It is important that patients on warfarin have regular blood tests to monitor their International Normalised Ratio levels. Patients can be tested in their general practice (GP) surgery or hospital anticoagulant clinic. The Department has not made an assessment of how best to provide coagulometers as the decision on how best to run and fund testing is a local decision. Self-testing is possible if the clinician was confident of the results and if the GP or anticoagulant clinic chose to fund the testing in this way. We are not aware of patients being asked to pay for a coagulometer to self-test.

The country is well prepared to deal with any impacts of COVID-19 and we have stockpiles of generic drugs, in the event of any supply issues or significant increases in demand.

The Department is working closely with industry, the National Health Service and others in the supply chain to help ensure patients can access the medicines they need, and precautions are in place to reduce the likelihood of future shortages.

The steps being taken to protect United Kingdom supplies in response to the COVID-19 outbreak were set out in the Department’s press statement issued on 11 February 2020. This statement can be read at the following link:

https://www.gov.uk/government/news/government-to-monitor-impact-of-coronavirus-on-uk-medicine-supply

No assessment has been made of the merits of reclassification of warfarin clinics as anti-coagulation clinics as provision of these is a matter for clinical commissioning groups.

Information on the number of patients on long-term Warfarin prescriptions who have access to self-monitoring technology is not collected centrally.

NHS England and clinical commissioning groups (CCGs) have responsibility for commissioned services for patients who receive anticoagulation treatments. It is for individual CCGs to commission treatment and services for patients on anticoagulation treatment or other medications which require monitoring, as they are best placed to identify what is needed in their local areas.

There is guidance in place to support CCGs in planning services for patients who receive anticoagulation treatments. Under its Diagnostics Assessment Programme, the National Institute for Health and Care Excellence (NICE) has published guidance on self-monitoring of anticoagulation treatments which is attached and also available at:

http://www.nice.org.uk/guidance/dg14

NICE has also published quality standards on the management and treatment of atrial fibrillation which set out that self-monitoring should be offered as an option to appropriate patients. The guidance is also attached and available at:

http://www.nice.org.uk/guidance/qs93/chapter/Quality-statement-6-developmental-Selfmonitoring-of-anticoagulation

Warfarin was until recently approved for use in plant protection products against grey squirrels. That approval expired on 31 March 2014, although if purchased before that date it may be used until 30 September 2015. A new application for approval may be submitted at any time. Defra would like people to have the tools that they need to control grey squirrels. However, it is a commercial decision for the company that manufactures the product whether to apply for approval. Warfarin remains approved for indoor use in biocidal products for control of grey squirrels which may find their way into property and cause a nuisance.

This information is not collected centrally.

Responsibility for determining the overall national approach to improving clinical outcomes from health care services lies with NHS England. Support for people with long-term conditions is covered in the NHS Outcomes Framework and in the mandate to NHS England. Through the mandate we are monitoring how well the national health service is performing in supporting people to look after themselves.

It is for individual clinical commissioning groups (CCGs) to commission treatment and services for patients on long-term warfarin or other medications which require monitoring, as they are best placed to identify what is needed in their local areas. It is the responsibility of NHS England to support CCGs and ensure that they are safely and effectively discharging their commissioning responsibilities, and are making progress in delivering outcomes. This support may include providing supportive commissioning resources, tools or guidance.

Under its Diagnostics Assessment Programme, the National Institute for Health and Care Excellence (NICE) is developing guidance on self-monitoring coagulometers for self-testing or self-managing coagulation status in patients with atrial fibrillation or heart valve disease for whom long-term vitamin K antagonist therapy is intended. NICE expects to issue guidance in July 2014. NHS England advises that it will then consider what action, if any, is required, taking this guidance into account.

NHS England advises that information on the number of patients who are on warfarin long-term and use self-monitoring technology is not collected as it is difficult for accurate and meaningful information to be gathered and reported. This is due to the way in which self-monitoring technology is available to patients via CCGs or purchased privately. The Department has no plans to collect these data.

Responsibility for determining the overall national approach to improving clinical outcomes from health care services lies with NHS England. Support for people with long-term conditions is covered in the NHS Outcomes Framework and in the mandate to NHS England. Through the mandate we are monitoring how well the national health service is performing in supporting people to look after themselves.

It is for individual clinical commissioning groups (CCGs) to commission treatment and services for patients on long-term warfarin or other medications which require monitoring, as they are best placed to identify what is needed in their local areas. It is the responsibility of NHS England to support CCGs and ensure that they are safely and effectively discharging their commissioning responsibilities, and are making progress in delivering outcomes. This support may include providing supportive commissioning resources, tools or guidance.

Under its Diagnostics Assessment Programme, the National Institute for Health and Care Excellence (NICE) is developing guidance on self-monitoring coagulometers for self-testing or self-managing coagulation status in patients with atrial fibrillation or heart valve disease for whom long-term vitamin K antagonist therapy is intended. NICE expects to issue guidance in July 2014. NHS England advises that it will then consider what action, if any, is required, taking this guidance into account.

NHS England advises that information on the number of patients who are on warfarin long-term and use self-monitoring technology is not collected as it is difficult for accurate and meaningful information to be gathered and reported. This is due to the way in which self-monitoring technology is available to patients via CCGs or purchased privately. The Department has no plans to collect these data.

No assessment has been made by the Department or NHS England of the costs to the national health service of people on long-term warfarin having to attend regular general practitioner or hospital appointments for simple blood tests or of the potential annual cost savings to the NHS of people with diabetes being able to self-monitor their blood glucose levels

Responsibility for determining the overall national approach to improving clinical outcomes from health care services lies with NHS England.

It is for individual clinical commissioning groups (CCGs) to commission treatment and services for patients on long-term warfarin or other medications which require monitoring, as they are best placed to identify what is needed in their local areas. It is the responsibility of NHS England to support CCGs and ensure that they are safely and effectively discharging their commissioning responsibilities, and are making progress in delivering outcomes. This support may include providing supportive commissioning resources, tools or guidance.

No assessment has been made by the Department or NHS England of the costs to the national health service of people on long-term warfarin having to attend regular general practitioner or hospital appointments for simple blood tests or of the potential annual cost savings to the NHS of people with diabetes being able to self-monitor their blood glucose levels

Responsibility for determining the overall national approach to improving clinical outcomes from health care services lies with NHS England.

It is for individual clinical commissioning groups (CCGs) to commission treatment and services for patients on long-term warfarin or other medications which require monitoring, as they are best placed to identify what is needed in their local areas. It is the responsibility of NHS England to support CCGs and ensure that they are safely and effectively discharging their commissioning responsibilities, and are making progress in delivering outcomes. This support may include providing supportive commissioning resources, tools or guidance.

Data on the use of treatments for atrial fibrillation (AF) are not centrally collected. However, data on the percentage¹ of patients with AF who receive either oral anticoagulant drug therapy or an anti-platelet therapy² is collected via the Quality and Outcomes Framework (QOF) AF3 indicator. The latest data available is from 2011-12 where this percentage in England was 93.7%³.

Responsibility for determining the overall national approach to improving clinical outcomes from health care services lies with NHS England. We are advised NHS England has no plans to introduce a national patient survey for users of anticoagulation services.

It is for individual clinical commissioning groups to commission treatment and services for patients with AF as they are best placed to identify what is needed in their local areas.

Under its Diagnostics Assessment Programme, the National Institute for Health and Care Excellence (NICE) is developing guidance on self-monitoring coagulometers for self-testing or self-managing coagulation status in patients with AF or heart valve disease for whom long-term vitamin K antagonist therapy is intended. NICE expects to issue guidance in July 2014. NHS England advises that it will then consider what action, if any, is required, taking this guidance into account.¹ The percentage is that of patients with AF whose records show they have been prescribed anti-coagulant or anti-platelet drug therapy in the preceding six months.² For the purposes of the QOF, acceptable anti-coagulation agents are warfarin and phenindione, acceptable anti-platelet agents are aspirin, clopidogrel and dipyridamole.³ Source:

Health and Social Care Information Centre

NHS England has advised that information on the number of patients who are on warfarin long-term and use self-monitoring technology is not collected as it is difficult for accurate and meaningful information to

be gathered and reported. This is due to the way in which self-monitoring technology is available to patients via clinical commissioning groups or purchased privately.

Neither the Department nor NHS England has made an estimate of the number of people on warfarin who do not self-monitor their own condition due to the cost of buying the necessary self-monitoring devices. However, we understand that the charity Anticoagulation Self-Monitoring Alliance has a number of case studies highlighting instances where this has occurred.

The National Institute for Health and Care Excellence is currently undertaking an assessment of the self-monitoring technology and will be reporting on its clinical and cost effectiveness in the summer of 2014. Depending on the outcome of this assessment, further evaluation will be taken at the time to determine what action, if any, is required.

NHS England has advised that information on the number of patients who are on warfarin long-term and use self-monitoring technology is not collected as it is difficult for accurate and meaningful information to

be gathered and reported. This is due to the way in which self-monitoring technology is available to patients via clinical commissioning groups or purchased privately.

Neither the Department nor NHS England has made an estimate of the number of people on warfarin who do not self-monitor their own condition due to the cost of buying the necessary self-monitoring devices. However, we understand that the charity Anticoagulation Self-Monitoring Alliance has a number of case studies highlighting instances where this has occurred.

The National Institute for Health and Care Excellence is currently undertaking an assessment of the self-monitoring technology and will be reporting on its clinical and cost effectiveness in the summer of 2014. Depending on the outcome of this assessment, further evaluation will be taken at the time to determine what action, if any, is required.

Responsibility for determining the overall national approach to improving clinical outcomes from healthcare services lies with NHS England.

We are advised that NHS England has made no assessment of the number of long-term warfarin users in England who have the opportunity to self-monitor their blood clotting levels.

It is for individual clinical commissioning groups (CCGs) to commission treatment and services as they are best placed to identify what is needed in their local areas. National Institute for Health and Care Excellence guidelines and quality standards provide evidence on best practice and CCGs use these to help inform their commissioning intentions. NHS Improving Quality, working with the Strategic Clinical Networks, is supporting commissioners and providers to deliver the right services.

Responsibility for determining the overall national approach to improving clinical outcomes from healthcare services lies with NHS England.

We are advised that NHS England has made no assessment of the number of long-term warfarin users in England who have the opportunity to self-monitor their blood clotting levels.

It is for individual clinical commissioning groups (CCGs) to commission treatment and services as they are best placed to identify what is needed in their local areas. National Institute for Health and Care Excellence guidelines and quality standards provide evidence on best practice and CCGs use these to help inform their commissioning intentions. NHS Improving Quality, working with the Strategic Clinical Networks, is supporting commissioners and providers to deliver the right services.

Responsibility for determining the overall national approach to improving clinical outcomes from healthcare services lies with NHS England.

We are advised that NHS England has made no assessment of the number of long-term warfarin users in England who have the opportunity to self-monitor their blood clotting levels.

It is for individual clinical commissioning groups (CCGs) to commission treatment and services as they are best placed to identify what is needed in their local areas. National Institute for Health and Care Excellence guidelines and quality standards provide evidence on best practice and CCGs use these to help inform their commissioning intentions. NHS Improving Quality, working with the Strategic Clinical Networks, is supporting commissioners and providers to deliver the right services.

There is no statutory prohibition on national health service organisations providing prescribing guidance to clinicians.

Clinicians can prescribe any product which they consider necessary for the treatment of their patient under the NHS. This is subject to two provisos in primary care: firstly, that the product is not included in Schedules 1 or 2 to the NHS (General Medical Services contract) Regulations 2004 and secondly, that the clinician is prepared to justify any challenges to their prescribing by the relevant NHS commissioner. The availability of specific prescribed treatments in NHS secondary care may be subject to the agreement of the relevant commissioner to fund them, but NHS commissioners are required to fund drugs and treatments recommended in National Institute for Health and Care Excellence technology appraisal guidance where a clinician believes they are appropriate.

Prescription charges and the cost of prescription prepayment certificates (PPCs) have historically been reviewed and announced towards the end of a financial year. PPCs are available for those who need a number of prescriptions in a limited time period, or frequent prescriptions over the course of a year and can reduce the cost of paying for medicines. A patient may be entitled to free prescriptions if they meet one of the exemption criteria identified in legislation, such as a qualifying medical condition.

The Department has made no such assessment.

Dabigatran etexilate (Pradaxa) and rivaroxaban (Xarelto) both hold European marketing authorisations. Dabigatran etexilate is indicated for the prevention of the formation of blood dots in the veins in adults who have had an operation to replace a hip or knee, and to prevent strokes and the formation of clots in adults with non-valvular atrial fibrillation who are considered to be at risk of stroke. Rivaroxaban is indicated for the prevention of venous thromboembolism in patients who are undergoing surgery to replace a hip or knee; the prevention of stroke caused by a blood clot in the brain and systemic embolism in patients with non-valvular atrial fibrillation; to treat deep vein thrombosis (DVT) and pulmonary embolism following a severe case of DVT; and to prevent DVT reoccurring.

The National Institute for Health and Clinical Excellence (NICE) has issued technology appraisal (TA) guidance to the national health service on the use of dabigatran etexilate and rivaroxaban for a number of indications. Details of NICE'S guidance are shown in the table.

Other than those representations received in the Department's capacity as a stakeholder in appraisals, we have not received any representations from NICE on these drugs.

The Government do not specify the content of medical training curricula. The content and standard of medical training is the responsibility of the General Medical Council (GMC), which is an independent professional body and the competent authority for medical training in the United Kingdom. Its role is that of custodian of quality standards in medical education and practice.

Guidance and information for general practitioners and patients about anticoagulation services, including the role of self-monitoring, has been published by the National Institute for Health and Clinical Excellence (NICE) Commissioning Guide: Anticoagulation Therapy Service (NICE, 2007) and NHS Improvement: Anticoagulation for Atrial Fibrillation: A Simple Overview to Support the Commissioning of Quality Services (2011). Copies of these documents have been placed in the Library.