Daratumumab plus bortezomib plus dexamethasone recommended through CDF for relapsed multiple myeloma
- Daratumumab plus bortezomib plus dexamethasone recommended through CDF for relapsed multiple myeloma in final guidance.
- Final draft guidance recommends:
- Nivolumab with ipilimumab for advanced renal cell carcinoma through CDF.
- Draft guidance does not recommend:
- Enzalutamide for hormone-relapsed non-metastatic prostate cancer in (final draft).
- Ribociclib with fulvestrant for advanced breast cancer.
- Dacomitinib for lung cancer.
- Patient decision aid encourages use of ‘greener’ asthma inhalers.
- The following medicines have been accepted:
- Lenvatinib as monotherapy for advanced or unresectable hepatocellular carcinoma
- Certolizumab pegol for moderate to severe plaque psoriasis (restricted)
- Rufinamide as adjunctive therapy in the treatment of seizures associated with Lennox-gastaut syndrome (restricted)
- Erenumab for the prophylaxis of migraine in adults (restricted)
- Dasatinib for Philadelphia chromosome positive chronic myelogenous leukaemia resistant or intolerant to prior therapy including imatinib
- Blinatumomab for paediatric patients with acute lymphoblastic leukaemia
- Mepolizumab as add-on treatment for severe eosinophilic asthma (restricted)
- Testosterone gel as testosterone replacement therapy for hypogonadism (restricted).
- Class 4 medicines defect information issued for:
- Chloramphenicol 0.5% W/V Antibiotic Eye Drops: incorrect patient information leaflet and braille missing
- Zoledronic acid 5mg solution for infusion: some packs containing Patient Information Leaflet for Temozolomide 180mg Capsules
- Company led drug alert: certain batches of Nutriflex Omega Special 2500ml recalled due to out of specification result in glucose chamber at end of shelf-life.
- Safety alert issued for Zeiss Lucia 611P intraocular lens.
- Follow-up survey finds continued cataract rationing imposed by CCGs despite NICE guidance.
- HRT supply issue update from the Department of Health and Social Care.
- New guideline published on the prevention and management of accidental awareness during general anaesthesia.
- Specialist perinatal community services rolled out nationwide.
- Latest data shows hepatitis C deaths fell by 16% between 2015 and 2017.
- New tools launched to help health professionals boost prevention impact.
- Views invited on HPV vaccines draft guidance focusing on vaccination of boys and people living with HIV.
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
DARATUMUMAB PLUS BORTEZOMIB PLUS DEXAMETHASONE RECOMMENDED THROUGH CDF FOR RELAPSED MULTIPLE MYELOMA
The National Institute for Health and Care Excellence (NICE) has published evidence-based recommendations which recommends daratumumab (Darzalex) plus bortezomib plus dexamethasone for use within the Cancer Drugs Fund (CDF) as an option for treating relapsed multiple myeloma in people who have had one previous treatment. It is recommended only if the conditions in the managed access agreement for daratumumab plus bortezomib plus dexamethasone are followed. Currently, treatment options for multiple myeloma include bortezomib or carfilzomib (both with dexamethasone) if a person has had thalidomide as the first treatment. For those who have had bortezomib first, carfilzomib is not a treatment option and retreatment with bortezomib is becoming routine. NICE guidance says clinical trial results show that, as a second treatment, daratumumab plus bortezomib plus dexamethasone improves how long people live for before the disease gets worse when compared with bortezomib plus dexamethasone. The results also suggest that people who have daratumumab plus bortezomib plus dexamethasone live longer. However, how much longer they live in total is unclear because there are no long-term trial data. NICE says the benefits of daratumumab plus bortezomib plus dexamethasone compared with carfilzomib plus dexamethasone are unclear because they haven't been compared directly in a trial. The estimates of cost effectiveness presented by the company and evidence review group differ greatly. These differences depend mostly on the estimates of how much longer people will live if they have daratumumab plus bortezomib plus dexamethasone rather than bortezomib plus dexamethasone. According to NICE committee, if the company's estimates are confirmed by extra trial data, there is potential for daratumumab plus bortezomib plus dexamethasone to be cost effective, which is why it has been recommended for use in the CDF while extra data on long-term survival are collected.
NIVOLUMAB WITH IPILIMUMAB RECOMMENDED FOR ADVANCED RENAL CELL CARCINOMA THROUGH CDF (DRAFT GUIDANCE)
NICE has published final draft guidance which recommends nivolumab (Opdivo) with ipilimumab (Yervoy) for use within the Cancer Drugs Fund (CDF) as an option for adults with untreated advanced renal cell carcinoma that is intermediate-or poor-risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria. It is recommended only if the conditions in the managed access agreement for nivolumab with ipilimumab are followed. Current treatment for untreated advanced renal cell carcinoma is usually pazopanib, sunitinib, tivozanib or cabozantinib. For people with untreated advanced renal cell carcinoma that is at intermediate or high risk of getting worse, the results of a clinical trial (CheckMate214) show that nivolumab with ipilimumab is more effective than sunitinib in the short-term, but its long-term effects are uncertain. NICE says nivolumab with ipilimumab has the potential to be cost effective, but more evidence is needed to address the clinical uncertainties. Longer-term follow-up of patients in CheckMate214 would help to address the uncertainties about how long people live, and how long they live without their disease getting worse. Therefore, nivolumab with ipilimumab is recommended for use in the CDF for people who have untreated advanced renal cell carcinoma while the manufacturer of nivolumab and ipilimumab collects further data.
ENZALUTAMIDE NOT RECOMMENDED FOR HORMONE-RELAPSED NON-METASTATIC PROSTATE CANCER (FINAL DRAFT GUIDANCE)
NICE has published final draft guidance which does not recommend enzalutamide (Xtandi), within its marketing authorisation, for treating high-risk hormone-relapsed non-metastatic prostate cancer in adults. Currently, when prostate cancer no longer responds to hormone treatment (androgen deprivation therapy), but has not yet spread beyond the prostate, the only option is to continue hormone treatment. The company proposes using enzalutamide in this setting. According to NICE, clinical trial evidence shows that adding in enzalutamide extends the time until the cancer starts spreading to other parts of the body. But there is no evidence that it increases how long people live. Cost-effectiveness estimates comparing enzalutamide plus androgen deprivation therapy with androgen deprivation therapy alone are uncertain. NICE says this is because it is not possible to estimate accurately how long people who take enzalutamide live, and the costs and benefits of treatments used after enzalutamide in the economic analysis do not reflect NHS practice. The estimates are not within the range that NICE usually considers a cost-effective use of NHS resources.
RIBOCICLIB WITH FULVESTRANT NOT RECOMMENDED FOR ADVANCED BREAST CANCER (DRAFT GUIDANCE)
NICE has issued draft guidance which does not recommend ribociclib (Kisqali) used with fulvestrant to treat people with advanced breast cancer. The draft guidance, which is now the subject of public consultation until 9 May 2019, does not recommend the drug combination for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in people who have had previous endocrine therapy. Clinical trial evidence suggests that compared with fulvestrant alone, ribociclib with fulvestrant increases the length of time before the disease progresses in people with previously untreated advanced disease and in people after a prior endocrine treatment. The committee also heard from the patient expert that patients value improvements in progression-free survival and want to delay chemotherapy for as long as possible. However, it is not known whether ribociclib increases the length of time people live, because the final trial results are not available yet. Because of the uncertainties in the clinical evidence, and cost-effectiveness estimates that are much higher than NICE normally considers to be an acceptable use of NHS resources, ribociclib with fulvestrant has not been recommended for routine use in the NHS. NICE says although more data may address the uncertainties in the clinical trial evidence,because ribociclib with fulvestrant does not have plausible potential to be cost effective at the offered price, it cannot be recommended for use within the CDF. NICE has provisionally approved abemaciclib used with fulvestrant for the same indication within the CDF and already recommends ribociclib used with an aromatase inhibitor for people with previously untreated hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.
DACOMITINIB NOT RECOMMENDED FOR LUNG CANCER (DRAFT GUIDANCE)
Dacomitinib (Vizimpro) is not recommended, within its marketing authorisation, for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults in draft guidance. Locally advanced or metastatic EGFR mutation-positive NSCLC is usually first treated with afatinib, erlotinib or gefitinib. According to NICE, evidence from a randomised controlled trial suggests that people who take dacomitinib live longer than people who take gefitinib. They also live longer before their disease gets worse. But there is no direct evidence comparing dacomitinib with afatinib, which may be more effective than erlotinib and gefitinib. There is also uncertainty about the assumptions used in the cost-effectiveness modelling, including about utility values, the treatments used after disease progression, how survival has been extrapolated and the results of the indirect comparisons. Dacomitinib does not meet NICE’s criteria to be considered a life-extending treatment at the end of life. It also does not meet NICE’s criteria to be included in the Cancer Drugs Fund. The most plausible cost-effectiveness estimates are above what NICE normally considers an acceptable use of NHS resources.
PATIENT DECISION AID ENCOURAGES USE OF ‘GREENER’ ASTHMA INHALERS
People with asthma will be helped to choose the inhaler that is best for them, and best for the environment, by a new patient decision aid from NICE (see OnMedica article), which highlights that some inhalers have a much higher carbon footprint than others. The aid aims to help people with asthma, alongside health professionals, to identify which inhalers could meet their needs and control their symptoms. Where several inhalers could be viable options, patients can opt for the more environmentally friendly option, which may help to cut the health service’s carbon footprint, in line with the new NHS Long Term Plan. It is the first time that NICE has addressed the carbon footprint of a medicine or medical device in one of its publications. The new aid is partially funded by the Sustainable Development Unit (SDU). The decision aid also says that all used inhalers should be returned to local pharmacies for environmentally safe disposal or recycling where available – it directs users to information from Recycle Now, the national recycling campaign.
SCOTTISH MEDICINES CONSORTIUM
LENVATINIB ACCEPTED AS MONOTHERAPY FOR ADVANCED OR UNRESECTABLE HEPATOCELLULAR CARCINOMA
Following a full submission, lenvatinib (Lenvima®) has been accepted for use within NHS Scotland, under a Patient Access scheme (PAS), as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapy. In a phase III study in patients with unresectable hepatocellular carcinoma who had not received treatment for advanced disease, lenvatinib was non-inferior to another multikinase inhibitor for overall survival.
CERTOLIZUMAB PEGOL ACCEPTED FOR MODERATE TO SEVERE PLAQUE PSORIASIS (RESTRICTED)
The SMC has accepted certolizumab pegol (Cimzia) for restricted use within NHS Scotland, under a PAS, for the treatment of adult patients with moderate to severe plaque psoriasis who need systemic treatment. This is restricted to patients who have patients who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contra-indication to these treatments. Certolizumab pegol has shown a similar reduction in the signs and symptoms of psoriasis in adults with moderate to severe plaque psoriasis compared with another tumour necrosis factor (TNF) antagonist.
RUFINAMIDE ACCEPTED AS ADJUNCTIVE THERAPY IN THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (RESTRICTED)
Following an abbreviated submission, rufinamide (Inovelon®) has been accepted for restricted use within NHS Scotland as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 1 years to ≤ 4 years. It is restricted to use in patients who have failed treatment with or are intolerant of other antiepileptic drugs. Rufinamide (Inovelon®) has previously been accepted for restricted use in adults and children aged > 4 years. The licence has been extended to include children aged 1 year to ≤ 4 years.
ERENUMAB ACCEPTED FOR THE PROPHYLAXIS OF MIGRAINE IN ADULTS (RESTRICTED)
The SMC has accepted erenumab (Aimovig®) for restricted use within NHS Scotland, under a PAS, for the prophylaxis of migraine in adults who have at least four migraine days per month. It is restricted to patients with chronic migraine and in whom at least three prior prophylactic treatments have failed. In studies in patients with episodic and chronic migraine, erenumab significantly reduced the number of migraine days per month compared with placebo.
DASATINIB ACCEPTED FOR PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKAEMIA RESISTANT OR INTOLERANT TO PRIOR THERAPY INCLUDING IMATINIB
The SMC has accepted dasatinib (Sprycel®) for use within NHS Scotland, under a PAS, for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. The SMC has previously accepted dasatinib for use in the treatment of adult patients with newly diagnosed Ph+ CML-CP (SMC No. 1170/16) and Ph+ CML-CP resistant or intolerant to prior therapy including imatinib (SMC No. 370/07). Dasatinib was accepted for use in the treatment of adult patients with Ph+ CML-CP resistant or intolerant to prior therapy including imatinib (SMC No. 370/07) following a submission under the orphan process.
BLINATUMOMAB ACCEPTED FOR PAEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKAEMIA
Following an abbreviated submission, blinatumomab (Blincyto®) has been accepted for use within NHS Scotland, under a PAS, as monotherapy for the treatment of paediatric patients aged one year or older with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukaemia which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation. The SMC accepted blinatumomab for use in adults following a submission under the end-of-life and ultra-orphan process.
MEPOLIZUMAB ACCEPTED AS AN ADD-ON TREATMENT FOR SEVERE EOSINOPHILIC ASTHMA (RESTRICTED)
The SMC has accepted mepolizumab (Nucala®) for restricted use within NHS Scotland, under a PAS, as an add-on treatment for severe refractory eosinophilic asthma in adolescents and children aged six years and older. It is restricted to patients who have eosinophils of at least 150 cells per microlitre (0.15 x 109/L) at initiation of treatment and have had at least four asthma exacerbations in the preceding year or are receiving maintenance treatment with oral corticosteroids. The SMC has previously accepted mepolizumab for restricted use in adults.
TESTOSTERONE GEL ACCEPTED AS TESTOSTERONE REPLACEMENT THERAPY FOR ADULT MALE HYPOGONADISM (RESTRICTED)
The SMC has accepted testosterone gel (Testavan®) for restricted use within NHS Scotland, as testosterone replacement therapy for adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. It is restricted to patients requiring a transdermal delivery system. Testosterone (Testavan®) is the bioequivalent to another testosterone transdermal preparation and costs less.
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
CHLORAMPHENICOL 0.5% W/V ANTIBIOTIC EYE DROPS: INCORRECT PATIENT INFORMATION LEAFLET AND BRAILLE MISSING
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 medicines defect information for Chloramphenicol 0.5% W/V Antibiotic Eye Drops. Martindale Pharmaceuticals has informed the MHRA of two issues with all unexpired batches of the product, PL 00156/0109, legal status ‘P’. The Braille is missing from the carton and the packs contain the Patient Information Leaflet (PIL) for the product with legal status ‘POM’. Healthcare professionals are advised that in order to maintain supply, the affected batches are not being recalled. The content of the PIL for the ‘P’ version is similar to that for the ‘POM’ version but there are some differences in the way the information is expressed. The correct PIL for the ‘P’ product can be downloaded here.
SOME PACKS OF ZOLEDRONIC ACID 5MG SOLUTION FOR INFUSION CONTAIN A PATIENT INFORMATION LEAFLET FOR TEMOZOLOMIDE 180MG CAPSULES
The MHRA has issued a class 4 medical defect information as it was informed by Ranbaxy (UK) Ltd a Sun Pharmaceutical Company, that some packs from the one batch of Zoledronic acid 5mg solution for infusion contains a Patient Information Leaflet (PIL) for Temozolomide 180mg Capsules. Healthcare professionals (HCPs) are advised to check the PIL when dispensing the batch. If the pack contains the wrong PIL, HCPs are advised to remove it and provide a copy of the correct PIL, whichcan be downloaded here.
CERTAIN BATCHES OF NUTRIFLEX OMEGA SPECIAL 2500ML BEING RECALLED DUE TO OUT OF SPECIFICATION RESULT IN THE GLUCOSE CHAMBER AT THE END OF SHELF-LIFE
The MHRA has issued a company-led drug alert for certain batches of Nutriflex Omega Special 2500ml. B. Braun Medical Ltd is recalling batches as ongoing stability studies have identified that they may have an out of specification result in the glucose chamber at the end of shelf-life.
ROYAL COLLEGE OF OPHTHALMOLOGISTS
SAFETY ALERT ISSUED FOR ZEISS LUCIA 611P INTRAOCULAR LENS
The Royal College of Ophthalmologists reports that it has been made aware of two ophthalmic units with a run of a small number of cases of fibrin membrane deposition in association with the Zeiss Lucia 611P intraocular lens. In these cases, the patients presented from a few days up to six weeks postoperatively, with a painless white eye, very mild or no uveitis, associated with a fibrin membrane at the level of the anterior capsule incorporating the capsulorrhexis edge in front of the lens. This was sometimes quite dense, mistaken in some cases initially as intralens opacification and in a number of cases required tissue plasminogen activator or occasionally surgery to remove the membrane and restore vision. A minority of those affected had some risk factors for postoperative inflammation, such as previous surgery or pathology, or small to medium pupils (not requiring iris hooks or expanders), but most of the patients had no specific risk factors. The lens company has issued a statement and are investigating. The MHRA has been informed.
FOLLOW-UP SURVEY FINDS CONTINUED CATARACT RATIONING IMPOSED BY CCGS DESPITE NICE GUIDANCE
A year on from the release on NICE guidance of the management of cataracts, the Royal College of Ophthalmologists (RCOphth) undertook a follow-up survey to determine the uptake of this guidance. The College found 62% of units are still restricting access to cataract surgery, which represents only a 5% increase in units changing to being NICE compliant in the year since the guidance was released. The College has stated that it is evident commissioners are continuing to ignore NICE guidelines and ration one of the most cost-effective procedures on the NHS. According to the RCOphth, following a Freedom of Information request, it was recently reported in the media that at commissioning level
53% of CCGs in England are restricting access to cataract surgery in direct contravention of NICE guidance. The RCOphth follow-up survey further confirms this picture from ophthalmologists working locally at trust level. The College says these findings show that the NICE guidance, recommending no restriction of cataract surgery based on visual acuity, has had very limited impact and commissioners are still inappropriately rationing cataract surgery in the majority of eye units. The College concludes that until NHS England mandates the uptake of NICE Guidance compliance it is not likely to improve significantly.
DISPENSING DOCTORS’ ASSOCIATION
HRT SUPPLY ISSUE UPDATE FROM THE DEPARTMENT OF HEALTH AND SOCIAL CARE
The Dispensing Doctors’ Association reports that the Department for Health and Social Care supply team has advised of supply issues with the following items:
- FemSeven Conti and Sequi patches (Theramex): long-term supply issues affecting both products means products are expected to be out of stock until late 2019.
- Elleste Range (Elleste Solo 1mg, 2mg; Elleste Duet Conti; Elleste Duet 1mg) is expected to be unavailable until the end of April 2019.
ROYAL COLLEGE OF ANAESTHETISTS
NEW GUIDELINE PUBLISHED ON THE PREVENTION AND MANAGEMENT OF ACCIDENTAL AWARENESS DURING GENERAL ANAESTHESIA
The Royal College of Anaesthetists and Association of Anaesthetists have published a new guideline offering practical guidance on the prevention and management of accidental awareness during general anaesthesia, which will be made available to all anaesthetists, clinical and medical directors of hospitals and health service management throughout the UK and Ireland. The 5th National Audit Project (or NAP5) of the Royal College of Anaesthetists and Association of Anaesthetists was the largest ever study into accidental awareness during general anaesthesia (AAGA). The purpose of this publication is to distil and interpret the findings of the 5th National Audit Project into actions that individuals (and organisations) can follow to reduce the risk of accidental awareness.
SPECIALIST PERINATAL COMMUNITY SERVICES ROLLED OUT NATIONWIDE
NHS England has announced that specialist perinatal community services have been rolled out nationwide, which will allow mums and mums-to-be who are experiencing anxiety, depression or other forms of mental ill health to access care much closer to home. Five years ago, two in five parts of the country had no access to specialist community perinatal mental health treatment, but there is now full geographical coverage, with services in every one of the 44 local NHS areas, and plans to develop them further. The expansion comes alongside the opening of four new mother and baby units, which means that the most seriously ill women can receive residential care without being separated from their babies in every region. Specialist community perinatal mental health teams can offer psychiatric and psychological assessments and care for women with complex or severe mental health problems during the perinatal period. They can also provide pre-conception advice for women with a current or past severe mental illness who are planning a pregnancy. (See OnMedica article)
PUBLIC HEALTH ENGLAND
LATEST DATA SHOWS HEPATITIS C DEATHS FELL BY 16% BETWEEN 2015 AND 2017
New data announced at the Public Health England (PHE) Research and Science Conference shows that deaths from serious hepatitis C related liver disease fell from 380 to 319 between 2015 and 2017 thanks to new curative treatments (see OnMedica article). PHE is urging those who may have been at risk of contracting hepatitis C, especially if they have ever injected drugs, to get tested. As well as the fall in hepatitis C deaths, greater access to new curative treatments is also linked to a reduction in the number of people with the disease requiring liver transplants. In 2017, registrations for a liver transplant due to hepatitis C fell to a 10-year low of 63, a 53% decrease compared to pre-2015 levels. Estimates indicate that up to 79,000 people are currently living with undiagnosed active hepatitis C infection. This is because people with the infection often have no specific symptoms until their liver has been significantly damaged and so are unaware they are infected. When symptoms do occur, they can often be mistaken for other conditions.
NEW TOOLS LAUNCHED TO HELP HEALTH PROFESSIONALS BOOST PREVENTION IMPACT
Public Health England has announced the launch of a series of new e-learning tools to boost health and care professionals’ knowledge and skills in dealing with some of the biggest issues in public health. The new interactive e-learning tools, developed by PHE and Health Education England e-Learning for Healthcare, offer bite-sized information on key public health issues to help professionals prevent illness, protect health and promote wellbeing. E-learning tools are now available for cardiovascular disease prevention, adult obesity, antimicrobial resistance, physical activity, social prescribing, giving children the best start in life and supporting those at risk of, or experiencing, homelessness. Each tool signposts to further information to help professionals embed prevention in their everyday practice, with short knowledge tests to help enhance learning.
EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL
VIEWS INVITED ON HPV VACCINES DRAFT GUIDANCE FOCUSING ON VACCINATION OF BOYS AND PEOPLE LIVING WITH HIV
The European Centre for Disease Prevention and Control (ECDC) invites citizens, organisations and public authorities to contribute their views in a public consultation on new guidance for the introduction of human papillomavirus (HPV) vaccines in EU countries. The guidance is the result of a systematic review and grading of the available evidence of the efficacy and effectiveness of the nine-valent HPV vaccine and also looks at the cost-effectiveness of adding boys to the girls-only HPV vaccination strategy. The last ECDC guidance on the introduction of HPV vaccines in EU countries was issued in 2012. Since then, a nine-valent HPV vaccine (protecting against nine HPV types) was introduced on the market in 2015. Moreover, as more and more EU/EEA Member States consider offering HPV vaccination to boys, this raised questions on the effectiveness and cost-effectiveness of this measure. The new guidance also looks at evidence on HPV vaccine efficacy and effectiveness for people living with HIV given the higher risk to them of HPV infection and HPV-related illness.