Community Access to Neutralising Monoclonal Antibodies (nMAB) and Oral Antivirals for Covid-19 Treatment

Key Messages

New COVID-19 treatments for the highest risk non-hospitalised patients are now available on the NHS. These drugs have been shown to reduce hospitalisation and may reduce death.

1. Patients Centrally Identified

Patients that have been identified centrally by NHS Digital national datasets to be in the ‘Highest Risk’ groups should:

  • have been sent a letter informing them of new Covid-19 treatments
  • be automatically contacted by a Covid Medicines Delivery Unit (CMDU) in the event of a positive PCR test result.

These patients should receive a letter, email or SMS from NHS Test & Trace advising them that they may be suitable for new COVID medications and that they will be contacted by a CMDU within 24 hours with further instructions about accessing new Covid-19 treatments.

Unfortunately, although every effort is being made to avoid it, it is possible that a patient may have been contacted by NHS Test & Trace but not be contacted by a CMDU within 24 hours.

These patients should be advised to contact DRSS on 01626 204950 for further information and advice. Practices may wish to share this in their automated phone messages to re-direct eligible patients.

It is expected that about 85% of patients that are eligible will be identified centrally by NHS Digital national datasets. No action by primary care will be required for these patients. CMDUs at each trust will be responsible for assessing patients and prescribing treatments.

2. Patients NOT Centrally Identified

  • Most patients who have not been identified by the central system are likely to be those diagnosed recently with illnesses such as malignancy. These patients’ local trust have been advised to make them aware of the fact that they are at high risk and eligible for new Covid-19 treatments if they test positive for COVID.

If these patients test positive for COVID they will contact their GP practice (in hours) or 111(out of hours) for referral to their local CMDU.

  • GPs may also encounter patients who are in the highest risk group but have not been identified. These patients should also be referred to their local CMDU via eRS.
  • If patients contact NHS 111/Devon Doctors, the call handler will pass the patient’s information to the clinical team after undergoing an NHS 111 pathways assessment. The clinician will refer the patient to DRSS by email if they feel they may be eligible for the new COVID treatments.

Scope

Patients must meet all the eligibility criteria.

Patients referred via this pathway are expected to have had a positive PCR test. Patients presenting late with COVID symptoms, referral should be made on the basis of a positive test from a lateral flow device, where it is not practical to obtain a PCR result within the 7 days.

This group of patients fall within the exceptions to the recently changed Government guidance on confirmatory PCR testing.

Pre-hospitalised patients are eligible for treatment if:
  • SARS-CoV-2 infection is confirmed by polymerase chain reaction (PCR) or lateral flow testing within the last 7 days

AND

  • Onset of symptoms of COVID-19 within the last 7 days

AND

  • The pattern of clinical presentation indicates that there is risk of deterioration from infection (rather than improvement/recovery)

AND

  • A member of a ‘Highest Risk’ groups

AND

  • NOT requiring hospitalisation or oxygen for COVID-19

AND

  • NOT under 12 years old

AND

  • NOT a child weighing less than 40kg

Adult/Over 18 ‘Highest Risk’ groups include:

  • Down’s Syndrome and other genetic disorders known to affect immune competence
  • Patients with a solid cancer
    • Metastatic or locally advanced inoperable cancer
    • Lung cancer (any stage)
    • Receiving any chemotherapy, PI3K inhibitors or radiotherapy within 12 months
    • Cancer resection within last 3 months, and no adjuvant chemotherapy or radiotherapy
    • Cancer resection within 3-12 months and receiving no adjuvant chemotherapy or radiotherapy are expected to be at less risk (and thus less priority) but still at increased risk compared with the non-cancer populations
  • Patients with haematological diseases and stem cell transplant recipients (HSCT)
    • HSCT within the last 12 months, or active graft versus host disease (GVHD)
    • Patients with a haematological malignancy who have had CAR-T cell therapy in the last 24months
    • Patients with a haematological malignancy who have systemic anti-cancer (SACT) or radiotherapy last 12 months
    • Thalassaemia or rare inherited anaemia
    • Sickle Cell disease
    • myeloma (excluding monoclonal gammopathy of undetermined significance (MGUS)
    • AL amyloidosis
    • chronic B-cell lymphoproliferative disorders (chronic lymphocytic leukaemia, follicular lymphoma)
    • myelodysplastic syndrome (MDS)
    • chronic myelomonocytic leukaemia (CMML)
    • myelofibrosis
  • Patients with renal disease
    • Renal transplant recipients
    • non-transplant renal patients who have received a comparable level of immunosuppression.
      • Please refer to the section on ‘Immune-mediated inflammatory diseases’ below for a list of qualifying immunosuppressive therapies
    • CKD Stage 4 or 5 (eGFR lower than 30ml/min) without immunosuppression
  • Patients with liver disease
    • Cirrhosis Child-Pugh class A, B and C.
    • Liver transplant
    • On immune suppressive therapy
  • Solid organ transplant recipients
  • Patients with immune mediated inflammatory disorders (IMID)
    • People who are on corticosteroids (equivalent to greater than 10mg per day of prednisolone) for at least the 28 days prior to positive PCR/LFT
    • Received a B-cell depleting therapy (e.g., rituximab, ocrelizumab, ofatumab, obinutuzumab) in the last 12 month
    • treated with cyclophosphamide (IV or oral) in the 6 months prior to positive PCR/LFT
    • people who are on /have received biologics or small molecule JAK-inhibitors within the last 6 months
    • people who are on current treatment with mycophenolate mofetil, oral tacrolimus, azathioprine/mercaptopurine (for major organ involvement such as kidney, liver and/or interstitial lung disease), methotrexate (for interstitial lung disease) and/or ciclosporin
  • Primary immune deficiencies
  • HIV/AIDS
    • High levels of immune suppression, uncontrolled/untreated HIV
    • On treatment for HIV with CD4 lower than 350cells/mm3

CD4 greater than 350 cells/mm3 and additional risk factors (e.g. age, diabetes, obesity, cardiovascular, liver or renal disease, homeless, alcoholic dependency)

  • Rare neurological conditions
    • Multiple sclerosis
    • Motor neurone disease
    • Myasthenia gravis
    • Huntington’s disease

12-17 years and over 40kg

Substantial risk: Complex life-limiting neurodisability with recurrent respiratory infections or compromise.

Children and young people at significant risk if 2 or more of these risk factors are present:

  • Primary immunodeficiency
  • Secondary immunodeficiency
    • HIV CD4 count lower than 200 cells/mm3
    • Solid organ transplant
    • Stem Cell transplant (within 12 months) or with GVHD
  • Immunosuppressive treatment
    • Chemotherapy within the last 3 month
    • Cyclophosphamide within the last 3 months
    • Corticosteroids greater than 2mg per kg per day for 28 days in last 4 weeks
    • B cell depleting treatment in the last 12 months

• Other conditions:

  • High BMI (greater than 95th centile)
  • severe respiratory disease (for example, cystic fibrosis or bronchiectasis with FEV1 less than 60%)
  • Tracheostomy or long-term ventilation
  • Severe asthma (paediatric intensive care unit (PICU) admission in 12 months)
  • Neurodisability and/or neurodevelopmental disorders
  • Severe cardiac disease
  • Severe chronic kidney disease
  • Severe liver disease
  • Sickle cell disease or other severe haemoglobinopathy
  • Down’s Syndrome
  • Complex or chromosomal genetic or metabolic conditions associated with significant comorbidity
  • Multiple congenital anomalies associated with significant comorbidity

nMABS are most effective in patients who have not mounted an antibody response to vaccination. Conditions such as neurological conditions, if mild and not on immunosuppressive treatment, or asthmatics on intermittent rescue steroid treatment may not need treatment but referrals will be triaged, and patients contacted by the CMDU accordingly.

Further information about these risk groups can be found here:

Interim clinical commissioning policy: neutralising monoclonal antibodies or antivirals for non-hospitalised patients with COVID-19

Assessment

Patients should be assessed and managed in the usual way.

Please see page 3 for the 'Adult Primary Care Covid-19 Assessment Pathway’ for more advice.

Other referral pathways e.g., ‘Covid-19 Oximetry @ home’ should be utilised in parallel as appropriate.

Red Flags

Patients who require hospitalisation for COVID-19 should be referred to an acute trust.

Please see page 3 for the ‘Adult Primary Care Covid-19 Assessment Pathway for more advice.

Investigations

SARS-CoV-2 polymerase chain reaction (PCR) or lateral flow (registered via gov.uk or NHS 119) testing within the last 7 days

This group of patients fall within the exceptions to the recently changed Government guidance on confirmatory PCR testing.

Exceptions include:

‘People who have received an email or letter from the NHS because of a health condition that means they may be suitable for new COVID-19 treatments. This applies when they develop any COVID-19 symptoms, and they should use the PCR test kit that was sent to them in the post for this purpose. If they have not received a PCR test kit they can arrange to have a PCR test.’

Please Note:

  • asymptomatic high-risk patients with a positive result on a LFD should NOT have a confirmatory PCR.

Management

Patients should be assessed and managed in the usual way.

Please see page 3 for the ‘Adult Primary Care Covid-19 Assessment Pathway for more advice.

GPs must not prescribe nMABs or antivirals for COVID-19. Community pharmacies and dispensing practices will not have access to stocks of these medicines.

Where will patients receive nMABs or antivirals treatment?

nMABs are administered intravenously or subcutaneously so a patient will need to safely travel to a CMDU site. If the CMDU decides that an antiviral is the most appropriate option, these will be dropped off to a patient’s home, either via a friend or family member of the patient, or via a delivery service.

Further information about the treatments available within Devon can be found here:

North and East Devon Formulary

South and West Devon Formulary

PANORAMIC study

Oral antivirals will be made available to a wider cohort of at-risk patients through a national study known as the PANORAMIC study. Further information is available here: PANORAMICtrial. Patients eligible for nMABs or oral antivirals under the UK interim commissioning policies must first be referred to the CMDU.

Referral

Scope

Patients must meet all the eligibility criteria.

Patients referred via this pathway are expected to have had a positive PCR test. Patients presenting late with COVID symptoms, referral should be made on the basis of a positive test from a lateral flow device, where it is not practical to obtain a PCR result within the 7 days.

This group of patients fall within the exceptions to the recently changed Government guidance on confirmatory PCR testing.

Pre-hospitalised patients are eligible for treatment if:
  • SARS-CoV-2 infection is confirmed by polymerase chain reaction (PCR) testing within the last 7 days

AND

  • Onset of symptoms of COVID-19 within the last 7 days

AND

  • The pattern of clinical presentation indicates that there is risk of deterioration from infection (rather than improvement/recovery)

AND

  • A member of a ‘Highest Risk’ groups

AND

  • NOT requiring hospitalisation or oxygen for COVID-19

AND

  • NOT under 12 years old

AND

  • NOT a child weighing less than 40kg

Further information about these risk groups can be found here:

Interim clinical commissioning policy: neutralising monoclonal antibodies or antivirals for non-hospitalised patients with COVID-19

Referral Instructions

If a patient meets the eligibility criteria, but has not been identified centrally by NHS Digital national datasets, GPs can refer to a CMDU by searching for the CMDU services on eRS, using the following:

e-Referral Service Selection:

Specialty: Infectious Diseases

Clinic Type: Not Otherwise Specified

Service: There will be an option for a service that includes ‘CMDU’ in the name

Please do not email referrals to DRSS (as previously advised) as this may introduce a delay in the referral reaching the service.

Referral Form

Referral form nMAB community access - no merge fields

Referral form nMAB community access - EMIS

Referral form nMAB community access - S1

Supporting Information

GP Information

NHS Devon - Pathway for COVID-19 Therapies (including nMABs)– Summary sheet

Patient Information

Treatments for coronavirus (COVID-19) - NHS (www.nhs.uk)

Easy read and other language versions of this information are available from: https://www.england.nhs.uk/coronavirus/treatments

Evidence

NHS England

Pathway Group

This guideline has been signed off on behalf of the NHS Devon Clinical Commissioning Group

Publication date: January 2022

Updated: July 2022

Last updated: 15-07-2022

 

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