Assessing the “value” of new drugs in the treatment of [prostate] cancer

Yesterday the American Society of Clinical Oncology (ASCO) issued the initial draft of “a conceptual framework for assessing the value of new cancer therapies based on treatment benefits, toxicities, and costs.” ASCO is interested in getting feedback from its members and from the patient community too.

We all know that the cost of new drugs has been escalating in recent years. This is particularly problematic when the new drugs in question have limited benefits for the majority of patients (say a month or less of survival on average) and/or they have to be given in combination with other new drugs that are already expensive. To give a specific example that may be about to face the prostate cancer patient community, think about the costs associated with combination therapy with abiraterone acetate + enzalutamide (Zytiga + Xtandi) or abiraterone acetate + radium-223 (Zytiga + Xofigo). Either of these combinations has a potential annual cost well over $100,000 and patient co-pays associated with such treatment could well be in excess of $20,000 a year.

The initial version of the ASCO Value Framework has been published in full in the Journal of Clinical Oncology, and is an open access article that anyone can read. Comment can be provided to ASCO through an on-line survey tool.

We should say immediately that the ASCO Value Framework article is complex, hard to understand in places, and does not address actual out-of-pocket costs that most patients might expect to pay … only the average wholesale price of the specific drug (i.e., what Medicare is required to reimburse a manufacturer by law). So that’s the downside from a patient perspective.

On the upside, ASCO has attempted to place “value” in context by defining terms and by seeking to compare relevant new drugs to each other in terms of their effectiveness and their side effects. Specifically, in the case of prostate cancer, they looked specifically at the “value” of three relatively new drugs used in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who had progressed after at least one cycle of docetaxel-based chemotherapy: abiraterone acetate (Zytiga), enzalutamide (Xtandi), and cabazitaxel (Jevtana). The relevant comparative data for these three drugs is summarized in Figure 5 of the paper by Schnipper et al.

A key factor in understanding the ASCO Value Framework is something called the “net health benefit” (NHB) of any specific treatment and the expectations related to the use of that treatment. (Can it cure the cancer or does it “only” delay death or have some other value such as palliation of pain?) Assessing the NHB of any particular treatment can be complex and is certainly subject to (a) the quality of the available data and (b) the assumptions made in determining the NHB of a particular drug or other treatment, so this is a far from perfect system. However, it may be better than nothing. In Figure 5 of the original paper, the reader can see that there are differences between the NHB values assigned to the three drugs evaluated. Whether these NHB values accurately reflect patient perceptions, however, would be extremely hard to determine — as ASCO clearly acknowledges in the text of the article.

The “New” Prostate Cancer InfoLink has a very simple perspective on the whole issue of the rising costs of health care (new drugs included).

As a society, here in America and in other countries around the world, we are not going to be able, successfully, to sustain the current business model, in which smaller and smaller health benefits are associated with higher and higher costs to society and to individual patients, particularly in the treatment of late stage diseases of any type. Trying to cure leukemia in a child who has 60+ years of productive life ahead of it is one thing. … Adding 3 months of non-productive life to an 80-year-old person with a possible life expectancy of another 3 years in quite a different thing. … Are they really “worth” the same? By comparison, even though they are expensive, some of the new drugs now available to treat hepatitis C can actually cure many people of the disease with a single course to treatment. Clearly that is a whole different scenario … and maybe we do need to work out how to “pay the piper” for a benefit that high.

Sooner or later we are going to have to face up to the realities of what we have never, in fact, been able to afford for everyone. The truly rich (a very small percentage of society) may choose to pay hundreds of thousands of dollars a year to seek and obtain care using extraordinarily expensive treatment options. The truly rich have always had that sort of choice available to them with respect to all sorts of options not available to most of us. Most of us, frankly, can’t afford such options. And that “most of us” includes an awful lot of people who have well over an “average” annual income and who have really very good health insurance coverage. Just as an example, a 20 percent co-pay on $150,000 a year in drug costs is well over what most of us can afford to take out of the bank to pay the out-of-pocket costs for health care in any one year unless it is going to give us a real long-term remission or a cure. There is no available treatment for late stage prostate cancer today that offers such a benefit, but some of the newer drugs for treatment of mCRPC are approaching $100,000 a year as an average wholesale cost. And the next generation of advances will very likely exceed that number. In the case of other forms of cancer, we are already well over the $100,000 barrier.

5 Responses

  1. In the context of the ASCO Value Framework, it is worth noting a media release from M. D. Anderson Cancer Center, issued yesterday, and associated with the publication of a new article in the journal Cancer.

    According to the media release and this new article, “the majority of existing treatments for hematologic, or blood, cancers are currently priced too high to be considered cost-effective in the United States.”

    The whole topic of the “value” of treatments (new and older) in the management of cancer and other serious chronic diseases seems highly unlikely to go away any time in the near future.

  2. In a just world, we could easily afford all new developments. There might well be steps being taken now towards this. Alas, Americans are told little about them. First, a day or two ago some British doctors voted to reinstate the National Health Service. Professor Allyson Pollock and a Member of Parliament proposed the “NHS Reinstatement Bill” a while ago. The vote was on a modified version of it, that takes account of the massive sell offs and reorganisations that have already occurred. Second, NHS doctors voted yesterday to exempt the UK’s NHS from the Transatlantic Trade and Investment Partnership. That agreement and others would ensure privatisation of all EU public services, resulting in a corporate coup led by the American industrial elite. So, if these two small steps succeed, we are on our way to a society free of corporate control of many sorts. Then one can nationalise firms like drug companies, or put them under strict control, let much more research be done directly for the public without profit motives (universities can handle that), and with struggle and patience ensure that medicines are available for all.

  3. Thank you for a temperate and well-reasoned summary of a very thorny and easily contentious issue.

    I would hope that if such discussions are carried out at a policy level, assumptions are not based on “settled truths” along the lines of “Zytiga costs such-and-such, Xofigo costs such-and-such, so the cost is $100,000/year”.

    The farther I go along my journey with advanced prostate cancer, the less I believe such numbers.

    More and more, I feel that Big Pharma and Big Insurance have colluded to mislead gullible Americans into thinking they’re getting a deal. Big Pharma quotes sky-high prices, and Big Insurance claims to “reduce” those prices, and the whole thing is nothing more than exercise in feel-good story-telling, e.g.:

    “This, whose retail value is $100K, can be yours for the low low price of $10K, thanks to the bargaining power of your loyalty club.”

    Well, if costs only $1K to manufacture, and is never sold anywhere for more than $20K, in what real sense is it truthful to say that its “retail value is $100K”?

  4. Here is one reason for those high prices and for the mantras about research costs and the need for rationing.

  5. More here. Note the comparison. Note Dekkers’ crassness.

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