NICE: ertugliflozin recommended in triple therapy for type 2 diabetes

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National Institute for Health and Care Excellence

  • Final guidance recommends:
    • Ertugliflozin in triple therapy for type 2 diabetes
    • Atezolizumab in combination for non-squamous non-small-cell lung cancer.
  • Nusinersen recommended for spinal muscular atrophy in draft guidance.
  • Assessment and management of thyroid disease draft guideline published.

Medicines and Healthcare products Regulatory Agency

  • Class 4 Drug Alert: certain Baxter Potassium Chloride containing intravenous infusions.
  • Medical device alert issued for various Aisys and Aisys CS2 anaesthesia devices - risk of patient awareness following inadequate anaesthesia.
  • Recommendations published on the use of paclitaxel drug-coated balloons and drug-eluting stents.

Royal College of Psychiatrists

  • College calls on NICE to update its antidepressant withdrawal guidance.

Scottish Intercollegiate Guidelines Network

  • Forthcoming guideline for diagnosis and management of epilepsy in children and young adults announced.

Public Health England

  • People urged to practise safer sex after rise in STIs in England.
  • Report finds vaccine for older adults gives significant protection against flu.
  • Survey finds over two thirds of NHS acute trusts in England now prohibit smoking.






NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

ERTUGLIFLOZIN IN TRIPLE THERAPY REGIMEN RECOMMENDED FOR TYPE 2 DIABETES

NICE has published final guidance which recommends ertugliflozin (Steglatro),with metformin and a dipeptidyl peptidase‑4 (DPP‑4) inhibitor as an option for treating type 2 diabetes in adults when diet and exercise alone do not provide adequate glycaemic control, only if the disease is uncontrolled with metformin and a DPP‑4 inhibitor, and a sulfonylurea or pioglitazone is not appropriate.

If patients and their clinicians consider ertugliflozin to be one of a range of suitable treatments, including canagliflozin, dapagliflozin and empagliflozin, the least expensive should be chosen.

Ertugliflozin is a sodium-glucose cotransporter 2 (SGLT‑2) inhibitor. Other SGLT‑2 inhibitors are already used with metformin and a DPP‑4 inhibitor for treating type 2 diabetes. NICE says ertugliflozin appears to have similar health benefits to other SGLT‑2 inhibitors when taken with metformin and a DPP‑4 inhibitor, and it has a lower acquisition cost. But it has only been compared with other SGLT‑2 inhibitors, not with other third-line treatments for type 2 diabetes (sulfonylureas or pioglitazone).

ATEZOLIZUMAB IN COMBINATION RECOMMENDED FOR LUNG CANCER

NICE has published final guidance which recommends atezolizumab (Tecentriq) plus bevacizumab (Avastin), carboplatin and paclitaxel as an option for metastatic non-squamous non-small-cell lung cancer (NSCLC) in adults:

  • who have not had treatment for their metastatic NSCLC before and whose PD-L1 tumour proportion score is between 0% and 49% or
  • when targeted therapy for epidermal growth factor receptor (EGFR)‑positive or anaplastic lymphoma kinase (ALK)‑positive NSCLC has failed.

It is recommended only if:

  • atezolizumab and bevacizumab are stopped at two years of uninterrupted treatment, or earlier if there is loss of clinical benefit (for atezolizumab) or if the disease progresses (for bevacizumab) and
  • the company provides atezolizumab and bevacizumab according to the commercial arrangements.

NICE says an indirect comparison of studies suggests that people having atezolizumab plus bevacizumab, carboplatin and paclitaxel live longer than those having pemetrexed plus carboplatin or cisplatin, with or without pemetrexed maintenance. This comparison also suggests that they live for longer before their condition worsens. Atezolizumab plus bevacizumab, carboplatin and paclitaxel meets NICE's criteria to be considered a life-extending treatment at the end of life. There is uncertainty about the company's long-term survival estimates, especially for people with EGFR- or ALK‑positive NSCLC. But including the most plausible assumptions and the commercial arrangements, the cost-effectiveness estimates are within what NICE normally considers acceptable for an end-of-life treatment.

NUSINERSEN RECOMMENDED FOR SPINAL MUSCULAR ATROPHY IN DRAFT GUIDANCE

NICE has published draft guidance which recommends nusinersen (Spinraza) as an option for treating spinal muscular atrophy (SMA) only if:

  • people have pre-symptomatic SMA, or SMA types 1, 2 or 3 and
  • the conditions in the managed access agreement are followed

In its provisional guidance, NICE says that clinical trial evidence shows that nusinersen improves a range of outcomes that are important to people with early- (type 1) and later-onset (type 2 and 3) SMA. Also, there is some evidence suggesting that nusinersen is effective for pre-symptomatic SMA. However, there is no long-term evidence, so the long-term benefits are highly uncertain. The committee considered that further data collection would help address these uncertainties. Furthermore, the cost-effectiveness estimates presented are higher than what NICE usually considers a cost-effective use of NHS resources. However, NICE said the estimates were difficult to interpret because of the limited evidence base to substantiate longer-term benefits, the difficulty in clearly distinguishing between the SMA subtypes, and the difference in what can be achieved for these various patients without nusinersen. The proposed managed access agreement therefore details various risk management strategies, including patient selection, starting and stopping rules, data collection, patient consent, exit strategy and commercial offer. The recommendation will be reviewed based on data collected in the managed access arrangement and guidance will be published by the end of the fifth year. Final guidance is expected to be published on 26 June 2019.

ASSESSMENT AND MANAGEMENT OF THYROID DISEASE DRAFT GUIDELINE PUBLISHED

NICE has published a draft guideline which covers the assessment and management of thyroid disease. It aims to improve quality of life by making recommendations on diagnosis, treatment, long-term care and support. The provisional recommendations cover:

  • Investigating suspected thyroid dysfunction or thyroid enlargement
  • Managing primary hypothyroidism
  • Follow-up and monitoring of primary hypothyroidism
  • Managing and monitoring subclinical hypothyroidism
  • Managing thyrotoxicosis
  • Follow-up and monitoring of hyperthyroidism
  • Managing and monitoring subclinical hyperthyroidism
  • Diagnosing, managing and monitoring thyroid enlargement with normal 11 thyroid function

Final guidance is expected to be published in November 2019.

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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

CLASS 4 DRUG ALERT: CERTAIN BAXTER POTASSIUM CHLORIDE CONTAINING INTRAVENOUS INFUSIONS

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for certain Baxter Potassium Chloride containing intravenous infusions. Baxter Healthcare Limited has informed the MHRA that a quality defect has been identified with the product where the front panel of a small number of infusion bags was found to be missing the red text. The red text highlights the presence of potassium chloride in the products formulation which is a risk-mitigating factor in the prevention of a potential mix-up with other solutions for infusion. Healthcare professionals are advised to:

  • Check complete inventory of the products and inspect the print on each bag to ensure the presence of the red print. This includes stock within the pharmacy, on wards and at any other relevant location within the hospital
  • Consider the possibility that the absence of red text may have resulted in units being stored in the incorrect location so please ensure that all locations where infusion bags are stored are checked.
  • If units have been supplied to any other facilities or departments within the institution, forward a copy of this letter to them.
  • If they have any home patients who use these products, to notify them.

MEDICAL DEVICE ALERT: VARIOUS AISYS AND AISYS CS2 ANAESTHESIA DEVICES - RISK OF PATIENT AWARENESS DUE TO INADEQUATE ANAESTHESIA

The MHRA has issued a medical device alert for Aisys and Aisys CS2 anaesthesia devices with Et Control option and software versions 11, 11SP01 and 11SP02 due to the risk patient awareness following inadequate anaesthesia. The device may fail to deliver the set agent concentration in End Tidal Control mode. Healthcare professionals are advised to:

  • Follow the instructions to upgrade software on devices listed in the manufacturer’s FSN GEHC Ref# 34098.
  • Devices with software upgraded as part of MDA/2019/001 are affected and will need the latest software upgrade.
  • If devices are not using the listed software versions, no further action is required.
  • Before using End Tidal Control (Et Control) mode, clinicians should undertake an appropriate risk assessment.
  • If using the device in End Tidal Control mode, additional patient monitoring is recommended.
  • Contact GE Healthcare at
    askuktechnicalsupport@ge.com
    or 01707 263570 to arrange the installation of the software update.
  • Report suspected or actual adverse events involving these devices through the local incident reporting system and/or national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. Also, report directly to manufacturers if the local or national systems do not.

RECOMMENDATIONS PUBLISHED ON THE USE OF PACLITAXEL DRUG-COATED BALLOONS AND DRUG-ELUTING STENTS

Following publicised concerns over an increase in patient mortality from two years after treatment, The independent Expert Advisory Group (EAG) has published its findings and recommendations on paclitaxel drug-coated balloon catheters and drug-eluting stents which are used to treat patients with peripheral arterial disease. The EAG has recommended that these devices are not used to treat patients with intermittent claudication. However, the devices may still be considered in patients with critical limb ischaemia, where it is felt that the benefits outweigh the risks and taking NICE guidance into account. The EAG also states that, where these devices are to be used, there should also be enhanced patient follow-up. After receiving these recommendations, the MHRA has limited the future use of these devices in routine clinical care, until more is known on this issue. Furthermore, the EAG recommended that future research is undertaken to evaluate the causal relationship between these devices and mortality. In line with the EAG’s recommendations, the MHRA will consider the available evidence supporting the use of these devices for other conditions.

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ROYAL COLLEGE OF PSYCHIATRISTS

COLLEGE CALLS ON NICE TO UPDATE ITS ANTIDEPRESSANT WITHDRAWAL GUIDANCE

The Royal College of Psychiatrists has published a position statement which urges NICE to update its guidance on antidepressant withdrawal so as to reflect the wide range of experience patients have (see OnMedica article). Current advice from the NICE suggests most people should be able to come off antidepressants over four weeks. However, the College states that it is increasingly apparent that some patients can suffer from more severe symptoms that can last much longer. This may affect those who have been prescribed antidepressants over a long period and who have stopped their use too quickly. After listening to the experiences of patients and clinicians, including GPs, the college has called for a greater focus on how to assist patients who do have problems when withdrawing from antidepressants, as well as more research to quantify how many people have problems when stopping antidepressants. The College also recommends:

  • The introduction of a routine monitoring system to provide comprehensive data on when and why patients are prescribed antidepressants.
  • Adequate resourcing to ensure clinicians, particularly GPs, have sufficient time and capacity to regularly review antidepressant use and provide support for and monitor withdrawal.
  • Training to be provided to all doctors on best practice for prescribing and managing use of antidepressants.
  • Commissioning of adequate support services for patients affected by more severe and prolonged antidepressant withdrawal, modelled on existing best practice.
  • Expanding the NHS’s flagship talking therapies programme further so that they are always available when appropriate as a complement, or alternative, to antidepressants.
  • A call for high-quality research into issues including which antidepressants are likely to work for which individual; and the benefits and harms of long-term use.

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SCOTTISH INTERCOLLEGIATE GUIDELINES NETWORK

FORTHCOMING GUIDELINE FOR DIAGNOSIS AND MANAGEMENT OF EPILEPSY IN CHILDREN AND YOUNG ADULTS ANNOUNCED

The Scottish Intercollegiate Guidelines Network is due to publish a national guideline in summer/autumn 2019 on the diagnosis and management of epilepsy in children and young adults. The guideline is expected to cover:

  • Diagnostic tests - diagnosing epilepsy and reducing inappropriate testing
  • Non-pharmacological treatment options for managing epilepsy
  • New antiepileptic medicines
  • Transitioning from paediatric to adult care.

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PUBLIC HEALTH ENGLAND

PEOPLE URGED TO PRACTISE SAFER SEX AFTER RISE IN STIS IN ENGLAND

A new report by Public Health England (PHE) shows the number of new sexually transmitted infections (STIs) diagnoses in 2018 increased by 5% in comparison to 2017 (from 424,724 to 447, 694) (see OnMedica article). The number of consultations at sexual health services, both in clinic settings and online, increased by 7% between 2017 and 2018 (from 3,337,677 to 3,561,548). PHE says the rise in STIs is likely to be due to people not using condoms correctly and consistently with new and casual partners, and an increase in testing improving detection of the most common STIs. The report also found:

  • In 2018, gonorrhoea diagnoses rose by 26% from 2017 (from 44,812 in to 56,259)
  • Cases of syphilis also increased and have more than doubled over the past decade from 2,847 in 2009 to 7,541 in 2018
  • Chlamydia remained the most commonly diagnosed STI, accounting for almost half of new STI diagnoses (218,095). Chlamydia most commonly affects 15 to 24-year-olds, who account for 60% (131,269) of new diagnoses - an increase of 2% since 2017.

Furthermore, the report highlights that the HPV vaccination programme has led to a marked decline in genital warts diagnosis, which are caused by some strains of HPV that the vaccine protects against. The rate of genital warts diagnoses among girls aged 15 to 17 years, most of whom would have been offered the quadrivalent HPV vaccine aged 12 to 13 years old, was 92% lower in 2018 compared to 2014. A decline of 82% was seen in same aged heterosexual boys over this time period, which suggests substantial herd protection

REPORT FINDS VACCINE FOR OLDER ADULTS GIVES SIGNIFICANT PROTECTION AGAINST FLU

The annual flu report published by PHE shows that Influenza A(H1N1)pdm09 was the main strain circulating this season although Influenza A(H3N2) also circulated later on. Low to moderate levels of flu activity were seen in the community although the impact on secondary care in terms of hospitalisations and ICU admissions were high. The report also shows that the flu vaccine offered to those eligible for immunisation this season reduced the likelihood of visiting the GP because of flu by approximately 44%. The adjuvanted vaccine, which was given to the majority of adults aged 65 and over for the first time this season, was estimated to have provided approximately 60% protection against the flu strains circulating this winter. More children also took up the offer of the flu vaccine this winter than ever before, with around three million being vaccinated. Next season, all children up to the age of 10 years will be offered the nasal spray vaccine which means that all children in primary school will be eligible across the whole of the UK.

SURVEY FINDS OVER TWO THIRDS OF NHS ACUTE TRUSTS IN ENGLAND NOW PROHIBIT SMOKING

PHE is calling for all NHS trusts to ban smoking on hospital grounds after a survey found more than two thirds (69%) of NHS acute trusts in England already prohibit smoking on site as part of their journey to becoming smokefree. However, despite this progress, almost a third (31%) have not yet enforced total smoking bans across hospital premises. The survey highlighted examples of how trusts are successfully implementing smokefree policies, including:

  • effective leadership to ensure policies implemented quickly
  • establishing smokefree steering or working groups
  • investing in dedicated staff to deliver stop smoking support to inpatients
  • tannoy system reminders about ‘no smoking’ to reduce confrontation
  • promoting healthy environments - for example, fruit and veg stalls at hospital main entrances
  • shelters with plants and trees
  • partnerships with local schools to produce ‘no smoking’ signage

Some NHS trusts reported that implementing policies on e-cigarette use and allowing vaping in designated areas had helped them to achieve smokefree status. As well as encouraging trusts to prohibit smoking on site, the Smokefree NHS campaign calls for all patients who smoke to be offered evidence-based quitting support. The NHS Long Term Plan has committed to offering NHS-funded tobacco treatment services to all inpatients who smoke, regardless of why they are in hospital, by 2023 to 2024.

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