Understanding Inclisiran
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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 communications from practices about this medication, given the way it has been introduced. It has been discussed by all of our Local Medical Committees.
New medications are normally discussed by an Area Prescribing Board, 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 Boards were uniquely advised by NHS England to designate this medication as Green, rather than discuss this in the usual way.
We are aware that there has been active promotion of this medication in some of our Wessex area. This sample data shows the prescribing rates in General Practice for each of our Integrated Care Systems.
| BSW | Analyse | OpenPrescribing |
| Dorset | Analyse | OpenPrescribing |
| Frimley | Analyse | OpenPrescribing |
| Hampshire & IOW | Analyse | OpenPrescribing |
A journal article with further information is available here.
Safety and efficacy
We advise practices to review the BMA/RCGP information that outlines considerations when prescribing this medication and the responsibilities of a clinician choosing to do so.
We would like to draw your attention to this specific section of the advice, should you choose to prescribe the medication.
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
You may additionally wish to review this article from a GP Update course.
Resource considerations
When there is an activity shift there needs to also be a resource shift.
NHSE has agreed through DHSC with Community Pharmacy England that general practice will purchase Inclisiran at a nominal charge of £45.00 plus VAT and be reimbursed at £60.00 (an increase from £50.00), with the differential given to offset incurred costs. This update is planned for inclusion in the Drug Tariff from 1st April 2025. See NHS England » Funding and supply of inclisiran (Leqvio®)
We encourage practices to consider the costs of taking on prescribing and administration of this medication without funding. Issues to consider within this include
- GP time or appointment to counsel prior to initiation
- Consultations and communications about any side effects
- Clinician time and appointment to administer.
- Staff training
- Cost of maintaining and administering a long-term recall system
If resource for administration of this medication is not currently available in your integrated care system, we suggest you consider the concept of a “reverse” Locally Commissioned Service and calculate the impact to your practice per year when deciding on if you wish to take on the prescribing, administration and maintaining recall systems. We have a helpful template for this.
Costing a Service – Wessex LMCs
Based on the documents below, we estimate that 0.475% of the practice population in England is eligible for this medication. On average, for a practice that has 10000 patients this would translate into 48 patients being eligible.
Patients Registered at a GP Practice, January 2024 – NHS Digital
Hampshire & IOW ICB have recently launched a Locally Commissioned Service for this work which demonstrates that the administration of Inclisiran has been defined as not being a GMS or PMS contractual requirement
Wessex LMCs opinion
Wessex LMCs, alongside all other South West England Local Medical Committees, do not recommend practices prescribe and administer Inclisiran without the provision of adequate resource in the form of a Locally Enhanced Service.
We highlight the need for the development of resource allocation mechanisms by Integrated Care Boards to enable the administration of Inclisiran, ensuring its availability for all our communities. It is not in the interest of our populations for practices to administer this and other novel medications without proper resource allocation, as this impedes the development of such mechanisms for the ‘left shift of care that is essential for the success of our Integrated Care systems.
Prior to considering Inclisiran prescription and administration, we encourage consideration of safety and efficacy information, alongside optimization of existing medication and lifestyle advice. If satisfied in this regard, we advise subsequent consideration of capacity and resource implications associated with assuming such responsibilities, deciding whether to accept or decline.
Practices contemplating declining a request to prescribe and administer this medication may find it beneficial to develop a practice or Primary Care Network policy to guide this decision-making process.