Resources for Your Hemophilia A Patients

ADVATE support for your patients

Takeda is proud to provide a variety of programs and resources for hemophilia A patients.

ADVATE is covered on
over 99%* of Commercial and Medicaid Health Plans.⁺¹

⁺Source: FINGERTIP FORMULARY^®, as of 03/08/2023, is subject to change without notice by a health plan or state.

*Product coverage divided by total therapeutic category coverage, based on the Rx and Medicaid coverage using DRG medical lives.

Get started

Download these helpful tools or contact Takeda Patient Support for assistance with accessing ADVATE.

Access tools and resources

Sample letter of medical necessity

Download and use this letter as a template if a payer requires a statement of medical necessity for ADVATE.

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PA request form checklist

Reference the items listed in the PA request form checklist as they may be necessary to obtain a prior authorization decision for ADVATE.

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ADVATE Patient Type Brochure: Need for a Personalized Dosing Regimen

Reference this patient type brochure if you have patients with active lifestyles who need a personalized dosing regimen.

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ADVATE Patient Type Brochure: Staying the Course

Reference this patient type brochure if you have patients who are currently on ADVATE and looking to stay the course with treatment.

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ADVATE Patient Type Brochure: On Demand

This brochure details the patient type who treats his bleeding episodes as they occur.

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ADVATE Patient Type Brochure: Higher Risk of Bleeds

This brochure details the patient type for those who have higher risk for bleeds.

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ADVATE billing and coding information

Healthcare providers are responsible for ensuring accurate and appropriate diagnostic coding to obtain reimbursement. Use the appropriate codes noted below or download the quick reference ADVATE Billing and Coding sheet.

NDC codes^2,3

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ADVATE nominal strength	Factor VIII potency range (IU per vial)	NDC codes^*
250 IU	200-400	0944-3051-02^†
375 IU	200-400	0944-3051-02^†
500 IU	401-800	0944-03052-02^†
750 IU	401-800	0944-03052-02^†
1000 IU	801-1200	0944-03053-02^†
1500 IU	1201-1800	0944-03054-02^†
1700 IU	1201-1800	0944-03054-02^†
2000 IU	1801-2400	0944-03045-10^‡
2500 IU	2401-3600	0944-03046-10^‡
3000 IU	2401-3600	0944-03046-10^‡
4000 IU	3601-4800	0944-03047-10^‡
^*NDC codes have been formatted to comply with HIPAA guidelines. Please ensure that NDC codes are properly formatted to comply with specific payor requirements, as applicable. ^†Includes 2 mL sWFi diluent. ^‡Includes 5 mL sWFi diluent.

ICD-10 Diagnosis codes⁴

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ICD-10 Code	Description
D66	Hereditary factor VIII deficiency

Healthcare Common Procedure Coding System (HCPCS)⁵

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HCPCS Code [J Code]	Description
J7192	Factor VIII (antihemophilic factor, recombinant) per IU, not otherwise specified

Current Procedural Terminology codes³

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CPT Codes	Description
96374	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intravenous push, single or initial substance/drug
96376	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); each additional sequential intravenous push of the same substance/drug provided in a facility (List separately in addition to code for primary procedure. Do not report 96376 for a push performed within 30 minutes of a reported push of the same substance or drug; 96376 may be reported by facilities only)

Hospital Revenue codes⁶

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Hospital Revenue Codes	Description
0636	Pharmacy, drugs requiring detailed coding.

ADVATE [Antihemophilic Factor (Recombinant)] Important Information

Indications

ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for:

Control and prevention of bleeding episodes.
Perioperative management.
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

ADVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product.

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions

Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms include dizziness, paresthesia, rash, flushing, facial swelling, urticaria, dyspnea, pruritus, and vomiting. Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment.

Neutralizing Antibodies

Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.

ADVERSE REACTIONS

Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
The most common adverse reactions observed in clinical trials (>5% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea.

Click to read Full Prescribing Information.

References References

Decision Resources Group. Fingertip Analytics reporting tool. Accessed July 10, 2019.
Advate. Prescribing information. Baxalta US Inc; 2018.
Takeda data on file.
ICD-10-CM tabular list of diseases and injuries 2019. Centers for Disease Control and Prevention. Accessed October 2, 2019. ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/Publications/ICD10CM/2019/icd10cm_tabular_2019.pdf
2019 Alpha-Numeric HCPCS file. Centers for Medicare & Medicaid Services. Accessed October 2, 2019. https://www.cms.gov/medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS-Items/2019-Alpha-Numeric-HCPCS-File
Medicare claims processing manual. Centers for Medicare & Medicaid Services. Accessed October 2, 2019. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c18.pdf