Guidance

Waiver of prescription charges for HEAL-COVID and STIMULATE-ICP clinical trial platforms

Updated 29 March 2023

Background

This document provides guidance to GPs, prescribers, pharmacists and pharmacy staff on procedures which have been developed to ensure that patients identified as eligible to receive community therapeutic treatments after testing positive for coronavirus (COVID-19) and those participating in either the HEAL-COVID clinical trial platform or the STIMULATE-ICP clinical trial platform, receive trial medicines free of charge when prescribed using the NHS prescription form FP10 or electronic prescription service (EPS).

Currently, prescription charges are applicable to patients who are not otherwise exempt. In early 2020, ministers made amendments to legislation to enable, should they wish to do so, prescriptions to be provided free of charge to patients for treatments for pandemic infections including COVID-19.

On 10 December 2021, the Department of Health and Social Care (DHSC) announced that from 10 December 2021 until 31 March 2022, arrangements would be made for the purposes of regulation 13 of the NHS (Charges for Drugs and Appliances) Regulations 2015 for antiviral medicines to be supplied to patients who have tested positive for COVID-19 and who are in the eligible cohorts of patients identified by the UK Chief Medical Officers. Where the patients are not already eligible for free prescriptions, the antiviral medicines will be supplied free of charge.

On 31 March 2022 DHSC announced that the arrangements that were made for the purposes of regulation 13 of the NHS (Charges for Drugs and Appliances) Regulations 2015, for antiviral medicines to be supplied for free to patients who have tested positive for COVID-19 and who are eligible to receive antiviral treatments for COVID-19 via COVID medicines delivery units (CMDUs), will be extended until 31 March 2023. Where this cohort of patients are not already eligible for free prescriptions, the antiviral medicines will continue to be supplied free of charge. This waiver will also apply to therapeutic treatments that are being made available through the National Institute for Health and Care Research (NIHR)-funded HEAL-COVID clinical trial platform treating patients who have been hospitalised for COVID-19, for long-term effects and STIMULATE ICP treating community patients for long COVID.

The arrangements that were made for antiviral medicines to be supplied for free to patients who have tested positive for COVID-19 and who are eligible to receive antiviral treatments for COVID-19 via CMDUs will end on 31 March 2023. The prescription charges waiver will continue to apply to therapeutic treatments that are being made available through the NIHR-funded HEAL-COVID clinical trial platform treating patients who have been hospitalised for COVID-19, for long-term effects and STIMULATE ICP treating community patients for long COVID until 31 March 2024.

HEAL-COVID and STIMULATE-ICP clinical trial platforms

The HEAL-COVID clinical trial will be comparing different treatments to determine whether they can improve the longer-term outcomes for patients who have been hospitalised due to COVID-19. Patients enrolled in the trial are randomised to a trial drug arm and are usually discharged from hospital with a supply of the required medication. For those participants who require the drugs to be supplied for a longer period, GPs will be asked to issue repeat prescriptions.

STIMULATE-ICP, in contrast to HEAL-COVID will be testing the effectiveness of repurposed drugs to treat long COVID by measuring the effects of 3 months of treatment, including on peoples’ symptoms, mental health and other outcomes. This is a community trial and it is anticipated that participants will need to access the trial drugs on prescription from GPs in the same way as HEAL-COVID.

Under normal clinical trial arrangements, the clinical trial team would arrange for the trial drugs to be supplied directly to participants in a process that falls outside the provisions of the charges regulations. However, because some participants in these trials will be required to take the drugs for up to 12 months and the drugs are being used outside their normal licensed indications, the Medicines and Healthcare products Regulatory Agency (MHRA) have advised that GPs should prescribe the trial drugs to exercise holistic patient care, recording and monitoring. GPs will therefore be using a FP10 prescription form or the EPS service in the normal way.

Waiver of prescription charges

For treatment courses that are for a prolonged period, the GPs of the patients enrolled in either the HEAL-COVID or STIMULATE-ICP trials are being asked to prescribe the required drugs to ensure that the medicine is properly recorded in the patient record and that the patients are monitored appropriately. GPs will be asked to write the trial drugs on a separate prescription from any other medicines the patient is taking and to include an FS endorsement on the prescription whether electronically or by hand to enable pharmacists to dispense the medication free of charge.

FS prescription endorsement

Prescriptions issued to participants in the clinical trials will need to carry a free supply (FS) endorsement to ensure that it is apparent that the items can be dispensed without attracting a prescription charge.

If the prescription is being issued via the EPS, prescribers will need to select the FS endorsement on the EPS system for each item prescribed under the clinical trial. DHSC has made the decision to exceptionally use the FS endorsement for this purpose as it is already available to prescribers and meets the requirements for this particular service.

In EPS, the FS endorsement must not be manually added by a prescriber to the free text field EPS dosage area or other free text sections of the prescription. Prescribers should confirm FS by selecting the appropriate flag, so that the prescription carries the FS flag correctly.

Prescribers and dispensers are encouraged to follow the process below.

For prescribers

Prescribers should follow one of the processes below to communicate to the dispenser that the items prescribed should be issued without a prescription charge, and to ensure the prescription form is processed for pharmacy reimbursement correctly:

• select the FS, free supply option on the prescribing system against each item prescribed under the clinical trial. Prescribers must not free-type the FS endorsement into the dosage instructions for EPS prescriptions as this will not be recognised by the NHS Business Services Authority (NHSBSA) during processing (if FS is erroneously manually endorsed into the dosage area or a different free text field of an EPS prescription, then the prescriber may be asked to cancel the prescription and re-issue a new prescription in the correct format)

• endorse the front of the paper prescription form by writing FS and signing next to each item prescribed for participants in the HEAL-COVID or STIMULATE-ICP clinical trials

The FS endorsement will stay with the electronic prescription within the EPS prescribing and dispensing systems through to processing by the NHSBSA.

If the FS prescriber endorsement cannot be correctly applied to applicable items on prescriptions issued via EPS, prescribers should revert to issuing paper prescriptions with FS endorsed manually against each item prescribed under the clinical trial. If a FP10 paper prescription form is required, the FS endorsement will be printed or handwritten on the front of the prescription form next to the applicable items.

For dispensers

For prescriptions that only contain items endorsed with FS:

• a prescription charge should not be levied. The reverse of the FP10 form or EPS token does not need to be completed and a patient’s signature is not required. For electronic prescriptions with FS endorsed items only, the message code 0017, letter code Y for ‘was prescribed free of charge STI sexual health medication’ should be populated in the EPS electronic reimbursement endorsement message (EREM) before the prescription is submitted for payment to the NHSBSA. Note some pharmacy systems may automatically apply this code if only FS endorsed items are prescribed using EPS
• prescribers will be asked to write the COVID treatment drugs on a separate prescription from any other medicines the patient is taking
• paper prescriptions with items endorsed with FS should be placed in the red separator for exempt prescriptions when submitted to the NHSBSA for processing

For prescriptions containing both items endorsed with FS and chargeable items:

• if a patient is not exempt from prescription charges, the amount paid for the chargeable items should be entered on the form and the patient should sign the form or token. The EPS EREM should be charge paid (prescription message code 0001 charge paid at current rate or 0000 charge paid at old rate, where applicable)
• all paper prescriptions with an FS endorsement should be placed in the red separator for exempt prescriptions when submitted to the NHSBSA for processing
• if a patient is exempt from prescription charges, they should select the exemption box that entitles them to free NHS prescriptions, read the declaration and sign the form or token (a patient declaration and signature if not needed if the exemption is for those aged under 16 or aged 60 or over and the date of birth is printed on the form, for prescriptions where only free of charge (FOC) items are prescribed and where real time exemption checking (RTEC) confirms an exemption). A charge should not be levied. The EPS EREM should be one exemption category, the exemption category that entitles the patient to free NHS prescriptions such as 0005 for the maternity exemption, 0006 for the medical exemption
• all paper prescriptions with an FS endorsement should be put in the red separator when submitted to the NHSBSA for processing

To avoid a prescription charge being deducted from the contractor’s reimbursement, all paper prescriptions endorsed with FS must be placed in the red separator for exempt prescriptions when submitted to the NHSBSA for processing.

Dispensing doctors will be adopting the red separator for the purposes of processing any prescription that has an item endorsed FS.

If a patient claims that their prescription is for clinical trials, but the script has not been endorsed with FS by the prescriber, the prescription would need to be returned to the prescriber for endorsement. The pharmacist can either advise the patient to return to their prescriber to get the prescription endorsed, or the pharmacist can return the prescription on the patient’s behalf, if they get the patient’s consent to do this. For an EPS prescription, the original script would need to be cancelled or marked as not dispensed and a new prescription issued. For a paper FP10, the prescriber could hand endorse against each clinical trial item on the prescription.

Only those items prescribed for treatments related to the clinical trials should be endorsed with FS for free supply of medicines. Even if an item on the prescription could be used for the clinical trials it should not be provided free of charge without the prescriber endorsement. GPs will be asked to write the trial drugs on a separate prescription from any other medicines the patient is taking.

Patients expect their confidentiality to be respected, and prescribers, pharmacists and their staff should take all necessary steps to protect and respect their patients’ confidentiality when processing information about their personal details, medication and the clinical indication for which their treatment has been prescribed.

Patients, or their representative, are not required to sign the prescription form or make a declaration of entitlement in the following instance where items are prescribed on an FP10:

• free of charge contraceptives

• free of charge sexual health treatments

• free of charge treatments for participants in HEAL-COVID and STIMULATE- ICP clinical trials

• age exemptions, for those aged 60 and over, or those under 16 years of age, if a computer-generated date of birth is recorded in the patient details on the front of the form

Patients, or their representative, are required to complete the back of the prescription form in all other instances - if they must pay for items or are entitled to exemption from charges.