Download Commissioning statement for bivalirudin

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DORSET MEDICINES ADVISORY GROUP
COMMISSIONING STATEMENT ON THE USE OF BIVALIRUDIN (ANGIOX®▼) FOR THE TREATMENT OF STSEGMENT-ELEVATION MYOCARDIAL INFARCTION
SUMMARY
The use of Bivalirudin will be commissioned by NHS Dorset Clinical Commissioning Group in line with NICE TA
230 (Bivalirudin for the treatment of ST-segment-elevation myocardial infarction).
Bivalirudin is indicated as an anticoagulant in adult patients undergoing
percutaneous coronary intervention (PCI), including patients with ST-segment
elevation myocardial infarction (STEMI) undergoing primary PCI.
BACKGROUND
NICE recommends that; ‘Bivalirudin in combination with aspirin and clopidogrel is
recommended for the treatment of adults with ST-segment-elevation myocardial
infarction undergoing primary percutaneous coronary intervention.’
Bivalirudin is also indicated for the treatment of adult patients with unstable
angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for
urgent or early intervention. However, this is not addressed by the NICE TA 230 or
this commissioning statement.
RELEVANT NICE
GUIDANCE
The use of Bivalirudin will be commissioned by NHS Bournemouth and Poole and
NHS Dorset in line with NICE TA 230 (Bivalirudin for the treatment of ST-segmentelevation myocardial infarction).
https://www.nice.org.uk/guidance/ta230
FORMULARY STATUS
Red
PBR STATUS
Drug cost not included in PbR
COMMISSIONING
IMPLICATIONS
To be initiated in secondary care by a physician experienced in either acute
coronary care or in coronary intervention procedures.
RELEVANT CLINICAL
COMMISSIONING
PROGRAMME
Planned and Specialist Clinical Working Group
Patients undergoing PCI, including patients with ST-segment elevation myocardial
infarction (STEMI) undergoing primary PCI
PRESCRIBING
INFORMATION
The recommended dose of bivalirudin for patients undergoing PCI is an
intravenous bolus of 0.75 mg/kg body weight followed immediately by an
intravenous infusion at a rate of 1.75 mg/kg body weight/hour for at least the
duration of the procedure. The infusion of 1.75 mg/kg body weight/hour may be
continued for up to 4 hours post-PCI and at a reduced dose of 0.25 mg/kg body
weight/hour for an additional 4 – 12 hours as clinically necessary. In STEMI
patients the infusion of 1.75 mg/kg body weight/hour should be continued for up
to 4 hours post-PCI and continued at a reduced dose of 0.25 mg/kg body
weight/hour for an additional 4 – 12 hours as clinically necessary.
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Patients should be carefully monitored following primary PCI for signs and
symptoms consistent with myocardial ischaemia.
Use with other anticoagulant therapy
In STEMI patients undergoing primary PCI, standard pre-hospital adjunctive
therapy should include clopidogrel and may include the early administration of
UFH.
Patients can be started on Angiox 30 minutes after discontinuation of
unfractionated heparin given intravenously, or 8 hours after discontinuation of
low molecular weight heparin given subcutaneously.
This prescribing information is not exhaustive. The manufacturer’s summary of
product characteristics (SPC) and the most current edition of the British National
Formulary should be consulted for full information on contra-indications,
warnings, side-effects and drug interactions.
PATIENT PATHWAY
IMPLICATIONS
No change required to NICE myocardial infarction with ST-segment elevation
https://pathways.nice.org.uk/pathways
SUMMARY OF
EVIDENCE TO SUPPORT
FORMULARY STATUS
NICE TA230 https://www.nice.org.uk/guidance/ta230
ASSESSMENT OF COST
IMPLICATIONS
Summary of Product Characteristics https://www.medicines.org.uk
Assuming one 250 mg vial is used per patient, the acquisition cost of treatment
with bivalirudin is £310.00 (British national formulary [BNF] edition 61]), excluding
VAT, according to the TA. Pricing information is no longer readily available from
the BNF, dm+d or Drug Tariff (November 2016). Costs may vary in different
settings because of negotiated procurement discounts.
The NICE costing template associated with NICE TA 230, estimates a net saving of
£35,468 as a result of implementing the TA, based on 171 patients receiving
treatment with bivalirudin.
REFERENCES
Bivalirudin for the treatment of ST-segment-elevation myocardial infarction
https://www.nice.org.uk/guidance/ta230 published July 2011, accessed
November 2016.
Summary of Product Characteristics https://www.medicines.org.uk last update
November 2016, accessed November 2016.
DATE APPROVED
November 2011 – Bournemouth, Dorset and Pool Prescribing Forum. Produced
by Chief Pharmacist, NHS Bournemouth and Poole.
REVIEWED
November 2016
REVIEW DATE
November 2018 or before, in light of new information.
CONTACT FOR THIS
POLICY
Vanessa Sherwood, Senior Pharmacist, NHS Dorset CCG