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Reimbursement and Managed Care News for January 2008

OBTN, January 2008, Volume 2, Issue 1

Topics covered in this issue include:1) Dosing Patterns and Costs of Erythropoesis-Stimulating Agents in Patients With Cancer2) New Practice Guideline Updates Treatment of Nonâ%uFFFD%uFFFDSmall Cell Lung Cancer3) Large Health Insurer Begins Genetic Risk Counseling for Cancer4) Multiple Myeloma Guidelines Now Include Combination Therapy With Bortezomib5) Survey Finds That Managed Car Executives Are Misinformed About the Value and Cost of Cancer Biologics

Dosing Patterns and Costs of Erythropoesis-Stimulating Agents in Patients With Cancer

A retrospective study of nearly 9,000 patients with cancer receiving epoetin alfa or darbepoetin alfa found that costs and dosing regimens varied considerably among patients, and may point to recommendations for managed care organizations in determining how to address recent controversies in erythropoiesis-stimulating agent (ESA) prescribing.

Table

Aggregate information was collected from a medical claims database, covering erythropoietin use from 2002 to 2006. The investigators, from Ortho Biotech, found that approximately 4,300 patients taking epoetin and 4,500 taking darbepoetin met the criteria for inclusion into the study. Mean patient ages were 56.6 and 56.4 years, respectively. Three-quarters of the patients in both groups were women. The indicates the dosing frequencies among the two groups, with the patients receiving darbepoetin being more likely to receive longer dosing frequencies, although the duration of therapy was identical (61 days).

ESA Dosing Frequencies and Utilization

Dosing Frequency

Drug

Q1W

Q2W

> Q3W

Cumulative Mean

Epoetin

46.7%

41.2%

12.1%

292,035 units

Darbepoetin

10.1%

55.2%

34.7%

1,099 ug

The mean cost of treatment regimens were $3,656 for patients receiving epoetin and $5,029 for those receiving darbepoetin.

The authors concluded that extended dosing of both ESAs was common in patients receiving cancer chemotherapy, but drug costs between the two were significantly different.

Another study addressed the hot issue of how “followon” or generic-type biologic agents can save money for the health system, particularly ESAs. Researchers from Express Scripts, a pharmacy benefit manager, assumed that if 70% of patients switched to a “biogeneric” version of epoetin alfa (because its patent expired in 2004), $2 billion can be saved in the first year alone. Noting that this is the fourth largest class of biologics (behind autoimmune diseases, multiple sclerosis, and oncologics), Edmond Weisbart, MD, Chief Medical Officer, Medical Affairs, Express Scripts Inc., believes that $71 billion can be saved in just 10 years if only four categories of biotech agents are considered (ESAs, growth hormone, insulins, and interferon beta 1a and 1b).

Barron JJ, Mody SH, McKenzie RS, et al: Drug utilization and associated costs of erythropoiesis-stimulating agents in managed care patients with cancer receiving chemotherapy. Presented at the 2007 educational meeting of the Academy of Managed Care Pharmacy, October 26, 2007, Boston.

Weisbart E: Follow-on biologics: Critical considerations: Presented at the 2007 educational meeting of the Academy of Managed Care Pharmacy, October 25, 2007, Boston.

New Practice Guideline Updates Treatment of Non—Small Cell Lung Cancer

The non—small cell lung cancer NSCLC guideline produced by the National Comprehensive Cancer Network, Jenkintown, Pennsylvania, has been modified with some significant updates.

Principal changes include the addition of a new section devoted to the management of thymomas and thymic tumors, which addresses surgery, radiotherapy, and chemotherapy.

The choices for postoperative adjuvant chemotherapy regimens in patients with earlystage NSCLC have been enlargened with the addition of more cisplatin-based regimens and chemotherapy regimens to use for patients with comorbidities or for those who cannot tolerate cisplatin therapy. The alternative treatment choices are in large part based on carboplatin regimens.

The new guidelines also added screening advice for individualizing therapy for patients with this type of cancer. Specifically, molecular markers can be checked for patients with NSCLC to determine if the tumors contain epidermal growth factor receptor mutations. If so, these patients may respond well to tyrosine kinase inhibitors, such as erlotinib.

NCCN updates non-small cell lung cancer guidelines. National Comprehensive Cancer Network (www.nccn.org/ about/news/newsinfo. asp?NewsID=121), November 10, 2007.

Large Health Insurer Begins Genetic Risk Counseling for Cancer

If members of Aetna Inc., of Hartford, Connecticut, fill out an online survey about their family cancer history, this insurer—the third largest in the United States—will offer a program to provide counseling and possible genetic testing.

According to an announcement by the insurer, if a member’s personal health or family history indicates a possible increased risk for an inherited cancer (specifically breast, colorectal, and ovarian), the member then completes a survey, and an appointment can be scheduled with a genetic counselor from Informed Medical Decisions. This confidential phone call is designed to assist the member to determine his or her cancer risk level, assess whether a genetic lab test is appropriate, and respond to questions and concerns. The genetic counseling costs $375 but it was unclear as to whether the member would bear or share in that cost. Subsequent genetic testing would be reimbursed through the health plan’s medical benefit plan, with coinsurance and/or deductibles.

If the member proceeds with genetic testing, the tests are coordinated by the genetic counselor, who will share the results with the member’s physician. Once complete, a second telephone call with the member is scheduled to discuss the results and determine next steps, which may include behavioral modification or risk-reduction strategies.

Although this program may be the first by a major insurer to help spur genetic testing and counseling, it must be remembered that it is in Aetna’s (or any insurer’s) best interest to identify patients at high risk of cancer or other potentially high-cost disease and avoid coverage. The insurer disclosed that this program is based on a pilot program with its own employees conducted in 2006, in which Aetna did a financial analysis based on whether controlling costs by having people mitigate their own inherited risk is a viable concept. No results of that financial analysis have been released, but since the program has been opened to its general members, one might assume that it was at least not an expensive proposition.

Aetna to Offer Access to Confidential Telephonic Cancer Genetic Counseling to Health Plan Members (press release). Aetna Inc (www.aetna.com/news/2007/1127.htm) November 27, 2007.

Multiple Myeloma Guidelines Now Include Combination Therapy With Bortezomib

Recently, the multiple myeloma guidelines produced by the National Comprehensive Cancer Network (NCCN), Jenkintown, Pennsylvania, were modified to incorporate the latest scientific study results for this deadly cancer.

For patients with either relapsed or refractory multiple myeloma, bortezomib (Velcade) combined with pegylated liposomal doxorubicin is now listed as a category 1 recommendation, specifically for patients with progressive disease who have undergone stem cell transplant or for those who are not transplant candidates.

The organization made the addition based on the results of a phase 3 trial, demonstrating a median 3-month increased time to progression with the combination therapy and 3-month increased duration of response, compared with monotherapy. The NCCN noted that bortezomib monotherapy is still a category 1 recommendation, but combining this biologic with liposomal doxorubicin is preferred in patients with relapsed or nonresponding disease.

NCCN updates multiple myeloma guidelines. National Comprehensive Cancer Network (www.nccn.org/about/news/newsinfo. asp?NewsID=120), November 26, 2007.

Survey Finds That Managed Car Executives Are Misinformed about the Value and Cost of Cancer Biologics

Are we paying too much money for too incremental a benefit? This critical question is being asked more often in board rooms, as the number and utilization of oncology biopharmaceuticals proliferate. One of the problems, however, is that there is misinformation as to the cost and value of these products. A group of U.S. researchers tried to answer this question by conducting a telephone survey of managed care executives.

Fifty medical directors or pharmacy directors from managed care organizations or pharmacy benefit management firms were asked to evaluate the benefits associated with bevacizumab (Avastin), erlotinib (Tarceva) and sunitinib (Sutent). They were asked specifically to estimate and compare the monthly average wholesale prices and overall survival and progression-free survival data. The investigators used these data to calculate cost-effectiveness ratios; they returned to the survey respondents with these figures and the actual pricing and survival figures and asked the managed care executives to provide their answer to the question: Do these medications offer good value?

The researchers found that most of those surveyed were misinformed about the pricing (most overestimated costs) and survival benefits offered (most underestimated the benefits). The mean cost-effectiveness ratio based on their responses were $180,000/quality-adjusted life-year (QALY) for bevacizumab, $170,000/QALY for erlotinib, and $172,000/ QALY for sunitinib. The threshold for an agent being considered cost effective is generally acknowledged to be $50,000/QALY.

These data did not compel some of the respondents to label the products as being of low value, however, in the case of bevacizumab, 48% of the managed care executives still believed it provided good value for the money. Twenty-eight percent and 32% of those considered erlotinib and sunitinib, respectively, to be of good value. Only 30% deemed bevacizumab to not be a good value, compared with 52% for erlotinib and 46% for sunitinib. The remainder did not express either opinion.

Oncologist

Interestingly, these figures are far lower than estimates provided by oncologists in 2006 research (Nadler E et al: 2006;11[2]:90-95), who estimated the cost effectiveness of these therapies at around $300,000/QALY.

Two-thirds of the managed care executives responding to the survey also pointed out that “patients should have access to ‘effective’ cancer treatment regardless of cost.”

Nadler E, Broderick WC, Kim J, et al: Do payers believe new cancer drugs offer good value? Presented at the 2007 educational meeting of the Academy of Managed Care Pharmacy, October 26, 2007, Boston.

Age Makes a Difference in Convincing Members to Quit Smoking

Managed care organizations have reason to be ambivalent about the effectiveness of their programs to convince members to kick their smoking habits. A great number of resources have been poured into programs and medications that often demonstrate equivocal results, considering the rate of recidivism. Many health plans are happy if the primary care physician takes the lead on smoking cessation and counsels the patient, but the plans realize that their efforts may be more successful if patient age is considered in its design.

A 2005 survey of a Midwestern health plan’s membership found that 24.5% of 3,756 younger adults (18-24 yr) smoke compared with 17.1% of 3,405 older men and women (25-65 yr). Yet, they smoke fewer cigarettes per day (45.5% vs. 69.2%, respectively) and smoke less frequently upon wakening (11.2% vs. 21.8%, respectively) and not as frequently as their older counterparts. Younger daily smokes demonstrated a lower interest in quitting within the next 6 months (57.9%) compared with older daily smokers (66.3%).

A follow-up study conducted 12 months later of a subset of members describing themselves as daily or nondaily smokers at baseline found that the younger smokers were more likely to change smoking status. For example, daily smokers were more likely to have had one or more quit attempts in the past year (60.6% vs. 49.6%, respectively) but less likely to have used either nicotine replacement therapy or buproprion treatment (27.0% vs. 65.8%, respectively. On the other hand, they were more likely to go “cold turkey” (51.2% vs. 33.7%, respectively).

The authors of this study believe that “physicians and medical care organizations should pay particular attention, because these young smokers reported receiving much less help than older smokers did,” which may relate to their lower use of pharmacologic therapy compared with older adults.

Daily Smokers Use of Quit Methods in 12 Months

Survey Question

Aged 18-24 yr

Aged 25-65 yr

Tried nicotine replacement

19.1%

44.2%

Tried buproprion

7.9%

21.6%

Used telephone counseling

0.8%

8.8%

Used Web-based counseling

1.6%

8.8%

Assisted by doctor or clinic

6.4%

32.6%

Tried cold turkey method

51.2%

33.7%

Solber LI, Boyle RG, McCarty M, et al: Young adult smokers: Are they different?

2007;13:626-632.

O’Grady MA, Gitelson E, Swaby RF, et al: Development and implementation of a medical oncology quality improvement tool for a regional community oncology network: The Fox Chase Cancer Center Partners Initiative.

2007;5(9):875-882.

Am J Manag Care J Natl Compr Cancer Network