Reimbursement and Managed Care News: September 2007

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â–º Exemestane Is a Cost-Effective Alternative to Tamoxifen in Estrogen Receptor—Positive Breast Cancer

A popular approach to adjuvant breast cancer treatment is to switch after two to three years of tamoxifen to an aromatase inhibitor to maximize disease-free survival. This protocol has been proven in studies to be clinically effective. Canadian economists have now confirmed that this approach is cost effective as well.

Following patients over 7.5 years, health economists from the University of Toronto and Sunnybrook Health Sciences Centre, Toronto found that a protocol using the aromatase inhibitor exemestane (Aromasin) in patients with estrogen receptor—positive breast cancer improved not only disease-free survival compared with patients not switching from tamoxifen resulted in greater diseasefree survival, but at a cost of CN$2,889 per patient (or $2,407 at 1.2 Canadian dollar to 1 U.S. dollar).

At an incremental cost-effectiveness ratio of CN$24,185 per quality-of-lifeyear gained, this would be considered by most health economists and health plans a cost-effective approach.

Risebrough NA, Verma S, Trudeau M, et al: Cost effectiveness of switching to exemastane versus continued tamoxifen as adjuvant therapy for postmenopausal women with primary breast cancer

. Cancer ,i>August 1, 2007.

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A More Accurate Way of Deciding Which Prostate Cancers to Treat?

For managed care plans, physicians, and patients alike, the diagnosis of prostate cancer is followed by the inevitable choices of watchful waiting, immediate surgical removal, and/or treatment with chemotherapy, depending on a number of issues, including anticipated tumor growth or spread. Scientists from London believe they may have found a genetic marker to better predict which prostate tumors are wolves in sheep’s clothing and require aggressive intervention.

Past research showed that the TMPRSS2 and ERG genes were typically fused in prostate tumors. However, new evidence from the Institute of Cancer Research of the United Kingdom indicates that patients with a double fusion of these genes, which appears in 7% of patients with prostate cancer, may portend far worse prognoses than for patients with single fusions of the genes.

The investigators found that the alteration, known as 2+Edel, is associated with 25% survival after eight years, compared with 90% survival in patients without the double fusion. The hazard rate for prostate-cancer related death was six times higher for patients with the double fusion than for those without it.

The authors of the study believe that this finding will enable physicians to go beyond the Gleason score, which is currently used to classify tumors. Physicians using the Gleason score may grade tumors differently, which may influence physician and patient decision making.

The use of the genetic test may lead to health plans and physicians more efficiently using resources and improve quality of life, by avoiding prostate surgery or other expensive intervention for those without the double fusion and in whom tumors are not aggressive.

Attard G, Clark J, Ambroisine L, et al: Duplication of the fusion of TMPRSS2 to ERG sequences identifies fatal human prostate cancer

July 16, 2007; (E-pub, ahead of print).

. Oncogene

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Senate Proposal Would Increase Payments to Oncologists…

Senate Bill S.1750 was introduced in July by Pennsylvania Senators Robert Casey, Jr. (D) and Arlen Specter (R) that would significantly affect reimbursement for oncology services and medications. It is similar to a House bill sponsored by Congressmen Artur Davis (D-AL) and Jim Ramstad (R-MN).

The bill includes provisions to eliminate prompt payment discounts from the calculation of the average sales price, which would raise payments to oncologists for office-administered cancer agents. It also includes payment codes for planning of treatment and the use of pharmacy facilities, which are not currently reimbursed by Medicare. Also, this proposal, called the Community Cancer Care Preservation Act of 2007, would reinstate reasonable payments for the initiation of cancer medications.

More details on Senate Bill S.1750 are available through the website of the Community Oncology Alliance (www.communityoncolo gy.org), including the text of the bill and contact information for Senators in all 50 states.

…But Medicare Seeks to Cut Physician Payments Across the Board

The physician fee schedule for 2008, released under a proposed rule, would drop payment rates under the Medicare Physician Fee Schedule by 9.9%. The size of the proposed reduction is a result of Congressional overruling cuts in the past, calculated through the use of a formula mandated by the Balanced Budget Act of 1997.

“For the past five years, Congress has intervened to prevent the implementation of the negative updates resulting from use of this formula,” said Leslie V. Norwalk, Esq., Acting Administrator, Center for Medicare and Medicaid Services. “CMS will continue working with Congress as well as physician groups to identify payment methods that help improve the quality and efficiency of care in a way that is cognizant of the costs to taxpayers and to Medicare and its beneficiaries. The Medicare program needs to compensate physicians appropriately for the services they provide to people with Medicare.”

As part of this proposal, the CMS is also seeking to change the method for determining the average sales price for part B drugs by better defining bundled arrangements and then mandating that pharmaceutical manufacturers provide price concessions based on the dollar value of the units of each drug sold under that bundled arrangement. The agency believes that the effect of this proposal will be to “better reflect the true costs incurred by physicians when purchasing part B covered drugs,” according to a press release.

Furthermore, the proposal includes a new requirement: physicians must report hemoglobin or hematocrit data on claims for drugs used to treat anemia secondary to anticancer treatment.

CMS proposes policy, payment changes for physicians services in 2008 (press release). Baltimore, Centers for Medicare and Medicaid Services, July 2, 2007.

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Factors Influencing Treatment Interruptions With Imatinib

Why do patients who have access to imatinib (Gleevec) treatment for chronic myelogenous leukemia (CML) stop therapy? This was the subject of a study of managed care plan members by researchers from a U.S. data analysis firm.

Using retrospective analysis of electronic health care claims data from adult patients with CML, the researchers collated data from patients who began treatment with imatinib from June 2001 through March 2004. Patients who failed to refill imatinib within 30 days of the prior prescription were identified. The medication possession ratio (MPR), a measure of compliance with therapy, was calculated as total days’ supply of imatinib divided by 365.

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Two hundred sixty-seven patients comprised the study group (average age, 50 yr; 57% men). The mean MPR was 77.7%, and 31% of patients were identified as having interrupting treatment at least once. However, each patient resumed the therapeutic regimen within a 12-month follow-up period. Factors negatively influencing compliance included the number of concomitant medications taken ( = .002), increasing cancer complexity ( = .003), and a higher starting dose of imatinib ( = .04). Interestingly, the researchers found that women were approximately twice as likely as men to have a treatment interruption ( = .009).

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The researchers also found that lower compliance with imatinib therapy was associated with significantly higher health care costs ( < .001): A 10-point difference in MPR was associated with a 14% difference in health care costs. “For example, patients with an MPR of 75% incur an additional $4,072 in medical costs annually compared with patients with an MPR of 85%,” stated the authors.

Darkow T, et al: Treatment interruptions and non-adherence with imatinib and associated health care costs: A retrospective analysis among managed care patients with chronic myelogenous leukaemia

2007;25:481-496.

. Pharmacoeconomics

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“Patient-Centered” Management Reduces Services Use But Not Outcomes

One of managed care’s most powerful tools is intensive case management of patients with complex diseases. Although it is widely acknowledged that this advocacy approach is appreciated by both patients and health plans, it is unknown how certain types of case management approaches might affect patient care. Researchers from Carnegie Mellon University, Pittsburgh performed a prospective cohort study of managed care plan members who underwent “patient-centered” case management to better understand how it influences service utilization and patient outcomes.

Patient-centered case management differs from traditional case management in that it emphasizes end-of-lifeand pain management, education, provider coordination, and patient advocacy.

The study comprised 756 patients from a commercial California health plan who had life-limiting diagnoses and multiple comorbid conditions. Three-quarters of the patients were diagnosed with cancer. Patients were either assigned to receive usual management or the study intervention. Both patient groups utilized identical provider networks, and accessed the same benefits. The patient-centered case management patients (47% of the study participants) were provided intensive education materials, multiple home visits (an initial visit and on average 0.8 visits/ patient/mo additionally), frequent contact with case managers (average, 10 hr/patient/mo; average, 14 telephone contacts/patient/mo), and goal-oriented care plans. Patients remained in the management protocol on average for more than three months.

The researchers found that 42% fewer oncology patients receiving the patient-centered management chose to utilize either chemotherapy or radiation compared with usual-management oncology patients). They also revealed that the study patients had reductions in inpatient diagnoses, which they believe are indicative of “uncoordinated care”: nausea (-44%), anemia (-33%), and dehydration (-17%).

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They noted that overall costs were reduced but this was not at the expense of patient survival. In fact, fewer of the study patients died during follow-up than did those with usual care (26% vs. 28%, respectively; = .80).

Comparison of Patients Undergoing Patient-CenteredCase Management With Those Undergoing Usual Care

Patient-Centered Management

Inpatient Admissions

-38%

Inpatient Delays

-36%

ER Visits

-30%

Hospice Days

+62%

19-Month Survival

+2%

The authors concluded that use of an intensive patient-centered management program “sharply reduces utilization and costs over usual management without shortening life.”

Sweeney L, Halpert A, WaranoffJ: Patient-centered management of complex patients can reduce costs without shortening life

2007;13:84-92.

. Am J Manag Care

â–º Inappropriate Medications Rife in Last Year of Life

The use of the Beers’ criteria (or list), which specifies medicines for which use in the elderly should be avoided or monitored with caution, has received greater attention since the publication of the Institute of Medicine’s report on reducing medical errors in the health care system. A retrospective review of data from a managed care plan has revealed that inappropriate prescribing in elderly patients is also common even in the last year of a patient’s life.

The pharmacy and medical records of Medicare beneficiaries who were members of a large national managed care plan during a three-year span were reviewed. A sample of 4,602 patients in their last year of lifewere studied, of whom 2,031 had at least one pharmacy claim that conflicted with the Beers’ criteria (44%). Fifteen percent of patients had two conflicts with the Beers’ criteria. Most common inappropriate medications included propoxyphene (15%), zolpidem (3.8%), and amitriptyline (2.8%).

Perhaps unsurprisingly, patients with cancer were most likely to receive propoxyphene and accounted for 35% of its use in this sample. Propoxyphene is a pain medication that is inappropriate for the elderly population because of its sedating characteristics, which place patients at risk for falls and hip fractures. Psychoactive medications accounted for most of the offending agents.

Fahlman C, Lynn J, Finch M, et al: Potentially inappropriate medication use by Medicare+Choice benefi ciaries in the last year of life. J Palliat Med 2007;10:686-695.

For more information regarding Beer’s criteria, visit www.dcri.duke.edu/ccge/curtis/beers.html.

Summary of Drugs Cited Within Beer's Criteria

alprazolam (Xanax) amiodarone (Cordarone) amitriptyline (Elavil) amphetamines anorexic agents barbiturates belladonna alkaloids (Donnatal) bisacodyl (Dulcolax) carisoprodol (Soma) cascara sagrada chlordiazepoxide (Librium, Mitran) chlordiazepoxide-amitriptyline (Limbitrol) chlorpheniramine (Chlor-Trimeton) chlorpropamide (Diabinese) chlorzoxazone (Paraflex) cimetidine (Tagamet) clidinium-chlordiazepoxide (Librax) clonidine (Catapres) clorazepate (Tranxene) cyclandelate (Cyclospasmol) cyclobenzaprine (Flexeril) cyproheptadine (Periactin) dessicated thyroid dexchlorpheniramine (Polaramine) diazepam (Valium) dicyclomine (Bentyl) digoxin (Lanoxin) diphenhydramine (Benadryl) dipyridamole (Persantine) disopyramide (Norpace, Norpace CR) doxazosin (Cardura) doxepin (Sinequan) ergot mesyloids (Hydergine) estrogens ethacrynic acid (Edecrin) ferrous sulfate (iron) fluoxetine (Prozac) flurazepam (Dalmane) guanadrel (Hylorel) guanethidine (Ismelin) halazepam (Paxipam) hydroxyzine (Vistaril, Atarax) hyoscyamine (Levsin, Levsinex)

indomethacin (Indocin, Indocin SR) isoxsuprine (Vasodilan) ketorolac (Toradol) lorazepam (Ativan) meperidine (Demerol) meprobamate (Miltown, Equanil) mesoridazine (Serintil) metaxalone (Skelaxin) methocarbamol (Robaxin) methyldopa (Aldomet) methyldopa-hydrochlorothiazide (Aldoril) methyltestosterone (Android, Virilon, Testrad) mineral oil naproxen (Naprosyn, Avaprox, Aleve) Neoloid nifedipine (Procardia, Adalat) nitrofurantoin (Microdantin) orphenadrine (Norflex) oxaprozin (Daypro) oxazepam (Serax) oxybutynin (Ditropan) pentazocine (Talwin) perphenazine-amitriptyline (Triavil) piroxicam (Feldene) promethazine (Phenergan) propantheline (Pro-Banthine) propoxyphene (Darvon) and combination products quazepam (Doral) reserpine (Serpalan, Serpasil) temazepam (Restoril) thioridazine (Mellaril) ticlopidine (Ticlid) triazolam (Halcion) trimethobenzamide (Tigan) tripelennamine