Monday, April 18, 2016

European Scientists Develop Possible Cure for ADA-SCID

 

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 group of scientists and doctors in Milan have developed a potential cure for children born with adenosine deaminase deficiency-severe combined immune deficiency (ADA-SCID), a rare condition in which a single genetic defect prevents them from developing a robust immune system, leaving them susceptible to infections. [ read more ]

Study Shows HSCT Tied to Long-Term MG Remission

A retrospective study has found that treatment with autologous hematopoietic stem cell transplant (HSCT) can result in durable, symptom-free, treatment-free remission of myasthenia gravis. [ read more ]

Webinar Series Launched for Young Adults Living with Primary Immunodeficiencies

PI Voices is a new young adult webinar series developed by the Immune Deficiency Foundation and sponsored by CSL Behring to address the unique needs of young adults living with primary immunodeficiency disease. [ read more ]

Industry News

 
 

Bayer AG

In March, the U.S. Food and Drug Administration approved Kovaltry, Bayer AG's therapy to treat hemophilia A, the most common form of hemophilia.
[ read more ]

From Pfizer

The U.S. Food and Drug Administration has approved Celltrion’s Inflectra (infliximab-dyyb), a biosimilar version of Johnson & Johnson’s Remicade drug used to treat autoimmune diseases. It is the second biosimilar drug approved in the U.S., for which Pfizer has exclusive commercialization rights. [ read more ]

From Baxalta

Baxalta and the Clinical Immunology Society (CIS) have announced the 2016 Fellowship Award, which offers a $60,000 award to two individuals in the third or fourth year of their fellowship program with a concentration or focus on primary immunodeficiency. [ read more ]

IVIG & Albumin Supply Index

 
 

Featured Product Of The Month

Gamunex-C (Grifols)

GAMUNEX-C (immune globulin intravenous [human] 10% liquid) is indicated for the treatment of primary humoral immunodeficiency in patients ages 2 years and older, which includes but is not limited to congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies; idiopathic thrombocytopenic purpura to raise platelet counts to prevent bleeding or to allow a patient to undergo surgery; and chronic inflammatory demyelinating polyneuropathy to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse. The product is supplied in single-use, tamper-evident vials (shrink band) containing the labeled amount of functionally active IgG in 10, 25, 50, 100, 200 and 400 mL sizes. The four large vial size labels incorporate integrated hangers. Gamunex-C is not made with natural rubber latex. It may be stored for 36 months at 2 degrees to 8 degrees Centrigrade from the date of manufacture, and product may be stored at temperatures not to exceed 25 degrees Centigrade for up to six months anytime during the 36-month shelf life, after which the product must be immediately used or discarded.

For more information about Bivigam, 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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