Resources & Patient Assistance | Neulasta® Onpro® (pegfilgrastim)

Amgen is committed to providing access and resources to Onpro^® patients

Broad national coverage with opportunities to save¹

Most commercially insured patients pay $5 or less out of pocket per dose of Neulasta^®

85% of prescriptions for Neulasta^® for patients with commercial insurance cost $5 or less per dose

The remaining 15% of prescriptions cost an average of $697 per dose of Neulasta^®^*

^*These data are based on paid claims data from national data providers for the period 1/1/2018-12/31/2018. Actual cost may vary depending on dose, insurance coverage, and eligibility for support programs.

Traditional Medicare (Part B)

46% of prescriptions for Neulasta^® for patients with Medicare Part B insurance cost $5 or less per dose

The remaining 54% of prescriptions cost patients an average of $908 per dose of Neulasta^®^*

^*Patients with traditional Medicare (Part B) may also carry supplemental insurance, such as Medigap. 99% of prescriptions for Neulasta^® for patients with Medicare coverage and supplemental insurance (such as Medigap) pay, on average, less than $2 per dose of Neulasta^®, while the remaining 1% of prescriptions cost patients an average of $28 per dose.

Medicare Advantage

62% of prescriptions for Neulasta^® for patients with Medicare Advantage insurance cost $5 or less per dose

The remaining 38% of prescriptions cost patients an average of $748 per dose of Neulasta^®^*

Medicaid

99% of prescriptions for Neulasta^® for patients with Medicaid insurance cost $0 per dose of Neulasta^®

The remaining 1% of prescriptions cost patients an average of $615 per dose of Neulasta^®^*

^*These data are based on paid claims data from national data providers for the period 1/1/2018–12/31/2018. Actual cost may vary depending on dose, insurance coverage, and eligibility for support programs.

The list price for Neulasta^® is $6231^* per dose. Neulasta^® is a single dose administered once per chemotherapy cycle. Most patients do not pay the list price. Actual cost will vary.

^*List price is also referred to as wholesale acquisition cost or WAC. WAC is the price at which Amgen sells its products to wholesalers.

SUPPORT FROM
EVERY ANGLE

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contact, to provide support designed around you and your patients.

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Resources for your office

Benefit Verification

Submit, store, and retrieve benefit verifications for all patients currently on Amgen medications electronically with ease from our secure Amgen Assist 360™ Provider Portal.

Reimbursement Counselors

Call an Amgen Reimbursement Counselor directly for your benefit verification needs.

Field Reimbursement Specialists

Schedule a remote or live appointment with a Field Reimbursement Specialist who can assist with:

General reimbursement questions, including product coding and billing information
Prior authorization and claims denials/appeals
Payer-specific inquiries and policy updates
Financial assistance, including Amgen FIRST STEP™ co-pay program support

Office toolkit

Resources for your patients

Nurse Ambassadors

Patients are connected with a single point of contact who can help them find resources that are most important to them.* Amgen Nurse Ambassadors are there to support, no replace, your treatment plan and are trained to assist a patient with financial coverage and emotional wellness throughout their treatment journey.^†

Referrals to day-to-day living resources

Patients can learn about independent nonprofit organizations that may provide community resources, one-on-one counseling services, and local support groups

Financial and co-pay assistance

For eligible^‡ commercially insured patients, the Amgen FIRST STEP™ co-pay program can help. Please see details below
For patients with government insurance like Medicare, we provide referrals to independent nonprofit patient assistance programs that may be able to help them afford the co-pay cost of their medicine*^,§
For uninsured patients, the Amgen Safety Net Foundation, a nonprofit patient assistance program sponsored by Amgen, helps qualified patients access Amgen medicines at no cost

*Resources include referrals to independent nonprofit patient assistance programs. Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofit’s criteria. Amgen has no control over these programs and provides referrals as a courtesy only.

^†Patients should always consult their healthcare provider regarding medical decisions or treatment concerns.

^‡Terms, conditions, and program maximums apply. This program is not open to patients receiving prescription reimbursement under any federal, state, or government-funded healthcare program. Not valid where prohibited by law.

^§Amgen Assist 360™ can refer patients to independent nonprofit patient assistance programs that may be able to help them afford the co-pay costs for their prescribed medicine.

Amgen FIRST STEP™

For eligible* commercially insured patients

Amgen FIRST STEP™ can help your eligible commercially insured patients cover their out-of-pocket prescription costs, including deductible, co-insurance, and co-payment.

$0 out-of-pocket for first dose or cycle
$5 out-of-pocket for subsequent doses of cycles, up to the brand program benefit maximum
No income eligibility requirement

Visit Amgen FIRST STEP™ now

*Terms, conditions, and program maximums apply. This program is not open to patients receiving prescription reimbursement under any federal, state, or government-funded healthcare program. Not valid where prohibited by law.

Help your patients enroll today!

Download enrollment form

There are three easy ways to help patients submit their enrollment form for Amgen Assist 360™

Call 1‑888‑4ASSIST
(1‑888‑427‑7478)

Monday through Friday
9:00 am to 8:00 pm ET

Fax 1‑888‑407‑9787

Mail PO Box 220354
Charlotte, NC 28222‑9924

Eligibility for returns of damaged on-body injector for Neulasta^®

The Neulasta^® Onpro^® kit, purchased directly from Amgen or an authorized distributor, is eligible for return and credit or a replacement shipment due to malfunction or failure of an on-body injector for Neulasta^®, including situations where it did not perform as described in the Instructions for Use. New return policy effective October 1, 2017, allows Customer to obtain replacement if product is mishandled or improperly stored, patient no-show or refusal, and similar situations.

Visit AmgenAssist360.com

or call 1‑888‑4ASSIST (1‑888‑427‑7478)
Monday to Friday 9:00 am to 8:00 pm ET

Help guide the patient experience

The patient educational video gives patients an overview of Neulasta^® and how the on-body injector for Neulasta^® works.

This video does not replace the Instructions for Use. Please consult the Instructions for Use when using the Neulasta^® Onpro^® kit.

Additional patient resources

Patient brochure
Helps patients understand infection risk, how Neulasta^® may help, and how Neulasta^® Onpro^® works.

Download

Sharps container program
Patients can order a FREE sharps container for on-body injector disposal.

Enroll

Your patient may also call 1‑844‑MYNEULASTA (1‑844‑696‑3852) to receive a container in
7 to 10 business days.

24/7 telephone support
Patients get 24/7 telephone support for questions about Neulasta^® Onpro^®.

1-844-MYNEULASTA

(1-844-696-3852)

Important Safety Information

Contraindication

Neulasta^® (pegfilgrastim) is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim or filgrastim
Reactions have included anaphylaxis

Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of Neulasta^®
Evaluate for an enlarged or ruptured spleen in patients who report left upper abdominal or shoulder pain

Acute Respiratory Distress Syndrome (ARDS)

ARDS has occurred in patients receiving Neulasta^®
Evaluate patients who develop a fever and lung infiltrates or respiratory distress after receiving Neulasta^®
Discontinue Neulasta^® in patients with ARDS

Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis can occur in patients receiving Neulasta^®
Majority of events occurred upon initial exposure and can recur within days after discontinuation of initial anti‐allergic treatment
Permanently discontinue Neulasta^® in patients with serious allergic reactions

Allergies to Acrylics

On‐body injector (OBI) for Neulasta^® uses acrylic adhesives
Patients who are allergic to acrylic adhesives may have a significant reaction

Use in Patients With Sickle Cell Disorders

In patients with sickle cell trait or disease, severe and sometimes fatal sickle cell crises can occur in patients receiving Neulasta^®
Discontinue Neulasta^® if sickle cell crisis occurs

Glomerulonephritis

Has occurred in patients receiving Neulasta^®
Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
Generally events resolved after dose reduction or discontinuation of Neulasta^®
If suspected, evaluate for cause and if cause is likely, consider dose‐reduction or interruption of Neulasta^®

Leukocytosis

Increased white blood cell counts of 100 x 109/L have been observed
Monitoring CBCs during Neulasta^® therapy is recommended

Capillary Leak Syndrome (CLS)

CLS has been reported after G‐CSF administration, including Neulasta^®
Characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
Episodes vary in frequency, severity, and may be life‐threatening if treatment is delayed
Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include intensive care

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

G‐CSF receptor has been found on tumor cell lines
The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which Neulasta^® is not approved, cannot be excluded

Potential Device Failures

Missed or partial doses have been reported in patients receiving pegfilgrastim via the on‐body injector (OBI) due to the device not performing as intended
In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered
Instruct patients to notify their healthcare professional immediately in order to determine the need for a replacement dose if they suspect that the device may not have performed as intended

Aortitis

Aortitis has been reported in patients receiving Neulasta^®. It may occur as early as the first week after start of therapy
Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count)
Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Neulasta^® if aortitis is suspected

Nuclear Imaging

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results

Most common adverse reactions

Bone pain
Pain in extremity

Please see Neulasta^® full Prescribing Information.

Neulasta^® Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.

Neulasta^® Injection: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector (OBI) for Neulasta^® (Neulasta^® Onpro^® kit).

Special Instructions for the On‐body Injector (OBI) for Neulasta^®

A healthcare provider must fill the on‐body injector (OBI) with Neulasta^® using the co‐packaged prefilled syringe and then apply the OBI to the patient’s skin (abdomen or back of arm). The back of the arm may only be used if there is a caregiver available to monitor the status of the OBI. Approximately 27 hours after the OBI is applied to the patient’s skin, Neulasta^® will be delivered over approximately 45 minutes. A healthcare provider may initiate administration with the OBI on the same day as the administration of cytotoxic chemotherapy, as long as the OBI delivers Neulasta^® no less than 24 hours after the administration of cytotoxic chemotherapy.

The prefilled syringe co‐packaged in the Neulasta^® Onpro^® kit contains additional solution to compensate for liquid loss during delivery through the OBI. If this syringe is used for manual subcutaneous injection, the patient will receive an overdose. If the prefilled syringe for manual use is used with the OBI, the patient may receive less than the recommended dose.

Do not use the OBI to deliver any other drug product except the Neulasta^® prefilled syringe co‐packaged with the OBI. Use of the OBI has not been studied in pediatric patients.

The OBI should be applied to intact, non‐irritated skin on the arm or abdomen.

A missed dose could occur due to an OBI failure or leakage. Instruct patients using the OBI to notify their healthcare professional immediately in order to determine the need for a replacement dose of pegfilgrastim if they suspect that the device may not have performed as intended. If the patient misses a dose, a new dose should be administered by single prefilled syringe for manual use as soon as possible after detection.

Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient.

Refer to the Healthcare Provider Instructions for Use for the OBI for full administration information.

For any OBI problems, call Amgen at 1‐800‐772‐6436 or 1‐844‐MYNEULASTA (1‐844‐696‐3852).

Amgen is committed to providing access and resources to Onpro® patients

Broad national coverage with opportunities to save1

Most commercially insured patients pay $5 or less out of pocket per dose of Neulasta®

85% of prescriptions for Neulasta® for patients with commercial insurance cost $5 or less per dose

The remaining 15% of prescriptions cost an average of $697 per dose of Neulasta®*