FFF Enterprises: BioSupply Trends Newsletter
Wednesday, Jan 25, 2017

Study Identifies Why TB Vaccines Are Ineffective


In this Issue

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

Researchers at the Washington University School of Medicine in St. Louis have discovered the reason the tuberculosis vaccine, Bacillus Calmette-Guérin, and other investigational vaccine candidates are not more effective is because the immune response is too slow; it’s not because they elicit an immune response that is too weak to control the infection. [ read more ]

Hemophilia B Gene Therapy Is Effective Despite Immune Reactions

In a Phase I/II study of nine patients with hemophilia B who underwent Spark Therapeutics’ SPK-9001 gene therapy, two patients experienced adverse autoimmune reactions, necessitating treatment with steroids and resulting in the production of lower levels of the blood-clotting protein factor IX (FIX); however, neither patient has suffered from bleeds or required rescue treatment with FIX infusions. [ read more ]

AMA Joins with Other Organizations to Reform Prior-Authorization Requirements

The American Medical Association and a coalition of 16 other organizations representing physicians, medical groups, hospitals, pharmacists and patients have devised a set of 21 principles to guide reform of utilization-management programs, including prior-authorization and step-therapy requirements. [ read more ]

Industry News


From Bio Products Laboratory

The U.S. Food and Drug Administration has approved Bio Products Laboratory’s Gammaplex 10% (immune globulin intravenous [human] 10% liquid) for the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura in adults. [ read more ]

From CSL Behring

The U.S. Food and Drug Administration has accepted CSL Behring's biologics license application for Privigen (immune globulin intravenous [human] 10% liquid) to treat chronic inflammatory demyelinating polyneuropathy.  [ read more ]

From Grifols

Grifols has opened a new Biomat USA Inc. plasma donor center in Sparks, Nev. The state-of-the-art 15,000-square-foot facility is Grifols’ second location in the Sparks/Reno area and the latest addition to its extensive plasma collection network. [ read more ]

IVIG & Albumin Supply Index


What's New at FFF

Bivalirudin (Fresenius Kabi)

Bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients 1) with unstable angina undergoing percutaneous transluminal coronary angioplasty; 2) undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor as in the REPLACE-2 study; and 3) with, or at risk of, heparin-induced thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome, undergoing PCI. It is available for intravenous use, and is supplied in a single-use vial containing 250 mg of Bivalirudin. It is intended for use with aspirin, and has been studied only in patients receiving concomitant aspirin.

For more information about Bivalirudin, login to biosupply.fffenterprises.com
*Call for eligibility through your GPO affiliation.

These products can be ordered from FFF Enterprise's BioSupply Online Ordering System or by calling
Wow! Customer Care at (800) 843-7477.

Current Medicare IVIG / SCIG Rates

Rates per gram are effective January 1, 2017, through March 31, 2017.

Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
Bivigam J1556 $74.29 $73.10
Carimune NF J1566 $64.08 $63.05
Flebogamma J1572 $65.36 $64.31
Gammagard S/D J1566 $64.08 $63.05
Gammaplex J1557 $78.01 $76.76
Octagam J1568 $70.80 $69.66
Privigen J1459 $77.35 $76.11
Cuvitru J3490 / J3590 / J7799 ** **
Hizentra J1559 $98.46 $96.88
HyQvia J1575 $129.69 $127.61
Gammagard Liquid J1569 $80.39 $79.10
Gammaked J1561 $72.88 $71.71
Gamunex-C J1561 $72.88 $71.71

*Reflects 2% sequestration reduction applied to 80% Medicare payment portion as required under Budget Control Act of 2011.
** Cuvitru does not yet have Medicare rates.



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

Subscribe to IG Living

IG Living is the only magazine for the immune globulin (IG) community for patients who suffer from chronic illness and their caregivers.

Subscribe to BioSupply
Trends Quarterly

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

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