Managed care coverage: reimbursement support services for ISENTRESS® (raltegravir) Tablets

A Program of Reimbursement Support and Patient Assistance Services

Merck & Co., Inc. knows that health care reimbursement sometimes can make it difficult to access the medications that patients need. To ease the process, we have created the SUPPORT program to help patients who have been prescribed ISENTRESS.

What Is the SUPPORT program for ISENTRESS?

SUPPORT is a 2-part program specifically designed to help patients who have been prescribed ISENTRESS.

Reimbursement Support Services^a

A free program that helps you and your patient find answers to questions related to insurance coverage and helps you locate a network pharmacy to fill your patient's prescription for ISENTRESS

Patient Assistance for Eligible Patients^a

A service that provides ISENTRESS free of charge to eligible patients

How to Contact SUPPORT

SUPPORT provides easy and free reimbursement support services and patient assistance for qualifying individuals through a single toll-free call to 1-800-850-3430, Monday through Friday, 9 AM to 6 PM ET. In addition, callers may leave a confidential message for a reimbursement counselor 24 hours a day.

Reimbursement Support Services for Patients

SUPPORT provides personalized support and patient advocacy regarding individual reimbursement issues. SUPPORT reimbursement counselors are available from Monday through Friday, 9 AM to 6 PM ET, at
1-800-850-3430.

Services Provided:

Dedicated, personalized support
Complete investigation of insurance benefits, including information about your coverage and out-of-pocket costs
Answers to questions about insurance coverage
Collaboration with you and your patient to assist with issues related to payments, reimbursements, payment denials, and appeals
Help with the Prior Authorization and Medical Necessity processes
Comprehensive searches for alternate reimbursement resources (for example, state and federal assistance programs) and enrollment assistance for qualified patients
Assessment of qualifications for patient assistance

Although this program provides direct help with individual reimbursement problems, we cannot guarantee either coverage for or a specific reimbursement rate for ISENTRESS. If your patient does not qualify for coverage, the reimbursement counselor can help your patient apply for patient assistance.

Contacting SUPPORT for Reimbursement Support Services

Dedicated reimbursement counselors are available from 9 AM to 6 PM ET, Monday through Friday, at
1-800-850-3430. If you are calling about an insurance question, please be ready to give the following patient information:

Name
Address
Date of birth
Social Security number
Insurance policy number
Name of policyholder
Group number

Your patient's personal identifying information will be available to LASH Group, the administrator of the program, but will not be disclosed to anyone else, except as needed to administer the program or as required by law.

Download the SUPPORT program brochure for patients:

	English
	[PDF: 691 KB, 6 pages]

Patient Assistance for Eligible Patients

A SUPPORT reimbursement counselor can help your patient apply for the SUPPORT Patient Assistance Program, which provides ISENTRESS free of charge to eligible patients without insurance coverage.^b Eligible patients must complete the enrollment form and send it to the SUPPORT program.

Benefits of the Program

Convenience: You can start the enrollment process by phone, fax, or mail
Ease: Just complete a simple enrollment form
Fast response: ISENTRESS can be shipped directly to your patient's home within 10 days of receipt of the completed enrollment form, unless you specify that his or her prescribed ISENTRESS be sent to your office
Refills: A single enrollment form covers 1 prescription and refills. You can begin the prescription-refill process with a simple call to 1-800-850-3430 (certain exceptions may apply)

Patients/Consumers:

Patients can call 1-800-850-3430, Monday through Friday, 9 AM to 6 PM ET to obtain an enrollment application or can download an enrollment form below. The enrollment application must be completed by the patient and his or her doctor.

Download an enrollment form:

	English
	[PDF: 621 KB, 3 pages]

Who Is Qualified?
Your patient may obtain patient assistance through the SUPPORT program if he or she has been prescribed ISENTRESS and all 3 of the following conditions apply:

Your patient lives in the United States (he or she does not have to be a US citizen) and has a prescription for ISENTRESS from a doctor licensed in the United States.

AND
Your patient does not have insurance or other coverage options for ISENTRESS.^b The dedicated reimbursement counselor will ensure that all alternate sources for reimbursement coverage—such as private insurance, HMOs, Medicaid, Medicare, state pharmacy assistance programs, veterans assistance, or any other social service agency—have been exhausted.

AND
Your patient cannot afford to pay for ISENTRESS. The reimbursement counselor will determine whether your patient qualifies for ISENTRESS free of charge on the basis of established criteria and his or her unique financial situation.

How Do You Apply for Patient Assistance?

You can start the patient assistance enrollment process by phone, by fax, or by mail.

Phone^c
Simply call 1-800-850-3430, 9 AM to 6 PM ET, Monday through Friday, and a reimbursement counselor will begin the enrollment process.

Fax^c
STEP 1: Complete and sign the enrollment form available for download above.

Remember that all sections on the enrollment form must be completed and that both you and your patient must sign the form
Incomplete or incorrectly completed forms will slow down the processing of your request

STEP 2: To ensure shipment of ISENTRESS to qualified patients within 10 days, fax the completed form to
1-866-410-1913.

Mail
Remember, if you do not have access to a fax machine, you may mail the signed original enrollment form. Once you have completed and signed the enrollment form, simply fold it, seal it in the postage-paid envelope, and mail it to the following address:

SUPPORT^™
PO Box 305
San Bruno, CA 94066

Your ISENTRESS will be shipped within 10 days of receipt of the completed enrollment form, if your patient qualifies.

Other Important Information
ISENTRESS that is distributed through the SUPPORT program is free of charge to all eligible patients. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., is not associated with any individuals or organizations that may charge patients a fee for helping them complete forms for our program. These individuals or organizations are acting independently of Merck, have no affiliation with Merck, and do not have the consent of Merck.

Although Merck will make every effort to grant assistance, Merck cannot guarantee product patient assistance. Merck reserves the right to change or discontinue the program at any time.

^a	The SUPPORT program is also available to assist patients who were either enrolled in the Expanded Access Program or a clinical trial program.
^b	If your patient does not meet the SUPPORT program's criteria, and there are special circumstances of financial and medical hardship that apply to the situation, you and your patient can request that an exception be made, provided that his or her income is not above a set limit.
^c	If you choose to start the patient assistance enrollment process by phone or fax, promptly complete and sign the downloadable enrollment form and mail it to the address above. Signed enrollment forms must be received for all patients who receive ISENTRESS through the SUPPORT program.

SUPPORT is a trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

ISENTRESS is used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients
This indication is based on analyses of plasma HIV-1 RNA levels up through 48 weeks in 3 double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral—nonnucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), and protease inhibitor (PI)—treatment-experienced adults and 1 was conducted in treatment-naïve adults
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response
The safety and efficacy of ISENTRESS have not been established in pediatric patients

For the treatment of patients with HIV-1 infection, the dosage of ISENTRESS is 400 mg administered orally, twice daily with or without food. During coadministration with rifampin, the recommended dosage of ISENTRESS is 800 mg twice daily with or without food

During the initial phase of treatment, patients responding to ARV therapy may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium complex, cytomegalovirus, Pneumocystis jiroveci pneumonia, Mycobacterium tuberculosis, or reactivation of varicella zoster virus), which may necessitate further evaluation and treatment
Coadministration of ISENTRESS with drugs that are strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 may result in reduced plasma concentrations of raltegravir
Rifampin, a strong inducer of UGT1A1, reduces plasma concentrations of ISENTRESS. Therefore, the dose of ISENTRESS should be increased during coadministration with rifampin
The impact of other inducers of drug metabolizing enzymes, such as phenytoin and phenobarbital, on UGT1A1 is unknown
In drug interaction studies, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of the following: hormonal contraceptives, methadone, lamivudine, tenofovir, etravirine
Coadministration of ISENTRESS with drugs that inhibit UGT1A1 may increase plasma levels of raltegravir
The most common adverse reactions of moderate to severe intensity^d (>2%) that occurred at a higher rate than the comparator were insomnia in treatment-naïve patients and headache, nausea, asthenia, and fatigue in treatment-experienced patients
Creatine kinase elevations were observed in subjects who received ISENTRESS. Myopathy and rhabdomyolysis have been reported; however, the relationship of ISENTRESS to these events is not known. Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions
ISENTRESS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
To monitor maternal-fetal outcomes of pregnant patients exposed to ISENTRESS, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263

Intensities were defined as follows: Moderate (discomfort enough to cause interference with usual activity); or Severe (incapacitating with inability to work or do usual activity).

Before prescribing ISENTRESS, please read the Prescribing Information and Patient Information.

For additional copies of the Prescribing Information, call 1-800-672-6372, visit isentress.com, or contact your Merck representative.