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.

Bristol Myers Squibb Access Support®

BMS Access Support^® Can Provide
Patient Access and Reimbursement Assistance Bristol Myers Squibb is committed to helping patients gain access to their prescribed BMS medications.
That’s why we offer BMS Access Support. BMS Access Support provides resources to help patients understand
their insurance coverage. In addition, we can share information on sources of financial support, including
co-pay assistance for eligible commercially insured patients.

How BMS Access Support May HelpFind out how BMS can work with patients and their healthcare
providers to help access a prescribed BMS medication.

Financial Support OptionsThere may be programs and services that could help with the
cost of treatment. Learn about what options are available.

Additional ResourcesWe provide videos, tools, and other resources that may help
with your access and reimbursement needs.

Have Questions About Our Program
or Possible Financial Support? If you have questions about coverage for a prescribed BMS medication, BMS Access Support may be able to
help. Patients and their healthcare provider can complete an enrollment form to learn about programs that
may be of assistance. Visit our website or contact BMS Access Support to learn more.

Call Bristol Myers Squibb Access Support at
1-800-861-0048, 8 am to 8 pm ET, Monday-Friday

Visit www.BMSAccessSupport.com

The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider
and the patient. Bristol Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item.

Next: Resources

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