Medicare Moves to Pay for Prostate Cancer Drug Provenge - The Washington Post

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By Rob Stein

The federal health insurance program for the elderly moved Wednesday to pay for an expensive vaccine recently approved to treat men with advanced prostate cancer.

The Centers for Medicare and Medicaid Services proposed paying for the vaccine, known as Provenge, which costs $93,000 a patient. The proposal will be subject to public comment for 30 days, and a final decision will be issued 60 days after that.

“The evidence is adequate to conclude that” Provenge “ improves health outcomes for Medicare beneficiaries” with metastatic prostate cancer, “and thus is reasonable and necessary for that indication,” CMS said in announcing its decision.

Although Medicare is not supposed to take cost into consideration when making such rulings, the decision by CMS to launch a formal examination raised concerns among cancer experts, drug companies, lawmakers, prostate cancer patients and advocacy groups.
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Study Knocks Diagnostic Value of PSA Velocity

By Charles Bankhead, Staff Writer, MedPage Today

If prostate biopsy is based on PSA velocity alone, the number of unnecessary biopsies would be almost four times the number of additional cancers diagnosed, data from a large clinical trial showed.

In the absence of other predictive factors, PSA velocity would have identified 115 prostate cancers at a cost of 433 unnecessary biopsies, according to Andrew Vickers, PhD, of Memorial Sloan-Kettering Cancer Center in New York City and colleagues.

If used as sole justification for a biopsy, PSA velocity would trigger about one of every seven prostate biopsies, they reported online in the Journal of the National Cancer Institute.

Moreover, adding PSA velocity to a multifactor model resulted in minuscule improvement in diagnostic accuracy, particularly for high-grade cancers.

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Study Suggests Lower PSA Cutoff for Biopsy

By Charles Bankhead, Staff Writer, MedPage Today

An initial PSA value <3 ng/mL predicted a low risk of prostate cancer and a remote likelihood that a man would die of the disease, results of a large screening study showed.

Fewer than 6% of men developed prostate cancer over an 11-year period following a first-time screening PSA value lower than 3 ng/mL. Subsequently, 23 men died of the disease, resulting in a mortality of 0.15%, Dutch investigators reported in a study that will be presented here at the Genitourinary Cancers Symposium later this week.

The median time to diagnosis of prostate cancer in men with the lowest initial PSA values exceeded eight years, said Monique Roobol, MD, of Erasmus University Medical Center in Rotterdam.

The low cancer risk and prolonged interval to diagnosis have potentially major implications for use of PSA to screen for prostate cancer.

Early Baldness May Have Link to Prostate Cancer

By Michael Smith, North American Correspondent, MedPage Today

Men who start to lose their hair at age 20 may be more likely to develop prostate cancer later in life, a case control study suggested.

The study, involving 388 men with a history of prostate cancer and 281 without, found that those with prostate cancer were twice as likely to have early balding compared with healthy controls, reported Philippe Giraud, MD, PhD, of the Hôpital Européen Georges Pompidou in Paris, and colleagues.

However, the study found no link between hair loss at age 20 and early diagnosis of prostate cancer or tumor aggressiveness, Giraud and co-authors reported online in the Annals of Oncology.

Noting that there's currently no evidence of benefit for general screening for prostate cancer, the investigators suggested that their finding may help identify a subgroup of men who would benefit both from screening and possible early treatment.

Walking May Lower Mortality Risk in Prostate Cancer

By Charles Bankhead, Staff Writer, MedPage Today

Prostate cancer survivors can literally walk themselves to a lower risk of dying of the disease -- with some men achieving an almost 50% lower mortality risk, data from a large cohort study showed.

The study, involving more than 2,000 survivors of nonmetastatic prostate cancer, found those who walked at a normal to brisk pace for at least 90 minutes a week had a 46% lower mortality hazard -- and three or more hours of vigorous physical activity each week lowered the hazard to 49%, according to Stacey A. Kenfield, ScD, of the Harvard School of Public Health, and colleagues.

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Prostate CA Vaccine Stirs Interest, Lawsuits

By Charles Bankhead, Staff Writer, MedPage Today

For the second time in as many months, the Centers for Medicare and Medicaid Services (CMS) finds itself named in a lawsuit related to the agency's handling of the prostate cancer immunotherapy sipuleucel-T (Provenge).

Judicial Watch, a Washington-based public interest group, has sued HHS to gain access to documents related to the CMS decision to conduct a one-year national coverage analysis to assess whether the therapy is "reasonable and necessary," thus qualifying for Medicare coverage.

According to a Freedom of Information Act request filed in last November, Judicial Watch wants access to "all records concerning CMS' national coverage analysis of the vaccine Provenge, including but not limited to the criteria being used to analyze Provenge."

The legal action apparently has evolved from a suspicion that the national coverage analysis is the first step toward cost-based healthcare rationing.

In a statement posted on the Judicial Watch website, representatives of the organization noted that sipuleucel-T "costs $93,000 to administer the three necessary treatments. Medicare and the FDA are legally prohibited from denying approval of a medical treatment based solely on cost. Yet, multiple press reports suggest that cost is the major factor in the unusual decision by CMS to undertake a review of the treatment which could signal a move by the Obama administration to begin implementing healthcare rationing based on the cost of treatments."
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Age No Barrier to Prostate Cancer Tx

By Todd Neale, Staff Writer, MedPage Today

Decisions about prostate cancer treatment may rely too heavily on age, research suggests.

In a study of nearly 12,000 men, older patients were less likely to get local therapy, regardless of disease risk, Matthew Cooperberg, MD, MPH, of the University of California San Francisco, and colleagues reported online in the Journal of Clinical Oncology.


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FDA Panel Rejects Prostate Drugs for CA Prevention from MedPage Today

An FDA advisory panel has voted overwhelmingly that GlaxoSmithKline's dutasteride (Avodart) and Merck's finasteride (Proscar) should not be used to prevent prostate cancer because the drugs are linked to a higher incidence of high-grade tumors.

Although the 5-alpha reductase inhibitors were shown to prevent low-risk cancers better than placebo, clinical trials painted a disturbing link between both drugs and an increased incidence of higher-risk prostate cancers.

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Hit to the Wallet Corrects ADT Use for Prostate Cancer from MedPage Today

By Charles Bankhead , Staff Writer, MedPage Today

Medicare accomplished what clinical guidelines and evidence-based medicine couldn't: it reduced unnecessary use of androgen deprivation therapy (ADT) in prostate cancer.

Inappropriate use decreased by almost 30% from 2003 to 2005, following enactment of the Medicare Modernization Act, which lowered physician reimbursement for ADT. Appropriate use of ADT did not change during the same time period, according to an article in the Nov. 4 issue of the New England Journal of Medicine.

"Our findings suggest that reductions in reimbursement may influence the delivery of care in a potentially beneficial way, with even the modest [reimbursement] changes in 2004 associated with a substantial decrease in the use of inappropriate therapy," Vahakn B. Shahinian, MD, of the University of Michigan in Ann Arbor, and co-authors wrote in conclusion.
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Risks Top Benefits of Screening in Men With Low PSA - from MedPage Today

By Charles Bankhead, Staff Writer, MedPage Today

Men with low prostate-specific antigen (PSA) values may face more risks than benefits from aggressive approaches to prostate cancer screening and evaluation -- along with potential overtreatment -- data from a large cohort study suggest.
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Comorbidities May Be Key in Prostate Cancer Tx Decisions from MedPage Today

By Nancy Walsh, Staff Writer, MedPage Today

A questionnaire for men with prostate cancer that evaluates comorbidities may help in clinical decision-making about treatment by estimating their likelihood of dying from other conditions, researchers found.

A study of almost 3,000 responses to the Total Illness Burden Index for Prostate Cancer (TIBI-CaP) questionnaire found that those men who scored highest were 10 times more likely to die of causes other than prostate cancer compared with men with the lowest scores (HR 10.3, 95% CI 5.4 to 19.5), according to Timothy Daskivich, MD, of the University of California, Los Angeles, and colleagues.

These results suggest that the presence and severity of comorbidities should be a key consideration in clinical decision-making for prostate cancer because of the indolence of many early stage cases, Daskivich and co-authors wrote in a research letter published in the August 9/23 Archives of Internal Medicine.
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Bone Density May Predict Prostate Cancer in Old Age from MedPage Today

By John Gever, Senior Editor, MedPage Today

Bone scans might help identify men at high risk for aggressive prostate tumors as they age, researchers said.

Starting at about age 70, men in a long-term prospective cohort study who were diagnosed with high-risk prostate cancers tended to have relatively high levels of bone mineral content when measured up to 35 years earlier, reported Stacy Loeb, MD, of Johns Hopkins University, and colleagues.

The findings, from a longitudinal study of 519 men that began in 1958, were reported in the July issue of the British Journal of Urology International. "Although the biology underlying this association requires additional study, these findings suggest that host factors in the bony milieu may be related to prostate cancer development and the progression to advanced disease," Loeb and colleagues wrote.
They noted that the frequency of bone metastases in patients with prostate cancer suggested some biological association between these tumors and bone. The researchers also cited a previous study suggesting a link between higher bone mineral density and prostate cancer incidence, although the connection seemed weak.
In the current study, Loeb and colleagues looked at data from the Baltimore Longitudinal Study of Aging, in which participants have undergone comprehensive medical exams about every two years since 1958.
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CMS Considers Payment Policy for Provenge from MedPage Today

By Emily P. Walker, Washington Correspondent, MedPage Today

The Centers for Medicare and Medicaid Services announced it has started the process of deciding whether to cover the costly prostate cancer immunotherapeutic agent sipuleucel-T (Provenge).

In late April, the FDA approved Provenge for the treatment of men with asymptomatic or minimally symptomatic metastatic prostate cancer, after clinical trials showed treatment with Provenge improved median overall survival by 4.1 months compared with placebo (25.8 months versus 21.7 months).

Provenge is extremely expensive. Each infusion costs $31,000, and three infusions over the course of a month are necessary, bringing the total cost of treatment to $93,000.

In its National Coverage Decision (NCD), CMS will decide whether paying for Provenge is reasonable and necessary.
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Swedish Study Adds Fuel to PSA Screening Debate from MedPage Today

By John Gever, Senior Editor, MedPage Today

Screening based on prostate-specific antigen (PSA) dramatically reduced mortality from prostate cancer in a large 14-year randomized trial in Swedish men, researchers said.

Death rates associated with prostate cancer among nearly 10,000 men recruited for PSA screening in 1994 were 0.50%, compared with 0.90% in a similar group not invited for testing, reported Jonas Hugosson, MD, of Sahlgrenska University Hospital in Goteborg, Sweden, and colleagues online in Lancet Oncology.

After statistical adjustments, Hugosson and colleagues found a relative risk for prostate cancer death of 0.56 (95% CI 0.39 to 0.82) among those invited for screening. The risk reduction was even greater among invitees who actually underwent PSA testing.

Yet despite the large impact on mortality, the researchers were reluctant to endorse screening wholeheartedly.

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Radiation Versus Watching a Toss-Up for Prostate CA - from MedPage Today

By Charles Bankhead, Staff Writer, MedPage Today

There is still not enough evidence to show that radiation therapy for localized prostate cancer is better than surveillance, according to a report prepared for the Centers for Medicare and Medicaid Services (CMS).

Only retrospective analyses have compared irradiation with no treatment or no initial treatment. Data comparing the relative efficacy of different types of radiation therapy also are insufficient to permit definitive conclusions regarding efficacy, safety, and toxicity, according to the report from investigators at Tufts University in Boston.
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FDA Approves Prostate Cancer Vaccine from MedPage Today

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By Charles Bankhead, Staff Writer, MedPage Today





 The FDA approved the immunotherapeutic agent sipuleucel-T (Provenge) for the treatment of advanced prostate cancer, almost three years after the agency rejected an advisory group's recommendation in favor of the drug.

The approval makes the agent available for treatment of men with asymptomatic or minimally symptomatic metastatic prostate cancer.

"The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available," Karen Midthun, MD, acting director of the FDA Center for Biologics Evaluation and Research, said in a statement.

Often described as a vaccine, sipuleucel-T is an autologous cellular immunotherapy designed to stimulate a patient's immune system to mount a response against prostate cancer.
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Zinc Linked to Prostate Cancer Survival from MedPage Today

By Ed Susman, Contributing Writer, MedPage Today

Men diagnosed with early stage prostate cancer have an increased chance of surviving the disease if they have eaten a diet rich in zinc, researchers said here at the annual meeting of the American Association for Cancer Research.

"Those men with high zinc intake were 74% less likely to die of prostate cancer than those with the lowest zinc intake," Mara S. Meyer, MS, a doctoral candidate at the Harvard School of Public Health, said during a poster presentation (95% CI 0.10 to 0.68, P=0.005).

Researchers also reported a trend indicating that men who consumed high levels of marine omega-3 docosahexaenoic acid were 30% less likely to die of prostate cancer than men who consumed the lowest levels of the fatty acids (95% CI 0.47 to 1.03, P=0.26).
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PSA Test Might Help Guide Surveillance from MedPage Today

By Charles Bankhead, Staff Writer, MedPage Today

An index derived from three forms of prostate-specific antigen (PSA) may identify low-risk prostate cancers that eventually will require treatment, results of a clinical study suggest.

Men whose tumors eventually developed unfavorable characteristics had significantly higher mean prostate health index (PHI) values compared with men whose tumors remained low risk (37 versus 30, P=0.03), Robert W. Veltri, PhD, of Johns Hopkins, and colleagues reported here at the American Association for Cancer Research meeting.

The PHI is a composite score derived from measurement of total PSA, free PSA, and pro-PSA.

Use of the index alone or in combination with biopsy specimens demonstrated about 70% accuracy for predicting which tumors would develop unfavorable characteristics, according to the researchers.
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Infertility Linked to Prostate Cancer from MedPage Today

By Nancy Walsh, Contributing Writer, MedPage Today

Male infertility may be an early and identifiable risk factor for the later development of aggressive prostate cancer, a large study found.

On multivariate analysis, men with male factor infertility were 2.6 times more likely to develop high-grade prostate cancer than those without fertility problems (HR 2.6, 95% CI 1.4 to 4.8, P=0.003), according to Thomas J. Walsh, MD, of the University of Washington in Seattle, and colleagues.

This finding emerged from an analysis of data from a cohort of 22,562 men in California who sought evaluation for infertility between 1967 and 1998, the investigators reported online in Cancer.
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New Test Gets Positive Results for Prostate CA - in Meeting Coverage, ASCO GU from MedPage Today

By Crystal Phend, Senior Staff Writer, MedPage Today

Another novel urine test appears to improve detection of prostate cancer, particularly of aggressive tumors, researchers reported.

The test, which measures a gene fusion product called TMPRSS2:ERG, or T2:ERG, predicted a positive biopsy significantly more accurately than did serum prostate specific antigen (PSA) alone or in combination with other clinical predictors, according to a study led by James B. Amberson, MD, of the laboratory company DIANON Systems in Shelton, Conn.
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