March 2008 Practice Update

ODAC Recommends ESAs Continue to be Indicated for Treatment of Chemotherapy-Induced Anemia But with New Restrictions
On March 13, the Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) convened to discuss the risks of erythropoeisis-stimulating agents (ESAs) when administered to patients with cancer. The advisory committee recommended continuing the ESA indication for treatment of chemotherapy-induced anemia; however, the panel also recommended several changes to the safety labels on the drugs Aranesp, Epogen, and Procrit, placing significant restrictions on their use for cancer patients.

By a vote of 13 to 1, ODAC recommended that ESAs continue to be marketed for ESA use for treatment of chemotherapy-induced anemia in patients with cancer.While the panel rejected a proposal to modify the current indication to restrict use only to patients with small cell lung cancer, it supported recommendations to amend the label and include statements that ESA usage is not indicated for patients receiving potentially curative treatments and for patients with metastatic disease of the breast and/or head and neck. The panel did not reach consensus on when to initiate ESA therapy. The panel also supported requiring implementation of an informed consent/patient agreement for the treatment of anemia for these patients, but the panel rejected a recommendation calling for FDA to mandate a restricted distribution system for oncology patients receiving ESAs.

Dr. Samuel Silver presented the views ASH and ASCO regarding the safety and appropriate use of ESAs. The testimony emphasized that pending the publication of more definitive and peer-reviewed data on safety signals in the target population of the ASH-ASCO guideline, our organizations do not see sufficient evidence of harm to support recommending complete cessation of the use of ESAs across all patients with malignancies. Further, Dr. Silver reminded the advisory committee that there is compelling evidence to support safe use of ESAs in anemic patients with low-risk myelodysplasia.The testimony also addressed the need to better inform patients about the risks and benefits of ESA therapy and that additional studies are necessary to address lingering safety questions.

Read the ASH-ASCO 2007 clinical practice guideline update on the use of epoetin and darbepoetin.

Earlier this week, the FDA approved a revised label for ESAs. As part of the changes, the boxed warning has been updated to state that ESAs "shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small-cell lung, head and neck, lymphoid, and cervical cancers, when dosed to target hemoglobin of greater than or equal to 12 grams per d/l."

The revised label has also been updated to include additional data from studies of the product in the oncology setting. ESA labels were updated in November to include additional information about the risks of the drugs in patients with cancer and chronic renal failure.

OUTLOOK: ODAC's recommendations are non-binding.The FDA now will review ODAC's recommendations and make a decision on whether to further revise the drug labeling.ASH will continue to meet with FDA and Congress about its concerns on the impact these potential restrictions could have on patients with hematologic diseases. Specifically, it is not clear what ODAC's recommendations would mean for treating patients with stage four lymphoma. In addition, while ODAC's recommendations did not address ESA therapy for patients with myelodyslasia, ASH will continue to work to ensure that insurers allow coverage. ASH will keep the practice community apprised of all developments.

ASH Members Meet with Congress about Medicare Physician Payment
On March 13, members of the Government Affairs Committee met with several congressional offices to urge that the scheduled 10.6 percent cut in Medicare physician fees that are scheduled to begin on July 1, 2008 be replaced with a positive update.

The current methodology for determining CMS physician reimbursement is based on the sustainable growth rate (SGR), which uses a complex conversion factor to calculate changes in physician reimbursement rates from year to year. Unfortunately, the SGR poorly reflects the actual rate of biomedical inflation, and in recent years has significantly underestimated the costs associated with providing care. This has forced Congress to repeatedly enact temporary relief as the gulf between reimbursements rates calculated using the SGR and those reflecting the true cost of care continues to widen.

While most members of Congress are supportive of preventing the physician reimbursement cuts, they are also struggling with how to pay for this estimated $12-$15 billion over the next five years. There has been extensive discussion and controversy about decreasing reimbursement from the Medicare Advantage plans as one way to pay for the physician payment fix. In addition, the Medicare Payment Advisory Committee has discussed further ways for Medicare to improve quality and efficiency including: expansion of the Physician Quality Reporting Initiative program, implementing structural measures, including purchasing and electronic health record, collecting and sharing data on physician's comparative costs to improve efficiency and testing pilot programs such as efficiency in treating chronic conditions and development of medical homes for beneficiaries.

ASH will continue discussions with Congress on the physician reimbursement issue and will keep the practice community apprised of all developments.

Radioimmunotherapy Agents: Controversy over Medicare Reimbursement Continues
ASH attended the March 5 CMS Advisory Panel on Ambulatory Payment Classification Groups (APC) on pricing policy for the radioimmunotherapy agents of Zevalin and Bexxar. The legislative language in the Medicare, Medicaid, and SCHIP Extension Act of 2007, has been interpreted by CMS in a way that does not cover the full costs of treatment and therefore, facilities may be reluctant to provide this treatment for non-Hodgkin lymphoma. Presentations from Dr. Robin Joyce of Harvard Medical School and from Glaxo-Smith Kline consistently reported that this class of drugs is under-reimbursed, that inadequate payment may jeopardize access to the therapy and that all components of the therapeutic regimen should be included in the reimbursement policy. The APC concluded that it will reevaluate the payment for this class of drugs by reviewing hospital claims data and information from stakeholders.

ODAC RecommendsApproval of Romiplastim for ITP
On March 12, presented its biologic license application for Nplate (romiplostim) to ODAC. ODAC voted that the clinical data demonstrate a favorable risk-benefit profile for certain patients with chronic idiopathic thrombocytopenic purpura (ITP).

However, ODAC also requested a risk management program, due to the small number of patients and relatively short timeframe involved in the cited studies.The details of a risk management program will need to be determined.

The ASH guidelines on ITP was extensively cited in the discussions. The Food and Drug Administration will review the ODAC recommendations and render its decision. ASH will keep the practice community apprised regarding FDA's decision on this application.

von Willibrand Guideline Released
On February 29, the National Heart, Lung, and Blood Institute (NHLBI) released "von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel report (USA)" in the journal Haemophilia. ASH is providing a link to this guideline as a service to our members and at the request of NHLBI.

Update on Heparin Recall
On February 11, 2008, the FDA advised health-care practitioners to limit use of the Baxter injectable blood-thinning drug heparin due to serious allergic reactions and hypotension in patients who receive high "bolus" doses of the drug. Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable heparin. They have also recalled all of their multi-dose and single-use vials of heparin. As a precautionary measure, they have recalled heparin lock flush solutions.

After launching an investigation in both the United States and abroad, the FDA has found a heparin-like compound present in some of the heparin Active Pharmaceutical Ingredient produced by Scientific Protein Labs.

At this time, the FDA does not have proof that this contaminant is causing the adverse events. This contaminant is present in significant quantities, accounting for 5 percent to 20 percent of the total mass of each sample tested. More information, including questions and answers on heparin sodium injection, is available online.

CMS Tamper Resistant Requirements for Medicaid Effective April 1
Effective April 1, all written prescriptions for Medicaid patients must be on paper with at least one tamper-resistant feature as outlined by CMS and defined by individual states. By October 1, three tamper-resistant features are required. Additional information on CMS' requirements is available online.

ASH Encourages Comments to National Quality Forum on PQRI Hematology Measures
PQRI provides payment incentives for reporting of Medicare quality measures.Currently, ASH members can participate in six measures – four hematology measures developed by ASH and two for health information technology. ASH encourages its members to participate in this pay for performance federal initiative. Preliminary results show that participation on hematology measures is lower, ranging from 8 percent to 10.69 percent, than the nationwide average usage for all measures, which was 15.74 percent.

The hematology measures are currently in comment phase toward approval by the National Quality Forum (NQF). ASH encourages members to comment by March 21. Your active support of these measures will ensure that they are ultimately approved by NQF and therefore, continue to be available in the 2009 PQRI program.

Electronic Health Record EHR Demonstration Opportunity
Medicare is seeking 12 communities across the country to participate in a five-year demonstration project to show the benefits of interoperable Electronic Health Records. Physician practices will be eligible for incentive payments. For additional information, please read Kerry Weem's article.