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Prostate Cancer

Jennifer Klemm, PhD; and Stanton R. Mehr
Prostate cancer is the most prevalent non-cutaneous malignancy among men, accounting for over 240,000 new diagnoses each year in the United States.1 Because of its indolent nature and the excellent curative options for early-stage disease, prostate cancer deaths are more modest, occurring in fewer than 34,000 men each year.1 According to estimates from the American Cancer Society, the 5-year survival for patients with prostate cancer is almost 100%, and the 10-year survival is 91%.2

In a significant portion of patients, prostate cancer progresses very slowly or poses limited danger. Therefore, it is sometimes said that “more people die with prostate cancer than of prostate cancer.” Conservative approaches to treatment for patients with indolent prostate disease often include little more than periodic monitoring with prostate-specific antigen (PSA) testing.

Even patients with indolent prostate cancer often choose active treatment approaches, which can include surgery or radiation therapy followed by hormonal therapy, which essentially reduces testosterone to post-castration levels. In patients with active disease, this approach prolongs survival, but in a proportion of these patients, the disease will progress. Once patients reach this advanced stage, called metastatic castrate-resistant prostate cancer (CRPC), the disease is no longer indolent, having a median survival of only 16 to 20 months.3,4 For these patients and the healthcare system, the question of value is more of a consideration.

Nearly 2.36 million American men are estimated to have prostate cancer,5 and the total cost of caring for these patients has been estimated to be $9.86 billion.6 Approximately 10% to 20% of these men will develop CRPC within 5 years of diagnosis.7 In 1 health economic study of CRPC patients, the total per patient prostate cancer–related costs were $21,588 annually.8 In another study, performed in 2006 prior to the approval of the 4 most recent agents, the mean costs for the last year of life were $33,691.6 Current costs are almost certainly significantly greater.

Current Treatment Options

For patients who have metastatic CRPC, metastases are most often found in the bone, with 1 study reporting that 84% of all patients with CRPC have bone metastases upon diagnosis.9 These patients generally receive either the bisphosphonate zoledronic acid or the more recently approved targeted agent denosumab to prevent or delay skeletalrelated events (SREs) associated with bone metastases.10 Radiation therapy may also be used to control bone pain, and surgical intervention is sometimes necessary as well. In addition to these palliative treatments, the active treatments described below are prescribed, depending on whether these patients are currently experiencing symptoms or not.

For asymptomatic metastatic CRPC patients, the National Comprehensive Cancer Network recommends treatment with 1 course (3 doses) of sipuleucel- T (Provenge),10 the first therapeutic vaccine to be approved by the US Food and Drug Administration (FDA) and which has been shown to produce a survival advantage of 4.1 months.11 Asymptomatic patients are also often treated with secondary hormonal therapy, such as ketoconazole or an antiandrogen, although no survival benefit has ever been established for this approach.

Once patients develop symptomatic disease, they generally receive treatment with the chemotherapeutic agent docetaxel (Taxotere), which has demonstrated a survival advantage of 2.4 months.12 After failure of docetaxel, several options exist, including (1) the targeted hormonal agent abiraterone acetate (Zytiga), providing a survival benefit of 3.9 months,13 (2) another chemotherapy agent, cabazitaxel (Jevtana), providing a survival benefit of 2.4 months,14 (3) docetaxel rechallenge, and (4) secondary hormonal therapy.

Economics

All of the above-outlined, recently approved treatment options for CRPC patients come at a high price tag. Sipuleucel- T is the most expensive therapy, costing $93,000 for a full course, but only 1 course of therapy is given to each patient. The average wholesale price of cabazitaxel is $9600 for 1 course of treatment, with a median of 6 courses given in the pivotal trial, for a median total of $57,600 per patient.15 Abiraterone costs $5000 per month and the average duration of treatment in its pivotal trial was 8 months, for an average total of $40,000 per patient.13

Abiraterone has the additional challenge of being an oral drug, which is often covered (or not covered) under a patient’s pharmacy benefit rather than as a medical benefit. Because prescription drug coverage is typically less generous than medical coverage, patients prescribed oral targeted agents often find themselves responsible for paying thousands of dollars in coinsurance. Thus, the amount of patient out-ofpocket costs often becomes the deciding factor in treatment choice, with patients often forgoing life-prolonging therapy due to the high cost of the drug.

For the prevention of SREs, the cost of denosumab is $1650 per dose, compared with $844 for zoledronic acid,16,17 but the drug acquisition costs are not the only considerations when determining overall cost-effectiveness. Because denosumab is administered via subcutaneous injection rather than intravenous infusion, it saves both chair time and infusion costs relative to zoledronic acid. In addition, denosumab avoids 0.11 SREs per year in patients with CRPC.15 In 1 health economic study, when all costs were considered, including the cost of avoided SREs, denosumab was associated with a $51,319 incremental increase per SRE avoided over a 3-year period in this patient population.15 Based on a willingness-to-pay threshold of $70,000 per SRE avoided, denosumab was costeffective in nearly 50% of cases at 1 year and 79% of cases at 3 years.15

Additional Drivers of the Cost of Care

According to 1 analysis, costs incurred by patients with CRPC are greatest in the 6 months preceding death because of home-care services, hospitalization, and palliative-care costs.18 This analysis was conducted before the advent of the newer, more expensive drugs now available for the treatment of CRPC. In the current landscape, drug costs are certain to be a formidable driver of costs. However, unlike many therapies in the past, these drugs produce a survival advantage, making them potentially a good value despite their high cost.

In a recently published health economic study of patients with prostate cancer, ambulatory costs were determined to be the main driver of the cost of care, accounting for 57% of the total costs.8 Ambulatory costs were those incurred during physician office visits and visits at outpatient facilities, such as outpatient procedures and services (eg, laboratory work, radiology services). The next most costly driver of the cost of care for patients with CRPC was inpatient costs, absorbing 30% of the total costs. Pharmacy costs accounted for less than 10% of the total cost, and emergency department costs were negligible.

Payer Perspective

Interview with Kenneth Schaecher, MD


EBO: Prostate cancer is a bit unusual as a carcinoma because it is either aggressive or very slow growing and there are a number of options to treat it (eg, surgical resection, cryotherapy, radiologic therapy, chemotherapy, immunomodulatory treatment). How do health plan efforts to help patients make choices that are most appropriate for them provide value?

Dr Schaecher: Helping patients make the choice that is right for them is a challenge because of the fragmented nature of the sites of care for prostate cancer. Urologists attempt to provide counseling but their bias is to do surgery, and patients may be unintentionally steered in that direction. Patients themselves let their own biases choose therapies. For example, they may decide on proton-beam therapy, based on marketing, rather than other forms of radiation therapy, which are equally efficacious but much less costly.

Our health plan is embarking on “shared decision-making” pilots around this area, in an effort to help patients objectively wade through the volume of information on the various treatment modalities in an objective and organized manner free of individual provider or marketing biases. These shared decision-making tools will be available at both specialty care sites and primary care offices for patients diagnosed with prostate cancer and working through the decision process as to how they wish to proceed with treatment.

EBO: What is your view on prostate-specific antigen (PSA ) testing and its ability to stratify patients at risk for aggressive malignancy?

Dr Schaecher: The role of PSA testing has become more controversial, given the recent recommendations of the US Preventive Services Task Force to discontinue use of this test as a means to screen for prostate cancer. This recommendation was based upon their review of a number of studies but especially 2 large studies that showed the harms from this testing likely outweighed the benefits.

This recommendation has not been universally supported by urologists and some other practitioners, as they feel PSA testing has some benefit when used in conjunction with a digital rectal exam of the prostate and when viewed serially over time rather than as a single value.

From a payer perspective, I believe there is increased skepticism regarding the value of PSA testing as it is primarily being performed by primary care physicians (PCPs) and they remain for the most part uninformed about the nuances of this testing. There is a great deal of evidence to support that PSA testing is not a sensitive tool for determining the aggressiveness of prostate cancer, but at the same time it is a readily available and accepted test by PCPs and thus is used.

EBO: How strong a role does your organization’s medical technology assessment group play in policy making for prostate cancer treatments (versus a Pharmacy & Therapeutics [P&T] Committee)?

Dr Schaecher: It depends on the treatment. Drugs are typically assessed by a P&T Committee whereas other treatments like surgical procedures, radiation, or cryotherapy are evaluated by the Technology Assessment Committee. There can be some overlap in committee function should there be a pharmaceutical treatment that is administered by some unique device. In that circumstance, the technology assessment committee would take the lead and present its final determination to P&T for notification and discussion.

EBO: Does your health plan cover the Provenge vaccine?

Dr Schaecher: We do cover Provenge, but we apply prior authorization that is specific to the FDA labeling.

EBO: Do you believe that therapeutic vaccines like Provenge will provide an avenue to good value in prostate cancer treatment?

 
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