Shaping better health
REMEDY : BNSSG referral pathways & Joint Formulary

COVID Medicine Delivery Unit (CMDU)

Checked: 23-12-2021 by vicky.ryan Next Review: 15-12-2022

Overview

Neutralising monoclonal antibodies (nMABs) are a new type of COVID-19 treatment which are usually administered intravenously. 

From 16 December 2021, access to monoclonal antibodies as a treatment for COVID-19 will be extended to non-hospitalised patients who are PCR positive and aged 12 and above who are considered at highest risk of progression to severe disease, hospital admission or death. Eligible patients may receive antiviral therapy if an nMAB is contraindicated.  

WHAT are they?

Neutralising Monoclonal Antibodies (nMABs)

nMABS are synthetic monoclonal antibodies that bind to the spike protein of the Covid virus, which prevents entry into the host cell and replication.

The nMAB which will be in use:

  • Xevudy (sotrovimab) - will be in use for the omicron variant, symptom onset within 5 days

Antiviral

  • Molnupiravir (2nd line to be used if not possible to use nMABs) 

WHERE will they be used?

The nMABs are given via an IV infusion and current plans are that it will be administered within a hospital setting with facilities for monitoring.

If the patient cannot have the nMAB, the antiviral may be considered. It is a 5-day course and needs to be given within 5 days of symptom onset. GP practices should not issue a prescription for antivirals and currently the antivirals are only available from hospital pharmacies or through a national trial (further information will be available about this shortly)

Eligibility

Patients will be identified as high risk at the point of a positive PCR test and be sent an email and/or SMS text to inform them of this as of Monday 20 December 2021.

If they are eligible for treatment, the acute trust will arrange for the patient to come in for the infusion, or a course of antivirals will be sent to the patient.

Patient who are assessed as not eligible will be informed of this by the CMDU triage service (hosted by Sirona) and offered remote monitoring via Oximetry@home.

Eligibility criteria

Pre-hospitalised patients are eligible if:

  • PCR positive covid test result received within last 5 days.
  • AND onset of symptoms of COVID-19 within last 5 days.
  • AND a member of a highest risk group (see below).

Exclusion criteria

Patients are not eligible if they meet any of:

  • Require hospitalisation or a new need for supplemental oxygen.
  • Children <40kg
  • Children <12 years of age

Eligible conditions (Highest risk group)

Determined by an independent advisory group commissioned by the Dept of Health and Social Care. This list is copied from the commissioning policy:  Interim Commissioning Policy: nMABS or antivirals for Covid 19

  • Downs syndrome and other genetic disorders
    • Patients with Down’s syndrome and other genetic conditions that might reasonably be expected to reduce immune competence, beyond the primary immune deficiency syndromes
  • Sickle cell disease
    • All patients with a diagnosis
  • Patients with a solid cancer
    • Active metastatic cancer and active solid cancers (at any stage)
    • Patients receiving chemotherapy within the last 12 months
    • Patients receiving radiotherapy within the last 6 months
  • Patients with a haematological malignancy
    • Allogeneic haematopoietic stem cell transplant (HSCT) recipients in the last 12 months or active graft vs host disease (GVHD) regardless of time from transplant
    • Autologous HSCT recipients in the last 12 months
    • Individuals with haematological malignancies who have
      • received chimaeric antigen receptor (CAR)-T cell therapy in the last 24 months, or
      • anti-CD20 monoclonal antibody therapy in the last 12 months
    • Individuals with chronic B-cell lymphoproliferative disorders receiving systemic treatment or radiotherapy within the last 3 months
    • Individuals with chronic B-cell lymphoproliferative disorders with hypogammaglobulinaemia or reduced peripheral B cell counts
    • Individuals with acute leukaemias and clinically aggressive lymphomas who are receiving chemotherapy or within 3 months of completion at the time of vaccination
    • Individuals with haematological malignancies who have received anti-CD38 monoclonal antibody or B cell maturation agent (BCMA) targeted therapy in the last 6 months
    • Individuals with chronic B-cell lymphoproliferative disorders not otherwise described above
  • Patients with renal disease
    • Renal transplant recipients (including those with failed transplants within the past 12 months), particularly those who:
      • Received B cell depleting therapy within the past 12 months (including alemtuzumab, rituximab [anti-CD20], anti-thymocyte globulin)
      • Have an additional substantial risk factor which would in isolation make them eligible for nMABs or oral antivirals
      • Not been vaccinated prior to transplantation
    • Non-transplant patients who have received a comparable level of immunosuppression
    • Patients with chronic kidney stage (CKD) 4 or 5 (an eGFR less than 30 ml/min/1.73m2) without immunosuppression
  • Patients with liver disease
    • Patients with cirrhosis Child’s-Pugh class B and C (decompensated liver disease).
    • Patients with a liver transplant
    • Liver patients on immune suppressive therapy (including patients with and without liver cirrhosis)
    • Patients with cirrhosis Child’s-Pugh class A who are not on immune suppressive therapy (compensated liver disease)
  • Patients with immune mediated inflammatory disorders (IMID)
    • IMID treated with rituximab or other B cell depleting therapy in the last 12 months
    • IMID with active/unstable disease on corticosteroids, cyclophosphamide, tacrolimus, cyclosporin or mycophenolate.
    • IMID with stable disease on either corticosteroids, cyclophosphamide, tacrolimus, cyclosporin or mycophenolate.
    • IMID patients with active/unstable disease including those on biological monotherapy and on combination biologicals with thiopurine or methotrexate
    • IMID with stable disease on either corticosteroids, cyclophosphamide, tacrolimus, cyclosporin or mycophenolate.
    • IMID patients with active/unstable disease including those on biological monotherapy and on combination biologicals with thiopurine or methotrexate
  • Primary immune deficiencies
    • Common variable immunodeficiency (CVID)
    • Undefined primary antibody deficiency on immunoglobulin (or eligible for Ig)
    • Hyper-IgM syndromes
    • Good’s syndrome (thymoma plus B-cell deficiency)
    • Severe Combined Immunodeficiency (SCID)
    • Autoimmune polyglandular syndromes/autoimmune polyendocrinopathy, candidiasis, ectodermal dystrophy (APECED syndrome)
    • Primary immunodeficiency associated with impaired type I interferon signalling
    • X-linked agammaglobulinaemia (and other primary agammaglobulinaemias)
  • HIV/AIDS
    • Patients with high levels of immune suppression, have uncontrolled/untreated HIV (high viral load) or present acutely with an AIDS defining diagnosis
    • On treatment for HIV with CD4 350 cells/mm3 and additional risk factors (e.g. age, diabetes, obesity, cardiovascular, liver or renal disease, homeless, those with alcohol-dependence)
  • Solid organ transplant recipients
    • All recipients of solid organ transplants not otherwise specified above
  • Rare neurological conditions
    • Multiple sclerosis
    • Motor neurone disease
    • Myasthenia gravis
    • Huntington’s disease

Referral

You may come across some high-risk patients who have slipped through the net, or if the local CMDU has not contacted the patient within 24 hours of receipt of the result, they will be asked to contact either the GP practice or NHS 111. You can refer to the Covid Medicines Delivery Unit (CMDU) via the eRS and/or using the email below:

Via e-RS

Infectious diseases - BNSSG Covid-19 (nMABS) Delivery Unit (CMDU).

  • Send with the date of the most recent positive PCR test
  • Date of symptoms start (if known)
  • Make sure patient contact details are included (a telephone number is essential)
  • Hospital and ward if in Mental Health hospital

Via email

Contact sirona.bnssg.covidvw@nhs.net Subject: Referral for BNSSG Covid-19 CMDU  Include the patient’s:

  • Full name
  • NHS number
  • Date of Birth
  • Address including post code
  • GP practice
  • Date of most recent positive PCR test
  • Date of symptoms start (if known)
  • Make sure patient contact details are included (a telephone number is essential)
  • Hospital and ward if in Mental Health hospital

IMPORTANT: State in the subject line  “Referral for BNSSG Covid-19 CMDU” (this email also accepts referrals for pulse oximetry virtual ward so essential that it is clear that referral is for CMDU please)

Mental Capacity

A pool of clinicians across BNSSG support the service by checking those referred are eligible (according to centrally published criteria) and discussing treatment options with the patient. 

In rare cases where patients lack capacity it may be necessary for the service to seek help from the patient’s GP. The time critical nature of the treatment means decisions need to be made on the day or within 24 hours for the majority of cases. The CMDU clinician will contact the practice – initially by phone and then by sending details to the email address the practice provides – with details of the eligibility criteria and treatments available. They will ask the GP whether the patient meets the criteria and if so – on balance – whether treatment is likely to be in the patients bests interest. For example, would traveling to hospital for a day case infusion be unduly distressing, would they accept an IV cannula, would they take a large capsule twice a day.

Screeners will make every effort to make this decision independently and the patient’s GPs will be asked to support only in exceptional circumstances.

Additional information

WHAT IF there are side effects/risks?

Anaphylaxis is very rare but if there is a prior history of anaphylaxis to nMABS, patients will be offered an anti-viral treatment (Molnupiravir) instead of an NMAB, which will be issued by the hospital. Other side effects include:

  • Injection site reactions
  • Infusion reactions (nausea, chills, dizziness, flushing, urticaria)

Effectiveness of the nMABs

Drug

 

Hospital admission rate – control

Hospital admission rate – treatment

Number Needed to Treat

Relative risk reduction

Ronapreve1

3.2%

1.0%

46

70%

Sotrovimab2

6%

1.0%

20

 85%

Molnupiravir3

9.7%

6.8%

35

 30%

 

Summaries of Product Characteristics:

  1. SPC/Ronapreve
  2. SPC/Xevudy
  3. SPC/Lagevrio

 

National letter sent to high-risk patients for preparation

Email/SMS/text sent to high-risk patients following positive COVID test from Monday 20 Dec 2021

Panoramic Clinical Study

The Panoramic study is looking at the use of oral anti-viral treatment for patients with recently acquired COVID infection. Please see the attached Information on Panoramic Study looking at oral anti-viral treatment for COVID patients for further details and how patients can sign up.