EMA: victoza recommended for children with type 2 diabetes
- Draft guidance published:
- Dacomitinib now recommended for non-small-cell lung cancer
- Osimertinib not recommended for lung cancer
- Cemiplimab recommended for cutaneous squamous cell carcinoma on CDF
- Lanadelumab not recommended for recurrent attacks of hereditary angioedema.
- Dementia quality standard published.
- Draft guideline on diverticular disease diagnosis and management published.
- CHMP meeting highlights for June 2019:
- Three new medicines (Giapreza, Azacitidine Celgene and Lacosamide UCB) recommended for approval
- Extensions of indication for 11 medicines
- Negative opinion on Evenity
- Re-examination of negative opinion for Xyndari requested
- Negative opinion on extension of indication for Revolade and Translarna
- Withdrawal of application for ABP 710.
- Victoza recommended for children with type 2 diabetes.
- Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections.
- Medical device alert issued for IntelliVue MX40 patient-worn monitors – increased power consumption and no visual or audible alarms when batteries are low.
- FreeStyle Libre Sensors to be exempt from discount deduction.
- Joint prehabilitation report calls for changes to delivery of cancer care across UK.
- LGB women failing to attend cervical screening mistakenly believe they are not are risk.
- Early cancer detection and survival to be prioritised by NHS.
- RCN partners with Health Education England to create sexual health education directory.
- Fall in adult smokers in England reported.
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
DACOMITINIB RECOMMENDED AS A FIRST-LINE TREATMENT FOR NON-SMALL-CELL LUNG CANCER
NICE has published final draft guidance which now recommends dacomitinib (Vizimpro) as a first-line treatment option for people with untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults. . This is a change from the committee’s initial decision which found dacomitinib to not be a cost-effective use of NHS resources. This once-a-day pill will be available on the NHS for adults with locally advanced or metastatic NSCLC, that has tested positive for the epidermal growth factor receptor (EGFR) mutation. Dacomitinib is a tyrosine kinase inhibitor that targets the EGFR mutation to kill the cancerous cells and prevent them from replicating. NICE has already recommended three other drugs of this type for untreated EGFR-positive NSCLC: afatinib; erlotinib; and gefitinib. Clinical trial results showed that people who took dacomitinib had longer overall survival rates than those who took gefitinib (34.1 months compared with 26.8 months). Dacomitinib also increased the length of time before the disease worsened (14.7 months for dacomitinib compared with 9.2 months for gefitinib). It was however noted that dacomitinib had a higher incidence of side effects than gefitinib, so a lower dose may be needed.
OSIMERTINIB NOT RECOMMENDED FOR LUNG CANCER
NICE has published final draft guidance which does not recommend osimertinib (Tagrisso), with its marketing authorisation, for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults. Locally advanced or metastatic EGFR mutation-positive NSCLC is usually first treated with afatinib, erlotinib or gefitinib. Evidence from a randomised controlled trial suggests that people who take osimertinib live longer than people who take erlotinib or gefitinib. They also live longer before their disease gets worse. But there is no direct evidence comparing osimertinib with afatinib, which may be more effective than erlotinib and gefitinib. Osimertinib does not meet NICE’s criteria to be considered a life-extending treatment at the end of life. The most plausible cost- effectiveness estimates are above what NICE normally considers an acceptable use of NHS resources.
CEMIPLIMAB RECOMMENDED FOR CUTANEOUS SQUAMOUS CELL CARCINOMA ON CDF
NICE has issued draft guidance which recommends cemiplimab (Libtayo) within the Cancer Drugs Fund (CDF) as an option for treating locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) in adults when curative surgery or curative radiotherapy is not appropriate. It is recommended only if the conditions in the managed access agreement are followed. SCC is the second most common type of skin cancer in the UK. Usually, squamous cell carcinomas are slow-growing and only spread to other parts of the body if they are left untreated for a long time. Occasionally though, they can behave more aggressively and spread at a relatively early stage. CSCC can be cured in most people if caught early enough but a small percentage reaches an advanced state, usually in older people. It is estimated that around 560 people per year with locally advanced or metastatic CSCC in adults, where curative surgery or curative radiotherapy is not appropriate, are eligible for treatment with cemiplimab. Although there is significant uncertainty around the evidence for cemiplimab, NICE committee noted that the overall response rates reported in the trials are very promising. CSCC accounts for 20% of skin cancers and 23% of non-melanoma skin cancers. Although death is rare, the median overall survival rate of metastatic CSCC is poor at less than two years.
LANADELUMAB NOT RECOMMENDED FOR RECURRENT ATTACKS OF HEREDITARY ANGIOEDEMA
NICE has published draft guidance which does not recommend lanadelumab (Takhzyro), within its marketing authorisation, for the routine prevention of recurrent attacks of hereditary angioedema in people aged 12 years and older. Although its marketing authorisation covers the full treatment pathway, the company positioned lanadelumab for the population currently eligible for long-term prophylactic C1-INH in the current NHS England commissioning policy. The guidance says C1-INH is the most appropriate comparator for the company’s proposed positioning. Evidence from a randomised controlled trial comparing lanadelumab with placebo with short follow-up suggests that people having lanadelumab have fewer hereditary angioedema attacks compared with placebo. There are no data directly comparing lanadelumab with C1-INH therefore a small cross-over trial comparing Cinryze (a C1-INH) with placebo was used to estimate the relative effectiveness of lanadelumab and C1-INH indirectly. Lanadelumab does not meet NICE’s criteria to be considered a life-extending treatment at the end of life. In line with its summary of product characteristics, a lower dosing frequency of lanadelumab (once every four weeks) could be used if disease is stably attack-free, but there is currently no evidence that includes switching to this lower dosing frequency and this has a large impact on the cost-effectiveness estimates. Similarly, the dose per administration, and therefore the cost, of C1-INH has a large impact on the estimates of cost effectiveness, and it is unclear what dose of Berinert (a C1-INH) is used in clinical practice. Furthermore, the discounted price of C1-INH treatments paid by the NHS is not currently included in the cost-effectiveness results. NICE has concluded all estimates of cost effectiveness for lanadelumab compared with C1-INH are highly uncertain. Because some cost-effectiveness estimates that were considered clinically plausible are substantially higher than what NICE normally considers an acceptable use of NHS resources, NICE did not recommend lanadelumab for routine use in the NHS.
DEMENTIA QUALITY STANDARD PUBLISHED
NICE has published a quality standard which covers the prevention, assessment, and management of dementia, as well as health and social care support for people with dementia. It describes high-quality care in priority areas for improvement, including new and updated recommendations on:
- People accessing behaviour change interventions and programmes in mid-life are advised that the risk of developing dementia can be reduced by making lifestyle changes.
- People with suspected dementia are referred to a specialist dementia diagnostic service if reversible causes of cognitive decline have been investigated.
- People with dementia are given the opportunity to discuss advance care planning at diagnosis and at each health and social care review.
- People with dementia have a single named practitioner to coordinate their care.
- People with dementia are supported to choose from a range of activities to promote wellbeing that are tailored to their preferences.
- People with dementia have a structured assessment before starting non-pharmacological or pharmacological treatment for distress.
- Carers of people with dementia are offered education and skills training.
DIVERTICULAR DISEASE: DIAGNOSIS AND MANAGEMENT DRAFT GUIDELINE PUBLISHED
NICE has published a draft guideline which covers the diagnosis and management of diverticular disease in people aged 18 years and over. It includes information of the symptoms and signs of diverticular disease, diagnosing acute diverticulitis, and managing complications of complicated acute diverticulitis. It also covers information and advice for people with the disease.
EUROPEAN MEDICINES AGENCY
CHMP MEETING HIGHLIGHTS - JUNE 2019
The European Medicines Agency’s human medicines committee (CHMP) has recommended three medicines for approval and 11 extensions of indication at its June 2019 meeting:
- Giapreza (angiotensin II), for the treatment of refractory hypotension in adults with septic or other distributive shock.
- Azacitidine Celgene (azacitidine), for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukemia; and
- Lacosamide UCB (lacosamide), for the treatment of partial-onset seizures with or without secondary generalisation.
- Extensions of indication recommended by the Committee were for Cyramza (ramucirumab), Dupixent (dupilumab), Ebymect (dapagliflozin / metformin), Edistride (dapagliflozin), Fiasp (insulin aspart), Flebogamma DIF (human normal immunoglobulin), Forxiga (dapagliflozin), Imbruvica (ibrutinib), Tecentriq (atezolizumab), Xigduo (dapagliflozin / metformin) and Zinforo (ceftaroline fosamil).
However, the CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for Evenity (romosozumab), intended for the treatment of osteoporosis.
The applicant for Xyndari (glutamine) has requested a re-examination of the Committee's negative opinion for this medicine adopted at the May 2019 meeting. The CHMP will re-examine the opinion and issue a final recommendation.
The CHMP adopted a negative opinion for an extension of therapeutic indication for Revolade (eltrombopag) to add the treatment of previously untreated patients with severe aplastic anaemia from two years of age. The Committee also adopted a negative opinion for an extension of the therapeutic indication of Translarna (ataluren) to add the treatment of patients with Duchenne muscular dystrophy who are no longer able to walk.
The application for an initial marketing authorisation for ABP 710 (infliximab) was withdrawn. This medicine was intended for the treatment of some inflammatory diseases.
VICTOZA RECOMMENDED FOR CHILDREN WITH TYPE 2 DIABETES
The CHMP has recommended granting an extension of indication to Victoza (liraglutide) to include the treatment of children and adolescents aged 10 years or older with type 2 diabetes. This medicine is already approved for use together with diet and exercise in adults with type 2 diabetes, on its own or as an add-on to other diabetes medicines. Currently, the only two approved treatment options for paediatric type 2 diabetes patients in most countries are metformin and insulin. However, more than half of young patients do not achieve glycaemic control on metformin alone, even when combined with lifestyle interventions, and treatment with insulin has considerable side effects such as weight gain, or a high risk of hypoglycaemia. Therefore, there is a medical need for alternative treatment options for children and adolescents with type 2 diabetes. Victoza is the first non-insulin, besides metformin, to get a positive opinion for paediatric use for type 2 diabetes. The active substance in Victoza, liraglutide, is an ‘incretin mimetic’. This means that it acts in the same way as incretins, a group of metabolic hormones that stimulate an increase of the amount of insulin released by the pancreas in response to food. This helps with the control of blood glucose levels. Liraglutide has been used in adults for approximately 10 years, so there is an extensive amount of data available in particular with regards to safety. The opinion adopted by the CHMP is an intermediary step on Victoza’s path to patient access in this new indication. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.
BACTERIAL LYSATE MEDICINES FOR RESPIRATORY CONDITIONS TO BE USED ONLY FOR PREVENTION OF RECURRENT INFECTIONS
The EMA has recommended that bacterial lysate medicines authorised for respiratory conditions should only be used for the prevention of recurrent respiratory infections, with the exception of pneumonia. This follows a review that concluded that there are no robust data showing that these medicines are effective at treating existing respiratory infections, or for the prevention of pneumonia, therefore they should not be used for these purposes. In the review, the CHMP considered the results of clinical studies, data on side effects reported with these medicines, and advice from an expert group on infectious diseases. Although data are limited, the review found some evidence of effectiveness of these medicines in the prevention of recurrent respiratory tract infections and the safety profile is in line with what is expected for this type of product. The CHMP therefore has recommended the use of the medicines for prevention can continue, but the companies must provide further data on safety and effectiveness from new clinical studies by 2026. The prescribing information of the medicines will be updated with the new indication and a warning against use for prevention of pneumonia.
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
INTELLIVUE MX40 PATIENT-WORN MONITORS – INCREASED POWER CONSUMPTION AND NO VISUAL OR AUDIBLE ALARMS WHEN BATTERIES ARE LOW
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for IntelliVue MX40 patient-worn monitors, manufactured by Phillips, due to increased power consumption and no visual or audible alarms when batteries are low. Devices may lose power earlier than expected and users may not realise the loss of monitoring due to no alarm, which could contribute to a delay in emergency treatment. Actions to be taken by all medical nursing and technical staff involved in the use and maintenance of these devices are detailed in the Field Safety Notice.
PHARMACEUTICAL SERVICES NEGOTIATING COMMITTEE
FREESTYLE LIBRE SENSORS TO BE EXEMPT FROM DISCOUNT DEDUCTION
The Pharmaceutical Services Negotiating Committee (PSNC) has reported that the assumed level of discount normally applied when community pharmacy contractors dispense medicines and appliances will no longer be applied to FreeStyle Libre Sensors. PSNC advised that FreeStyle Libre Sensors would enter the Drugs for which Discount is Not Deducted (DND) list (Part II of the Drug Tariff) from 1st July 2019. Since extra NHS funding was made available for the prescribing of Freestyle Libre Sensors in April 2019, there has been a surge in the number of prescriptions dispensed by community pharmacies for this item. The sensors can only be ordered directly from the manufacturer, Abbott Ltd, and contractors have reported to PSNC that they were dispensing each pack at a loss because there is no discount available, yet the item was subject to the discount deduction scale. PSNC stated that due to the unique nature of FreeStyle Libre Sensors and its restricted ordering system, PSNC had requested that it be considered for addition to the DND list to help mitigate against any further losses incurred by contractors when dispensing this appliance.
THE ROYAL COLLEGE OF ANAESTHETISTS
JOINT PREHABILITATION REPORT CALLS FOR CHANGES TO DELIVERY OF CANCER CARE ACROSS UK
The Royal College of Anaesthetists, Macmillan Cancer Support, the National Institute for Health Research Cancer and Nutrition Collaboration has launched a report calling for changes to the delivery of cancer care across the UK, with a greater focus on prehabilitation including nutrition, physical activity and psychological support. 70% of the 1.8 million people in the UK living with cancer are also living with one or more other long-term health conditions. The guidance report, Prehabilitation for people with cancer, promotes evidence that when services are redesigned so that prehabilitation is integrated into the cancer pathway patients feel empowered and quality of life is improved, physical and psychological resilience to cancer treatments is maximised and long-term health is improved. The report includes the following recommendations:
- Interventions targeted at improving physical and/or mental health should start as early as possible and in advance of any cancer treatment (not just the first cancer treatment).
- Prehabilitation, as a component of rehabilitation, should underpin the whole cancer pathway and is an approach that should be adopted for all people with cancer.
- All cancer treatments should be led through cancer multidisciplinary teams (MDT) which should have representation from those delivering prehabilitation, therefore providing oversight of the prehabilitation needs of the person to ensure prehabilitation is taking place.
- All people with cancer should have a co-developed personalised prehabilitation care plan as part of their overall care.
- Education in nutrition, exercise, psychology and behavioural change, should be integrated throughout the undergraduate and postgraduate training of health and care professionals.
- Services delivering prehabilitation should be co-designed and produced with patients and carers.
- Implementation and effectiveness of prehabilitation should be audited as part of a quality assurance and improvement framework delivered and reported according to recognised standards.
- The Professional Standards Authority, Chartered Institute for the Management of Sport and Physical Activity and the British Association of Sport and Exercise Sciences should work together to define an approach to achieving accreditation and/or regulation for exercise professionals in prehabilitation.
LGB WOMEN FAILING TO ATTEND CERVICAL SCREENING MISTAKENLY BELIEVE THEY ARE NOT ARE RISK
Up to 50,000 lesbian, gay and bisexual (LGB) women have never been for a cervical cancer screening test because they wrongly think they are not at risk, NHS England has warned (see OnMedica article). However, any sexual activity can pass on the virus which causes the vast majority of cervical cancers. Analysis of data from the LGBT (Lesbian, Gay, Bisexual and Transgender) Foundation has revealed that nearly one in five – 19% – of LGB women who are eligible for cervical screening has never been to an appointment. An estimated four out of five cases of cervical cancer, 83%, could be prevented if everyone attended regular screenings. Charities have previously warned of the common misconception that women who have sex with women do not need to be screened, even though the virus that causes cervical cancer is passed on through any type of sexual activity. NHS England is rolling out a new HPV testing process into cervical screening services by 2020, which it says is more sensitive and reliable than the current process and could prevent around 600 additional cancers a year.
DEPARTMENT OF HEALTH AND SOCIAL CARE
EARLY CANCER DETECTION AND SURVIVAL TO BE PRIORITISED BY NHS
The Department of Health and Social Care has announced that cancer screening programmes will be overhauled and diagnosis made faster and more accurate with new state-of-the-art technology as part of a blueprint for rapidly improving detection and survival. The Implementation Framework, agreed by the NHS and laid out in Parliament, provides a blueprint for how this will be achieved at a local level. The one-year metric will be used to measure progress. Steps in the framework include:
- a radical overhaul of screening programmes
- new state-of-the-art technology to make diagnosis faster and more accurate
- more investment in research and innovation
- the roll-out of new Rapid Diagnostic Centres across the country, building on the success of a pilot scheme with Cancer Research UK
- NHS England extending lung health checks, targeting areas with the lowest survival rates
- Health Education England increasing the cancer workforce, which will lead to 400 clinical endoscopists and 300 reporting radiographers by 2021.
ROYAL COLLEGE OF NURSING
RCN PARTNERS WITH HEALTH EDUCATION ENGLAND TO CREATE SEXUAL HEALTH EDUCATION DIRECTORY
The Royal College of Nursing (RCN) has partnered with Health Education England to create a sexual health education directory. The resource, which includes films and case studies, has been developed in response to the staffing crisis in sexual health, where there is too much responsibility falling on too few nurses, the RCN says. It aims to help nursing staff establish what their training needs are and then address them.
FALL IN ADULT SMOKERS IN ENGLAND REPORTED
The number of adult cigarette smokers in England has dropped by around 1.8m from 7.7m (19.8%) in 2011 to 5.9m (14.4%) in 2018, new official figures from NHS Digital show (see OnMedica article). The prevalence of adult smokers throughout the UK was 14.7%. Of the constituent countries, England had the lowest (14.4%). Prevalence was highest in Scotland (16.3%), followed by Wales (15.9%) and then Northern Ireland (15.5%). The report also includes figures on prevalence of smoking by age, prescriptions data, E-cigarette prevalence, hospital admissions and mortality attributable to smoking, and selected local level analyses. However, just under 11% of pregnant women were known to be smokers at the time of delivery in 2018-19. This is similar than the level recorded in 2017-18, but down from 15% in 2008/09. There were also 489,300 estimated hospital admissions attributable to smoking in 2017-18, an increase of 1% on 2016-17 (484,700) and an increase of 11% on 2007-08 (440,400). For males, this accounted for 6% of all hospital admissions and for 3% of all admissions for females. Local authorities in Blackpool and Sunderland recorded the highest rates of hospital admissions attributable to smoking - above 2,900 per 100,000 population - while Wokingham had the lowest rate (721 per 100,000 population), followed by Rutland (877), Isle of Wight (877) and Redbridge (913). There were an estimated 77,800 deaths attributable to smoking in 2017, which is similar to 2016 (77,900) and a decrease of 6% per cent from 2007 (82,400). For males, this accounted for 20% of all deaths, and 12% of all deaths for females.