Monday, August 16, 2021

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Third Pfizer COVID-19 Vaccine Dose Boosts Protection

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

Research shows a third dose of the Pfizer COVID-19 vaccine can strongly boost protection against the delta variant beyond the protection afforded by the standard two doses. Specifically, antibody levels against the delta variant in people ages 18 years to 55 years who receive a third dose of vaccine are greater than five-fold than following a second dose. Among people ages 65 years to 85 years, antibody levels against the delta variant after receiving the third dose are greater than 11-fold than following a second dose. And, there is an "estimated potential for up to a 100-fold increase in delta neutralization post-dose three compared to pre-dose two." [ read more ]

Flu Vaccine Linked to Less Severe COVID-19 Infection

A new study that analyzed the electronic medical records of more than 74,700 people from the United States, United Kingdom, Italy, Germany, Israel and Singapore who tested positive for COVID-19 found those who had gotten the flu vaccine during the previous six months were less likely to have had health complications related to their COVID-19 infection. [ read more ]

Those with COVID-19 Virus Immunity Better Protected with Vaccine

According to the Centers for Disease Control and Prevention, there is growing laboratory evidence that people who had one bout of COVID-19 get a dramatic boost in virus-fighting immune cells — and a bonus of broader protection against new mutants — when they're vaccinated. [ read more ]

Recombinant von Willebrand Factor Reduces Spontaneous Bleeding

Results of a Phase III clinical trial suggest recombinant von Willebrand factor is efficacious in reducing spontaneous bleeding for patients with severe von Willebrand disease previously treated in an on-demand manner, and without new risks identified. [ read more ]

Industry News

From Grifols Therapeutics

Grifols has initiated a voluntary withdrawal of nine Gamunex-C 10% lots: A1GKF00022, A1GKF00032, A1GKF00042, A4GKE01012, A4GKE01092, A3GLE01432, A4GLE01512, A1GLE01582, A1GLE01642. [ Call (800) 520-2807 ]

From Octapharma USA

The U.S. Food and Drug Administration has granted approval for Octagam 10% (immune globulin intravenous [human]), the first and only intravenous immune globulin indicated for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease. [ read more ]

From Moderna

Moderna has dosed its first participant in a Phase 1 study of mRNA-6231, an mRNA-encoded IL-2 modified for the expansion of regulatory T cells. The company hopes to bring the potential of mRNA therapeutics to people living with autoimmune diseases. [ read more ]

From Kadmon Pharmaceuticals

Kadmon Pharmaceuticals won approval from the U.S. Food and Drug Administration to market Rezurock, a new treatment for chronic graft-versus-host disease, a debilitating immune condition that can affect as many as half of the blood cancer patients who undergo bone marrow transplants. [ read more ]

IVIG & Albumin Supply Index

What's New at FFF

• ACETAMINOPHEN INJECTION (B. BRAUN MEDICAL)

ACETAMINOPHEN INJECTION is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older; management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older; and reduction of fever in adult and pediatric patients. It is a clear colorless solution supplied sterile and nonpyrogenic in 50 mL and 100 mL fill PAB containers packaged 24 per case.

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

• VAXELIS (SANOFI PASTEUR)

VAXELIS is a three-dose vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenza type b in children 6 weeks through 4 years old. It is supplied in a single-dose vial in packages of 10 and a 0.5 mL single-dose prefilled syringe with a Luer lock connection and a tip cap without a needle in packages of 10.

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

• 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.

Subscribe to BioSupply
Trends Quarterly

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