EMPLICITI TM (elotuzumab)

Transcription

1 A REFERENCE GUIDE TO REIMBURSEMENT and CODING EMPLICITI TM (elotuzumab) for injection, for intravenous use (300 mg and 400 mg vials) In combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies INDICATION EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. SELECTED IMPORTANT SAFETY INFORMATION EMPLICITI with lenalidomide and dexamethasone is associated with the following Warnings and Precautions: Infusion Reactions, Infections, Second Primary Malignancies, Hepatotoxicity, Interference with Determination of Complete Response, Pregnancy/Females and Males of Reproductive Potential, and Adverse Reactions. Please see additional Important Safety Information on page 20 and accompanying

2 Bristol-Myers Squibb Is Committed to Helping Support Access This brochure is designed to help appropriate patients get access to our medications by providing helpful reimbursement information for healthcare offices. Healthcare benefits vary significantly; therefore, it is important that oncology offices verify each patient s insurance coverage prior to initiating therapy. Table of Contents ICD-10-CM Codes... HCPCS Codes CPT Codes... NDC Information Codes... Coding and Billing Units... Dosing and Administration... EMPLICITI Distribution... Ordering EMPLICITI... General Reimbursement Information... Co-Pay Assistance Program... Patient Affordability... Important Safety Information Healthcare providers should code healthcare claims based upon the service that is rendered, the patient s medical record, the coding requirements of each health insurer, and best coding practices. The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. 2

3 MULTIPLE MYELOMA: ICD-10-CM Codes for EMPLICITI ICD-10-CM codes are used to identify a patient s diagnosis and inpatient procedure. On October 1, 2015, the newest version of these codes, ICD-10-CM, was implemented throughout the United States. This version replaces the previous version, ICD-9-CM. The ICD-10-CM diagnosis codes contain categories, subcategories, and codes. Characters for categories, subcategories, and codes may be letters or numerals All categories are 3 characters Subcategories are either 4 or 5 characters Codes may be 3, 4, 5, 6, or 7 characters The ICD-10-CM codes for the labeled indication for EMPLICITI are provided below by Bristol-Myers Squibb and should be verified with the payer. Some health plan and Medicare insurers may specify which codes are covered under their policies. Please code to the level of specificity documented in the medical record. For additional coding questions, call BMS Access Support at or visit ICD-10-CM Codes for EMPLICITI 1 C90 Multiple myeloma and malignant plasma cell neoplasms C90.0 Multiple myeloma C90.00 Multiple myeloma not having achieved remission C90.02 Multiple myeloma in relapse Note: If infusion is the only reason for the patient encounter, physicians and hospitals may report the code below as the primary diagnosis 1 : Z51.12 Encounter for antineoplastic immunotherapy The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. 3

4 Healthcare Common Procedure Coding System (HCPCS) and Revenue Codes for EMPLICITI Recommended HCPCS Code for EMPLICITI 2 HCPCS Code Description Billing Units J9176 Injection, elotuzumab, 1 mg 1 mg = 1 billing unit Use the following claim formats when EMPLICITI is administered to patients on an outpatient basis and billed to health plans: Physician office: CMS-1500 (paper format) or ASC 837P (electronic format) Hospital outpatient: UB-04 (CMS-1450) [paper format] or ASC 837I (electronic format) JW modifier Effective January 1, 2017, providers and suppliers are required to report the JW modifier on Part B drug claims for discarded drugs and biologicals. Also, providers and suppliers must document the amount of discarded drugs or biologicals in Medicare beneficiaries' medical records. 3 All the coding information presented is applicable to outpatient procedures only. Please see pages 8-9 for more information. Revenue Codes 4 (for Use in the Hospital Outpatient Setting) Revenue Code Description 0636 Drugs requiring detailed coding 0335 Chemotherapy administration, IV 0260 IV solutions The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. 4

5 CPT Codes for the Administration of EMPLICITI Current Procedural Terminology (CPT)* codes that may be appropriate when administering EMPLICITI appear in the table below. Recommended CPT Codes for EMPLICITI 5 CPT Code Description APC Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug Each additional hour List separately in addition to code for primary procedure Use in conjunction with Report for infusion intervals of greater than 30 minutes beyond 1-hour increments 5692 Please contact the payer or BMS Access Support for additional coding information regarding EMPLICITI. * CPT codes and descriptions only are 2017 by American Medical Association (AMA). All rights reserved. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association. APC=ambulatory payment classification; 5695=Level V Drug Administration; 5692=Level II Drug Administration. 6,7 The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. 5

6 NDC Information for EMPLICITI The National Drug Codes (NDCs) for EMPLICITI, listed in the table below, are often necessary in addition to the appropriate J-code when filing a claim for reimbursement. NDC Information for EMPLICITI mg single-dose vial mg single-dose vial The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. 6

7 5010 Electronic Transaction Coding for EMPLICITI For electronic transactions, including 837P and 837I, the NDC is to be preceded by the qualifier N4 and followed immediately by the 11-digit NDC code for payers that require it 9 This is typically followed by the quantity qualifier, such as UN (units), F2 (international units), GR (gram), or ML (milliliter), and the quantity administered Transaction Coding for EMPLICITI 8 How Supplied NDC NDC Qualifier NDC Basis of Measurement Sample NDC 5010 Format 300 mg (lyophilized powder) single-dose vial N4 UN N UN1 400 mg (lyophilized powder) single-dose vial N4 UN N UN1 The examples given in the far-right column demonstrate NDC quantity reporting for 1 vial of EMPLICITI. The actual amount of drug used can vary based on factors such as patient weight. Currently, reporting NDC quantity varies from payer to payer, so the provider should consult each specific payer to determine the required format. The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. 7

8 Coding and Billing Units for EMPLICITI Please contact the payer or BMS Access Support for additional information on coding and billing units CMS-1500 Form A Physician Office Item 19: Many payers require detailed information about the drug in Box Typically, payers require the drug name, total dosage and strength, method of administration, 11-digit NDC, and basis of measurement B Item 21: Enter the appropriate ICD-10-CM diagnosis codes for the type of multiple myeloma being treated 9 A B D E F C Item 24A: NDC information is required in the shaded area above the line on which a drug is reported in 24D. 9 The NDC is preceded by the qualifier N4 and followed by the quantity qualifier (UN) and the quantity administered. 9 For example, use N UN1 for the 300-milligram (mg) vial or N UN1 for the 400-mg vial 8 C D Item 24D: Enter the relevant HCPCS (J9176) and CPT codes (96413 for EMPLICITI infusion, and for each additional hour for infusions longer than 90 minutes). 2,5,9 In addition, it is required that you enter J9176-JW on next line to record waste 3 This sample form is for informational purposes only. The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. E F Item 24E: Enter the diagnosis code reference letter or number from Box 21 that relates to the date of service and the services or procedures performed that are entered on that same line under 24D 9 Item 24G: Billing units are reported here. 9 1 mg = 1 billing unit 8

9 Coding and Billing Units for EMPLICITI (cont d) UB-04 Form Outpatient Hospital 1 2 3a PAT. 4 TYPE CNTL # OF BILL b. MED. REC. # 6 STATEMENT COVERS PERIOD 7 5 FED. TAX NO. FROM THROUGH 8 PATIENT NAME a 9 PATIENT ADDRESS a b b c d e 10 BIRTHDATE 11 SEX ADMISSION CONDITION CODES 12 DATE 13 HR 14 TYPE 15 SRC 16 DHR 29 ACDT STAT STATE 31 OCCURRENCE 32 OCCURRENCE 33 OCCURRENCE 34 OCCURRENCE 35 OCCURRENCE SPAN 36 OCCURRENCE SPAN 37 CODE DATE CODE DATE CODE DATE CODE DATE CODE FROM THROUGH CODE FROM THROUGH a b VALUE CODES 40 VALUE CODES 41 VALUE CODES CODE AMOUNT CODE AMOUNT CODE AMOUNT a A B C b D c d 42 REV. CD. 43 DESCRIPTION 44 HCPCS / RATE / HIPPS CODE 45 SERV. DATE 46 SERV. UNITS 47 TOTAL CHARGES 48 NON-COVERED CHARGES a b A Form Locator (FL) 42: Enter the 4-digit revenue code that best describes the service provided, in accordance with hospital billing policy. 10 For chemotherapy administration, revenue codes 0260 (intravenous [IV] therapy) or 0335 (radiology therapeutic: chemotherapy IV) could be used. 4 The Centers for Medicare & Medicaid Services (CMS) recommends using revenue code 0636 (drugs requiring detailed coding) A B C PAGE OF CREATION DATE TOTALS 52 REL. 53 ASG. INFO BEN. 50 PAYER NAME 51 HEALTH PLAN ID 54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI 57 OTHER PRV ID 58 INSURED S NAME 59 P.REL 60 INSURED S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO A B C B FL 43: Enter the modifier N4 followed by the 11-digit NDC in positions Report the quantity qualifier (UN) followed by the quantity administered (300 mg or 400 mg). For example, use N UN1 for the 300-mg vial or N UN1 for the 400-mg vial 8,10 A B C A B 63 TREATMENT AUTHORIZATION CODES 64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME C C 67 A B C D E F G H I J K L M N O P Q 70 PATIENT 71 PPS 72 REASON DX a b c CODE ECI a b c DX 69 ADMIT 73 DX PRINCIPAL a. OTHER PROCEDURE b. OTHER PROCEDURE PROCEDURE DATE F QUAL 76 ATTENDING NPI CODE CODE DATE CODE DATE LAST FIRST OTHER PROCEDURE d. c. OTHER PROCEDURE e. OTHER PROCEDURE QUAL 77 OPERATING NPI DATE CODE CODE DATE CODE DATE LAST FIRST 81CC 80 REMARKS 78 OTHER NPI QUAL a b LAST FIRST c 79 OTHER QUAL NPI d LAST FIRST UB-04 CMS-1450 APPROVED OMB NO THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF. This sample form is for informational purposes only. E The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. A B C A B C D E FL 44: Enter the relevant HCPCS (J9176) and CPT codes (96413 for EMPLICITI infusion, and for each additional hour for infusions longer than 90 minutes). 2,5,10 In addition, it is required that you enter J9176-JW on the next line to record waste 3 FL 46: Billing units are called service units and are placed here mg = 1 billing unit FLs 67A-67Q: Enter the appropriate ICD-10-CM diagnosis codes for the type of multiple myeloma being treated 10 F FL 80: Some payers require detailed information about the drug in FL 80. 9,10 Typically, payers require the drug name, total dosage and strength, method of administration, 11-digit NDC, and basis of measurement 9

10 Dosing and Administration for EMPLICITI EMPLICITI dosing in combination with lenalidomide and dexamethasone 8 Patients must be premedicated before each dose of EMPLICITI as described below When administered with lenalidomide and dexamethasone, the recommended dosage of EMPLICITI is 10 mg/kg administered intravenously (IV): Every week for the first 2 cycles (28-day cycles) Every 2 weeks thereafter (28-day cycles) Continue treatment until disease progression or unacceptable toxicity Pretreatment on days that EMPLICITI is administered hours prior 28 mg dexamethasone orally minutes prior 8 mg IV dexamethasone + H 1 blocker: Diphenhydramine (25 50 mg orally or IV) or equivalent + H 2 blocker: Ranitidine (50 mg IV or 150 mg orally) or equivalent + Acetaminophen ( mg orally) Please see EMPLICITI dosing schedule on the next page. Please refer to the EMPLICITI, lenalidomide, and dexamethasone full Prescribing Information for additional information. 10

11 EMPLICITI dosing in combination with lenalidomide and dexamethasone (cont'd) 8 EMPLICITI + lenalidomide and dexamethasone dosing schedule EMPLICITI 10 mg/kg IV Cycles 1 and 2 (28 days each): EMPLICITI dosed once a week Lenalidomide 25 mg PO REST PERIOD Dexamethasone PO (mg) * Dexamethasone intravenously (mg) Cycles 3+ (28 days each): EMPLICITI dosed once every 2 weeks EMPLICITI 10 mg/kg IV Lenalidomide 25 mg PO REST PERIOD Dexamethasone PO (mg) * Dexamethasone intravenously (mg) 8 8 PO=orally. *Oral dexamethasone (28 mg) taken between 3 and 24 hours before EMPLICITI infusion. Dexamethasone intravenously and other premedications are given minutes prior to EMPLICITI infusion. On days that EMPLICITI is not administered, but a dose of dexamethasone is scheduled, dexamethasone 40 mg should be given orally. 8 11

12 How EMPLICITI Is Distributed Physician Offices Specialty Distributor Phone Number Website Cardinal Health Specialty Pharmaceutical Distribution Monday-Friday, 7 AM-6 PM CST 24-hour emergency on call cardinalhealth.com CuraScript Specialty Distribution McKesson Specialty Health Monday-Friday, 8:30 AM-7 PM EST Monday-Friday, 7 AM-7 PM CST Oncology Supply Monday-Friday, 8 AM-7:00 PM CST; Friday, 8 AM-7 PM CST For offices that prefer to use the services of a specialty pharmacy, specialty pharmacies can obtain EMPLICITI from the distributors listed below. Hospitals and Infusion Centers Specialty Distributor Phone Number Fax Orders and Website ASD Healthcare Monday-Thursday, 7 AM-6:30 PM CST; Friday, 7 AM-6 PM CST (24-hour emergency on call) fax number: Cardinal Health Specialty Pharmaceutical Distribution DMS Pharmaceutical Group, Inc. McKesson Plasma and Biologics Smith Medical Partners Monday-Friday, 7 AM-6 PM CST (24-hour emergency on call) Monday-Friday, 8:30 AM-5 PM CST Monday-Friday, 8 AM-6:30 PM CST Monday-Thursday, 8 AM-6 PM CST; Friday, 8 AM-4:30 PM CST fax number: fax number: cardinalhealth.com fax number: fax number: fax number: fax number: Above information is accurate as of 06/2018. The EMPLICITI distribution program includes extended payment terms to Bristol-Myers Squibb authorized EMPLICITY distributors. Healthcare providers and institutions should contact their EMPLICITI distributor to understand specific payment terms that may be available to them from their distributor. 12

13 Determining Your Order 8 Because dosing for EMPLICITI is weight-based, the dose of EMPLICITI will vary by patient, and may be provided through a combination of vial sizes.* Step 1: Calculate total dose in mg needed (weight in kg x 10 = total dose in mg) Step 2: Determine quantity of single-dose vials needed based on total dose (see table below) A person weighing 60 kg would require a total dosage of 600 mg of EMPLICITI (two 300 mg vials) A person weighing 91 kg would require a total dosage of 910 mg of EMPLICITI (two 300 mg vials and one 400 mg vial) A person weighing 123 kg would require a total dosage of 1230 mg of EMPLICITI (three 300 mg vials and one 400 mg vial) *EMPLICITI is supplied in 300 mg or 400 mg single-dose vials. 8 13

14 Medicare Drug Reimbursement for EMPLICITI What is the Medicare reimbursement allowable for EMPLICITI? Physicians* The payment limit is 106% of average sales price (ASP), not including sequestration, and represents one billing unit of EMPLICITI, which is billed for each 1 mg 11 The amount paid to physicians for EMPLICITI HCPCS code J9176 is published at the beginning of each calendar quarter in Payment Allowance Limits for Medicare Part B Drugs, 12 which can be downloaded at McrPartBDrugAvgSalesPrice/2018ASPFiles.html Medicare Part B will pay physicians 80% of the allowed price for EMPLICITI HCPCS code J9176; the patient is responsible for 20% co-insurance, which may be covered by secondary insurance (private supplemental coverage, Medicaid, etc) 13 Hospital outpatient facilities* Drugs paid separately under the hospital outpatient fee schedule are based on 106% of average sales price (ASP), not including sequestration, for one billing unit for the corresponding HCPCS code. This is 1 mg for EMPLICITI HCPCS code J * The Payment Allowance Limits 12 are published each quarter at Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2018ASPFiles.html Hospital inpatient settings Reimbursement in the inpatient setting is bundled into the Medicare Diagnosis Related Groups called MS-DRGs 14,15 This prospective rate changes on October 1 each year and does not allow for drugs to be paid separately 16 * While the statutory amount that Medicare will reimburse for a Part B Drug in a physician office will remain at ASP +6%, sequestration has resulted in a reduction to the Medicare portion of the payment to Medicare providers. Essentially, all payments from Medicare carriers to the providers (including physician offices, hospitals, etc) will be reduced by 2%. 17 See The Centers for Medicare & Medicaid Services' (CMS) Internet Only Manual (IOM) Publication , Chapter

15 Commercial Insurance Reimbursement for EMPLICITI Physicians Drug reimbursement, like service reimbursement, is usually based on a fee schedule 18 The fee schedules are based on the ASP or AWP, as published by a credible source, 19,20 or an average costing methodology as determined by the payer, such as usual, customary, and reasonable (UC&R) 21 Hospital outpatient facilities In this setting, reimbursement is most commonly based on percentage of charges 20 Alternatively, some hospitals use the same ASP or AWP methodologies typically used by physician offices 20 Other methodologies include capitated model, cost minus submitted charges, or discount off submitted charges 20 Hospital inpatient settings Inpatient rates are prospective, meaning they are predetermined per discharge 14 There are private payers that pay on a version of the DRGs 15 There are also payers that pay on a negotiated and fixed rate per day called a per diem 15 ; there are capitated rates for inpatients as well 14 New drugs may be carved out of per diems or capitated rates, if the hospital negotiates to do so 22 15

16 The BMS Oncology Co-Pay Assistance Program Offers Financial BMS Assistance Oncology Co-Pay to Eligible, Commercially- Three Simple Wa Insured Patients Assistance Program Bristol-Myers BMS supports Squibb access supports to certain access BMS to Oncology certain Bristol-Myers products through Squibb the oncology products through the BMS Oncology Co-Pay Assistance Program. The The program provides financial financial assistance with the out-ofpocket assistance deductibles, with the out-of-pocket co-pay, or co-insurance deductibles, costs co-pay, for or eligible co-insurance patients costs who have been prescribed certain Bristol-Myers for eligible commercially Squibb oncology insured products. patients who have been prescribed certain BMS Oncology products. How the Program works: Enrolled patients only pay $25 per product The patient $25 must pay per product the first $25 or of the co-pay for each dose of a BMS medication covered by this Program. Bristol-Myers Squibb will cover the remaining amount up to a maximum of $25,000 per year, per patient, per product $25 PORTFOLIO Get Suppo PORTFOLIO Contact your Access & Reimburse for general assistance and to schedul ONCOLOGY RHEUMATOLOGY Other Other restrictions restrictions apply. apply. Final determination Final determination of Program of Program eligibility eligibility is based on review of completed application. Please is based see page on review 18 for full of Terms a completed and Conditions, application. including Please complete see full eligibility Terms requirements. and Conditions, including complete eligibility requirements. Call BMS Access Support at AM to 8 PM ET, Monday Friday Please note: The Program will cover the out-of-pocket expenses of a Please note: The Program will cover the out-of-pocket expenses of a Bristol-Myers Squibb to speak medication with a only. regionally BMS product only. It does not cover the costs of any other healthcare It does not cover the costs of any other healthcare provider charges, or any other treatment assigned costs. Patients specialist provider charges, or any other treatment costs. Patients may be may be responsible responsible for for non drug-related non drug-related out-of-pocket out-of-pocket costs, costs, depending depending on their specific healthcare benefits. on their specific healthcare benefits. Visit www. for infor including Oncology p to help yo to BM 2018 Bristol-Myers Squibb Company. All rights reserved. Access Support and Access Support logo are registered trademarks of Bristol-Myers Squibb Company. M *The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. BMS and its agents make no guarantee regarding reimbursement for any service or item. MMUS _07_01_TermsAndCond_RA_May2018_ _v3_RS.indd 2 Secure provider portal for real-time monitoring of BMS Access Support cases Online resources available anytime at to help your patients with access and reimbursement needs Patient Financial Resources for eligible commercially insured patients, patients enrolled in Federal Healthcare Programs, and patients without prescription drug coverage 16

17 How the Patient Enrolls Into the Co-Pay Assistance Program 1 Obtain an enrollment form in one of the following ways: Call BMS Access Support at , 8 AM to 8 PM ET, Monday-Friday Visit or Log on to 2 You and your patient complete the enrollment form. The patient s name, address, insurance carrier, and member identification number are required. Please fax the completed enrollment form to BMS Access Support determines patient eligibility, including verifying commercial insurance. BMS Access Support then notifies the provider and patient of enrollment and the appropriate next steps. Visit to download an application form. Fax the completed form to

18 Co-Pay Assistance Program Terms and Conditions Patient Eligibility: You have commercial (private) insurance that covers your prescribed Bristol-Myers Squibb (BMS) medication, but your insurance does not cover the full cost; that is, you have a co-pay obligation (out-ofpocket cost) for your prescribed medication. You are not participating in any state or federal healthcare program including Medicaid, Medicare, Medigap, CHAMPUS, TriCare, Veterans Affairs (VA), or Department of Defense (DoD), or any state, patient, or pharmaceutical assistance program. Patients who move from commercial (private) insurance to a state or federal healthcare program will no longer be eligible. If you purchased your prescription insurance through a Health Exchange (also known as a Health Insurance Marketplace or Small Business Options Program [SHOP] Marketplace), you are currently eligible. You live in the United States or Puerto Rico. Program Benefits: You must pay the first $25 of the co-pay for each dose of a BMS medication covered by this Program. This Program will cover the remainder of the co-pay, up to a maximum of $25,000 per BMS medication during a calendar year. (For clarification, if a patient is prescribed two BMS medications in combination, the maximum is $50,000.) Patients are responsible for any costs that exceed the Program s per medication $25,000 maximum. In order to receive the Program benefits, the patient or provider must submit an Explanation of Benefits (EOB) form, or a Remittance Advice (RA). The submitted form must include the name of the insurer, plan information, and show that the BMS medication supported by this Program was the medication that was given. The form must be submitted within 180 days of receiving each dose. The Program may apply to retroactive out-of-pocket expenses that occurred within 120 days prior to the date of the enrollment. These benefits are subject to the $25 patient co-pay requirement and the 12-month Program maximum of $25,000 per medication. The Program benefits are limited to the co-pay costs for BMS medications covered by this Program that the patient receives as an outpatient. 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. All Program payments are for the benefit of the patient only. Program Timing: The enrollment period is 1 calendar year. Patients must enroll by December 31, Additional Terms and Conditions of Program: 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 patient s insurance. Patients, pharmacists, and healthcare providers must report the receipt of co-pay assistance benefits as may be required by patient s insurance provider. This offer is not valid with any other program, discount, or incentive involving a BMS medication eligible for this Program. Only valid in the United States and Puerto Rico; this offer is void where prohibited by law, taxed, or restricted. The Program benefits are nontransferable. No membership fees. This offer is not conditioned on any past, present, or future purchase, including additional doses. The Program is Not Insurance. Bristol-Myers Squibb reserves the right to rescind, revoke, or amend this offer at any time without notice. 18

19 Information About Financial Support For patients with commercial (private) insurance Bristol-Myers Squibb product co-pay assistance programs may be available For patients with coverage through federal healthcare programs They are not eligible for co-pay assistance programs sponsored by Bristol-Myers Squibb However, BMS Access Support can help refer patients to an independent foundation that offers support for their individual needs For patients without prescription drug coverage Access Support can refer you to independent charitable foundations that may be able to provide financial support, including the Bristol-Myers Squibb Patient Assistance Foundation (BMSPAF), a charitable organization that provides medicine, free of charge, to eligible, uninsured patients who have an established financial hardship. The BMSPAF accepts the Access Support application. For more information, you can visit It is important to note that charitable foundations are independent from Bristol-Myers Squibb Company. Each foundation, including BMSPAF, has its own eligibility criteria and evaluation process. Bristol-Myers Squibb cannot guarantee that a patient will receive assistance 19

20 Important Safety Information for EMPLICITI Infusion Reactions EMPLICITI can cause infusion reactions. Common symptoms include fever, chills, and hypertension. Bradycardia and hypotension also developed during infusions. In the trial, 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose. If a Grade 2 or higher infusion reaction occurs, interrupt the EMPLICITI infusion and institute appropriate medical and supportive measures. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart it on that day. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment. Premedicate with dexamethasone, H1 Blocker, H2 Blocker, and acetaminophen prior to infusing with EMPLICITI. Infections In a clinical trial of patients with multiple myeloma (N=635), infections were reported in 81.4% of patients in the EMPLICITI with lenalidomide/dexamethasone arm (ERd) and 74.4% in the lenalidomide/dexamethasone arm (Rd). Grade 3-4 infections were 28% (ERd) and 24.3% (Rd). Opportunistic infections were reported in 22% (ERd) and 12.9% (Rd). Fungal infections were 9.7% (ERd) and 5.4% (Rd). Herpes zoster was 13.5% (ERd) and 6.9% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Monitor patients for development of infections and treat promptly. Second Primary Malignancies In a clinical trial of patients with multiple myeloma (N=635), invasive second primary malignancies (SPM) were 9.1% (ERd) and 5.7% (Rd). The rate of hematologic malignancies were the same between ERd and Rd treatment arms (1.6%). Solid tumors were reported in 3.5% (ERd) and 2.2% (Rd). Skin cancer was reported in 4.4% (ERd) and 2.8% (Rd). Monitor patients for the development of SPMs. Hepatotoxicity Elevations in liver enzymes (AST/ALT greater than 3 times the upper limit, total bilirubin greater than 2 times the upper limit, and alkaline phosphatase less than 2 times the upper limit) consistent with hepatotoxicity were 2.5% (ERd) and 0.6% (Rd). Two patients experiencing hepatotoxicity discontinued treatment; however, 6 out of 8 patients had resolution and continued treatment. Monitor liver enzymes periodically. Stop EMPLICITI upon Grade 3 or higher elevation of liver enzymes. After return to baseline values, continuation of treatment may be considered. Interference with Determination of Complete Response EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein. Pregnancy/Females and Males of Reproductive Potential There are no studies with EMPLICITI with pregnant women to inform any drug associated risks. There is a risk of fetal harm, including severe lifethreatening human birth defects associated with lenalidomide and it is contraindicated for use in pregnancy. Refer to the lenalidomide full prescribing information for requirements regarding contraception and the prohibitions against blood and/or sperm donation due to presence and transmission in blood and/or semen and for additional information. Adverse Reactions Infusion reactions were reported in approximately 10% of patients treated with EMPLICITI with lenalidomide and dexamethasone. All reports of infusion reaction were Grade 3 or lower. Grade 3 infusion reactions occurred in 1% of patients. Serious adverse reactions were 65.4% (ERd) and 56.5% (Rd). The most frequent serious adverse reactions in the ERd arm compared to the Rd arm were: pneumonia (15.4%, 11%), pyrexia (6.9%, 4.7%), respiratory tract infection (3.1%, 1.3%), anemia (2.8%, 1.9%), pulmonary embolism (3.1%, 2.5%), and acute renal failure (2.5%, 1.9%). The most common adverse reactions in ERd and Rd, respectively (>20%) were fatigue (61.6%, 51.7%), diarrhea (46.9%, 36.0%), pyrexia (37.4%, 24.6%), constipation (35.5%, 27.1%), cough (34.3%, 18.9%), peripheral neuropathy (26.7%, 20.8%), nasopharyngitis (24.5%, 19.2%), upper respiratory tract infection (22.6%, 17.4%), decreased appetite (20.8%, 12.6%), and pneumonia (20.1%, 14.2%). Please see accompanying Full Prescribing Information in at pocket. the end of this document. 20

21 References 1. American Medical Association HCPCS Level II. Professional ed. Chicago, IL: American Medical Association; American Medical Association HCPCS Level II. Professional ed. Chicago, IL: American Medical Association; Centers for Medicare & Medicaid Services. MLN Matters, Number MM9603 Revised. MLNMattersArticles/Downloads/MM9603.pdf. Revised June 10, Accessed June 8, Palmetto GBA. Medicare Part A Billing Guide. May Part_A_Billing_Guide.pdf/$File/Part_A_Billing_Guide.pdf. Accessed June 8, American Medical Association. Current Procedural Terminology Professional ed. Chicago, IL: American Medical Association; Centers for Medicare & Medicaid Services. January 2016 Integrated OCE Summary. Medicare/ Coding/OutpatientCodeEdit/Downloads/2016-Jan IOCESummary. pdf. Accessed June 8, Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual. Chapter 17 Drugs and Biologicals. Revision December 22, cms.gov/ Regulations-and-Guidance/Guidance/Manuals/Downloads/ clm104c17.pdf. Accessed June 8, EMPLICITI [package insert]. Princeton, NJ: Bristol-Myers Squibb Company. 9. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual. Chapter 26 Completing and Processing Form CMS-1500 Data Set. Revision April 28, Guidance/Manuals/ Downloads/clm104c26.pdf. Accessed June 8, Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual. Chapter 25 Completing and Processing the Form CMS-1450 Data Set. Revision February 3, Manuals/downloads/clm104c25.pdf. Accessed June 8, Centers for Medicare & Medicaid Services ASP drug pricing files. Medicare/Medicare-Fee-for-Service-Part-B-Drugs/ McrPartBDrugAvgSalesPrice/2018ASPFiles.html. Accessed June 8, Payment Allowance Limits for Medicare Part B Drugs. Effective July 1, 2016 through September 30, gov/medicare/medicare-fee-for-service-part-b-drugs/ McrPartBDrugAvgSalesPrice/2018ASPFiles.html June Centers for Medicare & Medicaid Services. Medicare & You You. pdf. Accessed June 8, Centers for Medicare & Medicaid Services. Acute inpatient PPS. Service-Payment/AcuteInpatientPPS/index.html?redirect=/ acuteinpatientpps. Accessed June 8, AMCP Task Force on Drug Payment Methodologies. AMCP Guide to Pharmaceutical Payment Methods, Executive Edition. J Manag Care Pharm. 2007;13(8 suppl C):S1-S Centers for Medicare & Medicaid Services. Details for title: CMS-1632-F and IFC, CMS-1632-CN2 and Changes due to The Consolidated Appropriations Act of cms.gov/medicare/medicare-fee-for-service-payment/ AcuteInpatientPPS/FY2016-IPPS-Final-Rule-Home-Page- Items/FY2016-IPPS-Final-Rule-Regulations.html. Accessed June 8, CMS Medicare FFS Provider e-news. March 8, FFSProvPartProg/Downloads/ standalone.pdf. Accessed June 8, Robinson JC. Insurers' strategies for managing the use and cost of biopharmaceuticals. Health Aff (Millwood). 2006;25(5): American Society of Clinical Oncology. Payment reform glossary. ASCO website. org/files/aia/payment%20reform%20glossary%20final.pdf. Accessed April 25, Magellan Rx Management. Medical Pharmacy Trend Report Accessed June 8, US Bureau of Labor Statistics. Definitions of health insurance terms. Accessed June 8, Academy of Managed Care Pharmacy. Managed care terms. AMCP website. Accessed June 8,

22 Three Simple Ways to Get Support Contact your Access & Reimbursement Manager for assistance and to schedule an office visit Call Bristol-Myers Squibb Access Support at AM to 8 PM ET, Monday Friday to speak with your regionally assigned specialist Visit for information and resources, including the BMS Access Support program enrollment form, to help your patients with access to Bristol-Myers Squibb oncology products Bristol-Myers Squibb is committed to helping appropriate patients get access to our medications by providing access and reimbursement support services. The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. EMPLICITI TM is a trademark of Bristol-Myers Squibb Company. Access Support and Access Support logo are registered trademarks of Bristol-Myers Squibb Company Bristol-Myers Squibb Company All rights reserved. MMUS /18

23 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EMPLICITI safely and effectively. See full prescribing information for EMPLICITI. EMPLICITI (elotuzumab) for injection, for intravenous use Initial U.S. Approval: RECENT MAJOR CHANGES Dosage and Administration (2.4) 5/ INDICATIONS AND USAGE EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. (1) DOSAGE AND ADMINISTRATION With lenalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity. (2.1) Premedicate with dexamethasone, diphenhydramine, ranitidine and acetaminophen. (2.2) DOSAGE FORMS AND STRENGTHS For Injection: 300 mg or 400 mg lyophilized powder in a single-dose vial for reconstitution. (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Infusion reactions: Premedication is required. Interrupt EMPLICITI (elotuzumab) for Grade 2 or higher and permanently discontinue for severe infusion reaction. (2.2, 2.3, 5.1) Infections: Monitor for fever and other signs of infection and treat promptly. (5.2) Second Primary Malignancies (SPM): Higher incidences of SPM were observed in a controlled clinical trial of patients with multiple myeloma receiving EMPLICITI. (5.3) Hepatotoxicity: Monitor liver function and stop EMPLICITI if hepatotoxicity is suspected. (5.4) Interference with determination of complete response: EMPLICITI can interfere with assays used to monitor M-protein. This interference can impact the determination of complete response. (5.5) ADVERSE REACTIONS Most common adverse reactions (20% or higher) are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at or FDA at FDA-1088 or USE IN SPECIFIC POPULATIONS Pregnancy: Embryo-fetal toxicity with combination three drug dosage regimen. (8.1) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 5/2017 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing 2.2 Premedication 2.3 Dose Modifications 2.4 Administration 2.5 Reconstitution and Preparation 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Infusion Reactions 5.2 Infections 5.3 Second Primary Malignancies 5.4 Hepatotoxicity 5.5 Interference with Determination of Complete Response 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Immunogenicity 7 DRUG INTERACTIONS 7.1 Drug Interactions 7.2 Laboratory Test Interference 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing The recommended dosage of EMPLICITI is 10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter in conjunction with the recommended dosing of lenalidomide and low-dose dexamethasone as described below. Continue treatment until disease progression or unacceptable toxicity. Refer to the dexamethasone and lenalidomide prescribing information for additional information. Patients must be premedicated before each dose of EMPLICITI [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)]. Administer dexamethasone as follows: On days that EMPLICITI is administered, give dexamethasone 28 mg orally between 3 and 24 hours before EMPLICITI plus 8 mg intravenously between 45 and 90 minutes before EMPLICITI. On days that EMPLICITI is not administered but a dose of dexamethasone is scheduled (Days 8 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally. The recommended dosing is presented in Table 1. Table 1: Recommended Dosing Schedule of EMPLICITI in Combination with Lenalidomide and Dexamethasone Cycle 28-Day Cycles 1 and 2 28-Day Cycles 3+ Day of Cycle Premedication* EMPLICITI (mg/kg) intravenously Lenalidomide (25 mg) orally Days 1-21 Days 1-21 Dexamethasone (mg) orally Dexamethasone* (mg) intravenously Day of Cycle * Premedicate with the following 45 to 90 minutes prior to EMPLICITI infusion: 8 mg intravenous dexamethasone, H1 blocker: diphenhydramine (25 to 50 mg orally or intravenously) or equivalent; H2 blocker: ranitidine (50 mg intravenously) or equivalent; acetaminophen (650 to 1000 mg orally). Oral dexamethasone (28 mg) taken between 3 and 24 hours before EMPLICITI infusion.

24 EMPLICITI (elotuzumab) EMPLICITI (elotuzumab) 2.2 Premedication Dexamethasone When EMPLICITI is used in combination with lenalidomide, divide dexamethasone into an oral and intravenous dose and administer as shown in Table 1 [see Dosage and Administration (2.1)]. Other Medications In addition to dexamethasone, complete administration of the following medications 45 to 90 minutes prior to EMPLICITI infusion: H1 blocker: diphenhydramine (25 to 50 mg orally or intravenously) or equivalent H1 blocker. H2 blocker: ranitidine (50 mg intravenously or 150 mg orally) or equivalent H2 blocker. Acetaminophen (650 to 1000 mg orally). 2.3 Dose Modifications If the dose of one drug in the regimen is delayed, interrupted, or discontinued, the treatment with the other drugs may continue as scheduled. However, if dexamethasone is delayed or discontinued, base the decision whether to administer EMPLICITI on clinical judgment (i.e., risk of hypersensitivity). If a Grade 2 or higher infusion reaction occurs during EMPLICITI administration, interrupt the infusion and institute appropriate medical and supportive measures. Upon resolution to Grade 1 or lower, restart EMPLICITI at 0.5 ml per minute and gradually increase at a rate of 0.5 ml per minute every 30 minutes as tolerated to the rate at which the infusion reaction occurred. Resume the escalation regimen if there is no recurrence of the infusion reaction (see Table 2). In patients who experience an infusion reaction, monitor vital signs every 30 minutes for 2 hours after the end of the EMPLICITI infusion. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart on that day [see Warnings and Precautions (5.1)]. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment. Dose delays and modifications for dexamethasone and lenalidomide should be performed as recommended in their Prescribing Information. 2.4 Administration Administer the entire EMPLICITI infusion with an infusion set and a sterile, nonpyrogenic, low-protein-binding filter (with a pore size of 0.2 to 1.2 micrometer) using an automated infusion pump. Initiate EMPLICITI infusion at a rate of 0.5 ml per minute. The infusion rate may be increased in a stepwise fashion as described in Table 2 if no infusion reactions develop. The maximum infusion rate should not exceed 5 ml per minute. Table 2: Infusion Rate for EMPLICITI Cycle 1, Dose 1 Cycle 1, Dose 2 Cycle 1, Dose 3 and 4 and All Subsequent Cycles Time Interval Rate Time Interval Rate Rate 0-30 min 0.5 ml/min 0-30 min 3 ml/min min 1 ml/min 30 min or more 60 min or more 2 ml/min ml/min 5 ml/min Adjust the infusion rate following a Grade 2 or higher infusion reaction [see Dosage and Administration (2.3)]. Do not mix EMPLICITI with, or administer as an infusion with, other medicinal products. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of EMPLICITI with other agents. 2.5 Reconstitution and Preparation Calculation of Dose Calculate the dose (mg) and determine the number of vials needed for the 10 mg/kg dosage based on patient weight. Determine the volume of sterile water for injection (SWFI) needed for reconstitution as shown in Table 3. Table 3: Strength Reconstitution Instructions for EMPLICITI Amount of Sterile Water for Injection, USP Required for Reconstitution Deliverable Volume of Reconstituted EMPLICITI in the Vial Postreconstitution Concentration 300 mg vial 13 ml 12 ml* 25 mg/ml 400 mg vial 17 ml 16 ml* 25 mg/ml * After reconstitution, each vial contains overfill to allow for withdrawal of 12 ml (300 mg) and 16 ml (400 mg), respectively. Reconstitution Aseptically reconstitute each EMPLICITI vial with a syringe of adequate size and a less than or equal to 18-gauge needle (e.g., 17-gauge). A slight back pressure may be experienced during administration of the Sterile Water for Injection, USP, which is considered normal. Hold the vial upright and swirl the solution by rotating the vial to dissolve the lyophilized cake. Invert the vial a few times in order to dissolve any powder that may be present on top of the vial or the stopper. Avoid vigorous agitation. DO NOT SHAKE. The lyophilized powder should dissolve in less than 10 minutes. After the remaining solids are completely dissolved, allow the reconstituted solution to stand for 5 to 10 minutes. The reconstituted preparation results in a colorless to slightly yellow, clear to slightly opalescent solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the solution if any particulate matter or discoloration is observed. Dilution Once the reconstitution is completed, withdraw the necessary volume for the calculated dose from each vial, up to a maximum of 16 ml from 400 mg vial and 12 ml from 300 mg vial. Further dilute with 230 ml of either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP, into an infusion bag made of polyvinyl chloride or polyolefin. The volume of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP can be adjusted so as not to exceed 5 ml/kg of patient weight at any given dose of EMPLICITI. Complete the EMPLICITI infusion within 24 hours of reconstitution of the EMPLICITI lyophilized powder. If not used immediately, the infusion solution may be stored under refrigeration conditions: 2 C to 8 C (36 F-46 F) and protected from light for up to 24 hours (a maximum of 8 hours of the total 24 hours can be at room temperature, 20 C to 25 C [68 F-77 F], and room light). 3 DOSAGE FORMS AND STRENGTHS For injection: 300 mg or 400 mg of elotuzumab as a white to off-white lyophilized powder in a single-dose vial for reconstitution. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Infusion Reactions EMPLICITI can cause infusion reactions. Infusion reactions were reported in approximately 10% of patients treated with EMPLICITI with lenalidomide and dexamethasone in the randomized trial in multiple myeloma. All reports of infusion reaction were Grade 3 or lower. Grade 3 infusion reactions occurred in 1% of patients. The most common symptoms of an infusion reaction included fever, chills, and hypertension. Bradycardia and hypotension also developed during infusions. In the trial, 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose. Administer premedication consisting of dexamethasone, antihistamines (H1 and H2 blockers) and acetaminophen prior to EMPLICITI infusion [see Dosage and Administration (2.2)]. Interrupt EMPLICITI infusion for Grade 2 or higher infusion reactions and institute appropriate medical management [see Dosage and Administration (2.3)].