Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the US FDA's withdrawal of authorisation for the use of Sotrovimab for treatment of covid-19 on 5 April 2022, what steps he is taking to ensure the (a) stringency and (b) consistency of his Department's reviews of (i) Evusheld and (ii) other covid-19 treatments.
Answered by Maggie Throup
The Antivirals and Therapeutics Taskforce engages with other nations to share learning on the use, deployment and evaluation of COVID-19 therapeutics and antivirals which may inform policy. The UK Health Security Agency is monitoring the effectiveness of all COVID-19 therapeutics, including sotrovimab. The RAPID C-19 collaborative, the National Health Service and other relevant experts provide advice to the United Kingdom Chief Medical Officers on whether treatments should be recommended for deployment, taking account of all available evidence.
The Department is currently reviewing prophylaxis and the efficacy of Evusheld. The Therapeutics Clinical Review Panel provides advice on the appropriate patient cohorts for potential new COVID-19 therapies, including preventative treatments. Final clinical policies and eligibility would be proposed by the NHS and agreed by the UK Chief Medical Officers.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what data they hold on the patients who are eligible to receive emergency COVID treatments; and if they do not hold any, how they plan to ensure this is collated so patients know in advance of their eligibility and can be told which COVID Medicines Delivery Unit they will be dealing with.
Answered by Lord Kamall
In England, approximately 1.8 million individuals are potentially eligible under the clinical access policy for new treatments to reduce the risk of deterioration or hospitalisation from COVID-19 infection. NHS Digital has identified patients classed as eligible through a coding match against patient records.
Eligible patients have been notified by email or by letter and advised that if they register a positive COVID-19 test, they will be contacted by the local COVID Medicine Delivery Unit (CMDU) to triage and assess for treatment suitability. If patients are not contacted within 24 hours or are not digitally identifiable by NHS Digital, they should seek advice from their general practitioner or NHS 111 for a referral to a CMDU.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what plans they have (1) to review the treatment options for immune-compromised individuals, and (2) to deploy Bebtelovimab as a treatment for such patients.
Answered by Lord Kamall
The Antivirals and Therapeutics Taskforce works with the RAPID C-19 Collaborative to review data from clinical trials for COVID-19 treatments. Bebtelovimab and other monoclonal antibodies are reviewed as part of this process. However, as Bebtelovimab has not received regulatory approval in the United Kingdom, it is not currently being procured for National Health Service patients. Licensing decisions are made by the independent regulator, the Medicines and Healthcare products Regulatory Agency.
Asked by: Bell Ribeiro-Addy (Labour - Streatham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department has put in place a monitoring system to test the effectiveness of covid-19 treatments currently available.
Answered by Maggie Throup
NHS England and NHS Improvement collect data on treatments for patients hospitalised due to COVID-19, hospital-onset COVID-19 and non-hospitalised patients treated through COVID Medicines Delivery Units. Data is collected on the numbers of treatments prescribed and administered and a summary at national and regional level is published weekly at the following link:
NHS England and NHS Improvement continue to work with the research community to monitor observational data and gain further insight into the impact of treatments on outcomes. In addition, the PANORAMIC study of novel COVID-19 antivirals is expected to publish outcomes of its research in due course. The study is collecting further data on how these treatments work in the United Kingdom where the majority of the population is vaccinated.
Asked by: Bell Ribeiro-Addy (Labour - Streatham)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many patients in the UK have been treated by covid-19 medicines delivery units.
Answered by Maggie Throup
As of 5 June 2022, approximately 47,000 non-hospitalised patients in England have been treated by COVID Medicines Delivery Units (CMDUs). CMDUs are operational in England, with equivalent services in Scotland, Wales and Northern Ireland. As of 5 June, approximately 62,000 non-hospitalised patients in the United Kingdom have received COVID-19 treatments through these services.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether they will review the (1) operation of, and (2) access to, the COVID Medicines Delivery Unit (CMDU) system, with particular reference to the role of the 119 telephone number in that process.
Answered by Lord Kamall
There are currently no plans to enable self-referral. When an individual within the eligible treatment cohort registers a positive test, their eligibility is identified through clinical coding which notifies the local COVID Medicine Delivery Unit (CMDU) to contact the patient to assess their suitability for treatment. If patients are not contacted within 24 hours or are not digitally identifiable, they can contact their general practitioner (GP) or NHS 111 for a referral to a CMDU. CMDUs have access to the patient’s medical history to ensure that the treatments available are safely and appropriately prescribed for the individual.
The Antivirals and Therapeutics Taskforce and NHS England and NHS Improvement review the operations of CMDUs to ensure they remain fit for purpose. The 119 service provides assistance to order tests and report results for patients who are not able to do so online. The 119 service does not provide clinical advice and cannot confirm eligibility for treatment or refer patients to CMDUs to be assessed for treatment.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what plans they have to enable a system whereby COVID Medicines Delivery Units (1) can be contacted by patients directly for emergency treatment, and (2) have direct access to patient medical records so it can give the appropriate clinical advice to each patient.
Answered by Lord Kamall
There are currently no plans to enable self-referral. When an individual within the eligible treatment cohort registers a positive test, their eligibility is identified through clinical coding which notifies the local COVID Medicine Delivery Unit (CMDU) to contact the patient to assess their suitability for treatment. If patients are not contacted within 24 hours or are not digitally identifiable, they can contact their general practitioner (GP) or NHS 111 for a referral to a CMDU. CMDUs have access to the patient’s medical history to ensure that the treatments available are safely and appropriately prescribed for the individual.
The Antivirals and Therapeutics Taskforce and NHS England and NHS Improvement review the operations of CMDUs to ensure they remain fit for purpose. The 119 service provides assistance to order tests and report results for patients who are not able to do so online. The 119 service does not provide clinical advice and cannot confirm eligibility for treatment or refer patients to CMDUs to be assessed for treatment.
Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what monitoring and data systems are in place to evaluate the effectiveness of emergency treatments administered to patients vulnerable to covid-19.
Answered by Maggie Throup
NHS England and NHS Improvement collect data on treatments for eligible patients hospitalised due to COVID-19, hospital-onset COVID-19 and non-hospitalised patients treated through COVID Medicines Delivery Units. Data is collected on the numbers of treatments prescribed and administered and published weekly at the following link:
Data is also collected on hospitalisation rates for treated and untreated patients. NHS England and NHS Improvement continue to work with the research community to monitor this observational data and understand the impact of treatments on patient outcomes.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of the efficacy of existing COVID-19 antiviral treatments for eligible patients in reducing rates of hospitalisation and death.
Answered by Lord Kamall
A range of treatment options are available to non-hospitalised patients at higher risk from COVID-19 to reduce severe disease, hospitalisation and death. These treatments are available through COVID Medicines Delivery Units and include the oral antivirals nirmatrelvir+ritonavir (Paxlovid), molnupiravir and the infusion antiviral remdesivir.
Evidence from clinical trials suggests these treatments can reduce the risk of hospitalisation. For molnupiravir, interim results found a 50% reduction in the relative risk of hospitalisation or death compared to placebo. However, updated results indicate molnupiravir reduces the relative risk of hospitalisation or death by 30% compared to placebo. Pfizer’s final analysis on the clinical trials of nirmatrelvir+ritonavir showed an 88% reduction in hospitalisation or death compared to a placebo within five days of symptom onset. No assessment of how these treatments have impacted rates of hospitalisation since December has been made.
Both molnupiravir and nirmatrelvir+ritonavir are being trialled as part of the PANORAMIC national study. Results for molnupiravir are expected in summer 2022. Recruitment for the nirmatrelvir + ritonavir opened on 11 April 2022. The study will collect further data on how these treatments work in a United Kingdom context where the majority of the population is vaccinated. It will also provide baseline information on how antivirals could be used for best clinical effect in combination with antibodies or other antiviral drugs as they become available. A 2021 trial showed that among non-hospitalised patients at high risk for COVID-19 progression, a three-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalisation or death than placebo.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what percentage of eligible patients have received doses of COVID-19 antiviral therapies within the 5-day guidelines set out by the Joint Committee on Vaccination and Immunisation (JCVI).
Answered by Lord Kamall
Since they were established in December 2021, COVID Medicines Delivery Units have provided antiviral or monoclonal antibody treatments to over 43,000 patients in England. Of these, over 20,100 patients have been treated with antivirals. The clinical access policies specify that the oral antivirals molnupiravir and nirmatrelvir+ritonavir must be administered within five days of the patient starting to experience symptoms. Over 95% of eligible non-hospitalised patients who have received an antiviral treatment to date were treated within five days from the onset of symptoms. However, the antiviral infusion remdesivir is suitable to be administered within seven days of the patient becoming symptomatic.