$idhifa (enasidenib) for patients with relapsed refractory aml and an idh2 mutation$

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.

10-digit NDC	59572-705-30	59572-710-30
11-digit NDC^a	59572-0705-30	59572-0710-30
NDC for IDHIFA
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

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®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

Depending on the patient’s insurance situation, there are programs and organizations that may help pay for IDHIFA.

Celgene Commercial Co-pay Program

For eligible patients with commercial or private insurance (including healthcare exchanges).*

Provides assistance to help patients meet co-pay/co-insurance costs
Reduces co-pay responsibility to $25 for IDHIFA

Eligibility criteria for patients include*

Gross annual household income of $100,000 or less^†
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)

For qualified patients who are uninsured or underinsured.^‡

IDHIFA may be available at no cost to patients who meet insurance and financial criteria
We can also help educate patients about insurance coverage or other programs for which they may qualify

Independent third-party organizations

For patients who are unable to afford their medication (including patients with Medicare, Medicaid, or other government-sponsored insurance).^§

Celgene Patient Support® can provide you with information about independent third-party organizations that may be able to help patients with the cost of:

Deductibles
Co-payments/co-insurance
Insurance premiums

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 may be subject to a random audit to verify income.

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

^§Financial and medical eligibility requirements vary by organization.

Insurance-Related Assistance

On behalf of the patient, 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
Access 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 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 3 simple ways for you to enroll in Celgene Patient Support®. Choose the option that is easiest for you.

Enroll online now

You can enroll in Celgene Patient Support® here

Call 1-800-931-8691

Patients can be enrolled over the phone at 1-800-931-8691, Monday–Thursday, 8 am–7 pm ET, and Friday, 8 am–6 pm ET (translation services available)

Email or fax the enrollment form

Download the English or Spanish enrollment form and return it to us by email at patientsupport@celgene.com or fax it to us at 1‑800‑822‑2496

Patient Financial Assistance Brochure

Download

Clinical Resources

Guides for Healthcare Professionals

IDHIFA Clinical Brochure

HCP Testing Overview

IDHIFA Nurse Guide

Hospital Formulary Kit

Patient & Caregiver Resources

Resources Available for Patients and Caregivers

IDHIFA Wallet
Cards

IDHIFA Patient
Brochure

Patient Financial
Assistance Brochure

Caregiver Brochure

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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, as early as 10 days and at 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 1 month after the last dose. Pregnant women, patients becoming pregnant while receiving IDHIFA, or male patients with pregnant female partners should be apprised 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

LACTATION

Many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants, advise women not to breastfeed during treatment with IDHIFA and for at least 1 month 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