Monday, May 17, 2021

FDA OKs Pfizer COVID Vaccine for Ages 12-15

Main article image
 

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 U.S. Food and Drug Administration has given Pfizer and BioNTech's COVID-19 vaccine emergency use approval to administer it in children ages 12 years through 15 years. Previously, the vaccine had EUA only for individuals age 16 and older. read more ]

More Women Doctors' Patients Get Flu Shot

New research suggests elderly patients treated by female physicians are more likely than those treated by male physicians in the same outpatient practice to be vaccinated against influenza (flu), a trend that is true for all racial and ethnic groups studied. According to the researchers, this could provide insight into improving vaccination rates for flu, COVID-19 and other illnesses. read more ]

6-Foot Rule Isn't Protective

Staying 6 feet away from others does little to affect the risk of exposure to COVID-19 in indoor spaces, according to a new study at MIT. The researchers say the rule is based on an outdated understanding of how the coronavirus moves in closed spaces. read more ]

Pfizer Vaccine Safe for Autoimmune Diseases Patients

An Israeli study shows the Pfizer COVID-19 vaccine is effective and safe for people suffering from autoimmune inflammatory rheumatic diseases. Eighty-six percent of patients who participated in the study developed sufficient antibodies to protect them from the virus, and the prevalence and seriousness of side effects among them were similar to those in the general population. read more ]

Industry News

 
Industry News Image
 

From Merck & Co.

Merck and Co. is planning a Phase III trial to study the drug molnupiravir in nonhospitalized COVID-19 patients who have at least one risk factor for poor outcomes such as advanced age, obesity or diabetes. This would be the first pill to target the coronavirus in people at risk of severe disease. read more ]

From Sanofi

Sanofi has agreed to acquire Tidal Therapeutics, a privately held Cambridge, Mass.-based biotech developing messenger RNA-based treatments for cancer. read more ]

From CSL Behring

The U.S. Food and Drug Administration has approved a label update for Hizentra (immune globulin subcutaneous [human] 20% liquid) for chronic inflammatory demyelinating polyneuropathy (CIDP). The update simplifies dosage adjustments between two safe and effective doses proven to prevent CIDP relapse — without the need for intravenous immune globulin treatment in the event of a relapse on the low dose. 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

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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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