Monday, August 17, 2020

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Studies Show Flu and Pneumonia Vaccines May Reduce Risk of Developing Alzheimer's

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

Two studies show the influenza (flu) and pneumonia vaccines lessen the risk of developing Alzheimer's disease (AD). In the first study, the protective association appeared to be strongest for those who received their first vaccine at a younger age, for example at age 60 years versus 70 years. The second found getting a pneumococcal vaccine between the ages of 65 years and 75 years reduced risk of developing AD by 25 percent to 30 percent; however, the largest reduction in the risk of AD — up to 40 percent — was seen among people vaccinated against pneumonia who didn't have a known genetic risk factor for AD. [ read more ]

New Combination Diagnostic Distinguishes Between COVID-19 and Seasonal Flu

The Centers for Disease Control and Prevention has developed a combination diagnostic that tests for the coronavirus SARS-CoV-2 and the A and B forms of influenza, helping to save limited reagents and testing capacity by otherwise using two tests, one for COVID-19 and another for seasonal flu, on every patient who presents with respiratory symptoms. The emergency use authorization for the combination diagnostic was based on data that showed analysis of 115 test samples, most of which were infected with either SARS-CoV-2, influenza A or influenza B, correctly identified all the samples, resulting in an overall percent agreement of 100. [ read more ]

CDC Alters Guidelines for Individuals Seeking to Return to Work After Testing Positive for COVID-19

CDC has made changes to testing requirements for those seeking to go back to work after a positive COVID-19 diagnosis. Prior to the changes, anyone who tested positive required a PCR test with a negative result before being allowed to go back to work. Now, CDC says people are eligible to return to work if they meet the following criteria: 1) If they have been symptom-free for at least 10 days without the assistance of a fever reducer like Tylenol or Advil; 2) If they have experienced an improvement in symptoms of any kind to include headache, diarrhea, confusion and cough; and 3) If they have been diagnosed with COVID-19 but have not experienced symptoms; however, they must wait 10 days from the date of the test before returning to work. Those who have had COVID-19 with severe symptoms, including the need for oxygen or a ventilator, hospitalization for low blood pressure or multi-organ failure must wait 20 days before returning to work, with at least one 24-hour period of no fever without the use of medication. [ read more ]

Clinical Trial Seeks to Find Long-Term Treatment for Hemophilia-A Using Gene Therapy

A Phase I clinical trial to assess a potential long-term treatment for severe hemophilia A using a gene therapy that targets synthesis of coagulation factor VIII (FVIII) has begun at Froedtert and Medical College of Wisconsin. [ read more ]

Industry News

From Emergent Biosolutions

Emergent Biosolutions Inc. is working with Mount Sinai Health System and ImmunoTek Bio Centers to develop, manufacture and conduct clinical trials to evaluate a COVID-19 hyperimmune globulin product, COVID-HIG, including a postexposure prophylaxis study on healthcare providers at high risk of COVID-19 infection and other high-risk populations. [ read more ]

From Novovax

Under Operation Warp Speed, the federal effort to make coronavirus vaccines and treatments available to the American public as quickly as possible, the Health and Human Services Department and the Defense Department have agreed to pay Novavax $1.6 billion to expedite the development of a coronavirus vaccine if it is shown to be effective in clinical trials. [ read more ]

From Sanofi and GlaxoSmithKline

Sanofi and GlaxoSmithKline have signed a $2.1 billion contract with the U.S. Department of Health and Human Services and the Department of Defense under Operation Warp Speed for the development and manufacturing of their COVID-19 vaccine. The funding will go toward late-stage development of the vaccine, including a Phase III clinical trial. The companies will also supply 100 million doses of the vaccine to the federal government. [ read more ]

IVIG & Albumin Supply Index

What's New at FFF

• HIZENTRA PRE-FILLED SYRINGES (CSL BEHRING)

HIZENTRA (immune globulin subcutaneous [human] 20% liquid) PRE-FILLED SYRINGES for primary immunodeficiency patients are ready to use, eliminating the need to transfer the drug from the vial to a syringe. The syringes come in 5 mL and 10 mL (fully assembled) and 20 mL (requiring the plunger rod to be screwed onto the syringe stopper prior to use).

For more information about HIZENTRA PRE-FILLED SYRINGES, log in to biosupply.fffenterprises.com

• 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

• 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

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.

Log in to BioSupply for Immune Globulin Products

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.

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Trends Quarterly

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