Reimbursement and Managed Care News: June 17, 2010

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Cost Effectiveness of Extended Letrozole Treatment After Discontinuation of Tamoxifen

The MA-17 trial assessed whether patients with early-stage breast cancer taking letrozole for five years after having received adjuvant tamoxifen experienced improved survival compared with those receiving placebo for the second five-year stage. The original study was discontinued when it was half completed, as the survival benefit was significant over placebo. As participants who were in the placebo arm were offered to continue with letrozole, the study was unblended, and the investigators decided to analyze whether those taking letrozole treatment compared with those from the placebo group who elected to continue with letrozole treatment, after what was a essentially a 2.5-year break in therapy, and if any health economic benefit was revealed.

A total of 1,655 patients in the placebo group decided to initiate letrozole therapy after unblinding. Six hundred thirteen elected to forego any therapy. The patients were followed up for two more years, and the cost-effectiveness analysis was performed based on the resulting improvement in survival. A Markov decision-analysis model was used to map the likelihood that patients would proceed to recurrence, maintain remission, or experience other health outcomes associated with therapy, based on the MA-17 clinical trial results.

Taken from the United Kingdom’s National Health Service perspective and using U.K. costs for treatment pathways, the researchers found that patients in the letrozole group gained 14.14 quality-adjusted life-years (QALYs) at a cost of £8,477 ($12,370) over the expected lifetime. Patients who did not elect to use letrozole after the placebo arm was discontinued gained 13.84 QALYs at a lifetime cost of £4,524 ($6,601). For patients receiving letrozole, the mean cost per QALY was £13,154 ($19,195), which is well beneath the threshold of what is expected to be cost effective.

The researchers conclude that compared with five years of tamoxifen therapy and no further active treatment, continuing five years of letrozole therapy is a cost-effective intervention.

Karnon J, DiTrapani F, Kaura S: Cost effectiveness of late extended adjuvant letrozole following a prolonged therapy break from tamoxifen. Presented at the American Society of Community Oncology’s San Antonio Breast Cancer Symposium, San Antonio, December 14, 2007.

The Effect of Consumer Cost Sharing on Mammography Rates

It has long been known that patients do not comply as well with pharmaceutical regimens when they are asked to shoulder more of the cost in terms of copayments (a fixed payment per prescription) or coinsurance (a percentage of the total cost of the prescription). Does this also apply to preventive interventions? According to researchers from Brown University, Providence, Rhode Island, the answer is yes.

In a retrospective study of members of 174 Medicare managed care plans conducted from 2001 to 2004, the investigators evaluated mammography testing frequencies for more than 366,000 women between the ages of 65 and 69 years. Over time, 18 of the health plans changed their benefit design, requiring cost sharing by the member (considered to be more than $10 per mammogram or a coinsurance of more than 10%), when none of the plans had required cost sharing earlier. This change affected 11.4% of the women whose claims records had been studied.

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Mammography performed every two years in those plans after the cost share was introduced or increased was eight percentage points lower than in those with full coverage ( < .001). In fact, in plans that retained full coverage, mammography rates increased by 3.4 percentage points. Unsurprisingly, the difference in mammography rates increased further in low socioeconomic groups.

As in prescription drug coverage, small increases in consumer cost sharing had a significant effect on the use of preventive mammography screening in this Medicare population. The investigators suggested that removing cost shares for this specific population may help improve mammography rates.

Trivedi AN, Rakowski W, Ayanian JZ: Effect of cost sharing on screening mammography in Medicare health plans.

2008;358:375-383.

N Engl J Med

National Poll: Government Coverage Decision on Anemia Drugs Hurt Patient Outcomes

A poll sponsored by US Oncology, a large oncology provider network, revealed that the vast majority of physicians surveyed believe that the issuance of the National Coverage Decision by the Centers for Medicare and Medicaid Services regarding erythropoeisis-stimulating agents (ESAs) has resulted in preventable adverse patient events.

The national coverage decision set specific guidelines for reimbursement of ESAs based on hematocrit/hemoglobin levels in patients with cancer being treated for anemia. The guideline levels were set in reaction to studies showing that patients given ESAs above these levels were at risk for increased mortality.

Of the 307 hematologists and oncologists surveyed (of whom < 20% belonged to a US Oncology practice), 91% indicated that they had seen adverse events related to the coverage decision in the 12 weeks after its implementation. The most common are listed in the Table. In more than one-half of the adverse events reported, the physicians complained that the patient’s anemia was inadequately treated, resulting directly in the inability to reach target chemotherapy dose. For the clinicians who noted that preventable transfusions were required, they noted that this affected an average of 17% of their Medicare oncology patients. Twenty-nine percent of respondents indicated that the coverage policy has resulted in more transfusions given overall, 20% more patients with anemia, and 25% noted lower quality of life for patients.

Preventable adverse events/outcomes resulting fromESA coverage decisions, reported by the clinicians

Percentage

Outcome

73%

Transfusion required

65%

Persistent anemia despite compliance

with coverage guidelines

54%

Inability to reach target chemotherapy

dose/duration because of anemia

39%

Failed to meet hemoglobin response

rates within 8 wk, ESA discontinued

ESA = Erythropoeisis-stimulating agents.

The founder of the organization conducting the survey, Kenneth J. Tomaszewski, MD, stated in press release: “The need to determine how policy change affects real-life practice is critical to understanding its true impact. This study provides evidence that the national coverage decision, as it relates to ESAs, may have costs associated with quality- of-life decrements and increased treatment times that may outweigh the benefits for some patients.”

Oncologists report adverse patient events from CMS national coverage decision on ESAs. HONI Online, February 7, 2008.

Updated Breast Cancer Clinical Practice Guidelines

As newer approaches to oncology therapy and management continue to reach the market, professional organizations try to keep up with the pace of advances. The National Comprehensive Cancer Network (NCCN) has released the latest update to its Clinical Practice Guidelines in Oncology—Breast Cancer series.

According to NCCN, one of the revisions focuses on a rare form of breast neoplasm—inflammatory breast cancer. It is found in up to 6% of all cases of breast cancer but is highly aggressive. The new guidelines recommend that inflammatory breast cancer without metastases be treated initially using anthracycline therapy with or without a taxane drug. If the patient responds to the chemotherapy, the patient should undergo total mastectomy followed by radiation therapy.

Another revision includes the incorporation of a gene-based assay of tumor tissue, which NCCN believes can guide chemotherapy treatment decision making in patients with small hormone receptor—positive, HER2-negative tumors that are moderately or poorly differentiated or larger tumors.

The updated guidelines also include new recommendations involving breast reconstruction procedures after mastectomy.

NCCN updates breast cancer guidelines. National Comprehensive Cancer Network (www.nccn.org), January 22, 2008.

DNA Testing for Disease: Will Insurance Worries Limit Their Value?

A test for certain DNA mutations can predict up to a fivefold increased likelihood that a man may develop prostate cancer in the future. The test costs only $300. Wouldn’t most men consider getting the test to better understand whether they are at high risk?

Genetic testing can be an extremely valuable tool to detect or even prevent disease, particularly in areas where biotechnology can play a role in treatment. This has been seen in women who have been found to have genetic markers that indicate a high likelihood of future breast cancer; some have elected to undergo preventive mastectomy to reduce or eliminate the risk. However, people who have genetic testing results reported as part of their medical record are also concerned about health insurers becoming aware of their positive test results and being labeled as uninsurable as a result.

New York Times

According to an article in the , the National Institutes of Health concede that instead of embracing genetic testing, they are seeing clear signs that the public is shying away from it. Francis S. Collins, MD, Director of the National Human Genome Research Institute, commented in the article, “If that continues, the future of medicine that we would all like to see happen stands the chance of being dead on arrival.”

It is not just insurers who are wary, it is employers as well, who sponsor more than one-half of the health insurance plans in the United States. Although discrimination in the workplace is prohibited by the Americans With Disabilities Act, employers are still largely free to not hire someone who, though not presently ill, they believe may become ill and add to mounting health care costs. It is illegal to exclude people enrolled in group policies based on genetic testing, but this does not apply to individual policies.

A study from Georgetown University found that in nearly 10% of hypothetical underwriting decisions, insurance providers indicated they would deny coverage to individuals, charge higher premiums, or exclude targeted disorders from benefits, based on a person’s genetic test results.

Harmon A: Insurance fears lead many to shun DNA tests.

February 24, 2008.

New York Times

Women With Breast Cancer Get Lower Pay

The physical and emotional toll on women who suffer breast cancer is high, but according to a new report from Canada, working women who suffer breast cancer also suffer another financial burden—lower pay.

Researchers, principally from Laval University, Quebec City, found that women were at risk for losing more than 25% of the income they had originally within one year of being diagnosed with breast cancer.

They evaluated 459 women who were actively working when they were diagnosed with early- stage breast cancer. A total of 403 indicated that they cut back on work hours or missed work because of the disease. Although 10% of the women surveyed said that they had lost the majority of their income, mean wage losses were 27% (median, 19%). This figure accounted for other forms of compensation the women might have received, including disability payments and sick-leave pay.

The researchers noted that this study did not consider missed pay increases or lost opportunities for promotion while the women were undergoing therapy, and therefore, the income loss story may be incomplete.

Lauzier S, Maunsell E, Drolet M, et al: Wage losses in the year after breast cancer: Extent and determinants among Canadian women.

February 26, 2008 (E-pub before print).

J Natl Cancer Inst

Lack of Health Insurance Equals Delayed Cancer Diagnoses

Previous studies have proven that health insurance status has a direct effect on whether patients seek care (and seek care appropriately) for many disease categories. Logically, this should not be any different for a serious diagnosis like cancer, and data exist to support this assumption, particularly for cancer-screening services, such as mammography or colonoscopy. Furthermore, regional studies have linked insurance coverage status with stage of cancer at presentation, but this has not yet been shown on a national basis. Researchers from the American Cancer Society sought to close this gap in the data.

The investigators studied the records of 3.7 million U.S. patients who received their diagnosis from 1998 to 2004. The records were obtained from a hospital-based cancer registry. The patient population was representative of U.S. population demographics, reflecting insurance coverage, ethnicity, and socioeconomic status.

Based on the analysis, the researchers found that compared with fully insured (private insurance) patients, individuals who were not insured or who had Medicaid coverage were significantly more likely to have a delayed diagnosis, presenting with advanced-stage cancer. Supporting previous research, this finding was particularly significant for cancers for which routine screening for early detection is recommended, such as colorectal, lung, or breast cancer.

The probability of a late stage cancer diagnosis was increased not only by insurance coverage but by race and ethnicity as well, pointed out the researchers, who showed that regardless of insurance status, African Americans and Hispanics were more likely to have their cancers diagnosed at a later-stage compared with Caucasians.

They concluded, “Although many factors other than insurance status also affect the quality of care received, adequate insurance is a crucial factor for receiving appropriate cancer screening and timely access to medical care.”

Odds ratio for presenting with advanced-stage cancerat diagnosis associated with insurance coverage.

Insurance Status

Odds Radio

Colorectal Cancer

Medicaid Coverage

1.6

No Coverage

2.0

Private Insurance

1.0

Melanoma

Medicaid Coverage

3.3

No Coverage

2.3

Private Insurance

1.0

Halpern MT, Ward EM, Pavluck AL, et al: Association of insurance status and ethnicity with cancer stage at diagnosis for 12 cancer sites: A retrospective analysis.

2008; 9:222-231.

Lancet Oncology