Monday, April 20, 2020

First Patient Outside U.S. Treated in Global Kevzara Clinical Trial Program for Patients with Severe COVID-19

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
 

The first patient outside of the U.S. has been treated as part of a global clinical program evaluating Kevzara (sarilumab) in patients hospitalized with severe COVID-19. Kevzara inhibits IL-6, which may play a role in driving the inflammatory immune response that causes acute respiratory distress syndrome observed in patients with severe COVID-19 infection. The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the United States with Regeneron conducting U.S. trials and Sanofi conducting trials outside of the U.S. The first U.S.-based trials will begin in New York hospitals. read more ]

Flu Vaccine Reduces Risk of Respiratory Morbidity and Mortality in AIRDs

A new study shows inactivated influenza (flu) vaccine is associated with a reduced risk for respiratory morbidity and mortality in patients with autoimmune rheumatic diseases (AIRDs). Results showed vaccination reduced the risk for hospitalizations with pneumonia, chronic obstructive pulmonary disease exacerbations, all-cause mortality and death due to pneumonia in the 2006-2009 and 2010-2015 flu seasons. read more ]

Study Finds Alternative IVIG Dosing Methods Saves Millions

A study has found intravenous immune globulin (IVIG) dosing optimization using alternative dosing weights can save up to $3.89 million and reduce outpatient infusion times. read more ]

Industry News

 
Industry News Image
 

From CSL Behring, Takeda, Biotest, BPL, LFB and Octapharma

Biotest, BPL, LFB and Octapharma have joined an alliance formed by CSL Behring and Takeda Pharmaceutical Company Limited to develop a potential plasma-derived therapy for treating COVID-19. The alliance will begin immediately with the investigational development of one unbranded anti-SARS-CoV-2 polyclonal hyperimmune immune globulin medicine with the potential to treat individuals with serious complications from COVID-19. read more ]

From AstraZeneca

AstraZeneca is donating nine million face masks to support healthcare workers around the world as they respond to the COVID-19 global pandemic. AstraZeneca has partnered with the World Economic Forum's COVID Action Platform, created with the support of the World Health Organization, to identify countries in greatest need.  [ read more ]

From HEMA Biologics

The U.S. Food and Drug Administration has approved Sevenfact (coagulation factor VIIa [recombinant]-jncw) for the treatment and control of bleeding episodes in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies).  [ read more ]

From Inovio Pharmaceuticals

A new COVID-19 vaccine candidate has entered Phase I clinical human testing. Inovio Pharmaceuticals will inject its first volunteer test subject with the INO-4800 DNA vaccine candidate it has developed, which works by injecting a specifically engineered plasmid (a small, independent genetic structure) into a patient so his or her cells can produce a desired, targeted antibody to fight off a specific infection.  [ read more ]

From Octapharma

Octapharma USA is supporting a new clinical trial that will investigate whether intravenous immune globulin (IVIG) can halt coronavirus progression to respiratory failure requiring transfer into the intensive care unit and mechanical ventilation in admitted COVID-19 patients, and whether adding IVIG to the standard of care will reduce days requiring oxygen therapy and total hospital days.   [ read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

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

YUTIQ  (EYEPOINT PHARMACEUTICALS)

YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection, is a corticosteroid indicated for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. It is supplied in a sterile single-dose preloaded applicator with a 25-gauge needle, packaged in a sealed sterile foil pouch inside a sealed Tyvek pouch inside a carton box.

For more information about YUTIQ, 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

ACYCLOVIR  (FRESENIUS)

ACYCLOVIR (sodium injection) is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) infections and varicella-zoster (shingles) infections in immunocompromised adults and children. It is also indicated for severe initial episodes of herpes simplex infections in patients who may not be immunocompromised. It is available in two sizes: a 10 mL single-dose vial containing acyclovir sodium equivalent to 500 mg acyclovir, packaged in trays of 10 vials; and a 20 mL single-dose vial containing acyclovir sodium equivalent to 1 gram of acyclovir, packaged in trays of 10 vials.

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

ZIRABEV  (INTERNATIONAL MEDICATION SYSTEMS)

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.

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