Monday, November 16, 2020

Study Shows Pfizer's Coronavirus Vaccine Is More Than 90 Percent Effective

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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
 

A coronavirus vaccine study conducted by Pfizer examined the first 94 confirmed cases of Covid-19. Among the more than 43,000 volunteers who got either two doses of the vaccine or a placebo, fewer than 10 percent of infections were found in participants who had been given the vaccine, versus more than 90 percent of the cases in people who were given a placebo. read more ]

COVID-19 Herd Immunity Could Be Reached with Only 47 Percent of the Population Infected

In a study that has not yet been peer-reviewed, researchers found herd immunity could be achieved when only around 47 percent of the population has been infected, rather than frequently cited estimates of 60 percent or higher. The study also suggests the end state of the pandemic will be characterized by "bursts" or "spikes" of infections in different regions. read more ]

Study Shows COVID-19 Vaccine Produces Robust Immune Response in Elderly

Early clinical trial results of the COVID-19 vaccine being developed by the University of Oxford and AstraZeneca show it produces a robust immune response in elderly people, encouraging researchers that it will spare those in later life from serious illness or death from the virus. read more ]

COVID-19 Immunity Could Last Up to Seven Months

A study that sampled the antibodies from nearly 6,000 people found immunity persists for at least five months to seven months after being infected with SARS-CoV-2, the virus that causes COVID-19, although the researchers believe immunity lasts longer. read more ]

Industry News

 
Industry News Image
 

From Regeneron

The U.S. Food and Drug Administration has approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. read more ]

From Octapharma

An updated prescribing information for NUWIQ, Octapharma's human cell line-derived recombinant factor VIII, has been approved by the U.S. Food and Drug Administration. NUWIQ is approved for the prevention and treatment of bleeding in people with haemophilia A.  [ read more ]

From HEMA Biologics

The U.S. Food and Drug Administration has approved SEVENFACT® (coagulation factor VIIa [recombinant]-jncw) for the treatment and control of bleeding episodes in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies).  [ read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

SULFAMETHOXAZOLE AND TRIMETHOPRIM (SOMERSET THERAPEUTICS)

SULFAMETHOXAZOLE and TRIMETHOPRIM injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients 2 months of age and older for treatment of infections caused by designated, susceptible bacteria. It is supplied in 5 mL single-dose and 10 mL and 30 mL multiple-dose vials, with each 5 mL dose containing 80 mg trimethoprim (16 mg/mL) and 400 mg sulfamethoxazole (80 mg/mL) for infusion with 5% dextrose in water.

For more information about SULFAMETHOXAZOLE and TRIMETHOPRIM, log in to biosupply.fffenterprises.com

DEXMEDETOMIDINE HYDROCHLORIDE (BAXTER)

DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride injection is a relatively selective alpha2-adrenergic agonist indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting, and sedation of nonintubated patients prior to and/or during surgical and other procedures. It is available as 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in 50 mL and 100 mL GALAXY containers, respectively.

For more information about DEXMEDETOMIDINE HYDROCHLORIDE, log in to biosupply.fffenterprises.com

IXINITY (APTEVO BIOTHERAPEUTICS)

IXINITY (coagulation factor IX [recombinant]) is a human blood coagulation factor indicated for adults and children 12 years and older with hemophilia B for control and prevention of bleeding episodes and perioperative management. It is supplied as a lyophilized powder in single-use glass vials containing the labeled amount of factor IX activity, expressed in international units (IU). Kits include one single-use vial (containing nominally 250, 500, 1000, 1500, 2000 and 3000 IU per vial), a 10 mL syringe prefilled with 5 mL of sterile water for injection with plunger rod attached, and a vial adapter with filter.

For more information about IXINITY, log in to biosupply.fffenterprises.com

STERILE WATER (WEST-WARD PHARMACEUTICALS)

STERILE WATER for injection is a sterile nonpyrogenic preparation of water that contains no bacteriostat, antimicrobial agent or added buffer designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. It is supplied only in single-dose containers to dilute or dissolve drugs for injection.

For more information about STERILE WATER, log in to biosupply.fffenterprises.com

AMIODARONE HYDROCHLORIDE (WEST-WARD PHARMACEUTICALS)

AMIODARONE HYDROCHLORIDE injection is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. The 50 mg/mL injection dosage is supplied in 3 mL single-dose vials in cartons of 10 and 25.

For more information about AMIODARONE HYDROCHLORIDE, log in to biosupply.fffenterprises.com

ANAVIP (RARE DISEASE THERAPEUTICS)

ANAVIP [Crotalidae Immune F(ab')2 (Equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American rattlesnake envenomation. It is supplied as a sterile lyophilized preparation in a single-use vial. When reconstituted with 10 mL of 0.9% NaCl solution, each vial contains not more than 12 mg per mL of protein, and will neutralize not less 780 times the LD50 of Bothrops asper venom and 790 times the LD50 of Crotalus durissus venom in a mouse neutralization assay. Each carton contains 1 vial of ANAVIP.

For more information about ANAVIP, log in to biosupply.fffenterprises.com

HIZENTRA PRE-FILLED SYRINGES (CSL BEHRING)

HIZENTRA (immune globulin subcutaneous [human] 20% liquid) PRE-FILLED SYRINGES for primary immunodeficiency patients are ready to use, eliminating the need to transfer the drug from the vial to a syringe. The syringes come in 5 mL and 10 mL (fully assembled) and 20 mL (requiring the plunger rod to be screwed onto the syringe stopper prior to use).

For more information about HIZENTRA PRE-FILLED SYRINGES, log in to biosupply.fffenterprises.com

ALBUMINEX 5% (BIO PRODUCTS LABORATORY)

ALBUMINEX 5% is a 5% albumin solution indicated for adults and children to treat hypovolemia; ascites; hypoalbuminemia, including from burns; acute nephrosis; acute respiratory distress syndrome; and cardiopulmonary bypass. It is supplied in 5 g/dL clear type II glass vials.

For more information about ALBUMINEX 5%, log in to biosupply.fffenterprises.com

ALBUMINEX 25% (BIO PRODUCTS LABORATORY)

ALBUMINEX 25% is a 25% albumin solution indicated for adults and children to treat hypovolemia; ascites; hypoalbuminemia, including from burns; acute nephrosis; acute respiratory distress syndrome; and cardiopulmonary bypass. It is supplied in 25 g/dL clear type II glass vials.

For more information about ALBUMINEX 25%, log in to biosupply.fffenterprises.com

TYMLOS  (RADIUS HEALTH)

TYMLOS (abaloparatide) injection, for subcutaneous use, is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. It is supplied in a glass cartridge containing 3,120 mcg of abaloparatide in 1.56 mL of sterilized, clear, colorless fluid as a pre-assembled single-patient-use disposable pen packaged in a cardboard carton. Each pen provides a 30-day supply for once-daily injection of 80 mcg abaloparatide in 40 mcL. Sterile needles are not included.

For more information about TYMLOS, log in 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 Oct. 1, 2020, through Dec. 31, 2020.

 
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
FLEBOGAMMA J1572 $80.77 $79.47
GAMMAGARD SD J1566 $136.61 $134.42
GAMMAPLEX J1557 $107.32 $105.60
OCTAGAM J1568 $82.46 $81.14
PANZYGA 90283 / J1599 ** **
PRIVIGEN J1459 $83.01 $81.67
SCIG
CUTAQUIG 90284 / J3590 ** **
CUVITRU J1555 $140.22 $137.97
HIZENTRA J1559 $108.55 $106.81
HYQVIA J1575 $144.86 $142.54
XEMBIFY J1558 $142.23 $139.95
IVIG / SCIG
GAMMAGARD LIQUID J1569 $86.40 $85.02
GAMMAKED J1561 $84.37 $83.02
GAMUNEX-C J1561 $84.37 $83.02

* Reflects 2% sequestration reduction applied to 80% Medicare payment portion as required under Budget Control Act of 2011.
** ASP-based Medicare payment rate not yet available; payment rate assigned by your Medicare Administrative Contractor.

 

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

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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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