FDA Approves Risk Management Plan for ESAs

Cancer patients will learn more from their doctors about the possible risks and benefits of erythropoiesis-stimulating agents (ESAs) to manage anemia during chemotherapy under a new program just approved by the FDA.

ESAs can be given to chemotherapy patients to reduce the need for blood transfusions.  However, there can be problems with ESAs including causing some tumors to grow faster or some patients to die sooner.  They can also increase risk for blood clots, heart failure, heart attack or stroke.

ESAs, including Procrit®, Epogen®, and Aranesp®, are now covered by a REMS or Risk Evaluation and Mitigation Strategy which requires that patient receive a Medication Guide from their health care providers that tells them how to safely use an ESA drug.

In addition, health care providers who use ESAs with their patients must be be actively enrolled in  the APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) Oncology program and receive training in their safe use.  Continue reading…

Posted by Kate Murphy on February 23rd, 2010
Posted in: Research & Treatment News | No Comments »
Tags: Aranesp, Epogen, erythropoetin stimulating agents, ESA, FDA, Procrit

Amgen Changes Pricing Policy for Aranesp

As of October 1, 2008 Amgen will no longer offer rebates to oncologists and oncology clinics who purchase Aranesp® (darbepoetin alfa) although they will provide larger discounts at the time of purchase.

They also will no longer base discounts for Neulasta® (pegfilgrastim) and Neupogen© (filgrastim) on purchases of Aranesp, a process known as bundling.  Neulasta and Neupogen help raise white cell counts lowered by chemotherapy and are designed to prevent infection resulting from treatment.

Nancy Roach, Chairperson of the C3: Colorectal Cancer Coalition, told the New York Times,

It’s a step in the right direction.

In addition, she told C3 Research News that

C3 supports fair pricing policies for drugs used in cancer treatment that don’t interfere with physicians making the best decision for their patients based on evidence of safety and effectiveness.

Although rebates and discounts are offered by others in the pharmaceutical industry, there was criticism of Amgen’s pricing policies as evidence emerged showing potential safety problems when the drug was used in ways other than indicated on its FDA-approved label.

An Amgen spokesperson told the New York Times that perceptions that physicians might be over-prescribing Aranesp were not true.

Nevertheless, we believe these contracting changes, along with other modifications, help to clear up those possible misperceptions.

For cancer patients, Aranesp is used to prevent blood transfusions in patients who are receiving chemotherapy. An erythropoetin stimulating agent (ESA), it boosts red cell counts.  Other ESAs include PROCRIT® and EPOGEN® (epoetin alfa).  PROCRIT is sold by Ortho Biotech, EPOGEN by Amgen.

Aranesp, Epogen, and Procrit are not appropriate for cancer patients who are not receiving chemotherapy, and their use should be restricted to the lowest dose possible to prevent blood transfusion.  Recent labeling changes also restrict use of ESAs to patients whose cancer treatment is not aimed at a cure.  The dosage and administration section of the revised labels state that “Therapy should not be initiated at hemoglobin levels ≥ 10 g/dL.

A revised Medication Guide for patients was also released in August, 2008 reflecting the new labeling and potential for faster tumor growth, shorter survival, and serious cardiovascular side effects.

Posted by Kate Murphy on August 28th, 2008
Posted in: Research & Treatment News | No Comments »
Tags: Amgen, Aranesp, erythropoetin stimulating agents, ESA