GPC Update: October 2025
There are widespread concerns with the manner and speed with which NHS England have attempted to push Inclisiran, which is a black triangle injectable drug. As there continues to be a number of questions in relation to this, we have published a briefing for practices.
GPC 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).
Given workload, liability and still-evolving long-term outcomes evidence, practices should not prescribe/administer inclisiran without an adequately funded locally commissioned service.
GPC guidance: Inclisiran (Leqvio®) in General Practice: BMA Briefing
We also reiterate the joint BMA/RCGP statement regarding the lack of current evidence about the benefits of Inclisiran, and other articles questioning the evidence of effectiveness .
We advise practices to consider declining requests to prescribe Inclisiran on the grounds that general practices in LLR are neither contracted nor funded to provide the service and/or the current lack of evidence of effectiveness. If a consultant or other specialist feel that Inclisiran will benefit an individual patient the hospital can arrange to provide and deliver it.
Practices are welcome to use the template letter, if you are asked to provide this service and wish to kindly decline as practices are not currently funded or contracted to deliver.
Background
During 2023/24 Inclisiran was part of the Basket of Services. It was included in the first drafts of the Community Based Service specification but has now been removed.
There was an additional £10 per Inclisiran injection provided as a Personally Administered Item. This was reduced to £5, and the payment is expected to sieze.
Inclisiran is a medication given by subcutaneous injection that is administered by a clinician, with the aim of reducing blood levels of Cholesterol. We have received several emails from practices about this medication.
New medications are discussed by the Leicester, Leicestershire and Rutland Area Prescribing Committee, which has representatives from both Primary and Secondary care, with a resulting local formulary stating if a drug is “Red”, “Amber” or “Green” to prescribe. We understand all local area prescribing committees were uniquely advised by NHS England to designate this medication as Green, rather than discuss this in the usual way.
The LMSG prescribing guidelines, in the section on Inclisiran, give it a ‘Green’ status, but add that the guidelines are “for prescribers who feel competent to use this medication.1”
General medical practitioners are independent registered practitioners who take full responsibility for any prescription they sign. The General Medical Council requires registered doctors to prescribe only when they “are satisfied that the medicine or treatment serve the patient’s needs.” When prescribing based on the recommendation of another doctor the GMC further requires that “you must be satisfied that the prescription is needed, appropriate for the patient and within the limits of your competence.2”
Inclisiran is a relatively new and novel drug, that many GPs advise they do not feel competent to prescribe. We note that an editorial in the British Medical Journal called on the National Institute for Clinical Excellence to reconsider their guidance on Inclisiran as the “recommendation is premature without data on cardiovascular outcomes.2” The British Medical Association and Royal College of General Practitioners have produced a joint statement advising a cautious approach to prescribing by general practitioners.3
Since Inclisiran is a black triangle drug, if you do decide to prescribe it before the long-term outcome and safety data is realised, please ensure you:
- Undertake shared decision making with your patients, ensuring a full and detailed informed consent is taken, documenting the lack of long-term evidence and unknown long term safety profile of this new and novel medication,
- Encourage your patients to report all side effects to you, however minor, ensuring you fill in a MHRA “yellow card” when they are reported to you and
- Report any potential drug interactions or concerns of your own at the earliest opportunity
The LMC view is that it is up to individual clinicians to decide whether they wish to prescribe this medication, given the above guidance and the responsibility that come with it. You may wish to develop a practice view on this and factors such as your competence and confidence as a prescribing clinician, practice workforce capacity and costs involved in the recall process might inform this.
There was initially £10 available to practices, per patient, if ordered as a personally administered medication. This has now reduced to £5, and we understand will reduce to zero at the end of the 23/24 financial year. Practices will need to decide if this adequately covers the costs of providing the medication when factors such as GP time to counsel prior to initiation, consultations about any side effects, clinician time to administer and staff training are considered. There are also wider financial considerations including the cost of maintaining a long-term recall system with an unknown future level of income, along with the impact of tax and current inflationary pressures. The LMC view is that the provision of Inclisiran injections must be commissioned as a specific, appropriately funded service.