Access & Reimbursement

Getting Patients Started on IDHIFA®

IDHIFA® is only available through the list of contracted specialty pharmacies or through authorized distributors for in-office dispensing by community physicians, hospitals, institutions, Veterans Affairs, and Department of Defense.

Specialty Pharmacies and Authorized Distributors

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Reimbursement information

National Drug Codes (NDCs)
10-digit NDC	11-digit NDC^a	Dosage strength	Description
59572-705-30	59572-0705-30	50 mg/tablet	Bottle of 30 pale yellow-to-yellow oval-shaped tablets; each film-coated tablet is debossed “ENA” on one side and “50” on the other side.
59572-710-30	59572-0710-30	100 mg/tablet	Bottle of 30 pale yellow-to-yellow capsule-shaped tablets; each tablet is debossed “ENA” on one side and “100” on the other side.

National Drug Codes (NDCs)
10-digit NDC	59572-705-30	59572-710-30
11-digit NDC^a	59572-0705-30	59572-0710-30
Dosage strength	50 mg/tablet	100 mg/tablet
Description	Bottle of 30 pale yellow-to-yellow oval-shaped tablets; each film-coated tablet is debossed “ENA” on one side and “50” on the other side.	Bottle of 30 pale yellow-to-yellow capsule-shaped tablets; each tablet is debossed “ENA” on one side and “100” on the other side.

^aThe red zero converts the 10-digit NDC to the 11-digit NDC. Some payers may require each NDC to be listed on the claim. Payer requirements regarding the use of NDCs may vary. Electronic data exchange generally requires use of the 11-digit NDC.

ADDITIONAL PRODUCT INFORMATION

IDHIFA® (enasidenib) bottles and product information

How supplied

The 50-mg and 100-mg doses are supplied in bottles with a desiccant canister

Storage

Store tablets at 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F)
Keep the bottle tightly closed
Store in the original bottle (with a desiccant canister) to protect from moisture

Commonly used ICD-10 Codes*

C92: Myeloid leukemia
- C92.0: Acute myeloblastic leukemia
  - C92.00: Acute myeloblastic leukemia, not having achieved remission
  - C92.01: Acute myeloblastic leukemia, in remission
  - C92.02: Acute myeloblastic leukemia, in relapse

*When selecting diagnosis codes, providers should consult a current ICD-10-CM manual and always select the most appropriate diagnosis code(s) with the highest level of detail to describe a patient’s actual condition.

Celgene Patient Support®

Celgene Patient Support®A single source for access support

Celgene Patient Support® provides:

A single Specialist assigned to help patients in your geographic area
Assistance with understanding patient insurance coverage for IDHIFA®
Information about financial assistance for IDHIFA®

Financial Assistance

There are programs and organizations that may help pay for IDHIFA®, depending on a patient's insurance situation.

Celgene Commercial Co-pay Program

Co-pay responsibility for IDHIFA® is reduced to $25 (subject to annual benefit limits) for eligible patients with commercial or private insurance (including healthcare exchanges).*

Eligibility criteria for patients include*

Commercial or private insurance that does not cover the full cost of IDHIFA®
Residence in the United States or a US territory
Patients with government healthcare insurance (for example, Medicare [Parts B, C, and D], Medicaid, Medigap, Tricare) are not eligible

Celgene Patient Assistance Program (PAP)

IDHIFA® may be available at no cost for qualified patients who are uninsured or underinsured.^†

Independent third-party organizations

Patients who are unable to afford their medication (including patients with Medicare, Medicaid, or other government-sponsored insurance) may be able to receive help from independent third-party organizations.^‡

Transportation assistance^‡

Celgene Patient Support® can provide information about financial assistance for transportation costs to and from medical appointments.

Independent third-party organizations may be able to help patients with transportation costs, such as gasoline, parking, tolls, and taxi, bus, or train fare, to and from medical appointments

*Other eligibility requirements and restrictions apply. Please see full Terms and Conditions on the Celgene Patient Support® website.

^†Patients must meet specified financial and eligibility requirements to qualify for assistance.

^‡Financial and medical eligibility requirements vary by organization.

Insurance-Related Assistance

Our Specialists are available to assist with each of the following steps in the insurance approval process for IDHIFA®*:

Benefits investigation

Initiate a benefits investigation to determine co-payment and other out-of-pocket costs
Assess prior authorization requirements or precertification requirements
Educate patients about insurance coverage or other programs for which they may qualify

Prior authorization assistance/precertification assistance^†

If you need assistance with the prior authorization or precertification process or are following up on a prior authorization or precertification, Celgene Patient Support® can help.

Assist with the prior authorization or precertification process by providing the prescription form and any other necessary forms for completion
Follow up with the insurance provider to determine the outcome

Appeals assistance^†

If the patient's insurance company denies a prior authorization, precertification, or claim for IDHIFA®, Celgene Patient Support® can:

Provide information about the appeals process after a denied prior authorization, and/or claim
Supply a checklist of the required documentation for submission to the insurance company
Submit the appeal to the insurance company at the request of the patient and follow up on the status until a decision is reached

*Celgene cannot provide insurance advice or make insurance decisions.

^†Celgene provides a facilitation service and will not provide any medical input into a prior authorization or an appeal.

Enrolling in Celgene Patient Support®

We have 2 simple ways for you to enroll in Celgene Patient Support®. Choose the option that is easiest for you.

Visit us online at www.celgenepatientsupport.com

Email us at patientsupport@celgene.com or fax to 1-800-822-2496

Need additional information?
Call us at 1-800-931-8691
Monday–Friday, 8 am – 8 pm ET, (translation services available)

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Indication

IDHIFA® (enasidenib) is indicated for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

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Important Safety Information

WARNING: DIFFERENTIATION SYNDROME

Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

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WARNINGS AND PRECAUTIONS

Differentiation Syndrome: See Boxed WARNING. In the clinical trial, 14% of patients treated with IDHIFA experienced differentiation syndrome, which may be life-threatening or fatal if not treated. Differentiation syndrome has been observed with and without concomitant hyperleukocytosis, in as early as 1 day and up to 5 months after IDHIFA initiation. Symptoms in patients treated with IDHIFA included acute respiratory distress represented by dyspnea and/or hypoxia and need for supplemental oxygen; pulmonary infiltrates and pleural effusion; renal impairment; fever; lymphadenopathy; bone pain; peripheral edema with rapid weight gain; and pericardial effusion. Hepatic, renal, and multi-organ dysfunction have also been observed. If differentiation syndrome is suspected, initiate systemic corticosteroids and hemodynamic monitoring until improvement. Taper corticosteroids only after resolution of symptoms. Differentiation syndrome symptoms may recur with premature discontinuation of corticosteroids. If severe pulmonary symptoms requiring intubation or ventilator support and/or renal dysfunction persist for more than 48 hours after initiation of corticosteroids, interrupt IDHIFA until signs and symptoms are no longer severe. Hospitalization for close observation and monitoring of patients with pulmonary and/or renal manifestation is recommended.

Embryo-Fetal Toxicity: Based on animal embryo-fetal toxicity studies, IDHIFA can cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with IDHIFA and for at least 2 months after the last dose. Advise pregnant women of the potential risk to the fetus.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) included total bilirubin increased (81%), calcium decreased (74%), nausea (50%), diarrhea (43%), potassium decreased (41%), vomiting (34%), decreased appetite (34%), and phosphorus decreased (27%)
The most frequently reported ≥Grade 3 adverse reactions (≥5%) included total bilirubin increased (15%), potassium decreased (15%), phosphorus decreased (8%), calcium decreased (8%), diarrhea (8%), differentiation syndrome (7%), non-infectious leukocytosis (6%), tumor lysis syndrome (6%), and nausea (5%)
Serious adverse reactions were reported in 77.1% of patients. The most frequent serious adverse reactions (≥2%) were leukocytosis (10%), diarrhea (6%), nausea (5%), vomiting (3%), decreased appetite (3%), tumor lysis syndrome (5%), and differentiation syndrome (8%). Differentiation syndrome events characterized as serious included pyrexia, renal failure acute, hypoxia, respiratory failure, and multi-organ failure

DRUG INTERACTIONS

Coadministration of IDHIFA increases the exposure of OATP1B1, OATP1B3, BCRP, and P‑glycoprotein (P‑gp) substrates, which may increase the incidence and severity of adverse reactions of these substrates. If coadministered, decrease the dosage of the substrate as recommended in the respective prescribing information and as clinically indicated.

LACTATION

Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with IDHIFA and for at least 2 months after the last dose.

Please see full Prescribing Information, including Boxed WARNING.

Celgene Commercial Co-pay Program Terms and Conditions

Eligibility

Patients must meet the following criteria to enroll:

Covered by commercial or private insurance
Reside in the United States or US territory
Not participating in a federal or state-funded healthcare program, including, but not limited to, Medicare (Parts B, C, and D) or Medicaid, Medigap, CHAMPUS, VA, DOD, or Tricare
Gross annual household income must not exceed $100,000
- Gross household income is the total income before income tax deductions from all people living in your household. Gross income refers not only to the salaries and benefits received, but also to receipts from any personal business, investments, dividends, and other income

Program Benefits

For Celgene oral hematology products, Celgene provides assistance to reduce the co-pay of eligible patients to $25 per prescription with a maximum benefit of $10,000 per enrollment period
For Celgene IV products, the Program will cover the co-pay for each prescription of a Celgene product up to a maximum of $10,000 per enrollment period
- In order to receive the Program benefits for a Celgene IV product, patients or their providers must submit an Explanation of Benefits (EOB) form
Patients are responsible for any costs that exceed the Program’s $10,000 maximum
The Program will not cover, and shall not be applied toward, the cost of any dosing procedure, any other healthcare provider service or supply charges or other treatment costs, or any costs associated with a hospital stay

Program Timing

If eligible, patients will be enrolled from the date of enrollment through the end of the then current calendar year

Additional Terms and Conditions of the Celgene Commercial Co-pay Programs

Patients, pharmacists, and healthcare providers must not seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through this Program. Patients must not seek reimbursement from any health savings, flexible spending, or other healthcare reimbursement accounts for the amount of assistance received from the Program
Acceptance of this offer confirms that this offer is consistent with your insurance and that you will report the value of the co-pay assistance you receive as may be required by your insurance provider
Only valid in the United States and US territories; this offer is void where prohibited by law, taxed or restricted. Absent a change in Massachusetts law, effective July 1, 2019, Massachusetts residents will no longer be eligible to participate in this Program
The Program benefits are nontransferable
Acceptance in this Program is not conditioned on any past, present, or future purchase, including additional doses
The Program cannot be combined with any other coupon, rebate, voucher, free trial, or similar offer
The Program is not insurance
Celgene reserves the right to rescind, revoke, or amend this Program at any time without notice