- Previous decision reversed for ocrelizumab for primary progressive multiple sclerosis in final draft guidance.
- Abemaciclib with fulvestrant recommended for hormone receptor-positive, HER2-negative advanced breast cancer through CDF in final guidance.
- Prostate cancer: diagnosis and management guideline published.
- Management guidelines published for:
- Ulcerative colitis
- Crohn’s disease.
- PICO negative pressure wound dressings recommended for closed surgical incisions.
- Curos disinfecting cap shows promise but more evidence needed to support routine adoption in the NHS.
- Lead-I electrocardiogram devices not recommended for routine adoption.
- Company-led drug alert issued for Macopharma intravenous infusion bags.
- Views sought on Acnecide face products to be made available from general sales outlets.
- Class 1 alert: Use of Antiviral Medicines in Primary Care for Influenza Season 2018/19.
- Epanutin 50mg infatabs shortage reported.
- NHS BSA reports new licensed products available.
- New programme to spot heart conditions and prevent strokes announced.
- NHS funds handheld headache-relieving device.
- Figures show 15% increase on 2016/17 in admissions where obesity was recorded either a primary or secondary diagnosis.
- NHS Fit Notes report allows for regional comparisons to be made.
- ‘Clean care for all – it's in your hands’ global campaign launched.
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
PREVIOUS DRAFT DECISION REVERSED FOR OCRELIZUMAB FOR PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS
In its final draft guidance, NICE has reversed its previous draft decision not to recommend ocrelizumab (Ocrevus) for treating primary progressive multiple sclerosis (PPMS) in adults. This follows an agreement between the company and NHS England on the terms of a new commercial arrangement which will make ocrelizumab, the first disease-modifying treatment for PPMS, available at a lower price. The details of the commercial arrangement are confidential. Ocrelizumab has been shown to slow the advance of PPMS, although by how much and for how long are uncertain. Given the unmet clinical need of people with this form of MS, the cost-effectiveness estimates for ocrelizumab at the new lower price compared with best supportive care alone are in the range that NICE considers an acceptable use of NHS resources. The company estimates around 2,700 people could be eligible for treatment with ocrelizumab. It is given as an infusion during an outpatient appointment once every six months. The average cost per patient per year is £19,160 at its list price, based on twice yearly 600 mg infusions. NICE published guidance last year which recommended ocrelizumab for some adults with the relapsing-remitting form of MS.
ABEMACICLIB WITH FULVESTRANT RECOMMENDED FOR BREAST CANCER THROUGH CDF
NICE has published final guidance which recommends abemaciclib (Verzenios) with fulvestrant for use within the Cancer Drugs Fund (CDF) as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer in people who have had endocrine therapy only if:
- exemestane plus everolimus would be the most appropriate alternative and
- the conditions in the managed access agreement for abemaciclib with fulvestrant are followed.
Current treatment for advanced hormone receptor-positive, HER2-negative breast cancer after endocrine therapy when chemotherapy is not needed immediately, is usually exemestane, tamoxifen, or exemestane plus everolimus. NICE does not recommend fulvestrant monotherapy. Clinical trial evidence suggests that compared with fulvestrant alone, abemaciclib with fulvestrant increases the length of time before the disease progresses. However, it is uncertain whether people having abemaciclib with fulvestrant live longer, because people in the trial have not been followed-up for long enough. NICE says this uncertainty in the clinical benefit adds to the uncertainty about the cost-effectiveness estimates. The cost-effectiveness estimates are based on an indirect comparison. Also, survival data are incomplete. Therefore, the cost-effectiveness estimates are highly uncertain. Most of the plausible estimates are likely to be higher than what NICE normally considers an acceptable use of NHS resources, although the company's preferred estimate is lower. More evidence is needed to address clinical uncertainties. Longer follow-up data from the trial on how long people live are likely to reduce the uncertainty in the clinical- and cost-effectiveness results. For these reasons, NICE recommended abemaciclib with fulvestrant for use in the Cancer Drugs Fund, while these data are collected.
PROSTATE CANCER: DIAGNOSIS AND MANAGEMENT GUIDELINE PUBLISHED
NICE has published a guideline which covers the diagnosis and management of prostate cancer in secondary care, including information on the best way to diagnose and identify different stages of the disease, and how to manage adverse effects of treatment. It also includes recommendations on follow-up in primary care for people diagnosed with prostate cancer. This guideline replaces NICE guideline CG175 (January 2014) and includes new and updated recommendations on:
- MRI and biopsy
- localised and locally advanced prostate cancer
- follow-up for localised or locally advanced prostate cancer
- treatment for metastatic prostate cancer
- bone-targeted therapies
ULCERATIVE COLITIS: MANAGEMENT GUIDELINE PUBLISHED
NICE has published a guideline which covers the management of ulcerative colitis in children, young people and adults. It aims to help professionals to provide consistent high-quality care and it highlights the importance of advice and support for people with ulcerative colitis. This guideline includes new recommendations on inducing remission in mild-to-moderate ulcerative colitis, which supplement the existing recommendations on: patient information and support; treating acute severe ulcerative colitis; providing information about surgery; maintaining remission; pregnancy and monitoring bone health, growth and pubertal development.
CROHN’S DISEASE: MANAGEMENT GUIDELINE PUBLISHED
NICE has published a guideline which covers the management of Crohn’s disease in children, young people and adults. It aims to reduce people’s symptoms and maintain or improve their quality of life. The guideline includes new recommendations on maintaining remission after surgery, which supplement existing recommendations on: providing information and support; inducing remission; maintaining remission; surgery; monitoring for osteopenia and assessing fracture risk; conception and pregnancy.
PICO NEGATIVE PRESSURE WOUND DRESSINGS RECOMMENDED FOR CLOSED SURGICAL INCISIONS
NICE has published final guidance which finds there is evidence to support the case for adopting PICO negative pressure wound dressings for closed surgical incisions in the NHS. They are associated with fewer surgical site infections and seromas compared with standard wound dressings. PICO negative pressure wound dressings should be considered as an option for closed surgical incisions in people who are at high risk of developing surgical site infections. Risk factors for surgical site infections are described in the NICE guideline on preventing and treating surgical site infections. NICE says cost modelling suggests that PICO negative pressure wound dressings provide extra clinical benefits at a similar overall cost compared with standard wound dressings.
CUROS DISINFECTING CAP SHOWS PROMISE BUT MORE EVIDENCE NEEDED TO SUPPORT ROUTINE ADOPTION
NICE has published final guidance which finds Curos disinfecting cap shows promise for preventing infections when using needleless connectors, but there is currently insufficient evidence to support the case for routine adoption in the NHS. Research is therefore recommended to address uncertainties about the clinical benefits of using Curos. This research should:
- determine if Curos adds value to the standard bundle of care for preventing infections when using needleless connectors
- explore the use of Curos in people at high risk of infection, including those whose condition is managed in the community
- clearly define the patient groups included and use consistent outcomes.
NICE says it will facilitate this research, in collaboration with the company, clinical and academic partners, and will update its guidance if or when substantive new evidence becomes available.
LEAD-I ELECTROCARDIOGRAM DEVICES NOT RECOMMENDED FOR ROUTINE ADOPTION
NICE has published final diagnostics guidance which finds there is not enough evidence to recommend the routine adoption of lead-I electrocardiogram (ECG) devices (imPulse, Kardia Mobile, MyDiagnostick and Zenicor-ECG) to detect atrial fibrillation when used for single time point testing in primary care for people with signs or symptoms of the condition and an irregular pulse. Further research is recommended to show how using lead‑I ECG devices in this way affects:
- the number of people with atrial fibrillation detected, compared with current practice (see section 6.1 of NICE’s recommendations) and
- primary and secondary care services, particularly how ECGs generated by the devices would be interpreted in practice, including staff time needed to interpret the ECG traces and associated costs (see section 6.2 of NICE’s recommendations).
Centres currently using these devices for this indication are encouraged to take part in research and data collection.
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
COMPANY-LED DRUG ALERT ISSUED FOR MACOPHARMA INTRAVENOUS INFUSION BAGS
The Medicines and Healthcare products Regulatory Agency has issued a company-led drug alert for Macopharma intravenous infusion bags. Macopharma is recalling certain batches of intravenous infusion bags as a precaution, due to the detection of metal particles in two infusion bags. Although no incidents have been reported in the UK, the MHRA understands that these products have a fast turnover and that affected batches were delivered through 2017 with the last batch delivered in November 2018. Although it is unlikely that there is much stock remaining in the supply chain, healthcare professionals are advised to check inventory, quarantine any affected stock and notify Macopharma Customer Services.
VIEWS SOUGHT ON ACNECIDE FACE PRODUCTS TO BE MADE AVAILABLE FROM GENERAL SALES OUTLETS
The MHRA are proposing to make Acnecide ‘Face’ products available from general sales outlets with more limited conditions of use than the current pharmacy products. The products are Acnecide Face 5% w/w Gel and Acnecide Face Wash 5% w/w Gel. They are preparations (face gel and face wash) containing benzoyl peroxide intended for the treatment of mild acne affecting the face in adults and adolescents aged 12 years and over. The Commission on Human Medicines has advised that Acnecide `Face’ products can be available as General Sale List medicines and is seeking views on this proposal.
DEPARTMENT OF HEALTH AND SOCIAL CARE
CLASS 1 ALERT: USE OF ANTIVIRAL MEDICINES IN PRIMARY CARE FOR INFLUENZA SEASON 2018/19
The Department for Health and Social Care has issued a class 1 alert advising GPs and other prescribers working in primary care that they should no longer prescribe antiviral medicines, for the prophylaxis and treatment of influenza on an FP10 prescription form. Community pharmacists should no longer supply antiviral medicines in primary care, on presentation of an FP10 prescription form. This is in accordance with NICE guidance and Schedule 2 of the National Health Service General Medical Services Contracts (Prescription of drugs etc.) Regulations 2004, commonly known as the Grey List or Selected List Scheme.
DISPENSING DOCTORS' ASSOCIATION
EPANUTIN 50MG INFATABS SHORTAGE REPORTED
The Dispensing Doctors' Association (DDA) reports on Pfizer’s announcement that they are out of stock of Epanutin 50mg Infatabs until November 2019. Pfizer has been given approval from the Medicines and Healthcare products Regulatory Agency to import Dilantin 50mg Infatabs (phenytoin base) from Canada, in order to alleviate the shortage. Pfizer warns however that there are some differences between Dilantin and Epanutin Infatabs which prescribers will need to be aware of. They highlight that there are differences in the way the dosage regimen is described between the two products. The dosing of both products should be individualised as there may be wide interpatient variability in phenytoin serum levels and dosing requirements can also be variable. Healthcare professionals are advised to refer to the prescribing information documents of both products.
NHS BSA REPORTS NEW LICENSED PRODUCTS AVAILABLE
- Colonis Pharma Ltd levothyroxine sodium 25mcg/5ml oral solution and sugar-free variants of levothyroxine sodium 50mcg/5ml, 100mcg/5ml, 125mcg/5ml oral solution
- Thame Laboratories Ltd clonidine 50mcg/5ml oral solution sugar free x100ml
- Essential Pharmaceuticals Ltd amlodipine 5mg/5ml oral suspension sugar free
- MIP Pharma GmbH cefazolin 2g powder for solution for injection vials
- Rosemont Pharmaceuticals Ltd topiramate 50mg/5ml and 100mg/5ml oral suspension sugar free.
NEW £9 MILLION PROGRAMME TO SPOT HEART CONDITIONS AND PREVENT STROKES ANNOUNCED
A new £9 million programme to spot heart conditions to save at least 200 lives and offer protection to thousands more, has been announced by NHS England (see OnMedica article). The scheme, which will run until next March, will see almost 20,000 people at higher risk of experiencing a stroke receive targeted checks and treatment. Patients will be identified by specialist nurses and clinical pharmacists across the country who are trained to treat atrial fibrillation – which increases the chance of having a stroke. Specialist clinicians will identify patients in each surgery who have been diagnosed with atrial fibrillation but are not receiving treatment. Anyone identified as being at risk will be offered a personalised treatment plan developed with their GP. The new scheme will treat more than 18,000 people, preventing around 700 strokes, saving an estimated 200 lives and stopping long-term health problems among thousands more, including disability. The programme will run across 23 areas of the country with the highest rates of the condition receiving funding for specialist clinical pharmacists to help identify people who could benefit from medication.
NHS FUNDS HANDHELD HEADACHE-RELIEVING DEVICE
NHS England has announced it will fund a handheld gadget that uses low-levels of electric current to disrupt pain signals and relieve the suffering of those who are having ‘cluster’ headaches, excruciating attacks of pain (see OnMedica article). Cluster headaches are rare, but they’re more common in men and tend to start when a person is in their 30s or 40s. The NHS-funded device is placed on the neck where it stimulates the vagus nerve which can lead to a reduction of pain. Around 66,000 people in the UK experience a cluster headache and NHS England says the device holds out hope for the one in 20 who do not respond to traditional treatments such as prescription of triptans (painkillers), oxygen or anticonvulsants. Under the NHS scheme, patients could be prescribed the ‘easy-to-use’ technology and carry it with them so that they can use it regularly to prevent cluster headaches or when they feel one coming on.
15% INCREASE ON 2016/17 IN ADMISSIONS WHERE OBESITY WAS RECORDED EITHER A PRIMARY OR SECONDARY DIAGNOSIS
NHS Digital has published Statistics on Obesity, Physical Activity and Diet, England, 2019 which has shown a 15% increase since 2016/17 in admission to NHS hospitals where obesity was recorded either a primary or secondary diagnosis. New figures in the report show that:
- Around two thirds of the admissions where obesity was recorded as either a primary or secondary diagnosis in 2017/18 were for women (66%)
- Of the 6,627 Finished Consultant Episodes for bariatric surgery in 2017/18, 79% of the patients were female.
Furthermore, the number of items prescribed by primary care for obesity treatment decreased by 8% from 401,000 items in 2017 to 371,000 items in 2018 and continues a downward trend since a peak of 1.45 million items in 2009. The Net Ingredient Cost (NIC) saw an increase for the first time in five years, rising from £6.9m in 2017 to £8.1m in 2018.
In addition, the prevalence of adult obesity stood at 29% in 2017, an increase from 26% in 2016. Prevalence of child obesity in both Reception and Year 6 was over twice as high in the most deprived areas than in the least deprived areas; 13% compared to 6% in reception year, and 27% compared to 12% in Year 6.
The figures also show that 68% of men and 64% of women aged 19 and over met the government's physical activity guidelines for adults in 2017/18, however 21% of men and 23% of women were classed as inactive in 2017/18; and only 20% of boys and 14% of girls were meeting the government’s physical activity guidelines for children.
Lastly, figures revealed that women (32%) were more likely to consume the recommended five portions of fruit and vegetables a day, than men (26%), while only 18% of children consumed the recommended five portions of fruit and vegetables a day in 2017.
NHS FIT NOTES REPORT ALLOWS FOR REGIONAL COMPARISONS TO BE MADE
Coverage in NHS Digital’s latest fit notes publication has increased to include data from 96% of GP practices and it is the first time that the coverage has been high enough to allow regional comparisons to be made across clinical commissioning groups (CCGs). The figures published by NHS Digital shows that between April and December 2018, 6.9m fit notes were issued in England – with 3.9m issued to women (56.7%) and 3.0m issued to men (43.3%). Of these, 93.1% were declared “not fit for work” and 6.9% were declared “maybe fit for work”. In the latest month’s figures (December 2018), “mental health and behavioural disorders” accounted for 32.9% of fit notes with a known diagnosis. Diseases of “musculoskeletal system and connective tissue” was the second most common diagnosis, which accounted for 16.7% of fit notes with a known diagnosis in December 2018. In December 2018, Knowsley CCG issued the highest number of fit notes (3,125 per 100,000 population) and Westminster CCG issued the lowest number of fit notes (688 per 100,000 population).
WORLD HEALTH ORGANISATION
‘CLEAN CARE FOR ALL – IT'S IN YOUR HANDS’ GLOBAL CAMPAIGN LAUNCHED
The World Health Organisation (WHO) has launched a global campaign called “Clean care for all – it's in your hands”, which aims to achieve universal health coverage (UHC), i.e. achieve better health and well-being for all people at all ages, including financial risk protection, access to quality essential health care services and access to safe, effective, quality and affordable essential medicines and vaccines for all. WHO states that infection prevention and control, including hand hygiene, is critical to achieve UHC as it is a practical and evidence-based approach with demonstrated impact on quality of care and patient safety across all levels of the health system. In addition, the European Centre for Disease Prevention and Control supports the campaign and highlights the importance of infection prevention and control measures as one of the main strategies to tackle the growing threat posed by antibiotic resistance.