Ibrutinib +venetoclax

[Kiwidi]

Can anyone please clarify which countries have approved and now fund the use of this combination as a fixed term first-line treatment for CLL? 🙏Is it FDA approved?

[gardening-girl]

EU approval August 4, 2022

jnj.com/european-commission...

FDA has not approved the combination.

I don't know about other countries.

[Kiwidi in reply to gardening-girl]

Thank you

[CLLerinOz Administrator Volunteer]

I'm not sure if there's a complete listing of where ibrutinib plus venetoclax has been approved for untreated CLL but, in addition to the EU approval shared by  gardening-girl , NICE approved it for all untreated CLL patients in the UK earlier this year in April 2023: healthunlocked.com/cllsuppo...

It was also approved in Canada in March 2023 for those with previously untreated CLL: healthunlocked.com/cllsuppo... and janssen.com/health-canada-a... .

The Pharmaceutical Benefits Advisory Committee in Australia will consider a recommendation to approve it for untreated CLL at its March 2024 meeting. The following post has information for Australians who want to contribute to the public consultation process: healthunlocked.com/cllsuppo...

CLLerinOz

[Kiwidi in reply to CLLerinOz]

Thank you so much.

[mantana in reply to CLLerinOz]

Also, because it was approved in EU - does not mean the combination is funded throughout the EU. The OP asked "which countries ... fund".

EU is a group of 27 countries, each having their own medical budgets and procedures introducing new treatments.

[CLLerinOz Administrator Volunteer in reply to mantana]

Thanks for this update. I think the same holds in Canada where provinces may make individual decisions related to funding medications.

CLLerinOz

[RSilver in reply to CLLerinOz]

That is true

[LeoPa in reply to mantana]

I'd be gone three times over before my insurance company agrees to pay for the combination 😔

[Skyshark in reply to LeoPa]

Hope you have access to V+O. It has very much the same PFS durability as V+I. Just a bit more intense for first 9 weeks.

[LeoPa in reply to Skyshark]

Thank you, I hope I'll never have to find out😊. But if I do, by that time it'll be hopefully available🙏

[hervec in reply to mantana]

In france the combinaison is funded according to "Favorable opinion for reimbursement, ibrutinb in combination with venetoclax, in the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) who do not have a 17p deletion and/or a TP53 mutation, and are ineligible for treatment with full-dose fludarabine ." since april 2023.

[Kiwidi in reply to hervec]

Thank you. We have a submission in on the approval of the funding of this for younger patients based on the fact that it is short term and won’t cost the government in later support and treatment. I would like it to be for all but I suppose it is a start. I am interested where the rest of the world was at with this. It totally makes sense to have a 15 month treatment especially in NZ where cost seems to be so much of an issue!

[Skyshark in reply to Kiwidi]

The issue with V+I is it costs about 55% more than V+O but doesn't have that much better PFS duration. Overall PFS at 4 years is 79% for V+I (CAPTIVATE FD) and 75% for V+O (CLL14 older unfit ptns), most of that gain is from the 3 addition cycles on treatment and for mCLL+TP53wt. With a proper MAIC, due to age and unfitness of CLL14 It's probably even. There are some additional savings for 20% of patients that won't need 10 days in hospital with 19 extra blood tests for high risk TLS and costs of 9 days IVs, it's about 50% more overall. It's a big cost saving compared to BTKi monotherapy.

[Snakeoil in reply to Skyshark]

My reading is overall PFS of 95.4% at just shy of four years. However, this is for MRD guided which is not clinical practice…yet.

After a median follow-up of 43.7 months (interquartile range, 35.1 to 51.5), disease progression or death had occurred in 12 patients (4.6%) in the ibrutinib–venetoclax group.

nejm.org/doi/full/10.1056/N...

[Newdawn Administrator in reply to Snakeoil]

I wasn’t in a position to do a cost and efficacy analysis when I needed treatment and the Flair trial was the only option to avoid the absolute certainty of FCR (although chemo was a possible arm of Flair).

I’m immensely grateful for the 2.8 yrs it’s given me since in full remission and not subject to ongoing medication. As I’ve said previously, there’s the reality of starting at the top of the treatment tree as a first therapy and what happens next but we take what we have at the time. In the case of I&V, results suggest it was a major win situation over alternatives at the time. The other benefit was obviously the funding source of my medication because I appreciate anything that assists the NHS.

Newdawn