Government Policy

[MCA]

Other Questions & Answers Update 10/6/2022

Sir Christopher Chope Con Christchurch Asked 1/6/2022

To ask the Secretary of State for Health and Social Care, how many NHS patients in England have been treated with Evusheld to date; and when will that drug become generally available on prescription to those with immunosuppressed conditions to protect against covid-19.

This is a holding answer. It may be superseded/updated at a future date.

[Maggie Throup Conservative Erewash] Answered 8/6/**2022

The Department of Health and Social Care has indicated that it will not be possible to answer this question within the usual time period. An answer is being prepared and will be provided as soon as it is available.

Sir Alan Campbell Lab Tynemouth Asked 12/5/2022

To ask the Secretary of State for Health and Social Care, what plans his Department has to order Evusheld for use in the NHS.

**[Maggie Throup Conservative Erewash] Answered 8/6/2022

The Department continues to examine the potential introduction of prophylaxis, which includes deployment and administration processes. On 17 March 2022, Evusheld was granted conditional marketing approval by the Medicines and Healthcare products Regulatory Agency. However, the approval highlighted uncertainty over the dose required for protection against the Omicron variants.

We have asked clinicians to advise on the most appropriate option for the National Health Service in line with all available data, the public health situation and other treatments available.

Zara Sultana Lab Coventry South Asked 1/6/2022

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the impact of the decision to end free access to lateral flow tests on the rates of covid-19 (a) infection, (b) severe illness and (c) death for people who are (i) at highest risk of developing severe covid-19 and (ii) clinically vulnerable to covid-19; and if the Government will reinstate the provision of free lateral flow covid-19 tests.

[Maggie Throup Conservative Erewash]) Answered 8/6/2022

The most recent data indicates that rates of infection, hospitalisation and deaths in England have declined in the last month. We will continue to monitor prevalence and other factors to determine whether additional testing may be required.

For those who are immunosuppressed, testing to support effective COVID-19 treatments remains available. We will keep data on rates of infection, severe illness and death among all groups under review, including those whose immune systems mean they are at higher risk from COVID-19.

Tulip Siddiq Lab Hampstead & Kilburn Asked 25/5/2022

To ask the Secretary of State for Health and Social Care, whether the Government has (a) made an assessment of which groups of immunosuppressed patients should be eligible for treatment with the drug, Ronapreve, as a result of their lack of response to the covid-19 vaccine and (b) plans to undertake antibody testing on those individuals to assess their response to that drug.

[Maggie Throup Conservative Erewash] Answered 7/6/2022

While the Medicines and Healthcare products Regulatory Agency has approved Ronapreve for prophylaxis, the treatment has since been found to be ineffective against the Omicron variant and therefore has been withdrawn from general use. There are currently no plans to implement targeted antibody testing for immunocompromised patients. National Health Service clinicians can arrange antibody testing for patients based on their assessment of clinical need.

Alex Sobel Lab Leeds West Asked 17/5/2022

To ask the Secretary of State for Health and Social Care, what assessment he has been made of the adequacy of access for stage 4 cancer patients to (a) Evusheld and (b) other drugs that help increase resistance to covid-19.

**[Maggie Throup Conservative Erewash] Answered 7/6/2022

Patients with active metastatic cancer are eligible for novel antiviral and antibody treatment in the community through the COVID Medicine Delivery Units. The Medicines and Healthcare products Regulatory Agency highlighted the uncertainty of the appropriate dose of pre-exposure prophylactic medications, such as Evusheld, for protection against the Omicron variant. Understanding the efficacy of these treatments is necessary prior to any procurement or deployment. The UK Health Security Agency is currently undertaking further testing on Evushelds effectiveness against the Omicron variant. This will inform any decisions on the procurement of this treatment.

Alex Cunningham Lab Stockton North Asked 13/8/2022

To ask the Secretary of State for Health and Social Care, what plans his Department has to make Evusheld available to immunocompromised people.

**[Maggie Throup Conservative Erewash] Answered 7/6/2022

Evusheld has been granted conditional marketing approval by the Medicines and Healthcare products Regulatory Agency (MHRA) on 17 March 2022. However, the MHRA highlighted uncertainty over the appropriate dose needed for protection against the Omicron variant. Understanding the efficacy of Evusheld is necessary prior to any procurement or deployment.

The UK Health Security Agency is currently undertaking further testing on the treatment’s effectiveness against the Omicron variant. This will inform any decisions on the potential procurement of this treatment.

Daisy Cooper Lib Dem St Albans Asked 23/5/2022

To ask the Secretary of State for Health and Social Care, with reference to the Answer of 20 April 2022 to Question 151279, on Evusheld, how long the Antivirals and Therapeutics Taskforce or its predecessor took to assess and make a recommendation on the available antiviral treatments for covid-19.

**[Maggie Throup Conservative Erewash] Answered 30/5/ 2022

Since the formation of the Antivirals Taskforce in April 2021, it has worked with RAPID C-19 to review clinical trials data for the oral antivirals then in development and with the National Health Service on potential patient cohorts and deployment models. This process supported the procurement of two oral antivirals, Molnupiravir and Paxlovid, in October 2021. Molnupiravir subsequently received conditional marketing authorisation from the Medicines and Healthcare products Regulatory Agency on 4 November 2021 and Paxlovid on 31 December 2021.

Chris Green Con Bolton West Asked 18/5/2022

To ask the Secretary of State for Health and Social Care, how many immunocompromised patients of (a) working age and (b) all ages did not receive their ordered antiviral courses within five days of first experiencing symptoms from covid-19, To ask the Secretary of State for Health and Social Care, how many immunocompromised patients of (a) working age and (b) all ages did not receive their ordered antiviral courses within five days of first experiencing symptoms from covid-19, as recommended by

**[Maggie Throup Conservative Erewash]Answered 26/5/2022

To date, 21,405 individuals in England have been prescribed an antiviral-based COVID-19 treatment under the clinical access policy for non-hospitalised patients at highest risk from infection due to a compromised immune response. Of these, 1,079 people of all ages and 800 aged 17 to 69 years old received an antiviral treatment more than five days from the date of recorded symptom onset. Under the policy, patients can be treated with the antiviral Remdesivir within seven days of symptom onset.…

NB

COVID-19 Therapeutics: Antivirals and neutralising-monoclonal antibodies (AVs and nMABs): Non-hospitalised treatments - REGIONAL SUMMARY

Up to the week ending 22/5/2022 States that only 124 Non- hospitalised patients had been given Remdesiver

Chris Green Con Bolton West Asked 18/5/2022

To ask the Secretary of State for Health and Social Care, how many covid-19 antiviral courses have been administered to patients in a hospital setting since those courses became available.

[Maggie Throup Conservative Erewash] Answered 26/5/2022

Between 5 July 2020 and 15 May 2022, 635 courses of Paxlovid and 55,523 courses of remdesivir were administered to hospitalised patients and those with hospital-onset COVID-19 in En

[MCA]

Two of the questions I asked Lord Mendesohn have now been answered.

Asked By Lord Mendelsohn HOL 7/6/2022

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 14 June 2022

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 HOL 7/6/2022

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.

Same Answer as above

I just wondered what people thought of the validity of the response especially from people who have used the CMDU system.The first part of answer “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.”

This would appear to be those in cohorts who recieved a PCR test kit with a special indenifying barcode in December. No need then to log anything or contact 119.

The Second part 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.

Clearly if you havent sent off PCR test how are you digitally identified as no list of individuals is said to exist? and lateral flow tests do not identify individuals unless your name is already pre linked to it. (as was the PCR)

I does not specifically mention reporting lateral flow tests to 119 or logging them online which is what we are now asked to do.

I just wondered what people thought of the validity of the response especially from people who have used the CMDU system and reported only lateral flow tests. Also about the statement re acess to medical records for people not referred to by a clinician or gp.

[MCA]

One of the questions asked by Bob Blackman has now been answered in part.

Question:
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. (11649)

Tabled on: 01 June 2022

Answer:
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:

Statistics » COVID-19 Therapeutics (antivirals, neutralising monoclonal antibodies and interleukin 6 inhibitors)

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.

[MCA]

Lord Mendelsohn House of Lords Updates in Bold 17/6/2022

Asked 11/5/2022

To ask Her Majesty’s Government, further to the Written Answer by the Parliamentary Under-Secretary of State for the Department of Health and Social Care on 20 April (151279), what estimate they have made of when the UK Health Security Agency (UKHSA) will complete the testing of Evusheld against Omicron sub-variants; and why this has taken longer to complete than in (1) the US, and (2) the EU.

Answer 16 June 2022

AstraZeneca commissioned the UK Health Security Agency (UKHSA) to complete testing as part of studies into the effectiveness of Evusheld against Omicron variants. Initial data has been shared with AstraZeneca and testing continues for the Omicron variant BA.4. As timing of the results are dependent on a number of factors, we are currently unable to confirm the date of completion. AstraZeneca will review such data and determine whether further testing should be commissioned.

When undertaking testing, the UKHSA follows strict processes designed to ensure such treatments are effective. These processes may differ from regulations in other jurisdictions.

Asked 12/5/2022

To ask Her Majesty’s Government what assessment they have made of the number of individuals who are continuing to shield due to their immunocompromised condition.

Answer 8 June 2022

The Government ended the shielding programme on 15 September 2021 and wrote to everyone previously considered to be clinically extremely vulnerable and on the shielded patient list.

We will assess of the number of individuals continuing to shield when information on COVID-19 and treatments for people in England who are at the highest risk of infection is published by the Office for National Statistics on 17 June 2022. We expect that this information will provide data to estimate the proportion of people who report they are shielding and whose immune systems mean they continue to be at high risk from COVID-19.

Asked 17/5/2022

1 To ask Her Majesty’s Government what guidance they have given to Work Coaches for recommending employment requiring in-person attendance to immunocompromised individuals.

2 To ask Her Majesty’s Government what assessment they have made, if any, of the economic impact on immunocompromised individuals who are continuing to shield due to COVID-19.

3 To ask Her Majesty’s Government what assessment they have made, if any, of the psychological impact on immunocompromised individuals who are continuing to shield due to COVID-19.

4 To ask Her Majesty’s Government, further to the Written Answer by Parliamentary Under Secretary of State (Minister for Vaccines and Public Health) in the Department of Health and Social Care on 20 April (151279), what level of efficacy against Omicron they would deem as “sufficient” in order to secure a supply of Evusheld.

5 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 on 30 May 2022

1 The Department is committed to providing the best possible support for all claimants to meet their individual circumstances. Claimants with a health condition or disability, including those who are immunocompromised, continue to have tailored commitments agreed based on their personal circumstances, including considering the impact of their health and wider situation.

Any work-related requirements are set in discussion with the claimant, tailored to their individual capability and circumstances, making them realistic and achievable. The guidance available to DWP staff outlines the easements which may be applied including that work search reflects the type and location of jobs which are appropriate to the individual.

Although DWP does not routinely provide guidance specifically on supporting people who are immunocompromised, we do ensure that staff are aware of the sources of information available to them relating to medical conditions that are associated with this. Staff are signposted to tools, guidance support and websites to effectively use resources from both internal and external sites, such as information directly from the NHS.

This ensures that staff can access the most up to date advice and can use this to inform how they support individual customers.

We empower our Work Coaches to use all available resources to best support each claimant, however they are not trained to provide comprehensive healthcare advice therefore while we do discuss the implications certain jobs may have on their health, we would not advise against jobs the claimant wishes to apply for.

2&3 Answered 27 May 2022

No specific assessment has been made. People designated as clinically extremely vulnerable (CEV) were advised to shield between 22 March 2020 to 15 September 2021. However, shielding is not current policy. Individuals previously considered as CEV include but are not limited to those who are immunocompromised.

The Office of National Statistics (ONS) recently conducted a survey of people previously considered to be CEV. In April 2022, the survey found that 46% were very or somewhat worried about the current effect of the pandemic on their life, with 25% reporting that the pandemic posed a major or significant risk to their mental health. The survey found that 29% were in paid employment, 7% reported they had lost income due to shielding or isolating and 20% worked from at home. Insights for those whose immune systems mean they continue to be at high risk from COVID-19 and who are continuing to shield will be included in a future ONS survey release in June 2022.

4 Answered 27 May 2022

There is no pre-determined view of a ‘sufficient’ level of efficacy. The Department will seek expert clinical advice on the results of the UK Health Security Agency’s testing to inform future decision making. RAPID C-19 will consider all data relating to the use of Evusheld as a pre-exposure prophylaxis treatment before providing advice to the Chief Medical Office

5 Answered 27 May 2022

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 18/5/2022

• To ask Her Majesty’s Government who is responsible for leading the COVID-19 enhanced protection programme (EPP); and what is the process for (1) charities, and (2) patient organisations, to be designated as stakeholders for the programme.
• To ask Her Majesty’s Government what plans they have to (1) communicate, and (2) consult, with (a) charities, and (b) patient organisations, as part of the COVID-19 enhanced protection programme (EPP); and what format this will take.
• To ask Her Majesty’s Government, further to the Written Answer by Lord Kamall on 27 April (HL7561), what conclusions they have reached following meetings with groups representing the immunocompromised community on how they can be involved in (1) creating, and (2) disseminating, (a) communication, and (b) guidance, to people about how to safely manage their ongoing risk.
• To ask Her Majesty’s Government when they will appoint a ministerial lead specifically responsible for the immunocompromised in order to improve future (1) policy, (2) communication, and (3) guidance, for that group.
• 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.
• 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).

1, 2&3 Answered on 6 June 2022

SAME ANSWER We regularly engage with charities and patient organisation representing and supporting immunocompromised and immunosuppressed people. Further to discussions with these groups, we are establishing an engagement forum for charities and patient organisations to discuss issues relating to the enhanced protection programme and to seek the views of these stakeholders in advance of any updates to guidance. We will continue to update these stakeholders on the enhanced protection programme through webinars, meetings and correspondence.

The enhanced protection programme is a tripartite scheme administered by the Department, NHS England and NHS Improvement and the UK Health Security Agency (UKHSA). Dame Jenny Harries, the Chief Executive of the UKHSA, is the senior responsible owner for the programme. There is no formal process for designating patient organisations as stakeholders

4 Answered 27/5/2022

The Parliamentary Under Secretary of State for Vaccines and Public Health (Maggie Throup MP) has Ministerial responsibility for immunocompromised groups.

5 Answered 27 May 2022

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.

6 Answered on 27 May 2022

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.

Asked 24/5/2022

To ask Her Majesty’s Government what data outcomes are being collected by the COVID-19 Medicines Delivery Unit following the administration of (1) anti-virals, and (2) Sotrovimab, to COVID-positive patients; and when this data will be published?

Awaiting Answer due 9/6/2022

Asked 24/5/2022

To ask Her Majesty’s Government, further to the Written Answers by Lord Kamall on 18 May (HL158 and HL159) and 20 May (HL160), what steps they are taking to improve the data they need to ensure that they can (1) make informed decisions regarding policies to protect the immunocompromised, and (2) deliver treatments where needed.

Answered 7 June 2022

NHS Digital is working with data sources in primary and secondary care to improve the access to relevant data which identifies those who are immunocompromised and build a technical platform to identify such patients for different interventions, such as treatments and vaccines. The Department has also established the Therapeutics Clinical Review Panel which studies high risk patient cohorts which could be eligible for COVID-19 therapies. The panel will provide advice to the United Kingdom Chief Medical Officers on eligibility for treatments. In addition, the National Institute for Health and Care Research is commissioning a rapid study on those who remain vulnerable to poor outcomes from COVID-19 despite vaccination.

Asked 24/5/2022

To ask Her Majesty’s Government whether clinical guidelines have been produced about the prescription of longer courses of anti-virals for refractory infections in immunocompromised individuals; if not, what assessment they have made of the impact of a lack of guidelines on doctors’ ability to issue appropriate prescriptions; and what assessment they have made of the impact of the COVID-19 Medicines Delivery Unit’s decision-making processes on treatment access for patients with immunodeficiency.

Answered 7 June 2022

Clinical access policies for the routinely available COVID-19 treatments in the National Health Service apply to treatment decisions being made by clinicians working with COVID Medicine Delivery Units in England. These decisions typically reflect the use within a medicine’s marketing authorisation, including the dose and duration of treatment to be provided, although there are mechanisms which allow the consideration of off-label use. The RAPID C-19 collaboration, led by the National Institute for Health and Care Excellence, monitors any emerging evidence from clinical trials which informs these clinical access decisions.

The clinical access policy states that the antivirals Molnupiravir and nirmatrelvir+ritonaivir should be taken for five days. Any treatment duration beyond the marketing authorisation is not included in this policy unless it is supported by evidence on the benefit and safety in clinical trials. No specific assessment of the impact of prescription guidelines and the COVID-19 Medicine Delivery Units’ decision-making process has been made.

[MCA]

Here are some further answers to questions agreed with Lord Mendelshon.

Asked By Lord Mendelsohn HOL 6/6/2022

To ask Her Majesty’s Government what budget they have set for the purchase of new Antiviral or Monoclonal Antibody drug treatments for COVID-19, including (1) those under current review like Evusheld, and (2) those under future review by the COVID-19 Antivirals and Therapeutics Taskforce; and if these should prove efficacious in the protection of immunosuppressed patients, whether this funding will be sufficient to meet current supply needs.

Answered By Lord Kamall 20 June 2022

There is currently no funding allocated for these treatments. Funding for additional procurement of novel treatments is considered on a case-by-case basis, as guided by clinical need and subject to business cases and due process.

Asked By Lord Mendelsohn HOL 6/6/2022

To ask Her Majesty’s Government whether they are considering the purchase of the Monoclonal Antibody drug Beblitovimab; and other than Evusheld, whether they have any similar drugs under consideration.

Answered By Lord Kamall 20 June 2022

The Antivirals and Therapeutics Taskforce is working with the RAPID C-19 Collaborative to review clinical trials data for COVID-19 treatments. Bebtelovimab and other monoclonal antibodies are being reviewed as part of this process. However, Bebtelovimab has not received regulatory approval in the United Kingdom and therefore is not currently being considered for procurement.

Asked By Lord Mendelsohn HOL 6/6/2022

To ask Her Majesty’s Government whether any delay in purchasing drugs such as Evusheld or Beblitovimab is because of budget limitations; and whether they are will now allocate funding to purchase these new treatments.

Answered By Lord Kamall 20 June 2022

COVID-19 treatments must be effective against the currently circulating variants in the United Kingdom and be granted marketing authorisation prior to procurement. Evusheld was granted conditional marketing authorisation in March 2022. However, the Medicines and Healthcare products Regulatory Agency raised uncertainty on the dosage required for protection against the Omicron variant. The UK Health Security Agency is currently undertaking further testing on Evusheld’s effectiveness against Omicron. While the data for Beblitovimab shows efficacy against the Omicron variants currently circulating, the treatment has not received marketing authorisation in the UK.

There is currently no funding allocated for these treatments. However, funding for additional procurement of novel treatments is considered on a case-by-case basis, as guided by clinical need and subject to business cases and due process.

[CaroleCW]

@MCA @Adrian thought you might like to see U.K. HSA’s response to my Freedom of Information request on Evusheld testing

[MCA]

@CaroleCW
Well done a response rather than the excuses that I recieved when I requested info on Evusheld.

it appears to tie in with response by Lord Kammal
Answer 16 June 2022

AstraZeneca commissioned the UK Health Security Agency (UKHSA) to complete testing as part of studies into the effectiveness of Evusheld against Omicron variants. Initial data has been shared with AstraZeneca and testing continues for the Omicron variant BA.4. As timing of the results are dependent on a number of factors, we are currently unable to confirm the date of completion. AstraZeneca will review such data and determine whether further testing should be commissioned.

So they have finished testing on BA1 and BA2 and state they have provided information to AZ.

But still testing in relation to BA4

I think they have used the AZ request for ongoing collaboration with UKHSA as an excuse to delay procurement the decision to purchase can not be dependant upon AZ as that would make no commercial sense. MHRA also undertook to continue to liease with AZ after granting approval they havent mentioned the outcome of those investigations perhaps in relation to dosage.

I have many further questions to discuss with Lord Mendelohns assistant next week including these specifically concerning the dates timing and instigation of all this testing;

**DRAFT FORMAT

|1|To ask Her Majesty’s Government in relation the answer provided by Lord Kamall to (HL157) on the 16/6/2022 to confirm that if the requirement to carry out further testing of Evusheld on 14th March 2022 and consequent delay in procurement arose from a request by Astra Zeneca to share data. Can they clarify further that Astra Zeneca only requested was to share data as part of an ongoing collaboration process and the decision to postpone procurement was their own and made independently of any recommendation to do so from Astra Zeneca .
|
|2|To ask Her Majesty’s Government in relation the answer provided by Lord Kamall to (HL157) on the 16/6/2022 whether the decision to collaborate on further testing is part of the usual process involving new drugs after authorisation and in itself is not a usually reason to delay the procurement process unless e.g. the drug has been withdrawn from use elsewhere.|

|3|To ask Her Majesty’s Government in relation the answer provided by Lord Kamall to (HL157) on the 16/6/2022 to confirm that the further testing of Evusheld now being carried out by UKHSA is additional to other studies into the effectiveness of Evusheld against Omicron that have been instigated by e.g. Astra Zeneca post 17/3/2022.|

|4|To ask Her Majesty’s Government in relation the answer provided by Lord Kamall to (HL157) on the 16/6/2022 022 if it has considered the findings of a study “Further antibody escape by Omicron BA.4 and BA.5 from vaccine and BA.1 serum” published by bioRxiv 23/5/2022 in its evaluation of Evusheld and the process of sharing data with Astra Zeneca.|

|5|To ask Her Majesty’s Government in relation the answer provided by Lord Kamall to (HL157) on the 16/6/2022 what date was the commissioning request by Astra Zeneca received by UKHSA. 2 is this commissioning separate to the continuing work of evaluation by the MHRA
|6|To ask Her Majesty’s Government in relation the answer provided by Lord Kamall to (HL157) on the 16/6/2022 is the completion of testing referred to as commissioned by Astra Zeneca a consequence of and subsequent to it starting the process referred to in the answer given by Lord Kammal to (HL218) on the 25/5/2022.|

|7|To ask Her Majesty’s Government in relation the answer provided by Lord Kamall to (HL157) on the 16/6/2022 if it is it willing to publish jointly with Astra Zeneca the initial findings of UKHSA in relation to the effectiveness or otherwise of Evusheld against BA2 ,which remains the most common form of the virus in the UK.

8 To ask Her Majesty’s Government in relation the answer provided by Lord Kamall to (HL157) on the 16/6/2022, where they confirm that UKHSA have completed testing against BA1 & BA2 and shared results with Astra Zeneca. Accordingly are they now able to make a decision regarding procurement. If not, unless adverse results are indicated, can they clarify why this ongoing and indefinite collaboration process should prevent them making a procurement decision now, especially when other data is available regarding less prevalent variants of concern.

Ill keep you posted

[MCA]

Further answers to questions agreed with Lord M

Asked By Lord Mendelsohn HOL 6/6/2022

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 21 June 2022

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 HOL 7/6/2022

To ask Hr Majesty’s Government what assessment they have made of whether their strategy to protect immuno-compromised individuals is over reliant on (1) second line treatments using Sotrovimab, and (2) fourth line treatments using Molnupiravir.

Answered By Lord Kamall 21 June 2022

Recent evidence suggests that antivirals and neutralising monoclonal antibodies significantly improve clinical outcomes in non-hospitalised patients with COVID-19 who are at high risk of progression to severe disease. Available treatment options for eligible patients are the first line of nirmatrelvir/ritonavir or sotrovimab as clinically indicated; the second line of remdesivir; and the third line, molnupiravir.

These treatments have various safety profiles for patients with a range of characteristics, which ensures safe access. All patients are clinically assessed to ensure they receive the most appropriate treatment according to their health conditions. Therefore, there is no over reliance on one specific treatment path. The Antivirals and Therapeutics Taskforce is working with the RAPID C-19 Collaborative to review further COVID-19 treatments.

Asked By Lord Mendelsohn HOL 7/6/2022

To ask Her Majesty’s Government what data they have, if any, on the success of treatments provided by COVID Medicines Delivery Units in the UK; and whether they are looking at the data on patients unable to access a CMDU and their outcomes.

Awaiting answer

Asked By Lord Mendelsohn HOL 7/6/2022

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 21 June 2022

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.

[CaroleCW]

Thanks. Yes agree that the Govt are using “AstraZeneca requested…” as a euphemism re keeping talks open. AZ would in no way hold up anything given they are already supplying Evusheld in over 30 or so countries now. I’ll take a detailed read of your excellent draft over the next few days.

[MCA]

No masks, no free tests, low sick pay – the UK government is back in Covid...

[MCA]

What more to be said the government are denying to even acknowledge we exist they pretend testing of Evusheld was initially instigated by them out of concern.
No it was AZ who asked them to continue testing Evusheld prior to MHRA approval and uniquely they aren’t testing any other of the treatments we have to rely upon. I have checked this via freedom of info requests etc

The fabrication of excuses is tantamount to discrimination in terms of policy. BA 4 and BA 5 are already manifest but the policy remains to live with covid.

Please if anyone out there has a connection to a law firm let’s move together on this and whilst there are groups who are protesting it usually only heard by those effected rather those who can change things. Lord Mendelsohn has been very outspoken on our behalf but even he is limited in what can be said.

I like all who read this don’t want to spend the rest of my life not hugging my loved ones, wearing masks when not at a party, and scared to be in a crowd. I make no apologies this ain’t political it’s genuine anger it’s bad enough having cancer but to nick a line why so many have owed so little to the few who govern I am amazed but not surprised BCUk will probably remove this but let me know if you agree.

[Ted369]

Bless you MCA, I 100% agree with you, just a shame it feels like no one else is listening.

[MCA]

Press Release

EMBARGOED 5th July 2022 1100hrs

The APPG-Vulnerable Groups to Pandemics today launches a consultation for an independent clinical consensus statement for protective measures for VGP to be led by Dr Lennard Lee, medical oncologist at the University of Oxford.

The national consultation link for clinicians is:- https://forms.office.com/r/piiDftfL0m

• The APPG-VGP was founded by MPs and Peers who are concerned about the needs of vulnerable groups to pandemics and who would like to encourage actions to promote a greater priority for prevention, treatment and support for those groups.

• There has an increasing amount of work showing that whilst vaccines are effective for the population, there is good evidence that vaccine effectiveness wanes in cancer patients (REF: https://www.ox.ac.uk/news/2022-05-24-population-scale-study-highlights-ongoing-risk-covid-19-some-cancer-patients-despite) and many immunocompromised patients do not generate any antibody responses following vaccination.

• New treatments have been developed that can protect immunocompromised groups. This will give them more protection from coronavirus and could provide the critical-boost to vaccination.

• These drugs are antibody treatments and have been developed from British company, AstraZeneca. Evusheld is one of these drugs and has been given regulatory approval for use in the United Kingdom (Evusheld approved to prevent COVID-19 in people whose immune response is poor - GOV.UK). It is given as a one-off treatment and administered in a similar fashion to a vaccine.

• There is no clinical consensus about the appropriateness of this drug in the UK. There are at least 11 different medical specialities treating immunocompromised groups across our four nations.

The APPG-VGP has therefore launched a comprehensive consultation about the potential for an independent clinical consensus statement for protective measures for Vulnerable groups during the pandemic.

Gaining the full support of clinicians and doctors across the United Kingdom is important to ensure that Vulnerable Groups during the pandemic continue to get the very best clinical care in the NHS during the coronavirus pandemic.

We ask that interested parties disseminate the link to their contact lists of clinicians treating vulnerable or immunocompromised groups. The national consultation link for clinicians is:- https://forms.office.com/r/piiDftfL0m"

Dr Lennard YW Lee, DPhil (Oxon), MRCP-UK, BmBCh (Oxon), MA (Cantab)

“Immunocompromised patients may not develop a good immune response following vaccination. They may need a novel treatment that gives an antibody immunity boost and more protection from coronavirus. The consultation is needed to understand the views of the medical community and develop agreement on this novel form of protective antibody treatment.

Bob Blackman MP, Co-chair APPG -VGP

“Coronavirus rates have started to rise again and so it is very important that we consider what else can be done to protect vulnerable groups. New treatments could give a critical antibody immunity boost. This will help immunocompromised people feel much more confident about their levels of protection and reduce pressures in hospitals"

ENDS

[MCA]

Well meaning but unfortunatly Niro Fiddles whilst Rome burns

[CaroleCW]

Maybe the APPG announcement might trigger Lord Kamall into real action ….

[CaroleCW]

@MCA Did you spot this potential discrepancy in written Parliamentary responses :
16 June Lord Kamall to Lord Mendelsohn re UKHSA “testing continues for the Omicron variant BA.4” on Evusheld efficacy.
Maggie Throup used identical response to Catherine West MP’s query on 20 June.
However 21 June Maggie Throup’s response to Tulip Siddique MP states “AstraZeneca has not commissioned the UKHSA to initiate testing for the Omicron variant BA.4”.

So perhaps HSA was testing BA.4 of their own volition and Maggie Throup was trying to backtrack/cover up this fact with her later response?

[MCA]

@CaroleCW

Good Spot!

As you say on the 16th June it appeared they were waiting to see if AZ wanted to commission further testing, on the 20th they stated in both Hof C and Hof L that further testing was being undertaken by UKHSA but not who instigated it and on the 21st confirmed this was not instigated by AZ. So clearly AZ did not provide them with a further excuse to delay by commissioning more testing as they probably hoped, so they did their own, maybe to give further excuse for delay. No mention of BA5 is that the next on excuse list?

That said, as the testing against BA1 started on 14/3/2022 was before MHRA approval was granted on 17th March this testing appeared to be part of the ongoing process of collaboration not as a result of the MHRA expressing concerns “There is not yet enough data to know how effective Evusheld is against Omicron or the duration of its effect against this variant, and the MHRA will work with the company to establish this

Notwithstanding no further testing applied to Sotrovimab on 2/12/2022 when MHRA stated “it is too early to know whether the omicron variant has any impact on sotrovimab’s effectiveness but the MHRA will work with the company to establish this”

The change of tack would appear simply to be part of the ongoing process of manufacturing reasons for delay.

[MCA]

The APPG -VGP are releasing details of the letter posted above today at 11am

https://appg-vulnerablegroups.org/

[Ben]

Thank you all contributors to this thread, especially MCA, for keeping us patients informed and putting pressure on government to buy and roll out Evusheld. Like many of us it would make a huge difference to me (with Chronic lymphocytic leukaemia (CLL) on Acalabrutinib).

I think it has been pointed out that the government’s stated reason for delay – that insufficient evidence is available on Evusheld’s effectiveness against Omicron variants – is in stark contrast to policies of other goverments. And it is in contrast to the continued use of vaccinations and treatments also with little such evidence.

I spotted some recent (June 29) documents from the US FDA which address the “new variants” issue directly, and conclude that although there are no trials, and lab studies do indicate reduced effectiveness against Omicron, pharmacokinetic modelling indicates that by doubling the dose, equivalent protection can be obtained. The documents can be found (search “Evusheld”) on:

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

The most relevant passage is

“Update [6/29/2022] There are different variants (and subvariants) of SARS-CoV-2, and FDA continues to evaluate how well Evusheld (tixagevimab co-packaged with cilgavimab) neutralizes them. Currently, the Omicron BA.2, BA.2.12.1, BA.4, and BA.5 subvariants are circulating in the United States. Nonclinical data and pharmacokinetic modeling suggest that activity against these subvariants may be retained for six months at drug concentrations achieved following an Evusheld dose of 300 mg of tixagevimab and 300 mg cilgavimab.

Therefore, on June 29, 2022, FDA revised the Evusheld Fact Sheet for Healthcare Providers to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection. The previous Fact Sheet for Healthcare Providers did not provide a specific recommendation on the dosing interval.

We continue to monitor the neutralizing activity of Evusheld against emerging SARS-CoV-2 variants and will provide additional updates as needed.

For further details please refer to the Frequently Asked Questions for Evusheld.”

[MCA]

@Ben I did read the FDA update. The Gov have shifted from testing and had consultation with clinicians the matter appears to be with Ministers see my Post under Any News about Authoristion of Preventative Treatments. I am hoping to get an update from Lord Mendelshons assistant ASAP and will then post any news i get.