Monday, April 19, 2021

COVID-19 Vaccines Effective in Pregnancy

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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
 

Research shows the Moderna and Pfizer-BioNTech COVID-19 vaccines trigger strong immune responses in pregnant and breastfeeding women, equivalent to that of other women of reproductive age. read more ]

COVID-19 Vaccine Safe in Teens

A recent clinical trial shows the Pfizer and BioNTech's COVID-19 vaccine is safe, effective and produces robust antibody responses in 12- to 15-year olds, paving the way for them to seek U.S. and European approval to use the shot in this age group within weeks. read more ]

Bill Eliminates 2% Sequestration

The Senate has passed a bill that, among other healthcare provisions, eliminates the 2% across-the-board cut to all Medicare payments, known as sequestration, until the end of 2021. To pay for the change, the bill will increase the fiscal year 2030 sequester cuts. read more ]

Pfizer Vaccine Protective for 6 Months

A recent study shows Pfizer's COVID-19 vaccine is 91.3 percent effective at preventing the virus for up to six months after the second dose and 100 percent effective against severe disease. In addition, researchers have found similar protection is offered by Moderna's vaccine. read more ]

Industry News

 
Industry News Image
 

From BioNTech

The founders of BioNTech, Ozlem Tureci and Ugur Sahin, were using the messenger RNA (mRNA) technology to cause the body's immune system to fight cancerous tumors when the SARS-CoV-2 virus broke out in China. After switching focus to co-develop the COVID-19 vaccine with Pfizer, they are returning to their original work and hope to develop a cancer vaccine using mRNA technology in a couple of years.  [ read more ]

From Moderna and Pfizer

The Clinical Research Forum, a nonprofit membership association of top clinical research experts and leaders from the nation's leading academic health centers, has awarded Moderna and Pfizer with the first Award for Extraordinary Impact on Health that honors exceptional clinical and translational research that benefits all peoples and nations. read more ]

From Abbott and Quidel

The U.S. Food and Drug Administration has approved the over-the-counter sale of two rapid antigen at-home tests: Abbott's BinaxNOW test and Quidel's QuickVue. The two tests were previously available by prescription only. read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

CEFAZOLIN  (APOTEX CORP.)

CEFAZOLIN for injection, USP, is a cephalosporin antibacterial indicated for the treatment of the following conditions caused by susceptible isolates of the designated microorganisms: respiratory tract infections, urinary tract infections, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia, endocarditis and perioperative prophylaxis. It is supplied as a sterile white or off-white powder of crystalline powder in a carton containing 25 vials of 1 gram of cefazolin sodium.

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

CEFEPIME  (APOTEX CORP.)

CEFEPIME for injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms: 1) pneumonia, 2) empiric therapy for febrile neutropenic patients, 3) uncomplicated and complicated urinary tract infections, including pyelonephritis, 4) uncomplicated skin and skin structure infections and 5) complicated intra-abdominal infections (used in combination with metronidazole) in adults. It is supplied in cartons of 10 1 gram or 2 gram single-dose vials.

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

CEFTRIAXONE  (APOTEX CORP.)

CEFTRIAXONE for injection, USP, is indicated for the treatment of the following infections when caused by susceptible organisms: 1) lower respiratory tract infections, 2) acute bacterial otitis media, 3) skin and skin structure infections, 4) complicated and uncomplicated urinary tract infections, 5) uncomplicated gonorrhea (cervical/urethral and rectal), 6) pelvic inflammatory disease, 7) bacterial septicemia, 8) bone and joint infections, 9) meningitis and 10) surgical prophylaxis. It is supplied as a sterile powder in a bulk package bottle containing 10 grams of ceftriaxone; in packages of 10 vials containing 250 mg, 500 mg, 1 gram and 2 grams of ceftriaxone; and in single packages containing 250 mg and 500 mg of ceftriaxone.

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

ALBUTEIN  (GRIFOLS BIOLOGICALS)

ALBUTEIN FlexBag 25% is an albumin solution indicated for hypovolemia, cardiopulmonary bypass procedures, acute nephrosis, hypoalbuminemia, ovarian hyperstimulation syndrome, neonatal hyperbilirubinemia, adult respiratory distress syndrome and prevention of central volume depletion after paracentesis due to cirrhotic ascites. It is supplied in 50 mL (12.5 g) and 100 mL (25 g) single-dose, latex-free, flexible containers free of polyvinyl chloride, diethylhexyl phthalate or other plasticizers.

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

XEMBIFY  (GRIFOLS THERAPEUTICS)

XEMBIFY (immune globulin subcutaneous, human-klhw) is a 10% immune globulin solution for subcutaneous injection indicated for treatment of primary humoral immunodeficiency in patients 2 years of age and older. It is supplied in 1 g, 2 g, 4 g and 10 g single-use vials.

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

EVKEEZA  (REGENERON PHARMACEUTICALS)

EVKEEZA (evinacumab-dgnab) injection is an ANGPTL3 (angiopoietin-like 3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol lowering therapies for the treatment of adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia. It is supplied as one 345 mg/2.3 mL or 1,200 mg/8 mL single-dose vial per carton.

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

ZILRETTA (FLEXION THERAPEUTICS)

ZILRETTA (triamcinolone acetonide injectable suspension) is an extended-release synthetic corticosteroid indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. It is supplied as 1) a 5 mL single-dose vial to deliver 32 mg of triamcinolone acetonide supplied as a sterile white to off-white powder in a clear vial, and 2) a 5 mL single-dose vial supplied as a sterile, clear liquid solution of 0.9% w/w sodium chloride (normal saline) containing 0.5% w/w sodium carboxymethylcellulose, and 0.1% w/w polysorbate-80 in a glass vial.

For more information about ZILRETTA, 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 April 1, 2021, through June 30, 2021.

 
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
ASCENIV J1554 $963.54 $948.09
BIVIGAM J1556 $140.98 $138.72
FLEBOGAMMA J1572 $72.16 $71.00
GAMMAGARD SD J1566 $128.43 $126.37
GAMMAPLEX J1557 $102.54 $100.89
OCTAGAM J1568 $84.04 $82.69
PANZYGA 90283 / J1599 ** **
PRIVIGEN J1459 $86.07 $84.69
SCIG
CUTAQUIG 90284 / J3590 ** **
CUVITRU J1555 $140.06 $137.81
HIZENTRA J1559 $112.27 $110.47
HYQVIA J1575 $147.32 $144.96
XEMBIFY J1558 $149.76 $147.36
IVIG / SCIG
GAMMAGARD LIQUID J1569 $92.22 $90.74
GAMMAKED J1561 $93.04 $91.55
GAMUNEX-C J1561 $93.04 $91.55

* 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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