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Written Question
Drugs: Licensing
Tuesday 24th November 2015

Asked by: Nick Thomas-Symonds (Labour - Torfaen)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what discussions he has had with NICE on conducting health technology appraisals for off-patent drugs that have been proven to be effective in new indications.

Answered by George Freeman

My Rt. hon. Friend the Secretary of State has had no discussions with the National Institute for Health and Care Excellence (NICE) on the subject of technology appraisals for off-patent drugs in new indications. NICE does not routinely appraise drugs outside their licensed indications.


NICE does, however, issue evidence summaries which summarise the published evidence for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, where there are no clinically appropriate licensed alternatives. They support decision-making on the use of an unlicensed or off-label medicine for an individual patient, where there are good clinical reasons for its use, usually when there is no licensed medicine for the condition requiring treatment, or the licensed medicine is not appropriate for that individual. Examples of evidence summaries can be found at:


http://www.nice.org.uk/advice?type=esuom


Written Question
Drugs: Licensing
Tuesday 24th November 2015

Asked by: Nick Thomas-Symonds (Labour - Torfaen)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what guidance his Department has provided for clinical commissioning groups on the commissioning of off-patent drugs for use in new indications.

Answered by George Freeman

NHS England supports the national commissioning system in England, including the provision of guidance to the service, where appropriate.


The National Institute for Health and Care Excellence (NICE) does not routinely appraise drugs outside their licensed indications. Where drugs are not appraised by NICE, it is the responsibility of clinical commissioning groups (CCGs) to decide how drugs should be funded locally, in line with any guidance from NHS England. The Department has produced no guidance and had no discussions with CCGs on off-label drug use.


Many thousands of patients benefit from the use of off-patent drugs, off-label, every day in the National Health Service. NICE publishes Evidence Summaries on unlicensed and off-label medicines. These provide a summary of the published evidence for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, usually when there is no licensed medicine for the condition requiring treatment or no licensed medicines are appropriate for a significant proportion of people requiring treatment.









Written Question
Drugs: Licensing
Tuesday 24th November 2015

Asked by: Nick Thomas-Symonds (Labour - Torfaen)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what discussions he has had with clinical commissioning groups on commissioning of off-patent drugs for use in new indications.

Answered by George Freeman

NHS England supports the national commissioning system in England, including the provision of guidance to the service, where appropriate.


The National Institute for Health and Care Excellence (NICE) does not routinely appraise drugs outside their licensed indications. Where drugs are not appraised by NICE, it is the responsibility of clinical commissioning groups (CCGs) to decide how drugs should be funded locally, in line with any guidance from NHS England. The Department has produced no guidance and had no discussions with CCGs on off-label drug use.


Many thousands of patients benefit from the use of off-patent drugs, off-label, every day in the National Health Service. NICE publishes Evidence Summaries on unlicensed and off-label medicines. These provide a summary of the published evidence for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, usually when there is no licensed medicine for the condition requiring treatment or no licensed medicines are appropriate for a significant proportion of people requiring treatment.









Written Question
Drugs
Friday 20th November 2015

Asked by: Nick Thomas-Symonds (Labour - Torfaen)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, pursuant to the Answer given by the Parliamentary Under-Secretary of State for Care Quality during Oral Questions on 17 November 2015 on the establishment of a working party to examine issues regarding the availability of off-patent, repurposed drugs, when the working party was established; what the working party's scope and terms of reference are; which organisations and individuals have been invited to join the working party; and when the next meeting of the working party will be convened.

Answered by George Freeman

The Government has not established a working party in relation to the Off-Patent Drugs Bill. We did hold a roundtable event in February 2015 with key stakeholders including charities and agreed several follow up actions. We have now agreed additional further actions:

- arrange a further roundtable event specifically for those charities who would like to explore the Bill in more detail;

- input in to the work of the Off-Patent Drugs Bill All Party Parliamentary Group; and

- hold a Ministerial drop-in session on 30 November, for those who would like to discuss the Bill further. This will be hosted by myself.


Written Question
Chronic Obstructive Pulmonary Disease
Monday 14th September 2015

Asked by: Nick Thomas-Symonds (Labour - Torfaen)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what steps he is taking to raise awareness of support groups to people with chronic obstructive pulmonary disease.

Answered by Jane Ellison

Raising awareness of support groups to people with chronic obstructive pulmonary disease is not a part of our public awareness campaign on breathlessness, however, we do signpost to the British Lung Foundation and the British Heart Foundation on our website.


Written Question
Chronic Obstructive Pulmonary Disease
Monday 14th September 2015

Asked by: Nick Thomas-Symonds (Labour - Torfaen)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what steps his Department is taking to raise public awareness of chronic obstructive pulmonary disease.

Answered by Jane Ellison

Public Health England has developed a campaign to raise awareness of the symptom of breathlessness which ran as a local pilot in Oldham and Rochdale from 24 February – 23 March 2014 and as a regional pilot in the East of England 2 February – 1 March 2015.

The Breathlessness campaign aims to encourage those with inappropriate breathlessness (breathlessness that is disproportionate to the level of activity undertaken i.e. at rest or on minimal exertion) to go and see their general practitioner (GP). It is primarily aimed at earlier diagnosis of heart and lung disease, including chronic obstructive pulmonary disease, with scope to reduce premature mortality and to improve the quality of life of those living with these conditions. The key message of the campaign is “If you get out of breath doing things that you used to be able to do, see your GP. Getting out of breath could be a sign of heart or lung disease. Finding it early makes it more treatable, so don’t ignore it, tell your doctor”.

Evaluation of the regional pilot is still underway, although early findings from follow-up in-depth interviews with a sample of local GPs and pharmacists and pre and post awareness tracking research among the public, are positive.


Written Question
Drugs: Licensing
Wednesday 9th September 2015

Asked by: Nick Thomas-Symonds (Labour - Torfaen)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what progress has been made in implementing non-legislative measures to provide routine access on the NHS to off-patent drugs that have been proven to be clinically effective for new indications.

Answered by George Freeman

The Department convened a roundtable event on 11 February 2015 to discuss what action, could most expeditiously be taken to ensure that robust evidence about new uses for existing drugs is produced, disseminated and then used to inform clinical decision making about these medicines.

A number of areas were identified where further work could help improve matters, including:

- supporting clinicians to identify the latest robust evidence on patient care and take it up in their own practice; and

- supporting and mapping clear pathways for innovators and those who want to "re-purpose" drugs.

Officials have since been engaging with stakeholders to progress outputs associated with this event.


Written Question
Drugs: Licensing
Wednesday 9th September 2015

Asked by: Nick Thomas-Symonds (Labour - Torfaen)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what steps his Department has taken to act upon the outcomes of the stakeholder roundtable discussion it convened on 11 February 2015 on access to off-patent drugs.

Answered by George Freeman

The Department convened a roundtable event on 11 February 2015 to discuss what action, could most expeditiously be taken to ensure that robust evidence about new uses for existing drugs is produced, disseminated and then used to inform clinical decision making about these medicines.

A number of areas were identified where further work could help improve matters, including:

- supporting clinicians to identify the latest robust evidence on patient care and take it up in their own practice; and

- supporting and mapping clear pathways for innovators and those who want to "re-purpose" drugs.

Officials have since been engaging with stakeholders to progress outputs associated with this event.


Written Question
Drugs: Licensing
Wednesday 9th September 2015

Asked by: Nick Thomas-Symonds (Labour - Torfaen)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what the outcome was of the stakeholder roundtable discussion on off-patent drugs convened by his Department on 11 February 2015.

Answered by George Freeman

The Department convened a roundtable event on 11 February 2015 to discuss what action, could most expeditiously be taken to ensure that robust evidence about new uses for existing drugs is produced, disseminated and then used to inform clinical decision making about these medicines.

A number of areas were identified where further work could help improve matters, including:

- supporting clinicians to identify the latest robust evidence on patient care and take it up in their own practice; and

- supporting and mapping clear pathways for innovators and those who want to "re-purpose" drugs.

Officials have since been engaging with stakeholders to progress outputs associated with this event.


Written Question
Drugs: Licensing
Wednesday 9th September 2015

Asked by: Nick Thomas-Symonds (Labour - Torfaen)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, with which organisations and individuals (a) Ministers and (b) officials in his Department have discussed the availability of repurposed off-patent drugs on the NHS since 12 February 2014.

Answered by George Freeman

Following the 11 February 2015 Roundtable Event on ‘Translating Evidence in to Clinical Practice’, officials are continuing to work with key stakeholders including charities, health professional networks, the General Medical Council, the National Institute for Health and Care Excellence and the Medicines & Healthcare products Regulatory Agency. Officials have since been engaging with stakeholders to progress outputs associated with this event.