Information intended for healthcare professionals only.
The production of this Guidelines card has been commissioned by Bayer plc. Bayer plc has reviewed this card for technical accuracy and regulatory compliance. The SMC has reviewed this card for technical accuracy and permission request only. The SMC were not involved in the production of this card.
Rivaroxaban (Xarelto®) SMC21281
The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows:
Advice: following a full submission
rivaroxaban (Xarelto) is accepted for restricted use within NHS Scotland.
Indication under review: Co-administered with acetylsalicylic acid for the prevention of atherothrombotic events in adult patients with:
- coronary artery disease, or
- symptomatic peripheral artery disease
at high risk of ischaemic events.
SMC restriction: use in patients with stable coronary artery disease that does not require dual antiplatelet therapy.
Addition of rivaroxaban to low-dose aspirin (acetylsalicylic acid) reduced the incidence of a composite outcome that included stroke, cardiovascular death and myocardial infarction, mainly due to reductions in stroke and cardiovascular death. It also increased the incidence of major bleeding.
About the SMC
The purpose of the SMC is to accept for use those newly licensed medicines that clearly represent good value for money to NHS Scotland. SMC analyses information supplied by the medicine manufacturer on the health benefits of the medicine and justification of its price. As the NHS has limited resources, the SMC works to make sure that those medicines which represent good value for money are accepted for routine use as quickly as possible so that they can benefit patients.
- Scottish Medicines Consortium. rivaroxaban (Xarelto) SMC2128. SMC, February 2019. www.scottishmedicines.org.uk/medicines-advice/rivaroxaban-xarelto-fullsubmission-smc2128/
This Guidelines card, which summarises Scottish Medicines Consortium (SMC) advice on rivaroxaban, has been initiated by Bayer plc. Bayer plc has reviewed this card for technical accuracy and regulatory compliance. Bayer plc has provided the prescribing information. The SMC has reviewed this card for technical accuracy and permission request only. The SMC was not involved in the production of this card. Copyright in the guidance rests with the SMC, and it may be freely reproduced for educational and not-for-profit purposes. No reproduction by, or for, commercial organisations, or for commercial purposes, is allowed without the express written permission of the SMC. The SMC guidance provided on this page is reproduced with permission of the Scottish Medicines Consortium. This card only displays the concise SMC guidance; readers are strongly advised to refer to the full guidance at www.scottishmedicines.org.uk. MGP Ltd owns copyright of the Guidelines brand, logo, and the design and format of this Guidelines card. The views and opinions expressed are not necessarily those of Bayer plc, or of Guidelines, its publisher, advisers, or advertisers.
Date of preparation: February 2019