Tisagenlecleucel recommended through CDF for relapsed or refractory diffuse large b-cell lymphoma after two or more systemic therapies

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National Institute for Health and Care Excellence

  • Tisagenlecleucel recommended through CDF for relapsed or refractory diffuse large b-cell lymphoma after two or more systemic therapies.
  • Treatments recommended in final draft guidance:
    • Daratumumab for relapsed multiple myeloma through CDF
    • Tildrakizumab for moderate to severe plaque psoriasis - change from previous draft guidance
    • Certolizumab pegol for moderate to severe plaque psoriasis
  • Coexisting severe mental illness and substance misuse draft quality standard published.
  • ELISA tests not recommended for routine adoption in the NHS in draft guidance.

Scottish Medicines Consortium

  • The following treatments have been recommended:
    • Liposomal formulation of daunorubicin/cytarabine for acute myeloid leukaemia.
    • Letermovir for prophylaxis of cytomegalovirus reactivation and disease.
  • Tisagenlecleucel not recommended relapsed or refractory diffuse large B-cell lymphoma.
  • Rituxumab and Epoetin alfa (Eprex®) not recommended due to lack of submissions.

All Wales Medicines Strategy Group

  • The following treatments have been recommended:
    • Romiplostim for chronic immune thrombocytopenic purpura
    • Ciclosporin for severe vernal keratoconjunctivitis in children.

Scottish Intercollegiate Guidelines Network

  • Risk reduction and management of delirium guideline published.

Medicines and Healthcare products Regulatory Agency

  • Medical device alert issued for enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device.
  • Positive EAMS scientific opinion given to atezolizumab for first-line treatment of breast cancer.

Royal Pharmaceutical Society

  • Reminder: gabapentin and pregabalin reclassified to Schedule 3 Controlled Drugs from 1 April 2019.

Dispensing Doctors’ Association

  • Supply issues update published.

NHS England

  • All major hospitals make a pledge to provide urgent same day services.
  • All hospitals to be contractually obliged to comply with sepsis guidelines.

World Health Organization

  • New global influenza strategy launched.

European Centre for Disease Prevention and Control

  • Measles and rubella monitoring report: case numbers continue to increase overall.

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

TISAGENLECLEUCEL RECOMMENDED THROUGH CDF FOR RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA AFTER TWO OR MORE SYSTEMIC THERAPIES

NICE has published final guidance which recommends tisagenlecleucel (Kymriah) therapy for use within the Cancer Drugs Fund as an option for treating relapsed or refractory diffuse large B-cell lymphoma in adults after two or more systemic therapies, only if the conditions in the managed access agreement are followed. There is no standard treatment for relapsed or refractory diffuse large B-cell lymphoma after two or more systemic therapies. Salvage chemotherapy (that is, chemotherapy to control the disease) is the most common treatment option. Evidence from a single-arm study with short follow-up and a small observational study suggests that people having tisagenlecleucel may live for longer or have more time before their disease relapses. But longer follow-up from the study is needed and there are no data directly comparing tisagenlecleucel with salvage chemotherapy. To assess the comparative effectiveness of tisagenlecleucel and salvage chemotherapy, data from the first CORAL extension study are used. Limitations in the available data mean that the exact size of the benefit of tisagenlecleucel compared with salvage chemotherapy is difficult to establish. Tisagenlecleucel meets NICE's criteria to be considered a life-extending treatment at the end of life. All the cost-effectiveness estimates for tisagenlecleucel compared with salvage chemotherapy are uncertain because of limitations in the data. Because some of these estimates are higher than what NICE normally considers an acceptable use of NHS resources and are associated with a high degree of uncertainty, tisagenlecleucel cannot be recommended for routine use in the NHS. Collecting more data on progression-free survival, overall survival and immunoglobulin usage will reduce the uncertainty in the evidence. Therefore, tisagenlecleucel is recommended for use in the Cancer Drugs Fund.

[See also Scottish Medicines Consortium - Tisagenlecleucel not recommended relapsed or refractory diffuse large B-cell lymphoma]

DARATUMUMAB RECOMMENDED FOR RELAPSED MULTIPLE MYELOMA THROUGH CDF (FINAL DRAFT GUIDANCE)

NICE has published final draft guidance which recommends daratumumab (Darzalex), through the Cancer Drugs Fund, for patients with relapsed multiple myeloma who have had one previous therapy, only if the conditions in the managed access agreement are followed. In the evidence considered by the independent committee, daratumumab, used in combination with bortezomib plus dexamethasone, extended the length of time people live before their disease progresses by 18 months compared to existing therapies. Daratumumab is a monoclonal antibody treatment, which kills multiple myeloma cells by recognising CD38, a protein commonly expressed in this particular type of cancer cell and is the only myeloma treatment of this kind.

TILDRAKIZUMAB NOW RECOMMENDED FOR MODERATE TO SEVERE PLAQUE PSORIASIS (FINAL DRAFT GUIDANCE)

NICE has recommended tildrakizumab (Ilumetri), for adult patients with moderate to severe plaque psoriasis in final draft guidance, only if:

  • the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and
  • the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and
  • the company provides the drug according to the commercial arrangement.

A new price submitted by the company now means that it can be offered as an alternative for patients who are unable to take systemic non-biological treatments. This is a change from draft guidance that found tildrakizumab was not cost-effective. Clinical trial results show that tildrakizumab improves severe psoriasis more than placebo or etanercept, a drug which is already recommended by NICE. Tildrakizumab is a biological treatment that reduces inflammation. It is administered at week 0 and 4 and every 12 weeks thereafter. Self-injection is possible from the third and fourth dose onwards.

CERTOLIZUMAB PEGOL RECOMMENDED FOR MODERATE TO SEVERE PLAQUE PSORIASIS (FINAL DRAFT GUIDANCE)

NICE also recommended certolizumab pegol (Cimzia®) as a treatment option for moderate to severe plaque psoriasis in final draft guidance, only if:

  • the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and
  • the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and
  • the lowest maintenance dosage of certolizumab pegol is used (200 mg every 2 weeks) after the loading dosage and
  • the company provides the drug according to the commercial arrangement.

RADIALLY EMITTING LASER FIBRE TREATMENT OF ANAL FISTULA RECOMMENDED FOR USE UNDER SPECIAL ARRANGEMENTS ONLY

NCE has published final guidance which has found that the current evidence on the safety and efficacy of radially emitting laser fibre treatment of an anal fistula is limited in quantity and quality. NICE says that, although there are no major safety concerns, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Clinicians wishing to do radially emitting laser fibre treatment of an anal fistula should:

  • Inform the clinical governance leads in their NHS trusts.
  • Ensure that patients understand the procedure's safety and efficacy, as well as any uncertainties about these. Provide them with clear written information to support shared decision making. In addition, the use of NICE's information for the public is recommended.
  • Audit and review clinical outcomes of all patients having radially emitting laser fibre treatment of an anal fistula. NICE has identified relevant audit criteria and has developed an audit tool (which is for use at local discretion).

NICE recommends that the procedure should only be done by clinicians experienced in cannulating fistulas, and who are trained in the use of lasers; and that further research should report details of patient selection, including fistula size, recurrence rates in the medium and long term, and quality-of-life outcomes.

COEXISTING SEVERE MENTAL ILLNESS AND SUBSTANCE MISUSE DRAFT QUALITY STANDARD PUBLISHED

NICE has published a draft quality standard which covers the assessment, management and care provided to people aged 14 and over who have coexisting severe mental illness and substance misuse. It describes high-quality care in priority areas for improvement, including:

  • Those with suspected or confirmed severe mental illness are asked about their use of alcohol and drugs.
  • Patients are not excluded from mental health or substance misuse services because of coexisting severe mental illness and substance misuse.
  • Patients with coexisting severe mental illness and substance misuse have a care coordinator working in community mental health services if they are receiving care from secondary care mental health services.
  • Patients with coexisting severe mental illness and substance misuse are followed-up if they miss an appointment.

The draft quality standard is open for consultation until 10 April 2019. The final quality standard is expected to publish in September 2019.

ELISA TESTS NOT RECOMMENDED FOR ROUTINE ADOPTION IN THE NHS (DRAFT GUIDANCE)

NICE has published draft guidance which finds the enzyme-linked immunosorbent assay (ELISA) tests for therapeutic monitoring of tumour necrosis factor (TNF)-alpha inhibitors (drug serum levels and antidrug antibodies) show promise but there is currently insufficient evidence to recommend their routine adoption in rheumatoid arthritis. The ELISA tests covered by the guidance are Promonitor, IDKmonitor, LISA-TRACKER, RIDASCREEN, MabTrack, and tests used by Sanquin Diagnostic Services. The draft guidance recommends that laboratories currently using ELISA tests for therapeutic monitoring of TNF-alpha inhibitors in rheumatoid arthritis should do so as part of research and further data collection. Furthermore, the results of the economic model are uncertain. So, although NICE finds the tests show some promise, they are not recommended for routine use in the NHS. NICE says further research would be valuable. Closing date for comments is 4 April 2019.

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SCOTTISH MEDICINES CONSORTIUM

LIPOSOMAL FORMULATION OF DAUNORUBICIN/CYTARABINE ACCEPTED FOR ACUTE MYELOID LEUKAEMIA

The Scottish Medicines Consortium (SMC) has accepted liposomal formulation of daunorubicin/cytarabine (Vyxeos®) for use within NHS Scotland, under a Patient Access Scheme, for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (AML) or AML with myelodysplasia-related changes. In a randomised phase III study, in adults (aged 60 to 75 years) with high risk AML, liposomal daunorubicin/cytarabine improved overall survival when compared with a standard of care regimen.

LETERMOVIR ACCEPTED FOR PROPHYLAXIS OF CYTOMEGALOVIRUS REACTIVATION AND DISEASE

The SMC has accepted letermovir (Prevymis®) for use within NHS Scotland, under a Patient Access Scheme, for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). Letermovir, compared with placebo, reduced the incidence of CMV reactivation and disease in CMV-seropositive adults undergoing allogeneic HSCT.

TISAGENLECLEUCEL NOT RECOMMENDED RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

Following a full submission assessed under the end of life and ultra-orphan medicine process, the SMC has not recommended tisagenlecleucel (Kymriah®) for use within NHS Scotland, for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Tisagenlecleucel was associated with an overall response rate of 53% in a single-arm, open-label, phase II study in patients with relapsed or refractory DLBCL. However, according to the SMC, the submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the submitting company did not present a sufficiently robust economic analysis to gain acceptance by the SMC.

[See also National Institute for Health and Care Excellence - Tisagenlecleucel recommended through CDF for treating relapsed or refractory diffuse large b-cell lymphoma after two or more systemic therapies]

MEDICINES NOT RECOMMENDED DUE TO LACK OF SUBMISSIONS

In the absence of a submission from the holder of the marketing authorisation, the SMC has not recommended the following medicines:

  • Rituxumab (MabThera®) for use within NHS Scotland, in combination with glucocorticoids, for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis.
  • Epoetin alfa (Eprex®) for the treatment of symptomatic anaemia (haemoglobin concentration of ≤10g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/mL).

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ALL WALES MEDICINES STRATEGY GROUP

ROMIPLOSTIM RECOMMENDED FOR CHRONIC IMMUNE THROMBOCYTOPENIC PURPURA

The All Wales Medicines Strategy Group (AWMSG) has recommended romiplostim (Nplate®) as an option for use within NHS Wales for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients aged one year to < 18 years who are refractory to other treatments (for example, corticosteroids, immunoglobulins). This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS price.

CICLOSPORIN RECOMMENDED FOR SEVERE VERNAL KERATOCONJUNCTIVITIS IN CHILDREN

The AWMSG has recommended ciclosporin (Verkazia®) as an option for use within NHS Wales for the treatment of severe vernal keratoconjunctivitis in children from four years of age and adolescents (until the age of 18).

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SCOTTISH INTERCOLLEGIATE GUIDELINES NETWORK

RISK REDUCTION AND MANAGEMENT OF DELIRIUM GUIDELINE PUBLISHED

The Scottish Intercollegiate Guidelines Network (SIGN) has publishes a guideline with recommendations based on current evidence for best practice in the detection, assessment, treatment and follow up of adults with delirium, as well as reducing the risk of delirium. The guideline applies to all settings: home, long-term care, hospital, and hospice. The remit excludes delirium secondary solely to alcohol and illicit substances use. It also excludes delirium in children.

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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

MEDICAL DEVICE ALERT ISSUED FOR ENFLOW® IV FLUID AND BLOOD WARMER - RISK OF UNSAFE LEVELS OF ALUMINIUM LEACHING FROM THE DEVICE

The Medicines and Healthcare products Regulatory Agency has issued a medical device alert for enFlow® IV fluid and blood warmer system. The manufacturer - Vyaire - has informed the MHRA that the cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels. Healthcare professionals (HCPs) are advised to:

  • Use an alternative fluid warming device if available.
  • If alternatives are available, quarantine affected devices as per the manufacturer’s Field Safety Notice.
  • If no alternative is available, carry out and document a local risk assessment based on a clinical risk-benefit analysis before using this fluid warmer. Overriding clinical need for fluid warming should take precedence over considerations of risk of aluminum release.
  • Report adverse events involving these devices through the local incident reporting system and/or national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. HCPs should also report directly to manufacturers if the local or national systems do not.

POSITIVE EAMS SCIENTIFIC OPINION GIVEN TO ATEZOLIZUMAB FOR FIRST-LINE TREATMENT OF BREAST CANCER

The Early access to medicines scheme (EAMS) has given a positive scientific opinion to Roche Products Limited for atezolizumab as 1st line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%. In patients with triple-negative breast cancer that has progressed to advanced stage disease, where it is locally inoperable or has spread to other parts of the body, the cancer is usually poorly responsive to chemotherapy and patient survival is a matter of months. The addition of atezolizumab to nab-paclitaxel chemotherapy has been shown to notably slow the progression of cancer and increase patient survival despite worse tolerability than chemotherapy alone.

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ROYAL PHARMACEUTICAL SOCIETY

REMINDER: GABAPENTIN AND PREGABALIN RECLASSIFIED TO SCHEDULE 3 CONTROLLED DRUGS FROM 1 APRIL 2019

The Royal Pharmaceutical Society has issued a support alert reminding healthcare professionals that from 1 April 2019 gabapentin and pregabalin will be reclassified to Schedule 3 Controlled Drugs (CDs). This means that prescriptions for gabapentin and pregabalin will need to meet full prescription requirements for Schedule 3 CDs. In addition, both the Department of Health and the Scottish government strongly recommended that the maximum quantity prescribed should not exceed 30 days. Furthermore, gabapentin and pregabalin will be exempt from safe custody requirements. NHS England has produced a briefing note on the rescheduling of gabapentin and pregabalin as Schedule 3 CDs for community pharmacies and GP Practices in England. NHS England has produced a letter advising on how to handle gabapentin and pregabalin in health and justice health services. NHS England has also produced guidance with information on changes to the law relating to the reclassification of pregabalin and gabapentin.

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DISPENSING DOCTORS’ ASSOCIATION

SUPPLY ISSUES UPDATE PUBLISHED

The Dispensing Doctors’ Association has published an update from the Department for Health and Social Care (DHSC) regarding

supply issues that may affect products throughout March, including:
  • Metoprolol 50mg and 100mg tablets: Supplies of both presentations are currently available but may be limited and intermittent for a number of months.
  • Bumetanide: Mylan have informed DHSC they are not currently manufacturing bumentanide 5mg tablets, and they are not able to provide a date for when this product will be made available. Supplies of the 1mg remain available.
  • Tizanidine: the main suppliers of tizanidine are currently out of stock of tizandine 2mg and 4mg tablets, however small amount remains in the wholesalers.
  • Sandimmun (ciclosporin): Novartis have notified DHSC of a supply issues affecting Sandimmun (ciclosporin) capsules due to a manufacturing site transfer. 
  • Sevelamer 800mg tablets: short-term supply issue due to two suppliers discontinuing their product from the UK market resulting in an increase in demand on other supplier’s products.
  • Metopirone: manufacturing issues resulting in the main supplier being out of stock until July 2019.

A number of injectables and vaccines are also affected.

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NHS ENGLAND

ALL MAJOR HOSPITALS MAKE A PLEDGE TO PROVIDE URGENT SAME DAY SERVICES

NHS England has reported that all major hospital will provide urgent same day services to improve care for patients and cut unnecessary admissions by next winter (see OnMedica article). Many hospitals are already providing comprehensive care without admitting patients who come to A&E with conditions such as pneumonia or other breathing difficulties through same day emergency care (SDEC) services. NHS England says SDEC services can prevent patients deteriorating from unnecessary or long stays in hospital, free up beds in hospital wards, and improve the flow of patients through A&E – allowing doctors and nurses to focus on those who need the most urgent care. But clinical leaders believe that around half a million more patients a year across England could be assessed, diagnosed, treated and allowed to return home without the need for an overnight stay. From Spring, local pilots will test how new NHS standards for urgent and emergency care could support the ambition to ensure patients across the country benefit from this service, with hospitals to be measured on their success in reducing overnight admissions.

ALL HOSPITALS TO BE CONTRACTUALLY OBLIGED TO COMPLY WITH SEPSIS GUIDELINES

NHS England has announced that from April, all NHS trusts in England will  be contractually obliged to comply with sepsis guidelines and could face fines if they breach them (see OnMedica article). The guidance, drawn up with the Royal College of Physicians, The Royal College of GPs, NICE and the UK Sepsis Trust, states that staff should look for sepsis at an early stage in patients coming to A&Es and those who are already on wards. Hospital staff must alert senior doctors if patients with suspected sepsis do not respond to treatment within an hour. Hospital teams will also be expected to take sufficient note of non-specific symptoms and concerns expressed by relatives and carers such as acute changes in behaviour.

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WORLD HEALTH ORGANISATION

NEW GLOBAL INFLUENZA STRATEGY LAUNCHED

The World Health Organisation (WHO) has launched its Global Influenza Strategy for 2019-2030 which aims to protect people in all countries from the threat of influenza. The goal of the strategy is to prevent seasonal influenza, control the spread of influenza from animals to humans, and prepare for the next influenza pandemic. The new strategy outlines a path to protect populations every year and helps prepare for a pandemic through strengthening routine programmes. It has two overarching goals:

  1. Build stronger country capacities for disease surveillance and response, prevention and control, and preparedness. To achieve this, it calls for every country to have a tailored influenza programme that contributes to national and global preparedness and health security.
  2. Develop better tools to prevent, detect, control and treat influenza, such as more effective vaccines, antivirals and treatments, with the goal of making these accessible for all countries.

WHO will expand partnerships to increase research, innovation and availability of new and improved global influenza tools to benefit all countries. At the same time WHO will work closely with countries to improve their capacities to prevent and control influenza. Important to the strategy is the on-going success of the Pandemic Influenza Preparedness Framework, an access and benefit sharing system that supports the sharing of potentially pandemic viruses, provides access to life saving vaccines and treatments in the event of a pandemic and supports the building of pandemic preparedness capacities in countries through partnership contributions from industry.

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EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL

MEASLES AND RUBELLA MONITORING REPORT, MARCH 2019: CASE NUMBERS CONTINUE TO INCREASE OVERALL

The European Centre for Disease Prevention and Control has published a monitoring report based on measles and rubella data from The European Surveillance System for the period 1 February 2018 to 31 January 2019. Twenty-nine countries reported measles data for January 2019, with 881 cases reported by 19 countries and 10 countries reporting no cases. Germany did not report measles data for January 2019. Overall, case numbers continued to increase compared with the previous two months. Romania, Italy, Poland and France had the highest case counts with 261, 165, 133 and 124 cases, respectively. Notable increases were reported in Italy, Poland, France and Austria.

  • Italy reported 165 cases in January, compared with 76 in December and 58 in November.
  • Poland reported 133 cases in January, compared with 114 in December and 79 in November.
  • France reported 124 cases in January, compared with 54 in December and 61 in November.
  • Austria reported 25 cases in January, compared with one in December and four in November.

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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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