Biosupply Trends Marketplace News
Monday, November 23, 2015
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Study Shows Diminished Quality of Life for PI Patients

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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
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In a recent study, primary immunodeficiency disease patients scored significantly lower on a number of instruments assessing health-related quality of life compared with normal controls and other chronic disease patients. [ read more ]

IVIG May Be First-Line Therapy for Statin-Triggered Autoimmune Myopathy

A small three-patient case study at the Johns Hopkins Myositis Center suggests that intravenous immune globulin could be used as a first-line treatment for statin-triggered autoimmune myopathy. [ read more ]

CMS Issues Final Biosimilars Rules

At the end of October, the Centers for Medicare and Medicaid Services issued final rules detailing how it will pay for services provided to Medicare beneficiaries in 2016.
[ read more ]

Industry News

blue molecules

From Bio Products Laboratory

The first specific replacement therapy, Coagadex, for hereditary factor X deficiency (coagulation factor X) has been approved by the U.S. Food and Drug Administration for individuals 12 years and older for on-demand treatment and control of bleeding episodes, as well as for perioperative management of bleeding in individuals with mild hereditary factor X deficiency.
[ read more ]

From ProMetic Life Sciences

The U.S. Food and Drug Administration has cleared the Investigational New Drug application for ProMetic Life Sciences’ intravenous immune globulin product for the treatment of primary immunodeficiency disease. This Phase III open-label, single-arm, two-cohort multicenter clinical trial is slated to begin in the fourth quarter of 2015.
[ read more ]

From Baxalta

Baxalta has submitted an application to the U.S. Food and Drug Administration for approval of an investigational 20 percent concentration immunoglobulin subcutaneous (IGSC 20%) treatment for patients with primary immunodeficiency disease (PI). This U.S. filing is based on positive results of a Phase II/III study of IGSC 20% in North American patients at least 2 years old with PI.
[ read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Supply Index from April - October 2015
 
Log in to BioSupply for IVIG and Albumin Product Pricing
 

Featured Products Of The Month

Bivigam (BioTest)

BIVIGAM (immune globulin intravenous (human) 10% liquid) is indicated for the treatment of primary humoral immunodeficiency, including but not limited to the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. The product has a median half-life of 30 days, contains no sucrose/glucose/maltose, is stabilized with glycine, has trace amounts of IgA, contains a latex-free stopper, features tamper-evident seals and can be stored for up to 24 months (until expiration date on vial packaging) at 2 degrees to 8 degrees Centigrade.

For more information about Bivigam, go to biosupply.fffenterprises.com

Miacalcin (Mylan Institutional)

MIACALCIN (calcitonin-salmon) synthetic injection is for subcutaneous or intramuscular use and is indicated for the following conditions: 1) hypercalcemia; 2) Paget’s disease of bone; and 3) postmenopausal osteoporosis. It is available as a sterile solution in individual 2 mL multi-dose vials containing 200 IU per mL, and should be refrigerated between 2 degrees to 8 degrees Centigrade.

Zarxio (Sandoz Inc.)

ZARXIO (filgrastim-sndz) injection is for subcutaneous or intravenous use. It is a leukocyte growth factor indicated to: 1) patients with cancer receiving myelosuppressive chemotherapy; 2) patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; 3) patients with cancer undergoing bone marrow transplantation; 4) patients undergoing autologous peripheral blood progenitor cell collection and therapy; and 5) patients with severe chronic neutropenia. This product must be stored in a refrigerator at 2 degrees to 8 degrees in the original pack to protect from light. Do not shake, do not freeze. Prior to injection, the product may be allowed to reach room temperature for a maximum of 24 hours.

Imovax Rabies (Sanofi Pasteur)

IMOVAX Rabies is a vaccine indicated for pre-exposure and post-exposure prophylaxis against rabies and is approved for use in all age groups. The freeze-dried vaccine is stable if stored in the refrigerator between 2 degrees to 8 degrees Centigrade. Do not freeze. The product is a sterile, stable, freeze-dried suspension of rabies virus prepared from strain PM-1503-3M obtained from the Wistar Institute, Philadelphia, PA.

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, 2015, through December 31, 2015.

Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
Bivigam J1556 $76.98 $75.75
Carimune NF J1566 $66.21 $65.15
Flebogamma J1572 $71.31 $70.17
Gammagard S/D J1566 $66.21 $65.15
Gammaplex J1557 $74.56 $73.37
Octagam J1568 $85.60 $84.23
Privigen J1459 $76.10 $74.88
SCIG
Hizentra J1559 $84.69 $83.33
HyQvia J3490 or J3590 ** **
IVIG / SCIG
Gammagard Liquid J1569 $77.13 $75.89
Gammaked J1561 $80.59 $79.30
Gamunex-C J1561 $80.59 $79.30

*Reflects 2% sequestration reduction applied to 80% Medicare payment portion as required under Budget Control Act of 2011.
**Pricing not yet available.

Resources

FFF customers may order the following complementary resources to help you with your practice:

Seasonal Flu Poster flu myths and facts brochure
immune globulin reference charts
•  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.

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