Biosupply Trends Marketplace News
Monday, September 18, 2023

CDC Recommends Newly Approved COVID-19 Vaccines

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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The Centers for Disease Control and Prevention (CDC) is recommending all Americans age 6 months and older receive the updated Moderna and Pfizer-BioNTech COVID-19 booster vaccines that more closely target circulating strains, including BA.2.86, amid rising cases and hospitalizations across the country. The U.S. Food and Drug Administration recently approved the emergency use of the vaccines. According to CDC, 1) adults and persons with weakened immune systems are at greatest risk for hospitalization and death, and healthy children and adults can still experience severe disease; 2) the vaccines continue to be the best way to protect individuals against severe disease, outweighing any potential risks; 3) serious reactions after COVID-19 vaccination are rare (in one study, the risk of cardiac complications, including myocarditis, in males 12 to 17 years old was 1.8 to 5.6 times higher after COVID-19 infection than after COVID-19 vaccination); 4) the vaccines are covered by insurance, including private insurance, Medicare plans and Medicaid plans, and uninsured children and uninsured adults also have access through the Vaccine for Children Program and Bridge Access Program, respectively. read more ]

 

ACIP Updates 2023-24 Flu Vaccine Recommendations

The Advisory Committee on Immunization Practices (ACIP) has updated the composition of the influenza (flu) vaccines for the 2023-2024 season. The egg-based and cell- or recombinant-based vaccines will include an A/Victoria/4897/2022 (H1N1)pdm09-like virus; an A/Darwin/9/2021 (H3N2)-like virus; a B/Austria/1359417/2021 (B/Victoria lineage)-like virus; and a B/Phuket/3037/2013 (B/Yamagata lineage)-like virus. These recommendations include only one update compared to the 2022-2023 U.S. flu vaccine composition. read more ]

 

Moderna's Updated COVID-19 Vaccine Generates Strong Immune Response Against New Variant

Moderna's updated COVID-19 vaccine generates an 8.7-fold increase in neutralizing antibodies in humans against the BA.2.86 variant that has raised fears about the resurgence of infections. The vaccine is pending approval by the U.S. Food and Drug Administration for the fall 2023 vaccination season. read  more ]

 

Serious COVID-19 Patients at a 43% Higher Risk of AD

Patients with a more severe case of COVID-19 demonstrate a 43 percent increased risk for new-onset autoimmune diseases (AD) in the three to 15 months following acute infection, according to a new study published in Clinical Rheumatology. read  more ]

Industry News

Industry News Image

From Verrica Pharmaceuticals

The U.S. Food and Drug Administration (FDA) has approved Ycanth (cantharidin) for the topical (used on the skin) treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. Ycanth is the first FDA-approved treatment for molluscum contagiosum. read more ]

From Pfizer

Pfizer's ABRYSVO, a respiratory syncytial virus (RSV) vaccine, has been approved by the U.S. Food and Drug Administration for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth up to 6 months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. read more ]

From Sandoz

Tyruko (natalizumab-sztn), an integrin receptor antagonist biosimilar, has been approved by the U.S. Food and Drug Administration as a monotherapy to treat all indications covered by the reference medicine Tysabri (natalizumab) for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease, as well as Crohn's disease in adults. Tyruko is the first and only FDA-approved biosimilar for relapsing forms of MS. read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

YCANTH™ (VERRICA PHARMACEUTICALS)

YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. It is supplied in a sealed glass ampule contained within a single-use applicator and enclosed in a protective paperboard sleeve. Each ampule contains 7 mg/mL of YCANTH.

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

NOVAVAX COVID-19 VACCINE (NOVAVAX, INC)

The Novavax COVID-19 Vaccine (Adjuvanted/Protein Subunit) is a vaccine indicated for active immunization to prevent coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. It is supplied in boxes of 10 doses of two 2.5mL-5 dose multi-dose vials.

For more information about NOVAVAX COVID-19 VACCINE (ADJUVANTED/PROTEIN SUBUNIT), log in to biosupply.fffenterprises.com

MODERNA COVID-19 VACCINE (mRNA) (MODERNA U.S. INC.)

Moderna COVID-19 Vaccine (mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. It is supplied in cartons of 10 5.5 mL multiple-dose vials and cartons of 10 7.5 mL multiple-dose vials.

For more information about MODERNA COVID-19 VACCINE (mRNA), log in to biosupply.fffenterprises.com

AREXVY (GLAXOSMITHKLINE BIOLOGICALS)

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older. It is supplied as two components: a single-dose vial of lyophilized antigen component (powder) and a single-dose vial of adjuvant suspension component (liquid) (packaged without syringes or needles) in cartons of 10 vials.

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

BEYFORTUS (SANOFI PASTEUR)

BEYFORTUS is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. It is supplied as one 50 mg/0.5 mL single-dose pre-filled syringe, in a carton of five 50 mg/0.5 mL single-dose pre-filled syringes, one 100 mg/mL single-dose pre-filled syringe and in a carton of five 100 mg/mL single-dose pre-filled syringes.

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

ASCENIV (ADMA BIOLOGICS)

ASCENIV (immune globulin intravenous, human - slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents 12 to 17 years of age. It is supplied in single-use, tamper-evident 50 mL vials containing 5 grams of protein.

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

DIAZEPAM INJECTION (FRESENIUS KABI)

DIAZEPAM INJECTION is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety; in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis; as an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present and to diminish the patient's recall of the procedures; as a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, stiff-man syndrome and tetanus; as a useful adjunct in status epilepticus; and as a useful premedication for relief of anxiety and tension in patients who are to undergo surgical procedures, as well as intravenously prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure. It is supplied in a 10 mg/2 mL clear, colorless to yellow solution in a prefilled syringe with luer lock.

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

ABRYSVO (PFIZER INC.)

ABRYSVO is a vaccine indicated for active immunization for the prevention of lower respiration tract disease caused by respiratory syncytial virus in individuals 60 years of age and older. It is supplied in a kit that includes a vial of lyophilized antigen component, a prefilled syringe containing sterile water diluent component and a vial adapter in cartons of one, five and 10 kits.

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

INDOCIN (ZYLA LIFE SCIENCES)

INDOCIN is a nonsteroidal anti-inflammatory drug indicated for moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to severe ankylosing spondylitis; moderate to severe osteoarthritis; acute painful shoulder (bursitis and/or tendinitis); and acute gouty arthritis. The 50 mg suppositories (indomethacin suppositories USP) are white, opaque and rectal supplied in boxes of 30.

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

MENVEO ONE-VIAL (GLAXOSMITHKLINE)

MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in individuals 2 months through 55 years of age. It is supplied in cartons containing five vials of MenCYW-135 liquid conjugate component and cartons containing five vials of MenA lyophilized conjugate component.

For more information about MENVEO ONE-VIAL, log in to biosupply.fffenterprises.com

CALCIPOTRIENE FOAM (MAYNE PHARMA)

CALCIPOTRIENE FOAM is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. It is supplied in a 60 gram aluminum can.

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

DORYX MPC (MAYNE PHARMA)

DORYX MPC is a tetracycline-class drug indicated for the treatment of rickettsial infections; sexually transmitted infections; respiratory tract infections; specific bacterial infections; ophthalmic infections; anthrax, including inhalational anthrax (post-exposure); alternative treatment for selected infections when penicillin is contraindicated; adjunctive therapy in acute intestinal amebiasis and severe acne; and prophylaxis of malaria. The DORYX MPC (doxycycline hyclate delayed-release) 60 mg and 120 mg tablets are white, oval tablets containing yellow pellets and debossed with "D6" on one face and plain on the other. The 60 mg tablets are supplied in bottles of 60 and 120, and the 120 mg tablet is supplied in bottles of 30.

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

ALTUVIIIO (BIOVERATIV THERAPEUTICS)

ALTUVIIIO (antihemophilic factor [recombinant], Fc-VWF-XTEN fusion protein-ehtl) is a recombinant DNA-derived, factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding. It is supplied in kits comprising a single-dose vial containing nominally 250, 500, 750, 1000, 2000, 3000 or 4000 IU of factor VIII potency, a prefilled syringe with 3 mL sterile water for injection and a sterile vial adapter (reconstitution device).

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

LIDOCAINE HYDROCHLORIDE 4% (SINTETICA US LLC)

LIDOCAINE HYDROCHLORIDE injection 4% is indicated for the production of topical anesthesia of the mucous membranes of the respiratory tract or the genito-urinary tract. It may be injected trans-tracheally to anesthetize the larynx and trachea, and it may be administered by retrobulbar injection to provide anesthesia for ophthalmic surgery. It is supplied in a pack of 10 200 mg/5 mL single-dose ampules.

For more information about LIDOCAINE HYDROCHLORIDE 4%, log in to biosupply.fffenterprises.com

LIDOCAINE HYDROCHLORIDE 1%/2% (SINTETICA US LLC)

LIDOCAINE HYDROCHLORIDE injection 1% and 2% are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal, and by central neural techniques such as lumbar and caudal epidural blocks when the accepted procedures for these techniques as described in standard textbooks are observed. The 1% injection is supplied in a pack of 10 20 mg/2mL, 50 mg/5 mL and 100 mg/10 mL single-dose ampules. The 2% injection is supplied in 40 mg/2 mL, 100 mg/5 mL and 200 mg/10 mL single-dose ampules.

For more information about LIDOCAINE HYDROCHLORIDE 1%/2%, log in to biosupply.fffenterprises.com

HEPARIN SODIUM (TECHDOW)

HEPARIN SODIUM injection is an anticoagulant indicated for prophylaxis and treatment of venous thrombosis and pulmonary embolism; prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; atrial fibrillation with embolization; treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); prevention of clotting in arterial and cardiac surgery; prophylaxis and treatment of peripheral arterial embolism; and use as an anticoagulant in blood transfusions, extracorporeal circulation and dialysis procedures. It is supplied in a concentration of 1,000 mL in 2 mL single-dose vials and 1 mL, 10 mL and 30 mL multiple-dose vials; in a concentration of 5,000 mL in 1 mL and 10 mL multiple-dose vials; in a concentration of 10,000 mL in 1 mL and 5 mL multiple-dose vials; and in a concentration of 20,000 mL in 1 mL multiple-dose vials.

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

MENQUADFI (SANOFI)

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)

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

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, 2023, through Sept. 30, 2023.

 
Calculate Your Current Medicare IVIG/SCIG Rates
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
ASCENIV J1554 $982.81 $967.05
BIVIGAM J1556 $145.93 $143.59
FLEBOGAMMA DIF J1572 $112.23 $110.43
GAMMAGARD SD J1566 $155.53 $153.04
GAMMAPLEX J1557 $118.97 $117.06
OCTAGAM J1568 $88.24 $86.82
PANZYGA 90283 / J1599 $131.48 $129.37
PRIVIGEN J1459 $95.98 $94.44
SCIG
CUTAQUIG J1551 $143.86 $141.55
CUVITRU J1555 $162.75 $160.14
HIZENTRA J1559 $128.03 $125.98
HYQVIA J1575 $166.55 $163.88
XEMBIFY J1558 $139.99 $137.74
IVIG / SCIG
GAMMAGARD LIQUID J1569 $92.06 $90.59
GAMMAKED J1561 $101.28 $99.66
GAMUNEX-C J1561 $101.28 $99.66
 

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
•  Immune Globulin (Human) Chart
•  Hyperimmune Globulin Chart
•  Coagulation Catalog
•  Seasonal Influenza Vaccine Reference Guide
   

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