Monday, Apr 22, 2019

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New Study Will Evaluate hsIgG vs. IVIG in ITP Patients

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

In January, Momenta Pharmaceuticals performed dosing of the first subject in the Phase I/II clinical trial of M254, hypersialylated immunoglobulin G (hsIgG). The four-part study will evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of intravenous M254 in approximately 65 subjects, including healthy volunteers and patients with immune thrombocytopenic purpura. [ read more ]

IVIG Plus Ciclosporin Is Safe in IVIG-Refractory KD Patients

A new study has found combined primary therapy with intravenous immune globulin (IVIG) and ciclosporin is safe and effective for favorable coronary artery outcomes in Kawasaki disease patients who were predicted to be unresponsive to IVIG. [ read more ]

Serum Albumin a Strong Predictor of Mortality in Sepsis

A retrospective, correlational study of all patients admitted to a U.S. regional hospital's intensive care unit with a primary diagnosis of sepsis showed admission serum albumin level, serum albumin trend over time and lowest serum albumin level were all significant unique predictors of mortality. [ read more ]

Industry News

From ADMA Biologics

ASCENIV (immune globulin intravenous, human [slra 10% liquid]), formerly referred to as RI-002, has been approved by the U.S. Food and Drug Administration (FDA) to treat primary humoral immunodeficiency disease (PI) in adults and adolescents 12 years to 17 years old. The company anticipates having the product available for commercial launch during the second half of 2019. [ read more ]

From Takeda Pharmaceuticals

In March, the U.S. Food and Drug Administration (FDA) approved Takeda Pharmaceuticals' second submission for its new plasma manufacturing facility near Covington, Ga., for the production of Flexbumin 25% solution [albumin (human)], indicated for hypovolemia, hypoalbuminemia (burns, adult respiratory distress syndrome and nephrosis), cardiopulmonary bypass surgery and hemolytic disease of the newborn. The Georgia facility received its first FDA approval to manufacture Gammagard Liquid [immune globulin infusion (human)] 10% solution in June 2018. [ read more ]

From GCAM Inc.

GCAM Inc., a U.S.-based plasma collection company, has added additional plasma collection centers located in Brownsville, Texas. With the newest additions, GCAM now runs 10 plasma donation centers nationwide. [ read more ]

IVIG & Albumin Supply Index

Log in to BioSupply for IVIG and Albumin Product Pricing

What's New at FFF

• ANDEXXA® (PORTOLA)

ANDEXXA [coagulation factor Xa (recombinant), inactivated-zhzo] is the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. It is supplied in cartons of four single-use vials containing 100 mg of ANDEXXA as a white to off-white lyophilized cake or powder.

For more information about ANDEXXA, login to biosupply.fffenterprises.com

• LidoDose® (GENSCO PHARMA)

Prepare your patients for a less painful flu season with LidoDose, the single dose™ topical anesthetic and antiseptic for preprocedural preparation of the skin prior to an injection and pain associated with any procedure requiring penetration of the skin, including vaccinations.

For more information about LidoDose, login to biosupply.fffenterprises.com

• ALBUMINEX® (BIO PRODUCTS LABORATORY)

ALBUMINEX [Human 5% and 25%], prepared from the pooled plasma of U.S. donors in FDA-licensed facilities in the U.S., comes in 5% and 25% albumin solutions indicated for adults and children for hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardipulmonary bypass. ALBUMINEX 5% is supplied in 12.5 g and 25 g single-dose vials. ALBUMINEX 25% is supplied in 50 mL and 100 mL single-dose vials.

For more information about ALBUMINEX, login to biosupply.fffenterprises.com

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 April 1, 2019, through June 30, 2019.

Product	J Codes	ASP + 6% (before sequester)	ASP + 4.3%* (after sequester)
IVIG
Flebogamma	J1572	$72.85	$71.68
Gammagard S/D	J1566	$119.62	$117.70
Gammaplex	J1557	$88.40	$86.98
Octagam	J1568	$64.94	$63.90
Privigen	J1459	$81.44	$80.13
SCIG
CUVITRU	J1555	$131.69	$129.58
Hizentra	J1559	$101.94	$100.31
HyQvia	J1575	$141.09	$138.83
IVIG / SCIG
Gammagard Liquid	J1569	$84.31	$82.96
Gammaked	J1561	$77.50	$76.25
Gamunex-C	J1561	$77.50	$76.25

*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.

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Trends Quarterly

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