w BioSupply Trends Newsletter: Wednesday, July 1, 2015

Wednesday, July 1, 2015

Pricing and Policies for Biosimilars Are Announced

In this Issue


•	IVIG/Albumin Supply Index
•	Open Market Pricing
•	New Products from FFF
•	Current Medicare IVIG Rates
•	Resources
•	Subscribe to IG Living and BioSupply Trends Quarterly

The Centers for Medicare and Medicaid Services plans to begin paying for biosimilars through its Part B, Part D and state coverage policies by this summer, according to a question-and-answer document released in April. In addition, the insurance billing codes for biosimilars, which will differ from the codes for their reference products, are expected to be released July 1, with reimbursements applying retroactively to the biosimilar’s FDA approval date. [ read more ]

Studies Find Interventions Increase HPV Vaccine Coverage

Three recent studies have found that interventions increase the rates of HPV vaccination among teens and young women. The HPV vaccine series is recommended for routine use in girls and boys aged 11 to 12 years, in young women up to age 26, in young men up to age 21, and in men up to age 26 who have sex with other men or who have compromised immune systems. However, the HPV vaccine series has the lowest completion rates of any other vaccine.

To read more on these studies:

Practice and Community Based Interventions to Increase Human Papillomavirus Vaccine Coverage [ read more ]
Impact of an Electronic Health Record (EHR) Reminder on Human Papillomavirus (HPV) Vaccine Initiation and Timely Completion [ read more ]
ACA Provisions Associated With Increase In Percentage Of Young Adult Women Initiating And Completing The HPV Vaccine [ read more ]

Influenza Often Overlooked with Bacterial Coinfection

A new study has found that many influenza-positive patients are not clinically diagnosed with influenza. Instead, influenza goes undiagnosed in favor of a diagnosis of bacterial disease coinfection. Without a flu diagnosis, treatment can be adversely affected, especially for those who are hospitalized or with high-risk conditions. [ read more ]

Industry News

From Baxter

Baxter has submitted a marketing authorization application to 17 authorities in Europe for approval of its investigational 20% concentration subcutaneous immune globulin (SCIG) treatment for primary immunodeficiencies (PI) based on results of a Phase 2/3 study in European patients. Results from a separate study of SCIG 20% among patients with PI in North America are expected to be available in the fall, and based on the outcomes, Baxter intends to file for U.S. approval of the product before the end of 2015. [ read more ]

From Leading Biosimilars Developers

In May, the Biosimilars Forum was launched by 11 of the leading biosimilar developers in the U.S. - Actavis, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Hospira, Merck, Pfizer, Samsung, Sandoz and Teva - to educate and advocate for public policies and practices that encourage access, awareness and adoption of biosimilars.
[ read more ]

From Protein Sciences Corp.

The FDA has granted exclusivity to Flublok influenza vaccine for a period of 12 years. The regulatory exclusivity means that no product similar to Flublok can be approved by FDA before Jan. 16, 2025. Flublok is the first vaccine awarded this status.
[ read more ]

IVIG & Albumin Supply Index

IVIG and Albumin Supply Index from December - April 2015

Log in to BioSupply for IVIG and Albumin Product Pricing

New Products From FFF

• VariZIG Liquid Formulation (Cangene Corp.)

Varicella zoster immune globulin (human) indicated for post-exposure prophylaxis in high-risk individuals, including immunocompromised children and adults; newborns of mothers with varicella shortly before or after delivery; premature infants; infants less than 1 year old; adults without evidence of immunity and pregnant women

• Zerbaxa (ceftolozane/tazobactam) 1 g/0.5 g (Merck)

Injection indicated for adult patients for the treatment of complicated urinary tract infections, including pyelonephritis, caused by the following Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa

• Stratis Needle-Free Injection System 0.5 mL (PharmaJet)

Needle-free injection system that delivers vaccines either intramuscularly or subcutaneously via a narrow, precise fluid stream syringe that delivers the medicine or vaccine through he skin (only approved for use with AFLURIA 5 mL 10 DS vial)

• Novoeight 250 IU vial, 500 IU vial, 1000 IU vial, 1500 IU vial, 2000 IU vial, 3000 IU vial (Novo Nordisk)

Antihemophilic factor (recombinant) indicated for use in adults and children with hemophilia A for 1) control and prevention of bleeding, 2) perioperative management and 3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes

• Sivextro Tedizolid Phosphate 200 mg tablet-6 pk, 200 mg tablet-30 pk, 200 mg IV vial-10pk (Merck)

Antibacterial drug for the treatment of adults with skin infections and to reduce the development of drug-resistant bacteria

• Tice BCG 50 mg SDV (Merck)

Intravesical vaccine for the treatment and prophylaxis of carcinoma in situ of the urinary bladder, and prophylaxis of stage Ta and/or T1 papillary tumor of the urinary bladder

• Gardasil 9 0.5 ml PFS (Merck)

Human papillomavirus 9-valent vaccine approved for females ages 9 years through 26 years

FFF Enterprises offers a wide portfolio of plasma products, vaccines and critical-care biopharmaceuticals, to view our complete list of products visit our website – Product Catalog. These products can be ordered by calling Wow! Customer Care at (800) 843-7477.

Current Medicare IVIG Rates

Rates per gram are effective July 1, 2015 through September 30, 2015.

Product	J Codes	ASP + 6% (before sequester)	ASP + 4.3%* (after sequester)
Bivigam	J1556	$78.02	$76.76
Carimune NF	J1566	$64.50	$63.46
Flebogamma	J1572	$69.50	$68.39
Gammagard Liquid	J1569	$77.57	$76.32
Gammagard S/D	J1566	$64.50	$63.46
Gammaked	J1561	$79.60	$78.33
Gammaplex	J1557	$73.06	$71.89
Gamunex-C	J1561	$79.60	$78.33
Octagam	J1568	$77.33	$76.09
Privigen	J1459	$76.56	$75.34

*Reflects 2% sequestration reduction applied to 80% Medicare payment portion as required under Budget Control Act of 2011.

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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