Monday, September 21, 2020

CMS Publishes 2020-2021 Seasonal Influenza Vaccines Pricing Allowance

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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 Centers for Medicare and Medicaid Services (CMS) has published the Medicare Part B payment allowance limits for seasonal influenza and pneumococcal vaccines for the 2020-2021 season. Payment allowance limits are 95 percent of the average wholesale price as reflected in the published compendia except where the vaccine is furnished in a hospital outpatient department. When the vaccine is furnished in the hospital outpatient department, payment for the vaccine is based on reasonable cost. Payment rates can be viewed on the CMS website. read more ]

Moderna's COVID-19 Vaccine Induced Similar Immune Response in Older Adults as in Younger Participants

Moderna's experimental COVID-19 vaccine, mRNA-1273, induced immune responses in older adults similar to those in younger participants, offering hope that it will be effective in people considered to be at high risk for severe complications from the coronavirus. The latest data from an early Phase I study includes an analysis from 20 additional people detailing how the vaccine performed in older adults. The vaccine is one of three that are currently in Phase III clinical trials. read more ]

Hospitalized COVID-19 Patients Significantly Improved with IVIG Plus SOC

In a prospective study of 16 COVID-19 patients who were randomized 1:1 to receive either standard of care (SOC) plus 0.5 g/kg per day of intravenous immune globulin (IVIG) for three days with 40 mg of methylprednisolone 30 minutes before infusion versus SOC alone showed IVIG significantly improved hypoxia and reduced hospital length of stay and progression to mechanical ventilation A-a gradient >200 mm Hg. read more ]

Study Finds Antibodies That Fight the Coronavirus Do Not Fade Quickly

A study conducted in Iceland that involved 30,000 people found antibodies that people make to fight the coronavirus last for at least four months after diagnosis and do not fade quickly, as some earlier reports suggested. read more ]

Industry News

 
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From Octapharma

The Centers for Medicare and Medicaid Services has modified the External Infusion Pump Local Coverage Determination to include Cutaquig 16.5%, Octapharma's subcutaneous immune globulin, for use with electric and mechanical pumps for adult primary immunodeficiency disease (PI) patients. read more ]

From AstraZeneca

AstraZeneca has started Phase III trials of its experimental coronavirus vaccine in the United States, becoming the third company to start late-stage trials of a vaccine to prevent COVID-19. The company is recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV and who are at increased risk of infection from the SARS-CoV-2 virus."  [ read more ]

From ADMA Biologics

ADMA Biologics has launched the COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma. ImmunoRank was developed in collaboration with Leinco Technologies Inc. and is intended to be an aid to identify individuals who produce an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV-2 neutralizing antibodies in human plasma of all immune globulin classes.  [ read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Days On Hand
     
 
 
 
     

What's New at FFF

ANAVIP (RARE DISEASE THERAPEUTICS)

ANAVIP [Crotalidae Immune F(ab')2 (Equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American rattlesnake envenomation. It is supplied as a sterile lyophilized preparation in a single-use vial. When reconstituted with 10 mL of 0.9% NaCl solution, each vial contains not more than 12 mg per mL of protein, and will neutralize not less 780 times the LD50 of Bothrops asper venom and 790 times the LD50 of Crotalus durissus venom in a mouse neutralization assay. Each carton contains 1 vial of ANAVIP.

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

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.

 

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

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Trends Quarterly

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

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