Guidance

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.

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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.

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Resource considerations

When there is an activity shift there needs to also be a resource shift.

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 some point during 2024.

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

NICE approves ground-breaking cholesterol-lowering drug inclisiran | News | News | NICE

We have seen the contents of a Locally Enhanced Service in the Bristol, North Somerset and South Gloucestershire Integrated Care System that offers practices an additional amount to administer this medication. This document demonstrates that the administration of inclisiran has been defined as not being a GMS or PMS contractual requirement.

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Views from NHSE and Integrated Care Boards

link to www.england.nhs.uk

NHSE issued information in April 2023 regarding funding of inclisiran.

This document has been quoted in an ICB position statement but there appears to be a discrepancy about how it is interpreted. Our understanding is that it primarily outlines funding provisions for background drug budgets in both primary and secondary care, attributing changes in funding and guidance for secondary care due to increased numbers of patients now being initiated in hospitals. However, it does not appear to explicitly address long term central resource for the administration of the drug or management of recall systems in primary care.

Whilst it is important for practices to consider Integrated Care Board position statements, our view is that as autonomous independent businesses they are not bound by an ICB position that states they should administer the medication in Primary Care based on our current understanding. This concept is further reflected in that practices are not bound by the opinion we offer for consideration on this webpage.

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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.

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Last Reviewed Date
02/04/2024