National Institute for Health and Care Excellence
Regulator / Inspectorate
Noted
AI-generated response summary
• NICE described existing guidance relevant to the management of Direct Oral Anticoagulants (DOACs), including cross-referencing MHRA safety advice and technology appraisal guidance on reversal agents. • NICE stated it would continue to monitor new evidence in this area of practice. • NICE indicated it would develop or update its guidance accordingly, should new evidence emerge.
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Dear Ms Bewley,
I write in response to your regulation 28 report, regarding the very sad death of Mrs Ruth Eggleton. I would like to express my sincere condolences to Mrs Eggleton’s family. The National Institute for Health and Care Excellence (NICE) has reflected on the circumstances surrounding Mrs Eggleton’s death and the concerns raised in your report regarding the lack of an evidence-based protocol for determining when to withhold and/or reverse a DOAC, and when to prescribe alternative anticoagulant medication. We agree that consideration should be given to reversing and withholding anticoagulation when a person prescribed these medications experiences significant bleeding. The reason for anticoagulation (which is not mentioned in your report) must be balanced against the estimated risk of further bleeding. In rare cases, alternative anticoagulation may be considered. Unfortunately, there is very little research evidence on which guidelines relevant to this complex decision could be based, and a high degree of clinical judgement is required in each case. NICE has some published guidance relevant to this topic, for example in recommendation 1.5.13 of our guideline on head injury: assessment and early management [NG232] we cross-reference the MHRA safety advice on DOACs for a list of reversal agents and NICE's technology appraisal guidance on andexanet alfa for reversing anticoagulation from apixaban or rivaroxaban. However, it is impractical for NICE to develop useful and useable guidance in circumstances where high- quality evidence is lacking, and decisions must be carefully tailored to the individual circumstances of each patient.
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NICE will continue to monitor new evidence in this area of practice, and will develop or update our guidance accordingly. Please do let me know if you require any further information and again, I offer my sincerest condolences to Mrs Eggleton’s family.
I write in response to your regulation 28 report, regarding the very sad death of Mrs Ruth Eggleton. I would like to express my sincere condolences to Mrs Eggleton’s family. The National Institute for Health and Care Excellence (NICE) has reflected on the circumstances surrounding Mrs Eggleton’s death and the concerns raised in your report regarding the lack of an evidence-based protocol for determining when to withhold and/or reverse a DOAC, and when to prescribe alternative anticoagulant medication. We agree that consideration should be given to reversing and withholding anticoagulation when a person prescribed these medications experiences significant bleeding. The reason for anticoagulation (which is not mentioned in your report) must be balanced against the estimated risk of further bleeding. In rare cases, alternative anticoagulation may be considered. Unfortunately, there is very little research evidence on which guidelines relevant to this complex decision could be based, and a high degree of clinical judgement is required in each case. NICE has some published guidance relevant to this topic, for example in recommendation 1.5.13 of our guideline on head injury: assessment and early management [NG232] we cross-reference the MHRA safety advice on DOACs for a list of reversal agents and NICE's technology appraisal guidance on andexanet alfa for reversing anticoagulation from apixaban or rivaroxaban. However, it is impractical for NICE to develop useful and useable guidance in circumstances where high- quality evidence is lacking, and decisions must be carefully tailored to the individual circumstances of each patient.
Page | 2
NICE will continue to monitor new evidence in this area of practice, and will develop or update our guidance accordingly. Please do let me know if you require any further information and again, I offer my sincerest condolences to Mrs Eggleton’s family.