We are pleased to inform you that The Centers for Medicare and Medicaid Services (CMS) has released the October 2010 Average Sales Price Pricing File containing the payment amount for Fluzone® High-Dose, Influenza Virus Vaccine, CPT®a 90662.
We recognize that many of you have expressed interest in utilizing the newly licensed Fluzone High-Dose vaccine for your patients 65 years of age and older, but have been waiting for this payment information from CMS before you adjusted your Fluzone vaccine reservation with sanofi pasteur. That payment information is now published for Fluzone High-Dose vaccine and can be accessed at: http://www.cms.gov/McrPartBDrugAvgSalesPrice/01a19_2010aspfiles.asp#TopOfPage. Click on the 2010 files in the left column and then select the October file from the list of zip files that appear in the center of the page.
Fluzone High-Dose vaccine is shipping now and all existing orders will be fully shipped by the week of October 4th. Adjust your Fluzone (Influenza Virus Vaccine) Reservation and receive all new Fluzone High-Dose vaccine orders within 5 business days. If you have not already done so, we strongly recommend that you consider switching some of your remaining Fluzone vaccine reservation to Fluzone High-Dose vaccine to ensure you have the correct Fluzone vaccine presentation for each of your patient populations.
Fluzone High-Dose vaccine was designed specifically to generate a more robust immune response to influenza in people 65 years of age and older. Understanding that this vaccine is included in the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices' influenza immunization recommendations and is a payable benefit under Medicare Part B, you now have a new tool to help prevent influenza in your patients.
Sanofi Pasteur continues to ship Fluzone vaccine and the 6-week window of visibility to future shipments is available and we expect to completely ship your current Fluzone vaccine reservation by the week of November 8, 2010.
If you would like to speak to a representative to learn more about Fluzone vaccine or Fluzone High-Dose vaccine, contact your sanofi pasteur representative or call 1-800-VACCINE (1-800-822-2463).
Consider the facts:
Influenza Disease Information
People 65 years of age and older are more likely to die or be hospitalized from influenza and its complications than younger adults. While those 65 years of age and older only represent about 15% of the US population, they account, on average, for 90% of all deaths due to seasonal influenza and its complications. Recent studies indicate that one of the reasons for this disproportionate burden is that people 65 years of age and older have weakened immune systems and do not respond to the standard-dose influenza vaccine as well as younger adults.1,2
Fluzone High-Dose Vaccine Information
In a pivotal clinical trial which included patients 65-97 years of age, Fluzone High-Dose vaccine produced up to 80% greater higher antibody titers than Fluzone vaccine.3
This vaccine was licensed under the Food and Drug Administration's accelerated approval process. This process is used for products for serious and life-threatening diseases to address an unmet medical need as is the case for patients 65 years of age and older who suffer a disproportionate burden due to influenza and its complications.
Fluzone High-Dose vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. This indication is based on the immune response elicited by Fluzone High-Dose vaccine; there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine.
The most common local and systemic adverse reactions to Fluzone High-Dose vaccine include soreness, pain, and swelling at the vaccination site; fever, headache, malaise, and myalgia. Other adverse reactions may occur. Fluzone High-Dose vaccine should not be administered to anyone with a history of hypersensitivity to any vaccine component, including eggs, and egg products. The decision to give Fluzone High-Dose vaccine should be based on the potential benefits and risks, especially if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine. The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.Vaccination with Fluzone High-Dose vaccine may not protect all individuals
Before administering Fluzone High-Dose vaccine, please see accompanying full Prescribing Information.
aCPT = Current Procedural Terminology is a registered trademark of the American Medical Association
References: 1. Monto AS, Ansaldi F, Aspinall R, et al. Influenza control in the 21st century: optimizing protection of older adults. Vaccine. 2009;27:5043. 2. Poland GA, Mulligan MJ. The imperative of influenza vaccines for elderly individuals-an evolving story. J Infect Dis. 2009:200:61-163. 3. Fluzone Vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2009.
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