Background

We recently issued some information on Inclisiran but wished to further update this as several practices have contacted us to inform us that they have felt under pressure by secondary care to prescribe this for some of their patients.

Inclisiran is a medication given by subcutaneous injection that is administered by a clinician, with the aim of reducing blood levels of Cholesterol.

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 advise practices to review the BMA/RCGP information published that outlines considerations when prescribing this medication and the responsibilities of a clinician choosing to do so.

https://www.rcgp.org.uk/policy/rcgp-policy-areas/inclisiran-position-statement

Please note 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.

It is up to individual clinicians to decide whether they wish to prescribe this medication, given the above guidance considering factors such as your competence and confidence as a prescribing and administering clinicians.

Nationally, there was initially £10 available to practices, per patient, if ordered as a personally administered medication. This was reduced to £5, and we understand this may reduce to zero at the end of the 23/24 financial year.

Practices would need to decide if this current funding and the potential withdrawal of this makes this a viable service to provide given the resources required to cover factors such as GP time to counsel prior to initiation, consultations about any side effects, clinician time to administer and staff training.

There are also wider financial considerations including the cost of maintaining a long-term recall system with an unknown future level of income and current inflationary pressures as well as estates and utilities costs. We would advise practices consider all these factors as they should with all non-core services.

While it is up to individual practices, The LMC does not currently recommend that practices prescribe and administer this medication, without the provision of a Locally Enhanced Service. 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.

We will update you if there are positive developments of an enhanced service for to be provided in general practice for the eligible population.

We anticipate further national developments via the BMA and RCGP about this medication which we will update for practices as it is released.

In Summary:

1. Inclisiran is not contracted in the GMS/PMS contract.
2. Inclisiran has not been commissioned as an ES by Lincolnshire ICB.
3. The administration fee has been reduced to £5 (from £10) for every injection given.
4. It seems unlikely that practices can administer inclisiran without financial loss.
5. There is no obligation on a practice to prescribe or administer inclisiran.
6. Practices should consider the BMA/RCGP guidance as well as the financial costs    should they wish to provide this service currently in absence of an enhanced service.