Category Archives: Cancer medicine (Oncology)

This is the week of the American Society for Clinical Oncology’s meeting so we can expect to inundated with news of medical progress, some real, some maybe real, some imagined. But all can be expected to be costly.

One of the most publicized studies is that of using exemestane (Aromasin) to prevent breast cancer in women at moderately increased risk. 4560 women were randomly assigned to a group using the drug or to placebo. The abstract from an article on the study published this week in the NEJM states:

At a median follow-up of 35 months, 11 invasive breast cancers were detected in those given exemestane and in 32 of those given placebo, with a 65% relative reduction in the annual incidence of invasive breast cancer (0.19% vs. 0.55%; hazard ratio, 0.35; 95% confidence interval [CI], 0.18 to 0.70; P=0.002). The annual incidence of invasive plus noninvasive (ductal carcinoma in situ) breast cancers was 0.35% on exemestane and 0.77% on placebo (hazard ratio, 0.47; 95% CI, 0.27 to 0.79; P=0.004). Adverse events occurred in 88% of the exemestane group and 85% of the placebo group (P=0.003), with no significant differences between the two groups in terms of skeletal fractures, cardiovascular events, other cancers, or treatment-related deaths. Minimal quality-of-life differences were observed.

The drug has fewer side-effects than other agents used to prevent breast cancer (tamoxifen and the aromatase inhibitors) but still in 3-4% of patients severe joint pain was reported.

Medicynical Note: Exemestane (Aromasin) costs about $3600/year. In this study about 2280 (half of the number randomized) patients were treated with exemestane for three years and according to the study 21 fewer cancers occurred than in the placebo group. This reduction of incidence from 32 in placebo to 11 given drug was cited in news articles as a “65% reduction in cancer occurrence.”

The cost of this preventive strategy/case prevented is $3600 (yearly cost) X 3 (number of years treated) X 2280 (number of patients treated)/ 21 (number of cases of cancer prevented) and was $1,172,571/case prevented.

In fact, relatively few cancers occurred in either group (32 and 11). The reduction of 21 cases was significant but the cost/cancer prevented is prohibitive. Given that these patients will also be followed with mammograms and physician exams (adding to the cost) it’s doubtful that this intervention will lead to a measurable survival benefit.

Nice article in NEJM on an approach to limiting the cost of cancer care:

The authors note that cancer care costs are rising rapidly and are unsustainable:

from $104 billion in 20061 to over $173 billion in 2020 and beyond.2 This increase has been driven by a dramatic rise in both the cost of therapy and the extent of care. In the United States, the sales of anticancer drugs are now second only to those of drugs for heart disease, and 70% of these sales come from products introduced in the past 10 years. Most new molecules are priced at $5,000 per month or more, and in many cases the cost-effectiveness ratios far exceed commonly accepted thresholds. (medicynical emphasis) This trend is not sustainable.

The authors suggest five strategies to control costs. They are basic and can be easily incorporated into oncologic practices. Whether they will be adopted or not is an open question. Read the article!!

The Ryan plan for cutting Medicare costs will cut some costs but  undoubtedly will also cut coverage and  increase out of pocket expenses, particularly for those with serious illness.  The Journal of Clinical Oncology documents this effect in this article on insurance coverage for cancer patients. The article notes:

The risk of high burdens is significantly greater for patients with cancer compared with other chronically ill and well patients. We find that 13.4% of patients with cancer had high total burdens, in contrast to 9.7% among those with other chronic conditions and 4.4% among those without chronic conditions. Among nonelderly persons with cancer, the following were associated with higher out-of-pocket burdens: private nongroup insurance, age 55 to 64 years, non-Hispanic black, never married or widowed, one child or no children, unemployed, lower income, lower education level, living in nonmetropolitan statistical areas, and having other chronic conditions.

Medicynical note:  As people age the prevalence of illness dramatically increases.  Many of the elderly, if not most, would be denied insurance in the current private market or be offered insurance that is priced so high that it would be unaffordable and/or inadequate.  Ryan’s plan makes no accomodation for elderly patients with medical problems, throwing them into the individual market.  It will formalize economic rationing of health care and penalize most severely the elderly who have limited or no health care savings.

In doing this the U.S. would (un) distinguish itself from all other industrialized nations who provide health coverage to all citizens regardless of illness and age.

So not only do we pay more for health care than any other country in the world but also provide the least comprehensive coverage for those who need it most. 

The Wall Street Journal notes the expense of cancer drugs and the inability of people and our non-system to pay the price.

Two pieces of news out this week underline this point, and its consequences. Medco’s Drug Trend Report says that the oncology-specialty drug market, i.e. targeted therapies, could increase total cancer-drug spending by about 15% annually through 2013. That’s partially because of increased use, but mostly because the cost of the therapies themselves are rising.

And:

Some 16% of patients had an out-of-pocket cost of greater than $500. And one in four of those patients “abandoned (medicynical emphasis) the prescription and did not follow up with another oncology medication within 90 days,” the researchers write. Lower income and Medicare coverage were also associated with a higher abandonment rate.

And:

A study published jointly this week by the Journal of Oncology Practice and the American Journal of Managed Care finds that 10% of patients failed to fill new prescriptions for oral cancer drugs. The research will also be presented at ASCO.

Medicynical Note: The Journal won’t call it so, but this is evidence of more economic rationing in our non-system.

The most amazing part of this story is that these new “targeted” drugs, while advances, have only a modest effect on survival of patients…..but a tremendous effect on the bottom lines of pharmaceutical companies.

They are a tour de force of scientific progress and creative marketing. But as to patient care and improved outcomes, only a slight benefit–while bankrupting individuals and the non-system.

We need to insist that we don’t pay more for these “advances” than other countries in the world.   The power of the government in providing patent protection, for a generation, should be used to assure that drugs are priced realistically and competitively.

Provenge a new agent that mobilizes the immune system in prostate cancer has shown small effect in improving the survival of patients, 4 months median benefit. But it’s ridiculous cost ($31,000/shot) may stimulate changes in our drug review and approval non-system.

In April 2010, the Food and Drug Administration (FDA) approved sipuleucel-T (Provenge), a novel cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic, metastatic, castration-resistant (hormone-refractory) prostate cancer.1,2 The pivotal clinical trial demonstrated the benefits of sipuleucel-T: an increase in median survival of 4.1 months as compared with placebo and fewer side effects than occur with docetaxel.2 Priced at $31,000 per treatment, with a usual course of three treatments, sipuleucel-T is one of the most expensive cancer therapies ever to hit the marketplace.

Because of the high cost and limited benefit Centers for Medicare and Medicaid Services (CMS) are doing their own review of the drug. In part this is essential as FDA is not at all allowed to consider cost in its approval process. As noted FDA and CMS somewhat different missions:

The FDA approves for marketing and otherwise regulates prescription drugs and medical products. The CMS administers Medicare, a health insurance program for people 65 years of age or older and people with certain disabilities. The agencies’ distinctions are underscored by the legal criteria they use in making decisions regarding new medical products. The FDA evaluates the “safety and effectiveness” of drugs and devices, whereas the CMS covers medical products that are “reasonable and necessary” for the diagnosis or treatment of illness.

Read the article for a more complete review of the agencies differences. Suffice it to say CMS gets to look into the reasonableness of use of the drug as well as the cost impact.

Medicynical Note: We now have drugs costing twice the median and average income in the US that are not curative and offer only limited survival benefit.

Are such unaffordable drugs analogous to the sound made by trees falling in the woods?