High utilization and/or cost growth trends in Washington State

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Topic Proposal for Robert Bree Collaborative
Eric Rose, M.D., F.A.A.F.P.
September 12, 2011
Topic Proposal for Robert Bree Collaborative:
Management of Localized Prostate Cancer
Summary
Localized prostate cancer (prostate cancer confined to the prostate gland) is highly common and
accounts for substantial health care costs. However, such cancers are often indolent, and aggressive
treatment may offer limited benefits, with significant risks. Conservative management approaches such
as “active surveillance” can be appropriate choices in some cases, but are rarely chosen. Non-evidencebased variation in practice patterns in the treatment of localized prostate cancer have been
documented, and men with prostate cancer often lack knowledge of the risks and benefits of different
management approaches at the time that they make treatment decisions. Increasing awareness of the
risks and benefits of different management options for localized prostate cancer, including conservative
management, could increase patients’ awareness of their options and their role in choosing treatment,
and may reduce costs of care.
Background
Prostate cancer is very common, with an estimated lifetime incidence of approximately 17 percent.
However, due to the fact that it is often of low aggressiveness, and that its incidence increases with
advancing age, it only causes death in approximately 2.7 percent of men.1,2
Prostate cancer is considered “localized” when it is stage T1 (non-palpable) and T2 (palpable but limited
to the prostate), with no involvement of lymph nodes or distant metastasis. In approximately 90
percent of patients diagnosed with prostate cancer, the cancer is localized at the time of diagnosis.3
Substantial variation in practice patterns
A 2010 study of 11,892 men with localized prostate cancer treated at 36 different clinical sites
concluded that “Substantial variation exists in management of localized prostate cancer that is not
explained by measurable factors… data suggest both overtreatment of low-risk disease and
undertreatment of high-risk disease”4
There is evidence of specialty-driven bias in treatment recommendations: In a survey of over 1,000
urologists and radiologists, for the same hypothetical patient, 93 percent of urologists indicated they
1
American Cancer Society. What are the key statistics about prostate cancer?
http://www.cancer.org/Cancer/ProstateCancer/DetailedGuide/prostate-cancer-key-statistics; retrieved September
11, 2011.
2
Lu-Yao GL, Albertsen PC, Moore DF, et al. Outcomes of localized prostate cancer following conservative
management. JAMA 2009;302:1202–1209.
3
National Cancer Institute. Cancer advances in focus: prostate cancer.
http://www.cancer.gov/cancertopics/factsheet/cancer-advances-in-focus/FS12_7.pdf. Accessed September 11,
2011.
4
Cooperberg MR, Broering JM, Carroll PR. Time trends and local variation in primary treatment of localized
prostate cancer. J Clin. Oncol. 2010; 28(7): 1117-23
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Topic Proposal for Robert Bree Collaborative
Eric Rose, M.D., F.A.A.F.P.
September 12, 2011
would recommend surgery as the primary treatment, and 72 percent of radiation oncologists indicated
they would recommend radiotherapy.5
High utilization and/or cost growth trends in Washington State without better
outcomes
Various options exist in the management of localized prostate cancer (such as surgery, radiation, or
hormonal “androgen deprivation” treatment). Available evidence does not clearly distinguish one
option as more or less appropriate than others.6,7. In low-risk cases, active treatment may have little
impact on survival. Conservative approaches, such as “active surveillance”, in which patients undergo
repeated physical exam, PSA testing, and prostatic biopsy on a fixed schedule, have been associated
with low mortality in clinical trials.8,9 Nonetheless, 94 percent of patients with localized prostate cancer
choose treatment rather than watchful waiting or surveillance. 10
Prostate cancer treatment accounted for $9.9 billion in health care costs in the United States in 200611.
Costs of care vary markedly with choice of initial treatment option. In one study that followed a cohort
of over 13,000 men over age 66 for five years, 5-year incremental costs of care ranged from $9,130 for
patients whose initial management approach was watchful waiting, to $26,896 for those whose initial
management was hormonal therapy.12
Newer, costlier treatments for prostate cancer, such as robotic minimally-invasive prostatectomy, were
estimated to have accounted for $350 million in incremental costs among men diagnosed with prostate
cancer in the U.S. in 2005.13
A source of waste and inefficiency in care delivery
As above, practice patterns vary widely with a trend towards adoption of newer, more expensive
therapeutic approaches, often with limited benefit.
5
Fowler FJ, McNaughton CM, Albertsen PC, et al. Comparison of recomnendations by urologists and radiation
oncologists for treatment of clinically localized prostate cancer. JAMA 2000;283(24):3217-3222.
6
Wilt TJ, MacDonald R, Rutks I, et al. Systematic review: Comparative effectiveness and harms of treatments for
clinically localized prostate cancer. Ann Intern Med 2008;148:435–448
7
Thompson I, Thrasher JB, Aus G, et al. Guideline for the management of clinically localized prostate cancer: 2007
update. J Urol 2007;177:2106–2131
8
Stattin P, Holmberg E, Johansson JE, et al. Outcomes in localized prostate cancer: National Prostate Cancer
Register of Sweden follow-up study. J. Nat. Ca Inst. 2010;102(13):950-958.
9
Van den Bergh RC, Essink-Bot ML, Roobol MJ, et al. Outcomes of men with screen-detected prostate cancer
eligible for active surveillance who were managed expectantly. Eur. Urol. 2009;55(1):1-8.
10
Harlan SR, Cooperberg MR, Elkin EP, et al. Time trends and characteristics of men choosing watchful waiting for
initial treatment of localized prostate cancer: results from CaPSURE. J. Urol. 2003;170(5):1804-1807.
11
National Cancer Institute. Cancer Trends Progress Report – 2009/2010 Update.
http://progressreport.cancer.gov/, retrieved September 11, 2011.
12
Claire F. Snyder, Kevin D. Frick, Amanda L. Blackford, Robert J. Herbert, Bridget A. Neville, Michael A. Carducci,
and Craig C. Earle. How does initial treatment choice affect short-term and long-term costs for clinically localized
prostate cancer? Cancer, 2010; DOI: 10.1002/cncr.25517
13
Nguyen PL Xiangmei G Lipsitz SR et al. Cost Implications of the Rapid Adoption of Newer Technologies for
Treating Prostate Cancer. J Clin Oncol. 2011 29(12):1517-24.
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Topic Proposal for Robert Bree Collaborative
Eric Rose, M.D., F.A.A.F.P.
September 12, 2011
More to the point, patients are often not fully aware of options or the consequences of treatment
modalities that they have chosen. In one survey of men with newly-diagnosed prostate cancer, the
majority overestimated the survival benefit of treatment (including those with high levels of health
literacy)14, and a majority could not correctly answer at least half of the items in a quiz regarding
advantages and disadvantages of various treatments for localized prostate cancer15. Examples of the
questions on this quiz are:
After surgery, the common complication is:
a) Pain on urination
b) Urine leakage
c) Diarrhea
d) Impotence
e) None of these
(correct answer is d)
One out of three patients who have surgery will need to wear diapers because of bladder control
problems
o True
o False
(correct answer is “true”).
Patient Safety issues
Treatments for early-stage prostate cancer can be associated with serious adverse effects, including
urinary, bowel, and sexual dysfunction.16 As noted above, there is evidence that patients lack
knowledge of these risks at the time they make decisions as to treatment.
Prostate cancer is more common, and associated with higher mortality, in men of African descent, and
African-American men may not be aware of this increased risk.17
What data are available to support that there is waste, variation, high
utilization, excess costs?
See above
Are the waste and quality aspects of this topic avoidable?
It is highly likely that an approach that seeks to inform patients with localized prostate cancer of their
options and the consequences of each will have benefit. It is a truism when a patient has to make a
decision among treatment options, if he is better informed, the result will be more likely to be
14
Mohan R, Beydoun H, Barnes-Ely ML eta l. Patients’ survival expectations before localized prostate cancer
treatment by treatment status. J. Am. Board Fam. Med. 2009;22(3):247-256
15
Beydoun HA, Mohan R, Beydoun MA, et al. Development of a scale to assess patient misperceptions about
treatment choices for localized prostate cancer. BJU Int. 2010;106(3):334-341.
16
Wei JT, Dunn RL, Sandler HM, et al. Comprehensive comparison of health-related quality of life after
contemporary therapies for localized prostate cancer. J Clin Oncol 2002;20:557–566
17
Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010 60(5):277-300.
Page 3 of 4
Topic Proposal for Robert Bree Collaborative
Eric Rose, M.D., F.A.A.F.P.
September 12, 2011
consistent with his values and priorities. Furthermore, it may be (though I am not aware of any studies
to this effect) that well-informed patients will be more likely to choose less-expensive options such as
active surveillance.
Are there proven means/strategies to address this topic?
See above
Does the availability of data and established guidelines make this topic a
prospect for developing a statewide solution by July 2012 that could bring
meaningful improvement to the delivery system?
Yes:
o
o
The National Comprehensive Cancer Network guidelines propose active surveillance as a
management option depending on the overall risk, as determined by stage, histologic grade
(“Gleason score”), and prostate specific antigen level, and estimated life expectancy.18
The American Urological Association’s current guidelines state “Active surveillance, interstitial
prostate brachytherapy, external beam radiotherapy, and radical prostatectomy are all options
for treatment of the low-risk patient. Study outcomes data do not provide clear-cut evidence for
the superiority of any one treatment… Patient preferences and health conditions related to
urinary, sexual, and bowel function should be considered in decision making. Particular
treatments have the potential to improve, to exacerbate or to have no effect on individual
health conditions in these areas, making no one treatment modality preferable for all
patients.”.7
These guidelines support a shared decision-making model incorporating careful consideration of risks
and benefits and the patient’s preferences. Tools to raise public awareness and support such a process,
with safeguards to protect patients’ decision-making autonomy, could help to ensure that management
of localized prostate cancer is consistent with each patients’ values, and may also result in lower costs of
care.
18
National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Prostate Cancer, version
4.2011. http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf, retrieved September 11, 2011.
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