Monday, June 15, 2020

Study Suggests Post-Infection Immunity to the COVID-19 Virus

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
 

In a recent study in nine adult rhesus macaque monkeys who were infected with the COVID-19 virus, results detected antibodies in all nine animals 35 days after infection that provided protection against the virus. However, additional research is needed to determine how long this natural immunity to the virus lasts. read more ]

Octapharma's IVIG Study for Treating Critical COVID-19 Patients Shows Positive Results

Octapharma USA's randomized open label study evaluating the standard of care (SOC) plus intravenous immune globulin (IVIG) compared to SOC alone in preventing mechanical ventilation in COVID-19 patients requiring high-flow oxygen has shown positive results. With 27 adult patients currently enrolled, Octapharma is extending funding for the study. read more ]

Some People's Immune Systems May Generate Faster and Stronger Response to COVID-19

A recent study shows some people who have never been exposed to the coronavirus (the virus that causes COVID-19) have helper T cells that may provide a stronger and faster recognition and response to the virus. The researchers believe this may be due to cross-reactivity, which occurs when helper T cells developed in response to another virus react to a similar but previously unknown pathogen. read more ]

Industry News

 
Industry News Image
 

From Octapharma

The U.S. Food and Drug Administration has approved Octapharma's investigational new drug application, allowing the company to begin a Phase III multicenter clinical trial evaluating the efficacy and safety of Octagam 10% (intravenous immune globulin, human [IVIG]) in COVID-19 patients with severe disease progression. The study began in May at approximately 10 U.S. research sites and will enroll approximately 54 adult patients diagnosed with COVID-19 who require oxygen supplementation. read more ]

From Bio Products Laboratory (BPL)

BPL has launched the sale of Albuminex 5% and 25% (human albumin) solution for injection with immediate supply available in the U.S. Both are approved by the U.S. Food and Drug Administration to treat hypovolemia; ascites; hypoalbuminemia, including from burns; acute nephrosis; acute respiratory distress syndrome; and cardiopulmonary bypass.  [ read more ]

From CSL Behring

CSL Behring and Seattle Children's Research Institute have formed an alliance to develop stem cell gene therapies for primary immunodeficiency diseases. The alliance will initially focus on developing treatment options for patients with Wiskott-Aldrich syndrome and X-linked agammaglobulinemia.  [ read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

ALBUMINEX 5% (BIO PRODUCTS LABORATORY)

ALBUMINEX 5% is a 5% albumin solution indicated for adults and children to treat hypovolemia; ascites; hypoalbuminemia, including from burns; acute nephrosis; acute respiratory distress syndrome; and cardiopulmonary bypass. It is supplied in 5 g/dL clear type II glass vials.

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

ALBUMINEX 25% (BIO PRODUCTS LABORATORY)

ALBUMINEX 25% is a 25% albumin solution indicated for adults and children to treat hypovolemia; ascites; hypoalbuminemia, including from burns; acute nephrosis; acute respiratory distress syndrome; and cardiopulmonary bypass. It is supplied in 25 g/dL clear type II glass vials.

For more information about ALBUMINEX 25%, log in to biosupply.fffenterprises.com

GEL-FLOW NT (PFIZER)

GEL-FLOW NT is indicated in surgical procedures, including those involving cancellous bone bleeding, as a hemostatic device when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is either ineffective or impractical. It can be used with or without thrombin to obtain hemostasis. The GEL-FLOW NT device consists of 550 mg of GELFOAM sterile powder, a syringe delivery system and two applicator tips for delivery of the flowable mixture to deep and narrow administration sites.

For more information about GEL-FLOW NT, please contact Wow! Customer Care

HYPERRAB 3 ML (GRIFOLS THERAPEUTICS)

HYPERRAB is now supplied in a 3 mL single-dose vial with a potency value of not less than 300 IU/mL. HYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis.

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

TEPADINA (AMNEAL BIOSCIENCES)

TEPADINA (thiotepa) is an alkylating drug indicated to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation for pediatric patients with class 3 beta-thalassemia; for treatment of adenodarcinoma of the breast or ovary; for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities; or for treatment of superfibial papillary carcinoma of the urinary bladder. It is supplied as a unit carton with one single-dose type 1 clear glass 15 mg or 100 mg vial with a bromobutyl stopper.

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

DEXYCU  (EYEPOINT PHARMACEUTICALS)

DEXYCU (dexamethasone intraocular suspension) 9% is a corticosteroid indicated for the treatment of postoperative inflammation. Each kit of DEXYCU contains a single dose for a single patient. Each kit also contains one sterile 18-gauge, 1.5-inch needle with a plastic cap attached, one sterile plastic 1-mL syringe for withdrawal of the vial contents, one sterile 25-gauge 8-mm cannula with a plastic cap attached for intraocular administration, and one syringe assembly pouch containing a sterile ring and a sterile syringe guide used for measuring and injection of the 0.005 mL dose.

For more information about DEXYCU, please contact Wow! Customer Care

TYMLOS  (RADIUS HEALTH)

TYMLOS (abaloparatide) injection, for subcutaneous use, is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. It is supplied in a glass cartridge containing 3,120 mcg of abaloparatide in 1.56 mL of sterilized, clear, colorless fluid as a pre-assembled single-patient-use disposable pen packaged in a cardboard carton. Each pen provides a 30-day supply for once-daily injection of 80 mcg abaloparatide in 40 mcL. Sterile needles are not included.

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

DEHYDRATED ALCOHOL  (AKORN)

DEHYDRATED ALCOHOL injection, USP, is indicated for therapeutic neurolysis of nerves or ganglia for the relief of intractable chronic pain in such conditions as inoperable cancer and trigeminal neuralgia (tic douloureux) in patients for whom neurosurgical procedures are contraindicated. Relief of trigeminal neuralgia usually is only temporary. Other conditions for which injection of alcohol has been reported include glossopharyngeal neuralgia, angina pectoris and severe claudication due to peripheral vascular insufficiency. It is supplied in 5 mL vial packages of 10.

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

SODIUM TETRADECYL SULFATE  (LEUCADIA PHARMACEUTICALS)

SODIUM TETRADECYL SULFATE injection 3% is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. It is supplied in a carton containing five 60 mg/2 mL multi-dose vials.

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

ZIRABEV  (PFIZER)

ZIRABEV (injection) is indicated for the treatment of metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment, and metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. It is supplied as a sterile solution for intravenous infusion supplied in a carton containing one single-dose vial in the following strengths: 100 mg/4 mL (25 mg/mL) and 400 mg/16 mL (25 mg/mL).

For more information about ZIRABEV, 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, 2020, through June 30, 2020.

 
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
FLEBOGAMMA J1572 $72.03 $70.88
GAMMAGARD SD J1566 $128.18 $126.12
GAMMAPLEX J1557 $110.42 $108.65
OCTAGAM J1568 $80.94 $79.64
PANZYGA 90283 / J1599 ** **
PRIVIGEN J1459 $82.43 $81.11
SCIG
CUTAQUIG 90284 / J3590 ** **
CUVITRU J1555 $138.85 $136.62
HIZENTRA J1559 $104.97 $103.29
HYQVIA J1575 $141.37 $139.10
XEMBIFY 90284 / J3590 ** **
IVIG / SCIG
GAMMAGARD LIQUID J1569 $79.50 $78.23
GAMMAKED J1561 $81.65 $80.34
GAMUNEX-C J1561 $81.65 $80.34

* 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

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.

Subscribe to BioSupply
Trends Quarterly

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

Home | About | Advertise | Subscribe | Contact – © FFF Enterprises, Inc.