Of cost, quality, and care for low-risk prostate cancer

A newly published study in the Annals of Internal Medicine has offered an analysis of the cost-effectiveness of “observation” as compared to immediate initial treatment for men diagnosed with low-risk, localized prostate cancer.

This study by Hayes and her Harvard-based colleagues is relatively sophisticated and well conducted. It uses the data from the PIVOT trial to reach the unsurprising conclusion that “observation is more effective and costs less than initial treatment” and furthermore that watchful waiting (as compared to active surveillance or actual treatment) “is most effective and least expensive under a wide range of clinical scenarios.”

While The “New” Prostate Cancer InfoLink is a strong advocate that “less” (in terms of immediate intervention) is often “more” (in terms of quality of life over time) for many men with an initial diagnosis of low- or very low-risk prostate cancer (especially many men of > 70 years of age), we need to be clear that the clinical applicability of this new study is bounded by a number of constraints.

In the first place, as stated above, there is a problem in that it is based on the data from the PIVOT trial, which recruited patients back in the mid 1990s and was focused on relatively elderly men in the US Veterans Affairs healthcare system. This group of men may not be entirely representative of the average American male, and they were certainly older that the average age for diagnosis of prostate cancer today.

Second, there is a general consensus that the way we are approaching diagnosis and management for prostate cancer today includes a component that was unavailable back in the 1990s … i.e., the application of sophisticated imaging techniques to try to determine who really needs biopsies and treatment (a process that is in the early stages of its evolution).

Third, “active surveillance” as it is practiced today really wasn’t an element of the PIVOT trial. The patients in that trial really were being “observed” largely on a watchful waiting-like protocol.

While the article by Hayes et al. really does give us yet another good reason to think hard about who really needs what type of care if they are at risk for or are diagnosed with prostate cancer, what it does not do is actually help us to know how to manage an individual patient. Each individual patient needs to be assessed with care and managed not just on the basis of what may or may not be in his prostate, but on the basis of the relative risks of treatment and “observation” of some type that apply to that specific patient. Men with high levels of anxiety about their health care may be more willing to accept (and live with) the risks and consequences of treatment for low-risk prostate cancer; men who place a very high premium on their quality of life (as opposed to the quantity of it) may prefer true observation as opposed to even active surveillance; older men may have different attitudes to their risk than younger men; etc.; etc.

At the end of the day, as a society, we most certainly need to find ways to rein in our overall spending on health care or we are we going to bankrupt future generations. On the other hand, cost is absolutely not the only factor that should drive healthcare decision-making (in the US or anywhere else for that matter). Cost has to be balanced against need for and quality of the care made available to the individual. Just as we cannot afford a society in which everyone gets given a Rolls Royce at birth and free gas for life, neither can we afford a society in which the quality of care provided to men with a possibly life-threatening disorder is driven by cost alone.

For those interested in more detail about the study by Hayes et al., there is a clear report, with video commentary, on the MedPage Today web site. We would also suggest that this article needs to be considered in the context of the two articles by Klotz and by Sartor that we mentioned last week in discussing the relative merits of active surveillance and less aggressive forms of observation. Another set of comments on this article can also be found on the Reuters web site.

4 Responses

  1. Mike, can you explain the differences between “active surveillance” to “watchful waiting?”


    As healthcare cost continues to emerge as a concern, it’s important that we understand realities about that cost and its potential threat to US financial resources. I’ve gradually become aware of a number of factors that are actually exerting or are poised to exert a downward pressure on costs of care. Here are some examples, with an emphasis on prostate cancer, some of which stem from reforms under the Patient Protection and Affordable Care Act (ACA).

    Competition, which tends to exert downward pressure on prices, among drugs(using bone mineral density protection, as an example: alendronate, ibandronate, risedronate, pamidronate, Zometa, transdermal estradiol patches, and denosumab)

    Generics substituting effectively for much more expensive brand name drugs (e.g., finasteride, a much less expensive but somewhat less effective choice than brand name Avodart as the 5-alpha reductase enzyme inhibitor element in androgen deprivation therapy; generic alendronate, a less expensive, somewhat less convenient, and perhaps somewhat less effective (for some) choice as bone mineral density protection. I’ve been trying to figure out when one of the LHRH agonists, which are quite expensive, will become available generically. It should be within the next few years, I think.) Our long and very expensive US investment in drug development under our private enterprise system, which has resulted in so many wonderful drugs, is now paying dividends as increasing numbers of drugs pass beyond patent protection and become available as generics. Generic drugs now are available for a wide and ever increasing proportion of health requirements.

    Decreased costs for covering formerly non-paying patients who will soon become or have become paying patients under the ACA — drugs and medical products whose costs have been amortized over costs for paying patients

    Decreased costs for covering formerly non-paying patients who will soon become or have become paying patients under the ACA — doctors, health professionals, hospitals whose costs have been amortized over costs for paying patients, who will no longer have to pick up a share of those costs

    Improved hospital efficiency — reducing doctor/hospital caused problems, etc. (e.g., as motivated by penalties under Medicare for excessive readmissions — already has driven down readmission rates by about 4.5%, 2012 versus previous 5 years)

    Electronic medical records — Three medical practices important to me have implemented electronic records within the past 3 or so years, including one just 2 months ago. I suspect we are in the implementing expense phase now but will soon be enjoying savings and improved care for years to come.

    Eliminating expensive tests no longer considered necessary — e.g., for prostate cancer, routine technetium-based bone scans, as well as CT scans, for staging new patients with no special risk characteristics that would warrant such tests.

    Avoiding unnecessary treatment, with effective, timely treatment as back-up if needed, as in active surveillance for eligible low-risk patients

    Prevention of serious conditions and their costly care by catching problems at a much earlier stage or preventing them entirely (e.g., using a statin drug, with some choices dirt cheap, to forestall cholesterol problems, also appearing to provide some prostate cancer benefit; prevention of osteoporosis with scans, drugs, and supplements)

    The potential of tort reform for medical malpractice (currently unrealized, but with the Administration signaling readiness)

    Decreasing costs for Medicare-covered durable medical equipment through market-driven pricing instead of the old dictated and excessive pricing (though the current auction process appears to need correction)

    Decreased drug costs for individuals and families previously uninsured or insured in the individual insurance market as they gain coverage and market clout through the new state health insurance exchanges and gain access to more efficient mail order pharmacies for many drugs. (I am appalled by the differences in prices for drugs paid by large insurers with clout and quantity purchasing power, often delivering drugs via mail order pharmacies, versus individuals and families going it alone with purchases at the local drug store.)

    As noted by the Kaiser Family Foundation, the rate of increase in health care costs has recently slowed substantially. The slowdown has been so extraordinary that the media are beginning to pick it up.

  3. Basically, “watchful waiting” is a passive management strategy and is most appropriate for men who have a limited life expectancy, or who value the quality of their life significantly more highly than its quantity. Watchful waiting is not designed to simply defer first-line treatment until is is clearly necessary. It is used to defer all treatment other than androgen deprivation therapy to manage end of life care if needed. Watchful waiting can be initiated at any stage after the initial diagnosis of prostate cancer whether it is localized, locally advanced, or metastatic.

    By contrast, “active surveillance” is an active management strategy designed primarily to defer or delay first-line therapy until it is clearly needed (which may occur within the first year after initial diagnosis or it may never happen at all). It is recommended only for men with low- or very low-risk, localized disease, although it is sometimes used in men with all the characteristics of low-risk disease except for a Gleason score of 3 + 4 = 7.

  4. Nice. You could not have explained that any better. WW and AS continue to be confused, though, by many.

    This website has got to be one of the best prostate cancer information sources and the website should be given to all the newly diagnosed, hyperbole aside.

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