Monday, May 24, 2016

Study Provides Clues for Improving Effectiveness of Flu Vaccine

 

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
 

A study conducted by scientists at the National Institute for Allergy and Infectious Diseases has found that seasonal flu vaccines work better if they stimulate an immune response to the flu surface protein neuraminidase that enables newly formed flu viruses to exit the host cell and cause further viral replication in the body. [ read more ]

Potential Tobacco-Based Vaccine Could Rival Egg-Based Vaccines

A new tobacco-based seasonal influenza vaccine being developed by Mitsubishi Tanabe Pharma and currently in Phase III studies uses technology that can produce the vaccine in four weeks, which is six times faster than egg-based methods. The company plans to launch the vaccine in the U.S. for the 2018-19 flu season. [ read more ]

New Health Economic Study Is Launched for PIs

Baxalta, the University of Sheffield in England and the International Patient Organisation for Primary Immunodeficiencies have partnered to launch a health economic study that will assess the major factors contributing to the burden of treatment for patients managing primary immunodeficiencies. [ read more ]

Industry News

 
 

From Baxalta

Baxalta has begun a Phase I, first-in-human clinical trial of BAX 826, a recombinant factor VIII treatment for hemophilia A that uses proprietary polysialic acid technology to extend its circulating half-life. [ read more ]

From Bio Products Laboratory (BPL)

BPL has submitted a biologics license supplement to the U.S. Food and Drug Administration for the use of Gammaplex 10% (immune globulin intravenous, human) in patients with primary immunodeficiencies (PIs). [ read more ]

From CSL Behring

CSL Behring has been granted seven years of marketing exclusivity by the U.S. Food and Drug Administration for Idelvion (coagulation factor IX [recombinant], albumin fusion protein). [ read more ]

IVIG & Albumin Supply Index

 
 

Featured Product Of The Month

Octagam 5%/10% (Octapharma)

Octagam 5% (immune globulin intravenous [human] 5% liquid) is indicated for the treatment of primary humoral immunodeficiency such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. It is supplied in 1.0-, 2.5-, 5-, 10- or 25-gram single-use bottles. Octagam 5% may be stored for 24 months at +2°C to +25°C (36°F to 77°F) from the date of manufacture. Octagam 10% (immune globulin intravenous [human] liquid preparation) is indicated for the treatment of chronic immune thrombocytopenic purpura in adults. It is supplied in 2-, 5-, 10- and 20-gram single-use bottles. Octagam 10% can be stored for 24 months at +2°C to +8°C (36°F to 46°F) from the date of manufacture. Within the first 12 months of shelf-life, the product may be stored up to nine months at ≤ +25°C (77°F); after storage at ≤ +25°C (77°F), the product must be used or discarded.

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

Bleomycin (Fresenius Kabi USA)

Bleomycin for injection is indicated to treat squamous cell carcinoma (head and neck, including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingival, epiglottis, skin, larynx; penis, cervix and vulva), lymphomas (Hodgkin's disease, non-Hodgkin's disease), testicular carcinoma (embryonal cell, choriocarcinoma and teratocarcinoma), malignant pleural effusion, as well as other conditions as determined by a physician. It is provided as a sterile lyophilized powder for reconstitution in 15- and 30-units-per-vial quantities. Bleomycin is intended for intramuscular, intravenous, subcutaneous or intrapleural administration as a palliative treatment, and has been shown to be useful as a single agent or in proven combinations with other approved chemotherapeutic agents.

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

Kovaltry (Bayer)

KOVALTRY, antihemophilic factor (recombinant), is a recombinant, human DNA sequence derived, full-length factor VIII concentrate indicated for use in adults and children 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. It is not indicated for the treatment of von Willebrand disease. Due to higher clearance (body-weight adjusted) in children 12 years and younger, higher or more frequent dosing may be needed. It is available as a lyophilized powder solution for intravenous injection in single-use glass vials, one vial per carton. Vial sizes include 250, 500, 1000, 2000 or 3000 IU. An administration set is provided in the package. Store at 2° to 8°C (36° to 46°F). Do not freeze.

Idelvion (CSL Behring)

IDELVION, coagulation factor IX (recombinant), albumin fusion protein (rIX-FP), a recombinant human blood coagulation factor, is indicated for children and adults with hemophilia B (congenital factor IX deficiency) for: 1) on-demand control and prevention of bleeding episodes; 2) perioperative management of bleeding; and 3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Idelvion is not indicated for immune tolerance induction in patients with hemophilia B. Idelvion is available as a lyophilized powder solution for intravenous injection in single-use vials. Vial sizes include 250, 500, 1000 or 2000 IU. Store at 2° to 25°C (36° to 77°F). Do not freeze.

Eptifibatide (Teva Pharma)

EPTIFIBATIDE injection is a platelet aggregation inhibitor indicated for: 1) treatment of acute coronary syndrome managed medically or with percutaneous coronary intervention (PCI); and 2) treatment of patients undergoing PCI, including intracoronary stenting. Each vial contains 75 mg in 100 mL (0.75 mg/mL) for intravenous infusion. Store at 2° to 8°C (36° to 46°F). Do not freeze.

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, 2016, through June 30, 2016.

Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
Bivigam J1556 $78.46 $77.20
Carimune NF J1566 $70.04 $68.91
Flebogamma J1572 $78.31 $77.05
Gammagard S/D J1566 $70.04 $68.91
Gammaplex J1557 $74.55 $73.36
Octagam J1568 $91.71 $90.24
Privigen J1459 $76.51 $75.28
SCIG
Hizentra J1559 $84.69 $83.33
HyQvia J1575 $114.70 $112.86
IVIG / SCIG
Gammagard Liquid J1569 $77.64 $76.40
Gammaked J1561 $83.64 $82.30
Gamunex-C J1561 $83.64 $82.30

*Reflects 2% sequestration reduction applied to 80% Medicare payment portion as required under Budget Control Act of 2011.

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.

Subscribe to BioSupply
Trends Quarterly

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

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