PCSK9i

PCSK9i is an element of the AHSN NENC Cardiovascular Prevention Programme and the nationally mandated lipid optimisation and FH programme. The aims are to overcome access barriers and improve uptake of the PCSK9 inhibitor.

Pathway Transformation Fund

The PCSK9 inhibitor has been recognised as part of the Pathway Transformation Fund which identifies and backs products with NICE approval that support the NHS Long Term Plan’s key clinical priorities but have lower than expected uptake.

Delivered with the support of the Academic Health Science Networks (AHSNs), and in partnership with the Rapid Uptake Product suppliers, the Pathway Transformation Fund seeks to improve access and overcome barriers to identified products.

In 2018, the NICE Advisory Board identified the following barriers to Rapid Uptake Products;

The Pathway Transformation Fund for PCSK9 inhibitors can help Trusts and lipid services address practical obstacles to introducing these products.

Delivery in North East and North Cumbria (NENC)

North East and North Cumbria were successful in securing Pathway Transformation Funding for three sites in the region; Northumbria Healthcare NHS Foundation Trust, South Tyneside & Sunderland NHS Foundation Trust and County Durham and Darlington NHS Foundation Trust.

Each of their projects are outlined below:-

Northumbria Healthcare NHS Foundation Trust

Lipid Optimisation and Secondary Prevention Project

This programme was designed with 3 aspects:

  1. Identification of patients Post Acute Coronary Syndrome events
    • Working with cardiology colleagues to review patient records, triaging and discussing cases at MDT meetings. Currently, this arm of the project has been delayed due to the impact of COVID on patients having blood tests and/or face-to-face appointments. Prior to COVID, a significant number of patients had been reviewed.
  2. Identification of high-risk patients with atherosclerotic cardiovascular disease (ASCVD) in the primary care.
    • Following searches of patient records in primary care using CDRC Precision templates for PCSK9i eligibility, pharmacists have reviewed and triaged identified patients.  Much of the work involves lipid optimisation and prescribing of High Intensity Statins (HIST) and/or the introduction of ezetimibe to lower cholesterol levels.  Only a small number of patients end up needing to be referred for PCSK9i consideration.
  3. Pharmacist led PCSK9i initiation clinic. Patients identified prospectively in 1. or retrospectively for 2. and in whom PCSK9i initiation criteria were met, can be trained, prescribed and followed up from this clinic with a PCSK9 inhibitor.
South Tyneside & Sunderland NHS Foundation Trust

Secondary Prevention Programme to optimise Lipid Lowering Therapy (LLT) for patients who have had coronary intervention/revascularisation or medically managed ACS admissions.

A MDT has been developed to review current LLT and patients not achieving a target of non HDL-c <2.5mmol/L.

Patients from vascular and stroke services are also being reviewed.

Patients are being seen in a pharmacist led lipid clinic and patients optimised on LLT or introduced to PCSK9i if eligible.

County Durham and Darlington NHS Foundation Trust (CDDFT)

A pharmacist led project to support the optimisation of current LLT across both primary and secondary care and to increase uptake and access to PCSK9 inhibitors for patients served by CDDFT.

Working in collaboration with cardiology, stroke and vascular teams in secondary care, patient pathways have been re-designed.  Using a risk stratification approach, those patients identified as being at risk from each speciality are referred to the lipid clinic for review by the pharmacist.

In primary care, through the use of CDRC Precision PCSK9i search templates, patients are identified and again, by using a risk stratification approach referred to a specialist pharmacist lipid clinic within secondary care where appropriate. Patients are also de-prescribed if medication is not working.

Additionally, in addressing one of the identified barriers, an education programme has also been developed with a series of webinars presented by the specialist pharmacist and clinicians from a number of specialties.  Innovatively, these sessions are delivered as both Facebook Lives and on Zoom.  They can be accessed via the Virtual Medical Educators (VME) Facebook page and the video is also available on their webpage.

In December 2020, there was a session on PCSK9i which is available to view below and on the Virtual Medical Educators webpage.

Details of the event series can be downloaded here: Lipid Optimisation Event Series

Pathway Transformation Funding

Following the success of the existing Pathway Transformation Funding projects, additional funding has been made available and applications are currently being invited.

AHSNs will work with local organisations to support development of applications. Please make any interested parties aware of this funding opportunity. The application form together with a generic guidance and product specific guidance can be downloaded below:

Pathway Transformation Funding Application forms

Pathway Transformation Fund 2020/21- Guidance for Lipid Management RUP

Pathway Transformation Fund Support for Rapid Uptake Products: 2020/21 Application Guidance

Applicants need to review these documents that also contain contact details if there are any further questions.

The closing date for applications is 30th April 2021.

PCSK9 inhibitor

PCSK9 inhibitor is a lipid lowering therapy (LLT) only prescribed to patients who have previously taken other forms of LLT (including high intensity statins & ezetimibe), however their cholesterol levels still remain above recommended levels.  It can also be administered to people who cannot tolerate statins.

It is given by patient injection every 2 to 4 weeks and works differently to statins by reducing the amount of PCSK9 protein in the body, produced by the liver. In reducing the amount of PCSK9 protein, the inhibitors allow the body to remove cholesterol more effectively.

PCSK9i is much more expensive than a statin, however, cost savings are made against the number of heart attacks and strokes prevented.

As it is classed as a ‘red drug’, It can only be prescribed by a specialist in secondary care.

Resources

Virtual Medical Educators website – https://www.virtualmedicaleducators.org/

Virtual Medical Educators Facebook page – https://www.facebook.com/virtualmedicaleducators

AHSN NENC Events page – https://ahsn-nenc.org.uk/news-and-events/events/

Accelerated Access Collaborative (AAC) – https://www.england.nhs.uk/aac/https://ahsn-nenc.org.uk/news-and-events/events/

Guides and Forms

Patient Evaluation Questionnaire

Patient Evaluation Questionnaire Scoring

CDRC – How to guide

CDRC – PCSK9i searches

Pathway Transformation Funding Application forms

Pathway Transformation Fund 2020/21- Guidance for Lipid Management RUP

Pathway Transformation Fund Support for Rapid Uptake Products: 2020/21 Application Guidance

For more information about the PCSK9i element of the CVD Prevention Programme contact Nikki Holdsworth.