Monday, May 20, 2019

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Studies Find Low IVIG Product Switching Rates in CIDP 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

Two independent studies showed a small number of chronic inflammatory demyelinating polyneuropathy (CIDP) patients switched brands of intravenous immune globulin (IVIG) over a two-year period, suggesting IVIG therapy is generally well-tolerated. However, differences existed in switch rates for different IVIG products. [ read more ]

Study Funds SCIG Maintains Stable Disease Activity in Myasthenia Gravis Patients While Transitioning from IVIG Therapy

A study that assessed the effectiveness, safety and tolerability of transitioning from intravenous immune globulin (IVIG) therapy to subcutaneous immune globulin (SCIG) therapy in the treatment of myasthenia gravis (MG) patients found SCIG enables MG patients to maintain stable disease activity. [ read more ]

New Gene Therapy Treatment Offers Possible Cure for SCID-X1

Researchers at St. Jude Children's Research Hospital have cured infants with X-linked severe combined immunodeficiency (SCID-X1) using gene therapy involving a re-engineered virus. [ read more ]

Industry News

From ADMA Biologics

ADMA Biologics has received approval from the U.S. Food and Drug Administration for its prior approval supplement for Bivigam (immune globulin intravenous [human] 10% liquid), allowing the company to use its optimized intravenous immune globulin manufacturing process to manufacture Bivigam, as well as market it to primary immunodeficiency patients in the U.S. ADMA anticipates the return of Bivigam to the market for commercial sale during the second half of 2019. [ read more ]

From GlaxoSmithKline

GlaxoSmithKline's Benlysta (belimumab), a B lymphocyte stimulator-specific inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) to treat chiildren 5 years and older with active, autoantibody-positive systemic lupus erythematosus who are receiving standard therapy. This approval extends the current indication in the U.S. approved by FDA in March 2011 for the intravenous formulation of Benlysta in adults with SLE. [ read more ]

From Sanofi SA

The U.S. Food and Drug Administration has given Sanofi SA's dengue vaccine, Dengvaxia, a narrow approval since the vaccine can cause severe infections in some people. According to FDA, Sanofi can sell the drug only to people age 9 years through 16 years who have laboratory confirmation of a previous dengue infection and live in areas where the disease is prevalent such as Puerto Rico, the U.S. Virgin Islands and American Samoa. [ read more ]

IVIG & Albumin Supply Index

Log in to BioSupply for IVIG and Albumin Product Pricing

What's New at FFF

• FIBRYGA (OCTAPHARMA USA)

FIBRYGA is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. It is not indicated for dysfibrinogenemia. FIBRYGA packages include one single-use bottle of FIBRYGA concentrate, one transfer device (Octajet) and one particle filter.

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

• JIVI (BAYER HEALTHCARE)

JIVI (antihemophilic factor [recombinant], PEGylated-aucl) is a recombinant DNA-derived Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for 1) on-demand treatment and control of bleeding episodes, 2) perioperative management of bleeding and 3) routine prophylaxis to reduce the frequency of bleeding episodes. JIVI is available as a lyophilized powder in single-use glass vials, one vial per carton. It is supplied with a sterile vial adapter with a 15-micrometer filter and a prefilled diluent glass barrel syringe, that together serve as a needleless reconstitution system.

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

• 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

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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.