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Monday, November 21, 2022
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New COVID-19 Variants Pose Threat to the Immunocompromised

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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Recent reports reveal the emergence of new omicron subvariants that not only evade AstraZeneca's Evusheld, the antibody drug authorized to prevent SARS-CoV-2 infection, but also the sole drug that has retained effectiveness as treatment for COVID-19, Eli Lilly's bebtelovimab, which is predicted to cause a serious threat to those who are immunocompromised. read more ]

 

Study Links Specific Gene Variant to COVID-19 Vaccine Efficacy

U.S. scientists have developed a new genomic test that proved 90 percent accurate at predicting a patient's risk of developing severe COVID-19, an advance that could help doctors quickly begin tailored treatment. read more ]

 

First Clinical Trial Tests Lab-Grown Blood in Humans

Tiny amounts of blood that has been grown in a laboratory have been infused into people in a world-first clinical trial in the United Kingdom to determine how well it performs inside the body. The goal is to manufacture vital ultra-rare blood types to improve treatment for people with blood disorders and rare blood types. read more ]

Industry News

Industry News Image

From Novavax

Sotyktu (deucravacitinib), a once-daily oral pill for adults who have plaque psoriasis (a chronic, systemic, immune-mediated disease) severe enough to make them candidates for systemic therapy and phototherapy, has been approved by the U.S. Food and Drug Administration. read more ]

From Pfizer-BioNTech

Pfizer and BioNTech reported on findings from an ongoing study of its updated COVID-19 booster vaccine that shows it generates a strong immune response against the BA.4 and BA.5 subvariants. Results are based on blood samples taken from adults one week after they received the updated booster. read more ]

From Pfizer

Top-line results from Pfizer's Phase III clinical trial MATISSE (MATernal Immunization Study and Efficacy) of its bivalent respiratory syncytial virus (RSV) prefusion vaccine candidate, RSVpreF (or PF-06928316), show that when administered to pregnant participants to help protect their infants from RSV disease after birth, vaccine efficacy was 81.8 percent against severe medically attended lower respiratory tract illness due to RSV in infants from birth through the first 90 days of life with high efficacy of 69.4 percent through the first six months of life. read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

METHYLPREDNISOLONE ACETATE (AMNEAL PHARMACEUTICALS)

METHYLPREDNISOLONE ACETATE injectable suspension is indicated for 1) control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness and transfusion reactions; 2) dermatologic diseases, including bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome); 3) endocrine disorders, including primary or secondary adrenocortical, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsupportive thyroiditis; 4) gastrointestinal diseases, including regional enteritis (systemic therapy) and ulcerative colitis; 5) hematologic disorders, including acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia and select cases of secondary thrombocytopenia; 6) trichinosis with neurologic or myocardial involvement and tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; 7) neoplastic diseases, including leukemias and lymphomas; 8) cerebral edema associated with primary or metastatic brain tumor or craniotomy; 9) ophthalmic diseases, including sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; 10) to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus; 11) respiratory diseases, including berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias and symptomatic sarcoidosis; and 12) as adjunctive therapy for short-term administration in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis and rheumatoid arthritis, including juvenile rheumatoid arthritis, and as treatment of dermatomyositis, polymyositis and systemic lupus erythematosus. It is supplied as a white to off-white homogenous suspension in 40 mg/mL and 80 mg/mL single-dose vials in cartons of 25.

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

ARTESUNATE (AMIVAS INC.)

ARTESUNATE for injection is an antimalarial indicated for the initial treatment of severe malaria in adult and pediatric patients. It is supplied as a white or almost white, sterile, fine crystalline powder for constitution in 110 mg single-dose, clear glass vials sealed with a rubber stopper and an aluminum overseal.

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

BRIVIACT (UCB INC.)

BRIVIACT (brivaracetam) tablets for oral use, oral solution and injection for intravenous use are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. BRIVIACT is supplied as 10 mg, 25 mg, 50 mg, 75 mg and 100 mg tablets in bottles of 60; as a 10 mg/mL oral solution; and in a carton of 10 50 mg/5 mL single-dose glass vials.

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

CIMZIA (UCB INC.)

CIMZIA (certolizumab pegol) for injection for subcutaneous use is a tumor necrosis factor blocker indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy; treatment of adults with moderately to severely active rheumatoid arthritis; treatment of adult patients with active psoriatic arthritis; treatment of adults with active ankylosing spondylitis; treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation; and treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is supplied in a packet containing two type I glass vials with rubber stopper and overseals each containing 200 mg of lyophilized CIMZIA for reconstitution; 2 2 mL type I glass vials containing 1 mL sterile water for injection; 2 3 mL plastic syringes; 4 20 gauge needles (1 inch); 2 23 gauge needles (1 inch); and 8 alcohol swabs.

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

KEPPRA (UCB INC.)

KEPPRA (levetiracetam) injection for intravenous use, tablets for oral use and oral solution are indicated for 1) the treatment of partial-onset seizures in patients 1 month of age and older and 2) for adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy and primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. KEPPRA injection is also indicated as an alternative for patients when oral administration is temporarily not feasible. KEPPRA injection is supplied in single-use 5 mL vials in cartons of 10. KEPPRA oral tablets are supplied in 250 mg blue, 500 mg yellow, 750 mg orange tablets in bottles containing 120 tablets, and 1,000 mg white tablets in bottles containing 60 tablets. KEPPRA oral solution is supplied as a 100 mg/mL clear, colorless, grape-flavored liquid in 16 fluid ounce white bottles.

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

NAYZILAM (UCB INC.)

NAYZILAM (midazolam) nasal spray is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. It is supplied in boxes of two single-dose nasal spray units, each contained within an individual blister pack.

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

NEUPRO (UCB INC.)

NEUPRO (rotigotine transdermal system) is a dopamine agonist indicated for the treatment of Parkinson's disease and moderate-to-severe primary restless legs syndrome. Each transdermal system is packaged in a separate pouch in 1 mg, 2 mg, 3 mg, 4 mg, 6 mg and 8 mg strengths in cartons of 30.

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

VIMPAT (UCB INC.)

VIMPAT (lacosamide) film coated tablets for oral use, injection for intravenous use and oral solution are indicated for the treatment of partial-onset seizures in patients 1 month of age and older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. VIMPAT tablets are supplied in 50 mg pink, 100 mg dark yellow, 150 mg salmon and 200 mg blue tablets in bottles of 60. VIMPAT injection is supplied in 200 mg/20 mL single-dose glass vials. VIMPAT oral solution is supplied as a 10 mg/mL clear, colorless to yellow or yellow-brown strawberry-flavored liquid in 200 mL glass bottles.

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

KETALAR (PAR PHARMACEUTICAL)

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

EPINEPHRINESNAP™-EMS Kit (SNAP MEDICAL INDUSTRIES)

EpinephrineSnap™-EMS is an epinephrine convenience kit designed to treat a single episode of an allergic reaction/anaphylaxis. The epinephrine in this kit is a non-selective alpha and beta adrenergic agonist indicated for the emergency treatment of allergic reactions, including anaphylaxis. The kit is supplied with (1) vial of epinephrine injection, (4) alcohol prep pads, (2) 23-gauge, 1-inch safety needles, (2) 1 mL luer lock Epinephrine Syringes™, and (1) instructions for use card.

For more information about EPINEPHRINESNAP™-EMS Kit, log in to biosupply.fffenterprises.com

EPINEPHRINESNAP™-V Kit (SNAP MEDICAL INDUSTRIES)

EpinephrineSnap™-V is an epinephrine convenience kit designed to treat a single episode of an allergic reaction/anaphylaxis. The epinephrine in this kit is a non-selective alpha and beta adrenergic agonist indicated for the emergency treatment of allergic reactions, including anaphylaxis. The kit is supplied with (1) vial of epinephrine injection, (4) alcohol prep pads, (3) 23-gauge, 1-inch safety needles, (3) 1 mL luer lock Epinephrine Syringes™, and (1) instructions for use card.

For more information about EPINEPHRINESNAP™-V Kit, 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 October 1, 2022, through December 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 $140.98 $138.72
FLEBOGAMMA DIF J1572 $79.74 $78.46
GAMMAGARD SD J1566 $148.00 $145.63
GAMMAPLEX J1557 $102.15 $100.51
OCTAGAM J1568 $84.20 $82.85
PANZYGA 90283 / J1599 $139.28 $137.04
PRIVIGEN J1459 $93.40 $91.91
SCIG
CUTAQUIG J1551 $127.21 $125.17
CUVITRU J1555 $149.00 $146.61
HIZENTRA J1559 $123.63 $121.65
HYQVIA J1575 $158.85 $156.30
XEMBIFY J1558 $137.79 $135.58
IVIG / SCIG
GAMMAGARD LIQUID J1569 $90.46 $89.01
GAMMAKED J1561 $89.34 $87.90
GAMUNEX-C J1561 $89.34 $87.90

*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

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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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