APC Recommendations:

To support the East of England Priorities Advisory Committee (PAC) policy statement and recommendations (See attachment)

1. Evolocumab and alirocumab are recommended for prescribing in line with NICE TA393 and NICE TA394 for patients with low density lipoprotein concentrations that are persistently* above the thresholds specified in table 1 despite maximal tolerated lipid lowering therapy as specified in locally agreed pathways e.g. after a trial of second or third statin, dose reduction, combination treatment with ezetimibe, and where adherence to treatment has been assessed and confirmed.

2. Prescribing should be initiated by a consultant lipidologist/chemical pathologist in a lipid clinic where these exist, or by a Hospital consultant, with a special interest such as a Diabetologist or Cardiologist, as agreed locally.

3. Prescribing should be retained in secondary care and supplied via the homecare model.

4. Patients should be monitored by the initiating clinic for efficacy, adherence to treatment, and adverse effects: » 6 weeks after starting treatment: If an adequate response (30% reduction in LDL-C from baseline**) has not been achieved after 6 weeks treatment, steps should be taken to address any issues around injection technique and adherence to treatment. NB this may be undertaken via a telephone consultation rather than a face to face clinic visit as agreed locally. » 3 months after starting treatment » 6 months after starting treatment » Annually thereafter.

5. Treatment should continue if: » A minimum reduction of 30% in LDL-C from baseline** is achieved after 3 months, and is sustained at ongoing reviews.

6. Prescribers must inform the patients GP that treatment has been initiated and request that the information is added to the patients Summary Care Record.

7. The use of evolocumab for the treatment of homozygous familial hypercholesterolaemia is an NHSE commissioning responsibility.

8. These recommendations will be reviewed in the light of further published evidence on the outcomes and long term safety of each agent.

*Persistently is defined as at least two consecutive LDL-C readings taken over a minimum period of 3 months.

**Baseline LDL-C is defined as the LDL-C level on optimised oral treatments prior to initiating PCSK9 inhibitor treatment.

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