Monday, March 21, 2016

NHIA Releases Data Quality Definitions for Home/Specialty Infusion

 

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
 

The National Home Infusion Association has released a final set of revised Standard Definitions for Patient Outcomes Data to use in collecting data related to patient events for assessing the safety, effectiveness and efficiency of home and specialty infusion care. [ read more ]

FDA Issues Recommendations on Zika Virus and Blood Donations

The U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus or have had a confirmed Zika virus infection. [ read more ]

2015-16 Flu Vaccine Is Nearly 60 Percent Effective

As of the end of February, preliminary overall 2015-16 influenza vaccine effectiveness was 59 percent, according to the Centers for Disease Control and Prevention, which is comparable to past estimates for seasons when most circulating flu viruses and vaccine viruses have been similar.
[ read more ]

Industry News

 
 

From CSL Behring

The U.S. Food and Drug Administration approved CSL Behring’s Idelvion (coagulation factor IX [recombinant], albumin fusion protein) for on-demand control and prevention of bleeding episodes, management of bleeding following surgery and as a routine preventive measure to reduce the frequency of bleeding episodes in children and adults with hemophilia B. [ read more ]

From Bio Products Laboratory

Bio Products Laboratory has launched a clinical trial evaluating the safety and pharmacokinetics of Subgam-VF 16% liquid immune globulin made from human plasma specifically for subcutaneous use for the treatment of primary immunodeficiency diseases.
[ read more ]

From Green Cross Biotherapeutics

Montreal-based Green Cross Biotherapeutics announced that Canadian regulatory authorities have approved a Canadian and U.S. Phase III clinical trial of its investigational 10% intravenous immune globulin (GC 5107) in patients with primary humoral immunodeficiency. An investigational new drug filing with the U.S. FDA is expected to soon follow. [ read more ]

IVIG & Albumin Supply Index

 
 

Featured Product 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

Adynovate (Baxalta)

ADYNOVATE is a factor VIII antihemophilic factor (Recombinant), PEGylated. Indicated in adolescent and adult patients (12 years and older) with hemophilia A for: 1) on-demand treatment and control of bleeding episodes; and 2) routine prophylaxis to reduce the frequency of bleeding episodes. Not indicated for the treatment of VWD. It is available in four vial sizes: 250 IU, 500 IU, 1000 IU and 2000 IU. Store Adynovate in powder form at 2°to 8°C (36°to 46°F). Do not freeze.

Corifact (CSL Behring)

CORIFACT is a factor XIII concentrate antihemophilic factor (Human). Indicated for adult and pediatric patients with congenital factor XIII deficiency for: 1) routine prophylactic treatment; and 2) perioperative management of surgical bleeding. It is available in 1000-1600 Units. Refrigerate Corifact at 2°to 8°C (36°to 46°F). Keep in original carton to protect from light. Do not freeze.

Nuwiq (Octapharma)

NUWIQ is a recombinant antihemophilic coagulation Factor VIII indicated in adults and children with Hemophilia A 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. Nuwiq is not indicated for the treatment of von Willebrand Disease. It is available in four vial sizes: 250 IU, 500 IU, 1000 IU and 2000 IU. Store at 2 – 8°C (35 – 46°F) for up to 24 months. Do not freeze.

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 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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