Purpose
This document replaces the Operational note published in January 2022 (PAR1279).
These updated commissioning recommendations reflect the loss of exclusivity of apixaban, enabling sufficient stock of generic product to be available to the NHS. The recommendations restate the commitment to ensure undiagnosed and untreated atrial fibrillation (AF) are addressed, as a priority for the improvement of national cardiovascular disease (CVD) outcomes.
All direct-acting oral anticoagulant indications
It is for the prescribing clinician to determine which Direct-acting Oral Anticoagulant(s) (DOACs) are clinically appropriate for an individual patient based upon the relevant NICE technology appraisal guidance.
Atrial Fibrillation
Treatment options
NICE Guidance (NG196 1.6.3 and 1.6.4 published 27 April 2021) states that “apixaban, dabigatran, edoxaban and rivaroxaban are all recommended as options for the treatment of atrial fibrillation, when used in line with the criteria specified in the relevant NICE technology appraisal guidance”.
NICE Guidance (NG196 1.6.5 published 27 April 2021) states that “if DOACs are contraindicated, not tolerated or not suitable in people with atrial fibrillation, then offer a vitamin K antagonist”.
Reviewing treatment
NICE Guidance (NG196 1.6.6 published 27 April 2021) states that “for adults with atrial fibrillation who are already taking a vitamin K antagonist 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”.
NICE Guidance (NG196 1.6.16 published 27 April 2021) states that “For people who are taking an anticoagulant, review the need for anticoagulation and the quality of anticoagulation (taking into account MHRA advice on direct-acting oral anticoagulants about bleeding risk and the need to monitor renal function in patients with renal impairment) at least annually, or more frequently if clinically relevant events occur affecting anticoagulation or bleeding risk”.
Treatment selection
For patients commencing treatment for AF: subject to the criteria specified in the relevant NICE technology appraisal guidance, clinicians should use the best value DOAC that is clinically appropriate for the patient.
Table 1 provides the available DOACs ranked from highest to lowest best value according to the November 2023 Drug Tariff and confidential framework prices.
Table 1
| Overall rank | DOAC | Notes |
|---|---|---|
| 1 (Best value) | generic apixaban | Best value twice a day treatment |
| 2 | Edoxaban (Lixiana®) | Best value once a day treatment |
| 3 | Rivaroxaban (Xarelto®) |
|
| 4 | Dabigatran (Pradaxa®) |
|
| 5 | Eliquis® (branded apixaban) |
|
If the highest ranked best value DOAC (generic apixaban) is contraindicated or not clinically appropriate for the specific patient then, subject to the criteria specified in the relevant NICE technology appraisal guidance, clinicians should then consider the next highest ranked DOAC (edoxaban) and so on until an appropriate treatment is identified.
For patients already prescribed a DOAC for the treatment of AF: subject to the criteria specified in the relevant NICE technology appraisal guidance, commissioners may wish to consider developing local policy to review patients’ current treatment.
When developing local policy, commissioners are encouraged to:
- Prioritise the identification of undiagnosed AF to allow earlier anticoagulation, where appropriate.
- Prioritise for review patients with AF who are not currently anticoagulated and initiate anticoagulation where appropriate.
- Ensure all patients prescribed DOACs have had a review of treatment and dose within the past 12 months.
- Ensure patients prescribed a vitamin K antagonist for stroke prevention in AF are reviewed to assess whether a DOAC is more appropriate.
- Where consideration is being given to changing between DOACs, take into account the specific risks of moving from a once-a-day treatment to a twice-a-day treatment (or vice-versa) and implement appropriate safeguards to ensure patients take the alternative drug correctly.
Detect, protect and perfect initiatives and investments
Detect, protect and perfect initiatives
The commercial framework for DOAC medications included Detect, Protect & Perfect initiatives available from Daiichi Sankyo & Bayer.
The investments committed by Bayer have now been fully allocated an no further DPP applications will be considered.
The investments committed by Daiichi Sankyo have not yet been fully allocated and therefore for the time being, remain open for applications. The grant application can be accessed here: DPP_Grant_Application_form.pdf (daiichi-sankyo.co.uk)