Monday, Nov 19, 2018

Banner Image - Patient Safety, Product Integrity, Fair Pricing

Human Vaccines Project Launches Study of How the Immune System Responds to the Flu

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

With a goal of understanding the immune system to develop longer-lasting protection against influenza (flu), researchers will conduct a comprehensive evaluation of the human immune system's response to flu. [ read more ]

Experimental Tandem Lung-Bone Marrow Transplant Shows Promise as Treatment for PI

A novel experimental tandem lung and bone marrow transplant has proved successful in seven patients with terminal lung disease who also had primary immunodeficiencies (PIs) or evidence of bone marrow failure. [ read more ]

Prednisolone Improves Coronary Artery Outcomes in KD Patients at High Risk of IVIG Resistance

A new study shows that a primary intravenous immune globulin (IVIG) and prednisolone combination therapy might prevent coronary artery abnormalities and contribute to lowering medical costs in Kawasaki disease (KD) patients.
[ read more ]

Industry News

From Genentech

After the deadly 2017-18 influenza (flu) season in the U.S., the U.S. Food and Drug Administration has approved Baloxavir (Xofluza), a new, single-dose medication to treat people 12 years and older who have had the flu for no more than 48 hours.[ read more ]

From Shire

Shire has filed its second submission to the U.S. Food and Drug Administration to manufacture Flexbumin 25% (albumin [human]) at its new plasma manufacturing facility near Covington, Ga. [ read more ]

From Leadiant Biosciences

The U.S. Food and Drug Administration has approved Leadiant Biosciences' Revcovi (elapegademase-Lvlr) injection for the treatment of adenosine deaminase severe combined immune deficiency in pediatric and adult patients. [ read more ]

IVIG & Albumin Supply Index

Log in to BioSupply for IVIG and Albumin Product Pricing

NOW AVAILABLE! Astero® & LidoDose® from Gensco Pharma

Astero®
Challenges with pressure ulcers and other chronic wounds? It is estimated that up to 60,000 Americans die each year as a direct result of pressure ulcer-related complications. Encourage wound healing with Astero®, a medicated Hydrogel wound dressing containing Lidocaine Hydrochloride 4%, an amide type local anesthetic, indicated for: painful wounds such as stage I-IV pressure ulcers, venous stasis ulcers, ulcerations caused by mixed vascular etiologies, diabetic skin ulcers, first and second degree burns, post-surgical incisions, cuts and abrasions.

LidoDose®
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.

Product	NDC Number	Size
Astero®	35781-2500-03	1 oz. (28.5 g) 30 mL
LidoDose®	35781-0301-05	1 mL 25-bx

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

• ARIPIPRAZOLE Unit Dose (Apotex)

Aripiprazole tablets are an atypical antipsychotic used to treat schizophrenia, bipolar disorder, major depressive disorder and irritability associated with autism.

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

• CYANOKIT (MERIDIAN)

CYANOKIT (hydroxocobalamin for injection) is indicated for the treatment of known or suspected cyanide poisoning. Each carton consists of one 250 mL glass vial, containing lyophilized hydroxocobalamin for injection, 5 g; one sterile transfer spike; one sterile intravenous infusion set; one quick-use reference guide; and one package insert. Diluent is not included.

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

• FULPHILA (MYLAN)

FULPHILA (pegfilgrastim-jmdp for injection) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti cancer drugs associated with a clinically significant incidence of febrile neutropenia. The clear, colorless solution is supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-jmdb and supplied with a 29-gauge 1/2-inch needle with an UltraSafe Passive Plus Needle Guard.

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

• IXIARO (VALNEVA)

IXIARO is indicated for active immunization against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older. Each 0.5 mL pre-filled syringe contains 6 antigen units of inactivated Japanese encephalitis.

For more information about IXIARO, 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

• XERAVA (TETRAPHASE PHARMA)

XERAVA (eravacycline) for injection is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older. It is supplied in a single-vial carton containing one 50 mg single-dose vial or in a 12-vial carton containing 12 50 mg single-dose vials.

For more information about XERAVA, 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

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 October 1, 2018, through December 31, 2018.

Product	J Codes	ASP + 6% (before sequester)	ASP + 4.3%* (after sequester)
IVIG
Flebogamma	J1572	$70.13	$69.01
Gammagard S/D	J1566	$75.89	$74.67
Gammaplex	J1557	$104.13	$102.46
Octagam	J1568	$73.44	$72.27
Privigen	J1459	$79.27	$77.99
SCIG
CUVITRU	J1555	$133.97	$131.82
Hizentra	J1559	$98.60	$97.02
HyQvia	J1575	$141.25	$138.98
IVIG / SCIG
Gammagard Liquid	J1569	$86.28	$84.90
Gammaked	J1561	$78.98	$77.72
Gamunex-C	J1561	$78.98	$77.72

*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.