New opportunities for the treatment of hyperlipidaemia: Initiation of PCSK9 monoclonal antibodies utilising a multi-disciplinary approach.

The challenge of delivering this new treatment was addressed by the FH service through the development of a steering group which consisted of a Consultant Cardiologist, Specialist Cardiology Pharmacists and clinical nurse specialists in FH. Trust supplementary guidelines were developed and agreed with North West (NW) London Collaboration of Clinical Commissioning groups (CCGs) that outlined clear instructions as to how this treatment would be delivered.

The aim was to provide effective lipid lowering treatment with the potential to reduce LDL-c by 50% from baseline as recommended by NICE QS41. This would be achieved through the development of a dedicated PCSK9 inhibitor (PCSK9i), drug administration service that encompasses a multidisciplinary approach to the application, initiation and follow-up of eligible patients. This approach would also complement the existing FH follow-up clinic assessments that are recommended in NICE CG71.

The project was implemented at a Tertiary Cardiac Centre where referrals for PCSK9i treatment are received from London and the home counties. To streamline the process for patients who often travel some distance, the PCSK9i service was developed to improve access to treatment. Prior to the introduction of the PCSK9i drug administration service, eligible patients were identified by the Consultant Cardiologist in the Coronary Prevention Clinic and a request would be submitted to the pharmacy to initiate PCSK9i treatment. This resulted in a random approach to identification of eligible patients as well as difficulties in follow-up and supply of medication. An increased awareness of PCSK9i also lead to a rise in referrals for treatment, which proved difficult to manage within the existing clinic capacity. To improve the efficiency of delivering this treatment the steering group re-evaluated the initial procedures and identified new processes to increase efficacy of service provision.

The steering group agreed a process that would facilitate a systematic course of action whereby identified patients are referred to the FH nursing team for triage and if appropriate, completion of a funding application is submitted to the commissioning pharmacist. Once eligibility criteria are established, (as per NICE TA 393 & NICE TA394) the funding application is sent to NW London CCG for consideration and approval/ decline is received within 5 working days. If the patient resides outside of NW London CCG then the same criteria are applied and internal approval / decline is provided by the commissioning pharmacist.

Following approval, patients are booked into a dedicated PCSK9i clinic where they receive education and training, prior to self-administration which is observed by the FH CNS. Patients are then seen at two weeks to confirm patient administration technique is satisfactory, then in the FH follow-up clinic at three months, six months and 18 months as per the locally agreed guidance. Applications for continued funding are completed by the FH nurse and submitted to the commissioning pharmacist at six and 18 months. Repeat prescriptions and supply of medication is arranged by the responsible pharmacist and delivered via the approved Homecare service. This provides a cost-effective means of medication supplies as the hospital is a tertiary cardiac centre and many patients attend from beyond the local area. The steering group met every three months initially to review the process and has adapted where necessary as experience was gained.

Implementing a dedicated PCSK9i drug administration service has improved access for patients, streamlined the process and efficacy for both staff and patients. Prior to the introduction of this service many patients were receiving inadequate or sub-optimal lipid lowering treatment. The service to date has provided PCSK9i to 115 patients since its commencement in September 2016.  104 patients continue with the treatment and are achieving at least a 30% reduction in LDL-c with an average reduction in LDL-c of 59.8% from baseline. Of note, approximately half of these patients were previously unable to tolerate any other lipid lowering medication and would have been at increased risk of developing CVD.

It has been difficult to estimate the cost impact of the PCSK9i service as existing resources were restructured to accommodate the increased workload during initial set-up. However, as demand has grown there is now a need to formulate a business case to allow for expansion as demand for the current service increases.

Informal feedback from patients attending the PCSK9i service has been positive, however, this will be measured formally in 2019. An ethics application is currently pending approval to conduct a qualitative research study into the “patient experience of treatment with PCSK9i”.

There are several learning points that have been identified from this project:

1. It would be useful to provide an education session for clinicians prior to launching a service, providing information regarding appropriate referral process and eligibility criteria. This would eliminate unnecessary workload from inappropriate referrals and promote awareness amongst clinicians in other specialities and broaden patient access.
2. A structured approach from the outset which tracks funding applications, patient follow up and medication supply is essential to ensure smooth running of service, continuity of treatment and patient satisfaction.
3. Regular meetings in the early stages of the service development and using a PDSA (Plan, Do, Study, Act) approach has enabled changes in the process to be implemented quickly and efficiently.
4. Good communication channels between the multidisciplinary team has also proved invaluable and the division of responsibilities/ tasks within the team is improved by the sharing of information via electronic platforms.
5. Patient feedback relating to the PCSK9i drug administration service, has been positive, with the majority reporting ease of administration and no side effects. However, contractual complications at the early stages of the project led to difficulties for both staff and patients in the delivery of medication.
6. Good relationships with pharmaceutical companies providing PCSK9i, has facilitated useful networking opportunities and knowledge in relation to new trial results.
7. Sharing our experience with colleagues through conference presentations and posters has provided a shared learning experience which is mutually beneficial.