EMA: omega-3 fatty acid medicines confirmed as ineffective in preventing further heart problems after a heart attack
- Abemaciclib with fulvestrant recommended for advanced breast cancer in final draft guidance.
- Draft guidance does not recommend fluocinolone acetonide intravitreal implant for recurrent non-infectious uveitis.
- Management guideline for urinary incontinence and pelvic organ prolapse in women published.
- New guidance for specialist respiratory care for babies born preterm issued.
- Draft updated recommendations on use of prophylactic progesterone in preterm labour and birth open for consultation.
- Ataluren recommended for Duchenne muscular dystrophy.
- Updated advice on efficacy and safety of opioids in the management of chronic pain open for consultation.
- One marketing authorisation and three extensions of indication recommended by CHMP.
- New gene therapy recommended to treat rare inherited blood condition.
- Omega-3 fatty acid medicines confirmed as ineffective in preventing further heart problems after a heart attack.
- Medical device alert: Fresenius 5008 & 5008s haemodialysis machines – low risk of inadequate fluid removal during treatment.
- ‘Pan-college’ guidance on valproate use published.
- RPS president requests ban on DNP.
- Psychiatrists advised to consider impact of social media on all children they assess.
- Consultation on draft guidance for pharmacist prescribers open.
- New data reveals overall number of amputations related to diabetes is increasing.
- NHS report success of type 2 diabetes prevention programme.
- £4.8m to be made available to scale up local digital adult social care projects.
- Free guide to improve public’s sleep launched.
- Data shows slight decline in hepatitis C diagnoses in 2017.
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
ABEMACICLIB WITH FULVESTRANT RECOMMENDED FOR ADVANCED BREAST CANCER
NICE has published final daft guidance which recommends abemaciclib (Verzenio) with fulvestrant, to be made available for NHS use within the Cancer Drugs Fund (CDF). The treatment could be an option for up to 4,800 women who have already had endocrine treatment for hormone receptor-positive, HER2-negative breast cancer which has spread to other parts of the body. It will be an option where exemestane plus everolimus would be the most appropriate alternative treatment. Clinical trial evidence suggests that compared with fulvestrant alone, abemaciclib with fulvestrant increases the length of time before the disease progresses. However, there is a lack of evidence around the overall survival benefit and around its cost-effectiveness, meaning it has been recommended for use within the CDF while more data is collected. Final guidance is expected to be published in May 2019. It will be reviewed when the final analysis of the MONARCH 2 study is available, which is expected to be February 2020.
FLUOCINOLONE ACETONIDE INTRAVITREAL IMPLANT NOT RECOMMENDED FOR RECURRENT NON-INFECTIOUS UVEITIS
NICE has published draft guidance which does not recommends fluocinolone acetonide intravitreal implant as an option for preventing relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye in adults. The draft guidance says the clinical trial results are difficult to interpret and very uncertain. The trial didn’t measure health-related quality of life and the number of recurrences reported may be overestimated. Also, people in the control group didn’t have any treatment after three months in the trial, which is not what is likely to happen in the NHS in England. Because of the uncertainty in the trial results, the cost-effectiveness estimates are also uncertain. Also, the analyses do not include the dexamethasone implant, which is a relevant comparator. The committee has requested that further clarification and analyses from the company should be made available for the second appraisal committee meeting and should also include a revised cost-effectiveness model. Closing date for comments is 24 April 2019.
URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE IN WOMEN: MANAGEMENT GUIDELINE PUBLISHED
NICE has published a guideline which covers the assessment and management of urinary incontinence and pelvic organ prolapse in women aged 18 and over. It also covers complications associated with mesh surgery for these conditions. However, in July 2018, the government announced a period of ‘high vigilance restriction’ on the use of a group of procedures, including vaginally inserted mesh and tape to treat stress urinary incontinence and pelvic organ prolapse, in England. This followed a recommendation by Baroness Cumberlege, who is chairing an independent review of surgical mesh procedures and has heard from women and families affected by them. For details, see the letter from NHS England and NHS Improvement to trust medical directors. At the time of publication of this updated NICE guideline, the high vigilance restriction period had been extended and, until it ends, professionals should continue to follow its requirements. The new guideline updates and replaces a number of previous guidance (NICE CG171, CG40, TA 56, IPG154, ESNM2).
GUIDELINE PUBLISHED FOR SPECIALIST RESPIRATORY CARE FOR BABIES BORN PRETERM
NICE has published a guideline which covers specific aspects of respiratory support (for example, oxygen supplementation, assisted ventilation, treatment of some respiratory disorders, and aspects of monitoring) for preterm babies in hospital. It includes a visual timeline of interventions and support for babies born preterm who need specialist neonatal respiratory care.
DRAFT GUIDELINE UPDATE PUBLISHED: PRETERM LABOUR AND BIRTH
NICE has published a draft guideline which covers the care of women at increased risk of or with symptoms and signs of preterm labour (before 37 weeks) and women having a planned preterm birth. It aims to reduce the risks of preterm birth for the baby and describes treatments to prevent or delay early labour and birth. Comments are invited on the new and updated recommendations following NICE’s review of the evidence on the use of prophylactic progesterone in preterm labour and birth. NICE is also proposing to delete some recommendations from the 2015 guidance. The consultation closes on 30 April 2019.
ALL WALES MEDICINES STRATEGY GROUP
ATALUREN RECOMMENDED FOR DUCHENNE MUSCULAR DYSTROPHY
The All Wales Medicines Strategy Group has recommended ataluren (Translarna®) for use within NHS Wales, under a Patient Access Scheme, for the treatment of Duchenne muscular dystrophy (DMD) resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged two years to less than five years.
SCOTTISH INTERCOLLEGIATE GUIDELINES NETWORK
UPDATE TO SIGN 163: MANAGEMENT OF CHRONIC PAIN OPEN FOR CONSULTATION
SIGN 136: Management of chronic pain was published in December 2013. Since then new advice has been published on the prescribing of opioids. This small revision will update the guideline to provide more current advice on the efficacy and safety of opioids for managing patients with chronic pain. It will replace Section 5.3 of SIGN 136. The proposed revision is available here, along with revisions to the algorithm in Annex 4. Feedback should be submitted by Friday 26 April 2019.
EUROPEAN MEDICINES AGENCY
ONE MARKETING AUTHORISATION AND THREE EXTENSIONS OF INDICATION RECOMMENDED BY CHMP
The European Medicines Agency’s (EMA) human medicines committee (CHMP) adopted recommendations for one new initial marketing authorisation and three extensions of indication in their March meeting:
- The Committee recommended granting a conditional marketing authorisation for Zynteglo (Autologous CD34+ cells encoding βA-T87Q-globin gene), an advanced therapy medicinal product (ATMP) for beta-thalassaemia, a rare inherited blood condition that causes severe anaemia (see below).
- The Committee recommended extensions of indication for Imnovid (pomalidomide), Mozobil (plerixafor) and Revlimid (lenalidomide).
NEW GENE THERAPY RECOMMENDED TO TREAT RARE INHERITED BLOOD CONDITION
EMA has recommended granting a marketing authorisation in the European Union for a genetically modified product for beta-thalassaemia, a rare inherited blood condition that causes severe anaemia. Zynteglo (Autologous CD34+ cells encoding βA-T87Q-globin gene (an orphan medicinal product)) is intended for adult and adolescent patients 12 years and older who need regular blood transfusions to manage their disease and have no matching donor for a stem cell transplant. Patients suffering from beta-thalassaemia cannot produce enough beta-globin, a key component of haemoglobin, the protein that carries the oxygen in the blood from the lungs to the rest of the body. As a consequence, they have far fewer red blood cells than normal and suffer from chronic severe anaemia. These patients often require lifelong blood transfusions for their anaemia. Chronic transfusions can cause iron overload, hence patients need to take medication to remove excess iron. So far, the only curative treatment option is stem cell transplantation from a healthy donor. However, in the absence of a matched family donor, finding appropriate donors is often difficult and stem cell transplantation with unrelated donors is associated with severe side-effects and reactions. Patients who depend on blood transfusions to manage beta-thalassaemia therefore have an unmet medical need for new treatments. In the two main studies to demonstrate the effects of Zynteglo it was shown that the majority of patients who do not have a β0/β0 genotype treated with Zynteglo no longer needed regular blood transfusions.
OMEGA-3 FATTY ACID MEDICINES CONFIRMED AS INEFFECTIVE IN PREVENTING FURTHER HEART PROBLEMS AFTER A HEART ATTACK
The EMA has confirmed that omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a dose of 1 g per day are not effective in preventing further problems with the heart and blood vessels in patients who have had a heart attack. This is the outcome of a re-examination requested by some of the companies that market the medicines concerned, following the EMA’s original recommendation in December 2018. This means that these medicines should no longer be used in this way. However, they can still be used to reduce levels of certain types of blood fat called triglycerides. Omega-3 fatty acid medicines have been authorised for use after a heart attack, in combination with other medicines, in several EU countries since 2000, at a dose of 1 g per day. At the time of their authorisation, available data showed some benefits in reducing serious problems with the heart and blood vessels. The CHMP has re-assessed the evidence accumulated over the years on these medicines for this specific use and consulted additional experts in the field. It concluded that, although there are no new safety concerns, the effectiveness of these medicines in preventing recurrence of problems with the heart and blood vessels has not been confirmed. The EMA concluded that the marketing authorisations of these medicines should be updated to remove this use.
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
FRESENIUS 5008 & 5008S HAEMODIALYSIS MACHINES – LOW RISK OF INADEQUATE FLUID REMOVAL DURING TREATMENT
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for Fresenius 5008 & 5008S haemodialysis machines due to the low risk of inadequate fluid removal during treatment. Fresenius Medical have informed the MHRA that inadequate ultrafiltration can occur due to sudden failure of the ultrafiltration pump - this cannot be identified during the manufacturer’s technical safety checks. This failure can happen suddenly, without the machine alarming, and currently can only be identified by observing incomplete fluid removal from patients after dialysis treatments. Healthcare professionals are advised to:
- Ensure that operators of these machines have read this notice and are alerted to the potential risk of inadequate fluid removal without the machine’s alarm sounding. Consider updating associated user guidance documents for these machines.
- Consider checks after each dialysis treatment to ensure that enough fluid has been removed.
- If frequent episodes of inadequate fluid removal by these machines are observed, notify the local technical/EMBE staff or the manufacturer. This will be noticeable if patient weight is frequently heavier than expected after treatment.
ROYAL COLLEGE OF GENERAL PRACTITIONERS
‘PAN-COLLEGE’ GUIDANCE ON VALPROATE USE PUBLISHED
The Royal College of GP’s, along with 12 other national bodies, have launched new practical guidance to support doctors and other health professionals around valproate use in women and girls in their reproductive years (see OnMedica article). The 'pan-College' advice is based on 2018 regulations issued by the MHRA around the prescribing and dispensing of valproate - but looks at the more challenging issues that clinicians across primary and specialist care might encounter in daily practice. These include transition from paediatric to adulthood services, competence to consent to treatment, and confidentiality.
ROYAL PHARMACEUTICAL SOCIETY
RPS PRESIDENT REQUESTS BAN ON DNP
The Royal Pharmaceutical Society (RPS) president has written to the home secretary, Sajid Javid, requesting a ban on the diet drug 2,4-Dinitrophenol (DNP). The RPS says DNP is an industrial chemical unfit for human consumption which is marketed illegally online to promote extreme weight loss, and is being sold via websites, social media accounts, or via people at the gym. The RPS president has urged the government to ban DNP in order to reduce the risk of harm, to commit to prosecuting those seeking to profit from it, and to encourage other countries to do the same.
ROYAL COLLEGE OF PSYCHIATRISTS
PSYCHIATRISTS ADVISED TO CONSIDER IMPACT OF SOCIAL MEDIA ON ALL CHILDREN THEY ASSESS
The Royal College of Psychiatrists is advising psychiatrists to consider the impact of social media on all children they assess for mental health problems and say that questions about technology use should be a routine part of those assessments, given the growing evidence of possible links between harmful content or excessive time spent online and poor mental health. Factors psychiatrists are being urged to consider include:
- Harmful content especially material which could impact on an existing mental illness, such as self-harm photos or images which promote eating disorders.
- How problematic technology use could be related to problems such as lack of/disrupted sleep, poor academic performance, low mood, and behavioural or eating difficulties.
- That conditions such as depression or eating disorders may make children more likely to spend too long online or use technology in a way that is harmful.
GENERAL PHARMACEUTICAL COUNCIL
CONSULTATION ON DRAFT GUIDANCE FOR PHARMACIST PRESCRIBERS OPEN
The General Pharmaceutical Council is seeking views on proposed guidance for pharmacist prescribers to make sure they provide safe and effective care when prescribing. The guidance sets out nine key areas that relate to the provision of safe and effective prescribing, including
- taking responsibility for prescribing safely
- keeping up to date and prescribing within your level of competence
- working in partnership with other healthcare professionals and people seeking care
- prescribing in certain circumstances
- prescribing non-surgical cosmetic medicinal products
- remote prescribing
- safeguards for the remote prescribing of certain medicines
- raising concerns
- information for pharmacy owners and employers of pharmacist prescribers.
The consultation closes 21 June 2019.
PUBLIC HEALTH ENGLAND
NEW DATA REVEALS OVERALL NUMBER OF AMPUTATIONS RELATED TO DIABETES INCREASING
New data from the Diabetes Foot Care Profiles, published by Public Health England’s National Cardiovascular Intelligence Network, shows that the number of major lower limb amputations (above the ankle) continues to rise – with 7,545 major amputations over the past three years between 2015 to 2018, compared with 6,957 between 2012 to 2015. In addition, the overall number of major amputations is increasing, as the number of people with diabetes rises, but the rate among people with diabetes is not significantly increasing. The data also shows that while the risk of diabetes is higher in some ethnic groups, especially those from South Asia, the rate of major amputations caused by diabetes is greatest in white males. There is also significant variation in the risk of amputation across the country. Other findings include:
- Patients from England had 147,067 hospital stays for diabetic foot disease.
- The average length of stay in hospital was eight days and the total number of days spent in hospital for diabetic foot disease was 1,826,734.
- 85,837 individual patients were admitted for foot disease and 33% of these had more than one stay over the three years.
- The rate of major amputations was greatest among men (male rate 10.5/10,000 population-years compared with females 4.9; and the white population rate of 9.6/10,000 and non-white 2.6).
NHS REPORT SUCCESS OF TYPE 2 DIABETES PREVENTION PROGRAMME AS PATIENTS LOSE ALMOST 60,000KG BETWEEN THEM
New figures show that the 17,000 people who attended most of the healthy living sessions lost an average of 3.4kg, over one kilogram more than originally predicted and a total of 59,000kg. The programme, which gives advice on dieting, exercise and healthy lifestyle, is being doubled in size over the next few years to treat around 200,000 people annually as part of the NHS Long Term Plan’s renewed focus on prevention. From July, online versions of the Diabetes Prevention Programme, which involve wearable technologies and apps to help those at risk of type 2 Diabetes, will be provided for patients who find it difficult to attend sessions because of work or family commitments. The programme is designed to stop or delay onset of type 2 diabetes through a range of personalised lifestyle interventions, including:
- education on lifestyle choices
- advice on how to reduce weight through healthier eating
- bespoke physical activity programmes.
£4.8M TO BE MADE AVAILABLE TO SCALE UP LOCAL DIGITAL ADULT SOCIAL CARE PROJECTS
NHS Digital has invited organisations that provide and commission adult social care services to bid for a share of £4.8m to enable them to roll out their local digital projects on a wider scale. The selected Digital Pathfinders will begin with a four-month development phase followed by a 13-month implementation phase if development is successful. Applications can be made by adult social care providers with not for profit status, local authorities and academic organisations based in England. Partnerships and consortiums are welcomed and encouraged. There are two main themes to this programme of work:
- Use of standards to support whole health and care system interoperability, for example:
- sharing of information across the health and social care system to support efficient access to care, and for direct care
- real time event alerts that notify a social care provider when a citizen receiving social care support has been admitted to hospital, discharged from hospital and other appropriate flags
- removal of fax machines from care providers through the implementation of appropriate safe and secure messaging platforms between health, care providers and local authorities
- Use of data for the prevention of escalating social care needs and for early intervention of those at risk of requiring social care, for example:
- predictive modelling for adult social care demands and needs across a population
- using data to highlight those whose combination of health, social and environmental indicators means that they are at higher risk of losing their independence.
The deadline for applications is Wednesday 22 May at 5pm.
ROYAL SOCIETY OF PUBLIC HEALTH
FREE GUIDE TO IMPROVE PUBLIC’S SLEEP LAUNCHED
The Royal Society of Public Health (RSPH) has collaborated with qualified sleep practitioner James Wilson - The Sleep Geek, to create a free e-learning resource on sleep for the public - Understanding Sleep: don’t hit snooze on your health. The resource sets out to inform the public of the links between sleep and health. Rather than taking a one size fits all approach, users are informed of the effects that a range of factors can have upon sleep, so that they can tailor their own lives and activities to be more sleep-friendly. The resource is divided into four parts, covering:
- An introduction to sleep as a public health issue
- Melatonin, drugs and alcohol.
- Sleep and culture.
- Sleep disorders.
EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL
DATA SHOWS SLIGHT DECLINE IN HEPATITIS C DIAGNOSES IN 2017
The European Centre for Disease Prevention and Control (ECDC) has reported that European surveillance data shows a 10% decrease in newly reported hepatitis C cases between 2016 and 2017. However, with more than 31,000 recorded cases in 2017, diagnoses remain at a high level in the European Union and European Economic Area (EU/EEA). In addition, variation in national testing practices and widespread under-reporting of diagnosed cases do not provide an accurate picture of the true epidemiological burden. Given that acute hepatitis is difficult to diagnose and most cases are identified through screening practices, it is likely that the majority of the hepatitis C cases classified as ‘unknown’ (75%) are chronic infections. Based on prevalence surveys, the ECDC estimates that around 5.6 million Europeans live with chronic hepatitis C in the EU/EEA.