Terra Sigillata

The travesty has come true, according to Karl Schwartz and Betsy de Parry of Patients Against Lymphoma.

The Centers for Medicare and Medicaid Services (CMS) has gone ahead with their plans to slash by half reimbursements to hospitals for two radioimmunotherapy drugs. For many hospital, reimbursement rates will be lower than their acquisition costs. We discussed this possibility back in August but had thought that CMS administrators would acknowledge the outcry from the lymphoma survivor/advocacy community, not to mention very strong statements from ASCO (American Society of Clinical Oncology) and ASH (American Society of Hematology).

“It (the ruling) will eliminate one of the few treatment options and perhaps the only treatment option for some patients with non-Hodgkins lymphoma who have failed chemotherapy treatment.” – Andrew I. Schafer, President, ASH

The two immunotherapy drugs in question are Bexxar^® (¹³¹I-tositumomab) and Zevalin^® (⁹⁰Y- or ¹¹¹In-ibritumomab tiuxetan) – both drugs are radioactive antibodies that target the CD20 protein on the surface of normal and malignant B-lymphocytes, killing the cells by the radioactive emissions of their respective radionuclides. The clinical benefits and cost-effectiveness of these drugs has been well-established.

But just to be sure patients are confused where CMS really stands, this statement says it all:

CMS warns that “it may terminate the provider agreement of any hospital that furnishes this or any other service to its patients but fails to also furnish it to Medicare patients who need it.”

Thus, if radioimmunotherapy (RIT) treatments are unavailable to Medicare patients, they will also be unavailable to anyone else. As noted on the Lymphomation blog:

(1) Patients in need will be denied access to a life saving therapy. (2) Future patients will be denied access to RIT and similar targeted drugs. (3) as ASH states, “It (the ruling) could have a chilling effect on the development of future drugs and radiopharmaceuticals for treating other forms of cancer and other diseases.”

So, yes, this news is certainly devastating for lymphoma patients, even those who might wish to pay out-of-pocket for RIT since hospitals may now be less likely to stock Bexxar or Zevalin.

But as Karl and Betty point out above, this ruling sets a “chilling” precedent in that such reimbursement guidelines may have long-term impact the desire of drug companies to invest in lymphoma therapies or other radiopharmaceuticals.

I still have yet to see any convincing argument, clinical or financial, to account for CMS’s reimbursement decision. Perhaps CMS is simply counting on the fact that lymphoma patients might not have the same numbers or political clout as prostate and breast cancer advocacy groups:

Frankly, the CMS decision would never stand if the treatment cuts were for breast cancer patients, a highly organized political group (to their credit).

Be warned, this CMS policy-of-error could easily be applied to treatments for other conditions, and future therapies for lymphomas as well. Will CMS, for example, miscalculate the costs for patient-specific cancer vaccines should they win approval?

Every cancer patient should be paying attention to the follow-up discussion on this issue. It could be the treatment for your cancer that is targeted next by CMS.

There may still be time to appeal to your Senators. But if other lymphoma patients or anyone else have ideas on where to go from here, I’m all ears.

Comments

#1 MartinM
November 12, 2007

But if other lymphoma patients or anyone else have ideas on where to go from here, I’m all ears.

Europe?
#2 Ruth
November 12, 2007

Bexxar wasn’t my study, but I was in the department when the FDA approved it. It was such a nice piece of research-now for nothing?
#3 Karl Schwartz
November 12, 2007

Thanks so much, Abel, for your help in this matter!

Here is the link to comments submitted by GSK, ASCO and ASH:
http://www.cms.hhs.gov/eRulemaking/downloads/CMS1392PPC177-195.pdf

CMS grouped comments as they came in so several commenters are in this group.

GSK’s letter is on pages 1 through 15.

ASH’s comments are on pages 18 through 21
with the RIT comments in pages 20 and 21.

ASCO’s letter is on pages 32-36,
with RIT comments in page 35.
#4 N.B.
November 12, 2007

Ugh, another scenario where insurance companies (although in this case it’s a government organization) are setting precedents for drug treatment. And this is way worse than the “prior authorization” limbo that a lot of patients get stuck in when their doctor has prescribed something that isn’t on the formulary–we’re talking about life-saving cancer therapies here.

This sort of thing is happening more and more often lately. I’m amazed at the god-complexes that third parties have developed; I guess that’s inevitable when Anthem or Caremark or Medicare gets to decide what the best therapy for you is instead of your physician.
#5 Betsy
November 12, 2007

Thanks for calling attention to this travesty. It is preposterous that our government is depriving cancer patients of any treatment option. In the case of these two particular drugs, one or the other may be the ONLY option for some patients who have failed chemotherapy. They must be saved.

Your support of this issue is greatly appreciated.
#6 anjou
November 12, 2007

Thank you!!!
#7 Dr. Val
November 12, 2007

Is there any way that the drug companies could lower the price of the drugs? Do they really need to cost as much as they do? If they didn’t cost so much to buy, the hospitals wouldn’t operate at a loss, and could continue to offer the therapies. I know that targeted therapies are very expensive to make – but what kind of margin does the drug manufacturer have? Just wondering.
#8 Karl Schwartz
November 12, 2007

Dr. Val,

It is widely known among clinical investigators that the sponsors are operating at a loss with RIT, even with sufficient insurance reimbursements, because of low prescribing rates cited in NY Times and Journal of Clinical Oncology, so the CMS ruling has made a very bad situation far worse, threatening the future of RIT.

My understanding is that many factors affect the costs of cancer drugs. (Abel can speak with more authority on this)

Biologics tend to be much more expensive to prepare, handle, and store. Radio-labeled biologics even more so. Development costs must be factored in as well (800 million to 1 Billion) – not to mention clinical testing (a ten year process in the case of Bexxar). Finally, it should be noted that stem cell transplants are many times more expensive (and toxic) than RIT, and that RIT can be an appropriate alternative to SCT, particularly in the elderly. The point of our letter was to show that we also have to look at the benefit (to society) side of the equation: when the patient becomes productive again, instead of sick and in need of more frequent less effective treatments.

(Also worth noting that CMS did not cut reimbursements for a close-cousin: Rituxan, which is prescribed many many times more.

~ Karl
#9 N.B.
November 12, 2007

Karl said:

(Also worth noting that CMS did not cut reimbursements for a close-cousin: Rituxan, which is prescribed many many times more.)

I swear that third parties are throwing darts at a big list of drugs when they’re deciding what to cover and what tier it should be on the formulary. It’s messy enough at the outpatient pharmacy level. I can’t even begin to imagine how convoluted this gets when we start talking about the truly hyper-expensive biologics used to treat cancers.
#10 Abel Pharmboy
November 12, 2007

Dr Val raises a good point and one that is certain to be under discussion at GSK and Biogen Idec (mfrs of each of the drugs). If the Medicare reimbursement decision dramatically reduces the demand for the RIT drugs, pharmacoeconomics dictate that the companies will either reduce the price or discontinue the drugs. Most certainly, the decision is likely to cause companies to think twice about prospectively supporting development of drugs for lymphoma when faced with an R&D pipeline of agents for, sadly, what are more profitable diseases.
#11 Dr. Val
November 13, 2007

Thanks Karl and Abel for your clarifications. This is so infurating! It seems wrong that pharma is raking in cash (profits in the billions/year) and then discontinuing life-saving therapies that don’t contribute to their bottom line. Since we can’t force them to do the right thing (they’re a business with investors to please) I guess you’re right – appealing to Senators is all we’ve got?
#12 Karl Schwartz
November 13, 2007

It’s worth noting that for RIT there is are two approved agents (Bexxar and Zevalin) and therefore, atypically, price competition out of the gate for Bexxar.

When Bexxar won approval the price of Zevalin (as best we can tell) did not edge downward. So I think we can conclude from this that these agents are expensive because they are expensive to make and provide, and not as a result of greed.

We might ask: Can society afford to pay for expensive therapies for cancers? The answer depends on what the agent gives in return. You have to compare the one time cost of an effective agent against the costs of repeated less effective therapies.

From my perspective the price of a car is not too much to pay for getting your life back. And with your life back you can earn and pay taxes (give back). And with improved outcomes you have something to build on. RIT plus something else could be widely curative, for example.

Finally not all targeted agents will be as expensive to produce, but some may be. If our society decides against reimbursing for expensive therapies for cancer, expect a heated argument from the patients with the disease.
#13 Betsy de Parry
November 13, 2007

RIT has been maligned as “too expensive.” I realize that one patient does not make a case, but I don’t believe my case was terribly unsual. Many patients experience side effects which are expensive to treat and are not included in the big picture when reviewing costs.

Diagnosed in January 2002, my disease was refractory to two different types of chemotherapy and both had to be suspended before I completed a full regimen of either – but I had more side effects than I care to recall. RIT became available in the nick of time, September 2002.

My medical bills during 2002 totaled $199,339.22. The cost of RIT, including the drugs, all necessary tests, doctors’ visits and scans associated with the treatment, was $36,929.50. The balance of $162,409.72 covered everything else – the chemo treatments that didn’t stop the disease but sent me to the hospital with numerous side effects that cost lots of money treat, etc. etc. etc.

Now I’ve been disease free for 5 full years. Put another way, the RIT treatment cost $7,385.90 per year since my recovery. That’s a pretty good deal for having my life back!
#14 Dr. Val
November 13, 2007

Betsy, I am so pleased that you have your life back. I think it’s absolutely worth the cost and would be very glad to have my tax dollars put towards your therapy. Unfortunately, my tax dollars don’t seem to go where they belong.
#15 Abel Pharmboy
November 13, 2007

Betsy, I am SO happy for you personally and grateful to you for your tireless advocacy of fellow former patients.

I hate to make this into a numbers game, but that appears what CMS is doing. So since we’re putting numbers on these things, I thought I would draw attention to the writings of Princeton’s Prof Uwe Reinhardt, whom I had the pleasure of being tutored on health economics recently as a result of a chance meeting.

In this paper in Health Affairs, he notes that the UK system (NICE: National Institute for Clinical Effectiveness) has agreed on a price of €30,000 (or $43,883 USD) of publicly funded health costs per quality-adjusted life-year (QALY). The US currently spends more than that but has not yet as a society decided what the upper limit should be.

Given Betsy’s calculation of her total treatment (the nearly $200K) and 5-year disease free survival, her QALY cost is about $40,000, including RIT. So not only is her five years a “good deal” but it would also be recognized as an expenditure within limits of the UK system.

Again, I in no way intend to reduce to mere numbers the value of each additional year of our meaningful lives with family and other loved ones. Prof Reinhardt contends, however, that Americans need to start making these decisions as our healthcare costs increase annually. So if Medicare policy is going to be based on pharmacoeconomics, CMS has no cogent argument for reducing RIT reimbursements to below hospital cost.
#16 TL Hines
November 14, 2007

This whole issue is fresh in my mind, because I received Bexxar in late September/early October as my first treatment, and it was covered by insurance. The final cost for the treatment–the “allowable amount” in insurance-ese–was $28,400. I don’t yet know the results of the treatment, and won’t know until next year. But for people like me, I think RIT can reasonably be chosen as first therapy over standard chemo. (There is very strong clinical trial data for first-line Bexxar.) So then the question becomes: how does $28,400 for an easy, two-week treatment of RIT compare to the cost of standard chemo? Or even to the cost of single agent Rituximab? I don’t have exact figures for either of those treatments, but I think, apples to apples, RIT costs compare very favorably in both cases. And, as Betsy points out, when you factor in length of remission “bang for the buck,” RIT is probably hands-down the most economical choice.
#17 Karl Schwartz
November 14, 2007

Regarding bang for the buck, Joanne’s clinical records have more pages in it than the Bible. It includes accounts of 4 different chemotherapy regimens, over 9 years, including CHOP in 1997 …

… And many biological therapies in between, such as rituxan x 8 and other experimental antibodies. Each time the nodal lesions returned before her hair did.

The stress and anxiety of living that way is hard to describe. Joanne is now living a very different kind of life, apparently disease free almost 3 years following Bexxar. I think you will all agree that this kind of turnaround, almost 12 years after the diagnosis of a stage 4 cancer is remarkable.

That’s not to say that RIT is the magic bullet for everyone. Unfortunately, but it clearly the most active agent we have and it is very easy to tolerate.

… In our case we decided to debulk with chemotherapy first in order to optimize the impact of the RIT. But without RIT I think given the relentless clinical behavior of her “indolent” lymphoma, my spouse would have required a stem cell transplant, which has a a high mortality rate, an uneven success rate, and a potentially degrading and lasting effect on quality of life.
#18 Tasha
November 19, 2007

CMS says “it may terminate the provider agreement of any hospital that furnishes this or any other service to its patients but fails to also furnish it to Medicare patients who need it.”

It doesn’t sound like their discouraging hospitals from using the drug. It sounds like they are bullying hospitals into continuing to use the drug, even though they will be paid much less for i.