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Monday, January 17, 2022
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Immunocompromised Eligible for Fourth COVID-19 Booster Shot

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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
 
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Individuals with immunocompromising diseases who received their booster five months ago are now eligible for a fourth booster dose of the mRNA vaccines (Pfizer-BioNTech and Moderna). And, an additional primary shot is recommended for those aged 5 years and older who got the Pfizer-BioNTech vaccine and those 18 and older who received Moderna vaccine. read more ]

FDA Expands COVID-19 Booster Shot Eligibility to 12- to 15-Year-Olds

The U.S. Food and Drug Administration (FDA) has expanded eligibility for the Pfizer-BioNTech COVID-19 booster shot to children ages 12 to 15 years old. FDA also shortened the time between the second Pfizer dose and the booster shot to five months, down from six months. read more ]

Pfizer-BioNTech to Test a Third COVID-19 Vaccine Dose in Young Children

Pfizer and BioNTech are testing a third dose of their COVID-19 vaccine in an ongoing trial of children ages 6 months to under 5 years after the companies found the two-dose regimen didn't generate a strong enough immune response in some children. The change to the trial protocol means the companies won't have data to submit to regulators until the first half of 2022. read more ]

The COVID-19 Omicron Variant May Have Developed in Immunocompromised People

Scientists in South Africa are investigating the "highly plausible hypothesis" that COVID-19 variants — such as the Omicron variant — got their start in people who were infected by COVID-19 but had immune systems weakened by other medical issues such as untreated HIV. read more ]

Industry News

Industry News Image

From Pfizer

The U.S. Food and Drug Administration has approved for emergency use Pfizer's Paxlovid, the first oral pill meant to treat mild-to-moderate COVID-19 infection in patients who are at high risk of progressing to severe illness. The pill, which is authorized for patients ages 12 years and older, should be started within five days of COVID-19 symptom onset. read more ]

From CSL Behring

CSL Behring is voluntarily withdrawing one lot of Hizentra 20% 10 g/50 mL (subcutaneous immune globulin [human]) at the patient level due to an increased frequency of reports of injection-site reactions and hypersensitivity-type events after administration. The recalled lot of Hizentra distributed to wholesalers beginning Oct. 5, 2021, is P100343632 with the NDC 44206-0455-10 and an expiry date of Nov. 24, 2023.

From Biosensor and Siemens

Two new over-the-counter at-home COVID-19 tests, one manufactured by SD Biosensor and distributed by Roche and the other manufactured by Siemens, have received emergency use authorization by the U.S. Food and Drug Administration (FDA) after being evaluated through the new accelerated pathway to support FDA review of tests with potential for large-scale manufacturing. read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

TICOVAC  (PFIZER)

TICOVAC is an intramuscular vaccine indicated for active immunization to prevent tick-borne encephalitis in individuals 1 year of age and older. It is supplied in 0.25 mL and 0.5 mL pre-filled syringes in one dose or in packages of 10.

FENTANYL CITRATE  (PFIZER)

FENTANYL CITRATE injection is indicated for 1) analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises; 2) use as an opioid analgesic supplement in general or regional anesthesia; 3) administration with a neuroleptic as an anesthetic premedication for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia and 4) use as an anesthetic agent with oxygen in selected high-risk patients such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. It is supplied in single-dose ampules of 100 mcg Fentanyl/2 mL, 250 mcg Fentalyl/5 mL, 500 mcg Fentanyl/10 mL and 1000 mcg Fentanyl/20 mL, as well as in trays of 25 containing 2 mL, 5 mL, 10 mL, 20 mL and 50 mL single-dose fliptop vials.

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

SENSORCAINE  (FRESENIUS KABI)

SENSORCAINE (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. It is supplied in 10 mL (2.5 mg/mL, 5 mg/mL and 7.5 mg/mL) and 30 mL (2.5 mg/mL and 5 mg/mL) single-dose vials in trays of 25, as well as 30 mL (2.5 mg/mL and 5 mg/mL) single-dose vials packaged in 5.

ADAPALENE AND BENZOYL PEROXIDE GEL  (TEVA)

ADAPALENE AND BENZOYL PEROXIDE GEL 0.3%/2.5% is a combination of adapalene, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris. It is supplied in a 45 gram pump.

For more information about ADAPALENE AND BENZOYL PEROXIDE GEL, log in to biosupply.fffenterprises.com

TROPHAMINE  (B. BRAUN MEDICAL)

TROPHAMINE (6% and 10% amino acid injections) is indicated for the nutritional support of infants (including those of low birth weight) and young pediatric patients requiring total parenteral nutrition via either central or peripheral infusion routes. It is supplied sterile and nonpyrogenic in 500 mL glass containers with solid stoppers.

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

ALBUTEIN FLEXBAG 5%  (GRIFOLS)

ALBUTEIN 5% (human) is an albumin solution indicated for hypovolemia, cardiopulmonary bypass procedures, hypoalbuminemia and plasma exchange. It is supplied in an easy-to-use, flexible container.

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

PYRIMETHAMINE TABLETS  (ALVOGEN)

PYRIMETHAMINE TABLETS 25 mg are indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination. They are supplied as tablets, each containing 25 mg pyrimethamine in bottles of 100 (NDC 47781-925-01) and 30 (NDC 47781-925-30) and in 30-count unit-dose blister cartons (NDC 47781-925-31).

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

PREVNAR 20  (WYETH PHARMACEUTICALS)

PREVNAR 20 (pneumococcal 20-valent conjugate vaccine), suspension for intramuscular injection is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. It is supplied in single-dose prefilled syringes in a package of 1 or 10.

For more information about PREVNAR 20, log in to biosupply.fffenterprises.com

ACETAMINOPHEN INJECTION  (B. BRAUN MEDICAL)

ACETAMINOPHEN INJECTION is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older; management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older; and reduction of fever in adult and pediatric patients. It is a clear colorless solution supplied sterile and nonpyrogenic in 50 mL and 100 mL fill PAB containers packaged 24 per case.

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

VAXELIS  (SANOFI PASTEUR)

VAXELIS is a three-dose vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years old. It is supplied in a single-dose vial in packages of 10 and a 0.5 mL single-dose prefilled syringe with a Luer lock connection and a tip cap without a needle in packages of 10.

For more information about VAXELIS, 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 January 1, 2022, through March 31, 2022.

 
Calculate Your Current Medicare IVIG/SCIG Rates
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
ASCENIV J1554 $963.54 $948.09
BIVIGAM J1556 $140.89 $138.72
FLEBOGAMMA DIF J1572 $71.79 $70.63
GAMMAGARD SD J1566 $139.18 $136.95
GAMMAPLEX J1557 $101.61 $99.98
OCTAGAM J1568 $83.23 $81.89
PANZYGA 90283 / J1599 $130.09 $128.01
PRIVIGEN J1459 $90.02 $88.57
SCIG
CUTAQUIG 90284 / J3590 $135.26 $133.09
CUVITRU J1555 $147.48 $145.11
HIZENTRA J1559 $117.85 $115.96
HYQVIA J1575 $154.19 $151.72
XEMBIFY J1558 $132.96 $130.83
IVIG / SCIG
GAMMAGARD LIQUID J1569 $93.33 $91.84
GAMMAKED J1561 $93.02 $91.53
GAMUNEX-C J1561 $93.02 $91.53

* 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.

 
Log in to BioSupply for Immune Globulin Products

Resources

FFF customers may order the following complementary resources to help you with your practice:

Seasonal Flu Poster flu myths and facts brochure
immune globulin reference charts
•  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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