PBR Exclusions 2006/07 Funding Application for Infliximab for the Treatment of Crohn S Disease

Funding application for Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia in adults; NICE TA 394 June 2016 Trust: GP name: Patient NHS No. Consultant Making Request: GP code/Practice code: Patient Hospital Number: Patient initials: Consultant Contact Details: GP post code: Patient DoB: Only fully completed forms will be accepted for consideration The completed form must be sent by the hospital commissioning team to the High Cost Drugs Team at [email protected] . If the patient does not fulfil routine commissioning criteria  The responsible commissioner will not normally fund any treatment where the patient does not meet the agreed criteria as outlined in this patient specific funding application form.  Following a clinical trial, the responsibility for ongoing funding remains with the provider or pharmaceutical company. The commissioner will only fund treatment that meets the commissioned pathway.  Applications can be made via the Individual Funding Requests process ONLY where the patient has exceptional clinical circumstances. Please check the commissioner websites for contact details of the IFR team.

Please tick 1. Confirm that the patient has low-density lipoprotein concentrations (LDL-C) persistently* above the thresholds specified in NICE TA393 and treatment is being 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. *Persistently is defined as at least two consecutive LDL-C readings over a minimum 3 month period (following titration up to maximal tolerated lipid-lowering therapy) which meet the NICE criteria as defined in table 1 within the NICE TA. Provide most recent LDL-C Yes No readings to demonstrate this.

First LDL-C (mmol/litre): Date measured: Second LDL-C (mmol/litre): Date measured: 2. Patient is 18 years or over Yes No 3. Confirm the indication category that applies to this patient Primary non-familial hypercholesterolaemia with high risk of CVD* and LDL-C persistently above 4.0 mmol/litre Primary non-familial hypercholesterolaemia with very high risk of CVD** and LDL-C persistently above 3.5 mmol/litre Mixed dyslipidaemia with high risk of CVD* and LDL-C persistently above 4.0 mmol/litre Mixed dyslipidaemia with very high risk of CVD** and LDL-C persistently above 3.5 mmol/litre Primary heterozygous-familial hypercholesterolaemia without CVD and LDL-C persistently above 5.0

Pharmacy and Medicines Optimisation Team 1 East and North Herts Clinical Commissioning Group (ENHCCG) mmol/litre Primary heterozygous-familial hypercholesterolaemia with high risk of CVD* or very high risk of CVD** and LDL-C persistently above 3.5 mmol/litre

*High risk of cardiovascular disease is defined as a history of any of the following: acute coronary syndrome (such as myocardial infarction or unstable angina requiring hospitalisation), coronary or other arterial revascularisation procedures, chronic heart disease, ischaemic stroke, peripheral arterial disease.

**Very high risk of cardiovascular disease is defined as recurrent cardiovascular events or cardiovascular events in more than 1 vascular bed (that is, polyvascular disease).

Abbreviations: CVD, cardiovascular disease; LDL-C, low-density lipoprotein cholesterol. 4. The patient has been treated optimally (including the use of combination therapy) according to locally agreed pathways without achieving target LDL-C, and where further escalation is not possible due to (tick one of the following): The maximum dose of oral lipid modifying therapy has been reached Yes No Further titration of oral lipid modifying therapy is limited by intolerance (as defined in CG71) Statin or lipid lowering therapy is contraindicated (as defined in the SPC)

5. Previous treatment tried. Please specify which drugs patient has previously received: Start date Stop date Treatment Reason for stopping/contraindication Simvastatin Atorvastatin Rosuvastatin Ezetimibe

6. Confirm that the patient is aware that treatment will not be continued if the target LDL-C concentration is not achieved or if they are Yes No not compliant with the therapy. 7. Funding will initially be provided for 4 months treatment via homecare prescription for: Evolocumab 140mg every 2 weeks

Funding will be provided for continuation of treatment where there is clear evidence of an initial and ongoing adequate Yes No response to treatment

An adequate response is defined as at least a 30% reduction in LDL-C concentrations from baseline (defined as LDL-C level on optimised oral treatments prior to initiating PCSK9 inhibitor treatment) Clinician declaration I confirm that the patient meets the criteria for treatment I confirm that I have discussed with the patient and that they understand and consent to their personal information being shared with Pharmacy and Medicines Optimisation Team 2 East and North Herts Clinical Commissioning Group (ENHCCG) commissioning and commissioning support organisations for the purposes of processing this funding request and validating subsequent invoices. I have recorded/will record this discussion in the patient’s notes. I confirm the risks and benefits of treatment have been/will be fully discussed with the patient and documented. I acknowledge and adhere to the cost effective use of evolocumab as advocated in NICE TA394 and believe that within this Trust the above patient would be best managed using the agent as requested above. I confirm that funding approval is subject to initiation and follow up of treatment response being undertaken by a consultant lipidologist/chemical pathologist, or by a hospital consultant, with a special interest such as a diabetologist or cardiologist I understand that approval is for an initial 4 months (8 doses). Continuation of funding is reliant upon the patient showing the response detailed above and upon this follow up information being provided to the commissioner Name of consultant: Name of Trust Chief Pharmacist (or deputy):

Signature: Date: Signature Date:

NICE TA 394 Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia June 2016 NICE Recommendation: Evolocumab is recommended as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if:  The dosage is 140 mg every 2 weeks.  Low-density lipoprotein concentrations are persistently above the thresholds specified below despite maximal tolerated lipid-lowering therapy. That is, either the maximum dose has been reached or further titration is limited by intolerance (as defined in NICE's guideline on familial hypercholesterolaemia: identification and management).  The company provides evolocumab with the discount agreed in the patient access scheme. Without CVD With CVD

Pharmacy and Medicines Optimisation Team 3 East and North Herts Clinical Commissioning Group (ENHCCG) High risk of CVD1 Very high risk of CVD2 Primary non-familial Not recommended at Recommended only if Recommended only if hypercholesterolaemia any LDL-C LDL-C concentration LDL-C concentration or mixed dyslipidaemia concentration is persistently >4.0mmol/l is persistently >3.5 mmol/l Primary Recommended only if LDL-C Recommended only if LDL-C concentration is heterozygous-familial conc. is persistently >5.0 persistently > 3.5 mmol/l hypercholesterolaemia mmol/l 1High risk of cardiovascular disease is defined as a history of any of the following: acute coronary syndrome (such as myocardial infarction or unstable angina requiring hospitalisation), coronary or other arterial revascularisation procedures, chronic heart disease, ischaemic stroke, peripheral arterial disease. 2Very high risk of cardiovascular disease is defined as recurrent cardiovascular events or cardiovascular events in more than 1 vascular bed (that is, polyvascular disease). Abbreviations: CVD, cardiovascular disease; LDL-C, low-density lipoprotein cholesterol.

Refer to CCG website for lipid modification guidelines: http://www.enhertsccg.nhs.uk/cardiovascular-system

Pharmacy and Medicines Optimisation Team 4 East and North Herts Clinical Commissioning Group (ENHCCG)