ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] Access and Resources

ADYNOVATE is covered on over 91%^† of Commercial and Medicaid health plans¹

Source: FINGERTIP FORMULARY^®, as of 06/15/2020, 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 Medical coverage using DRG medical lives.

ADYNOVATE Access: tools and resources

Download these helpful tools or contact the Hematology Support Center for assistance with accessing ADYNOVATE.

Sample letter of medical necessity

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

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Sample 1500 claim form

View itemized directions to fill out a CMS-1500 for ADYNOVATE in physician office settings.

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Prior authorization (PA) form checklist

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

Download worksheet

ADYNOVATE Patient Type Brochure: Staying the Course

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

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ADYNOVATE Patient Type Brochure: Looking for Adequate Bleed Coverage

Reference this brochure if you have patients who are looking to get their bleeds under control and would like to discuss a prophylaxis treatment regimen.

Download brochure

Materials made with you in mind: Nurse tools for patient management

Support your patients with tools for effective conversations and to develop a care partnership together.

ADYNOVATE overview

See how ADYNOVATE could fit in patients' lives

Download brochure

Bleed tracker

Help your patients build better tracking habits

Download brochure

Recognizing and managing bleeds

Educate your patients with clarity about their condition

Download brochure

Hemophilia management discussion guide

Kick-start more meaningful discussions about a patient's goals

Download guide

ADYNOVATE 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 ADYNOVATE Billing and Coding Sheet.

NDC codes²

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Nominal Strength	NDC Codes^*
250 IU	0944-4622-01^†
500 IU	0944-4623-01^†
750 IU	0944-4626-01^†
1000 IU	0944-4624-01^†
1500 IU	0944-4627-01^†
2000 IU	0944-4625-01^‡
3000 IU	0944-4628-01^‡

^*NDC numbers have been formatted to comply with HIPAA guidelines. Please ensure that NDC numbers are properly formatted to comply with specific payor requirements, as applicable.

^†Includes 2 mL sWFI diluent.

^‡Includes 2 mL sWFI diluent.

ICD-10 Diagnostics codes³

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ICD-10 Code	Description
D66	Hereditary factor VIII deficiency

Healthcare Common Procedure Coding System (HCPCS)⁴

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HCPCS Code	Description
J7207	Injection, factor VIII, (antihemophilic factor, recombinant), pegylated, 1 IU

Current Procedural Terminology codes⁵

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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 Code	Description
0636	Pharmacy, drugs requiring detailed coding

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information

Indications and Limitation of Use

ADYNOVATE is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

On-demand treatment and control of bleeding episodes
Perioperative management
Routine prophylaxis to reduce the frequency of bleeding episodes

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

DETAILED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions: Hypersensitivity reactions are possible with ADYNOVATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with other recombinant antihemophilic factor VIII products, including the parent molecule, ADVATE. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.

Neutralizing Antibodies: Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.

ADVERSE REACTIONS

The most common adverse reactions (≥1% of subjects) reported in the clinical studies were headache, diarrhea, rash, nausea, dizziness and urticaria.

Click here for ADYNOVATE Prescribing Information.
Click here for ADYNOVATE Prescribing Information en Español.

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 here for ADVATE Prescribing Information.
Click here for ADVATE Prescribing Information en Español.

myPKFiT^® for ADYNOVATE Intended Use

The myPKFiT software is intended for use by licensed healthcare professionals (HCPs) who are familiar with hemophilia care. The myPKFiT software can be used to generate ADYNOVATE dosage amount and frequency recommendations for routine prophylaxis for an individual patient 12 years of age and older and body weight of 29 kg or greater, using that patient’s age and body weight information and local laboratory FVIII one-stage clotting activity measurements of sparse samples collected from that patient.
A minimum of two sparse sampling points are required at the recommended 3 hours (± 30 minutes) and at 48 hours (±2 hours) and/or 72 hours (±2 hours).
HCPs will also be able to evaluate various prophylaxis dose regimens tailored to an individual patient’s needs and treatment plan.
The software output may be used to guide decisions on appropriate ADYNOVATE dose and infusion intervals to maintain FVIII activity levels at or above a user-specified minimum FVIII activity level between 1% to 3% above natural baseline for an individual patient in accordance with the FDA-approved dosing recommendations provided in the ADYNOVATE Prescribing Information (PI).
myPKFiT should only be used to evaluate prophylactic dosing regimens for hemophilia A patients treated with ADYNOVATE, as per the ADYNOVATE Prescribing Information (PI).
myPKFiT for ADYNOVATE is not indicated for the treatment of von Willebrand disease. MyPKFiT for ADYNOVATE should not be used for patients who have developed neutralizing antibody (inhibitor) to FVIII products.

myPKFiT for ADYNOVATE is Rx only. For safe and proper use of the myPKFiT software, please refer to the complete instructions for use in the User Manual.

Help your patients get started on ADYNOVATE

ADYNOVATE is covered on over 91%† of Commercial and Medicaid health plans1

ADYNOVATE Access: tools and resources

Materials made with you in mind: Nurse tools for patient management

ADYNOVATE billing and coding information

NDC codes2

ICD-10 Diagnostics codes3

Healthcare Common Procedure Coding System (HCPCS)4

Current Procedural Terminology codes5

Hospital Revenue codes6

Are you a U.S. healthcare professional?

ADYNOVATE is covered on over 91%^† of Commercial and Medicaid health plans¹

NDC codes²

ICD-10 Diagnostics codes³

Healthcare Common Procedure Coding System (HCPCS)⁴

Current Procedural Terminology codes⁵

Hospital Revenue codes⁶

Are you a U.S. healthcare
professional?