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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.

What’s new

ELIQUIS®(apixaban) in treatment guidelines

For the prevention of stroke and systemic embolism in patients with NVAF

NICE guidance

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:

  • Prior stroke or transient ischaemic attack
  • Age 75 years or older
  • Hypertension
  • Diabetes mellitus
  • Symptomatic heart failure”1

NICE recommends anticoagulation therapy – not aspirin monotherapy – for stroke prevention in patients with NVAF (NG196, 2021).2

  • "Do not offer aspirin monotherapy solely for stroke prevention for people with atrial fibrillation.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:

  • For most people the benefit of anticoagulation outweighs the bleeding risk
  • For people with an increased risk of bleeding, the benefit of anticoagulation may not always outweigh the bleeding risk, and careful monitoring of bleeding risk is important

1.6.2. When deciding between anticoagulation treatment options:

  • Discuss the risks and benefits of different drugs with the person and follow the recommendations on shared decision making in NICE's guideline on patient experience in adult NHS services
  • Follow the recommendations on patient involvement in decisions about medicines in NICE's guideline on medicines adherence and patient decision aids in NICE's guideline on medicines optimisation
  • Take into account any contraindications for each drug and follow the guidance in the British National Formulary and the MHRA advice on direct-acting oral anticoagulants, in particular for advice on dosages in people with renal impairment, reversal agents and monitoring

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:

  • Use a validated method of measurement such as the Rosendaal method for computer-assisted dosing or proportion of tests in range for manual dosing
  • Exclude measurements taken during the first 6 weeks of treatment
  • Calculate TTR over a maintenance period of at least 6 months

1.6.10. Reassess anticoagulation for a person with poor anticoagulation control shown by any of the following:

  • 2 INR values higher than 5 or 1 INR value higher than 8 within the past 6 months
  • 2 INR values less than 1.5 within the past 6 months
  • TTR less than 65%2

1.6.11. When reassessing anticoagulation, take into account and if possible address the following factors that may contribute to poor anticoagulation control:

  • Cognitive function
  • Adherence to prescribed therapy
  • Illness
  • Interacting drug therapy
  • Lifestyle factors including diet and alcohol consumption2

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.

FOOTNOTES

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

REFERENCES

  1. NICE technology appraisal guidance TA275. Apixaban for preventing stroke and systemic embolism in people with NVAF. February 2013.
  2. NICE guideline 196. Atrial fibrillation: diagnosis and management. April 2021.
  3. NICE technology appraisal guidance TA249. Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation. March 2012.
  4. NICE technology appraisal guidance TA256. Rivaroxaban for the prevention of stroke and systemic embolism in atrial fibrillation. May 2012.
  5. NICE technology appraisal guidance TA355. Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation. September 2015.
  6. SMC advice. Apixaban 2.5 mg and 5 mg film-coated tablets (ELIQUIS) SMC No. (836/13). January 2013.