NICE: encorafenib with binimetinib recommended for unresectable or metastatic melanoma

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National Institute for Health and Care Excellence

  • Final guidance recommends:
    • Encorafenib with binimetinib for unresectable or metastatic melanoma
    • Abemaciclib with an aromatase inhibitor for previously untreated breast cancer
    • Venetoclax with rituximab for previously treated leukaemia
    • High-intensity focused ultrasound for symptomatic benign thyroid nodules to be used only with special arrangements.
  • Draft guidance recommends:
    • Ertugliflozin as monotherapy or in a dual therapy regimen for type 2 diabetes (final)
    • VIV-TAVI implantation for aortic bioprosthetic valve dysfunction
    • Reinforcement of permanent stoma with mesh to prevent parastomal hernia to be used only with special arrangements.
  • Quality standard published: People’s experience using adult social care services.

Medicines and Healthcare products Regulatory Agency

  • Medical device alerts issued:
    • Various GE Healthcare parameter patient monitors
    • Potential breach of sterile packaging for several devices manufactured by ConvaTec Limited.

Royal College of Ophthalmologists

  • Safety alert issued: Do not use apraclonidine in infants below six months of age.

Pharmaceutical Services Negotiating Committee

  • Metoprolol supply warning issued.

Royal College of Nursing

  • Practice guidance on catheter care published.

Public Health England

  • Vaccine data shows children’s vaccine 87% effective against circulating flu strain.

NHS England

  • Roll-out of enhanced physio services in GP practices announced.
  • Advice line for new and expectant mothers across the country announced.

Department of Health and Social Care

  • Personal health budgets scheme set to expand.

Royal Society for Public Health

  • Call for further investigation into the “misleading marketing” of ‘healthy’ foods.

European Centre for Disease Prevention and Control

  • Zoonoses report finds no slowing down of antimicrobial resistance.

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

ENCORAFENIB WITH BINIMETINIB RECOMMENDED FOR UNRESECTABLE OR METASTATIC BRAF V600 MUTATION-POSITIVE MELANOMA

NICE has published final guidance which recommends encorafenib (Braftovi) with binimetinib (Mektovi), within its marketing authorisation, as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma in adults. It is recommended only if the company provides encorafenib and binimetinib according to the commercial arrangements. Current treatments for unresectable or metastatic BRAF V600 mutation-positive melanoma include targeted therapy, usually using a combination of a BRAF and MEK inhibitor (dabrafenib with trametinib) or sometimes monotherapy with a BRAF inhibitor (vemurafenib or dabrafenib). Clinical trial evidence shows that, compared with vemurafenib, encorafenib with binimetinib extends the time until melanoma progresses and also how long people live. There are no trials directly comparing it against dabrafenib with trametinib. But compared indirectly, encorafenib with binimetinib appears to be as effective as dabrafenib with trametinib. The guidance says that, when the commercial arrangements for encorafenib, binimetinib, dabrafenib and trametinib are taken into account, encorafenib with binimetinib is considered to be a cost-effective use of NHS resources. It is therefore recommended.

ABEMACICLIB WITH AN AROMATASE INHIBITOR RECOMMENDED FOR PREVIOUSLY UNTREATED BREAST CANCER

Abemaciclib (Verzenios) with an aromatase inhibitor has been recommended in NICE final guidance, within its marketing authorisation, as an option for treating locally advanced or metastatic, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer as first endocrine-based therapy in adults. Abemaciclib is recommended only if the company provides it according to the commercial arrangement. Palbociclib or ribociclib, taken with an aromatase inhibitor, are usually the first treatments for locally advanced or metastatic, hormone receptor-positive, HER2-negative breast cancer. They are cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors, as is abemaciclib. Clinical trial evidence shows that abemaciclib with an aromatase inhibitor increases how long people live without their disease getting worse, compared with an aromatase inhibitor alone. It is not known whether abemaciclib increases the length of time people live, because the final trial results are not available yet. Abemaciclib, palbociclib and ribociclib have different side effects, but they all appear to work as well as each other. The guidance says that, taking into account the commercial arrangements for all the CDK 4/6 inhibitors, abemaciclib is a cost-effective use of NHS resources and it can be recommended.

VENETOCLAX WITH RITUXIMAB RECOMMENDED FOR PREVIOUSLY TREATED LEUKAEMIA

Venetoclax (Venclyxto) with rituximab is recommended in NICE final guidance, within its marketing authorisation, as an option for treating chronic lymphocytic leukaemia in adults who have had at least one previous therapy. It is recommended only if the company provides it according to the commercial arrangement. People with previously treated chronic lymphocytic leukaemia usually have ibrutinib. Clinical trial evidence shows that venetoclax plus rituximab increases how long people live for before their disease gets worse compared with bendamustine plus rituximab (a combination that is not frequently used). There is no trial directly comparing venetoclax plus rituximab with ibrutinib. Indirect comparisons of venetoclax plus rituximab with ibrutinib have limitations, but can be used for decision making because there is no other evidence. Estimates from the cost-effectiveness analyses range from venetoclax plus rituximab being less costly and more effective to it being less costly and less effective, when compared with ibrutinib. The guidance says that, although it is uncertain how effective venetoclax, is compared with ibrutinib, a cost-comparison analysis shows that venetoclax plus rituximab is considered to be a cost-effective use of NHS resources and it is recommended for routine use in the NHS.

HIGH-INTENSITY FOCUSED ULTRASOUND FOR SYMPTOMATIC BENIGN THYROID NODULES TO BE USED ONLY WITH SPECIAL ARRANGEMENTS

NICE has published final guidance which finds the evidence on the safety of high-intensity focused ultrasound for symptomatic benign thyroid nodules raises no major safety concerns, however the current evidence on its efficacy is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Clinicians wishing to do high-intensity focused ultrasound for symptomatic benign thyroid nodules should:

  • Inform the clinical governance leads in their NHS trusts.
  • Ensure that patients understand the procedure's safety and efficacy, as well as any uncertainties about these. Provide them with clear written information to support shared decision making. In addition, the use of NICE's information for the public is recommended.
  • Audit and review clinical outcomes of all patients having high-intensity focused ultrasound for symptomatic benign thyroid nodules. NICE has identified relevant audit criteria and has developed an audit tool (which is for use at local discretion).

Further research should report details of patient selection, nodule size and position, and whether the nodule is cystic.

ERTUGLIFLOZIN RECOMMENDED AS MONOTHERAPY OR IN A DUAL THERAPY REGIMEN FOR TYPE 2 DIABETES (draft guidance)

NICE has published final draft guidance which recommends ertugliflozin (Steglatro) as an option for treating type 2 diabetes in adults for whom metformin is contraindicated or not tolerated and when diet and exercise alone do not provide adequate glycaemic control, only if:

  • a dipeptidyl peptidase 4 (DPP 4) inhibitor would otherwise be prescribed and
  • a sulfonylurea or pioglitazone is not appropriate.

Ertugliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if:

  • a sulfonylurea is contraindicated or not tolerated or
  • the person is at significant risk of hypoglycaemia or its consequences.

If patients and their clinicians consider ertugliflozin to be 1 of a range of suitable treatments including canagliflozin, dapagliflozin and empagliflozin, the least expensive should be chosen.

The final guidance is expected to be published on 27 March 2019.

VIV-TAVI IMPLANTATION RECOMMENDED FOR AORTIC BIOPROSTHETIC VALVE DYSFUNCTION (draft guidance)

NICE has published draft recommendations which find the current evidence on the safety and efficacy of valve-in-valve TAVI (ViV-TAVI) for aortic bioprosthetic dysfunction is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit:

  • Details of all patients should be entered into the
    UK TAVI registry.
  • Device-related adverse events should be reported to the Medicines and Healthcare products Regulatory Agency.
  • Patient selection should be done by a multidisciplinary team, which must include interventional cardiologists experienced in the procedure, cardiac surgeons, an expert in cardiac imaging and, when appropriate, a cardiac anaesthetist and a specialist in elderly medicine. The multidisciplinary team should determine the risk level for each patient and the device most suitable for them.
  • During the consent process, patients should be told about all treatment options, and their advantages and disadvantages.
  • ViV-TAVI is a technically challenging procedure that should only be done in specialised centres, and only by clinicians and teams with special training and experience in complex endovascular interventions.

The consultation closes 21 March 2019.

REINFORCEMENT OF A PERMANENT STOMA WITH MESH TO PREVENT A PARASTOMAL HERNIA TO BE USED ONLY WITH SPECIAL ARRANGEMENTS (draft guidance)

NICE has published draft recommendations which find the evidence on the safety of reinforcement of a permanent stoma with mesh to prevent a parastomal hernia shows there are serious but well-recognised complications. The evidence on efficacy is limited in quantity and quality. Therefore, this procedure should not be used unless special arrangements are in place for clinical governance, consent, and audit or research. Closing date for comments is 21 March 2019.

PEOPLE’S EXPERIENCE USING ADULT SOCIAL CARE SERVICES - QUALITY STANDARD PUBLISHED

NICE has published a quality standard which covers the experience of adults using social care services. It applies to all settings where people use social care services, including people's own homes, residential care and community settings. Its aim is to help people understand what care they can expect and to improve their experience by supporting them to make decisions about their care. It describes high-quality care in priority areas for improvement, such as:

  • Care and support needs assessment
  • Empowering people to manage their personal budget
  • Continuity of care and support
  • Using people's views to improve services

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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

MEDICAL DEVICE ALERT ISSUED FOR VARIOUS MULTIPLE PARAMETER PATIENT MONITORS

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for Multi parameter patient monitors: Carescape B450, B650, B850, B20, B40, B20i, B40i, B125, B105, Dash 3000,4000,5000, Solar 8000M/i, 9500 due to risk of loss of patient monitoring. GE Healthcare has informed the MHRA that if networks are incorrectly configured with multiple monitors, a prolonged bandwidth overload condition may occur and cause monitors to restart. Actions required include:

  • Be aware of the manufacturer's five field safety notices (FSNs) published in 2018: GEHC Ref # 36135, 36132, 36131, 36127 and 36127A.
  • Users should be aware that the FSNs provide guidance on what to do if there is a prolonged network overload and the monitor on the network does not resume normal functionality in approximately 90 seconds.
  • Staff responsible for network set up and maintenance should ensure that the network in the facility meets the network configuration requirements as described in the FSNs.

ALERT ISSUED ON SEVERAL DEVICES MANUFACTURED BY CONVATEC LIMITED DUE TO POTENTIAL BREACH OF STERILE PACKAGING

The MHRA has issued a medical device alert due to potentially breached sterile packaging of: rectal tubes, Unoversal drainage systems, SimpaVac, sterile suction connecting tubes, sterile connecting pieces, suction handles/sets (FilterFlow™/Deltaflo), oxygen catheters, sterile nasal oxygen cannulas, sterile oxygen connecting tubes, and sterile forceps. ConvaTec Limited has informed the MHRA that the use of affected devices may increase the risk of patients acquiring infections. This is an extension of the list of devices affected from a previous alert issued in November 2018. Healthcare professionals are advised to:

  • Identify if they have any affected devices - check the manufacturer's Field Safety Notice (FSN) dated 04 Jan 2019 for a list of affected product codes and lots.
  • Stop using and quarantine affected devices as instructed in the manufacturer's FSN.
  • Complete the 'Recall Response Form for END USERS' in the FSN, even if they don't have affected devices left in stock, and return it to
    convatecproductrecall@stericycle.com
    to arrange return of affected devices.
  • Report any incidents or complaints involving this product to
    unomedical
    -
    uk.customerservice@convatec.com
    and through their local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.
  • Note that this is an extension to MDA/2018/034 as more affected products have been identified. None of the products listed in the latest FSN were listed in the previous version of the FSN.

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ROYAL COLLEGE OF OPHTHALMOLOGISTS

SAFETY ALERT ISSUED - DO NOT USE APRACLONIDINE IN INFANTS BELOW SIX MONTHS OF AGE

The Royal College of Ophthalmologists has issued a safety alert after receiving a report from NHS Improvement of a severe adverse reaction in a six-month-old child with anisocoria who had been administered apraclonidine 1% to help exclude Horner syndrome. The College has published advice and recommendation, which include:

  • Apraclonidine 1% should not be used in the diagnosis of paediatric Horner syndrome.
  • Apraclondine 0.5% should not be used in children below the age of six months in the diagnosis of Horner syndrome and used with extra caution in children below the age of two years.
  • All children under the age of two years should remain in the facility for two hours following administration of the agent.

If considering the use of apraclonidine 0.5% for this purpose, all clinicians need to remember the drug is not licenced for children and its use is contraindicated according to the drug’s Summary of Product Characteristics. The College states that the decision to use apraclonidine needs careful weighing of the risks and benefits of the test, which should be discussed with patients/parents and documented in the records along with the fact that the drug’s use will be off license. The College recommends giving parents an information sheet or written documentation outlining possible side effects and clear instructions to attend an emergency department if there is abnormal drowsiness or concern the child is unwell. The use of apraclonidine drops in paediatric glaucoma is a separate issue and this advice does not pertain to that area, where there is a greater track record of safety and a greatly different risk-benefit balance.

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PHARMACEUTICAL SERVICES NEGOTIATING COMMITTEE

METOPROLOL SUPPLY WARNING ISSUED

The Pharmaceutical Services Negotiating Committee has warned that there are currently intermittent supply issues affecting Metoprolol 50mg and 100mg tablets due to the discontinuation of the product by some manufacturers and other manufacturers experiencing supply difficulties. Supplies of both strengths are available but stock may be limited and supply intermittent for a number of months. Suppliers of alternative beta-blockers have been contacted to determine if they can meet any additional demand and currently, the manufacturers of Carvedilol have indicated they would be unable to meet demand if patients were switched to this product. Manufacturers of Bisoprolol, Atenolol and Propranolol have indicated they have capacity to support any additional demand on their products.

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ROYAL COLLEGE OF NURSING

PRACTICE GUIDANCE ON CATHETER CARE PUBLISHED

The Royal College of Nursing has published a practice guidance on catheter care aiming to encourage widespread adoption of the National Occupational Standards across all NHS and independent health care sectors, by enabling a full understanding of the standards and providing quality care for patients.

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PUBLIC HEALTH ENGLAND

VACCINE DATA SHOWS CHILDREN’S VACCINE 87% EFFECTIVE AGAINST CIRCULATING FLU STRAIN

Public Health England (PHE) has published mid-season data on the effectiveness of this year’s flu vaccines, alongside data from other countries, in Eurosurveillance (See OnMedica article). The data suggest that the nasal spray flu vaccine is 87% effective in children aged two to 17 years against the main circulating strain, influenza A(H1N1)pmd09. The vaccine given to adults aged 18 to 64 in at-risk groups is estimated to be 39% effective against the same strain. Influenza A(H1N1)pdm09 has been the main strain circulating this season. As the number of cases is lower, a precise estimate for those aged 65 and over will not be available until the end of the season. Vaccine uptake in children aged two and three is 43% and 45.2% respectively, and among school-aged children, this ranges from 56.2% to 63.9% depending on year group.

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NHS ENGLAND

ROLL-OUT OF ENHANCED PHYSIO SERVICES IN GP PRACTICES ANNOUNCED

NHS England has announced plans to roll out enhanced physiotherapist service in GP practices to treat common aches and pains (see OnMedica article). Trials in 41 areas including Nottingham, West Cheshire and Gloucestershire have seen patients choosing to be assessed and treated for common musculoskeletal conditions by physiotherapists with enhanced skills based in GP practices, rather than waiting to see a GP to get a referral to hospital. Evaluation of the service found that in some areas they delivered hundreds of thousands of pounds of savings which the NHS can reinvest into patient care, while patient satisfaction with the care they received was very high. Patients will be able to book appointments directly with physios and other expert health professionals at a local practice, without the need to wait for a referral or travel to a specialist clinic. Initial findings from the pilots, supported by NHS England’s Elective Care Transformation Programme, show that faster treatment leads to faster recovery. Up to seven in 10 patients were successfully discharged after just one consultation, and one part of the country reduced the number of people requiring long-term physiotherapy care by a fifth. The service also helps people to manage their arthritis.

ADVICE LINE FOR NEW AND EXPECTANT MOTHERS ACROSS THE COUNTRY ANNOUNCED

NHS England has announced that new and expectant mothers across the country will be able to access immediate support through phone advice lines (see OnMedica article). Women can get advice on labour, breastfeeding, sleep and other health problems over the phone 24 hours a day, 365 days per year from the Surrey Heartlands Pregnancy Advice Line. Midwives direct people to the most appropriate place of care and provide midwifery advice for 999 operators and other healthcare professionals. The line also frees up midwives’ time to deliver more personal care onwards, by reducing the need for hospital visits and redirecting calls directly to a trained specialist.

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DEPARTMENT OF HEALTH AND SOCIAL CARE

PERSONAL HEALTH BUDGETS SCHEME SET TO EXPAND

The Department of Health and Social Care has announced that wheelchair users and people who access aftercare services under the Mental Health Act will soon have a right to a personal health budget (see OnMedica article). Personal health budgets allow people to choose their own health and care support, which could include specially adapted wheelchairs designed to maximise independence; a choice of personal assistants who can be specially trained to meet the individual’s needs; technology, equipment or an assistance dog to reduce the need for support from a carer. As well as extending the legal right to wheelchair users and people who access aftercare services under the Mental Health Act, the government will look to give personal health budgets to:

  • people with ongoing mental health needs
  • veterans
  • autistic people
  • people with learning disabilities
  • people receiving adult social care support.

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ROYAL SOCIETY FOR PUBLIC HEALTH

CALL FOR FURTHER INVESTIGATION INTO THE “MISLEADING MARKETING” OF ‘HEALTHY’ FOODS

The Royal Society for Public Health (RSPH) has called for further investigation into the misleading marketing of foods labelled as ‘healthy’ following an investigation by BBC Radio 5 Live Investigates, which discovered three of the top five supermarkets have healthy eating sections which stock products that are unhealthy, scoring red on the traffic light system. Many of these products are vegetarian, vegan, or free from certain ingredients, but are highly processed, with high levels of fat, salt, or sugar. The EU register of Nutrition and Health Claims defines set values required for a product to be allowed to list health or nutrition statements. There is no definition for ‘healthy’, so currently supermarkets can market products under this term as they wish. There is a risk that promoting products as healthy could cause consumers to make purchasing decisions based on misrepresentative information. Trading Standards Officers have the power to inspect and enforce EU law, yet the evidence suggests the lack of a definition of what is ‘healthy’ allows supermarkets to use this to their advantage. RSPH is looking at this issue proactively, and is calling for:

  • A move away from using the term ‘healthy’ for food marketing;
  • Supermarkets to promote the EatWell guide to inform purchasing decisions;
  • A review of how supermarkets are regulated.

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EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL

ZOONOSES REPORT FINDS NO SLOWING DOWN OF ANTIMICROBIAL RESISTANCE

Data released by the European Centre for Disease Prevention and Control (ECDC) and European Food Safety Authority (EFSA) reveal that antimicrobials used to treat diseases that can be transmitted between animals and humans, such as campylobacteriosis and salmonellosis, are becoming less effective. According to the report, which refers to 2017 data, resistance to fluoroquinolones (such as ciprofloxacin) is so high in Campylobacter bacteria in some countries that these antimicrobials no longer work for the treatment of severe campylobacteriosis cases. Most countries reported that Salmonella in humans is increasingly resistant to fluoroquinolones. Multidrug resistance (resistance to three or more antimicrobials) is high in Salmonella found in humans (28.3%) and animals, particularly in S. Typhimurium. In Campylobacter, high to extremely high proportions of bacteria were found to be resistant to ciprofloxacin and tetracyclines. However, combined resistance to critically important antimicrobials was very low to low in Salmonella and Campylobacter from humans and animals and in indicator E. coli from animals.

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