For commencing treatment with Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia in adults;
NICE TA393; June 2016
Patient NHS No. / Trust / GP namePatient hospital number / Consultant making request / GP code/ Practice code
Patient initials and date of birth / Consultant contact details / GP post code
Please ensure this form is countersigned by Trust Chief Pharmacist (or deputy) before onward transmission to CCG.
Only fully completed forms will be accepted for consideration by the CCGs.
If the answer to any of these questions is NO, then a full Individual Funding Request form will need to be completed and these may
be obtained from the relevant Individual Funding Co-ordinator.
Bedfordshire Clinical Commissioning Group (BCCG): Bedfordshire Clinical Commissioning Group (BCCG): e-mail (Preferred method):
or telephone 01494 555530. IFR team, South, Central and West CSU, Albert House, Queen Victoria Road,
High Wycombe, HP11 1AG.
Luton Clinical Commissioning Group (LCCG) ; Secure fax: 01582 511054, The Lodge, 4 George St West, Luton,
Beds, LU1 2BJ.
Please refer to the individual IFR policy for further details.
1. Please confirm that the patient has been treated optimally (including the use of combination therapy) in line with the various NICE publications, as appropriate for the diagnosis without achieving target LDL-C. / Yes / No1.1 Please confirm that further escalation is not possible due to (tick one of the following) (please tick box or type X)
The maximum dose of oral lipid modifying therapy has been reached
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)
1.2 Drug History: Please provide information on previous lipid lowering therapy below:
Drug history / Trialled / If current, please tick / Reason for stopping or contraindication if relevant
Yes / No
Simvastatin
Atorvastatin
Ezetimibe
Rosuvastatin
Others: please state
2. Please 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 specialist in the treatment of dyslipidaemias.
*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 / Yes / No
Baseline LDL-C (mmol/litre)
First LDL- C / Date measured / Second LDL-C / Date measured
3. Please confirm the indication category that applies to this patient (please tick box or type X)
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 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
Abbreviations: CVD, cardiovascular disease; LDL-C, low-density lipoprotein cholesterol.
Definitions:
**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).
4. Please 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 not compliant with the therapy. (please tick box or type X) / Yes / No
5. Continuation of funding:
Funding will initially be provided for 4 months treatment via homecare for alirocumab 75 mg or 150 mg every 2 weeks.
Funding will be provided for continuation of treatment where there is clear evidence of an initial and ongoing adequate response to treatment
A response is defined as a 30% reduction in LDL-C concentrations from baseline (defined as LDL-C level on optimised oral treatments prior to initiating PCSK9 inhibitor treatment)
5.1 Has an adequate response i.e. defined as a 30% reduction in LDL-C concentration from baseline been achieved ? r Yes r No
Continuation of funding after 4 months:
Please specify baseline LDL-C level? ………………………….
Please specify LDL-C level taken after 4 months ………………………
Continuation of funding after 12 months:
Please specify LDL-C level taken at 12 months …………………….
6. Please provide any other relevant information
Form completed by / Date:
I confirm that the patient meets the criteria for treatment: Consultant signature* / Date
I confirm that the patient meets the criteria for treatment:
Trust Chief Pharmacist (or nominated deputy) signature* / Date
*Electronic signatures are acceptabl
NICE TA 393 : Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia in adults; June 2016
1 Recommendations
1.1 Alirocumab is recommended as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if:
· Lowdensity lipoprotein concentrations are persistently above the thresholds specified in table1despite maximal tolerated lipidlowering 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 alirocumab with the discount agreed in the patient access scheme.
Table1 Lowdensity lipoprotein cholesterol concentrations above which alirocumab is recommended
Without CVD / With CVDHigh risk of CVD 1 / Very high risk of CVD 2
Primary nonfamilial hypercholesterolaemia or mixed dyslipidaemia / Not recommended at any LDLC concentration / Recommendedonlyif LDLC concentration is persistently above 4.0mmol/l / Recommended only if LDLC concentration is persistently above 3.5mmol/l
Primary heterozygousfamilial hypercholesterolaemia / Recommended only if LDLC concentration is persistently above 5.0mmol/l / Recommended only if LDLC concentration is persistently above 3.5mmol/l
1High risk of cardiovascular disease is defined as a history of any of the following: acute coronary syndrome (such as myocardial infarction or unstableangina 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 1vascular bed (that is, polyvascular disease).
Abbreviations: CVD, cardiovascular disease; LDLC, lowdensity lipoprotein cholesterol.
1.2 This guidance is not intended to affect the position of patients whose treatment with alirocumab was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.