New treatments available for MDS and CMML patients with COVID-19
30 Jan. 2022Have you got COVID-19? New Treatments are available for MDS and CMML patients
Covid-19 treatments for some severely immune-compromised patients are now available.
The Department of Health and Social Care (DHSC) has issued a ‘Rapid Policy Statement’ regarding ‘Neutralising monoclonal antibodies or antivirals for patients with COVID-19’, for both hospitalised and non-hospitalised settings.
The eligibility criteria for these drugs was revised on the 24th December.
The most important change is that MDS patients are eligible to receive these treatments. CMML patients on treatment are also eligible.
Two types of COVID-19 treatment are available:
- sotrovimab (Xevudy)
- molnupiravir (Lagevrio)
Sotrovimab is a biological medicine. It is also known as a neutralising monoclonal antibody (nMAb) while Molnupiravir is an antiviral medicine.
These treatments can help some people manage their COVID-19 symptoms and reduce the risk of becoming seriously ill.
> Read more on the NHS website:
https://www.nhs.uk/conditions/coronavirus-covid-19/treatments-for-coronavirus/
Molnupiravir capsule: an antiviral drug for the treatment of COVID-19
How to get a COVID-19 treatment: Take a PCR test if you get symptoms
If you are an MDS patient or a CMML patient on treatment, you are eligible for a COVID-19 treatment.
The NHS Test and Trace should have sent you a Priority PCR test kit to keep at home. A PCR test is a test that you can do at home and send to a lab to find out if you have COVID-19.
You have been given a test kit so you can get tested quickly if you have any of the main symptoms of COVID-19
A new MHRA Commissioning document come out which quite clearly lists the symptoms of Covid-19 as follows:
Fever, chills, sore throat, cough, shortness of breath or difficulty breathing, nausea, vomiting, diarrhoea, headache, red or watery eyes, body aches, loss of taste or smell, fatigue, loss of appetite, confusion, dizziness, pressure or tight chest, chest pain, stomach ache, rash, sneezing, sputum or phlegm, runny nose.
You should take the test as soon as possible, even if your symptoms are mild.
When registering your test, it's important to enter your NHS number and postcode correctly. This is so the NHS can contact you about treatment if you test positive for COVID-19.
Patients with MDS and CMML are having problems accessing Priority PCR kits and, potentially, anti-COVID-19 treatments
If you are having issues obtaining the right vaccine dose, or a PCR kit – please be reassured you are not on your own.
We had many reports from our members about:
- Problems in getting Priority PCR kits, which MDS and CMML (on treatment) patients are entitled to
- Patients simply not having received the letter informing them about the PCR kits and access to anti-COVID-19 treatments
We have flagged these issues to NHSE – please see this PDF document, summarising the problems and we keep campaigning on behalf of MDS and CMML patients.
If you have encountered an issue NOT covered in our summary – please email info@mdspatientsupport.org.uk with details.
In the meantime – the NHSE team is advising the following:
1- Ask your GP to send you this letter
Ask your GP to send you the following letter, which entitles you to the PCR kit and anti-COVID-19 treatments, should you test positive
This is the letter sent by NHSE to clinicians with a request to issue the letter above to vulnerable patients:
2 - Contact 119
Call 119 for advice, selecting the option for Test & Trace, if:
- you have not received a PCR test by 10 January 2022
- you develop symptoms before your PCR test arrives
- you lose your PCR test or it has any damage or missing parts
The NHSE lists the following services under 119:
- get a free PCR test or a lateral flow test
- get help reporting PCR or lateral flow test results
- get guidance on how to do tests
- ask questions related to travel and testing
- complain about a testing service or get advice about how to complain
- get advice on when to self-isolate, and financial support while you're self-isolating
You can also use the Test and Trace Digital Service: https://enquiries.test-and-trace.nhs.uk/s/
Many patients have reported that, on occasions, 119 teams were unable to assist.
On Fri 21/01/22, we have been assured that NHSE has formally requested 119 teams to assist with these issues – and staff are in the process of resolving these problems.
Again – please let us know if you continue to have problems when contacting 119 teams – and specify the nature of the problem. Email on info@mdspatientsupport.org.uk
Contacting NHSE Customer Contact Centre
This is a further avenue to help resolve issues – should 119 or other options have failed.
https://www.england.nhs.uk/
You can also expect the NHSE Resolution Team to contact you.
Further evidence of your eligibility to receive a Priority PCR Test and these new COVID-19 treatments
Interim Clinical Commissioning Policy: Neutralising monoclonal antibodies and intravenous antivirals in the treatment of COVID-19 in hospitalised patients. Patients with MDS are specifically mentioned on page 13 as eligible for these treatments.
More information on the new treatments, their eligibility and exclusion criteria
Below is a summary of the most main information regarding the new treatments. You can find a link to the full document above this article – as a downloadable PDF – in case you need to take the information to your GP.
What are the new treatment options for patients with COVID-19?
nMABs are synthetic monoclonal antibodies that bind to the spike protein of SARS-CoV-2, preventing subsequent entry of the virus into the host cell and its replication. This effectively ‘neutralises’ the virus particle. The following nMABs have conditional marketing authorisation (or Regulation 174 emergency use authorisation in Northern Ireland) for use in the treatment of COVID-19 in the UK:
- Sotrovimab (Xevudy®): an nMAB that both blocks viral entry into healthy cells and clears cells infected with SARS-CoV-2. It's given to your through a drip in your arm (infusion) over 30 minutes. Learn more: https://www.nhs.uk/medicines/sotrovimab/
- Molnupiravir: an oral antiviral drug which has been proven to halve the risk of hospital admissions and deaths from COVID-19, compared with placebo in patients with mild or moderate COVID-19. Moreover, molnupiravir has a favourable safety and tolerability profile. Learn more: https://www.nhs.uk/medicines/molnupiravir/
Non-hospitalised patients: Treatment Options
Commissioning position by DHSC
The proposal is: Sotrovimab is recommended to be available as a treatment option through routine commissioning for non-hospitalised adults and children (aged 12 years and above) with COVID-19 treated in accordance with the criteria set out in this document. Where treatment with sotrovimab is contraindicated or not possible, eligible patients may be offered an antiviral as an alternative.
Eligibility criteria
Patients must meet all of the eligibility criteria and none of the exclusion criteria.
Pre-hospitalised patients are eligible for treatment if:
- SARS-CoV-2 infection is confirmed by polymerase chain reaction (PCR) testing within the last 5 days
AND
- Onset of symptoms of COVID-19 within the last 5 days
AND
- A member of a ‘highest’ risk group (as defined in Appendix 1).
The eligible patients as outlined in this policy should initially be considered for treatment with an nMAB (sotrovimab).
Where an nMAB is contraindicated or the administration of an nMAB is not possible, patients may be treated with a five-day course of molnupiravir if the onset of symptoms is in the last 5 days.
Patients who have received an nMAB within a post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP) trial (such as the PROTECT-V trial) who meet the eligibility criteria of this policy can still receive treatment with an nMAB.
Exclusion criteria
Patients are not eligible for nMAB treatment in the community if they meet any of the following:
- The pattern of clinical presentation indicates that there is recovery rather than risk of deterioration from infection
- Require hospitalisation for COVID-19
- New supplemental oxygen requirement specifically for the management of COVID-19 symptoms
- Children weighing less than 40kg
- Children aged under 12 years
- Known hypersensitivity reaction to the active substances or to any of the excipients of sotrovimab as listed in the respective Summary of Product Characteristics
Hospitalised patients: Treatment options
Commissioning position by DHSC
Neutralising monoclonal antibodies or intravenous antivirals are recommended to be available as a treatment option for COVID-19 through routine commissioning for adults and children (aged 12 years and above) patients in hospital with COVID-19 infection in accordance with the criteria set out in this document.
Eligibility criteria
Patients must meet all of the eligibility criteria and none of the exclusion criteria under one of the following pathways:
Patients hospitalised for acute COVID-19 illness
Hospitalised patients are eligible to be considered for treatment with casirivimab and imdevimab if:
- SARS-CoV-2 infection is confirmed by polymerase chain reaction (PCR) test or where a multidisciplinary team (MDT) has a high level of confidence that the clinical and/or radiological features suggest that COVID-19 is the most likely diagnosis
AND
- Hospitalised specifically for the management of acute symptoms of COVID-19
AND
- Negative for baseline serum anti-spike (anti-S) antibodies against SARS-CoV-2 (see section on ‘Serum antibody status’ below)
AND
- Genotyping confirms the patient is infected with a non-Omicron variant.
For patients hospitalised with acute COVID-19 illness there are no available nMABs for the Omicron variant.
Please see access policies to dexamethasone (CAS alert), remdesivir and IL-6 inhibitors for these patients.
Clinicians are encouraged to enter all other patients admitted to hospital due to COVID-19 infection (including those infected with the Omicron variant, regardless of antibody status) into the RECOVERY trial, which is studying sotrovimab vs standard of care.
The following patients are NOT eligible for treatment in Group 1:
- Children weighing less than 40kg
- Children aged under 12 years
- Known hypersensitivity reaction to the active substances or to any of the excipients of casirivimab and imdevimab as listed in the Summary of Product Characteristics
Appendix 1: Patient cohorts considered at highest risk from COVID-19 and to be prioritised for treatment with nMABs
MDS UK Note:
Please consult the full document for more precise information and various hospital situations, including COVID-19 acquired in hospital. The following is a section of Appendix 1 detailing the list of eligible blood cancers, including MDS. Please note that CMML patients on treatment, although not explicitly mentioned, are also included.
Description: Patients with a haematological diseases and stem cell transplant recipients
Cohorts
The following patient cohorts were determined by an independent advisory group commissioned by the Department of Health and Social Care (DHSC).
- Allogeneic haematopoietic stem cell transplant (HSCT) recipients in the last 12 months or active graft vs host disease (GVHD) regardless of time from transplant (including HSCT for non-malignant diseases)
- Autologous HSCT recipients in the last 12 months (including HSCT for non-malignant diseases)
- Individuals with haematological malignancies who have received chimaeric antigen receptor (CAR)-T cell therapy in the last 24 months, or radiotherapy in the last 6 months
- Individuals with haematological malignancies receiving systemic anti-cancer treatment (SACT) within the last 12 months except patients with chronic phase chronic myeloid leukaemia (CML) in molecular response or first or second line tyrosine kinase inhibitors (TKI).
- All patients with myeloma (excluding MGUS) or chronic B-cell lymphoproliferative disorders (e.g. chronic lymphocytic leukaemia, follicular lymphoma) or myelodysplastic syndrome (MDS) who do not fit the criteria above.
- All patients with sickle cell disease.
- Individuals with non-malignant haematological disorder (e.g. aplastic anaemia or paroxysmal nocturnal haemoglobinuria) receiving B-cell depleting systemic treatment (e.g. anti-CD20, anti-thymocyte globulin [ATG] and alemtzumab) within the last 12 months.
More information on these treatments on NHS England pages. For a full list of conditions, please check these links:
https://www.england.nhs.uk/coronavirus/publication/interim-clinical-commissioning-policy-neutralising-monoclonal-antibodies-or-antivirals-for-non-hospitalised-patients-with-covid-19/
https://www.england.nhs.uk/coronavirus/publication/neutralising-monoclonal-antibodies-and-intravenous-antivirals-in-the-treatment-of-covid-19-in-hospitalised-patients/
Prioritising and protecting cancer services during the Omicron COVID-19 wave FAQs
COVID-19 Community Treatments
Q: What new treatments are being offered to people at the highest risk of becoming seriously ill if they become infected with Covid-19?
A: Since 16 December 2021, the NHS has been offering new treatments to people with coronavirus (COVID-19) who are at highest risk of going to hospital and becoming
seriously ill. Around 1.3 million of these highest risk patients are due to be contacted from 20 December with information on how they may be considered to receive these
treatments if they test positive for COVID-19 by PCR. A copy of the letter sent to 1.3 million patients is available here:
https://www.england.nhs.uk/coronavirus/publication/letter-to-patients-important-information-about-new-treatments-for-coronavirus/
Specialist doctors, including cancer doctors, have also been written to asking them to assist in identifying eligible patients not captured in the initial 1.3 million. A copy of this
letter is available here: https://www.england.nhs.uk/coronavirus/community-treatments/
Q: Who can access these treatments? How can I access them?
A: Further information on who can access these treatments and how they can be accessed
is available at www.nhs.uk/CoronavirusTreatments
Q: It doesn’t look like I am in the highest risk patient groups. Is there another way I can access coronavirus treatments?
A: If you are not in the highest risk group, you may be eligible to join the PANORAMIC study. The PANORAMIC study is open to individuals living anywhere in the UK who
meet the following criteria:
• Have received a PCR positive test for COVID-19.
• Feel unwell with symptoms of COVID-19 that started in the last five days.
• Are aged 50+, or 18-49 years old with an underlying medical condition that can
increase the risk of developing severe COVID-19.
Participants in the study will be randomly selected to either be in a group who receives a course of oral antiviral treatments, or a group that doesn’t. Two different groups are needed
so the study team can see any difference in the health of those who received the antiviral treatment compared to those who didn’t. All participants will be able to access any other
NHS care that they would normally expect to receive.
Further information on eligibility for the national study can be found on the PANORAMIC website: www.panoramictrial.org. If you receive a positive PCR test for COVID-19 and
believe you may be eligible for the study, we encourage you to call the trial team on freephone number 08081 560017 to discuss your eligibility to enrol in the study.
Q: What happens after an NHS clinician confirms I need treatment?
A: If a neutralising monoclonal antibody treatment is right for you, it will usually be given to you through a drip in your arm (infusion). You’ll usually get it at a local hospital or health
centre. Treatment takes approximately 30 minutes with time afterwards to check you feel OK.
Your local NHS provider will give you instructions on where the treatment will be given to you, and how to get there and back home safely. The NHS may be able to arrange for
your transport if you are unable to make your own COVID-safe travel arrangements.
If you are given an antiviral treatment, they normally come as capsules that you swallow and they can be taken at home. A hospital pharmacy will usually arrange for the
medicine to be delivered to you or it can be collected by someone else such as a friend, relative or NHS volunteer responder.
Q: Where is my local treatment centre? How do I travel there safely?
A: Your local NHS provider will give you instructions on where the treatment will be given to you. Some people are eligible for non-emergency patient transport services (PTS). To
find out if you're eligible for PTS and how to access it, you'll need to speak to the local NHS staff who have organised your appointment at the treatment centre.
Q: How do I know if I have a health condition that means I should get antiviral treatment or neutralising monoclonal antibodies?
A: A summary of the health conditions is provided at www.nhs.uk/CoronavirusTreatments, with more detail provided in Appendix 1 of the policy.
Most people with one of these health conditions will receive a letter or email from the NHS by the end of December 2021 and receive a PCR testing kit (to be used if COVID
symptoms are experienced) by 10 January 2022. This letter tells you about the treatments but does not guarantee treatment as doctors will need to assess you.
If you have a health condition which makes you eligible for one of these treatments and you test positive for COVID by PCR, you should be contacted by an NHS clinician to
discuss the treatments which may be suitable for you.
Q: What should I do if I think I might be eligible for treatment but have not been sent a PCR testing kit?
A: If you think you may have one of the health conditions which makes your eligible and you have not received a PCR testing kit, you can request one by calling 119, selecting the option for Test & Trace, and telling them that you think you might be eligible.
You can also request a PCR test kit to keep at home by going online at https://www.gov.uk/get-coronavirus-test. For the question, ‘Does the person who needs a test currently have any coronavirus symptoms?' you should answer: ‘No’. When it asks ‘Why are you asking for a test?’, select ‘I’ve been told to get a test by my local council, health protection team or healthcare professional’, and then select ‘A GP or other healthcare professional has asked me to get a test’.
Q: What should I do if I think I might be eligible for treatment but have not received a letter from the NHS about these treatments?
A: If you think you may have one of the health conditions which makes your eligible, but you haven’t received a letter, you can contact your GP practice or consultant to discuss
whether you are in the highest risk group. They will make an assessment of any conditions you may have, and will provide you with information on what to do, should you
test positive for coronavirus.
Q: What should I do if I think I’m eligible for treatments and have tested positive for COVID, but I have not been contacted by the NHS?
A: If you think you may have one of the health conditions which makes you eligible, but you haven’t received a letter, you can contact your consultant or GP practice if you test
positive to discuss whether you might be in the highest risk group. If they feel you may be eligible, they will be able to make a referral for you so that you can be considered for
treatment.
Q: Why have I received a letter or email about COVID treatment?
A: Health experts, including the UK chief medical officers, have looked at the health conditions which put people at the highest risk of coronavirus. The majority of patients in
this highest risk group will be informed by a letter or email which tells them that they may be eligible to receive these treatments, should they test positive for COVID.
If you have received a letter from NHS England about coronavirus treatments, it means your medical records show that you have, or previously had, one or more of those health
conditions, which means that these new treatments might be suitable for you if a PCR test confirms you have coronavirus.
You can find out how the NHS has used your information to identify and contact you about this treatment at www.digital.nhs.uk/coronavirus/treatments/transparency-notice.
Q: I need this information in another language or alternative format
A: Easy read and other language versions of the letter that went out to patients are available at https://www.england.nhs.uk/coronavirus/treatments.
Braille can also be posted to potentially eligible patients on request by emailing england.contactus@nhs.net.
Q: Where can I get further information?
A: Further information for patients is available here:
www.nhs.uk/CoronavirusTreatments
