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ELIQUIS® (apixaban) is indicated for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA), age ≥75 years, hypertension, diabetes mellitus, symptomatic heart failure (NYHA Class ≥II); treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults; and, prevention of venous thromboembolic events (VTE) in patients who have undergone elective hip or knee replacement surgery.
ELIQUIS®(apixaban) in treatment guidelines
For the prevention of stroke and systemic embolism in patients with NVAF
NICE recommends ELIQUIS as an option for preventing stroke and systemic embolism in people with NVAF with one or more risk factors (TA275, 2013).1
NICE NVAF technology appraisal guidance (TA275, 2013)
“Apixaban is recommended as an option for preventing stroke and systemic embolism within its marketing authorisation, that is, in people with non-valvular atrial fibrillation with one or more risk factors such as:
NICE recommends anticoagulation therapy – not aspirin monotherapy – for stroke prevention in patients with NVAF (NG196, 2021).2
NICE AF Guideline (NG196, 2021)
Anticoagulation treatment for prevention of stroke / systemic embolism in people with NVAF:2
1.6.1. When discussing the benefits and risks of anticoagulation use clinical risk profiles and personal preferences to guide treatment choices. Discuss with the person that:
1.6.2. When deciding between anticoagulation treatment options:
1.6.3. Offer anticoagulation with a DOAC to people with AF and a CHA2DS2-VASc score of 2 or above, taking into account the risk of bleeding. Apixaban, dabigatran, edoxaban and rivaroxaban are all recommended as options, when used in line with the criteria specified in the relevant NICE technology appraisal guidance.
1.6.4. Consider anticoagulation with a DOAC for men with AF and a CHA2DS2-VASc score of 1, taking into account the risk of bleeding. Apixaban, dabigatran, edoxaban and rivaroxaban are all recommended as options, when used in line with the criteria specified in the relevant NICE technology appraisal guidance.
NICE NG196 recommends that VKAs should only be offered to people with AF for whom DOACs are contraindicated, not tolerated, or not suitable2
1.6.5. If DOACs are contraindicated, not tolerated or not suitable in people with AF, offer a VKA.
1.6.6. For adults with AF who are already taking a VKA and are stable, continue with their current medication and discuss the option of switching treatment at their next routine appointment, taking into account the person’s time in therapeutic range.
1.6.7. Do not offer stroke prevention therapy with anticoagulation to people <65 years with AF and no risk factors other than their sex (that is, very low risk of stroke equating to a CHA2DS2-VASc score of 0 (men) or 1 (women).
1.6.8. Do not withhold anticoagulation solely because of age or risk of falls.
NICE AF guidance on reassessing anticoagulation for a person with poor anticoagulation control on a vitamin K antagonist (NG196, 2021):2
1.6.9. Calculate the person’s time in therapeutic range (TTR) at each visit. When calculating TTR:
1.6.10. Reassess anticoagulation for a person with poor anticoagulation control shown by any of the following:
1.6.11. When reassessing anticoagulation, take into account and if possible address the following factors that may contribute to poor anticoagulation control:
1.6.12. If poor anticoagulation control cannot be improved, evaluate the risks and benefits of alternative stroke prevention strategies and discuss these with the person2
ELIQUIS (apixaban), dabigatran, rivaroxaban and edoxaban are all recommended by NICE Guideline 196 (NICE NG196, 2021) as anticoagulation therapy options for the prevention of stroke in patients with NVAF in line with their respective marketing authorisations.2 DOACs have now received NICE Technology Appraisal guidance (NICE TA249 [dabigatran],3 NICE TA256 [rivaroxaban],4 NICE TA275 [apixaban]1 and NICE TA355 [edoxaban]),5 and all DOACs are recommended as an option for preventing stroke and systemic embolism in patients with NVAF and one or more risk factors, in line with their respective marketing authorisations.
For further information please visit www.nice.org.uk.
SMC advice for the use of ELIQUIS in patients with NVAF
Apixaban, 2.5 mg & 5 mg, film-coated tablets (ELIQUIS) SMC No. (836/13)6
The SMC has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in Scotland. The advice is summarised as follows:6
SMC NVAF advice (SMC No. 836/13, 2013)
ADVICE: following a full submission apixaban (ELIQUIS) is accepted for use within NHS Scotland.
Indication under review: for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA), age ≥75 years, hypertension, diabetes mellitus, symptomatic heart failure (NYHA class ≥II).6
For further information, please visit www.scottishmedicines.org.uk.
ADTC = Area Drug and Therapeutic Committee AF = Atrial Fibrillation
CHA2DS2-VASc = Congestive heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, Age 65–74, Sex category (female)
DOAC = Direct-acting Oral Anticoagulant
NICE = National Institute for Health and Care Excellence NVAF = Non-Valvular Atrial Fibrillation NYHA = New York Heart Association
SMC = Scottish Medicines Consortium TIA = Transient Ischaemic Attack TTR = Time in Therapeutic Range VKA = Vitamin K Antagonist