BBC1 South East Today Headline News - Evusheld Refusal by NICE

[Lady_Lymington]

So sad to see and hear of blood cancer patients entering their 4th year of shielding, with the announcement that NICE will not be funding Evusheld to some 500,000 clinically extremely vulnerable patients. What is even sadder is that BBC have not made it headline news nationally.

[Saju21]

Yes saw that too but the real issue is the late assessment by NICE and the fact it is now ineffective against current strains. A test of vfm is - would I pay privately for it now? Answer is no.

[Lady_Lymington in reply to Saju21]

It should’ve been available in March of last year along with the 30 + countries that did offer it. Shame on this Government and NICE!

[RogerPinner in reply to Lady_Lymington]

Did you see this dost from Kate (Eucalyptus22) yesterday

"NICE have made their decision to not make Evusheld available on NHS as there is insufficient evidence of its effectiveness against current variants. Well I guess that's what happens if you take a year to put the drug review through the NICE process.They do recognise though that the NICE process was the wrong route for its evaluation and that Rapid C would be more appropriate. They acknowledge that something has to be done to help the immunosuppressed.

A crumb of hope on a dark day.

Information is on Blood Cancer UK website and Evusheld for UK."

I'm not sure about the crumb of hope, given this government's history in this respect. Why didn't NICE tell the government they weren't the appropriate vehicle for evaluating this as soon as it was referred to them?

Roger

[Lady_Lymington in reply to RogerPinner]

Hi Roger. The whole thing stinks…….it isn’t rocket science when you consider how quickly the Covid 19 vaccination programme was rolled out. As you rightly said in another post Evusheld should have been rolled out as soon as it was approved by the MHRA. I understand Astra Zeneca have started a clinical trial into Evusheld’s successor , completion date is October 2024! So I guess that the sensible people who are classed as CEV and take their conditions seriously, will have to remain locked away.

[bennevisplace in reply to Lady_Lymington]

Indeed. A predictable end to a sorry tale of government duplicity.

The whiff of rat emerged as early as April 2021, when Forbes reported that hm gov had reneged on its pre-order of 1 million doses of AZD7442.

When, in response to months of pressure to fall into line with other G7 countries and fund Evusheld for the immunocompromised, the dhsc referred the decision to NICE, we knew that the rat's corpse had been flung into the long grass healthunlocked.com/cllsuppo...uk-department-of-health-evushelds-in-the-long-grass?responses=148393739

Let's hope for a better outcome with Evusheld MK2. The phase 3 clinical trial should begin second half of this year.

[Lady_Lymington in reply to bennevisplace]

Wholeheartedly agree. My concern is that although the Astra Zeneca trial started last month, the completion date is October 2024.....by the time the government have deliberated it will be 2025, and what happens if Covid has mutated many times over this period and the new vaccine rendered ineffective again?

[bennevisplace in reply to Lady_Lymington]

Good point. The weakness of monoclonal antibodies is the effort required to develop and tweak. None has stayed the course of Covid.

[Lady_Lymington in reply to bennevisplace]

We can only hope that another Pharma company can come up with something before 2025. Feel so let down. Not helped by the general publics attitude that Covid is gone or just a cold. Makes me mad!!

[bennevisplace in reply to Lady_Lymington]

It looks like AZ is allowing 6 months for phase 1 and 12 months for phase 3, hence October 24 completion. Potentially, phase 3 could start late summer. How long it will run depends on how fast Covid runs alongside. The study needs to see a minimum number of cases as a prerequisite to the statistical validity of results.

AZD7442 (Evusheld) took under 12 months from phase 3 initiation to FDA authorisation, between Dec 2020 and Dec 2021, a period with very high peak infection rates.

[Lady_Lymington in reply to bennevisplace]

Hi Bennevisplace. You have hit the nail on the head with Evusheld and the FDA authorisation. Had the UK government followed the FDA and the MRHA authorisation we could have had a taste of freedom for many months. As in my previous posts my apprehension is that by the time Evusheld Mark 2 is ready, Covid will have mutated multiple times rendering it ineffective and then the government or NICE will veto it again.

Best wishes

Jackie.

[mbear in reply to RogerPinner]

Spot on our Government has acted abysmally. I'm involved in a patient campaigne group who are very proactive. I took part in both ITV and BBC news broadcast way back in summer, highlighting the desperate need for Evusheld. There was a vigil outside parliament and endless letters sent to MP's. We had support from eminent doctors. It was initially approved here back in March but then announced months later the UK wouldn't be procuring it. Lots of pressure put on the health secretary and gov but they have been deaf to our plight. We have literally been abandoned and they got away with it. Sorry for having a rant.

[Lady_Lymington]

I am with you Roger. I fear that I will spend my remission from CLL mostly locked away along with thousands of others.

Jackie.

[Newdawn Administrator]

This post addresses the very understandable anger and frustration many of our membership feel about this situation. The way the whole issue has been dealt with has left many immunocompromised people feeling abandoned and short changed.

For this debate to continue, Admin ask that the discussion does not include personal comments and recriminations between members. Not everyone shares the same views particularly on fiscal matters but that’s no reason for members to be named and shamed. The response in question has therefore now been removed.

Posts of this nature will be removed and/or edited and puts the thread at risk of having replies turned off.

Regards,

Newdawn

[JIDD]

But see new version of Evusheld - dailymail.co.uk/health/arti...

[Lady_Lymington in reply to JIDD]

I have read the article....the comments left by readers I find upsetting

[Eucalyptus22 in reply to Lady_Lymington]

Done something I would never have dreamed of doing in my life. Created a Mail online account and commented to address some of the anti comments!!! Desperate times need Desperate measures 😃

[mrsjsmith in reply to Eucalyptus22]

I have just looked at some of the comments, and now I know why I am not on most of social media.

[Lady_Lymington in reply to mrsjsmith]

Me too, but isn't sad and disturbing that people can appear to be ignorant by not reading the article properly?

[bennevisplace in reply to JIDD]

A number of clinically vulnerable Britons have already been given Evusheld Two at Manchester University NHS Foundation Trust. Not true.

This is the phase 1 trial, which recruits a small number of healthy volunteers and is designed to prove safety and dosage. Clinically vulnerable subjects will be allowed to participate in the phase 3 trial, which can only start when phase 1 is done and dusted, a matter of months.

‘We hope we can make Evusheld Two available in the UK by the second half of the year,’ the source revealed. No way.

That would mean rushing through phase 1 in a couple of months, assessing the results in a month, enrolling the last recruit into phase 3 in a month, leaving a mere 6 months to fit all of the following into 2023: the clinical trial, trial results assessment, application for marketing authorisation, regulatory assessment, NICE assessment. Just not credible.

Journalistic licence, unnamed source. Mail readers who base their comments on this kind of stuff? Don't waste your time.

[Lady_Lymington in reply to bennevisplace]

I read about the AZ trial on the CLL support website. My understanding is that the trial for Evusheld 2 commenced last month (January) with completion date October 2024. Where did the Mail on Sunday get their information from I wonder?

[bennevisplace in reply to Lady_Lymington]

What I said earlier healthunlocked.com/cllsuppo... assumed that AZ would be doimg a phase 1 safety trial before a phase 3 trial. I checked with AZ press release astrazeneca-us.com/media/st... which desribes a combined phase 1/3 trial:

SUPERNOVA is a global Phase I/III, randomized, double-blind trial designed to establish the safety and efficacy of AZD5156 building on the established generalized safety and efficacy of EVUSHELD through the demonstration of comparable safety profiles and neutralizing antibody titre responses to COVID-19. The primary endpoints of the trial are safety and neutralizing activity of a single 600mg intramuscular (IM) dose of AZD5156 (300mg each of cilgavimab and AZD3152) compared to EVUSHELD for the prevention of COVID-19. The trial will be conducted at a variety of sites in the US, UK, EU and Asia. The trial intends to enrol participants 12 years of age or older with a minimum weight of 40kg who are immunocompromised and randomize in a 1:1 ratio to receive a single intramuscular (IM) dose of either 600mg of AZD5156 or EVUSHELD, administered in two separate, sequential IM injections. Participants will be followed for approximately one year, with SARS-CoV-2 neutralizing antibodies assessed at one, three and six months.

It would be strange if the phases were concurrent, in which case what is the point of phase 1? Neither AZ nor clinicaltrials.gov/ct2/show... clarify the relative timescales.

In any case, AZ's stated aim: AstraZeneca is accelerating the development of AZD5156 and is aiming to make it available in the second half of 2023, subject to trial readouts and regulatory reviews is a far cry from the drug actually being licensed in that time.