- Tinnitus: assessment and management guideline published.
- Fremanezumab recommended for preventing migraine in final draft guidance.
- Pembrolizumab not recommended for previously treated urothelial cancer in final draft guidance.
- Dupilumab not recommended for severe asthma with type 2 inflammation in draft guidance.
- Zio XT for detecting cardiac arrhythmias: draft guideline recommends more research.
- The following medicines have been accepted:
- Rucaparib for some gynaecological cancers and primary peritoneal cancer (restricted)
- Blinatumomab for acute lymphoblastic leukaemia (restricted)
- Lorlatinib for ALK-positive advanced non-small cell lung cancer (interim basis)
- Mexiletine not accepted for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.
- Guidance published on managing coronavirus (COVID-19) infection in pregnancy.
- Fertility care and emotional wellbeing guidance published.
- NHS to ramp up coronavirus testing labs.
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
TINNITUS: ASSESSMENT AND MANAGEMENT GUIDELINE PUBLISHED
NICE has published a guideline which covers the assessment, investigation and management of tinnitus in primary, community and secondary care. It offers advice to healthcare professionals on supporting people presenting with tinnitus and on when to refer for specialist assessment and management.
FREMANEZUMAB RECOMMENDED FOR PREVENTING MIGRAINE
The National Institute for Health and Care Excellence (NICE) has published final draft guidance which recommends fremanezumab (Ajovy) as an option for preventing migraine in adults, only if:
- the migraine is chronic, that is, 15 or more headache days a month for more than three months with at least eight of those having features of migraine
- at least three preventive drug treatments have failed and
- the company provides it according to the commercial arrangement.
NICE committee found that for people whose migraine has not responded to at least three oral preventive treatments, clinical trial evidence shows that fremanezumab works better than best supportive care in both episodic and chronic migraine. However, it is unclear if fremanezumab works better than botulinum toxin type A.
For chronic migraine, assuming fremanezumab works better than botulinum toxin type A, the most likely cost-effectiveness estimates are within the range NICE normally considers an acceptable use of NHS resources. So it is recommended for chronic migraine. In line with clinical practice, fremanezumab treatment should stop if it is not working well enough after 12 weeks.
For episodic migraine, uncertainty in the economic modelling about stopping treatment and quality of life affects the cost-effectiveness estimates. The most likely estimates for fremanezumab are higher than what NICE normally considers an acceptable use of NHS resources, therefore is not recommended for episodic migraine.
PEMBROLIZUMAB NOT RECOMMENDED FOR PREVIOUSLY TREATED UROTHELIAL CANCER
NICE has published final draft guidance which does not recommend pembrolizumab (Keytruda) for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy.
The decision comes after a review of new evidence collected while pembrolizumab was available via the Cancer Drugs Fund. NICE says uncertainty remains regarding the long-term benefit of this second-line immunotherapy treatment in comparison with other options, meaning it is not a cost-effective use of NHS resources at its current price.
Pembrolizumab will be withdrawn from the Cancer Drugs Fund once final guidance has been published. This means that no new patients will be offered pembrolizumab, although it will not affect those whose treatment was started before the final guidance was published.
For people with advanced or metastatic bladder cancer, chemotherapy is the first-line treatment. NICE has already recommended atezolizumab, which is also an immunotherapy, used as a second-line treatment.
The list price for pembrolizumab is £2,630 per 100mg vial, which would be given as 200mg intravenously every three weeks. Even when pembrolizumab is offered with its agreed discount, the most plausible cost-effectiveness estimate remains above what NICE normally considers acceptable, even for end-of-life treatments.
DUPILUMAB NOT RECOMMENDED FOR SEVERE ASTHMA WITH TYPE 2 INFLAMMATION IN DRAFT GUIDANCE
NICE has published draft guidance which does not recommend dupilumab (Dupixent) as add-on maintenance therapy, within its marketing authorisation, for treating severe asthma with type 2 inflammation that is inadequately controlled in people aged 12 years and over, despite maintenance therapy with high-dose inhaled corticosteroids and another maintenance treatment.
NICE says clinical trial results show that dupilumab plus standard asthma treatment performs better than placebo in reducing the use of oral corticosteroids and frequency of exacerbations in people with severe asthma with type 2 inflammation.
However, the cost-effectiveness estimates were higher than is considered to be a reasonable use of NHS resources, and therefore could not be recommended.
ZIO XT FOR DETECTING CARDIAC ARRHYTHMIAS: DRAFT GUIDELINE RECOMMENDS MORE RESEARCH
NICE has published a medical technology consultation document which finds that Zio XT shows promise for detecting cardiac arrythmias. However, NICE says there is not enough evidence on its diagnostic accuracy compared with standard care to support the case for routine adoption in the NHS.
NICE therefore recommends research be conducted to address uncertainties about the diagnostic accuracy and resource use associated with Zio XT compared with standard care. The research should determine the:
- relative diagnostic accuracy of Zio XT for detecting various types of arrhythmia compared with continuous ECG monitoring used as standard care in the NHS;
- resource use associated with Zio XT monitoring compared with standard care, in particular the number of outpatient visits and repeat tests needed.
SCOTTISH MEDICINES CONSORTIUM
RUCAPARIB ACCEPTED AS MONOTHERAPY FOR SOME GYNAECOLOGICAL CANCERS AND PRIMARY PERITONEAL CANCER (RESTRICTED)
Following a full submission assessed under the end of life and orphan medicine process, the Scottish Medicines Consortium (SMC) has accepted rucaparib (Rubraca®), under a Patient Access Scheme (PAS), for restricted use within NHS Scotland, as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. It is restricted to patients who do not have a BRCA mutation.
Evidence shows rucaparib significantly improved progression free survival compared with placebo in a phase III study in patients with platinum-sensitive serous or endometrioid ovarian, primary peritoneal or fallopian tube carcinoma who had received at least two previous platinum-based chemotherapy regimens.
BLINATUMOMAB ACCEPTED AS MONOTHERAPY FOR ACUTE LYMPHOBLASTIC LEUKAEMIA
Blinatumomab (Blincyto®) is accepted for restricted use within NHS Scotland, under a PAS, as monotherapy for the treatment of adults with Philadelphia chromosome negative, CD19 positive, B-precursor acute lymphoblastic leukaemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
This medicine is restricted to patients who are in first complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
In a single arm phase II study of patients with B-cell precursor ALL in first or later complete remission and with persistent or recurrent MRD, blinatumomab was associated with clinically relevant complete MRD response rates.
LORLATINIB ACCEPTED ON AN INTERIM BASIS AS MONOTHERAPY FOR ALK-POSITIVE ADVANCED NON-SMALL CELL LUNG CANCER
Following a full submission assessed under the end of life process, the SMC has accepted lorlatinib (Lorviqua®) for use within NHS Scotland, under a PAS, on an interim basis subject to ongoing evaluation and future reassessment, as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after:
- alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or
- crizotinib and at least one other ALK TKI
In the relevant subgroup of a non-comparative phase I/II study of previously-treated patients with ALK-positive advanced NSCLC, lorlatinib was associated with an objective response rate of approximately 40%.
MEXILETINE NOT ACCEPTED FOR THE SYMPTOMATIC TREATMENT OF MYOTONIA IN ADULT PATIENTS WITH NON-DYSTROPHIC MYOTONIC DISORDERS
The SMC has not accepted mexiletine (Namuscla®) for use within NHS Scotland, for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.
In a short-term, phase III, crossover study, mexiletine significantly improved muscle stiffness compared with placebo when measured on a visual analogue scale. However, the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance.
ROYAL COLLEGE OF OBSTETRICIANS AND GYNAECOLOGISTS
GUIDANCE PUBLISHED ON MANAGING CORONAVIRUS (COVID-19) INFECTION IN PREGNANCY
The Royal College of Obstetricians and Gynaecologists (RCOG), Royal College of Midwives and Royal College of Paediatrics and Child Health, has published guidance for healthcare professionals on managing coronavirus (COVID-19) infection in pregnancy. The guidance has had input from the Royal College of Anaesthetists, Public Health England and Health Protection Scotland.
It covers the most up-to-date advice on how coronavirus affects pregnant women and their unborn babies, how labour and birth should be managed in women with suspected or confirmed coronavirus, as well as information on neonatal care and infant feeding.
The RCOG states:
- Pregnant women do not appear to be more susceptible to the consequences of coronavirus than the general population and there is no evidence that the virus can pass to a baby during pregnancy
- As a precautionary approach, pregnant women with suspected or confirmed coronavirus when they go into labour are being advised to attend an obstetric unit for birth but their birth plan should be followed as closely as possible
- At the moment there is no evidence that the virus can be carried in breastmilk, so it is felt the benefits of breastfeeding outweigh any potential risks of transmission of coronavirus through breastmilk.
ROYAL COLLEGE OF NURSING
FERTILITY CARE AND EMOTIONAL WELLBEING GUIDANCE PUBLISHED
The Royal College of Nursing has published guidance for all health care professionals in all areas of fertility care and acknowledges the differences between emotional support and wellbeing, implications counselling and therapeutic counselling. It covers the following aspects:
- Recognising the need for emotional support
- Emotional support after confirmation of a pregnancy following fertility treatment
- The impact of repeated cycle failure – being childless not by choice
- The role of the counsellor
- Emotional support and diversity
NHS TO RAMP UP CORONAVIRUS TESTING LABS
NHS England has announced it will be working with Public Health England (PHE) to expand coronavirus testing, with enhanced labs, to enable the health service to carry out 10,000 tests daily (see OnMedica article).
PHE has developed a highly sensitive test to detect the virus, which has been rolled out to their regional labs across the country.
Approximately 1,500 tests are being processed every day at PHE labs with the great majority of tests being turned around within 24 hours. PHE has processed over 25,000 tests as of 10 March and has not exceeded capacity during this time.
As more people come forward to be tested, the NHS is now scaling up tests by 500%, with NHS England asking expert NHS laboratory services across the country to bring new capacity online, and other labs to begin checks, enabling 8,000 more samples to be analysed every day of the week.
As the testing programme is scaled up, positive test result confirmation will be accelerated, helping people to take appropriate action to recover or get treatment.
As well as testing of people who meet the criteria for being at risk, the NHS and PHE are also carrying out surveillance testing on others, including people in wards and surgeries showing signs of the virus, learning lessons from abroad and helping the UK to gain a better picture, earlier of the spread of the virus.
The additional resource to process more tests will mean local hospital labs will join specialist services, including those already provided by PHE, in being able to accurately detect the presence of the new virus, with learning and technology shared across NHS services nationwide.