NICE Approves Acalabrutinib (Calquence) for specified groups of CLL patients in England

[Jm954]

Thanks to Peggy4 for posting this yesterday, here's a bit more detail.

NICE has determined that Acalabrutinib will be available to CLL patients in the following groups:

* previously treated CLL patients.

*untreated patients with 17p deletion or TP53 mutations.

*untreated patients who are unsuitable for chemotherapy treatments, such as FCR or BR. This would be because perhaps their kidney function is poor or they are too frail to undergo chemotherapy.

Unfortunately NICE was unable to make a determination on the suitability and cost effectiveness of Acalabrutinib in the untreated patients who are suitable for chemotherapy because of a lack of evidence submitted by Astra Zeneca (AZ). As a charity we were very disappointed with this and advocated that Acalabrutinib should be available for all untreated CLL patients and we will continue to advocate that that should be the case.

The main clinical trial evidence that AZ presented to NICE came from the ELEVATE clinical trial, which compared Acalabrutinib (+/- obinutuzumab) with a combination of chlorambucil and obintizumab. This trial showed a significant improvement in progression-free survival (i.e. an increase in the length of time people survive without their CLL getting worse) in patients who took acalabrutinib, compared with those who had the chlorambucil. Patients for whom chlorambucil would've been an option at that time would have been the less fit patients who could not have tolerated FCR or BR.

Those patients who are fit for FCR or BR chemotherapy may choose to take the chemotherapy (perhaps if they have favourable genetic markers) or there is the option of a one year course of Venetoclax + Obintuzumab which was recently approved by NICE to be available via the Cancer Drugs Fund.

Unfortunately, there is now a potentially serious health inequality gap between the patient groups who have access to several targeted treatments and the untreated and fitter (generally younger) patients who only have one option (V+O) via the CDF.

We are grateful that AZ were able to reach an agreement with NICE regarding a favourable pricing structure which helped the appraisal reach a positive conclusion.

The use of Acalabrutinib in Scotland is currently being assessed by the Scottish Medicines Consortium (SMC) . We will report on the outcome of this assessment when it has made a determination on its use.

[Lawand1]

On a CLL Support webinar yesterday a Dr Hillman from Leeds also announced this good news. He talked about how acalabrutinib meant great efficacy but less negative side affects in most patients. A question I couldn’t get answered on the busy chat room which I’d appreciate any knowledge on is; is this drug an option for those that relapse on Ibrutinib or are they too similar? Thanks,

[Jm954 Administrator in reply to Lawand1]

They would be too similar in their mode of action to be effective if a patient relapsed on Ibrutinib. It would be important to have BTK mutation testing to see if LOXO 305 or another would be effective.

[Psmithuk]

Some good news, Jackie, though unclear whether this is England, Wales and NI (I see Scotland is also assessing it), or just England. I’m also unsure if the CDF is UK wide or only England.I wish they would specify whether 'National' health service is UK wide or not.

It’s still good news, despite my grumble!

Cx

[Jm954 Administrator in reply to Psmithuk]

I'm pretty sure that Wales and NI follow England so it will be available there for the same indications. They don't have their own approval systems.Jackie

[Psmithuk in reply to Jm954]

Thanks, Jackie.

[Jm954 Administrator in reply to Psmithuk]

It's pretty national except for Scotland.

[Eucalyptus22]

Good news for some groups but disappointed for the untreated suitable for FCR. Does this mean my Acalabrutinib will be withdrawn when Covid is over? I am one of the lucky ones who got this drug during covid. After 4 months on Acalabrutinib my bloods are now all normal and I've had no side effects. Slight wobble with bilirubin levels but they settled to normal with a bit of help from milk thistle. Went from stage 3 severe and progressive in Sept with an ALC of 139k, feeling really bad and needing blood transfusions to feeling better than I have felt in years. Acalabrutinib has given me my life back.

[Jm954 Administrator in reply to Eucalyptus22]

The good news is that your treatment will continue uninterrupted. I'm glad to hear that it's been so good for youJackie

[mrsjsmith]

Thank you for all your hard work Jackie.One thing that confuses me is I read about several members in US switching from Ibrutinib to Acalabrutinib ! Is that because of side effects and before they have relapsed !

Colette

[Jm954 Administrator in reply to mrsjsmith]

If you have the right insurance it seems you can pretty much choose your treatment and yes, some people do change to Acalabrutinib because of side effects and before relapse. Probably a good decision if you can't tolerate Ibrutinib.

[mrsjsmith in reply to Jm954]

Thank you Jackie,

Perhaps I should stop fussing as my side effects are minimal.

Colette

[annmcgowan]

Thanks to you both for all the hard work and the success which benefits many of this community. Well done.Ann

[wroxham-gb]

Thanks Jackie for the information.Sue