Reimbursement and Managed Care News

OBTNMay 2008Volume 2Issue 5

1) Cost Is Creeping Into the Therapy Decision-Making Discussion2) Rounding Down Chemotherapy Doses: Does It Save Money for the Health System?3) HER2 Testing and Treatment Patterns in Breast Cancer4) Cost Effectiveness of a Drug Combination in Malignant Mesothelioma5) The Effect of Epoetin Alfa on Quality of Life in Patients With Anemia6) ASCO Seeks to Improve Coordination of Care, Introduces Treatment Template7) What Factors Increase the Likelihood of Colon Cancer Screening?

Cost Is Creeping Into the Therapy Decision-Making Discussion

In years past, physicians have avoided the question as to whether cost of therapy should be considered in the treatment approach. As biologic therapy can cost far more than conventional pharmaceutical treatments, and patients are often asked to shoulder significant portions of that cost, it may be time to take the blinders off, according to an oncology roundtable.

At the National Comprehensive Cancer Network’s (NCCN) annual conference, roundtable participants suggested that it may be time to include cost information in treatment guidelines. Leonard Saltz, MD, of the Memorial Sloan-Kettering Cancer Center, New York City, claimed that physicians used to be “above the idea of considering cost.” That is no longer the case, according to the panelists.

David Ettinger, MD, of Johns Hopkins University, Baltimore, noted that if the guidelines (either from NCCN or other professional cancer societies) included cost data along with treatment protocols, “it might help doctors decide between two chemotherapy regimens for colorectal cancer that are similarly effective but vary widely in their cost.”

In related news, a survey of oncologists and rheumatologists regarding biologic therapy revealed that both of these specialists are now considering a cost discussion with their patients during the office visit.

The Biotechnology Monitor & Survey

found that when nearly 100 physician practices were queried, two-thirds of rheumatologists responded that the costs associated with therapy had “more often become part of the conversation.” Sixty-two percent of responding rheumatologists said that when prescribing biologics, they considered the cost of therapy “frequently” or “all the time.” In comparison, 46% of oncologists talk to their patients about their out-of-pocket costs, and 48% considered cost of therapy at least frequently.

Interestingly, only 14% of rheumatologists indicated that cost is never considered in therapeutic decision making. Nineteen percent of the responding oncologists claimed to never consider cost of therapy in the clinical decision.

Presented at the 13th Annual Meeting of the National Comprehensive Cancer Network, Hollywood, FL,

March 5—9, 2008.

2008

Emron, Wayne, New Jersey, 2008 (www.biotechmonitor. com).

Biotechnology Monitor & Survey.

Rounding Down Chemotherapy Doses: Does It Save Money for the Health System?

Drug wastage—the bane of pharmacy practice— and trying to avoid it is drummed into the head of retail pharmacists around the country. It is one thing to talk about wastage for a generic beta blocker for hypertension, for which the cost is nominal, but for a higher-cost chemotherapeutic agent, the amount of money lost in drug wastage is assumed to be very high—or is it? Pharmacists from the Veteran Affairs Health Care Center in Palo Alto, California, sought to quantify how much could be saved by enforcing the common practice of “rounding down” chemotherapy doses to the nearest vial unit size in their ambulatory infusion center, thus reducing or eliminating wastage of certain products.

The pharmacists reviewed the records of patients given infused chemotherapy over six months, ending April 30, 2007. Drug acquisition costs were used to estimate how much wastage was avoided in patients whose doses were rounded down and how that translated into cost savings to the center.

They found that one-quarter of the 333 patients receiving infused chemotherapy had their doses rounded down an average of 2% to the next vial size over the six months. The amount of chemotherapy saved was 2.3 g (230 mL), and the creation of 40 partial vials. The pharmacists calculated that the cost saved by the health care center was $6,600, which is the equivalent of $13,100 based on average wholesale price.

Although they did not study the clinical outcomes in the patients with cancer who received the lower doses, rounded down to the next vial size, the researchers believe that the practice does save significantly in drug acquisition cost and spares needless environmental waste.

Nguyen C, Miyahara RK, Joshi R: Cost avoidance associated with rounding down chemotherapy doses by a pharmacist in the ambulatory infusion center. Presented at the 2008 annual meeting of the Academy of Managed Care Pharmacy, San Francisco, April 16—19, 2008.

HER2 Testing and Treatment Patterns in Breast Cancer

Accurately gauging whether a woman is human epidermal growth factor receptor (HER) positive is essential to prescribing the most effective treatment. Biologic agents like trastuzumab are most effective in patients who test positive for HER2. However, little trial information is available to detect whether adequate molecularmarker testing precedes the decision to prescribe trastuzumab.

Researchers from HealthCore, Wilmington, Delaware, evaluated administrative claims databases from three health plans. The records of patients with breast cancer who were diagnosed over 13 months, ending June 30, 2006, were chosen for review.

The review found that of 380 women with breast cancer, who saw 179 different physicians, 88% underwent HER2 testing. Seventy two (22%) had positive tests, and 52 women were given trastuzumab, 51 of whom tested positive for HER2 (98%).

Is Trastuzumab Being Used Appropriately in Breast Cancer?

Women With Breast Cancer and Trastuzumab

HER2 Test Positive, Received Trastuzumab

98%

HER2 Test not Performed, Received Trastuzumab

0%

Women With Breast Cancer Overall

HER2 Test Performed

88%

HER2 Test not Performed

12%

Importantly, in 45 women who did not undergo HER2 testing, none received trastuzumab. The researchers did not evaluate whether the health plans in question employed prior authorization based on molecular testing, which may have altered practice. However, based on this investigation, they concluded that patients with breast cancer are appropriately receiving trastuzumab, based on systematic testing for HER2.

Barron J, Zhang B, Cziraky M: Human epidermal growth factor receptor-2 testing and treatment patterns among newly diagnosed breast cancer patients. Presented at the 2008 annual meeting of the Academy of Managed Care Pharmacy, San Francisco, April 16—19, 2008.

Cost Effectiveness of a Drug Combination In Malignant Mesothelioma

Clinicians are continually seeking new options in the treatment of malignant pleural mesothelioma. In patients with unresectable disease, prognosis is poor, and many different therapies have been tried. One phase III study (EMPHACIS) had shown some promising results with the use of pemetrexed combined with cisplatin. Researchers and economists from Australia, the United States, and the United Kingdom developed a health economic model to better understand if the therapeutic gains of this combination therapy translated into cost-effective care compared with standard treatment and alternative treatments used in the United Kingdom.

To properly evaluate the cost effectiveness of the combined therapy, two models were developed: (1) to model survival outcomes over time using patient-level data and (2) to compare the costs and outcomes using means and median data, principally against a combination of mitomycin C, vinblastine, and cisplatin (MVP treatment); vinorelbine monotherapy; and palliation of symptoms.

The researchers found that in the first model analysis, the total per-patient cost of pemetrexed and cisplatin was between $17,409 and $17,887, yielding an average increase of quality-adjusted life-years per patient of 0.20—0.28, or up to 3.36 mo. They calculated a range of incremental cost of per life-year gained values of $40,597 to $136,015, which indicates questionable cost effectiveness of this approach. In the second analysis, rather than using patient-level data, the means and medians were utilized, the incremental cost effectiveness ratio was estimated to be from $28,934 to $63,570, which depending on the currency exchange rate, could be within the acceptable range (< $50,000/life-yr gained).

Cordony A, Le Reun C, Smala A, et al: Cost-effectiveness of pemetrexed plus cisplatin: Malignant pleural mesothelioma treatment in UK clinical practice.

2008;11:4-12.

Value Health

The Effect of Epoetin Alfa on Quality of Life in Patients With Anemia

Medicare and many commercial insurers have employed reimbursement guidelines that look at hemoglobin or hematocrit thresholds for the use of erythropoeisis-stimulating agents in patients with anemia associated with cancer treatment or chronic disease. These policies do not seem to consider quality-of-life gains that may be associated with the therapy.

Researchers from Bethesda, Maryland, conducted a meta-analysis of trials that evaluated the effect of epoetin alfa on quality of life in patients with cancer, HIV/AIDS, and chronic kidney disease (CKD) and were published between January 1993 and September 2005. They were able to review 18 articles with similar inclusion criteria and endpoints. From these randomized, controlled clinical studies, they tried to correlate rising hemoglobin levels to improvements in quality of life among study participants.

The investigators revealed that statistically significant improvements in hemoglobin levels in patients with cancer receiving epoetin alfa compared with those receiving placebo or standard of care (range of between-group improvements, 1.2 to 1.9 g/dL). In patients with HIV/AIDS or CKD who received epoetin alfa improvements of 2.5—2.9 g/dL, and 2.7 g/dL, respectively) were noted compared with placebo or standard of care.

With regard to quality of life, statistically and clinically significant improvements were seen in fatigue and other measures across chronic conditions. Using a linear analog scale assessment scale for energy, improvements of at least 8 mm (which are considered clinically relevant) were frequently observed. Patients with cancer who received epoetin alfa compared with control groups demonstrated improvements of 0.8 to 19.8 mm, compared with control group patients. In those with HIV/AIDS or CKD, the improvements observed were even greater (range, 23—25 mm and 28 mm, respectively).

The researchers concluded that the treatment of anemia associated with either cancer, HIV/ AIDS, or CKD can significantly improve healthrelated quality-of-life scores, particularly fatigue. They believe that this improvement is clinically relevant.

Kimel M, Leidy NK, Mannix S, et al: Does epoetin alfa improve health-related quality of life in chronically ill patients with anemia? Summary of trials of cancer, hiv/aids, and chronic kidney disease.

2008;11:57-75.

Value Health

ASCO Seeks to Improve Coordination Of Care, Introduces Treatment Template

Treatment summaries can help improve not only coordination of care but also survivorship care, according to the American Society of Clinical Oncology (ASCO). It had produced a treatment plan and summary template for colorectal and breast cancer last year, but the Society has now released a generic version, which it believes can be applied to virtually any cancer.

The basic elements of the generic treatment plan and summary are designed “to improve patient treatment across health care settings by facilitating communication among oncologists, patients, and other care providers,” according to an ASCO press release. “The oncologist should complete the chemotherapy treatment plan before the patient begins receiving chemotherapy, to map out the patient’s planned treatment. After treatment is complete, the treatment summary will describe what care the patient actually received. The patient can keep these documents and share them with the doctors and other medical professionals who provide their follow-up care.” The Society indicated that it is developing ways to include these templated documents in electronic health records, which will help to provide improved sharing of patient information among the multidisciplinary treatment team.

The treatment summary and care planning template is available at www.asco.org. The Society reported that it is working to publish lung cancer templates this summer.

ASCO launches new template to document chemotherapy treatment and survivor care for cancer patients (press release). American Society of Clinical Oncology, March 18, 2008.

What Factors Increase the Likelihood of Colon Cancer Screening?

A lthough screening rates for colorectal cancer (CRC) have increased over the years, screening rates remain low nationally, a source of frustration for providers and health plans.

Scientists from the Veterans Affairs Center for the Study of Healthcare Provider Behavior, Sepulveda, California, reassessed member-reported responses to telephone surveys performed in 2000 and in 2003 implementation of a quality improvement program to measure CRC screening rates. All those participating in the surveys were members of a large managed care plan, based in Southern California. The researchers included in the definition of CRC screening the use of a fecal occult bleed test and/or colonoscopy (including flexible sigmoidoscopy).

At the baseline interview in 2000, health plan members reported mean screening rates of 38% of any test, 23% for endoscopy, 22% for the fecal occult blood test. As the Figure illustrates, results of a survey performed after 2003 showed that CRC screening rates increased, but not greatly.

Their analysis revealed that when people discussed the risk of CRC with a physician, the chance of having any of the screens more than doubled. If health plan members reported barriers to screening, the odds of a member screening decreased by at least 25%.

In related news, the American Cancer Society announced that it was recommending that two CRC screening tests be added to the guidelines for adults 50 years and older: (1) virtual colonoscopy and (2) a DNA test using stool samples. Neither of these tests are routinely covered by managed care plans at present, but it is hoped by the Society that inclusion in guidelines may be the first step to coverage. Recognizing that only half of the appropriate population receives any CRC screen, any additional tests that may attract others to arrange appointments for screenings can only improve this statistic. The DNA stool test may be just what the doctor ordered, a sensitive cancer screen that does not require the bowel preparation or trip to the colonoscopy suite necessary with the traditional invasive colonoscopy.

Farmer MM, Bastani R, Kwan L, et al: Predictors of colorectal cancer screening from patients enrolled in a managed care health plan.

2008;112:1230—1238.

Grady D: Two tests added to recommended list to prevent or detect colorectal cancer.

Cancer New York Times

March 6, 2008.

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