The Merck Access Program for RENFLEXIS® (infliximab-abda)

Before prescribing RENFLEXIS, please read the accompanying Prescribing Information including the Boxed Warning about serious infections and malignancies. The Medication Guide also is available.

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THE MERCK ACCESS PROGRAM

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Temporary Updates to the Terms and Conditions for the Merck Co-pay Assistance Program

The Co-pay Assistance Program consists of two sets of Terms of Conditions, one applicable when a claim is submitted by a patient’s health care provider (“Medical Benefit”) and the other applicable when purchased by a patient at a participating pharmacy (“Pharmacy Benefit”). Changes to both sets of Terms and Conditions for the Co-pay Assistance Program are set forth below.

Temporary Update to the Terms and Conditions – RENFLEXIS^® (infliximab-abda) for injection, for intravenous use 100 mg- (Medical Benefit): EFFECTIVE 06/15/2020 – 09/30/2021:

Patient will not have a minimum co-pay per administration of Program Product for any date of administration of Program Product between 06/15/2020 and 09/30/2021. The benefit available under the Co-pay Assistance Program is limited to the amount the patient’s private health insurance company indicates on the Explanation of Benefits (EOB) that the patient is obligated to pay for Program Product, up to an annual maximum. The maximum Co-pay Assistance Program benefit per patient, per calendar year (January 1 through December 31), is $20,000.

NOTE: Per the existing Terms and Conditions, for any date of administration of Program Product before 06/15/2020 or after 09/30/2021, patient must pay the first $5 of co-pay per administration of Program Product. The benefit available under the Co-pay Assistance Program is limited to the amount the patient’s private health insurance company indicates on the EOB that the patient is obligated to pay for Program Product, less $5, up to an annual maximum. The maximum Co-pay Assistance Program benefit per patient, per calendar year (January 1 through December 31), is $20,000.

For any patient whose enrollment date begins on 06/15/2020 through 09/30/2021, the Program may apply to patient out-of-pocket costs incurred for Program Product within 150 days prior to the date patient is enrolled in the Co-pay Assistance Program, subject to annual Program maximum and the applicable Terms and Conditions based on Program Product administration date. Patient or provider may contact The Merck Access Program for more information.

NOTE: Per the existing Terms and Conditions for patients who enrolled in the Program before 06/15/2020 and after 09/30/2021, the Program may apply to patient out-of- pocket costs incurred for Program Product within 90 days prior to the date patient is enrolled in the Co-pay Assistance Program, subject to annual Program maximum and the applicable Terms and Conditions based on Program Product administration date. Patient or provider may contact The Merck Access Program for more information.

For any Explanation of Benefits (EOB) from a patient's private health insurance that is dated between 06/15/2020 and 09/30/2021, the EOB must be submitted within 150 days of the date of the EOB for patient to receive co-pay assistance benefit; provided, however, that no EOB may be submitted more than 150 days after the expiration date of Co-pay Assistance Program. The EOB must reflect the patient’s out-of-pocket cost for Program Product and submission of the claim by the patient’s health care provider for the cost of Program Product.

NOTE: Per the existing Terms and Conditions, any EOB dated before 06/15/2020 or after 09/30/2021 from patient’s private health insurance must be submitted within 90 days of the date of the EOB for patient to receive co-pay assistance benefit; provided, however, that no EOB may be submitted more than 90 days after the expiration date of Co-pay Assistance Program. The EOB must reflect the patient’s out-of-pocket cost for the Program Product and submission of the claim by the patient’s health care provider for the cost of the Program Product.

Temporary Update to the Terms and Conditions – RENFLEXIS^® (infliximab-abda) for injection, for intravenous use 100 mg - (Pharmacy Benefit): EFFECTIVE 06/15/2020 – 09/30/2021:

Patient will not have a minimum out-of-pocket cost for the Program Product if Program Product is purchased between 06/15/2020 and 09/30/2021 (regardless of quantity supplied on the prescription), but Product must be purchased prior to the expiration date of the Co-pay Assistance Program. The benefit available under the Co-pay Assistance Program is limited to the amount of the patient’s actual out-of-pocket, on each prescription, up to an annual maximum. The maximum Co-pay Assistance Program benefit per patient, per calendar year (January 1 through December 31), is $20,000. The benefit available under the Co-pay Assistance Program is valid for the patient’s out-of-pocket cost for the Program Product only. It is not valid for any other out-of-pocket costs (for example, office visit charges or medication administration charges) even if such costs are associated with the administration of the Program Product.

NOTE: Per the existing Terms and Conditions, for any purchase of Program Product before 06/15/2020 or after 09/30/2021, patient must have an out-of-pocket cost for the Program Product and purchase the Program Product prior to the expiration date of the Co-pay Assistance Program. Patient must pay the first $5 of co-pay on each prescription for Program Product (regardless of quantity supplied on the prescription). The benefit available under the Co-pay Assistance Program is limited to the amount of the patient’s actual out-of-pocket cost over $5, on each prescription, up to an annual maximum. The maximum Co-pay Assistance Program benefit per patient, per calendar year (January 1 through December 31), is $20,000. The benefit available under the Co-pay Assistance Program is valid for the patient’s out-of-pocket cost for the Program Product only. It is not valid for any other out-of-pocket costs (for example, office visit charges or medication administration charges) even if such costs are associated with the administration of the Program Product.

All other Terms and Conditions for The Merck Co-pay Assistance Program remain in effect and must be satisfied to receive the benefit.

Merck Co-pay Assistance Program for RENFLEXIS^® (infliximab-abda) for injection, for intravenous use 100 mg (Effective January 1, 2021)

Terms and Conditions

The Co-pay Assistance Program for RENFLEXIS consists of two sets of Terms of Conditions, one applicable to RENFLEXIS for which a claim is submitted by a patient’s health care provider (“Medical Benefit”) and the other applicable to RENFLEXIS purchased by a patient at a participating pharmacy (“Pharmacy Benefit”). Both sets of Terms and Conditions for the Co-pay Assistance Program for RENFLEXIS are set forth below.

Merck may assign or transfer the Co-pay Assistance Program, in whole or in part, directly or indirectly, to an affiliated entity (“Affiliate”) or an entity that is not affiliated with Merck in the event of a divestiture, dissolution, spin-off, or other transaction (“NewCo”). In the event of such assignment or transfer, Merck and/or the applicable Affiliate or NewCo will notify patients and health care providers of such assignment or transfer, including whether new enrollment is necessary, and of patients’ option to terminate participation in the Co-pay Assistance Program. Any future offerings by an Affiliate or NewCo may differ from the Co-pay Assistance Program and will be subject to eligibility criteria, terms, and conditions established by an Affiliate or NewCo that could affect patients’ participation in the future.

Terms and Conditions – RENFLEXIS^® (infliximab-abda) for injection, for intravenous use 100 mg - (Medical Benefit):

To receive benefits under the Co-pay Assistance Program for RENFLEXIS (“Program Product”) the patient must enroll in the Co-pay Assistance Program and be accepted as eligible.
Patient must be prescribed the Program Product for an FDA-approved indication.
Patient must have private health insurance that provides coverage for the cost of the Program Product under a medical benefit plan.
The Co-pay Assistance Program is not valid for patients covered under Medicaid (including Medicaid patients enrolled in a qualified health plan purchased through a health insurance exchange [marketplace] established by a state government or the federal government), Medicare, a Medicare Part D or Medicare Advantage plan (regardless of whether a specific prescription is covered), TRICARE, CHAMPUS, Puerto Rico Government Health Insurance Plan (“Healthcare Reform”), or any other state or federal medical or pharmaceutical benefit program or pharmaceutical assistance program (collectively, “Government Programs”). The Co-pay Assistance Program is not valid for uninsured patients.
Subject to changes in state law, the Co-pay Assistance Program may become invalid for residents of Massachusetts prior to its expiration date.
Patient must have an out-of-pocket cost for the Program Product and be administered the Program Product prior to the expiration date of the Co-pay Assistance Program. The benefit available under the Co-pay Assistance Program is valid for the patient’s out-of-pocket cost for the Program Product only. It is not valid for any other out-of-pocket costs (for example, office visit charges or medication administration charges) even if such costs are associated with the administration of the Program Product. Claim for Program Product must be submitted by health care provider to patient’s private health insurance separately from other services and products.
Patient must pay the first $5 of co-pay per administration of Program Product. The benefit available under the Co-pay Assistance Program is limited to the amount the patient’s private health insurance company indicates on the Explanation of Benefits (EOB) that the patient is obligated to pay for the Program Product, less $5, up to an annual maximum. The maximum Co-pay Assistance Program benefit per patient, per calendar year (January 1 through December 31), is $20,000.
An EOB from patient’s private health insurance must be submitted within 90 days of the date of the EOB for patient to receive co-pay assistance benefit; provided, however, that no EOB may be submitted more than 90 days after the expiration date of the Co-pay Assistance Program. The EOB must reflect the patient’s out-of-pocket cost for the Program Product and submission of the claim by the patient’s health care provider for the cost of the Program Product.
Patient and health care provider agree not to seek reimbursement for all or any part of the benefit received by the patient through the Co-pay Assistance Program. Patient and health care provider are responsible for reporting receipt of Co-pay Assistance Program benefits to any insurer, health plan, or other third party who pays for or reimburses any part of the medication cost paid for by the Co-pay Assistance Program, as may be required.
Patient must be a resident of the United States or the Commonwealth of Puerto Rico. Product must originate and be administered to patient in the United States or the Commonwealth of Puerto Rico.
The Program may apply to patient out-of-pocket costs incurred for Program Product within 90 days prior to the date patient is enrolled in the Co-pay Assistance Program, subject to annual Program maximum and the applicable Terms and Conditions based on Program Product administration date. Patient or provider may contact The Merck Access Program for more information.
All information applicable to the Co-pay Assistance Program requested on the enrollment form must be provided, and all certifications must be signed. Forms that are modified or do not contain all the necessary information will not be eligible for benefits under the Co-pay Assistance Program.
No other purchase is necessary.
The Co-pay Assistance Program is not insurance.
The Co-pay Assistance Program form may not be sold, purchased, traded, or counterfeited. Void if reproduced.
The Co-pay Assistance Program is void where prohibited by law, taxed, or restricted. The Co-pay Assistance Program is not transferable. No substitutions are permitted.
The Co-pay Assistance Program benefit cannot be combined with any other Co-pay Assistance Program, free trial, discount, prescription savings card, or other offer. Benefits are not available through this Co-pay Assistance Program for RENFLEXIS^® (infliximab-abda) for injection, for intravenous use 100 mg purchased by patient at a pharmacy. Co-pay assistance may be available from Merck on RENFLEXIS purchased by patient at a pharmacy through separate Terms and Conditions, provided, however, that the per patient annual maximum Co-pay Assistance Program benefit on RENFLEXIS across Terms and Conditions is $20,000 per calendar year.
Merck reserves the right to rescind, revoke, or amend the Co-pay Assistance Program at any time without notice.
Data related to patient’s receipt of Co-pay Assistance Program benefits may be collected, analyzed, and shared with Merck, for market research and other purposes related to assessing Co-pay Assistance Programs. Data shared with Merck will be aggregated and de-identified, meaning it will be combined with data related to other Co-pay Assistance Program redemptions and will not identify patient.
These Terms and Conditions are valid for Program Product administered between January 1, 2021 and December 31, 2021.
Please read the accompanying Medication Guide for RENFLEXIS, including the information about serious infections and cancers, and discuss it with your doctor. The physician Prescribing Information also is included.
Expiration Date: 12/31/2021.

Terms and Conditions – RENFLEXIS^® (infliximab-abda) for injection, for intravenous use 100 mg - (Pharmacy Benefit)

To receive benefits under the Co-pay Assistance Program for RENFLEXIS (“Program Product”), the patient must enroll in the Co-pay Assistance Program and be accepted as eligible.
Patient must be prescribed the Program Product for an FDA-approved indication.
Patient must have private health insurance that provides coverage for the cost of the Program Product purchased by the patient at an eligible participating pharmacy.
The Co-pay Assistance Program is not valid for patients covered under Medicaid (including Medicaid patients enrolled in a qualified health plan purchased through a health insurance exchange [marketplace] established by a state government or the federal government), Medicare, a Medicare Part D or Medicare Advantage plan (regardless of whether a specific prescription is covered), TRICARE, CHAMPUS, Puerto Rico Government Health Insurance Plan ("Healthcare Reform"), or any other state or federal medical or pharmaceutical benefit program or pharmaceutical assistance program (collectively, "Government Programs"). The Co-pay Assistance Program is not valid for uninsured patients.
Subject to changes in state law, this coupon may become invalid for residents of Massachusetts prior to its expiration date.
Patient must have an out-of-pocket cost for the Program Product and purchase the Program Product prior to the expiration date of the Co-pay Assistance Program. Patient must pay the first $5 of co-pay on each prescription for Program Product (regardless of quantity supplied on the prescription). The benefit available under the Co-pay Assistance Program is limited to the amount of the patient’s actual out-of-pocket cost over $5, on each prescription, up to an annual maximum. The maximum Co-pay Assistance Program benefit per patient, per calendar year (January 1 through December 31), is $20,000. The benefit available under the Co-pay Assistance Program is valid for the patient’s out-of-pocket cost for the Program Product only. It is not valid for any other out-of-pocket costs (for example, office visit charges or medication administration charges) even if such costs are associated with the administration of the Program Product.
The Co-pay Assistance Program coupon benefit cannot be combined with any other Co-pay Assistance Program, free trial, discount, prescription savings card, or other offer. Benefits are not available through these Terms and Conditions for RENFLEXIS for which a claim was submitted by a health care provider to a patient’s private health insurance company. Co-pay assistance may be available from Merck for RENFLEXIS for which a claim was submitted by a health care provider to a patient’s private health insurance company through separate Terms and Conditions, provided, however, that the per patient annual maximum Co-pay Assistance Program benefit for RENFLEXIS across Terms and Conditions is $20,000 per calendar year.
Patient, pharmacist, and prescriber agree not to seek reimbursement for all or any part of the benefit received by the patient through the Co-pay Assistance Program. Patient is responsible for reporting receipt of Co-pay Assistance Program coupon benefits to any insurer, health plan, or other third party who pays for or reimburses any part of the medication cost paid for by the Co-pay Assistance Program, as may be required.
Co-pay Assistance Program coupon can be redeemed only by eligible residents of the United States or the Commonwealth of Puerto Rico at participating eligible retail or mail-order pharmacies in the United States or the Commonwealth of Puerto Rico. Product must originate in the United States or the Commonwealth of Puerto Rico.
Co-pay Assistance Program benefits are not available for patient costs incurred prior to the date the patient is determined to be eligible under and enrolled in the Co-pay Assistance Program.
All information applicable to the Co-pay Assistance Program requested on the enrollment form must be provided, and all certifications must be signed. Forms that are modified or do not contain all the necessary information will not be eligible for benefits under the Co-pay Assistance Program.
No other purchase is necessary.
The Co-pay Assistance Program is not insurance.
The Co-pay Assistance Program coupon may not be sold, purchased, traded, or counterfeited. Void if reproduced.
The Co-pay Assistance Program is void where prohibited by law, taxed, or restricted. The Co-pay Assistance Program is not transferable. No substitutions are permitted.
Merck reserves the right to rescind, revoke, or amend the Co-pay Assistance Program at any time without notice.
Co-pay Assistance Program coupon is the property of Merck and must be turned in on request.
Data related to patient’s receipt of Co-pay Assistance Program benefits may be collected, analyzed, and shared with Merck, for market research and other purposes related to assessing Co-pay Assistance Program programs. Data shared with Merck will be aggregated and de-identified, meaning it will be combined with data related to other Co-pay Assistance Program redemptions and will not identify patient.
Please read the accompanying Medication Guide for RENFLEXIS^® (infliximab-abda) for injection, for intravenous use 100 mg, including the information about serious infections and cancers, and discuss it with your doctor. The physician Prescribing Information also is included.
Expiration Date: 12/31/2021.

US-SBT-11028 04/21

RESOURCES FOR RENFLEXIS

RESOURCE

CLICK HERE

Electronic Enrollment

The Merck Access Program 2021 Electronic Enrollment FormThis form can be signed and submitted electronically. Use this form only if the patient is in the office and you are able to complete this form together.

The Merck Access Program 2021 Electronic Health Care Provider Enrollment FormThis Health Care Provider form can be signed and submitted electronically. Please note that the patient must also submit the Electronic Patient Enrollment Form, which can be found at www.merckaccessprogram-renflexis.com/hcc.

The Merck Access Program 2020 Electronic Health Care Provider Enrollment Form for RENFLEXIS® (infliximab-abda)

Online Portal

Enrollment

The Merck Access Program 2021 Enrollment Form Use this form for patients choosing to re-enroll.

Potential Independent Foundation Support

Coverage and reimbursement support

Biosimilars Reimbursement Flashcard

Prior Authorization Checklist

Sample Prior Authorization Letter

Appeal Checklist

Sample Appeal Letter

Coding and billing resources

Billing and Coding Card

Sample CMS-1500 Form

Sample UB-04 Form

Product support materials

RENFLEXISHCP.com

Product Information

Physician Prescribing Information

Medication Guide

The information available here is compiled from sources believed to be accurate, but Merck makes no representation that it is accurate. This information is subject to change. Payer coding requirements may vary or change over time, so it is important to regularly check with each payer as to payer-specific requirements.

The information available here is not intended to be definitive or exhaustive, and is not intended to replace the guidance of a qualified professional advisor. Merck and its agents make no warranties or guarantees, express or implied, concerning the accuracy or appropriateness of this information for your particular use given the frequent changes in public and private payer billing. The use of this information does not guarantee payment or that any payment received will cover your costs.

You are solely responsible for determining the appropriate codes and for any action you take in billing. Information about HCPCS codes is based on guidance issued by the Centers for Medicare & Medicaid Services applicable to Medicare Part B and may not apply to other public or private payers. Consult the relevant manual and/or other guidelines for a description of each code to determine the appropriateness of a particular code and for information on additional codes. Diagnosis codes should be selected only by a health care professional.

HCPCS=Healthcare Common Procedure Coding Systems.

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