Monday, February 19, 2018

Banner Image - Patient Safety, Product Integrity, Fair Pricing

European Union to Suspend Marketing Authorizations of All Hydroxyethyl Starch (HES) Products

In this Issue


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

The European Union is set to suspend marketing authorizations for all HES solutions for infusion, after decades of use of these products for plasma volume replacement following acute blood loss when crystalloids alone are not considered sufficient. This action was prompted by safety concerns related to continuing use of HES in critically ill patients and patients with sepsis, despite restrictions on its use in these patient populations implemented in 2013 by both the European Medicines Agency and the U.S. Food and Drug Administration. [ read more ]

Long-Term Rituximab Treatment Is Safe and Effective in Treating Autoimmune Neurological Diseases

A recent study shows long-term depletion of peripheral B cells with rituximab appears safe and effective in treating patients with immune-mediated neurological disorders such as neuromyelitis optica, multiple sclerosis and myasthenia gravis. [ read more ]

Study Shows Cancer Vaccine Eliminates Tumors in Mice

Researchers at the Stanford University School of Medicine have found that injecting two minute amounts of immune-stimulating agents directly into solid tumors in mice can eliminate all traces of cancer in the animals, including distant, untreated metastases. [ read more ]

Industry News

From Grifols

Grifols’ HyperRAB (rabies immune globulin [human]) has been approved by the U.S. Food and Drug Administration to treat rabies postexposure prophylaxis. The new formulation is twice the potency (300 IU/mL) of currently available rabies immune globulin options, offering a greater concentration of anti-rabies virus antibodies within each mL of volume, as well as the potential for fewer injections by significantly reducing the volume of medication administered in each dose. [ read more ]

From CutisPharma

The U.S. Food and Drug Administration has approved CutisPharma’s FIRVANQ (vancomycin hydrochloride) for oral solution for the treatment of Clostridium difficile-associated diarrhea and eneterocolitis caused by Staphylococcus aureas, including methicillin-resistant strains. [ read more ]

From GigaGen

GigaGen Inc. has been awarded a $3 million grant from the National Institutes of Health to advance its next-generation plasma therapy for patients with primary immune deficiencies. [ read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Supply Index from November 2017 - February 2018

Log in to BioSupply for IVIG and Albumin Product Pricing

MyFluVaccine Loyalty Program

Want priority access on flu vaccines
for the 2019-2020 season?

Then take advantage of our NEW inclusive MFV Loyalty Program and enroll for the 2019-2020 season when you go to book your flu vaccine orders for the 2018-2019 season through MyFluVaccine.com

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What's New at FFF

• DAPTOMYCIN (TEVA)

DAPTOMYCIN (injection) is indicated for the treatment of adult and pediatric patients (1 to 17 years old) with complicated skin and skin structure infections caused by Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. Equisimilis and Enterococcus faecalis (vancomycin-susceptible isolates only). It is not indicated to treat pneumonia. It comes in 500 mg lyophilized powder for reconstitution in a single-dose vial.

For more information about DAPTOMYCIN, 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 Jan. 1, 2018, through Mar. 31, 2018.

Product	J Codes	ASP + 6% (before sequester)	ASP + 4.3%* (after sequester)
IVIG
Carimune NF	J1566	$68.83	$67.73
Flebogamma	J1572	$67.31	$66.23
Gammagard S/D	J1566	$68.83	$67.73
Gammaplex	J1557	$77.62	$76.37
Octagam	J1568	$71.18	$70.04
Privigen	J1459	$76.96	$75.73
SCIG
CUVITRU	J1555	$137.89	$135.68
Hizentra	J1559	$98.31	$96.73
HyQvia	J1575	$140.63	$138.37
IVIG / SCIG
Gammagard Liquid	J1569	$81.45	$80.14
Gammaked	J1561	$81.41	$80.10
Gamunex-C	J1561	$81.41	$80.10

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

Log in to BioSupply for Immune Globulin Products

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

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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