Classification: Official
Publication approval reference: C1583

9 February 2022, Version 1

Policy update

The interim clinical commissioning policy on COVID-19 treatments for non-hospitalised patients has been updated to include:

• Additional treatment options:
  • PF-07321332 (nirmatrelvir) plus ritonavir – marketing name is Paxlovid – an oral antiviral, which should be taken with five days of symptom onset; and:
  • Remdesivir, an intravenous antiviral which can be commenced within seven days of symptom onset.
• Allowing a positive PCR OR registered lateral flow test to confirm COVID infection.

These changes will take effect from Thursday 10 February 2022.

This supporting information contains important new information about the availability of COVID-19 treatments for non-hospitalised patients. It should be used alongside the commissioning policy and the Frequent Asked Questions (FAQs) COVID community treatments document.

Key information you must know

• You will not need to prescribe or dispense neutralising monoclonal antibodies (nMABs) or antivirals for COVID treatment.
• A small proportion of highest risk patients testing positive through a PCR or registered lateral flow result will phone their GP practice (in hours) or 111 (out of hours) for an urgent referral to a COVID-19 Medicine Delivery Unit (CMDU) if they test positive for coronavirus via a PCR or lateral flow test. The majority of patients who test positive should be automatically phoned by their CMDU.
• You can refer patients to the local CMDU via DoS (or using the locally agreed process if one has been put in place and communicated in your local area).
• Inclusion of the patient’s medications in the referral is vital – some treatments have multiple potential drug interactions.

Immediate actions to take

• Ensure your service understands how to refer potentially eligible patients to COVID-19 Medicine Delivery Units (CMDUs) and has identified the local CMDU.
• Familiarise your service with the updated policy position, including the cohorts of patients included in the highest risk definition.

Background

Antivirals or neutralising monoclonal antibodies (nMABs) are recommended to be available as a treatment option for the highest risk non-hospitalised patients aged 12 years and over with COVID-19 treated in accordance with the criteria set out in the commissioning policy.

The highest risk cohorts have been agreed by the Government, based on advice from an independent DHSC-commissioned group of clinical experts. The cohorts are detailed in annex 1 of the commissioning policy. The policy will be kept under review as new data and licensing decisions emerge.

How will patients receive treatment?

Most of the highest risk patients have received a letter or email telling them in advance they may be eligible for these treatments in the event they test positive for COVID-19. They should also have received a priority PCR test to keep at home. Any ‘new entrants’ to cohorts (eg new diagnoses of multiple sclerosis) will be made aware of the policy via specialists and be able to request a PCR test to keep at home. From 10 February patients can also demonstrate COVID infection via a lateral flow test that has been registered with GOV.UK or 119, but they will be encouraged to also take a PCR test for coronavirus surveillance.

Each integrated care system (ICS) has established one or more local CMDUs to assess patients and where appropriate make available nMABs or antivirals as a treatment for COVID-19. The majority of CMDUs are based in hospital settings.

There are two routes by which eligible patients may access treatment:

1. NHS outreach: In the event of a positive PCR or (from 10 February) registered lateral flow test result, a local CMDU will contact the majority of patients directly to discuss the treatment and confirm eligibility. The CMDU will arrange treatment.
2. Patient in-reach (via PCR or lateral flow test): A small proportion of PCR and lateral flow results cannot be matched to a patient’s health record. We are encouraging those patients not contacted directly by the NHS within 24 hours of a positive lateral flow or PCR test result to phone their GP practice (in hours) or 111 (out of hours) for an urgent referral to a CMDU. GPs and 111 can refer these patients to CMDUs via DoS (111) or eRS (GP) (or using the alternative locally agreed process if one has been put in place and communicated in your local area).

These treatments must be delivered quickly following symptom onset. Practices and 111 should use the clinical policy document to identify if a patient is potentially eligible. They will not need to confirm eligibility or discuss treatment options as these will be carried out by the CMDU.

Handling in 111 services

NHS 111 will not need to prescribe or dispense nMABs or antivirals. However, CAS clinicians might need to refer patients to the local CMDU who can assess eligibility and arrange treatment.

Patients contacting 111 services may declare they believe they are eligible to receive nMAB or antiviral therapy. It is not the intention that 111 services should enquire about potential eligibility these therapies unless declared by the patient.

The diagram below (A: pathway for NHS111 calls) describes potential scenarios for patients expressing an interest in Covid treatments. If, at the onset of the call, a patient declares an interest in nMAB or antiviral therapy they should be asked if they have any concerns regarding current symptoms:

• If they do not have symptoms, and believe that they are eligible for nMAB or antiviral therapy they should be ‘early exited’ to a clinician.
• If they do have concerns about symptoms, they should continue down an NHS Pathways assessment.

For any patients declaring an interest in nMAB or antiviral therapy during the symptomatic assessment, the assessment should be completed. Patients who reach a higher acuity disposition (ambulance or ED) should be handled in the routine way with validation of the disposition.

If a patient declares interest in nMAB or antiviral therapy during a symptomatic assessment (assumed not declared at the onset of the call) the assessment should be completed.

In both of the above scenarios, patients reaching a final disposition lower than 999/ED, either following validation or by NHSP assessment, should be exited and passed to clinician.

Due to the time constraints for effective treatment these cases should be treated as a priority.

Actions for CAS clinicians

CAS clinicians should confirm eligibility (please see section 13 of FAQ document) based on access to available patient records. However, it is important to note that some patients will not have been recorded on the database as, for example, they are newly diagnosed with a condition that makes them eligible for a COVID-19 treatment.

If there is any uncertainty or ambiguity (either regarding eligibility or timescales) patients should be assumed eligible and referred to a CMDU who will clinically assess the patient.

Referral to CMDU for decision regarding treatment

Referral to CMDU is not possible via the usual automated processes from 111. An email must be created and sent manually by the clinician or co-ordinator (as agreed locally).

The local CMDU should be identified by use of ‘NHS Service finder’ searched for using z-code ‘Covid Medicine Delivery Unit (CMDU)’.

Referral should be made by secure email (address included in DoS profiling), including:

• Patient name
• Patient address
• Patient contact details (telephone and email where available)
• NHS number (where available)
• Details of patient’s medications.

Patients should be advised that further contact will be initiated by the CMDU.