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i 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. i 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