Monday, Mar 18, 2019

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WHO Issues New Flu Vaccine Composition Recommendations for 2019-20 Season

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 World Health Organization (WHO) advisory board issued its new recommendations on the composition of the influenza vaccines for use in the 2019-20 flu season in the Northern Hemisphere: The egg-based quadrivalent vaccines should contain an A/Brisbane/02/2018 (H1N1)pdm09-like virus; an A(H3N2) virus to be announced March 21; a B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage); and a B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage). The influenza B virus component of trivalent vaccines should contain a B/Colorado/06/2017-like virus of the B/Victoria/2/87-lineage. [ read more ]

Flu Shot Does Not Cause Pregnant Women to Miscarry

Reversing a previous study finding, a new study that examined the 2012-13, 2013-14 and 2014-15 flu seasons individually and together found no evidence of increased miscarriage risk after the flu vaccine during the first 28 days, and no significant association between miscarriage and the flu vaccine in the 29- to 56-day risk window and beyond. [ read more ]

Scientists Uncover Breakthrough in Development of Universal Flu Vaccine

Researchers at the University of Melbourne have identified parts of the influenza (flu) virus that haven't changed within the past century, a finding that shows promise for developing a one-time flu vaccine. [ read more ]

Industry News

From Novo Nordisk

In February, the U.S. Food and Drug Administration approved Esperoct (antihemophilic factor [recombinant], glycopegylated-exei), an extended half-life factor VIII molecule for replacement therapy in people with hemophilia A, which provides a 1.6-fold half-life prolongation in adults and adolescents and a 1.9-fold half-life prolongation in children, compared to standard half-life factor VIII products. [ read more ]

From Meridian Bioscience

Meridian Bioscience has received U.S. Food and Drug Administration (FDA) clearance for its new Alethia CMV Molecular Amplification Test (formerly, the illumigene brand) designed to specifically detect congenital Cytomegalovirus (cCMV) infection in newborns from an easy-to-collect saliva sample. It is the first qualitative test in a molecular amplification format that is cleared by FDA for cCMV testing in newborns.
[ read more ]

From Momenta Pharmaceuticals

In January, Momenta Pharmaceuticals completed dosing of the first subject in the Phase I/II clinical trial of M254, hypersialylated immunoglobulin G. 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 & 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

• OMIDRIA (OMEROS)

Omidria is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor that is added to ophthalmic irrigation solution used during cataract surgery or intraocular lens replacement. It is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain.

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

• ZEMDRI (ACHAOGEN)

ZEMDRI (plazomicin) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections, including pyelonephritis caused by the following susceptible microorganism(s): Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Enterobacter cloacae. It is supplied in single-dose (50 mg) 10-mL vials fitted with flip-off seals with royal blue polypropylene buttons as a clear, colorless to yellow, sterile solution.

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

• NAROPIN (FRESENIUS KABI)

Naropin (Ropivacaine) hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Naropin is preservative-free and is available through FFF in single dose containers in 2 (0.2%) and 5 (0.5%) concentrations.

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

• XYLOCAINE (FRESENIUS KABI)

Xylocaine (lidocaine HCI) injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks. Xylocaine is available in the following dosage forms: Xylocaine-MPF, Xylocaine MPF with Epinephrine and Xylocaine with Epinephrine.

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

• DIPHENHYDRAMINE (FRESENIUS KABI)

Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when Diphenhydramine hydrochloride in the oral form is impractical: antihistaminic, motion sickness and antiparkinsonism. Diphenhydramine is available in 50 mg/mL SDV packs of 25.

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

• DILTIAZEM (AKORN)

Diltiazem hydrochloride injection is a calcium ion influx inhibitor (slow channel blocker or calcium channel antgonist) indicated for the treatment of atrial fibrillation or atrial flutter and paroxysmal supraventricular tachycardia. Diltiazem is available through FFF in the following strengths and sizes: 25 mg/5 mL, 50 mg/10 mL and 125 mg/25 mL.

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

• ONDANSETRON (HERITAGE PHARMACEUTICALS INC)

ONDANSETRON injection, USP is a 5-HT3 receptor antagonist indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy and the prevention of postoperative nausea and/or vomiting. Ondansetron is available through FFF in 4 mg/2 mL vials packs of 25.

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

• POTASSIUM CHLORIDE (HOSPIRA)

Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. Potassium Chloride is available through FFF in the following concentrations and sizes: 10 mEq/5 mL, 20 mEq/10 mL and 40 mEq/20 mL.

For more information about POTASSIUM CHLORIDE,
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 January 1, 2019, through March 31, 2019.

Product	J Codes	ASP + 6% (before sequester)	ASP + 4.3%* (after sequester)
IVIG
Flebogamma	J1572	$68.79	$67.69
Gammagard S/D	J1566	$86.22	$84.84
Gammaplex	J1557	$91.78	$90.31
Octagam	J1568	$70.94	$69.80
Privigen	J1459	$80.64	$79.34
SCIG
CUVITRU	J1555	$136.05	$133.87
Hizentra	J1559	$101.12	$99.50
HyQvia	J1575	$141.78	$139.51
IVIG / SCIG
Gammagard Liquid	J1569	$84.45	$83.10
Gammaked	J1561	$80.23	$78.94
Gamunex-C	J1561	$80.23	$78.94

*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

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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.