Ortho Biotech to Submit Official Request for Reconsideration to CMS Regarding ESA Coverage Policy

BRIDGEWATER, N.J., Nov. 8 /PRNewswire/ -- Ortho Biotech Products, L.P., the company that markets PROCRIT(R) (Epoetin alfa), today will formally request that the Centers for Medicare and Medicaid Services (CMS) reconsider its final National Coverage Determination (NCD) for erythropoiesis-stimulating agents (ESAs). The company's request will be available online at www.orthobiotech.com and www.VoiceForCancerPatients.com.

The company will provide new scientific evidence and highlight specific areas in which it believes that CMS materially misinterpreted existing data in reaching its current NCD. These two conditions are specified by CMS as necessary for reconsideration of an NCD.

"The goal of our reconsideration request is to re-open an evidence-based dialogue with CMS to ensure that Medicare reimbursement for ESAs supports safe and effective treatment of anemia for patients receiving chemotherapy," said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/Nephrology, Ortho Biotech Products L.P. "The policy of most concern is the imposition of a coverage limit on ESA treatment once hemoglobin levels reach 10 grams per deciliter of blood (g/dL). We will present CMS with additional scientific data demonstrating the importance of individualizing ESA therapy -- particularly when to initiate and stop therapy -- based on the medical needs of Medicare patients."

    In its request, Ortho Biotech will present new evidence, including:
    -- Data addressing the hemoglobin concentrations at which Medicare
       patients receive transfusions;
    -- Data addressing transfusion risks associated with various hemoglobin
       concentrations at which ESA therapy is initiated;
    -- Data correlating maximum hemoglobin limits to achieved hemoglobin
       levels;
    -- Recent product labeling reviews in the EMEA and in the United States;
    -- New national practice guidelines;
    -- Further information concerning ESA U.S. registration trials; and
    -- Interim safety results of a large, randomized, placebo-controlled trial
       in patients with advanced Hodgkin's disease undergoing chemotherapy.

Ortho Biotech believes that PROCRIT is safe and effective for the treatment of anemia in patients with most types of cancer receiving concurrent chemotherapy when used according to its FDA-approved prescribing information. Epoetin alfa has been studied for more than 20 years and used in four million patients worldwide for approved indications.

About PROCRIT (Epoetin alfa)

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important U.S. Safety Information for PROCRIT

Boxed WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, and Tumor Progression

Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

    Cancer:
    -- ESAs shortened overall survival and/or time-to-tumor progression in
       clinical studies in patients with advanced breast, head and neck,
       lymphoid, and non-small cell lung malignancies when dosed to target a
       hemoglobin of greater than or equal to 12 g/dL.
    -- The risks of shortened survival and tumor progression have not been
       excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.
    -- To minimize these risks, as well as the risk of serious cardio- and
       thrombovascular events, use the lowest dose needed to avoid red blood
       cell transfusions.
    -- Use only for treatment of anemia due to concomitant myelosuppressive
       chemotherapy.
    -- Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

Contraindications

PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.

    Additional Important Safety Information
    -- The dose of PROCRIT should be titrated for each patient to achieve and
       maintain the following hemoglobin levels:
         -- Chronic renal failure patients -- hemoglobin levels between 10 to
            12 g/dL. If a patient does not attain hemoglobin levels of 10 to
            12 g/dL despite 12 weeks of appropriate PROCRIT therapy see DOSAGE
            and ADMINISTRATION in the PROCRIT Prescribing Information.
         -- Cancer or HIV patients -- the lowest hemoglobin level sufficient
            to avoid transfusion and not to exceed 12 g/dL.
    -- Monitor hemoglobin regularly during therapy, more frequently following
       a dosage adjustment or until hemoglobin becomes stable.
    -- Cases of pure red cell aplasia (PRCA) and of severe anemia, with or
       without other cytopenias, associated with neutralizing antibodies to
       erythropoietin have been reported in patients with chronic renal
       failure receiving PROCRIT by subcutaneous administration.  If any
       patient develops a sudden loss of response to PROCRIT, accompanied by
       severe anemia and low reticulocyte count, and anti-erythropoietin
       antibody-associated anemia is suspected, withhold PROCRIT and other
       erythropoietic proteins.  Contact ORTHO BIOTECH (1-888-2ASKOBI or
       1-888-227-5624) to perform assays for binding and neutralizing
       antibodies.  If erythropoietin antibody-mediated anemia is confirmed,
       PROCRIT should be permanently discontinued and patients should not be
       switched to other erythropoietic proteins.
    -- The safety and efficacy of PROCRIT therapy have not been established in
       patients with a known history of a seizure disorder or underlying
       hematologic disease (e.g., sickle cell anemia, myelodysplastic
       syndromes, or hypercoagulable disorders).
    -- In some female patients, menses have resumed following PROCRIT therapy;
       the possibility of pregnancy should be discussed and the need for
       contraception evaluated.
    -- Prior to and regularly during PROCRIT therapy monitor iron status;
       transferrin saturation should be greater than or equal to 20% and
       ferritin should be greater than or equal to 100 ng/mL.  During therapy
       absolute or functional iron deficiency may develop and all patients
       will eventually require supplemental iron to adequately support
       erythropoiesis stimulated by PROCRIT.
    -- During PROCRIT therapy, blood pressure should be monitored carefully
       and aggressively managed, particularly in patients with an underlying
       history of hypertension or cardiovascular disease.
    -- In studies, the most common side effects included fever (pyrexia),
       diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or
       loss of strength or weakness (asthenia, fatigue), shortness of breath,
       high blood pressure, headache, joint pain (arthralgias), abnormal skin
       sensations (as tingling or tickling or itching or burning;
       paresthesia), rash, constipation, and upper respiratory infection.

Please visit www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.