice.

In September, NHS England announced it would commission the rollout of ‘game changer’ drug inclisiran with ‘immediate effect’ for GPs to prescribe and administer to patients with primary hypercholesterolaemia or mixed dyslipidaemia with a previous cardiovascular event such as a heart attack or stroke. 

The drug, which is injected twice-yearly and can be used on its own or in conjunction with statins or other cholesterol-lowering drugs, was recommended for primary care delivery in NICE draft final guidance.

But the BMA GP Committee’s latest bulletin announced that the BMA and RCGP have issued a joint statement outlining their ‘serious concerns’ about its implementation in primary care.

The BMA has raised its concerns with NICE and NHS England, 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’, it said.

There are also concerns around capacity and a ‘lack of clear resources’ to support the additional workload for GP teams that are ‘already stretched to their limits’, it added.

The BMA advised practices that they should only prescribe the drug ‘if they feel comfortable’.

The joint statement, issued today, said: ‘Whilst the RCGP and BMA fully support innovation and promoting population health approaches to care, we have ongoing questions regarding the rollout of this novel medication that have yet to be answered.’

It added that the main concerns ‘centre on the fact this is a black triangle drug being proactively rolled out directly to primary care’.

These include a ‘lack of long-term data on cardiovascular outcomes’ with ‘relevant’ studies not due until 2026 and a lack of ‘long-term safety data’ with ‘potential unknown long term side effects and interactions of the medication’, it said.

The statement said: ‘Whilst waiting for clarification on these areas, we would encourage practices to continue to treat patients with high cholesterol following lipid guidelines focussing on all available options starting with lifestyle changes and statins, escalating patients to high-intensity statins and ezetimibe where appropriate and if considering injectable therapies consider all options, being aware that if you initiate inclisiran in primary care, as the decision-maker, you take full responsibility for the prescribing.’

GPs who decide to prescribe inclisiran before long-term data is available should ensure the patient is involved in a shared decision with ‘full and detailed informed consent’ including ‘documenting the lack of long-term evidence and unknown long term safety profile’, it added.

They should also encourage patients to report all side effects to them ‘however minor’ and ensure the GP completes an MHRA ‘yellow card’, while reporting any potential drug interactions or concerns of their own ‘at the earliest opportunity’, it said.

A trial is ‘currently underway in Greater Manchester to assess the feasibility of delivering inclisiran within a primary care setting, aiming to recruit 900 patients across approximately 20 practices’, it added.

The results will be available in 2022, it said.

The RCGP and BMA will update members once they have further details from NHS England regarding the proposals and the trials, they added.

Inclisiran is the first of a new kind of cholesterol-reducing treatment that uses gene silencing to improve the liver’s ability to get rid of harmful cholesterol from the blood.

The drug will initially be for people who have established cardiovascular disease, who have ideally been tried on a statin and ezetimibe before but people with genetically elevated cholesterol might also be eligible in the future.

Following an initial dose, inclisiran will be administered again after three months, six months and then twice yearly for life.

More than two in five (40%) people in England have high cholesterol, putting them at significant risk of getting heart disease, and roughly 6.5 million adults in England are currently receiving treatment such as statins.

It follows a large-scale clinical trial that assessed the drug in 2020.

And it comes as community pharmacies are to ‘urgently’ refer patients with an irregular pulse for a GP appointment on the same day, under a new hypertension case-finding scheme launched by NHS England.

Click to complete relevant cardiovascular CPD modules on Pulse learning. 

READERS' COMMENTS [9]

Sam Tapsell 3 December, 2021 3:02 pm

Too right,
Do statins work because;
1. they reduce lipids
2. They are anti-inflammatory?
I’m backing horse number 2…

Reply moderated
Paul Attwood 3 December, 2021 3:23 pm

How many cholesterol lowering drugs have zero or negative effect on CVS mortality? Is inclisiran one of those? We won’t know until the studies are done.

Until such time inclisiran should not even be licenced let alone given to GPs as an “extra” job to be done.

So until 2025 or later.

Reply moderated
Tracey Vell 3 December, 2021 3:29 pm

Lets let secondary care do all new drugs and innovative areas of practice and then lets not cry when we are left unfunded and outdated. CVD care is not extra work and NICE endorsed drugs always have completed safety trials. Long term effects are always later in time.
Delivering patient choice of life saving drugs is imperative

Reply moderated
Stephen Fowler 3 December, 2021 4:55 pm

I suggest a look at Dr Malcolm Kendrick’s work to see why most of us are barking up the wrong tree entirely

Reply moderated
Guy Wilkinson 3 December, 2021 5:10 pm

Tracey – trial underway locally. How do you possibly square this off as routine GMS work??

Reply moderated
Paul Attwood 6 December, 2021 2:23 pm

Interesting. This is a a rehash of a previous article now with the critical comments removed. On the basis of cockup or conspiracy I will go for the former. My last searchable post on this was about NICE approving it. I said;

So this drug reduces LDL levels. Several other drug groups do too but regarding these, longer term studies do not show reduction in CVD or reduction in mortality.

Have these studies been done on inclisiran? Probably a bit early I would think seeing as it takes years to demonstrate reduction, if any.

Is it a reasonable use of this drug or a desperate punt on its efficacy? A £500m gamble? Remember BloJo is known for spaffing up a wall.

Paul Attwood 6 December, 2021 2:25 pm

TV “Delivering patient choice of life saving drugs is imperative”.

And you know Inclisiran is life saving how?

Stephen Fowler 6 December, 2021 4:04 pm

So this drug reduces LDL levels. Several other drug groups do too but regarding these, longer term studies do not show reduction in CVD or reduction in mortality.

That’s the point that’s being missed – cardiovascular disease has nothing to do with LDL

Reply moderated
Shaba Nabi 10 December, 2021 10:11 am

Tracey – let’s be honest here.

If NHSE had not negotiated with the drug company to get a much lower acquisition cost in primary care, compared with secondary care, we would not be having this conversation.

Most novel drugs with no data on long term impacts, including morbidity and mortality, (as opposed to proxy outcomes of LDL lowering) are approved as red or amber by formulary groups. The only reason this is different is because of this cost advantage in primary care – and not for clinical reasons.

This is not core general practice. It should be funded as an enhanced service, but only AFTER adequate experience is gained in secondary care settings.

DOI: CCG Prescribing Lead and member of Clinical/Prescribing policy group of GPC