getting your patients started on vivitrol · 2019. 4. 9. · ios brih roirooc vitrolhils hbrlos...

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Your office can order VIVITROL directly from a distributor or through a pharmacy (specialty or other). GETTING YOUR PATIENTS STARTED ON VIVITROL This brochure will assist with: Specialty pharmacy process Buy-and-bill process VIVITROL ® Co-pay Savings Program Please see Important Safety Information on page 9. Also see Prescribing Information and Medication Guide. Review the Medication Guide with your patients.

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Page 1: GETTING YOUR PATIENTS STARTED ON VIVITROL · 2019. 4. 9. · iOs brih RoIroOc VITROLhiLs hbrLos VibROIhLVRisbROs cVcVLORue SPECIALTY PHARMACY PROCESS. 3 SPECIALTY PHARMACY PROCESS

Your office can order VIVITROL directly from a distributor or through a pharmacy (specialty or other).

GETTING YOUR PATIENTS STARTED ON VIVITROL

This brochure will assist with:

Specialty pharmacy process

Buy-and-bill process

VIVITROL® Co-pay Savings Program

Please see Important Safety Information on page 9. Also see Prescribing Information and Medication Guide. Review the Medication Guide with your patients.

Page 2: GETTING YOUR PATIENTS STARTED ON VIVITROL · 2019. 4. 9. · iOs brih RoIroOc VITROLhiLs hbrLos VibROIhLVRisbROs cVcVLORue SPECIALTY PHARMACY PROCESS. 3 SPECIALTY PHARMACY PROCESS

Option 1: Order directly from a specialty pharmacy

If you’re ordering VIVITROL directly from a specialty pharmacy, fax ALL of the following documents to the selected pharmacy:

· Copy of the signed VIVITROL prescription

· Prior Authorization Form (if applicable)

· Photocopy of the front and back of the patient’s insurance card (enlarged to ensure legibility)

· Printed co-pay card* (available at VIVITROLCopay.com)

Option 2: Work with a dedicated case manager

You can also work directly with a dedicated case manager for assistance in fulfilling VIVITROL prescriptions. Fax ALL of the following documents to Vivitrol2gether Support Services at 1-877-329-8484:

· Vivitrol2gether Support Services Enrollment Form (an editable PDF version of the Vivitrol2gether Support Services Patient Enrollment Form can be downloaded at VIVITROL.com)

· Photocopy of the front and back of the patient’s insurance card (enlarged to ensure legibility)

· Prior Authorization Form (if applicable)

Vivitrol2gether Support Services is a resource designed to help patients with:

· Reimbursement coverage verification

· Submission of VIVITROL prescriptions to a pharmacy (specialty or other)

· Submission of VIVITROL co-pay assistance for eligible patients*

· Patient transition services

CRITICAL

· Fax the PA form (if needed) and an enlarged photocopy of the patient’s pharmacy and health insurance cards to the health insurer’s toll-free fax number on the PA form. Pharmacies and health insurers typically prefer that these items come directly from your office.

· Follow up within 24 hours to ensure the prescription is being processed.

– Remember to identify the date of the scheduled injection.

– If the specialty pharmacy cannot process the prescription for VIVITROL, consider enrolling your patient into Vivitrol2gether to receive pharmacy routing assistance.

Work directly with Vivitrol2gether for assistance in fulfilling VIVITROL prescriptions. Our team is ready to support you and your patients. Call 1-800-VIVITROL (1-800-848-4876), 9am–8pm (EST) and visit VIVITROLhcp.com to access a variety of helpful resources.

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SPECIALTY PHARMACY PROCESS

ORDERING VIVITROL® (NALTREXONE FOR EXTENDED-RELEASE INJECTABLE SUSPENSION)

FROM A SPECIALTY PHARMACYWhen ordering VIVITROL, you can work directly with a pharmacy (specialty or other) or you can work with a Vivitrol2getherSM dedicated case manager. With Vivitrol2gether, you choose the VIVITROL fulfillment features that work best to support your patients.

*See page 8 for VIVITROL® Co-pay Savings Program eligibility requirements.

Please see Important Safety Information on page 9. Also see Prescribing Information and Medication Guide. Review the Medication Guide with your patients.

MEDICATION GUIDEPRESCRIBING INFORMATION

BUY-AND-BILL PROCESS

CO-PAY SAVINGS PROGRAM

IMPORTANT SAFETY INFORMATION FOR VIVITROL®

SPECIALTY PHARMACY PROCESS

Page 3: GETTING YOUR PATIENTS STARTED ON VIVITROL · 2019. 4. 9. · iOs brih RoIroOc VITROLhiLs hbrLos VibROIhLVRisbROs cVcVLORue SPECIALTY PHARMACY PROCESS. 3 SPECIALTY PHARMACY PROCESS

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SPECIALTY PHARMACY PROCESS

THE SPECIALTY PHARMACY PROCESS FLOW

Whether you have elected to send the prescription directly to the pharmacy (specialty or other) or have chosen to go through Vivitrol2getherSM, there are certain tasks that the specialty pharmacy will perform once you or your staff have completed the relevant forms.

†If specialty pharmacy is not contracted to fill prescriptions for a specific health insurer, the prescription is transferred to another pharmacy.

First VIVITROL® (naltrexone for extended-release injectable suspension) prescription

· Determine the specialty or other pharmacy options available based on the patient’s health plan coverage

· Discuss the VIVITROL® Co-pay Savings Program with the patient; eligible patients can sign up and provide the required information to the pharmacy

· Remind your patients to expect a call from the pharmacy and/or nurse coordinator to review important information about the first pharmacy order

Insurance, Co-pay Savings and Prescription Verification

· Specialty or other pharmacy performs a benefit verification on behalf of the patient and confirms prescription verification and prior authorization with the health plan†

· Co-pay savings are applied for eligible patients

· Patient authorizes payment

Schedule shipping and delivery

· Patient is contacted to schedule or confirm delivery date

· Patient is called about next steps and follow-up

Rx is filled and ready to ship

· Pharmacy contacts patient and provider’s office to authorize shipment

– After patient authorization, pharmacy will contact your office to set up delivery

· Prescription is filled by pharmacy and shipped to your office

Delivery of VIVITROL

· Office receives VIVITROL

· Patient receives injection of VIVITROL

· Your patient’s follow-up appointment is scheduled

Follow-up for next injection

· Schedule follow-up appointment for the next injection

Suggestions to help improve fill time

· Learn which pharmacies (specialty or other) work with your patients’ health plans

· Establish a relationship with the specialty pharmacy contact person and determine the best way for you to communicate (e.g., phone, email, or fax)

· Follow up regularly and be sure to communicate the required injection date of VIVITROL for each patient

1

2

3

4

5

6

Please see Important Safety Information on page 9. Also see Prescribing Information and Medication Guide. Review the Medication Guide with your patients.

MEDICATION GUIDEPRESCRIBING INFORMATION

BUY-AND-BILL PROCESS

CO-PAY SAVINGS PROGRAM

IMPORTANT SAFETY INFORMATION FOR VIVITROL®

SPECIALTY PHARMACY PROCESS

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VIVITROL® Provider Pricing ProgramDirect-purchase discount is available to eligible* providers through Besse Medical and Smith Medical Partners, the Alkermes-preferred distribution partners.

Available pricing

· For eligible* providers available through Besse Medical and Smith Medical Partners

· Single- and multiple-carton contract pricing discount

– 10% to 18% off wholesale acquisition cost (WAC) based on quantity purchased

· Extended payment terms of 75 days

– Accommodates reimbursement timing

BUY-AND-BILL PROCESS

ORDERING VIVITROL® (NALTREXONE FOR EXTENDED-RELEASE INJECTABLE SUSPENSION)

THROUGH BUY-AND-BILL

* Contact Besse Medical or Smith Medical Partners regarding eligibility for program pricing. Uninsured program pricing is not available through Smith Medical Partners.

†One unit contains 1 dose of VIVITROL.

Pricing

Description NDC 10 NDC 11Strength (Package

Size)

Order Quantity

Discount Price (%)

VIVITROL

380-mg vial

65757-300-01 65757-0300-01 380-mg vial 1 to 4 units† WAC — 10%

VIVITROL

380-mg vial

65757-300-01 65757-0300-01 380-mg vial 5 to 24 units† WAC — 15%

VIVITROL

380-mg vial

65757-300-01 65757-0300-01 380-mg vial 25 or more units† WAC — 18%

Please see Important Safety Information on page 9. Also see Prescribing Information and Medication Guide. Review the Medication Guide with your patients.

MEDICATION GUIDEPRESCRIBING INFORMATION

SPECIALTY PHARMACY PROCESS

CO-PAY SAVINGS PROGRAM

IMPORTANT SAFETY INFORMATION FOR VIVITROL®

BUY-AND-BILL PROCESS

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To get started with VIVITROL® Provider Pricing Program, set up an account with your chosen distribution partner

For Besse Medical:

· Go to Besse.com to access a Besse Business Application

· Applications can be completed online; downloaded, printed, and faxed to 1-888-375-0030; or scanned and emailed to [email protected]

· Besse Medical retains sole discretion for opening an account and establishing credit limits

When your Besse Medical account is set up, you are ready to order VIVITROL

· Order online at Besse.com

· Call 1-800-543-2111 to order by phone

· Fax your order to 1-800-543-8695

For Smith Medical Partners:

· Go to smpspecialty.com and click “Get Started” to become a customer

· Application can also be requested via email to [email protected] or by calling 1-800-292-9653

· Applications should be downloaded, printed and faxed to 630-227-9220; or scanned and emailed to [email protected]

· Include Physician’s State License and DEA Registration numbers with faxed or emailed application

· Smith Medical Partners retains sole discretion for opening an account and establishing credit limits

When your Smith Medical Partners account is set up, you are ready to order VIVITROL

· Order online at smpspecialty.com (registration required)

· Call 1-800-292-9653 to order by phone

· Fax your order to 630-227-9220

BUY-AND-BILL PROCESS

ORDERING VIVITROL® (NALTREXONE FOR EXTENDED-RELEASE INJECTABLE SUSPENSION)

THROUGH BUY-AND-BILL (CONTINUED)

VIVITROL is shipped overnight for next-day delivery so VIVITROL can be available when your patients need it.

Please see Important Safety Information on page 9. Also see Prescribing Information and Medication Guide. Review the Medication Guide with your patients.

MEDICATION GUIDEPRESCRIBING INFORMATION

SPECIALTY PHARMACY PROCESS

CO-PAY SAVINGS PROGRAM

IMPORTANT SAFETY INFORMATION FOR VIVITROL®

BUY-AND-BILL PROCESS

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Reimbursement codes for VIVITROL® (naltrexone for extended-release injectable suspension)Coding decisions should be made by the healthcare provider based on an independent review of the patient’s condition. Below is a list of codes you may find helpful.

ICD-10-CM Diagnosis CodesClaims submitted for VIVITROL should include at least one (1) ICD-10-CM diagnosis code to indicate the patient’s condition. Specific diagnosis codes should represent the condition as supported by the patient’s medical record. The diagnosis codes listed below may apply for patients for whom VIVITROL may be appropriate.

BUY-AND-BILL PROCESS

CODING AT A GLANCE

VIVITROL Coding

Professional Services

Professional Claims

NDC for VIVITROL1

HCPCS2

CPT3

ICD-10-CM Procedure4

Place of

Service Codes5

65757-0300-01

J2315

96372

3E023GC

11

21

22

55

Naltrexone for extended-release injectable suspension

Injection, naltrexone, depot form, 1 mg

Therapeutic, prophylactic, or diagnostic injection (specify material injected); subcutaneous or intramuscular

Introduction of other therapeutic substance into muscle, percutaneous approach

Office

Inpatient hospital

Outpatient hospital

Residential substance abuse treatment facility

Ambulatory Payment

Classification (APC)

Diagnosis-related Groups

APC for VIVITROL6

Inpatient/Outpatient

Groups7

0759 Naltrexone, depot form

894 Alcohol/drug abuse or dependence, left AMA

895 Alcohol/drug abuse or dependence with rehabilitation therapy

896Alcohol/drug abuse or dependence without rehabilitation therapy with MCC

897Alcohol/drug abuse or dependence without rehabilitation therapy without MCC

Patient Diagnosis

ICD-10-CM Diagnosis8

Alcohol Dependence

F10.20 Alcohol dependence, uncomplicated

F10.21 Alcohol dependence, in remission

F10.22 Alcohol dependence with intoxication

F10.23 Alcohol dependence with withdrawal

F10.24 Alcohol dependence with alcohol-induced mood disorder

F10.25 Alcohol dependence with alcohol-induced psychotic disorder

F10.26 Alcohol dependence with alcohol-induced persisting amnestic disorder

F10.27 Alcohol dependence with alcohol-induced persisting dementia

F10.28 Alcohol dependence with other alcohol-induced disorders

F10.29 Alcohol dependence with unspecified alcohol-induced disorder

Opioid Dependence

F11.20 Opioid dependence, uncomplicated

F11.21 Opioid dependence, in remission

F11.22 Opioid dependence with intoxication

F11.23 Opioid dependence with withdrawal

F11.24 Opioid dependence with opioid-induced mood disorder

F11.25 Opioid dependence with opioid-induced psychotic disorder

F11.28 Opioid dependence with other opioid-induced disorder

F11.29 Opioid dependence with unspecified opioid-induced disorder

AMA, against medical advice; CPT, Current Procedural Terminology; HCPCS, Healthcare Common Procedure Coding System; MCC, major complications and comorbidities. These are not all of the codes available for this program. A complete list of codes can be found at www.cms.gov.

Please see Important Safety Information on page 9. Also see Prescribing Information and Medication Guide. Review the Medication Guide with your patients.

MEDICATION GUIDEPRESCRIBING INFORMATION

SPECIALTY PHARMACY PROCESS

CO-PAY SAVINGS PROGRAM

IMPORTANT SAFETY INFORMATION FOR VIVITROL®

BUY-AND-BILL PROCESS

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BUY-AND-BILL PROCESS

BUY-AND-BILL PROVIDERS AND THE VIVITROL® (NALTREXONE FOR EXTENDED-RELEASE INJECTABLE SUSPENSION)

CO-PAY SAVINGS PROGRAM

This is not a guarantee of payment, coverage, or reimbursement. Alkermes does not provide any advice, recommendation, guarantee, or warranty relating to coverage, reimbursement, or coding for any product or service. Healthcare providers are responsible for determining coverage and reimbursement information and ensuring the accuracy and completeness of claim submissions for their patients. Coding, coverage, and reimbursement vary significantly by payer, patient, and setting of care and are subject to change. Additional information may exist. Actual coverage and reimbursement decisions are made by individual payers.

If you enroll, you can be directly reimbursed for your eligible patients’ co-pay or deductible expenses.

· Prescriber DEA/NPI: Drug Enforcement Agency number and National Provider Identifier number are required

· Complete all fields to avoid delays

VIVITROL® Co-pay Savings Program

How to enroll in the VIVITROL® Co-pay Savings ProgramIn order to enroll in the VIVITROL® Co-pay Savings Program, you must set up an account with OPUS Health.

To set up an account please follow these steps:

· Call OPUS Health at: 1-877-838-3836 to get a form to fill out.

· Fax the completed form to OPUS Health at 1-877-838-3836.

· OPUS Health will provide a prepopulated payment form for use in claims submission.

– Please allow 2 to 4 weeks for processing.

Once you are enrolled, reimbursement is simple and efficient

· Complete a VIVITROL® Co-pay Savings Program payment form for each eligible patient.

– OPUS Health will provide a prepopulated payment form for use by the provider.

· Fax the completed form to OPUS Health at 1-877-678-7496, including:

– Information on the co-pay card provided to the patient

– Explanation of benefits

– Patient copy of co-pay card (display RxID)

· Reimbursement for patient out-of-pocket (co-payment, co-insurance, or deductible) costs are sent directly to you from OPUS Health 2 to 4 weeks after submission.

– Opus Health will contact your office if your submission is not validated.

· Call OPUS Health at 1-877-838-3836 for assistance.

Please see Important Safety Information on page 9. Also see Prescribing Information and Medication Guide. Review the Medication Guide with your patients.

MEDICATION GUIDEPRESCRIBING INFORMATION

SPECIALTY PHARMACY PROCESS

CO-PAY SAVINGS PROGRAM

IMPORTANT SAFETY INFORMATION FOR VIVITROL®

BUY-AND-BILL PROCESS

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Additional Financial Assistance OptionsIf your patient is unable to cover a co-pay for VIVITROL or has no insurance, Vivitrol2getherSM may be able to help identify additional financial assistance options. Please contact Vivitrol2gether for more information. Call 1-800-VIVITROL (1-800-848-4876), 9am–8pm (EST).

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ELIGIBLE PATIENTS* CAN SAVE ON VIVITROL® (NALTREXONE FOR EXTENDED-RELEASE INJECTABLE SUSPENSION)

The VIVITROL® Co-pay Savings Program:

· Covers up to $500/month of VIVITROL co-pay or deductible expenses for eligible patients.* This may mean $0 co-pay or deductible expenses for your patients

· Has no income eligibility requirements

· Has no preset duration limits or expiration. The VIVITROL® Co-pay Savings Program card can be used multiple times. It never expires and remains active throughout the duration of treatment

· Allows patients to print co-pay cards directly from VIVITROLCopay.com. Patients can cut out the card and keep it in their wallet, so that they always have their ID number handy to give to a healthcare provider or pharmacy

Who is eligible?*Any patient with a prescription for VIVITROL for alcohol or opioid dependence who is 18 years or older with:

· Commercial health insurance

· No insurance or electing not to use commercial insurance

Who is not eligible?*Patients using federal or state healthcare programs to purchase their VIVITROL prescription, such as:

· Medicare, including Medicare Part D or Medicare Advantage plans

· Medicaid, including Medicaid Managed Care or Alternative Benefit Plans under the Affordable Care Act

· Medigap

· Veterans Administration

· Department of Defense

· TRICARE®

· State-funded programs such as medical or pharmaceutical assistance programs

The VIVITROL® Co-pay Savings Program is part of the comprehensive patient support services designed to help your eligible patients* with out-of-pocket expenses associated with their VIVITROL prescriptions.

CO-PAY SAVINGS PROGRAM

Your eligible patients can sign up for the VIVITROL® Co-pay Savings Program by visiting VIVITROLCopay.com.

90%

90%9 of insured patients using the program had no out-of-pocket expenses

for VIVITROL.*

* Eligibility for Alkermes-Sponsored Co-pay Assistance: Offer valid only for prescriptions for FDA-approved indications. Patients must be at least 18 years old. If patients are purchasing their VIVITROL prescriptions with benefits from Medicare, including Medicare Part D or Medicare Advantage plans; Medicaid, including Medicaid Managed Care or Alternative Benefit Plans (“ABPs”) under the Affordable Care Act; Medigap; Veterans Administration (“VA”); Department of Defense (“DoD”); TRICARE®; or any similar state-funded programs such as medical or pharmaceutical assistance programs, they are not eligible for this offer. Void where prohibited by law, taxed, or restricted. Alkermes, Inc. reserves the right to rescind, revoke, or amend these offers without notice.

MEDICATION GUIDEPRESCRIBING INFORMATION

SPECIALTY PHARMACY PROCESS

BUY-AND-BILL PROCESS

IMPORTANT SAFETY INFORMATION FOR VIVITROL®

Please see Important Safety Information on page 9. Also see Prescribing Information and Medication Guide. Review the Medication Guide with your patients.

CO-PAY SAVINGS PROGRAM

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IMPORTANT SAFETY INFORMATION FOR VIVITROL® (NALTREXONE FOR EXTENDED-RELEASE INJECTABLE SUSPENSION)

INDICATIONSVIVITROL is indicated for:

· Treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration.

· Prevention of relapse to opioid dependence, following opioid detoxification.

· VIVITROL should be part of a comprehensive management program that includes psychosocial support.

CONTRAINDICATIONS VIVITROL is contraindicated in patients:

·Receiving opioid analgesics

·With current physiologic opioid dependence

· In acute opioid withdrawal

· Who have failed the naloxone challenge test or have a positive urine screen for opioids

· Who have exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent

WARNINGS AND PRECAUTIONSVulnerability to Opioid Overdose:

·After opioid detoxification, patients are likely to have a reduced tolerance to opioids. VIVITROL blocks the effects of exogenous opioids for approximately 28 days after administration. As the blockade wanes and eventually dissipates completely, use of previously tolerated doses of opioids could result in potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.).

·Cases of opioid overdose with fatal outcomes have been reported in patients who used opioids at the end of a dosing interval, after missing a scheduled dose, or after discontinuing treatment. Patients and caregivers should be told of this increased sensitivity to opioids and the risk of overdose.

·Although VIVITROL is a potent antagonist with a prolonged pharmacological effect, the blockade produced by VIVITROL is surmountable. The plasma concentration of exogenous opioids attained immediately following their acute administration may be sufficient to overcome the competitive receptor blockade. This poses a potential risk to individuals who attempt, on their own, to overcome the blockade by administering large amounts of exogenous opioids.

·Any attempt by a patient to overcome the VIVITROL blockade by taking opioids may lead to fatal overdose. Patients should be told of the serious consequences of trying to overcome the opioid blockade.

Injection Site Reactions:

·VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising, or pruritus; however, in some cases injection site reactions may be very severe.

· Injection site reactions not improving may require prompt medical attention, including, in some cases, surgical intervention.

· Inadvertent subcutaneous/adipose layer injection of VIVITROL may increase the likelihood of severe injection site reactions.

·Select proper needle size for patient body habitus, and use only the needles provided in the carton.

·Patients should be informed that any concerning injection site reactions should be brought to the attention of their healthcare provider.

Precipitation of Opioid Withdrawal:

·When withdrawal is precipitated abruptly by administration of an opioid antagonist to an opioid-dependent patient, the resulting withdrawal syndrome can be severe. Some cases of withdrawal symptoms have been severe enough to require hospitalization, and in some cases, management in the ICU.

·To prevent occurrence of precipitated withdrawal, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before starting VIVITROL treatment:

– An opioid-free interval of a minimum of 7–10 days is recommended for patients previously dependent on short-acting opioids.

– Patients transitioning from buprenorphine or methadone may be vulnerable to precipitated withdrawal for as long as two weeks.

· If a more rapid transition from agonist to antagonist therapy is deemed necessary and appropriate by the healthcare provider, monitor the patient closely in an appropriate medical setting where precipitated withdrawal can be managed.

·Patients should be made aware of the risk associated with precipitated withdrawal and be encouraged to give an accurate account of last opioid use.

Hepatotoxicity:

·Cases of hepatitis and clinically significant liver dysfunction have been observed in association with VIVITROL. Warn patients of the risk of hepatic injury; advise them to seek help if experiencing symptoms of acute hepatitis. Discontinue use of VIVITROL in patients who exhibit acute hepatitis symptoms.

Depression and Suicidality:

·Alcohol- and opioid-dependent patients taking VIVITROL should be monitored for depression or suicidal thoughts. Alert families and caregivers to monitor and report the emergence of symptoms of depression or suicidality.

When Reversal of VIVITROL Blockade Is Required for Pain Management:

·For VIVITROL patients in emergency situations, suggestions for pain management include regional analgesia or use of non-opioid analgesics. If opioid therapy is required to reverse the VIVITROL blockade, patients should be closely monitored by trained personnel in a setting staffed and equipped for CPR.

Eosinophilic Pneumonia:

·Cases of eosinophilic pneumonia requiring hospitalization have been reported. Warn patients of the risk of eosinophilic pneumonia and to seek medical attention if they develop symptoms of pneumonia.

Hypersensitivity Reactions:

·Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis.

Intramuscular Injections:

·As with any IM injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder.

Alcohol Withdrawal:

· Use of VIVITROL does not eliminate nor diminish

alcohol withdrawal symptoms.

ADVERSE REACTIONS

·Serious adverse reactions that may be associated with VIVITROL therapy in clinical use include severe injection site reactions, eosinophilic pneumonia, serious allergic reactions, unintended precipitation of opioid withdrawal, accidental opioid overdose, and depression and suicidality.

·The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence (ie, those occurring in ≥5% and at least twice as frequently with VIVITROL than placebo) include nausea, vomiting, injection site reactions (including induration, pruritus, nodules, and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders.

· The adverse events seen most frequently in association with VIVITROL in opioid-dependent patients (ie, those occurring in ≥2% and at least twice as frequently with VIVITROL than placebo) were hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache.

You are encouraged to report side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION FOR VIVITROL®

MEDICATION GUIDEPRESCRIBING INFORMATION

SPECIALTY PHARMACY PROCESS

BUY-AND-BILL PROCESS

CO-PAY SAVINGS PROGRAM

IMPORTANT SAFETY INFORMATION FOR VIVITROL®

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Learn more at VIVITROL.com

ALKERMES and VIVITROL are registered trademarks of Alkermes, Inc. Vivitrol2gether is a service mark of Alkermes, Inc. ©2017 Alkermes, Inc. All rights reserved.

VIV-003356

vivitrol.com

References: 1. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; rev December 2015. 2. American Academy of Professional Coders. Drugs administered other than oral method (J0120-J8999). http://coder.aapc.com/hcpcs-codes-range/9/270. Accessed January 23, 2017. 3. American Medical Association. 2015 Current Procedural Terminology: Professional Edition. Chicago, IL: American Medical Association; 2015. 4. RJ Health Systems. ICD-9-CM to ICD-10-CM crosswalk for VIVITROL® (naltrexone for extended-release injectable suspension). July 2015. 5. Centers for Medicare & Medicaid Services. Place of Service Codes. CMS.gov website. http://www.cms.gov/Medicare/Coding/place-of-service-codes. Updated November 23, 2015. Accessed January 23, 2017. 6. Find-a-Code website. Ambulatory payment classifications. http://www.findacode.com/apc/0759-naltrexone-depot-form-apc-code.html. Accessed January 23, 2017. 7. List of diagnosis related groups (DRGs), FY2008. CMS website. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ MedicareFeeforSvcPartsAB/downloads/DRGdesc08.pdf. Accessed January 23, 2017. 8. ICD10Data.com website. Accessed January 23, 2017. 9. Data derived from insured patients enrolled in the VIVITROL® Co-pay Savings Program from March 2016 through February 2017.

Please see Important Safety Information on page 9. Please see enclosed Prescribing Information, including Medication Guide.

MEDICATION GUIDEPRESCRIBING INFORMATION

SPECIALTY PHARMACY PROCESS

BUY-AND-BILL PROCESS

CO-PAY SAVINGS PROGRAM

IMPORTANT SAFETY INFORMATION FOR VIVITROL®