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80-598: The National Institute for Health and Care Excellence ( NICE ) is an executive non-departmental public body of the Department of Health and Social Care . As the national health technology assessment body of England, it is responsible for judging the cost-effectiveness of medicines and making them available on the NHS through reimbursement, with its judgements informing decisions in Wales and Northern Ireland. It also provides

160-541: A Special Health Authority . Timothy Riley joined Sir Michael Rawlins (the then recently appointed Chair of NICE) at the Health Select Committee in February 1999 where questions were raised as to whether NICE was just a means to "ration" healthcare. Sir Michael Rawlins and Timothy Riley presented a compelling case that positioned NICE as a standards setting body first and foremost. However, the reality

240-399: A day. In children with asthma there was no clear effect on the time to first alleviation of symptoms. Whether it affects the risk of one's need to be hospitalized or the risk of death is not clear. There is no proof that zanamivir reduced hospitalizations or pneumonia and other complications of influenza, such as bronchitis , middle ear infection , and sinusitis . Zanamivir did not reduce

320-501: A different health care provider. If the person has a private health insurance policy the person could check to see whether the private insurance provider will fund the new treatment. About 8% of the population has some private health insurance from an employer or trade association and 2% pay from their own resources. Theoretically, it might be possible to draw up a table of all possible treatments sorted by cost per QALY gained. Those treatments with lowest cost per QALY gained would appear at

400-602: A document known as the 'appraisal consultation document'. This is sent to all consultees and commentators who are then able to make further comments. Once these comments have been taken into account the final document is drawn up called the 'final appraisal determination'. This is submitted to NICE for approval. The process aims to be fully independent of government and lobbying power, basing decisions fully on clinical and cost-effectiveness. There have been concerns that lobbying by pharmaceutical companies to mobilise media attention and influence public opinion are attempts to influence

480-700: A local commissioner withhold that from somebody? I’m not comfortable with that. I don’t support that." NICE has a service called Clinical Knowledge Summaries (CKS) which provides primary care practitioners with a readily accessible summary of the current evidence base and practical guidance. In 2022 PricewaterhouseCoopers did a study for the Association of the British Pharmaceutical Industry of 13 medicines recommended for asthma, kidney disease, stroke prevention and type 2 diabetes. They found that 1.2 million patients had not received

560-655: A range of clinical guidance to the NHS in England and Wales, which are considered by Northern Ireland. It was set up as the National Institute for Clinical Excellence in 1999, and on 1 April 2005 joined with the Health Development Agency to become the new National Institute for Health and Clinical Excellence (still abbreviated as NICE). Following the Health and Social Care Act 2012 , NICE

640-543: A small secretariat from the parent department, and any expenditure is paid for by that department. These bodies usually deliver a particular public service and are overseen by a board rather than ministers. Appointments are made by ministers following the Code of Practice of the Commissioner for Public Appointments . They employ their own staff and allocate their own budgets. These bodies have jurisdiction over an area of

720-490: A threshold of £30,000 per QALY. Over the years, there has been great controversy as to what value this threshold should be set at. Initially, there was no fixed number. But the appraisal teams created a consensus amount of about £30,000. However, in November 2008 Alan Johnson , the then Secretary of State, announced that for end-of-life cancer drugs the threshold could be increased above £30,000. The first drug to go through

800-604: A year, for judging a medicine cost-effective should be more than halved. They found that any intervention costing more than £13,000 per quality-adjusted life year risked causing more harm than good by denying cost effective treatment to other patients. The institute's approach to the introduction of new oral therapy for hepatitis C has been criticised. Sofosbuvir was approved in 2015. It costs about £30,000 for 12 weeks treatment. NHS England established 22 Operational Delivery Networks to roll out delivery and proposes to fund 10,000 courses of treatment in 2016-17. Each has been given

880-750: A “run rate” of how many patients they are allowed to treat. This is the NHS’ single biggest new treatment investment this year. In the North East London network patients with cirrhosis or fibrosis go to the front of the queue and three new patients at the Grahame Hayton Unit at the Royal London Hospital start treatment each month. Those without such complications may faced considerable delays before they start treatment. Non-departmental public body The term includes

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960-434: Is 66 mg/mL. It's insoluble in ethanol. Zanamivir is used for the treatment of infections caused by influenza A and influenza B viruses, but in otherwise-healthy individuals, benefits overall appear to be small. It decreases the risk of one's getting symptomatic, but not asymptomatic influenza. The combination of diagnostic uncertainty, the risk for virus strain resistance, possible side effects and financial cost outweigh

1040-458: Is Samantha Roberts, who succeeded Gillian Leng . NICE publishes guidelines in four areas: These appraisals are based primarily on evidence-based evaluations of efficacy, safety and cost-effectiveness in various circumstances. Since January 2005, the NHS in England has been legally obliged to provide funding for medicines and treatments recommended by NICE's technology appraisal board. This

1120-593: Is limited to the inhalation route. This restricts its usage, as treating asthmatics could induce bronchospasms . In 2006 the Food and Drug Administration (FDA) found that breathing problems (bronchospasm), including deaths, were reported in some patients after the initial approval of Relenza. Most of these patients had asthma or chronic obstructive pulmonary disease. Relenza therefore was not recommended for treatment or prophylaxis of seasonal influenza in individuals with asthma or chronic obstructive pulmonary disease. In 2009

1200-419: Is not a hard threshold, though research has shown that any threshold is "somewhat higher" than being in the range £35,000 - £40,000. The House of Commons Health Select Committee , in its report on NICE, stated in 2008 that "the ... cost-per-QALY it uses to decide whether a treatment is cost-effective is of serious concern. The threshold it employs is not based on empirical research and is not directly related to

1280-402: Is often associated with controversy, because the requirement to make decisions at a national level, can conflict with what is (or is believed to be) in the best interests of an individual patient. Approved cancer drugs and treatments such as radiotherapy and chemotherapy are funded by the NHS without any financial contribution being taken from the patient. Where NICE has approved a treatment,

1360-609: Is responsible for their costs and has to note all expenses. NDPB differ from executive agencies as they are not created to carry out ministerial orders or policy, instead they are more or less self-determining and enjoy greater independence. They are also not directly part of government like a non-ministerial government department being at a remove from both ministers and any elected assembly or parliament. Typically an NDPB would be established under statute and be accountable to Parliament rather than to His Majesty's Government . This arrangement allows more financial independence since

1440-427: Is the product of life span and quality rating with the new treatment less the same calculation for the old treatment, i.e. (1.25 x 0.6) less (1.0 x 0.4) = 0.35 QALY. The marginal cost of the new treatment to deliver this extra gain is £7,000 so the cost per quality life year gained is £7000/0.35 or £20,000. This is within the £20,000-£30,000 that is suggested by NICE to be the limit for drugs to be cost-effective. If

1520-416: Is to work on the development of the clinical guideline. This group consists of medical professionals, representatives of patient and carer groups and technical experts. They work together to assess the evidence for the guideline topic (e.g. clinical trials of competing products) before preparing a draft guideline. There are then two consultation periods in which stakeholder organisations are able to comment on

1600-399: Is unavailable'. Some of the more controversial NICE decisions have concerned donepezil , galantamine , rivastigmine (review) and memantine for the treatment of Alzheimer's disease and bevacizumab , sorafenib , sunitinib and temsirolimus for renal cell carcinoma . All these are drugs with a high cost per treatment and NICE has either rejected or restricted their use in the NHS on

1680-458: Is unique within NICE, in that it is the only collaborating centre to have responsibility for the adoption and dissemination support for guidance and quality standards in the social care arena . Drawing on the expertise of SCIE and their partners within the sector, each of the guidance products and quality standards had a needs assessment carried out to determine the requirements for tools to help embed

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1760-590: The Bill & Melinda Gates Foundation and Rockefeller Foundation . The notion of an Institute to determine the clinical effectiveness of interventions first emerged at the end of John Major 's Conservative Government as moves elsewhere were being made to set professionally agreed standards for clinical care. In 1997, the UK National Screening Committee (NSC) had been established by Sir Kenneth Calman and Muir Gray (now Sir Muir Gray) by

1840-542: The European System of Accounts (ESA.95). However, Statistics UK does not break out the detail for these bodies and they are consolidated into General Government (S.1311). Relenza Zanamivir is a medication used to treat and prevent influenza caused by influenza A and influenza B viruses . It is a neuraminidase inhibitor and was developed by the Australian biotech firm Biota Holdings. It

1920-653: The Social Care Institute for Excellence (SCIE) and four partner organisations - Research in Practice, Research in Practice for Adults, Personal Social Services Research Unit and the EPPI-Centre . Over a five year period, the NCCSC developed social care guidelines and supported the implementation of both the guidelines and social care quality standards. NICE received referrals for social care guidance from

2000-616: The law . They are coordinated by His Majesty's Courts and Tribunals Service , an executive agency of the Ministry of Justice , and supervised by the Administrative Justice and Tribunals Council , itself an NDPB sponsored by the Ministry of Justice. These bodies were formerly known as "boards of visitors" and are responsible for the state of prisons, their administration, and the treatment of prisoners. The Home Office

2080-425: The 4-amino DANA was shown to be 100 times better as an inhibitor than DANA, owing to the formation of a salt bridge with a conserved glutamic acid (119) in the active site. Glu 119 was also noticed to be at the bottom of a conserved pocket in the active site that is just big enough to accommodate the larger, but more basic guanidine functional group . Zanamivir, a transition-state analogue inhibitor of neuraminidase,

2160-595: The Australian CSIRO , in collaboration with the Victorian College of Pharmacy and Monash University . Zanamivir was the first of the neuraminidase inhibitors . The discovery was initially funded by the Australian biotechnology company Biota and was part of Biota's ongoing program to develop antiviral agents through rational drug design . Its strategy relied on the availability of the structure of influenza neuraminidase by X-ray crystallography . It

2240-655: The Department of Health and the Department for Education , and commission the guidance from the NCCSC. NICE, along with the NCCSC, carried out a scoping exercise with a scoping group and with input from key stakeholders, at both a workshop and a public consultation, to ensure the guidance to be produced was focused and achievable. A chairperson and members of the Guidance Development Group were appointed, and posed review questions which enabled systematic evidence reviews to take place, thus delivering

2320-555: The Labour government in office from 1997 to 2010, though the political controversy associated with NDPBs in the mid-1990s for the most part died away. In 2010 the UK's Conservative-Liberal coalition published a review of NDPBs recommending closure or merger of nearly two hundred bodies, and the transfer of others to the private sector. This process was colloquially termed the "bonfire of the quangos". NDPBs are classified under code S.13112 of

2400-416: The NHS budget, nor is it at the same level as that used by primary care trusts (PCTs) in providing treatments not assessed by NICE, which tends to be lower. Some witnesses, including patient organisations and pharmaceutical companies, thought NICE should be more generous in the cost per QALY threshold it uses, and should approve more products. On the other hand, some PCTs struggle to implement NICE guidance at

2480-444: The NHS has a limited budget and a vast number of potential spending options. Choices must be made as to how this limited budget is spent. Economic evaluations are carried out within a health technology assessment framework to compare the cost-effectiveness of alternative activities and to consider the opportunity cost associated with their decisions. By choosing to spend the finite NHS budget upon those treatment options that provide

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2560-491: The NHS must fund it. But not all treatments have been assessed by NICE and these treatments are usually dependent on local NHS decision making. In the case of cancer the Cancer Drugs Fund was set up in 2011 after complaints about NICE decisions on new and expensive cancer drugs with limited benefits. Treatment for fertility problems are approved but not always funded by clinical commissioning groups and they may cap

2640-459: The NICE process. NICE responded that they did follow the standard GRADE approach , and evidence from unblinded trials with subjective outcomes was appropriately downgraded. A Conservative shadow minister once criticized NICE for spending more on communications than assessments. In its defence, NICE said the majority of its communications budget was spent informing doctors about which drugs had been approved and new guidelines for treatments and that

2720-462: The Policy Team led by Timothy Riley for the Department of Health. The NSC aimed to ensure that evidence-based medicine informed policy making on what national screening programmes were approved for funding and what quality assurance mechanisms should be in place. This was a timely action as screening quality in breast cancer screening services came under question at Exeter in 1997 and followed in

2800-594: The UK Government. This total included 198 executive NDPBs, 410 advisory bodies, 33 tribunals, 21 public corporations, the Bank of England , 2 public broadcasting authorities and 23 NHS bodies. However, the classification is conservative and does not include bodies that are the responsibility of devolved government , various lower tier boards (including a considerable number within the NHS), and also other boards operating in

2880-493: The actual cost of assessing new drugs for the NHS includes money spent on NICE's behalf by the Department of Health. When these were added to NICE's own costs, the total cost of the technology appraisal programme far outstrips the cost of NICE communications. A report from the University of York Centre for Health Economics written by Karl Claxton in February 2015 suggested that the maximum threshold, currently around £30,000

2960-399: The appraisal and comment on the appraisal documents. Commentator organisations include the manufacturers of products to which the product undergoing appraisal is being compared. They comment on the documents that have been submitted and drawn up but do not actually submit information themselves. An independent academic centre then draws together and analyses all of the published information on

3040-444: The appraisal process can be formally initiated. Once this has been done NICE works with the Department of Health to draw up the scope of the appraisal. NICE then invites consultee and commentator organisations to take part in the appraisal. A consultee organisation would include patient groups, organisations representing health care professionals and the manufacturers of the product undergoing appraisal. Consultees submit evidence during

3120-481: The cost–effectiveness of new treatments by analysing the cost and benefit of the proposed treatment relative to the next best treatment that is currently in use. NICE guidance supports the use of quality-adjusted life years (QALY) as the primary outcome for quantifying the expected health benefits associated with a given treatment regime. By comparing the present value (see discounting ) of expected QALY flows with and without treatment, or relative to another treatment,

3200-582: The creation of a "public appointments commissioner" to make sure that appropriate standards were met in the appointment of members of NDPBs. The Government accepted the recommendation, and the Office of the Commissioner for Public Appointments was established in November 1995. While in opposition, the Labour Party promised to reduce the number and power of NDPBs. The use of NDPBs continued under

3280-444: The current threshold and other witnesses argued that a lower level should be used. However, there are many uncertainties about the thresholds used by PCTs." It went on to recommend that "an independent body should determine the threshold used when making judgements of the value of drugs to the NHS." The work that NICE is involved in, attracts the attention of many groups, including doctors, the pharmaceutical industry, and patients. NICE

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3360-498: The decision-making process. A fast-track assessment system has been introduced to reach decisions where there is most pressure for a conclusion. NICE carries out assessments of the most appropriate treatment regimes for different diseases. This must take into account both desired medical outcomes (i.e. the best possible result for the patient) and also economic arguments regarding differing treatments. NICE has set up several National Collaborating Centres bringing together expertise from

3440-494: The draft guideline. After the second consultation period, an independent Guideline Review Panel reviews the guideline and stakeholder comments and ensures that these comments have been taken into account. The Guideline Development Group then finalises the recommendations and the National Collaboration Centre produces the final guideline. This is submitted to NICE to formally approve the guideline and issue

3520-585: The drugs which could have given them the equivalent of 429,000 extra years in “complete good health” which could have translated into £17.9bn in “productivity gains” for the British economy. Under the Health and Social Care Act 2012 , NICE was given responsibility for developing guidance and quality standards for social care , using an evidence-based model. This was delivered by the NICE Collaborating Centre for Social Care (NCCSC), hosted by

3600-412: The enzyme. The GRID software by Molecular Discovery was used to determine energetically favourable interactions between various functional groups and residues in the catalytic site canyon. This investigation showed a negatively charged zone occurs in the neuraminidase active site that aligns with the C 4 hydroxyl group of DANA. This hydroxyl is, therefore, replaced with a positively charged amino group;

3680-484: The first drug appraisal by NICE was on the drug Relenza which was turned down amidst criticisms from Glaxo-Wellcome that the appraisal had been fast tracked. Later, this policy development whereby the criteria for decision making, the role of costs, and the degree to which decisions of NICE and the secretary of state would be binding on clinicians was analysed by Andrew Dillon , Trevor Gibbs, Timothy Riley, and Trevor A. Sheldon . As of 1 February 2022, its chief executive

3760-419: The four types of NDPB (executive, advisory, tribunal, and independent monitoring boards) but excludes public corporations and public broadcasters ( BBC , Channel 4 , and S4C ). The UK Government classifies bodies into four main types. The Scottish Government also has a fifth category: NHS bodies . These bodies consist of boards which advise ministers on particular policy areas. They are often supported by

3840-490: The government is obliged to provide funding to meet statutory obligations. NDPBs are sometimes referred to as quangos . However, this term originally referred to quasi-NGOs bodies that are, at least ostensibly, non-government organisations , but nonetheless perform governmental functions. The backronym "quasi-autonomous national government organization" is used in this usage which is normally pejorative. In March 2009 there were nearly 800 public bodies that were sponsored by

3920-520: The grounds that they are not cost-effective. A statement published by the Royal College of Physicians expressed concern that the 2021 NICE guidelines for ME/CFS did not properly evaluate or recommend graded exercise therapy and cognitive behavioral therapy for the treatment of ME/CFS. A study by 49 academics argued that the dissonance between the 2021 guidelines and the previous guideline was the result of deviating from usual scientific standards of

4000-523: The guidance and quality standards within the sector. These could include tailored versions of guidance for specific audiences, costing and commissioning tools and even training and learning packages. As of August 2013, NICE and the NCCSC had scheduled guidance delivery for five topics: domiciliary care , older adults with long-term conditions, transition between health and social care settings, transition from children's to adults' services and child abuse and neglect . As with any system financing health care,

4080-426: The guidance and subsequent recommendations. Service user and carer involvement took place throughout, as well as public consultation on the draft guidance. The Guidance Development Group then finalised the recommendations and the NCCSC produced the final guideline. This was submitted to NICE for formal approval and publication. The entire process from pre-scoping to publication took approximately 24 months. The guidance

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4160-407: The guidance to the NHS. To date NICE has produced more than 200 different guidelines. In October 2014 Andy Burnham said that a Labour government could reduce variation in access to drugs and procedures by making it mandatory for commissioners to follow NICE clinical guidelines. "We need to look at how you strengthen NICE. Where they have said something is effective and affordable, on what basis does

4240-419: The most efficient results, society can ensure it does not lose out on possible health gains through spending on inefficient treatments and neglecting those that are more efficient. NICE attempts to assess the cost–effectiveness of potential expenditures within the NHS to assess whether or not they represent 'better value' for money than treatments that would be neglected if the expenditure took place. It assesses

4320-598: The net/relative health benefit derived from such a treatment can be derived. When combined with the relative cost of treatment, this information can be used to estimate an incremental cost-effectiveness ratio (ICER), which is considered in relation to NICE's threshold willingness-to-pay value. As a guideline rule, NICE accepts as cost-effective those interventions with an incremental cost-effectiveness ratio of less than £20,000 per QALY and that there should be increasingly strong reasons for accepting as cost-effective interventions with an incremental cost-effectiveness ratio of over

4400-514: The new process was lenalidomide , whose ICER was £43,800. The following example from NICE explains the QALY principle and the application of the cost per QALY calculation. A patient has a life-threatening condition and is expected to live on average for one year receiving the current best treatment which costs the NHS £3,000. A new drug becomes available that will extend the life of the patient by three months and improve his or her quality of life, but

4480-451: The new treatment will cost the NHS more than three times as much at £10,000. Patients score their perceived quality of life on a scale from 0 to 1 with 0 being worst possible health and 1 being best possible health. On the standard treatment, quality of life is rated with a score of 0.4 but it improves to 0.6 with the new treatment. Patients on the new treatment on average live an extra 3 months, so 1.25 years in total. The quality of life gained

4560-546: The number of rounds. NICE has been criticised for being too slow to reach decisions. On one occasion, the Royal National Institute of Blind People said it was outraged over its delayed decision for further guidance regarding two drugs for macular degeneration that are already approved for use in the NHS. However the Department of Health said that it had 'made it clear to PCTs that funding for treatments should not be withheld simply because guidance from NICE

4640-572: The patient happened to live, but it has since acquired a high reputation internationally as a role model for the development of clinical guidelines. One aspect of this is the explicit determination of cost–benefit boundaries for certain technologies that it assesses. NICE also plays an important role in pioneering technology assessment in other healthcare systems through NICE International, established in May 2008 to help cultivate links with foreign governments. NICE International has received financial support from

4720-414: The patient was expected to live only one month extra and instead of three then NICE would issue a recommendation not to fund. The patient's primary care trust could still decide to fund the new treatment, but if not, the patient would then have two choices. He or she could opt to take the free NHS standard treatment, or he or she may decide to pay out of pocket to obtain the benefit of the new treatment from

4800-611: The public sector (e.g. school governors and police authorities). These appointed bodies performed a large variety of tasks, for example health trusts , or the Welsh Development Agency , and by 1992 were responsible for some 25% of all government expenditure in the UK. According to the Cabinet Office their total expenditure for the financial year 2005–06 was £167 billion. As of March 2020, there were 237 non-departmental public bodies. Critics argued that

4880-412: The risk of self reported investigator mediated pneumonia or radiologically confirmed pneumonia in adults. The effect on pneumonia in children was also not significant. Low to moderate evidence indicates it decreases the risk of one's getting influenza by 1 to 12% in those exposed. Prophylaxis trials showed that zanamivir reduced the risk of symptomatic influenza in individuals and households, but there

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4960-683: The royal medical colleges, professional bodies and patient/carer organisations which draw up the guidelines. The centres are the National Collaborating Centre for Cancer, the National Clinical Guideline Centre, the National Collaborating Centre for Women and Children´s Health, and the National Collaborating Centre for Mental Health . The National Collaborating Centre appoints a Guideline Development Group whose job it

5040-494: The small benefits of zanamivir for the prophylaxis and treatment of healthy individuals. Since then, genes expressing resistance to zanamivir were found in Chinese people infected with avian influenza A H7N9 during treatment with zanamivir. In otherwise-healthy individuals, benefits overall appear to be small. Zanamivir shortens the duration of symptoms of influenza-like illness (unconfirmed influenza or 'the flu') by less than

5120-683: The system was open to abuse as most NDPBs had their members directly appointed by government ministers without an election or consultation with the people. The press , critical of what was perceived as the Conservatives' complacency in power in the 1990s, presented much material interpreted as evidence of questionable government practices. This concern led to the formation of a Committee on Standards in Public Life (the Nolan Committee) which first reported in 1995 and recommended

5200-493: The technology under appraisal and prepares an assessment report. This can be commented on by the Consultees and Commentators. Comments are then taken into account and changes made to the assessment report to produce an evaluation report. An independent Appraisal Committee then looks at the evaluation report, hears spoken testimony from clinical experts, patient groups and carers. They take their testimony into account and draw up

5280-487: The threshold lying between the CQG (cost per QALY gained) of the last service that is funded and that of the next most cost effective service that is not funded. In practice this exercise is not done, but an assumed shadow price has been used by NICE for many years in its assessments to determine which treatments the NHS should and should not fund. NICE states that for drugs the CQG should not normally exceed £30,000 but that there

5360-403: The top of the table and deliver the most benefit per value spent and would be easiest to justify funding for. Those where the delivered benefit is low and the cost is high would appear at the bottom of the list. Decision makers would, theoretically, work down the table, adopting services that are the most cost effective. The point at which the NHS budget is exhausted would reveal the shadow price ,

5440-544: The wake of the 1995 Calman-Hine Report . The idea of what was originally called the National Institute for Clinical Excellence took root when Labour came to power in 1997. Frank Dobson became Secretary of State and was supported by a team of Ministers keen on introducing clinical and health outcome measures to achieve improvements in the quality and delivery of care. The team included Alan Milburn , Baroness Margaret Jay , and Tessa Jowell . The name and mission

5520-446: The zanamivir package insert contains precautionary information regarding risk of bronchospasm in patients with respiratory disease. GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza having received zanamivir inhalation powder, which was solubilized and administered by mechanical ventilation. In adults there was no increased risk of reported adverse events in trials. There

5600-463: Was agreed in a meeting between the Ministerial team, Timothy Riley and Felicity Harvey shortly after the election and it was agreed that NICE should be described in the first policy white paper , The New NHS: Modern, Dependable 1997. Timothy Riley led the team that developed the policy and for NICE and which managed the legislation through Parliament in addition to implementing the new institute as

5680-411: Was also known, as far back as 1974, that 2-deoxy-2,3-didehydro- N -acetylneuraminic acid (DANA), a sialic acid analogue, is an inhibitor of neuraminidase. Computational chemistry techniques were used to probe the active site of the enzyme, in an attempt to design derivatives of DANA that would bind tightly to the amino acid residues of the catalytic site, so would be potent and specific inhibitors of

5760-514: Was at least in part as a result of well-publicised postcode lottery anomalies in which certain less-common treatments were funded in some parts of the UK but not in others due to local decision making in the NHS. Before an appraisal, the Advisory Committee on Topic Selection draws up a list of potential topics of clinical significance for appraisal. The Secretary of State for Health and Social Care must then refer any technology so that

5840-408: Was found to reduce the time-to-symptom resolution by 1.5 days if therapy was started within 48 hours of the onset of symptoms. The bioavailability of zanamivir is 2%. After inhalation, zanamivir is concentrated in the lungs and oropharynx , where up to 15% of the dose is absorbed and excreted in urine. Zanamivir was first made in 1989 by scientists led by Peter Colman and Joseph Varghese at

5920-511: Was licensed to Glaxo in 1990 and approved in the US in 1999, only for use as a treatment for influenza. In 2006, it was approved for prevention of influenza A and B. Zanamivir was the first neuraminidase inhibitor commercially developed. It is marketed by GlaxoSmithKline under the trade name Relenza as a powder for oral inhalation. Zanamivir room temperature solubility in water is 36 mg/mL, in DMSO

6000-476: Was little evidence of the possible harms associated with the treatment of children with zanamivir. Zanamivir has not been known to cause toxic effects and has low systemic exposure to the human body. Zanamivir works by binding to the active site of the neuraminidase protein, rendering the influenza virus unable to escape its host cell and infect others. It is also an inhibitor of influenza virus replication in vitro and in vivo . In clinical trials, zanamivir

6080-750: Was no evidence of an effect on asymptomatic influenza or on other, influenza-like illnesses. Also there was no evidence of reduction of risk of person-to-person spread of the influenza virus. The evidence for a benefit in preventing influenza is weak in children, with concerns of publication bias in the literature. As of 2009, no influenza had shown any signs of resistance in the US. A meta-analysis from 2011 found that zanamivir resistance had been rarely reported. Antiviral resistance can emerge during or after treatment with antivirals in certain people (e.g., immunosuppressed ). In 2013 genes expressing resistance to zanamivir (and oseltamivir ) were found in Chinese patients infected with avian influenza A H7N9. Dosing

6160-503: Was renamed the National Institute for Health and Care Excellence on 1 April 2013 reflecting its new responsibilities for social care, and changed from a special health authority to an executive non-departmental public body (NDPB). NICE was established in an attempt to end the so-called postcode lottery of healthcare in England and Wales, where availability of treatments depended on the NHS Health Authority area in which

6240-430: Was that although NICE was principally aimed at aligning professional standards through clinical guidelines and audit, the acceptability of drugs, devices and technological interventions in defining those standards, could not be ignored and so the concept of a "fourth hurdle" for drugs accessing the NHS market was invoked. This controversial policy shift meant that NICE was critical for decisions on drug reimbursement. Indeed,

6320-533: Was the result. In 1999, the product was approved for marketing in the US and Europe for treatment of influenza A and B. The FDA advisory committee had recommended by a vote 13 to 4 that it should not be approved, because it lacked efficacy and was no more effective than placebo when the patients were on other drugs such as paracetamol. But the FDA leadership overruled the committee and criticised its reviewer, biostatistician Michael Elashoff. The review of oseltamivir, which

6400-414: Was then available to NICE standing committees to develop a quality standard on the topic. The quality standard was developed using the guidance and other accredited sources, to produce high-level concise statements that can be used for quality improvement by social care providers and commissioners, as well as setting out what service users and carers can expect of high quality social care services. The NCCSC

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