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, given the way it has been introduced.
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 recently 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
The LMC view has been that 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. We have stated that 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. However, in alignment with other South West LMCs, from June 2023 we are now stating that we do not recommend that practices prescribe and administer this medication in Primary Care, without the provision of a Locally Enhanced Service.
We understand some areas of the country are looking to develop a Locally Commissioned Service to deliver this medication, given the costs to practices who choose to take on this work. An example of this from Sussex is below.
One area that we cover has developed a community provision of this service that does not involve the practice of acute trust needing to administer the medication.
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. We have established that there is no longer a significant difference in cost to the NHS if Inclisiran is prescribed in primary or secondary care.
We anticipate further national developments via the BMA and RCGP about this medication which we will add here.