the government bean counters want a trial of a Finher like regimen vs the HERAregimen

[Lani]

ie, 9 wks vs 1 year of herceptin--now WHO is going to pay for that study
and what might the legal consequences be if those who got less herceptin did less well?

Health Policy. 2007 Dec 27 [Epub ahead of print]
Trastuzumab in early stage breast cancer: A cost-effectiveness analysis for Belgium.

Neyt M, Huybrechts M, Hulstaert F, Vrijens F, Ramaekers D.
Belgian Health Care Knowledge Centre (KCE), Wetstraat 62, 1040 Brussels, Belgium.
OBJECTIVES: Although trastuzumab is traditionally used in metastatic breast cancer treatment, studies reported on the efficacy and safety of trastuzumab in adjuvant setting for the treatment of early stage breast cancer in HER2+ tumors. We estimated the cost-effectiveness and budget impact of reimbursing trastuzumab in this indication from a payer's perspective. METHODS: We constructed a health economic model. Long-term consequences of preventing patients to progress to metastatic breast cancer and side effects such as congestive heart failure were taken into account. Uncertainty was handled applying probabilistic modeling and through probabilistic sensitivity analyses. RESULTS: In the HERA scenario, applying an arbitrary threshold of euro30000 per life-year gained, early stage breast cancer treatment with trastuzumab is cost-effective for 9 out of 15 analyzed subgroups (according to age and stage). In contrast, treatment according to the FinHer scenario is cost-effective in 14 subgroups. Furthermore, the FinHer regimen is most of the times cost saving with an average incremental cost of euro668, euro-1045, and euro-6869 for respectively stages I, II and III breast cancer patients whereas the HERA regimen is never cost saving due to the higher initial treatment costs. CONCLUSIONS: The model shows better cost-effectiveness for the 9-week initial treatment (FinHer) compared to no trastuzumab treatment than for the 1-year post-chemotherapy treatment (HERA). Both from a medical and an economic point of view, the 9-week initial treatment regimen with trastuzumab shows promising results and justifies the initiation of a large comparative trial with a 1-year regimen.
PMID: 18164510 [PubMed - as supplied by publisher]

[AlaskaAngel]

Hi Lani,

I am not a whiz at analysis, so if you do see more than I do, please correct me.

The question is, what would the legal consequences be if it turns out that those who got a longer treatment with Herceptin actually do the same (or even less well) in the long run than those who get the shorter FinHer?

I know it is a somewhat aggravating point to make, but resources are limited, IV treatments and monitoring are spendy, and there are an awful lot of people in this world with bc who aren't going to get trastuzumab because of that. Considering the extensive costs per person per a year's treatment (as well as the personal costs involved in doing a year of treatment), the cost of a trial could be relatively reasonable.

Respectfully,

AlaskaAngel

[Mitch]

Hi Lani, I've just joined this site and saw your comments re. the FinHer. I'm in NZ and had to pay for my herceptin - the Government here have only recently agreed to fund 3 treatments (9 weeks) for Her2 women. If you want more you have to pay for it - around $4,500 each one. Does worry us here and Her2 women are still attempting to get the Government to change their mind by taking them to court etc.- the only country in the OECD not to fund for 12 months. Scarey eh!!!

[Lani]

just being practical about the fact it would be almost impossible to do in the US

If it is done, it will probably be done in a country where people cannot get herceptin.

There they will feel lucky if they get the chance at all, and not cheated if they get it for the shorter time.

A similar case in point are the trials accelerated partial breast radiation therapy--there are no drug company funds to get, hospitals can't charge as much for 5 days of treatment as for 7 weeks so they don't want to encourage or fund the studies, and there are liability issues if it turns out it is not as effective or has other side effects (from giving the same amount of radiation over a shorter time period). This has greatly impacted these trials --numbers treated have been few in the US, it will take quite a while for enough data, experience to enable conclusions to be drawn regarding its efficacy/side effects.

[Cannon]

I'm more concerned about the idea that this a "cost-effectiveness" model using an arbitrary amount of 30,000 euro per year of life gained (currently about $44,000). I can tell you for sure that my life is worth more than that to me, to my children, to my siblings, friends, community.

Also, I do not buy the argument that resources are limited, from both a metaphysical and a practical point of view. At least in the industrialized nations, there is no reason every person should not be able to receive the appropriate medical care.

Alternatively, there may be people who are willing to participate in the test, who would consider the savings in time and convenience to be a good trade off for an unknown decrease in protection against recurrence. But even these people would be less likely to participate, given that the test would still require placebo to be given for the balance of the year, so there would be no savings in convenience for the test panel.

And I'm sure most of us would agree that if the SAME benefit could be gotten for less treatment (time, money. etc.), that would be a good thing. They are not saying that however, they are just saying it would be more cost-effective.

Rebecca

[dlaxague]

Rebecca said: "And I'm sure most of us would agree that if the SAME benefit could be gotten for less treatment (time, money. etc.), that would be a good thing. They are not saying that however, they are just saying it would be more cost-effective."

Actually, I think that's pretty much exactly what the FINher trial said. If memory serves (which it often does not, alas), results for the shortened duration actually seemed not just equal, but better. But the trial was small, and comparison of less vs. more was not head-to-head, so more research is needed. Certainly Genentech has no interest in a trial that might show that it's as good or better to use less of their very profitable drug. So as others have said, this trial would have to be driven by countries who are looking not just at effectiveness, but at responsible use of limited resources (stewardship) as well.

Debbie Laxague

[Lani]

the Fin Her study used an entirely different chemo cocktail given in an entirely different time course than either the HERA study or the No. American studies;

One can't compare apples with oranges. I, for one, have never seen the same cocktail offeredin the same way in any large study. and the FinHer study has yet to be carried out (or at least generate any published data) on a larger group of patients.

The FinHer was a tiny study compared with HERA and the No. American study, so those who interpret its numerical results as being the same or better do so at their own peril--to find differences you must compare large numbers and equal numbers. Thus the "experts" at conferences always preface their remarks by saying it was an "intriguing" but tiny study which needs to be repeated with more patients.

I won't play devil's advocate and don the "costume" of the hard nosed "there isn't enough data" mantra speakers I so frequently express irritation with--I don't go there because if there isn't enough data to prove something is better that doesn't mean it isn't better and shouldn't be considered.

The fact is we are only at the beginning of getting any of these answers and the answers aren't known.

What I will do is point out the fallacies of comparing likes with unlikes and large studies with small.

That is not to say your conclusion isn't true--it may very well be. Just whether your hypothesis has enough/the right data to prove it.

While at SABCS I heard Dr. Slamon read a suggestion submitted from the audience which formulated a way of getting the same information without added expense or time. He called it brilliant and asked the person to come to the front afterwards and collaborate on a paper.

So something is in the works!

[dlaxague]

Lani said: "That is not to say your conclusion isn't true--it may very well be. Just whether your hypothesis has enough/the right data to prove it."

Whoa, there. I reached no conclusion. I just restated that the Finher trial did show good results for shorter-term Herceptin administration. In fact I said, as you did, that the comparisons were not valid, as they were not head-to-head. I agree with you that this may or may not turn out to be true, but needs more study, which is unlikely to happen in this country. But as you said, there was no DISproof of the efficacy of shorter duration Herceptin either, and the questions raised are definitely intriguing.

What do you think about the presentation re: shorter trial duration, using data from mets trials to speed up implementation of therapies for primary disease? While the idea of getting newer better treatments into adjuvant use sooner certainly appeals (I myself missed out on adjuvant Herceptin even when most knew that it was important, because the adjuvant trials were in progress), the issue of yet-unknown longer term side effects is a worry.

Debbie
(sorry for the lack of links to what the heck I'm talking about. We have moved but have not finished the many repairs needed to settle in and my attention is more on such trivia as wallpaper removal than it is on interesting discussions like this one. I can find the SABCS presentation I mention above, if you don't have it.)

[Lani]

changes in adjuvant treatment...

You point out the salient features... we all want answers faster, but we don't want the speed desired to miss factors which might do more harm than good.