Monday, July 20, 2020

First COVID-19 Vaccine in the U.S. Produces Neutralizing Antibodies to the Virus in All Volunteers

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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
 

The first COVID-19 vaccine tested in the U.S., which requires two doses a month apart, has shown it produces neutralizing antibodies in the bloodstream — molecules key to blocking infection — in all volunteers at levels comparable to those found in people who survived COVID-19. A Phase III study of the vaccine in 30,000 volunteers nationwide is scheduled to begin July 27. read more ]

HHS to Fund and Conduct Three Coronavirus Vaccines

The Department of Health and Human Services (HHS) will test three possible coronavirus (COVID-19) vaccines in Phase III trials at more than 50 sites, mostly in the United States. The three vaccine trials will begin with Moderna's vaccine in July, Oxford/AstraZeneca's vaccine in August and Johnson & Johnson's vaccine in September. read more ]

Study Shows IVIG Increases Survival in Critically Ill COVID-19 Patients

A study in 93 critically ill COVID-19 patients found intravenous immune globulin (IVIG) treatment reduces inflammation, which is associated with poor clinical outcomes and death, and points to an increase in survival in critically ill COVID-19 patients when compared to a control group. The study of Octagam 5% administered at approximately 0.4g/kg body weight for five consecutive days to 51 of those patients resulted in overall survival of 60.8 percent in the treatment group that received Octagam versus 38.1 percent in the control group that did not receive IVIG, corresponding to a trend of 2.2 times reduced risk of death when receiving IVIG. read more ]

Live Attenuated Vaccines Such as MMR May Prevent Against Severe Infection from COVID-19

Another study has found a relationship between the measles-mumps-rubella (MMR) vaccine and protection against COVID-19. However, this latest study suggests live attenuated vaccines such as MMR may prevent the severe lung inflammation and sepsis associated with COVID-19 infection. read more ]

Industry News

 
Industry News Image
 

From CSL Behring

CSL Behring now offers Hizentra (immune globulin subcutaneous [human] 20% liquid) in prefilled syringes for primary immunodeficiency patients. The ready-to-use 5 mL, 10 mL and 20 mL single-use prefilled syringes eliminate the step of transfering the drug from the vial to a syringe. read more ]

From Repertoire Immune Medicines

Repertoire Immune Medicines, a clinical-stage biotech company, has received funding from the COVID-19 High Performance Computing Consortium to identify viral epitopes most likely to induce durable immunity to SARS-CoV-2, the virus that causes COVID-19, through induction of long-term memory in T cells. Under this grant, Repertoire will leverage the cloud computing resources of Amazon Web Service to simulate and predict the complex immunological interactions across patient populations that lead to clearance of SARS-CoV-2.  [ read more ]

From BioRender

BioRender has created a robust, interactive COVID-19 Vaccine and Therapeutics Tracker that is maintained regularly and updated daily. The comprehensive database covers both clinical vaccines and clinical drugs/treatments utilizing data visualization to show development progression of discrete vaccines and drugs.  [ 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 & Spray Kits, log in to biosupply.fffenterprises.com

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, log in to biosupply.fffenterprises.com

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 July 1, 2020, through Sept. 30, 2020.

 
Product J Codes ASP + 6%
(before sequester)
ASP + 4.3%*
(after sequester)
IVIG
FLEBOGAMMA J1572 $74.86 $73.66
GAMMAGARD SD J1566 $133.87 $131.72
GAMMAPLEX J1557 $107.07 $105.35
OCTAGAM J1568 $77.92 $76.67
PANZYGA 90283 / J1599 ** **
PRIVIGEN J1459 $82.55 $81.23
SCIG
CUTAQUIG 90284 / J3590 ** **
CUVITRU J1555 $139.17 $136.94
HIZENTRA J1559 $107.93 $106.20
HYQVIA J1575 $140.67 $138.41
XEMBIFY J1558 $168.42 $165.72
IVIG / SCIG
GAMMAGARD LIQUID J1569 $84.06 $82.72
GAMMAKED J1561 $83.38 $82.04
GAMUNEX-C J1561 $83.38 $82.04

* 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

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