Friday, Jun 28, 2019
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indications of ibrutinib (Imbruvica) to include use in combination with obinutuzumab (Gazyva) for adult patients with previously untreated chronic lymphocytic leukemia (CLL).
More here inc clinical trial data that supported this decision: onclive.com/web-exclusives/...
Jackie
This Is FANTASTIC news for Europe and of course for those of us living here. It talks about all age groups which is great. Our doctors are insistent that under 60 years, FCR is the only way.
Thank you so much
This carries some significant weight but countries will still need to approve individually I think. So that will be NICE in England.
Jackie
Hopefully here in Italy as well, seeing that Dr Tedeschi, who did the study is Italian! 🤞
Just for clarity for all our UK members. I might sound pedantic but I think we should distinguish between approval and funding. Approval allows doctors to write a prescription and pharma company’s to promote that drug or combination to doctors. Funding allows that prescription to be paid for by the NHS.
Anyone with a suitable private insurance scheme (perhaps through work) may well find they are able to get funding for this combo quite soon since BUPA and AXA etc are obliqued to fund any approved drug or combination and will even sometimes tho not often fund a off license combination if it has professional support and clinical evidence.
It won’t be very long before this combo and then later on maybe Venetoclax plus Obinituzimab or even venetoclax plus ibrutinib are available to those who are lucky to have private insurance (quite a few may have this through work though levels of cover do vary a lot).
I suspect though it may be much easier to get NICE to agree to fund the hopefully forthcoming venetoclax plus Obinituzimab indication (recently approved in the USA) rather than this one sadly however. Though I do hope I’m wrong and both sail through!
Approving a fixed term of twelve months of a treatment is a very different proposition than approving ibrutinib indefinitely.
So on approval, the good news is that since this decision will be ratified by the EU before the October 31 deadline of Brexit this combination will be officially approved as efficacious and “licensed” in the UK at exactly the same time as it is across Europe. This would not necessarily be the case for future drugs or combinations is far from clear if we have a no deal Brexit since MHRA would be reviewing drugs for the uk market entirely separately from the EMA.
You are right of course that NICE will have to look at this combination for NHS funding if it chooses to do so (which it almost certainly will) tho a company may decide not to submit evidence (eg Ibrutinib monotherapy first line). NICE has no influence on private health care.
The reason a pharma company might not submit evidence to NICE would be if they couldn’t find a way to make the cost to the NHS represent a significant enough quality and length of life benefit over what is already available. A company wouldn’t want NICE to reject them so may choose to only submit evidence in a group of people they think it can be clearly evidenced for in cost terms.
