- Suspected neurological conditions: recognition and referral guideline published.
- Updated guideline published on diagnosis and initial management of stroke and transient ischaemic attack in over 16s.
- Atezolizumab in combination recommended for non-small-cell lung cancer in final guidance.
- Ertugliflozin recommended in triple therapy regimen for type 2 diabetes in final draft guidance
- Sodium zirconium cyclosilicate recommended for hyperkalaemia in emergency care settings only in draft guidance.
- End-of-life care for adults: service delivery draft guideline published.
- 12 medicines approved by the CHMP:
- Esperoct for bleeding in patients 12 years and above with haemophilia A
- Ultomiris for paroxysmal nocturnal haemoglobinuria
- Doptelet for severe thrombocytopenia
- Dovato for the treatment of HIV infection
- Nuceiva for temporary improvement of vertical lines between the eyebrows
- Talzenna for germline BRCA1/2 mutations in breast cancer
- Grasustek for prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy
- Xromi for the prevention of vaso-occlusive complications of sickle cell disease
- Temybric Ellipta for maintenance treatment of moderate to severe COPD.
- Libtayo for advanced cutaneous squamous cell carcinoma.
- Ambrisentan Mylan for pulmonary arterial hypertension.
- Striascan for the diagnosis of Parkinson’s disease and dementia.
- Negative opinion adopted for Cabazitaxal Teva for prostate cancer.
- Extension of indication recommended for Lynparza for ovarian cancer.
- New long-lasting implant recommended to treat opioid dependence.
- Withdrawal of marketing authorisation for Lartruvo recommended.
- Update of prescribing information for Tyverb following re-analysis of treatment data.
- Medical device alerts issued:
- Nellix Endovascular Aneurysm Sealing System - Device recall and enhanced patient surveillance recommended
- Ethicon curved intraluminal staplers – risk of failure of staple lines.
- Class 4 medicines defect information: prednisolone 5mg tablets.
- Doctors asked for views on getting effective feedback from patients.
- Opt-out organ donation: views sought on organs and tissues to be excluded from the new system.
- New deal with pharma to help eliminate hepatitis C.
- NHS ‘sleep clinic’ programme improves children and parents’ mental health.
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
SUSPECTED NEUROLOGICAL CONDITIONS: RECOGNITION AND REFERRAL GUIDELINE
NICE has published a guideline which covers the initial assessment of symptoms and signs that might indicate a neurological condition (see OnMedica article). The new guideline offers comprehensive information on neurological conditions in general to help non-specialist healthcare professionals to identify people who should be offered referral for specialist assessment and care. The guideline makes recommendations about which symptoms and signs should prompt a referral for further neurological assessment. It also covers some examinations, assessment tools and investigative tests non-specialists could use to help them decide whether a person with a suspected neurological condition should have further investigation or be referred to a specialist.
STROKE AND TRANSIENT ISCHAEMIC ATTACK IN OVER 16s : DIAGNOSIS AND INITIAL MANAGEMENT - UPDATED GUIDELINE
NICE has published an updated guideline on the diagnosis and initial management of stroke and transient ischaemic attack (TIA). It recommends that people with acute ischaemic stroke should be offered a thrombectomy up to 24 hours after the onset of symptoms. The guideline says thrombectomy should be offered alongside clot-busting drugs if there is potential to salvage brain tissue. Until now, thrombectomy was usually only recommended up to 12 hours after the onset of symptoms. It also includes new recommendations on:
- initial management of suspected and confirmed TIA
- imaging for people with suspected TIA
- blood pressure control for people with acute intracerebral haemorrhage
- optimal positioning and early mobilisation for people with acute stroke
- decompressive hemicraniectomy for people with acute stroke
ATEZOLIZUMAB IN COMBINATION RECOMMENDED FOR NON-SMALL-CELL LUNG CANCER
NICE has published final draft guidance recommending atezolizumab (Tecentriq) given in combination as an option for some people with non-small-cell lung cancer that has spread. The draft guidance recommends atezolizumab plus bevacizumab (Avastin), carboplatin and paclitaxel as an option for adults with non-squamous, non-small-cell lung cancer (NSCLC) who:
- 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.
The positive recommendation follows an improved discount to the prices of atezolizumab and bevacizumab offered by the company. It is also made on the basis that treatment with atezolizumab and bevacizumab is stopped at two-years (or earlier if the disease worsens) to reflect the fact that the cost-effectiveness evidence was limited to two-years of treatment and the best length of treatment is unknown. The evidence suggests that people having atezolizumab plus bevacizumab, carboplatin and paclitaxel live longer than those having the current treatment (pemetrexed plus carboplatin or cisplatin, with or without pemetrexed maintenance). It also suggests that they live for longer before their condition worsens.
ERTUGLIFLOZIN RECOMMENDED IN TRIPLE THERAPY REGIMEN FOR TYPE 2 DIABETES
NICE has published final draft guidance which recommends ertugliflozin (Steglatro) with metformin and adipeptidyl peptidase-4 (aDPP-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 appears to have similar health benefits to other SGLT-2 inhibitors when taken with metformin and aDPP-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 type2 diabetes (sulfonylureas or pioglitazone).
SODIUM ZIRCONIUM CYCLOSILICATE RECOMMENDED FOR HYPERKALAEMIA IN EMERGENCY CARE SETTING
NICE has published draft guidance which recommends sodium zirconium cyclosilicate (Lokelma) as an option for treating hyperkalaemia in adults only if:
- it needs treating in an emergency care setting
- the drug is stopped after 28 days of maintenance treatment, or earlier if the hyperkalaemia resolves.
According to NICE there are clinical trials showing that sodium zirconium cyclosilicate is effective in lowering serum potassium levels and can resolve hyperkalaemia in the outpatient setting. However, the trials mostly include people with serum potassium levels that would not be treated in the NHS. There is no clinical evidence to show that sodium zirconium cyclosilicate extends life or improves quality of life compared with standard care in people having treatment in the NHS outpatient setting. Because of the limitations in the clinical evidence, NICE says the cost-effectiveness estimates for sodium zirconium cyclosilicate in the outpatient setting are highly uncertain and likely to be above what NICE normally considers a cost-effective use of NHS resources. This is why sodium zirconium cyclosilicate is not recommended in the outpatient setting for people with hyperkalaemia.
END-OF-LIFE CARE FOR ADULTS: SERVICE DELIVERY - DRAFT GUIDELINE
NICE has published a draft guideline which covers organising and delivering end-of-life care services for adults approaching the end of their life. It aims to ensure that people have access to end-of-life services in all care settings, according to their needs and wishes. It also includes advice on services for carers and other people important to adults who are approaching the end of their life. It is intended to be used alongside the NICE guideline on care of dying adults in the last days of life, which covers care planning and clinical interventions for people who are considered to be in the last days of life. For those approaching the end of their life, it is advised that patients and their carers should have access to someone who has expertise in end-of-life care and understands their needs whether in person, or through an out-of-hours advice line that can provide practical and emotional support over the phone. Additionally, new recommendations suggest that carers’ needs should be assessed, taking into consideration that the needs of younger carers may differ to those who are older. Evidence shows that when supported, carers can help maintain a better quality of life for the person dying. Practitioners are encouraged to listen to the needs of carers, to consider the physical and emotional strain they might experience, and to look at how their needs can be met as well as the needs of those they care for.
EUROPEAN MEDICINES AGENCY
12 MEDICINES APPROVED, ONE NEGATIVE OPINION ON CABAZITAXAL TEVA AND ONE EXTENSION OF INDICATION RECOMMENDED FOR LYNPARZA
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended 12 medicines for approval at its April 2019 meeting, including:
- Positive opinions for:
- Esperoct (turoctocog alfa pegol), an orphan medicine for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency) and
- Ultomiris (ravulizumab), an orphan medicine for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.
- Doptelet (avatrombopag) for the treatment of severe thrombocytopenia.
- Dovato (dolutegravir / lamivudine), for the treatment of HIV infection.
- Nuceiva (botulinum toxin type a), intended for temporary improvement of vertical lines between the eyebrows, when the severity of the facial lines has an important psychological impact in adults below 65 years of age.
- Talzenna (talazoparib) for the treatment of adult patients with germline BRCA1/2 mutations who have HER2-negative locally advanced or metastatic breast cancer.
- The biosimilar medicine Grasustek (pegfilgrastim) for prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy.
- Xromi (hydroxycarbamide), a hybrid medicine for the prevention of vaso-occlusive complications of sickle cell disease in patients over two years of age.
- Temybric Ellipta (fluticasone furoate / umeclidinium / vilanterol), an informed consent application for the maintenance treatment of adults patients with moderate to severe chronic obstructive pulmonary disease.
- The granting of a conditional marketing authorisation for Libtayo (cemiplimab), for the treatment of advanced cutaneous squamous cell carcinoma.
- Ambrisentan Mylan (ambrisentan), a generic medicine for the treatment of pulmonary arterial hypertension
- Generic medicine Striascan (ioflupane (123I)), a radiopharmaceutical intended for the diagnosis of Parkinson’s disease and other related diseases and dementia.
However, the CHMP adopted a negative opinion refusing a marketing authorisation for Cabazitaxel Teva (cabazitaxel). Developed as a hybrid medicine, Cabazitaxel Teva was expected to be used to treat prostate cancer.
The Committee also recommended an extension of indication for Lynparza (olaparib) to include it as a maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
NEW LONG-LASTING IMPLANT RECOMMENDED TO TREAT OPIOID DEPENDENCE
CHMP has recommended granting a marketing authorisation for Sixmo (buprenorphine) as a substitution treatment for opioid dependence. Sixmo is an implant that releases low levels of buprenorphine into the patient’s body for six months. It is indicated in clinically stable adult patients who require no more than 8 mg per day of sublingual (i.e. administered under the tongue) buprenorphine, within a framework of medical, social and psychological treatment. It consists of four small rods that are implanted in the patient’s upper arm by a trained physician under local anaesthetic and continuously delivers buprenorphine for six months. This new method of administration could enhance adherence to the treatment and reduce the potential for misuse or accidental overdoses in the home, as well as the risk of accidental ingestion of buprenorphine by others, especially children. The safety and efficacy of Sixmo was studied in three pivotal trials, in a total of 626 adult patients. One of the trials enrolled OUD (Opioid use disorder) adults who were considered clinically stable by their treating physician. The results demonstrated that 96.4% of patients in the Sixmo group responded to treatment, compared to 87.6% of patients treated with sublingual buprenorphine.
WITHDRAWAL OF MARKETING AUTHORISATION FOR LARTRUVO RECOMMENDED
The EMA has completed its assessment of the results of the ANNOUNCE study and concluded that Lartruvo (olaratumab) with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone. Therefore, the EMA is recommending that the
marketing authorisation of the medicine be revoked. In January 2019, when preliminary results of the ANNOUNCE study became available, the Agency recommended that no new patients should start treatment with the medicine. Having now assessed the full data from the study, the Agency has concluded that the benefit of Lartruvo in combination with doxorubicin is not confirmed. Regarding safety, the data did not show any new safety concerns.
UPDATE OF PRESCRIBING INFORMATION FOR TYVERB FOLLOWING RE-ANALYSIS OF DATA
The EMA is updating the prescribing information for Tyverb (lapatinib) following detection of errors in results of a study involving postmenopausal women who had ‘HR+/HER2+’ breast cancer and whose disease had worsened despite previous treatment with trastuzumab. The results had indicated a benefit of Tyverb over trastuzumab when each medicine was used together with an aromatase inhibitor. The detected errors were included in the prescribing information for Tyverb on 30 July 2018. However, these will now be removed while data are being re-analysed. In the meantime, the prescribing information will be amended to state, as before, that no data are available on the effectiveness of Tyverb compared with trastuzumab in this combination in patients previously treated with trastuzumab. In the light of this new information, doctors currently treating patients with Tyverb in combination with an aromatase inhibitor, whose disease had worsened despite previous treatment with trastuzumab, should decide whether to continue with the same therapy or consider an alternative treatment.
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
NELLIX ENDOVASCULAR ANEURYSM SEALING SYSTEM - DEVICE RECALL AND ENHANCED PATIENT SURVEILLANCE
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for Nellix Endovascular Aneurysm Sealing (EVAS) System. Endologix has stopped selling the Nellix EVAS device and is recalling unused stock. The MHRA recommends enhanced patient surveillance due to a high risk of graft failure beyond two years after implantation. Advice has been produced by MHRA’s Nellix independent Expert Advisory Group and updates guidance previously given in MDA/2019/002 issued 25 January 2019. This includes the following actions to be taken by healthcare professionals:
- Immediately stop further implants of the device.
- Identify if there is any device inventory that should be returned to Endologix following the instructions in the Field Safety Notice (dated 04 January 2019).
- Identify all patients implanted with a Nellix device under surveillance.
- Notify the nearest UK expert centre (identified in the protocol detailed in the MHRA alert - see appendix 1 with the number of patients currently remaining under surveillance and discuss in advance the support this centre can provide if a patient requires re-intervention.
- Continue to undertake lifelong follow-up of all patients according to normal clinical practice. Enhanced surveillance involving CT imaging should be repeated at least annually, unless the patient is considered unfit for secondary intervention. Arrange for early CT surveillance for all patients who have not received CT imaging within the last 12 months.
- The most recent scans should be compared to immediate post-operative images to identify signs of device failure. This includes significant device migration, Type I endoleak and/or aneurysm sac expansion. MHRA’s independent Expert Advisory Group has produced extra information on how to detect features of device failure. For more information please follow this link.
- Discuss with the nearest UK expert centre all patients being considered for secondary intervention
- Patients that are suitable for surgical explant may be treated either locally or referred on to a larger volume centre if appropriate
- All patients in whom a Nellix-in-Nellix intervention is proposed as the optimum treatment should be treated at one of the named UK expert centres, according to the conditions set out in the protocol detailed in the MHRA alert – see appendix 1.
ETHICON CURVED INTRALUMINAL STAPLERS – RISK OF FAILURE OF STAPLE LINES
The MHRA has issued a medical device alert for Ethicon Curved Intraluminal Staplers. Manufactured by Ethicon, the use of affected devices may result in failure of staple line which could lead to postoperative anastomotic leaks, gastrointestinal tissue injury and bleeding. Healthcare professionals are advised to take the following actions:
- Identify and quarantine all affected, unused devices as listed in the Field Safety Notice.
- If alternative devices are available, use the alternatives and return affected products to Ethicon.
- If alternative devices are not available, only use affected products following local risk assessment and in adherence to the guidance provided in the Field Safety Notice.
- Complete the Business Response Form and return to Ethicon.
- Report adverse events involving these devices through the local incident reporting system and/or national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. Report directly to manufacturers if local or national systems do not.
CLASS 4 MEDICINES DEFECT INFORMATION: PREDNISOLONE 5MG TABLETS
The MHRA has issued a class 4 medicines defect information alert for some batches of prednisolone 5mg tablets. Genesis Pharmaceuticals Ltd has informed the MHRA that there is an error on the Braille for certain batches which means that the strength reads as 1mg instead of 5mg. The printed text is correct on all packaging. As this poses a risk to patients who have compromised eye-sight and rely solely on Braille to determine their tablet strength, affected batches should not be dispensed to such patients. The MHRA advises that alternative batches of the product are available from a number of suppliers.
GENERAL MEDICAL COUNCIL
DOCTORS ASKED FOR VIEWS ON GETTING EFFECTIVE FEEDBACK FROM PATIENTS
Doctors are being asked for their views on how they should collect and reflect on feedback from their patients, in a consultation launched by the General Medical Council (GMC). As feedback from patients, as well as from colleagues, is part of the supporting information doctors need for revalidation, the regulator is now consulting on proposed changes to its guidance on how doctors should collect and reflect on feedback from patients, their families and carers to support their revalidation. The GMC wants doctors to review their patient feedback annually, rather than every five years when their revalidation is due; to use any unprompted feedback, such as letters, cards or comments; and to consider how to get feedback from a wide range of patients, including those with communication or learning difficulties.
DEPARTMENT OF HEALTH AND SOCIAL CARE
OPT-OUT ORGAN DONATION: CONSULTATION ON ORGANS AND TISSUES TO BE EXCLUDED FROM THE NEW SYSTEM
The Department of Health and Social Care is seeking views on which organs and tissues should be excluded from the new opt-out organ donation system. From 2020, everyone in England over the age of 18 will be considered to be in favour of donating their organs and tissue after death unless they:
- have said they do not want to donate (opted out)
- have appointed someone to decide for them after death
- are in an excluded group
The government proposes that transplants of certain organs and tissues will still need consent and wants views on whether the right parts of the body are excluded from the opt-out system.
NEW DEAL WITH PHARMA AIMS TO ELIMINATE HEPATITIS C
NHS England has announced that a new agreement has been made with three drug companies, which will aim to find and cure tens of thousands more people with hepatitis C. According to NHS England, over 30,000 people have already benefitted from new drugs which cure hepatitis C being made available on the NHS over the last few years. As a result of investment, the death rate from hepatitis C-related liver diseases has already fallen by more than 16% between 2015 and 2017. The NHS is also seeing cost savings from a fall in liver transplants for patients with hepatitis C, with a reduction of almost 40% in 2017 compared to 2015. In addition to providing all five new hepatitis C drugs at the best price for the NHS and taxpayers, the three drug companies will also launch initiatives – working with local health services, councils and voluntary groups – which will find potential patients, test for infection and provide treatment to those who need it.
NHS ‘SLEEP CLINIC’ PROGRAMME IMPROVES CHILDREN AND PARENTS’ MENTAL HEALTH
NHS England has reported that a pilot scheme designed to help vulnerable children improve their sleep patterns has delivered notable improvements to families’ health and wellbeing. The programme in Sheffield, developed by the NHS, the Children’s Sleep Charity and Sheffield City Council, delivers sleep clinics to children from troubled backgrounds or with very challenging behaviour, resulting in children sleeping well and performing better at school, while freeing up time for parents to recharge and be better able to look after their family. During the programme, specialists in sleep offer help and advice to parents over the phone and in one to one sessions, on how to help children – some of whom only sleep for four to five hours per night – to sleep better, including helping to get into a routine around bedtime and teaching mums and dads techniques which help kids to stay calm before bedtime despite impact on their wellbeing from ill health or trauma. As well as improving the mental health of children involved, NHS England says the measures had a significant impact on parents’ wellbeing, with the number of carers, mums and dads reporting illnesses like headaches, anxiety, depression and infections falling by 16%, from more than two-thirds to 51%.