Specialty Pharmacy

Featured Health Business Daily Story October 29, 2007

New Climate for Erythropoiesis-Stimulating Agents Offers Major Opportunity for Specialty Pharmacies to Achieve Better Outcomes

Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs and injectables more effectively.

The current environment of increased scrutiny of erythropoiesis-stimulating agents (ESAs) presents a prime management opportunity for specialty pharmacies to help bring about good outcomes, according to one industry expert.

Oncology is one of the costliest disease areas in specialty pharmacy, and the fact that ESAs are "a big portion of cancer care.sometimes is forgotten," said Helen Sherman, Pharm.D., senior director of pharmacy services and chief pharmacy officer at The Regence Group's PBM unit, RegenceRx. Even though these therapies, which include Epogen (epoetin alfa), Aranesp (darbepoetin alfa) and Procrit (epoetin alfa), are supportive-care drugs that help with symptoms, rather than curative, disease-treating products, they can cost between $7,000 and $11,500 for a 12-week treatment cycle that is concurrent with cancer treatment, she noted. Thus, any changes to protocols surrounding these drugs will have a huge impact on plans, she maintained in a Sept. 27 AIS audioconference titled Effective Health Plan Strategies for Managing Epoetin Products.

"There is no doubt that these have a proven benefit in reducing blood transfusions," said Sherman, who pointed out that evidence shows 50% of patients not treated with ESAs needed transfusions, while 20% to 25% treated with ESAs needed transfusions. However, she said, there "is no scientific proof that ESAs improve quality of life, function and survival."

Although ESAs' risks — including ones tied to exceeding certain levels of hemoglobin — have been well-known for a long time, said Sherman, some newer ones have come to light over the past year. "There are significant concerns that the risks outweigh the benefit" of ESA treatment in patients whose anemia is caused by cancer rather than chemotherapy. Similar concerns surround patients undergoing surgery who are given ESAs to prevent the need for transfusions, in addition to patients with advanced head and neck cancer and patients with metastatic breast cancer whose hemoglobin levels are aggressively pushed beyond 12 grams per deciliter (g/dL).

Safety issues with ESAs include risks of blood clots, strokes and heart attacks; tumor progression, which is "one of the most significant areas of concern," but an area with only "preliminary" theories; and decreased survival, which is "another emerging area," she said. Aggressive use of ESAs to quickly normalize hemoglobin levels had been the approach 10 or 15 years ago, she said, but data have shown there is increased risk with this. Similarly, concerns surround off-label uses. "The flags of what we do know cause concerns for areas that have not been studied," she said. "Off-label uses have grown over time. We don't know the risk-benefit profile from uses that have not been studied."

Concern Exists With CMS Guidelines

In CMS's response to ESAs' safety concerns, the agency "did a very thorough job of reviewing and weighing the evidence, but some areas are a mystery to us," said Sherman. With CMS's policy that it would pay for certain patients whose hemoglobin levels are below 10 g/dL, "it is not completely clear to us as to how CMS came to this" level. "It is implied in the guidelines that CMS is urging physicians to check hemoglobin levels in two weeks after treatment starts, but the guidelines are silent on what to do after" this point, she said. "There is no guidance on what happens after 10 g/dL. .There is concern that the guidelines don't match the labeling and that they go against the scientific evidence," Sherman said. "CMS's guidelines are inconsistent with the FDA-approved uses."

Regence's philosophy, explained Sherman, is "we screen for potential areas of risk, and we target hemoglobin levels. Reinforcing not overshooting the target level of 12 is our main focus. We make sure the risks are known to physicians and patients." In order to achieve this, the plan undergoes educational outreach to physicians, she said. According to Sherman, Regence will also start requiring treatment recheck levels between two and six weeks after the start of therapy. "As long as the hemoglobin is below 12, we support that and will cover that," she added.

In response to questions about whether 12.1 g/dL or 12.2 g/dL hemoglobin levels, for example, are acceptable, the plan's policy supports coverage for patients with hemoglobin levels between 12 and 13 g/dL "if the physician decreases the dose by 25%," she said.

Regence will also "increase the scope of our prior authorization" by "randomly checking with physicians two weeks out.to see how onboard they are with these guidelines," she noted.

CMS has said that it will post a frequently asked questions page on ESAs "soon," Sherman pointed out. "We at Regence will continue to dig into how CMS is using the threshold of 10 so we will know whether to adopt that or continue on the course of what we're doing."

"There is a considerable opportunity for [specialty pharmacies] to get the message out" about ESA use and its safety concerns, contended Sherman. Based on Regence's discussions with specialty pharmacy vendors, they "are certainly up on the emerging data and risks, but there is no sense of extensive interventions or attempts" to maintain patient hemoglobin levels of less than 12 g/dL, said Sherman. "There is an enormous opportunity to bring good patient care."

ESA Dosing May Be Above FDA Warning Levels

Michael Joslin, chief operating officer of CareCore Oncology and executive vice president of CareCore National, LLC, presented data that CCN collected from two unidentified physician networks in the northeastern U.S. that are associated with health plans. Plan A's data were collected in fall 2006, while Plan B's were from the beginning and spring of 2007. CCN is in the process of collecting new data, said Joslin, who was previously president of OncoMetrix, Inc. and orchestrated its merger with CCN earlier this year.

The data, which were self-reported by physicians, "do not represent 100% of the oncologists and hematologists using these drugs in Plan A or Plan B," noted Joslin. Data for the two plans showed that 60.3% and 61.1%, respectively, of patients treated for all diagnoses received initial ESA dosing at hemoglobin levels equal to or less than 11 g/dL - levels that reflect appropriate guidelines according to both the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN). That meant, though, that 39.7% and 38.9%, respectively, of ESA administration was above guideline-supported utilization. For patients with a cancer diagnosis only, 45.5% and 39.0%, respectively, were dosed at a hemoglobin level above 11 g/dL.

With continued ESA dosing, though, the same data revealed something "surprising" — that "there was use of products above a level of 12 g/dL," which represents a level above the FDA's warning threshold, said Joslin. For patients treated for all diagnoses, 1.5% in Plan A and 2.8% in Plan B were dosed at or above a hemoglobin level of 12 g/dL. For patients with a cancer diagnosis, none in Plan A were dosed at this level, but 1.9% in Plan B were dosed at this level.

CCN's ESA program has three goals, said Joslin. "The most significant of these goals" is member safety, he said. CCN "monitors for adherence and compliance to the FDA warning" of 12 g/dL — an "appropriate aspect of any ESA program," he contended. The second goal is an open formulary, by which the physician maintains the member's medical management. It is important, he said, that physicians "make decisions as to which ESA product is best suited for the patient. We do not favor one ESA or another." Appropriate administration is the last goal, which includes "compliance with national administration guidelines established by NCCN and ASCO." While Medicare is another authority that has established ESA guidelines, the current policy is "suspect," he said, so "we direct clients to NCCN and ASCO."

Joslin said that there are a number of ESA management options available for plans. They could choose an internal or an outsourced program. Plans also need to decide whether they want to undertake an outreach program for physicians, or perform a "soft" review or a "hard" prior authorization. Look at the frequency of the review or prior authorization — "an eight-week period is probably appropriate," said Joslin. Plans will need to determine the starting therapy hemoglobin level at the onset of the program. And because data show that not all physicians check a patient's iron stores before initiating ESA therapy, even though ASCO and NCCN recommend this step, plans should decide how they will ensure this is done. Options to do this are either soft or hard — requiring that physicians respond to a soft question-and-answer format, or requiring that they submit a copy of the lab results or at least acknowledge that they have a copy on hand.

According to Joslin, there are some additional considerations for ESA management:

• URAC and/or National Committee for Quality Assurance accreditation,
• Plan ESA utilization and network structure,
• Network communication,
• ESA program interface: phone/fax/Internet,
• State regulations, and
• Oncology/hematology physician expertise/support.

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