Monday, July 19, 2021

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eBST News: Flu Vaccine May Reduce Severity of COVID-19

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

A major study that analyzed nearly 75,000 COVID-19 patients found significant reductions in stroke, deep vein thrombosis and sepsis, and fewer admissions to emergency departments and intensive care units, among those who had been given the influenza (flu) vaccine. Previous research suggests the flu vaccine may provide some protection against COVID-19 by boosting the innate immune system — the body's general defenses that are not targeted against a particular pathogen. [ read more ]

FDA Amends HES Boxed Warning

The U.S. Food and Drug Administration (FDA) is requiring safety labeling changes to the prescribing information for the class of hydroxyethyl starch (HES) products to amend the boxed warning to warn about the risk of mortality, kidney injury and excess bleeding. FDA is also requiring related changes to the indications and usage, contraindications, warnings and precautions, and adverse reactions sections. [ read more ]

COVID-19 Vaccines Safe and Effective for Autoimmune Rheumatic Disease Patients

Researchers at three major centers in Israel have found the COVID-19 vaccines are safe and effective for individuals with autoimmune rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondylitis, lupus and vasculitis, especially for those taking medications. [ read more ]

COVID-19 Vaccines Not Protective for Immunocompromised

A new study from the University of Pittsburgh Medical Center indicates the existing COVID-19 vaccines do not adequately help form antibodies in those with compromised immune systems. The hope is the results will help direct alternative COVID-19 treatments for the immunocompromised. [ read more ]

Industry News

From Pfizer and BioNTech SE

Pfizer Inc. and BioNTech SE's COVID-19 vaccine will be tested in children less than 12 years old in a late-stage study seeking to extend COVID-19 protection across the entire range of ages. The trial will enroll as many as 4,500 participants at more than 90 sites spanning the U.S., Finland, Poland and Spain. [ read more ]

From Moderna and Pfizer

A new study conducted at Washington University in St. Louis suggests the Moderna and Pfizer vaccines are likely to provide long-lasting immunity to COVID-19. Specifically, it found people who were fully vaccinated had a robust immune response nearly four months later. [ read more ]

From Moderna

Moderna gave its mRNA-based seasonal flu vaccine to the first set of volunteers in a clinical trial. Pharmaceutical companies hope mRNA-based flu vaccines can be more effective than the traditional shots. Because they'd be faster to make, production wouldn't have to start so far in advance, and they could theoretically be more closely matched with the type of flu spreading each season. [ read more ]

From Sanofi

The U.S. Food and Drug Administration's Center for Biologics Evaluation and Research has given approval to Sanofi Pasteur for an additional influenza manufacturing facility located at its existing site in Swiftwater, Pa. The newly completed facility further expands production and distribution of Sanofi's Fluzone High-Dose Quadrivalent for the upcoming 2021–2022 influenza season in the United States. [ read more ]

IVIG & Albumin Supply Index

What's New at FFF

• CLOBEX (GALDERMA LABORATORIES)

CLOBEX (clobetasol propionate) shampoo 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years and older. It is supplied as a translucent, colorless to pale yellow viscous liquid in a 4-ounce bottle.

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

• DIFFERIN GEL (GALDERMA LABORATORIES)

DIFFERIN gel 0.3% is a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years and older. It is supplied in 15 g and 45 g tubes and a 45 g pump.

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

• DIFFERIN LOTION (GALDERMA LABORATORIES)

DIFFERIN lotion 0.1% is a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years and older. It is supplied as a white to off-white liquid in a 2-ounce bottle equipped with a lotion-dispensing pump.

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

• MIRVASO (GALDERMA LABORATORIES)

MIRVASO (brimonidine) topical gel 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years and older. It is supplied as a whit to light yellow opaque gel in a laminated tube or pump with a child-resistant cap in 30 g and 45 g tubes and a 30 g pump.

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

• TRI-LUMA CREAM (GALDERMA LABORATORIES)

TRI-LUMA cream is a combination of fluocinolone acetonide (a corticosteroid), hydroquinone (a melanin synthesis inhibitor) and tretinoin (a retinoid) indicated for the short-term treatment of moderate to severe melisma of the face in the presence of measures for sun avoidance, including the use of sunscreens. It is supplied as a light yellow cream in a 30 g aluminum tube.

For more information about TRI-LUMA CREAM, log in to biosupply.fffenterprises.com

• VECTICAL OINTMENT (GALDERMA LABORATORIES)

VECTICAL ointment is a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adult and pediatric patients 2 years and older. It is supplied in a 100 g collapsible aluminum tube.

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

• EPIDUO FORTE (GALDERMA LABORATORIES)

EPIDUO FORTE gel 0.3%/2.5% is a combination of adapalene (a retinoid) and benzoyl peroxide indicated for the topic treatment of acne vulgaris. It is supplied as a white to very pale yellow and opaque gel in 15 g, 30 g, 45 g, 60 g and 70 g pumps.

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

• ORACEA (GALDERMA LABORATORIES)

ORACEA is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. It is supplied in an amount equivalent to 40 mg in a bottle of 30.

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

• SOOLANTRA CREAM (GALDERMA LABORATORIES)

SOOLANTRA cream 1% is indicated for the treatment of inflammatory lesions of rosacea. It is supplied as a white to pale yellow cream in a laminated tube with a child-resistant cap in 30 g, 45 g and 60 g tubes.

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

• AKLIEF CREAM (GALDERMA LABORATORIES)

AKLIEF cream 0.005% is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years and older. It is supplied as a white cream in 30 g, 45 g and 75 g pumps.

For more information about AKLIEF CREAM, 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, 2021, through September 30, 2021.

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	J1572	$69.43	$68.31
GAMMAGARD SD	J1566	$131.77	$129.66
GAMMAPLEX	J1557	$99.62	$98.02
OCTAGAM	J1568	$83.21	$81.87
PANZYGA	90283 / J1599	**	**
PRIVIGEN	J1459	$86.36	$84.97
SCIG
CUTAQUIG	90284 / J3590	**	**
CUVITRU	J1555	$142.09	$139.81
HIZENTRA	J1559	$112.33	$110.53
HYQVIA	J1575	$148.34	$145.96
XEMBIFY	J1558	$133.89	$131.74
IVIG / SCIG
GAMMAGARD LIQUID	J1569	$95.42	$93.89
GAMMAKED	J1561	$95.55	$94.01
GAMUNEX-C	J1561	$95.55	$94.01

* 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.