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To ask the Secretary of State for Health and Social Care, whether he has considered requesting the National Institute for Clinical Excellence to set national clinical guidelines for developmental language disorders.
To ask the Secretary of State for Health and Social Care, whether he has considered requesting the National Institute for Clinical Excellence to set national clinical guidelines for developmental language disorders.
Topics for new or updated National Institute for Health and Care Excellence (NICE) guidance are considered through an established prioritisation process. Decisions as to whether NICE will create new, or update existing, guidance are overseen by a prioritisation board, chaired by NICE’s Chief Medical Officer.
The NICE Prioritisation Board considered developmental language disorder: diagnosis and management as a topic for guidance development at its meeting on 20 November 2025. They recognised that developmental language disorder is a significant condition that affects a large population. However, they agreed that there is unlikely to be sufficient evidence available at this time to be able to develop a useful and usable guideline. Therefore, the topic was not selected for guidance development at this time.
A briefing on the licensing, regulation and supply of new weight loss medications in England.
A briefing on the licensing, regulation and supply of new weight loss medications in England.
To ask the Secretary of State for Health and Social Care, whether (a) the Medicines and Healthcare products Regulatory Agency and (b) NICE will prioritise the regulatory timelines for medical devices that (i) respond to conditions outlined in the Major Conditions Strategy and (ii) where there is unmet need.
To ask the Secretary of State for Health and Social Care, whether (a) the Medicines and Healthcare products Regulatory Agency and (b) NICE will prioritise the regulatory timelines for medical devices that (i) respond to conditions outlined in the Major Conditions Strategy and (ii) where there is unmet need.
The Priority Review programme is not currently planned, but the Government is taking other significant steps for medical device regulatory reform, as part of a broader Medical Technology Strategy. Further information on the Medical Technology Strategy is available at the following link:
https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices, and designates United Kingdom Approved Bodies to conduct conformity assessments against the relevant regulatory requirements. The MHRA works closely with Approved Bodies to ensure their timely assessment.
Following a consultation on the future regulation of medical devices in 2021, the MHRA is leading a programme of work to introduce updated regulations for medical devices that prioritise patient safety, improve patient access to innovative medical devices, and ensure the UK remains an attractive market for medical technology innovators. In January of this year, the MHRA published a MedTech Regulatory roadmap that sets out the main activities in implementing the future regulations throughout 2024 and 2025. An international recognition framework for medical devices will form part of the future regulatory framework, which will provide an alternative route to the UK’s market, by leveraging approvals from comparable international regulators. The MHRA aims to publish an outline of the International Recognition Framework for medical devices later this spring, aligned to the Life Sciences Council, subject to necessary approvals.
In addition, the MHRA is leading the reform of the medical devices regulatory landscape and includes a new pathway to accelerate access to safe, innovative medical devices to help meet the unmet needs of patients. The Innovative Devices Access Pathway aims to bring new medical technologies and solutions to the National Health Service, to support the medical needs that are not currently being met. There are eight innovative medical technologies included in the pilot phase.
We are working alongside others to further the Life Sciences Vision, particularly improving regulation and regulatory processes around medical devices, and supporting broader ambitions in the vision aligned to the conditions set out in the Major Conditions Strategy. As we work to update the medical devices regulatory landscape, the MHRA is taking the Major Conditions Strategy into consideration, including the six groups of major health conditions.
The National Institute for Health and Care Excellence (NICE) is not a regulator but makes recommendations for the NHS on whether selected medical devices should be routinely adopted by the NHS, based on an assessment of their costs and benefits. Medical devices are prioritised for the NICE’s evaluation, in line with NICE’s published topic selection manual.
To ask the Secretary of State for Health and Social Care, if she will make a comparative assessment of the adequacy of the reasons the (a) National Institute for Health and Care Excellence has been unable and (b) Scottish Medicines Consortium has been able to recommend Enhertu for use on...
To ask the Secretary of State for Health and Social Care, if she will make a comparative assessment of the adequacy of the reasons the (a) National Institute for Health and Care Excellence has been unable and (b) Scottish Medicines Consortium has been able to recommend Enhertu for use on...
The National Institute for Health and Care Excellence (NICE) makes authoritative, evidence-based recommendations for the National Health Service in England on whether new licensed medicines should be routinely funded by the NHS, based on an assessment of their costs and benefits. Decisions on the availability of medicines in Scotland are a matter for the devolved administration.
The NICE published guidance in 2021 and 2023 recommending Enhertu, also known as trastuzumab deruxtecan, for the treatment of NHS patients with HER2-positive breast cancer through the Cancer Drugs Fund, and it is now available to eligible NHS patients in England in line with the NICE’s recommendations.
The NICE is currently evaluating Enhertu for the treatment of metastatic HER2-low breast cancer, and has not yet published final guidance. Stakeholders have had an opportunity to appeal against the NICE’s draft recommendations, and the NICE will consider any appeals through the established process and publish final guidance in due course.
To ask the Secretary of State for Health and Social Care, whether he is taking steps to ensure that the National Institute for Clinical Excellence and the Scottish Medicines Consortium collaborate effectively on drug approvals for metastatic breast cancer treatment.
To ask the Secretary of State for Health and Social Care, whether he is taking steps to ensure that the National Institute for Clinical Excellence and the Scottish Medicines Consortium collaborate effectively on drug approvals for metastatic breast cancer treatment.
The National Institute for Health and Care Excellence (NICE) is committed to publishing draft recommendations on all newly licensed treatments around the time of licensing in England and works closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure that licensing procedures and health technology assessments are as streamlined as possible.
Both NICE and the Scottish Medicines Consortium are permanent partners in the Innovative Licensing and Access Pathway which supports more rapid review and approval of promising new cancer treatments.
NICE is an England-only body. Health is a devolved matter and as such decisions on access to drugs in Scotland is a matter for the devolved Government.
The amendment is in my name and that of the noble and learned Lord, Lord Woolf. This group includes four amendments, three of which are mine. I am glad to see in it too Amendment 124, in the name of the noble Lord, Lord Hunt, because it goes to similar...
The amendment is in my name and that of the noble and learned Lord, Lord Woolf. This group includes four amendments, three of which are mine. I am glad to see in it too Amendment 124, in the name of the noble Lord, Lord Hunt, because it goes to similar...
That this House is concerned that the National Institute for Health and Clinical Excellence (NICE) has rejected official appeals by organisations including the Alzheimer's Society, Royal College of Nursing, Age Concern and the Royal College of Psychiatrists against NICE's decision to restrict access to NHS drug treatments to people in the moderate stages of Alzheimer's disease; notes that thousands of people with dementia, their carers, doctors and nurses have made representations to NICE that these drugs improve quality of life at a cost of ??2.50 per person per day; is concerned that NICE is proposing that from 22nd November 2006 clinicians should not prescribe effective drug treatments on the NHS to people in the early and late stages of Alzheimer's disease; is concerned that NICE recommends using the MMSE memory test to govern access to the drugs; believes that NICE's decision ignores the benefits the drugs bring to carers of people with Alzheimer's disease; fears that the decision will lead to an increase in NHS prescribing of dangerous sedative drugs; is further concerned that NICE does not have an independent appeal process; notes that NICE's appraisal of drugs for Alzheimer's disease has concluded; believes that the Department of Health now has a duty to ensure that doctors should be able to use their clinical discretion to prescribe effective Alzheimer's drug treatments; and urges the Secretary of State for Health to issue guidance to the NHS which makes clear that funding must be provided to allow clinicians flexibility to prescribe as appropriate.
That this House is concerned that the National Institute for Health and Clinical Excellence (NICE) has rejected official appeals by organisations including the Alzheimer's Society, Royal College of Nursing, Age Concern and the Royal College of Psychiatrists against NICE's decision to restrict access to NHS drug treatments to people in...
That this House is deeply concerned by the final decision of the National Institute for Health and Clinical Excellence (NICE) on drugs for Alzheimer's disease, which restricts access to NHS treatment to people in the moderate stages of the disease; believes that Alzheimer's drugs are clinically and cost-effective; notes that the drug treatments cost only ??2.50 per person per day; is concerned that clinicians will be prevented from prescribing effective drugs to thousands of people in the early and late stages of dementia; is deeply concerned that prohibiting Ebixa on the NHS, the only treatment available for people in the later stages, will lead to an increase in the prescription of dangerous sedative drugs; further believes people with dementia should be entitled to good quality care and access to effective drug treatments; further believes that this decision contradicts Government policy on early intervention, support for carers and maintaining independence; supports the appeal by members of the Action on Alzheimer's Drugs Alliance to NICE to overturn this damaging decision; further notes that the Department of Health has raised serious concerns about the way NICE has calculated the cost-effectiveness of these drugs; further believes that the Department of Health has a duty to hold NICE to account in circumstances where there are flaws in NICE's appraisal process; and calls upon the Government to consider seriously how people in the early and later stages of Alzheimer's disease can continue to have access to treatment.
That this House is deeply concerned by the final decision of the National Institute for Health and Clinical Excellence (NICE) on drugs for Alzheimer's disease, which restricts access to NHS treatment to people in the moderate stages of the disease; believes that Alzheimer's drugs are clinically and cost-effective; notes that...
That this House is disturbed and disappointed by the decision of the National Institute for Health and Clinical Excellence (NICE) to confirm its draft guidance published in January to restrict the prescription of the drugs donepezil, galantamine and rivastigmine to moderately severe sufferers of Alzheimer's; believes that this decision neglects patients at the early stages of the disease by denying them treatment which can prolong their ability to think and act independently; further believes that this decision neglects more severe sufferers of the disease as Exiba, currently the only drug available to treat the severe behavioural symptoms which occur in the later stages of Alzheimer's, is no longer available thus leaving the prescription of potentially dangerous sedatives as the only option for doctors; is concerned that this decision will put increased pressure on the family carers who care for the people afflicted with the disease; and urges NICE to review this decision and put patients' well-being at the fore of its considerations.
That this House is disturbed and disappointed by the decision of the National Institute for Health and Clinical Excellence (NICE) to confirm its draft guidance published in January to restrict the prescription of the drugs donepezil, galantamine and rivastigmine to moderately severe sufferers of Alzheimer's; believes that this decision neglects...
That this House notes with regret the sad death of Mr Jack Wilson, aged 66 years, of Washington on Sunday from bowel cancer; offers its deepest sympathies to Mr Wilson's family; further notes that Mr Wilson had been refused Cetuximab and may have survived longer had he received this treatment when requested; believes that other lives may be prolonged if the National Institute for Health and Clinical Excellence (NICE) becomes more effective in its role of ensuring parity of treatment throughout England; and urges the Government to fund all clinically agreed drug treatments and speed up NICE approvals so that the chance to live longer is not dependent on private means or where a person lives.
That this House notes with regret the sad death of Mr Jack Wilson, aged 66 years, of Washington on Sunday from bowel cancer; offers its deepest sympathies to Mr Wilson's family; further notes that Mr Wilson had been refused Cetuximab and may have survived longer had he received this treatment...
To ask the Secretary of State for Health what steps she will take to expedite the approval of (a) Xeloda and (b) Cetuximab by the National Institute for Health and Clinical Excellence.
To ask the Secretary of State for Health what steps she will take to expedite the approval of (a) Xeloda and (b) Cetuximab by the National Institute for Health and Clinical Excellence.
That this House welcomes the announcement from the National Institute for Health and Clinical Excellence (NICE) that it has passed proposals to reform the process of appraising health technologies to the Department of Health; is shocked at CancerBACUP's report that there are currently 23 licensed cancer drugs which have been delayed by the current system for many months, potentially affecting the lives of cancer patients across England and Wales; urges the Government to look urgently at the proposals from NICE and speed up the necessary process of appraising cancer drugs whilst maintaining its robust and transparent nature; and looks forward to a Government announcement to this effect in the near future.
That this House welcomes the announcement from the National Institute for Health and Clinical Excellence (NICE) that it has passed proposals to reform the process of appraising health technologies to the Department of Health; is shocked at CancerBACUP's report that there are currently 23 licensed cancer drugs which have been...
To ask the Secretary of State for Health, what criteria the National Institute for Clinical Excellence used to determine the appropriateness of drugs for use in the treatment of dementia; and what assessment has been made of the impact of the withdrawal of these drugs on people suffering with dementia;...
To ask the Secretary of State for Health, what criteria the National Institute for Clinical Excellence used to determine the appropriateness of drugs for use in the treatment of dementia; and what assessment has been made of the impact of the withdrawal of these drugs on people suffering with dementia;...
To ask the Secretary of State for Health, what discussions he has had with primary care trusts which do not make available the full range of drugs for treatment of Alzheimer's disease approved by the National Institute for Clinical Excellence.
To ask the Secretary of State for Health, what discussions he has had with primary care trusts which do not make available the full range of drugs for treatment of Alzheimer's disease approved by the National Institute for Clinical Excellence.
To ask the Secretary of State for Health, how many patients he estimates would be affected by the implementation of the recommendation by the National Institute for Clinical Excellence that Reminyl, Aricept and Exelon should not be prescribed to NHS patients with Alzheimer's disease and dementia.
To ask the Secretary of State for Health, how many patients he estimates would be affected by the implementation of the recommendation by the National Institute for Clinical Excellence that Reminyl, Aricept and Exelon should not be prescribed to NHS patients with Alzheimer's disease and dementia.