Monday, September 20, 2021

Banner Image - Patient Safety, Product Integrity, Fair Pricing

Convalescent Plasma Not Effective Against COVID-19 Disease Progression

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 clinical trial funded by the National Institutes of Health has revealed convalescent plasma did not prevent disease progression in a high-risk group of COVID-19 outpatients when administered within the first week of their symptoms. [ read more ]

IVIG Boosts Platelet Counts in COVID-Vaccine-Induced Thrombotic Thrombocytopenia

A case study of three patients with COVID-19 vaccine-induced immune thrombotic thrombocytopenia showed starting intravenous immune globulin (IVIG) was linked to reduced antibody-induced platelet activation and serum. According to the researchers, the finding will allow them to target this disease to limit the growing threat of clotting. [ read more ]

NIH Begins COVID-19 Booster Study in Autoimmune Patients

The National Institutes of Health (NIH) has begun a clinical trial to assess the antibody response to a booster shot of the COVID-19 vaccine in people with autoimmune disease who did not respond to the first dose. The trial will also investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody response to an additional COVID-19 vaccine dose. [ read more ]

COVID-19 Infection and Vaccine Elicits Powerful Immunity

According to a recent study, some people who have previously been infected with COVID-19 and later received a vaccine may develop a powerful immunity known as "hybrid vigor immunity" to the virus and variants of it that emerge. [ read more ]

Industry News

From Pfizer and BioNTech

The U.S. Food and Drug Administration has given full approval for Pfizer's and BioNTech's COVID-19 vaccine in people 16 years and older based on updated data from the companies' clinical trial and manufacturing review. Public health officials hope the action will convince unvaccinated Americans that the vaccine is safe and effective, as well as prompt more state and local governments and private employers to impose vaccine mandates. [ read more ]

From Octapharma USA

The U.S. Food and Drug Administration Office of Orphan Products Development has awarded seven years of marketing exclusivity for Octagam 10% (immune globulin intravenous [human]), the first and only intravenous immune globulin indicated for the treatment of adult dermatomyositis. [ read more ]

From ADMA Biologics

ADMA Biologics has been granted approval by the U.S. Food and Drug Administration for its in-house aseptic fill-finish machine, the VanRx SA25, which utilizes a state-of-the-art closed isolator design, allowing for the removal of human interventions and providing safe drug products for patients. [ read more ]

IVIG & Albumin Supply Index

What's New at FFF

• PREVNAR 20 (WYETH PHARMACEUTICALS)

PREVNAR 20 (pneumococcal 20-valent conjugate vaccine), suspension for intramuscular injection is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. It is supplied in single-dose prefilled syringes in a package of 1 or 10.

For more information about PREVNAR 20, log in to biosupply.fffenterprises.com

• DEXMEDETOMIDINE HCL (WEST-WARD PHARMACEUTICALS)

DEXMEDETOMIDINE HCL is a relatively selective alpha2-adrenergic agonist indicated for sedation of nonintubated patients prior to and/or during surgical and other procedures. It is supplied in 2 mL single-use clear glass vials in a carton of 25.

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

• 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 influenzae 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

• 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.