The final recommendation from NICE is that because of the high cost-effectiveness estimates and a lack of new data comparing lutetium‑177 vipivotide tetraxetan with relevant medicines, it cannot be recommended for use in the (NHS) Cancer Drugs Fund.
nice.org.uk/guidance/ta930/...
Not unexpected but still disappointing.
Thanks for posting. Very disappointing. Can we use the forum to continue to share good centres with 'affordable' LU tx that UK folk can access?
Thanks for posting. Indeed disappointing. And v expensive (£20k per dose + vat!). More affordable alternatives abroad. Others on this website have the experience and can perhaps comment.
Canada has just started negotations with Novartis and I wouldn't be surprised if in 6-12 months we end up in the same place as the UK, particularly now that the NHS has set the precedent.
The problem is that Pluvicto is expensive and is not a silver bullet, and as has been pointed out on this site some people have an excellent response where as others not so much.
The researchers have worked out a predictive biomarker called SUVmean that correlates to effectiveness of response. The higher the SUVmean the better the response.
Here is a short video lecture with Oliver Sator, the lead investigator of the Vision trial, talking about the significance of this predictive biomarker, particularly starting around the 6 minute mark.
urotoday.com/video-lectures...
The upshot is that if you're thinking about spending your own money you better make sure you're not just throwing it away.
Thanks, interesting video.
In Germany most university hospitals offer Lu177 therapy. Some offer Pluvicto, which is very expensive. Other clinics offer Lu177- PSMA I&T which is not approved yet and therefore costs less than Pluvicto. But it is still expensive if you have to pay it yourself. Both work equally well as far as currently known.
Do you happen to know which clincs offer Lu177 at a reasonsble price in Germany? I contacted Heidelberg for case evaluation - they are not accepting patients at the moment (info last week), Munich TUM did not reply (yet?).
Here is a list of clinics in Germany which offer PSMA PET/CT and in part Lu177 therapy. Follow the links to learn more. prostatakrebse.de/informati... The prices are all similar provided they do not offer Pluvicto.
As "best supportive care" improves, it will become increasingly harder to prove a benefit compared to a "best supportive care" control group. The VISION trial tested Pluvicto against a second therapy with one of abiraterone or enzalutamide (whichever wasn't used before), which we know won't work for very long. In the real world, the patient was more likely to get cabazitaxel or Ra223 at that stage, but those options weren't allowed in the control group. Cabazitaxel was the control in TheraP trial, but it used an inferior surrogate endpoint:
prostatecancer.news/2020/05...
The VISION trial also did not make the concordant/discordant distinction. Better patient selection improves results.
In the US, the sponsor of the Phase III clinical trial consults with the FDA to pre-determine what results the FDA will accept, so they design the trial accordingly. IDK if NICE offers that service to trial sponsors.
Good explanation. Pluvicto seems much less sensational now.
Thank you for posting. UK NHS here as well. Guys 'disappointing' is probably as classic a British understatement that I have read in a long while lol.
A friend of mine has recently had the following quote from The Royal Marsden:
£13,600 per LU177 cycle
£3,300 per PSMA scan
If he was to have x6 Cycles of LU177 plus the recommended x4 PSMA scans (one at the beginning and one scan after every 2 cycles) this gives a grand total of £95,400. At today's US dollar exchange rate this is USD $118,840. A very sobering self pay figure. He is fundraising and to be fair is on the way.
Hopefully this is positive for our US cousins to read, as Pluvicto is now approved in the US. Tall Allen raises a really good (and obvious) point. Why did NICE (the UK version of the FDA) not consult with the trial sponsor to predetermine which results they would accept, like the FDA do. Hopefully the Canadians are more switched on.
If anyone has any other recent prices that they can post then please do from Germany, Australia, Turkey, India etc.
Right just off to walk the dog and then to lie-down in a dark room.
£95,400 is a lot for just an extra 4 months or so of overall survival - and that's if you are one of the third for whom it works.
Exactly the calculation that NICE made I guess? Its a sad fact but they are looking at costs across the whole range of conditions and treatments and although it's harsh they are tasked to prioritise. I am not defending this btw. The NHS has many fine features but this stuff is hard when you are the one who loses out.
Just for clarity's sake
The UK version of the FDA is MHRA.
fda.gov/international-progr...
The US version of NICE is ICER.
ncbi.nlm.nih.gov/pmc/articl....
FDA and MHRA approve drugs for use in country based on RCT and whatever. Pluvicto is approved for use in both countries (and Canada as well).
NICE and ICER evalute approved drugs from a healthcare cost perspective and tries to come up with a price that the drug should be acquired based on cost benefit analysis. I'm not sure but NICE may also be responsible for negotiating the actual price on behalf of the NHS (if not, there's another org that does that). ICER reports are fed to health payers in the US who then individually negotiate prices with the drug merchant using the reports as they see fit.
FDA vs NICE is apples to oranges. There is very little daylight between the FDA and MHRA. The divergence here is coverage under a health plan (yes/no and under what conditions). The Brits are currently out of luck since the national plan has opted out of covering the drug, but the Americans are not entirely home free either as they have to navigate a tangle of plans, conditions, co-pays etc. Many Americans with good plans will get affordable access, some other americans may struggle.
I talk about this a bit more in another reply a little further down.
Thanks for explaining the medical bureaucracies in the various countries.
I know that NICE Scotland allows NHS there to cover abiraterone, whereas NICE England does not. Is there any hope that NICE Scotland will cover Pluvicto?
I couldn't say. Negotiations are closed door and closely held until a result is attained.
I think eventually Pluvicto will be covered in Canada, Scotland, England (CSE). Maybe just not this round. My MO (KN Chi) is one of the co-investigators on Vision and co-author on the NEJM paper. Our clinic has made an investment in delivering Radiotheranostics and investments are being made across the country as well. So I think CSE don't plan on being sidelined in this therapeutic space.
I saw in a previous post that you have an MBA, so do I. I think a little business case logic can explain what is happening today.
The merchant wants to maximize profit and already has the crown jewel, the US market, and rollout is just beginning so there is lots of runway. Also the total potential CSE market is just 1/3 the US market. Currently there is a game of chicken going on between the merchant and CSE. I think the the merchant doesn't feel the need to compromise at this time and is offering little to no discount. Eventually, the merchant will want to enter new markets: US saturation, emerging competitors and alternatives, or whatever. At that point a deal can be done. Also any one or all of CSE may fold due to political pressures (there is an election next year in Canada and Healthcare is always on the ballet).
It's not unheard of, at least in Canada, for the 1st round of negotiations to fail on expensive treatments, for everybody to walk away, and then come back and do a deal at a later time. The process accomodates this outcome, and allows any number of iterations to try and reach a deal.
Cheers
Did a little digging and actually looks like not approved at this time:
scottishmedicines.org.uk/me...
Honestly, it looks like it didn't even get to a vendor negotation, and was just dismissed on the basis of the cost benefit analysis. So no health plan coverage.
I don't know if its approved for use in Scotland on a "pay your own way" model.
We are in Canada, and as mentioned above, LU177 is not currently supported by any of our provincial medical programs. Cancer Care Ontario is currently reviewing the drug for coverage; however, I fear the conclusion will mirror the NHS decision.
We cannot wait that long. We have received a referral to a private clinic in Montreal. PSMA scan was covered under OHIP, following SOC (he is castrate resistant and has "failed" both docetaxel and Cabazitaxel - currently awaiting recovery from Covid to attempt carboplatin). Ongoing bloodwork and scans will continue under OHIP but we've been quoted $32,000 per infusion with six treatments expected. Some minor subsidy from Novartis might be available.
Assuming it goes ahead (pending final assessment) we will bite the bullet and spend a substantial portion of our savings on treatment. We are fortunate at least to have that option. Few do. We are not wealthy, but our retirement savings will not be needed to support him in longterm elder care, so we hope to buy some time with it, even if it's only months.
Initio is in BC, give them a call and get a quote. I heard $25,000 on the street but don't hold me to it. Obviously travel and accomodations are a factor.
initiomedical.ca/new-prosta...
We are in Ontario. Cost is lower in BC but would entail air travel and longer hotel costs/other expenses. Thanks for the info. I believe they're hoping to open up in Ontario but we can't wait.
Do you know what other provinces in Canada offer the Lu? Thank you so much.
As far as I know private clinics have only opened in BC and QC.
No province offers access to any lu-177 based treatment covered under a health plan for PCa.
Some provinces can and do participate in Pluvicto clinical trials, primarily BC and QC.
Thank you so much. I would think getting the Lu in Canada may be less costly than going to Germany, Australia, India. Much appreciate your sharing of information and knowledge.
My friend is just behind you - he's still on Cabazitaxil. I'm hopefully a little further off but these are really tough decisions, made even tougher by the regulators. Can I just add how humbling it is to read your reply, your love for your husband. My prayers for his response and many many more months.
I know this treatment dosn;t work for all men, but for those it did work for , would have given these men more time with their loved ones, when all other treatment had failed them.
We too are VERY disappointed by the decision , shame on NICE.
Even when this works, it only adds 4 months of life per Novartis (11 months v 15). It is more useful from a research perspective in order advance closer to a cure, but as a standard treatment it is absurdly expensive for a 4 month benefit. It is only approved in US due to our dysfunctional drug approval system.
Yes, there must be some type of cost-effectiveness standard applied to such treatments......
It is also approved in UK and Canada as well. Physicians are authorized to prescribe it as a treatment. In the UK the MHRA, and in Canada the HPFB, are the equivalent orgs to the US FDA - and all 3 have approved Pluvicto, meaning it can be marketed in country. There is a private clinic just a 10 minute drive from my house where I can get treatment if I'm willing to pay for it.
The issue is coverage under a health plan. The UK tried to negotiate to get the price down for coverage under the NHS but couldn't cut a deal. Canada's at bat now trying to negotiate a single national price on behalf of the individual provincial plans.
In the UK and Canada, it is either covered or its not. In the US there's a much broader spectrum of outcomes since each individual Health Insurer/payer (public and private) will make their own funding and coverage decisions.
Yes, when I said 'approved' I was referring to approved to be funded within the NHS. You are right that there private clinics in the UK where you can pay for the treatment.
Actually, I was trying to respond to jersey but looks like I screwed up. That's not unusual as mrs. skiingfiend can attest to. 😀
For the right candidates, it is a good treatment. It is just not something to offer everybody. My husband was offered it as part of a trial but without a comparison of FDG and PSMA scans. We instead flew to India to do the two scans which were much cheaper than in the UK, even factoring in the cost of the flights. Had there been more affordable scans in the UK, we could have avoided that long journey.
Re the comparison of PSMA and FDG scans: did you have guidance re what sort of outcome would bode well for proceeding with Pluvicto?
Yes. If the discordance was in less than 3 spots and bone marrow involvement was not as extensive as it happened to be, they would have offered him the treatment. Unfortunately, we left it too late. The FDG scan lit up way more than the PSMA one. non PSMA tumour in the liver too. On balance, they did not feel that they should offer it. But, they did try abiraterone (which NHS would not do after Enza) and they did a biopsy of the liver met to check genetics etc. I was impressed with the attempt to do everything possible for a patient.
I’m not generally a huge fan of NICE - ok someone has to look at cost/benefit but often NICE are not great at the input data balanced with the appropriate outcome benefit. It feels politics and money ALWAYS are the trump cards.
they are still trying to decide on the oral LHRH antagonist orgovyx (relugolix) and so way behind the curve of USA and Europe. And the evidence there seems straight forward and convincing so money is totally dominating there which feels political not a medical benefit/cost analysis
I received Ac-233, Lu-177 in Austria. It was the crazy expensive, $20,000 ea. ( needed substantial help on this end,) I had good PSMA expression and PSA dropped from 280 to .2 in 4 months(3 treatments). Being hormone sensitive with an immunotherapy behind me, Pluvicto wasn't available. Lots to be worked out in terms of knowledge, Dr. in Austria said some evidence that it might be more effective for those still hormone sensitive, so it may turn out to be most useful as an earlier treatment.
Correct me if I’m wrong here — but wrt this “4 months” number many are pointing to… wouldn’t this be an average, or perhaps a median? If so, I’d imagine that statistic is relevant for the FDA, investors, subsequent trial designs, and summary articles for the public. The number applies to a large group of patients, not to any one individual.
It would seem to me I can do better than that for my individual situation, by investigating what we know about how well might I respond based on SUVmean, etc biomarkers. From there the relevant statistic (for me) is how much extra time did patients with similar biomarkers get.
I don’t know if results have been stratified this way. However I have come across these:
urotoday.com/conference-hig...
urotoday.com/conference-hig...
Medians.
Investigators will continue to try to wring as much insight out of the Vision trial data as possible in order to inform treatment options. This process can go on for years.
The press releases you posted are summaries of new findings since the original trial results were published. They are intended to be consumed by Oncologists worldwide.
You should expect your MO to be able to talk about these findings.
Very sorry to hear this bad news.😞
Deal on PROTACs: ARV-766 development will be carried out by Novartis
Guess what? Your body has changed and will never be the same. First month on Xtandi - the good and the not so good
In the UK Olaparib only seems to be available for those testing positive for BRCA. Is this a cost issue that it is not widely available?
UPDATE: on Not the News I wanted to Hear
