Nivolumab with ipilimumab recommended through CDF for advanced renal cell carcinoma

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National Institute for Health and Care Excellence

  • Lenalidomide now recommended for multiple myeloma in combination with dexamethasone or after one previous therapy in two pieces of final draft guidance.
  • Final guidance published:
    • Nivolumab with ipilimumab recommended for use through CDF for advanced renal cell carcinoma
    • Enzalutamide not recommended for high-risk prostate cancer.

Scottish Medicines Consortium

  • The following medicines have been accepted:
    • Verzenios® for breast cancer in combination with fulvestrant (restricted)
    • Keytruda® as monotherapy for the adjuvant treatment of Stage III melanoma and lymph node involvement
    • Fixapost® for reducing IOP in patients with open angle glaucoma and ocular hypertension (restricted)
    • Reagila® for schizophrenia in adult patients (restricted).
    • Xonvea® not accepted for the treatment of nausea and vomiting in pregnancy.
  • Four medicines not accepted due to absence of submission.

Medicines and Healthcare products Regulatory Agency

  • Class 2 medicines recall: Co-amoxiclav for oral suspension variants.

Dispensing Doctors’ Association

  • DHSC reports supply shortages for May 2019.

NHS England

  • First ever treatment for children with spinal muscular atrophy to be funded.
  • Hydrogel to be funded and rolled out across UK to protect prostate cancer patients during radiation treatment.

Public Health England

  • Alert issued after hospitalisation and deaths linked to consumption of DNP.
  • Grant announced to help improve the health of rough sleepers.

Department of Health and Social Care

  • Brain cancer treatment aid now available across England.

Royal College of Physicians

  • COPD audit reveals great improvements in care but also areas for concern.

World Health Organisation

  • New guidelines for reducing the risk of cognitive decline and dementia published.

European Centre for Disease Prevention and Control

  • Monthly measles and rubella monitoring report for May 2019 published.

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

LENALIDOMIDE NOW RECOMMENDED FOR MULTIPLE MYELOMA IN TWO PIECES OF FINAL DRAFT GUIDANCE

Lenalidomide will now be available on the NHS for patients with a form of blood cancer as a first- and second-line drug. In final draft guidance, NICE has recommended lenalidomide in combination with dexamethasone as an option for previously untreated multiple myeloma in adults who are not eligible for a stem cell transplant and cannot take thalidomide. Currently, first treatment for multiple myeloma includes taking thalidomide (or bortezomib for those who can’t take thalidomide). NICE recognises that this can cause substantial side effects such as bruising, breathlessness and increased risk of infection and there is a need for new effective treatments for those who cannot take these drugs.

Additionally, in a second piece of final draft guidance, NICE has also recommended lenalidomide as an option for treating multiple myeloma in adults if they have had only one previous therapy, which includes bortezomib. Currently, patients are offered chemotherapy as a second treatment after bortezomib, however clinical evidence shows that lenalidomide with dexamethasone is substantially improves the length of time people live compared to bortezomib-based therapy. In one clinical study, patients taking lenalidomide lived on average seven months longer. NICE already recommends lenalidomide as a third-line treatment therefore it was considered appropriate to also recommend it as second-line option.

These recommendations partially update guidance on lenalidomide for the treatment of multiple myeloma in people who have received at least one prior therapy (TA171). Since lenalidomide is now recommended for use as a first treatment, it is expected that the need for a second-line treatment will reduce.

NIVOLUMAB WITH IPILIMUMAB RECOMMENDED FOR USE WITHIN CDF FOR ADVANCED RENAL CELL CARCINOMA

NICE has published final 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 (CheckMate 214) show that nivolumab with ipilimumab is more effective than sunitinib in the short-term, but its long-term effects are uncertain. NICE finds that 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 CheckMate 214 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 PROSTATE CANCER IN FINAL GUIDANCE

NICE has published final 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. Clinical trial evidence shows that adding in enzalutamide extends the time until the cancer starts spreading to other parts of the body. In addition, there is no evidence that it increases how long people live. NICE says that cost-effectiveness estimates comparing enzalutamide plus androgen deprivation therapy with androgen deprivation therapy alone are uncertain. This is because:

  • it is not possible to estimate accurately how long people who take enzalutamide live
  • the costs and benefits of treatments used after enzalutamide in the economic analysis do not reflect NHS practice.

In addition, the estimates are not within the range that NICE usually considers a cost-effective use of NHS resources.

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SCOTTISH MEDICINES CONSORTIUM

VERZENIOS® ACCEPTED FOR BREAST CANCER IN COMBINATION WITH FULVESTRANT (RESTRICTED)

The Scottish Medicines Consortium (SMC) has accepted Verzenios® (abemaciclib) for restricted use within NHS Scotland, under a Patient Access Scheme (PAS), for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or in women who have received prior endocrine therapy. It is restricted to use in women who have progressed on or after (neo) adjuvant endocrine therapy, or progressed during first-line endocrine-based therapy for advanced breast cancer. In a phase III randomised study in women with HR-positive, HER2-negative advanced breast cancer who had received prior endocrine therapy, Verzenios® (in combination with fulvestrant significantly increased progression-free survival compared with endocrine monotherapy.

KEYTRUDA® ACCEPTED AS MONOTHERAPY FOR THE ADJUVANT TREATMENT OF STAGE III MELANOMA AND LYMPH NODE INVOLVEMENT

Following a full submission considered under the orphan equivalent process, Keytruda® (pembrolizumab) is accepted for use within NHS Scotland, under a PAS, as monotherapy for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection. Recurrence-free survival was significantly longer in the Keytruda® group compared with placebo in a phase III study of adult patients with completely resected, stage III melanoma with lymph node involvement, which is why the SMC has accepted its use.

FIXAPOST® ACCEPTED FOR TREATMENT IN REDUCING IOP IN PATIENTS WITH OPEN ANGLE GLAUCOMA AND OCULAR HYPERTENSION (RESTRICTED)

Following an abbreviated submission, the SMC has accepted Fixapost® (latanoprost plus timolol) for restricted use within NHS Scotland, for treatment in the reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. This is restricted to use in patients who have proven sensitivity to preservatives. The combination product costs less than preservative-free latanoprost and timolol eye drops administered separately but is more expensive than the equivalent generic multi-dose eye drop preparation with preservative.

REAGILA® ACCEPTED FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULT PATIENTS (RESTRICTED)

Following a full submission, the SMC has accepted Reagila® (cariprazine) for restricted use within NHS Scotland for the treatment of schizophrenia in adult patients. This is restricted for use as a second-line therapy in patients where predominantly negative symptoms have been identified as an important feature. In patients with stable schizophrenia with predominantly negative symptoms, cariprazine improved negative symptoms more than another second-generation antipsychotic.

XONVEA® NOT RECOMMENDED FOR THE TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN

Xonvea® (doxylamine succinate and pyridoxine hydrochloride) is not recommended for use within NHS Scotland for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. The SMC states that Xonvea® significantly improved symptoms of nausea and vomiting compared with placebo in women with nausea and vomiting of pregnancy, however the submitting company did not present a sufficiently robust clinical or economic analysis to gain acceptance.

FOUR MEDICINES NOT ACCEPTED DUE TO ABSENCE OF SUBMISSION

The following medicines have not been accepted due to the absence of a submission:

  • Chenodeoxycholic acid Leadiant® (chenodeoxycholic acid) for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis) in infants, children and adolescents aged one month to 18 years and adults.
  • Sprycel® (dasatinb) for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia in combination with chemotherapy.
  • Darzalex® (daratumumab) in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
  • MabThera® (rituximab) for the treatment of patients with moderate to severe pemphigus vulgaris.

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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

CLASS 2 MEDICINES RECALL: CO-AMOXICLAV FOR ORAL SUSPENSION VARIANTS

The Medicines and Healthcare products Regulatory Agency has issued a class 2 medicines recall for Co-amoxiclav 125 mg/31.25 mg/5 ml and 25 mg/62.5 mg/5 ml Powder for Oral Suspension. Sandoz Ltd. have been notified of a potential packaging problem relating to poor seal adherence which could cause clumping of the powder within the bottle. The recall is a precautionary measure - no complaints or adverse events relating to this defect have been received by the company from the UK market. Healthcare professionals are advised to stop supplying the noted batches of this product. Remaining stocks of the impacted batches should be quarantined and returned to the original supplier.

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DISPENSING DOCTORS’ ASSOCIATION

DHSC REPORTS SUPPLY SHORTAGES FOR MAY 2019

The Dispensing Doctors’ Association reports that the Department for Health and Social Care has published its supply issues update for primary and secondary care for May 2019. New shortages reported include:

  • Injectables: Ancotil (flucytosine) injection, Arsenic acid, idazolam injection and Pentamidine 300mg in 5mL injection.
  • Orals: Cycloserine 250mg capsules, Epanutin (phenytoin) 50mg Chewable Infatabs, Labetalol tablets, Methadone 1mg/ml oral solution sugar free, Qlaira tablets, Questran Powder for Oral Suspension/Questran Light (colestyramine) 4g sachets, Rifadin (rifampicin) 300mg capsules, Sabril (vigabatrin) tablets, Sinemet (co-careldopa) tablets, Thorens (colecalciferol) 10,000i.u./ml oral drops, Xanax (alprazolam) tablets, Zolmitriptan 2.5mg orodispersible tablets, Loestrin 20 and Loestrin 30 tablets.
  • Eye drops/treatments: Iopidine (apraclonidine hydrochloride) 0.5% eye drops.

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NHS ENGLAND

FIRST EVER TREATMENT FOR CHILDREN WITH SPINAL MUSCULAR ATROPHY TO BE FUNDED

NHS England has announced it will provide a promising new treatment for spinal muscular atrophy (SMA) after negotiating a deal with the manufacturer (see OnMedica article). Nusinersen, also called Spinraza and made by Biogen, is the first treatment that targets the underlying cause of SMA. The condition affects the nerves in the spinal cord, making muscles weaker and causing problems with movement, breathing and swallowing. Where it develops in babies and toddlers, it can significantly reduce life expectancy. While not a cure, trials have shown that nusinersen can slow the effects of SMA in some cases, allowing babies and toddlers to develop stronger muscles and survive for longer without breathing support.

HYDROGEL TO BE FUNDED AND ROLLED OUT ACROSS UK TO PROTECT PROSTATE CANCER PATIENTS DURING RADIATION TREATMENT

An innovation that can reduce the side-effects of radiotherapy for prostate cancer patients by over 70% will be rolled out across the NHS, NHS England has announced. A deal made between the NHS and manufacturer Boston Scientific means hospitals in England will now be encouraged to use its hydrogel device for all patients who could benefit, making radiotherapy a safer and less painful treatment option for many men. The hydrogel acts as a spacer, reducing the amount of radiation that can pass through the prostate and damage the rectum during treatment, by temporarily positioning it away from the high dose radiation used in treatment. The gel, made mostly of water, is injected before treatment starts and then remains in place during radiation therapy, before being naturally absorbed by the body after about six months. In studies, its use has been shown to relatively reduce life-changing side effects, such as rectal pain, bleeding and diarrhoea, by over 70%, meaning significant improvements in quality of life for those battling prostate cancer.

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PUBLIC HEALTH ENGLAND

ALERT ISSUED AFTER HOSPITALISATION AND DEATHS LINKED TO CONSUMPTION OF DNP

Public Health England (PHE) has issued an alert after reports of hospitalisation and deaths linked to consumption of 2,4-dinitrophenol (DNP) and to underscore the need for rapid treatment in cases of suspected DNP poisoning. PHE advises that NHS frontline staff should remain vigilant for cases of DNP poisoning and that clinicians should note and act in accordance with clinical management advice:

  • Any individuals thought to have consumed DNP or considering its use should be advised of the risks.
  • Health professionals dealing with individuals suspected of consuming DNP should advise them to discontinue use immediately and obtain advice on clinical management from the National Poisons Information Service (NPIS) by reference to TOXBASE (www.toxbase.org). 
  • All patients with features suggesting DNP toxicity should be referred to hospital immediately for assessment and observation and all symptomatic cases should be discussed with the NPIS by phone (0344 892 0111).

GRANT ANNOUNCED TO HELP IMPROVE THE HEALTH OF ROUGH SLEEPERS

PHE has announced it is awarding the Department of Health and Social Care funding of £1.9 million to councils to test ways to improve rough sleepers' access to health services. Successful projects will focus on improving access to health services for people with co-occurring mental ill-health and substance misuse problems who are currently, or at risk of returning to, sleeping rough. To support local authorities and clinical commissioning groups to develop their applications for funding, PHE has also published guidance and further information on how to apply.The deadline to submit an application is Friday 5 July 2019, with successful projects announced later this year.

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DEPARTMENT OF HEALTH AND SOCIAL CARE

BRAIN CANCER TREATMENT AID NOW AVAILABLE ACROSS ENGLAND

The Department of Health and Social Care has announced the launch of a new treatment aid that will allow surgeons to identify areas of the brain affected by cancer more accurately, helping up to 2,000 patients a year. Known as ‘the pink drink’, 5-ALA uses fluorescent dye and ultraviolet light to make cancerous cells glow under UV light. This allows surgeons to more accurately identify the affected areas of the brain. The treatment aid will help to tackle some of the most difficult to treat cases and make sure healthy cells are left untouched.

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ROYAL COLLEGE OF PHYSICIANS

COPD AUDIT REVEALS GREAT IMPROVEMENTS IN CARE BUT ALSO AREAS FOR CONCERN

Care of patients with chronic lung conditions is improving but there are still significant deficiencies that need addressing, according to the

world’s largest clinical audit of chronic obstructive pulmonary disease(COPD) patients, run by the Royal College of Physicians (RCP). Data from almost 75,000 hospital admissions shows that more patients than ever are being seen by a specialist respiratory team – proven to reduce risk of dying from COPD, the collective term for emphysema and chronic bronchitis. However, the report states that patients are still not getting the best possible care, with large numbers still not being provided help to stop smoking or having previous spirometry results available. Findings from the report show:
  • 75% of patients are now being seen by a specialist respiratory team, with 64% seen within 24 hours. Patients who received a specialist review were 14% less likely to die as inpatients, and six times more likely to be offered smoking cessation therapy.
  • Two-thirds of smokers with COPD are offered help to stop smoking, however only 38% of these patients accept it.
  • There was no record of a spirometry test for 60% of patients. This test is required for a diagnosis of COPD to be confirmed.
  • 12% of admissions where a spirometry result was recorded showed no evidence of airflow obstruction (suggesting that these patients may not have COPD at all), despite them being managed for a COPD flare up.
  • Only one in five patients who received non-invasive ventilation (NIV) treatment did so within the recommended standard of two hours of admission – those that received NIV more than two hours after their admission were 23% more likely to stay in hospital longer than those who received it within two hours.

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WORLD HEALTH ORGANISATION

NEW GUIDELINES FOR REDUCING THE RISK OF COGNITIVE DECLINE AND DEMENTIA PUBLISHED

The World Health Organisation (WHO) has published new guidelines which provide the knowledge base for health-care providers to advise patients on what they can do to help prevent cognitive decline and dementia (see OnMedica article). They will also be useful for governments, policy-makers and planning authorities to guide them in developing policy and designing programmes that encourage healthy lifestyle. WHO guidelines state that people can reduce their risk of dementia by getting regular exercise, not smoking, avoiding harmful use of alcohol, controlling their weight, eating a healthy diet, and maintaining healthy blood pressure, cholesterol and blood sugar levels.

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EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL

MONTHLY MEASLES AND RUBELLA MONITORING REPORT FOR MAY 2019 PUBLISHED

The European Centre for Disease Prevention and Control (ECDC) has published as surveillance report which is based on measles and rubella data from The European Surveillance System (TESSy) for the period 1 April 2018 to 31 March 2019. Twenty-seven countries reported measles data for March 2019, with 1 548 cases reported by 22 countries and five countries reporting no cases. Czech Republic, Italy and Norway did not report measles data for March 2019. Overall, case numbers continued to increase compared with the previous two months. France, Lithuania, Poland, Romania, Bulgaria and Germany had the highest case counts with 295, 248, 219, 188, 185 and 123 cases, respectively. Notable decreases were reported in Belgium and Austria:

  • Belgium reported 68 cases in March, compared with 89 in February and 20 in January.
  • Austria reported one case in March, compared with 33 in February and 25 in January.

Notable increases were reported in France, Lithuania, Poland and Bulgaria:

  • France reported 295 cases in March, compared with 209 in February and 124 in January.
  • Lithuania reported 248 cases in March, compared with 72 in February and 12 in January.
  • Poland reported 219 cases in March, compared with 178 in February and 123 in January.
  • Bulgaria reported 185 cases in March, compared with 51 in February and zero in January.

The ECDC has also created an infographic showing the age distribution of measles cases and the countries affected in March and the number of measles cases 2017-2019.

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OnMedica

Editorial team, Wilmington Healthcare

OnMedica is an independent, easy to access on-the-go website for doctors. It provides GPs and specialists with easy to digest and up-to-date, relevant educational content whilst enabling the freedom to share and collaborate in a safe-space to further personal development.
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