NICE: brentuximab vedotin recommended for lymphoma

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National Institute for Health and Care Excellence

  • Brentuximab vedotin recommended for lymphoma in final guidance.
  • Suicide prevention draft quality standard published.
  • Draft recommendations published for:
    • Low-energy contact x-ray brachytherapy for locally advanced rectal cancer
    • Endovascular insertion of an intrasaccular wire mesh bloodflow disruption device for intracranial aneurysm
    • Bioprosthetic plug insertion for anal fistula.

Medicines and Healthcare products Regulatory Agency

  • Class 4 Medicines Defect Information: Ativan 4mg/1ml Solution for injection.

Royal College of Emergency Medicine

  • ‘Emergency Department Out-of-Hours Discharge Medications’ guideline published.

NHS England

  • Pioneering new brain surgery for deaf children to be made routinely available.
  • Annual NHS cancer checks top two million for the first time.

NHS Digital

  • Ambulance clinicians to access patient information on the move in a new pilot.

Royal Pharmaceutical Society

  • ‘Putting residents at the centre of pharmacy care home services’ report published.

World Health Organisation

  • New guidelines published on physical activity, sedentary behaviour and sleep for children under five years of age.

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

BRENTUXIMAB VEDOTIN RECOMMENDED FOR CD30-POSITIVE CUTANEOUS T-CELL LYMPHOMA

NICE has published final guidance which recommends brentuximab vedotin as an option for treating CD30‑positive cutaneous T‑cell lymphoma (CTCL) after at least one systemic therapy in adults, only if:

  • they have mycosis fungoides stage IIB or over, primary cutaneous anaplastic large cell lymphoma or Sézary syndrome and
  • the company provides brentuximab vedotin according to the commercial arrangement.

Brentuximab vedotin is licensed to treat CD30-positive CTCL after at least one systemic therapy. It is most likely to be used in the NHS as an alternative to systemic treatments to treat advanced disease. Clinical trial evidence shows that brentuximab vedotin is better than methotrexate or bexarotene in terms of response rates and extending how long people live without their disease getting worse. For some people with CTCL, brentuximab vedotin will be used as a bridge to a stem cell transplant. The most plausible cost-effectiveness estimates for brentuximab vedotin compared with current treatments are less than £30,000 per quality-adjusted life year gained, which is within the range considered to be a cost-effective use of NHS resources. However, these estimates are based on data from people with specific subtypes of advanced disease (mycosis fungoides stage IIB or over, primary cutaneous anaplastic large cell lymphoma and Sézary syndrome), so brentuximab vedotin is only recommended for these subtypes.

SUICIDE PREVENTION DRAFT QUALITY STANDARD PUBLISHED

NICE has published a draft quality standard which covers ways to reduce suicide and help people bereaved or affected by suicides in community and custodial settings. It describes high-quality actions in priority areas for improvement, such as:

  • Multi-agency suicide prevention partnerships
  • Reducing access to methods of suicide based on local intelligence.
  • Media reporting on suicide
  • Involving family or carers in the care of people with active suicidal thoughts or plans
  • Supporting people who are bereaved or affected by a suspected suicide.

It does not cover national strategies (including internet safety), general mental wellbeing, or areas such as the treatment and management of self-harm or mental health conditions.

DRAFT RECOMMENDATIONS FOR LOW-ENERGY CONTACT X-RAY BRACHYTHERAPY FOR LOCALLY ADVANCED RECTAL CANCER

NICE has published draft recommendations for the use of low-energy contact x-ray brachytherapy (the Papillon technique) for locally advanced rectal cancer. The procedure involves an X-ray tube which is inserted through the anus and placed in close contact with the cancer. It releases low-energy radiation into the cancer cells (brachytherapy). It may be done by itself or with other types of radiotherapy or chemotherapy. The aim is to kill the cancer cells while causing as little damage to surrounding healthy tissue as possible. However, current evidence on the safety and efficacy of low-energy contact X-ray brachytherapy for locally advanced rectal cancer is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research. NICE has advised that further research should include randomised controlled trials comparing this procedure with standard care and report details of patient selection (including tumour type and suitability for surgery), patient-reported outcomes, quality of life and long-term outcomes.

ENDOVASCULAR INSERTION OF AN INTRASACCULAR WIRE MESH BLOODFLOW DISRUPTION DEVICE FOR INTRACRANIAL ANEURYSM

NICE has published draft recommendations on the use of endovascular insertion of an intrasaccular wire-mesh blood-flow disruption device for intracranial aneurysm. Current evidence on the safety and efficacy of the procedure is adequate to support its use provided that standard arrangements are in place for clinical governance, consent and audit. Patient selection should be done by a multidisciplinary team, except for emergency situations, when this may be replaced by a discussion between an interventional neuroradiologist and neurosurgeon.

BIOPROSTHETIC PLUG INSERTION FOR ANAL FISTULA

NICE has published draft recommendations for the use bioprosthetic plug insertion for anal fistula. Current evidence on the safety and efficacy of the procedure is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit.

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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

MEDICINES DEFECT INFORMATION: ATIVAN 4MG/1ML SOLUTION FOR INJECTION

Pfizer Limited has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that the text on the carton label for Ativan 4mg/1ml Solution for injection has recently been updated and at this time, the product description on the carton was changed from 10 x 1ml ampoules to 10 x 2ml ampoules. The updated text reflects the size of the ampoules, which is 2ml. The concentration and total volume of the ampoules has not changed and remains 4mg Lorazepam in 1ml of solution. MHRA understands that the carton label is in the process of being revised to reflect the volume of solution contained in the ampoules and batches with the revised labels are expected to become available during Q3 2019.

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ROYAL COLLEGE OF EMERGENCY MEDICINE

EMERGENCY DEPARTMENT OUT-OF-HOURS DISCHARGE MEDICATIONS GUIDELINE PUBLISHED

The Royal college of Emergency Medicine has published a best practice guideline which covers out-of-hours discharge medications. This guideline is designed primarily for use in Type 1 emergency departments (ED), but the suggestions and drugs listed are of relevance to Type 2 and 3 departments for both adults and children. The subject of collection of prescription costs by the ED is outside the remit of this guideline. Recommendations include:

  1. The ED should have easy access to an appropriately stocked ‘To Take Out’ (TTO) Cupboard during the out-of-hours period.
  2. The ED needs to balance patient convenience, patient concordance and cost when deciding on the duration of the prescribed drug course to give out as a TTO.
  3. The stocking of the TTO cupboards should reflect the Patient Group Direction list for non-prescribers, local microbiology guidelines and the needs of the local population. Consideration should also be placed on the changing costs of medications and the need for review of the TTO cupboard contents on a regular basis.
  4. ED nursing staff and doctors should follow local guidance on how to safely give out TTOs from the ED.
  5. If medication is required urgently and is not available in the TTO cupboard it should be prescribed in the method most convenient for the patient – FP10 or Hospital TTO script. Non-urgent medication can be arranged via an advice slip to the GP.
  6. There should be close liaison between the pharmacy department and the emergency department, with regular meetings focussing on safe prescribing, TTO volumes and costs.

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NHS ENGLAND

PIONEERING NEW BRAIN SURGERY FOR DEAF CHILDREN TO BE MADE ROUTINELY AVAILABLE

NHS England has announced that pioneering brain surgery that allows children who are deaf to experience the sensation of hearing will be made routinely available (see OnMedica article). The surgery is for children who are profoundly deaf, aged five or under, who are unable to use conventional hearing aids or implants because their inner ear (cochlea) or auditory nerve did not develop properly. The highly complex procedure involves inserting a device directly into the brain to stimulate hearing pathways, bypassing the cochlea and auditory nerve that have not developed properly. After the implant has been inserted, long-term support is needed to help children learn to listen and understand new signals from their implant. Manchester University NHS Foundation Trust and Guy’s and St Thomas’ NHS Foundation Trust in London will offer the cutting-edge surgery.

ANNUAL NHS CANCER CHECKS TOP TWO MILLION FOR THE FIRST TIME

NHS England has reported that for the first time more than two million cancer checks were carried out last year. In 2018, patients underwent a record 2.2 million cancer checks following urgent referral by their GP, almost 6,000 a day or more than four every minute- an increase of almost a quarter of a million on the 1.9 million people who were seen in 2017. Record numbers of people also received treatment for cancer, with 308,058 receiving a first treatment in 2018, almost 13,000 more than in 2017 and the first time the number has topped 300,000. The NHS attributes the rise to a number of factors, including new guidance introduced in 2015 for GPs, lowering the threshold for cancer referral and more awareness raising than ever before with high profile celebrities such as Bill Turnbull, Stephen Fry and Jeremy Bowen recently sharing their stories, leading to a significant increase in people checking for cancer symptoms.

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NHS DIGITAL

AMBULANCE CLINICIANS TO ACCESS PATIENT INFORMATION ON THE MOVE IN A NEW PILOT

NHS Digital has announced that the London Ambulance Service will begin a pilot to enable its clinicians to securely access Summary Care Record (SRC) data on an iPad, without the need for a smartcard or N3, by using the new NHS Identity Service to authenticate to the system. This will give medics access to crucial information about a patient to prevent the patient having to repeat themselves, while they are in pain or distressed. This should reduce the time the medic needs to spend with each patient and will also aim to reduce A&E admissions. Around 60 medics will have access to patients’ SCRs and additional information securely on their iPads. This includes vital information about a patient’s medical history such as details of long-term conditions, significant medical history, ongoing prescriptions, known allergies and any other specific needs. The pilot will last 16 weeks.

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ROYAL PHARMACEUTICAL SOCIETY

‘PUTTING RESIDENTS AT THE CENTRE OF PHARMACY CARE HOME SERVICES’ REPORT PUBLISHED

The Royal Pharmaceutical Society has published a new report setting out a vision for improving the care of residents in care homes across Scotland. The report recommends that care homes have dedicated time from pharmacists and their teams embedded in their service. It highlights the need for regular medication reviews to reduce inappropriate polypharmacy and improve quality of life for residents. It illustrates how input from the pharmacy team results in improved palliative care, fewer falls, fewer unplanned admissions to hospital, improved appetite and more socially active residents.

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WORLD HEALTH ORGANISATION

NEW GUIDELINES ON PHYSICAL ACTIVITY, SEDENTARY BEHAVIOUR AND SLEEP FOR CHILDREN UNDER FIVE YEARS OF AGE

The World Health Organisation (WHO) has published new guidelines on physical activity, sedentary behaviour and sleep for children under five years of age (see OnMedica article). The guidelines were developed by a WHO panel of experts. They assessed the effects on young children of inadequate sleep, and time spent sitting watching screens or restrained in chairs and prams. They also reviewed evidence around the benefits of increased activity levels. The guideline includes recommendations on the amount of physical activity, time spent sedentary, duration of screen time and recommended amounts of sleep for children aged less than one year, 1-2 years old and 3-4 year olds.

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Editorial team, Wilmington Healthcare

OnMedica is an independent, easy to access on-the-go website for doctors. It provides GPs and specialists with easy to digest and up-to-date, relevant educational content whilst enabling the freedom to share and collaborate in a safe-space to further personal development.
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