FFF Enterprises: BioSupply Trends Newsletter
Monday, June 20, 2016

Plasma-Derived Factor VIII Results in Lower Incidence of Inhibitor Development

 

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 recent study showed that early replacement therapy with plasma-derived factor VIII (FVIII) was associated with a lower incidence of the development of neutralizing anti-FVIII alloantibodies (inhibitors) than was therapy with recombinant FVIII in patients with severe hemophilia A. [ read more ]

Individuals’ Immune Responses Are Linked to Flu Vaccine Effectiveness

New research shows that differences in individuals’ immune responses might be linked to the effectiveness of the seasonal influenza vaccine. By understanding who will produce an appropriate response to the vaccine, scientists could design and create more effective ones. [ read more ]

New Model Developed to Predict Flu Outbreaks

Researchers at Boston Children’s Hospital conducted a study that resulted in the development of a new model to accurately predict national and local influenza activity. [ read more ]

Industry News

 
 

From CSL Behring

The U.S. Food and Drug Administration has approved AFSTYLA (antihemophilic factor [recombinant]), CSL Behring’s novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A. [ read more ]

From Merck

Despite disagreement over study end points, the U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee has recommended in a 10-5 vote with one abstention to approve bezlotoxumab (Zinplava) to prevent the recurrence of Clostridium difficile infection in patients aged 18 years and older. [ read more ]

From Thermo Fisher Scientific

The U.S. Food and Drug Administration has given 510(k) clearance for Thermo Fisher Scientific’s new EliA IgG tests for detecting anti-thyroglobulin and anti-thyroid peroxidase autoantibodies in serum or plasma. [ 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

Aripiprazole (Apotex)

Aripiprazole tablets are an atypical antipsychotic used to treat schizophrenia, bipolar disorder, major depressive disorder and irritability associated with autism. It is supplied in 2, 5, 10, 15, 20 and 30 mg tablets. Store between 20° and 25°C (68° to 77°F).

For more information about Aripiprazole, go to biosupply.fffenterprises.com
*Call for eligibility through your GPO affiliation.

Verapamil HCI Injection (Exela Pharma Sciences)

Verapamil hydrochloride injectable (HCI) is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) that works by relaxing the muscles of the heart and blood vessels. It is indicated for the treatment of supraventricular tachyarrhythmias, including 1) rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardia, including those associated with accessory bypass tracts (Wolf-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes), and 2) temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation, except when the atrial flutter and/or fibrillation are associated with accessory bypass tracts (Wolf-Parkinson-White [WPS] and Lown-Ganong-Levine [LGL] syndromes). Verapamil HCI is supplied in 5 mg/2 mL single-dose vials (five vials per carton, 300 vials per case) and given as a slow intravenous injection over at least a two-minute period under continuous ECG and blood pressure monitoring. Store at 15° to 30°C (59° to 86°F).

For more information about Verapamil HCI, go to biosupply.fffenterprises.com
*Call for eligibility through your GPO affiliation.

Omidria (Omeros)

Omidria is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor that is added to ophthalmic irrigation solution used during cataract surgery or intraocular lens replacement. It is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. Omidria is supplied as a sterile solution concentrate in a clear, 5 mL glass, single-patient-use vial containing 4 mL of sterile solution. Prior to dilution, store at 20° to 25°C (68° to 77°F) and protect from light; after dilution, store up to four hours at room temperature or 24 hours if refrigerated.

For more information about Omidria, go 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, 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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