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ELIQUIS (apixaban) treatment guidelines

NICE guidance

NICE recommends ELIQUIS as an option for preventing stroke and systemic embolism in people with NVAF with 1 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 1 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 (CG180, 2014).2

  • Historically, the NICE guidelines (NICE CG36, 2006) recommended aspirin monotherapy for stroke prevention in appropriate patients with atrial fibrillation unsuitable for warfarin3
  • It has since been recognised that aspirin monotherapy vs. no treatment increases the risk of bleeding, while providing limited benefit in reducing the risk of stroke4

NICE AF Clinical Guideline (CG180, 2014)
“Do not offer aspirin monotherapy solely for stroke prevention to people with atrial fibrillation”2

NICE Guideline CG180 suggests that anticoagulation may be with ELIQUIS, dabigatran etexilate, rivaroxaban or a vitamin K antagonist. See guideline for further information and for full list of recommendations. Note: edoxaban is not included in these guidelines, as it did not have EU marketing authorisation at the time of publication. However, edoxaban and all other NOACs have received NICE technology appraisal final guidance.

NICE AF guidance on reassessing anticoagulation for a person with poor anticoagulation control on a vitamin K antagonist (CG180, 2014):2

1.5.12

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


  • INR values higher than 5 or 1 INR value higher than 8 within the past 6 months
  • INR values less than 1.5 within the past 6 months
  • TTR less than 65% (new 2014)2

1.5.13

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 consumption (new 2014)2

1.5.14

If poor anticoagulation control cannot be improved, evaluate the risks and benefits of alternative stroke prevention strategies and discuss these with the person (new 2014)2


Only ELIQUIS® is suggested as a consideration over warfarin in patients with NVAF and moderate renal impairment (CG182, 2015).5

NICE CKD Guidelines (CG182, 2015)2
“Consider apixaban in preference to warfarin in people with a confirmed eGFR of 30–50 ml/min/1.73 m2 and NVAF who have ≥1 of the following risk factors:

  • prior stroke or transient ischaemic attack
  • age ≥75
  • hypertension
  • diabetes mellitus
  • symptomatic heart failure”2

ELIQUIS, dabigatran etexilate, rivaroxaban and VKA are all recommended by NICE Clinical Guideline 180 (NICE CG180, 2014) as anticoagulation therapy options for the prevention of stroke in patients with NVAF in line with their respective marketing authorisations.2 Edoxaban was not considered for inclusion in either of the NICE guidelines (NICE CG180, 2014 and NICE CG182, 2015) as it did not have EU marketing authorisation at the time of publication. However, all NOACs have now received NICE Technology Appraisal guidance (NICE TA249 [dabigatran], NICE TA256 [rivaroxaban], NICE TA275 [apixaban] and NICE TA355 [edoxaban]), and all NOACs 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

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

ESC guidance

ESC AF guidelines recommend NOACs – including ELIQUIS – in preference to warfarin as first-line therapy for your eligible patients with NVAF.7

ESC guidelines for the management of AF (2016)
“When oral anticoagulation is initiated in a patient with AF who is eligible for a NOAC (apixaban, dabigatran, edoxaban, or rivaroxaban), a NOAC is recommended in preference to a vitamin K antagonist.”7

ESC AF guidelines recommend oral anticoagulation therapy for prevention of thromboembolism for:7

All male patients with a CHA2-DS2-VASc score of
2 or more7

and

All female patients with a CHA2-DS2-VASc score of 3 or more7

ESC AF guidelines recommend the consideration of NOAC treatment for patients with AF already on treatment with VKA if:7

The patient prefers a NOAC (and there is no contraindication to NOACs, e.g. patient has a prosthetic valve)7

or

TTR is not well controlled despite good adherence (TTR should be kept as high as possible (≥70%) and closely monitored)7

Diagnosemethoden

ELIQUIS is approved for a broad range of indications12

ELIQUIS is available for your patients with NVAF12

ELIQUIS is available for your patients with
DVT / PE12

Stay on top of ELIQUIS product updates


ELIQUIS (apixaban) SmPC

Please click here to access the ELIQUIS SmPC.

ELIQUIS (apixaban) Patient Information Leaflet

Please click here to access the ELIQUIS Patient Information Leaflet.

ADTC = Area Drug and Therapeutic Committee   
AF = Atrial Fibrillation   
CHA2DS2-VASc = Congestive heart failure or left ventricular dysfunction, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled)-Vascular disease, Age 65–74, Sex category (female)   
CKD = Chronic Kidney Disease   
eGFR = Estimated Glomerular Filtration Rate   
ESC = European Society of Cardiology   
NICE = National Institute for Health and Care Excellence   
NOAC = Non-vitamin K antagonist Oral Anticoagulant   
NVAF = Non-Valvular Atrial Fibrillation   
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. Available at https://www.nice.org.uk/guidance/ta275. Last accessed April 2018.
  2. NICE clinical guideline 180. Atrial fibrillation: management. June 2014. Last updated August 2014. Available at http://guidance.nice.org.uk/cg180. Last accessed April 2018.
  3. NICE clinical guideline 36. Atrial fibrillation: the management of atrial fibrillation. June 2006. Available at http://guidance.nice.org.uk/cg36. Last accessed February 2017.
  4. Ogilvie IM et al. Thromb Haemost 2011; 106: 34−44.
  5. NICE clinical guideline 182. Chronic kidney disease in adults: assessment and management. July 2014. Last updated January 2015. Available at https://www.nice.org.uk/guidance/cg182. Last accessed April 2018.
  6. SMC advice. Apixaban 2.5 mg and 5 mg film-coated tablets (ELIQUIS) SMC No. (836/13). January 2013. Available at https://www.scottishmedicines.org.uk/SMC_Advice/Advice/836_13_apixiban_Eliquis/apixaban_Eliquis. Last accessed April 2018.
  7. Kirchhof P et al. Euro Heart J 2016; 37: 2893–2962.
  8. NICE technology appraisal guidance TA341. Apixaban for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism. June 2015. Available at https://www.nice.org.uk/guidance/ta341. Last accessed February 2017
  9. SMC advice. Apixaban 2.5 mg and 5 mg film-coated tablet (ELIQUIS) SMC No. (1029/15). March 2015. Available at https://www.scottishmedicines.org.uk/SMC_Advice/Advice/1029_15_apixaban_Eliquis/apixaban_Eliquis. Last accessed April 2018.
  10. NICE technology appraisal guidance TA245. Apixaban for the prevention of venous thromboembolism after total hip or knee replacement in adults. January 2012. Available at https://www.nice.org.uk/guidance/ta245. Last accessed April 2018.
  11. SMC advice. Apixaban 2.5mg film-coated tablet (ELIQUIS) SMC No. (741/11). November 2011. Available at https://www.scottishmedicines.org.uk/SMC_Advice/Advice/741_11_apixaban_Eliquis/apixiban_Eliquis. Last accessed April 2018.
  12. ELIQUIS® (apixaban) Summary of Product Characteristics.
  13. NICE guideline NG 89 March 2018; Venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism. Available at nice.org.uk/guidance/ng89 Last accessed May 2018