Ronapreve - Immunocompromised patients

[RobertCLL]

Am I right that Ronapreve can be administered to immunocompromised patients, covid negative, who have not mounted an antibody response (non hospitalised patients)?

If so, any link to a uk government document?

This document implies that I am correct:

gov.uk/government/news/thou...

[lankisterguy Volunteer]

Hi RobertCLL,

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I believe you are correct. There was a posting by Jm954 just 3 weeks ago- see:

healthunlocked.com/cllsuppo...

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And these results: healthunlocked.com/cllsuppo...

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Other mentions: healthunlocked.com/cllsuppo...

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I believe the only question is how soon will UK hospitals have a supply of the drug in their hands.

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Len

[RobertCLL]

Thank you.

[Newdawn Administrator]

It mentions ‘in hospital’ several times suggesting to me that at the moment, in-patients will be the key recipients of Ronapreve. Usually when the NHS then use the word ‘initially’, in my experience it means they’ll be assessing how this works out before rolling out availability. From other info I’ve read, I know there is serious consideration of cost and I’d be very surprised if general availability becomes immediately available for every immunocompromised person who tests positive for Covid but doesn't require hospitalisation. I hope I’m very wrong however! I’d still be asking for it nonetheless.

Newdawn

[PaulaS Volunteer]

Hi Robert,

When I asked my haematologist about this, he said Ronapreve would only be given to people who have tested positive for Covid and are sick enough to be in hospital. That fits with what Newdawn has just said about the situation generally in the UK.

Having heard that Ronapreve is best used in early stages of Covid, I'm not very hopeful about this situation...

On top of the problem of cost and availability of the drug, there are staffing issues. It would be a LOT of extra work for haematology depts if they had to give Ronapreve (which is given intravenously in a clinic setting), to every immuno-compromised person who hasn't got an antibody result from the Covid vaccine.

It appears that even immuno-compromised people who test positive for Covid will not get Ronapreve in the UK, unless their symptoms are bad enough for them to be hospitalised.

Hopefully things will change over time..

Paula

[Indoorbowlers in reply to PaulaS]

At least your haematologist has heard of it! I asked my husband’s haematologist last week on his regular telephone review - and he knew all about the Provent trials for the prophylactic monoclonal antibodies but knew nothing about this treatment. Like you, my understanding is it needs to be given early; although expensive, it must be cheaper than weeks of hospital care! If I were a sceptic I would say they don’t want us to know about it!

[Walkingtall62 in reply to PaulaS]

Hi Paula. This is exactly what I was told this week. Firstly do your own thing at home (in my words!) and then should you have the need to go to hospital, the treatment will be given. UK NHS

[PaulaS Volunteer in reply to Walkingtall62]

Sorry you were told this so recently, Walkingtall. I was hoping things would be changing by now.

Monoclonal antibodies need to be given intravenously (or possibly sub-cutaneously), which takes more medical manpower/care to organise. I can understand over-worked doctors being reluctant to go down that road unless they really have to.

The new pills that have been in the news recently (eg Molnupiravir and Paxlovid) are much simpler for docs to prescribe. Not sure about their availability though. I'm hoping they'll soon be accessible to folk in the early stages of Covid (rather than us have to wait till we're so ill we're in hospital).

Paula

[bennevisplace]

Sorry Robert, I see nothing in that government press release to confirm your supposition.

In Product Characteristics this sentence "Ronapreve is indicated for the prophylaxis and treatment of acute Covid-19 infection" suggests that it may be given to prevent Covid-19.

The Patient Leaflet, though, makes it clear that they are talking about the prophylaxis of acute Covid-19:

- Ronapreve is used to treat patients with confirmed acute covid-19 infection.

- Ronapreve is used to prevent acute covid-19 infection.

- Clinical trial experience of use is limited to individuals aged 12 years and older and weighing at least 35.5 kg.

-Ronapreve is not a vaccine, it treats or prevents acute covid-19 infection.

This is confirmed by the MHRA document cas.mhra.gov.uk/ViewandAckn... first attachment:

Eligibility criteria

Patients must meet all of the eligibility criteria and none of the exclusion criteria.

Hospitalised patients are eligible to be considered for 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

AND:

• EITHER Aged 50 and over; OR Aged 12-49 AND determined to be

immunocompromised (see Appendix 1) by multi-disciplinary team (MDT) assessment

Exclusion criteria

The following patients are not eligible for treatment:

• 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 listed in the Summary of Product Characteristics (SmPC)

• Previously received treatment in hospital with casirivimab and imdevimab at the 2.4g

(combined) dose or higher

I think this tells us CLL folk that if you think you might have Covid, waste no time. Take a PCR test, get to hospital and ask for an antibody test ASAP. Because Ronapreve works best if given early.

[bkoffman CLL CURE Hero]

I hear it's in very short supply in the UK as it is in the US. All nice on paper, but not so great in the real world.

[bennevisplace in reply to bkoffman]

Yes we're short of mAbs for Covid19 in the UK, only Ronapreve is approved. Contrast with the US where AZD7442 will soon be added to the list.

[stevesmith1964]

HiI was given Ronapreve last Sunday and kept in hospital for 2 nights. I was covid positive on the previous Monday and my breathing started to go off slightly but SATs still 98%. My consultant organised an blue light ambulance to my local hospital... was impressed with his precautionary approach. The

Ronapreve worked and with 12 hrs my breathing was less strained. Now 1 week later I am all good.

[camper2 in reply to stevesmith1964]

So glad you have made a good recovery. Are you UK based? I do hope so.

[stevesmith1964]

Yep. Uk based and have an extremely pro active consultant.... he even changed me over to acalabrutinib due to very mild joint in one knee he believed caused by Ibrutinib. He calls me weekly to check I am OK.... great guy

[Poodle2 in reply to stevesmith1964]

Wow...calls you weekly?!🙂

[Newdawn Administrator in reply to stevesmith1964]

He sounds like a rare find Steve! I wrote to my haematologist 3 months ago and I’m still waiting for a response! 🙄

Newdawn

[stevesmith1964 in reply to Newdawn]

He is.... I was diagnosed in November stage 4 .... he and his team have been fantastic. Supportive , especially to my wife as we have a 4 and 2 year old.

[Poodle2 in reply to stevesmith1964]

That's great for you. I have a 7, 4 and 2-year old, diagnosed when 27 weeks pregnant and no one seems much concerned about me at all. I nearly died (honestly I thought I was not gonna make it) when I had covid and none of the doctors "gave a flying monkey" about me...Good for you though ❤

[Walkingtall62 in reply to stevesmith1964]

Maybe apologies for asking - do you want to share your consultants name, or area you are in. Take care

[stevesmith1964 in reply to Walkingtall62]

Sorry I don't share that level of information. I am based in the UK Midlands

[Walkingtall62 in reply to stevesmith1964]

Hi, that’s perfectly fine, I doubt I would. But thanks for letting me know. I am down south though. Take care. Best of luck

[Poodle2]

I spoke to my consultant about this last week.

"Ronapreve can be given to immunocompromised patients aged 15-49 once they are sick enough to be admitted to hospital. "

Quoting her word by word.

I questioned antibody testing, getting it before you actually get sick to be admitted - like they do it in the USA - I said 🤦🏻‍♀️🙂

She responded this was not America and NHS follows strict criteria which she had explained.

My only hope is that covid usually gets bad pretty quickly. If you are to be really sick with it it usually happens around day 5-6...that seems still in time for the infusion.

That's all I can share.

[mrsjsmith in reply to Poodle2]

Poodle,

I am confused by your consultants criteria for giving Ronapreve and the age cut off of 49 so I had a quick look at NICE guidance and NHS and am now even more confused. So if someone feels like wading through the advice and giving me an idiots guide précis I would be very grateful.

Colette

[Poodle2 in reply to mrsjsmith]

I was confused too! I asked her what would happen if I were 50 years old! She was just faffing about that it would depend on the personal case, circumstances...she looked it up on her computer 🤷🏻‍♀️I don't know🤷🏻‍♀️

Basically, what I took from it is that you won't be given any extra time and treatment until you are so sick that you end up in hospital (which is exactly what you want to avoid!!!!).

The government played this well. It is all over the media, this new great treatment is available - but really - in most cases only to those who are already very sick...

[mrsjsmith in reply to Poodle2]

Let’s hope neither of us needs to find out 🤞

[Poodle2 in reply to mrsjsmith]

Yes, 🤞🏻 and 🙏🏻.

That's all I can say ...

[PaulaS Volunteer in reply to Poodle2]

I got similar response from my consultant, Poodle, but no mention of age limits.

Paula

[Poodle2 in reply to PaulaS]

I really hope none of us needs it and if we do, it is the same as it was for stevesmith1964

[stevesmith1964 in reply to Poodle2]

I am 57 , I was only admitted to hospital to receive Ronapreve, my SATS were fine, it was give as a preemptive strick.

[PaulaS Volunteer in reply to stevesmith1964]

I suspect you had exceptionally good treatment, Steve, that very few of us in the UK will get. Hopefully things will change for all of us soon...

[stevesmith1964 in reply to PaulaS]

The NHS were great, hope they take the same approach the next time I get covid.... which I will, regardless of how careful I am.

[Poodle2 in reply to stevesmith1964]

I agree with Paula, exceptionally good treatment. It was made clear to me that I would need to be admitted to the hospital first with severe disease...

[PaulaS Volunteer in reply to Poodle2]

I was told the same, Poodle, at my last haematology appointment 3 months ago. Steve was unusual in getting the care that he did. I'm hoping things will soon change for the rest of us in the UK...

Paula