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Monday, September 19, 2022
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CDC Relaxes COVID-19 Guidelines

eBST Newsletter Main Article
 

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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With an estimated 95 percent of Americans 16 years and older having acquired some level of immunity to COVID-19, the Centers for Disease Control and Prevention (CDC) has dropped its recommendation that Americans quarantine themselves if they come into close contact with others. read more ]

 

Pfizer’s COVID Pill Provides Little to No Benefit for Younger Adults

A large study has found Pfizer’s COVID-19 pill, Paxlovid, appears to provide little to no benefit for younger adults ages 40 to 65; however, it reduces hospitalizations among people age 65 and older by approximately 75 percent when given shortly after infection. read more ]

Scientists Say COVID-19 Vaccine Trials Include T-Cell Response

A group of prominent scientists and physicians is urging the U.S. Food and Drug Administration to include in its guidance to vaccine developers a recommendation for T-cell assessment in COVID-19 vaccine clinical trials to more comprehensively measure immune response. According to the researchers, it is critical to measure T-cell responses in addition to antibodies to evaluate vaccine efficacy better and make informed decisions regarding ongoing protection against current and future variants. read more ]

New COVID-19 DNA Vaccine Provides Broader Protection

A team of researchers at Karolinska Institutet in Sweden, who are developing a DNA COVID-19 vaccine, have found it protects mice against serious infection from the beta variant of SARS-CoV-2, a variant that can evade the immune response, and activates immune cells (T cells) that recognize the coronavirus found in bats. The researchers now hope to be able to experiment safely on humans. read more ]

Industry News Image

From Novavax

The U.S. Food and Drug Administration has granted expanded emergency use authorization for Novavax’s COVID-19 vaccine adjuvanted for adolescents aged 12 years to 17 years. read more ]

From Pfizer and Moderna

Moderna’s and Pfizer-BioNTech’s bivalent formulations of the COVID-19 vaccines have been approved by the U.S. Food and Drug Administration for use as a single booster dose at least two months after completing primary or booster vaccination. Those eligible for the Pfizer vaccine include individuals fully vaccinated ages 12 and older even if previous booster doses have been received. Eligible individuals for Moderna’s vaccine include individuals age 18 and older. read more ]

From Abbott

Abbott has received U.S. Food and Drug Administration approval for a new addition to its Alinity line of laboratory diagnostic hardware designed to screen blood and plasma donations for potential contaminants. The Alinity “s” system is designed for a smaller space with additional automation options that allow users to leave the machine running for at least three hours while focusing on other duties. read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     
Albutein Flex Bag - Grifols

What's New at FFF

KETALAR (SANOFI PASTEUR)

KETALAR (ketamine hydrochloride) injection for intravenous or intramuscular use is a general anesthetic indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation; for the induction of anesthesia prior to the administration of other general anesthetic agents; and as a supplement to other anesthetic agents. The clear, colorless solution is supplied as the hydrochloride salt in concentrations equivalent to 200 mg in 20 mL multiple-dose vials, 500 mg in 10 mL multiple-dose vials and 500 mg in 5 mL multiple-dose vials, all of which come in units of 10.

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

MENQUADFI (SANOFI PASTEUR)

MENQUADFI meningococcal (groups A, C, Y, W) conjugate vaccine solution for intramuscular injection is indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y for use in individuals 2 years of age and older. It is supplied in a single-dose vial in packages of five vials.

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

SODIUM BICARBONATE (EXELA PHARMA SCIENCES)

SODIUM BICARBONATE injection, USP, is indicated 1) in the treatment of metabolic acidosis that may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis, 2) in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products and 3) in severe diarrhea that is often accompanied by a significant loss of bicarbonate. It is supplied in 50 mL vials with either 20 or 25 vials per carton, and 10 mL vials with 25 vials per carton.

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

PRIORIX (GLAXOSMITHKLINE BIOLOGICALS)

PRIORIX (vaccine, live) is indicated for active immunization for the prevention of measles, mumps and rubella in individuals 12 months of age and older. It is supplied in a box containing 10 single-dose vials of lyophilized antigen component and 10 single-dose prefilled ungraduated syringes of sterile water diluent (packaged without needles). After reconstitution, each vial contains one dose (approximately 0.5 mL) of PRIORIX.

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

FENTANYL CITRATE (FRESENIUS KABI)

FENTANYL CITRATE for injection is indicated for analgesic action of short duration during anesthetic periods, premedication, induction and maintenance and in the immediate postoperative period (recovery room) as needed; as an opioid analgesic supplement in general or regional anasthesia; for 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 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. The preservative-free solution is supplied in units of 10 1 mL single-dose prefilled syringes and 2 mL single-dose prefilled syringes.

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

ADRENALIN (PAR PHARMACEUTICAL)

ADRENALIN (epinephrine injection) is a non-selective alpha and beta adrenergic agonist indicated for emergency treatment of allergic reactions (type 1), including anaphylaxis; and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. It is supplied in a carton containing 25 3 mL single-dose vials containing 1 mg/mL Adrenalin solution.

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

SEVENFACT (HEMA BIOLOGICS)

SEVENFACT (coagulation factor VIIa [recombinant]-jncw) is a concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors. It is supplied as a room-temperature stable, white to off-white, lyophilized powder in single-use 1 mg or 5 mg vials, one vial per carton. The 1 mg vial is packaged with a pre-filled syringe containing 1.1 mL of sterile water for injection to reconstitute the diluent and one 13 mm vial adapter with a 5 micron filter. The 5 mg vial is packaged with a pre-filled syringe containing 5.2 mL of sterile water for injection to reconstitute the diluent and one 20 mm vial adapter with a 5 micron filter.

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

PACLITAXEL (TWI PHARMACEUTICALS)

PACLITAXEL protein-bound particles for injectable suspension (albumin bound) is a microtubule inhibitor indicated for the treatment of: 1) metastatic disease or relapse within six months of adjuvant chemotherapy (prior therapy should have included an anthracycline unless clinically contraindicated), 2) locally advanced or metastatic non-small cell lung cancer, as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy and 3) metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. It is supplied in a 100 mg single-dose vial individually packaged in a carton.

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

PREHEVBRIO (VBI VACCINES)

PREHEVBRIO (hepatitis B vaccine [recombinant]) is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. It is supplied in a 1.0 mL single-dose vial, or in a package of 10 single dose-vials.

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

LANREOTIDE (CIPLA USA)

LANREOTIDE injection is a somatostatin analog indicated for 1) the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy; and 2) the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors to improve progression-free survival. It is supplied in strengths of 60 mg/0.2 mL, 90 mg/0.3 mL and 120 mg/0.5 mL in single-dose prefilled syringes.

For more information about LANREOTIDE, 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.

For more information about SENSORCAINE, 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

These products can be ordered from FFF Enterprises' BioSupply Online Ordering System or by calling
Wow! Customer Care at (800) 843-7477.

Current Medicare IVIG / SCIG Rates

Rates per gram are effective July 1, 2022, through September 30, 2022.

 
Calculate Your Current Medicare IVIG/SCIG Rates
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
 
ASCENIV J1554 $963.54 $948.09
BIVIGAM J1556 $140.98 $138.72
FLEBOGAMMA DIF J1572 $81.04 $79.74
GAMMAGARD SD J1566 $146.35 $144.00
GAMMAPLEX J1557 $96.68 $95.13
OCTAGAM J1568 $84.04 $82.69
PANZYGA 90283 / J1599 $138.70 $136.48
PRIVIGEN J1459 $93.87 $92.36
 
CUTAQUIG 90284 / J3590 $120.28 $118.35
CUVITRU J1555 $149.71 $147.31
HIZENTRA J1559 $123.47 $121.49
HYQVIA J1575 $158.94 $156.39
XEMBIFY J1558 $135.69 $133.51
 
GAMMAGARD LIQUID J1569 $89.99 $88.55
GAMMAKED J1561 $86.78 $85.39
GAMUNEX-C J1561 $86.78 $85.39

*ASP + 4.3% applies only after July 1, 2022. On April 1, 2022, a 1% reduction in payment will apply until July 1, 2022, unless further Congressional action is taken to extend the moratorium.

 

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

IG Living is the only magazine for the immune globulin (IG) community for patients who suffer from chronic illness and their caregivers.

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BioSupply Trends Quarterly magazine is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace.

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