Amgen - Medical Professionals

Coding and Claims Processing

Required Documentation

Payors often require additional documentation to describe the drug used. For Neulasta® use, insurers may request information about the patient's cancer diagnosis and chemotherapy regimen.

Some claims processors may be unfamiliar with Neulasta®, and may require additional information. For example:

FDA approval date for Neulasta®.
FDA package insert.
Amount of product administered (6 mg).
Indication for treatment.
Chemotherapeutic regimen.

The type of information required varies by payor.

Some payors will recognize and use this supplemental information immediately, if it is sent with the initial claim.
Other payors will not recognize the information immediately. For example, some Medicare contractors will not accept this additional information until they have returned the claim to the provider for an additional development request (ADR).

Contact the Reimbursement Connection®, 1-800-272-9376, for the most updated policy information for each insurer.

Letters of Medical Necessity

With either initial or subsequent claims for a patient, payors may require additional information to verify the patient is an appropriate candidate for treatment. Letters of medical necessity are the most appropriate way to submit this information. When drafting a letter of medical necessity, physicians should be as specific as possible. Some of the information providers may wish to highlight include:

Date of Neulasta® (pegfilgrastim) FDA approval,
A description of the drug,
The amount of the drug administered,
The indication for treatment,
Information regarding chemotherapy regimen.
A description of the patient's condition, previous treatment, and other relevant patient information

The Reimbursement Connection® is available to help you identify the types of information that your payor requires. Please call 1-800-272-9376.

Neulasta® Indication and Important Product Safety Information

Neulasta® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Important Product Safety Information

Splenic rupture (including fatal cases), acute respiratory distress syndrome, and sickle cell crises have been reported. Allergic reactions, including anaphylaxis, have also been reported. The majority of these reactions occurred upon initial exposure. However, in rare cases, allergic reactions, including anaphylaxis, recurred within days after discontinuing anti-allergic treatment.
In a placebo-controlled trial, bone pain occurred at a higher incidence in Neulasta®-treated patients as compared to placebo-treated patients (31% vs 26%). The most common adverse events reported in either placebo- or active-controlled trials were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain.

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