5.3.6 nMABs and other antiviral drugs

Neutralising monoclonal antibodies and oral antivirals for COVID-19 for non-hospitalised patients

There are UK interim clinical commissioning policies for the treatment of COVID-19 with neutralising monoclonal antibodies (nMABs) and oral antivirals. The nMABs, Ronapreve and sotrovimab, have been made available for non-hospitalised patients who are considered to be at highest risk of progression to severe disease, hospital admission or death. There are national eligibility criteria for an nMAB, see Appendix One of the commissioning policy for non-hospitalised patients and the list of patient groups in the letter to clinicians (21 December 2021); the latter list includes patients who may not be identified automatically by NHS Digital. Antiviral treatment (molnupiravir) may be offered to patients in these cohorts if aged 18 and above where an nMAB is contraindicated or treatment with an nMAB is not possible. The nMABs are administered by intravenous infusion, Ronapreve may also be administered by subcutaneous injection. Molnupiravir is an oral antiviral.

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

Access to these medicines for non-hospitalised patients is through the local COVID Medicine Delivery Units (CMDU).

Referral to a CMDU
NHS England has produced guidance for general practice (see page 4 for criteria for referral to a CMDU). If a patient meets the criteria for referral to a CMDU, but has not been identified centrally by NHS Digital national datasets (estimated 15%), GPs can refer to a CMDU by searching for the CMDU services on e-RS, using the following:

Specialty: Infectious Diseases, Clinic Type: Not Otherwise Specified

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.

Where will patients receive nMABs or antiviral 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 treatment 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.

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.

Neutralising monoclonal antibodies (nMABs)

Ronapreve

(casirivimab and imdevimab)

Concentrate solution for subcutaneous injection or intravenous infusion

  • Ronapreve 6ml single-use vials: each pack contains two vials:
    • One 6ml vial contains 300mg of casirivimab per 2.5ml (120mg/ml)
    • One 6ml vial contains 300mg of imdevimab per 2.5ml (120mg/ml)
  • Ronapreve 20ml multidose vials: each pack contains two vials:
    • One 20ml vial contains 1,332mg of casirivimab per 11.1ml (120mg/ml)
    • One 20ml vial contains 1,332mg of imdevimab per 11.1ml (120mg/ml)

Notes

  1. The combination monoclonal antibody casirivimab plus imdevimab (marketed as Ronapreve) is recommended as a treatment option for:
    1. adults and children (aged 12 years and above) either hospitalised due to COVID-19 or with hospital-onset COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy (24 December 2021)
    2. non-hospitalised adults and children (aged 12 years and above) with COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy (24 December 2021) and the local prevalence of the Omicron variant (CEM/CMO/2021/021)
  2. Information on dose and administration is included in the policies
  3. Preparation and administration of casirivimab and imdevimab should be initiated and monitored by a qualified healthcare provider using aseptic technique. Administration should be under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Individuals should be monitored post intravenous infusion according to local medical practice. Refer to the Specialist Pharmacy Services institutional readiness document for further information on the handling, reconstitution and administration of the product.
  4. Pre-authorised use of Ronapreve for individual patients with COVID-19 is required using Blueteq (CEM/CMO/2021/021; CEM/CMO/2021/023)
  5. Use alongside other therapies for treating COVID-19 in hospitalised patients is addressed in the UK commissioning policy (24 December 2021)
  6. Further information on the timing of COVID-19 vaccination following administration of Ronapreve is available at the following site: Interactions information for COVID-19 vaccines – SPS – Specialist Pharmacy Services
  7. For information on recording the use of Ronapreve in discharge letters to primary care, see CEM/CMO/2021/023
Sotrovimab
  • Concentrate for solution for intravenous infusion 500mg in 8ml (62.5mg/ml) vials

Notes

  1. The monoclonal antibody sotrovimab is recommended as a treatment option for:
    1. adults and children (aged 12 years and above) with hospital-onset COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy (24 December 2021). See note 2 for patients hospitalised due to COVID-19
    2. non-hospitalised adults and children (aged 12 years and above) with COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy ( 24 December 2021)
  2. For patients hospitalised due to COVID-19 where Ronapreve is not clinically appropriate, see the policy here for alternative options including entering patients into the RECOVERY trial which is studying sotrovimab versus standard care
  3. Information on dose and administration is included in the policies
  4. Preparation and administration of sotrovimab should be initiated and monitored by a qualified healthcare provider using aseptic technique. Administration should be under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Individuals should be monitored post intravenous infusion according to local medical practice. Refer to the Specialist Pharmacy Services institutional readiness document for further information on the handling, reconstitution and administration of the product.
  5. Pre-authorised use of sotrovimab for individual patients with COVID-19 is required using Blueteq (CEM/CMO/2021/021; CEM/CMO/2021/023)
  6. Use alongside other therapies for treating COVID-19 in hospitalised patients is addressed in the UK commissioning policy (24 December 2021)
  7. Further information on the timing of COVID-19 vaccination following administration of sotrovimab is available at the following site: Interactions information for COVID-19 vaccines – SPS – Specialist Pharmacy Services
  8. For information on recording the use of sotrovimab in discharge letters to primary care, see CEM/CMO/2021/023

Antivirals

Molnupiravir
  • Capsules 200mg

Notes

  1. Molnupiravir is recommended as a treatment option for patients who meet commissioning policy eligibility criteria for treatment with a neutralising monoclonal antibody (nMAB), but in whom an nMAB is contraindicated or the administration of an nMAB is not possible (24 December 2021).
  2. GPs must not prescribe antivirals for COVID-19. Community pharmacies and dispensing practices will not have access to stocks of these medicines. Access to molnupiravir for patients is described above the entry for Ronapreve
  3. Molnupiravir is not recommended during pregnancy. Individuals of childbearing potential should use effective contraception for the duration of treatment and for 4 days after the last dose of molnupiravir. All healthcare professionals are asked to ensure that any patients who receive a COVID antiviral while pregnant are reported to the UK COVID-19 antivirals in pregnancy registry on 0344 892 0909 so that they can be followed up. For more information go to http://www.uktis.org. Clinicians are advised to refer to the Summary of Product Characteristics for molnupiravir for more information on use during pregnancy or lactation.
  4. Pre-authorised use of molnupiravir for individual patients with COVID-19 is required using Blueteq (CEM/CMO/2021/021)
Remdesivir
  • Concentrate for solution for intravenous infusion 5mg/ml vials
  • Powder for concentrate for solution for intravenous infusion 100mg vials

Notes

  1. Remdesivir is recommended as a treatment option for:
    1. adults and children (12 years and above) hospitalised due to COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy for remdesivir for patients hospitalised with COVID-19 (15 June 2021)
    2. adults and children (12 years and above) with hospital-onset COVID-19 in accordance with the criteria set out in the UK interim clinical commissioning policy for nMABs and intravenous antivirals in the treatment of COVID-19 in hospitalised patients (24 December 2021)
  2. Information on dose and administration is included in the policies.
  3. Patients should be monitored for hypersensitivity reactions during and following administration of remdesivir as clinically appropriate (refer to individual policies above).
  4. Renal and liver function should be monitored carefully during treatment with remdesivir as clinically appropriate (refer to individual policies above)
  5. Further information on the timing of COVID-19 vaccination following administration of remdesivir is available at the following site: Interactions information for COVID-19 vaccines – SPS – Specialist Pharmacy Services.
  6. Pre-authorised use of remdesivir for individual patients is required using Blueteq (CEM/CMO/2021/003; CEM/CMO/2021/023)
Last updated: 13-01-2022

 

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