Wednesday, July 21, 2015

AMA Adopts More Stringent Vaccine Requirement Policy

kid holding up an immunization record card

At its annual meeting in June, the American Medical Association adopted a new policy to seek more stringent state immunization requirements to allow exemptions for medical reasons only. The policy recommends that states have in place an established decision mechanism that involves qualified public health physicians to determine which vaccines will be mandatory for admission to school and other public venues. The recommendation includes that states grant exemptions to those mandated vaccines only for medical reasons. [ read more ]

In this Issue


•	IVIG/Albumin Supply Index
•	Open Market Pricing
•	New Products from FFF
•	Current Medicare IVIG Rates
•	Resources
•	Subscribe to IG Living and BioSupply Trends Quarterly

Study Outlines Barriers and Facilitators of Flu Vaccine Decisions

To understand why more individuals don’t get the annual influenza vaccine, researchers at the Oak Ridge Institute for Science and Education analyzed 29 flu vaccine-related communication research reports sponsored by the CDC’s National Center for Immunization and Respiratory Diseases between 2000 and 2013, from which they identified seven reasons that lead people to get the annual flu vaccine and six reasons they do not. [ read more ]

Center for Biologics Evaluation and Research (CBER) Update

The Center for Biologics Evaluation and Research (CBER), a branch within the FDA that is responsible for the release of influenza vaccine in the United States, has started their process for product licensing approvals and is reporting the release of a few early lots of influenza vaccine. [ read more ]

Industry News

From Baxter

On July 1, Baxter International spun off its Baxter BioScience global biopharmaceutical business into Baxalta, which will focus on developing new treatments for people with orphan diseases and underserved conditions. According to Baxter, Baxalta will build on its strengths in hematology and immunology, while seeking to expand its oncology portfolio for patients with limited treatment options. [ read more ]

From CSL Behring

CSL Behring has awarded its 2015 Interlaken Leadership Award (www.interlakenleadershipawards.com) to Mohammad Alsharabati, MD, from the University of Alabama at Birmingham for original research in the field of neuroimmunology. [ read more ]

From The Medicines Company

The U.S. Food and Drug Administration has approved The Medicines Company’s RAPLIXA (fibrin sealant) and the RaplixaSpray device to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical. [ read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Supply Index from January - July 2015

Log in to BioSupply for IVIG and Albumin Product Pricing

New Products From FFF

• VariZIG Liquid Formulation (Emergent BioSolutions)

Varicella zoster immune globulin (human) is indicated for post-exposure prophylaxis in high-risk individuals, including immunocompromised children and adults; newborns of mothers with varicella shortly before or after delivery; premature infants; infants less than 1 year old; adults without evidence of immunity; and pregnant women

• Zerbaxa 1.5 g vial/10 pack (Merck)

Combination cephalosporin-class antibacterial drug and a beta-lactamase inhibitor indicated for the treatment of the following infections caused by designated susceptible microorganisms:

Complicated intra-abdominal infections, used in combination with metronidazole
Complicated urinary tract infections, including pyelonephritis

• Stratis Needle-Free Injection System 0.5 mL (PharmaJet)

Needle-free injection system that delivers vaccines either intramuscularly or subcutaneously via a narrow, precise fluid stream syringe that delivers the medicine or vaccine through he skin (only approved for use with AFLURIA 5 mL 10 DS vial)

• Novoeight 250 IU vial, 500 IU vial, 1000 IU vial, 1500 IU vial, 2000 IU vial, 3000 IU vial (Novo Nordisk)

Antihemophilic factor (recombinant) indicated for use in adults and children with hemophilia A for:

Control and prevention of bleeding
Perioperative management
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes

• Sivextro Tedizolid Phosphate 200 mg tablet-6 pk, 200 mg tablet-30 pk, 200 mg IV vial-10pk (Merck)

Antibacterial drug for the treatment of adults with skin infections and to reduce the development of drug-resistant bacteria

• Tice BCG 50 mg SDV (Merck)

Intravesical vaccine for the treatment and prophylaxis of carcinoma in situ of the urinary bladder, and prophylaxis of stage Ta and/or T1 papillary tumor of the urinary bladder

• Gardasil 9 0.5 ml PFS (Merck)

Human papillomavirus 9-valent vaccine approved for females ages 9 years through 26 years

FFF Enterprises offers a wide portfolio of plasma products, vaccines and critical-care biopharmaceuticals, to view our complete list of products visit our website – Product Catalog. These products can be ordered by calling Wow! Customer Care at (800) 843-7477.

Current Medicare IVIG Rates

Rates per gram are effective July 1, 2015 through September 30, 2015.

Product	J Codes	ASP + 6% (before sequester)	ASP + 4.3%* (after sequester)
Bivigam	J1556	$78.02	$76.76
Carimune NF	J1566	$64.50	$63.46
Flebogamma	J1572	$69.50	$68.39
Gammagard Liquid	J1569	$77.57	$76.32
Gammagard S/D	J1566	$64.50	$63.46
Gammaked	J1561	$79.60	$78.33
Gammaplex	J1557	$73.06	$71.89
Gamunex-C	J1561	$79.60	$78.33
Octagam	J1568	$77.33	$76.09
Privigen	J1459	$76.56	$75.34

*Reflects 2% sequestration reduction applied to 80% Medicare payment portion as required under Budget Control Act of 2011.

Resources

FFF customers may order the following complementary resources to help you with your practice:


•	IG Immune Globulin (Human)
•	Hyperimmune Globulins
•	Anti-Inhibitor, Factor VIIa & IX
•	Factor VIII & von Willebrand Factor
•	Seasonal Influenza Vaccine

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Trends Quarterly

BioSupply Trends Quarterly magazine is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace.