Apretude Permanent J-Code ‌Now Available: J0739 – 6/24/22

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Full Prescribing Information, including Boxed Warning, for APRETUDE
APRETUDE

Permanent J-Code ‌Now Available J0739, injection, cabotegravir, 1 mg

Effective July 1, 2022

APRETUDE, the first and only long-acting injectable HIV PrEP option given every 2 months,1* has been issued a permanent J-code: J0739, injection, cabotegravir, 1 mg.2 See relevant product information below.

APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg ‌for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 ‌infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 ‌PrEP.1

Important Safety Information

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION

Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 ‌treatment regimen.

Please see additional Important Safety Information for APRETUDE below.

*

APRETUDE is administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered 1 month apart.1

APRETUDE Information

 

J-Code2

J0739, injection, cabotegravir, 1 mg

 
 

Effective Date

July 1, 2022

 
 

National Drug Code (NDC)1†

49702-0264-23

 
 

Product/Strength1

600-mg/3-mL single-dose (200-mg/mL) vial of cabotegravir extended-release injectable suspension

 
 

HCPCS Units

600 HCPCS units/single-dose vial of cabotegravir extended-release injectable suspension

 
 

Wholesale Acquisition Cost (WAC)3‡

$3700

 
 

ICD-10-CM Codes4,5

Z01.812 Encounter for preprocedural laboratory examination

Z11.3 Encounter for screening for infections with a predominantly sexual mode of transmission

Z11.4 Encounter for screening for HIV

Z20.2 Contact with and (suspected) exposure to infections with a predominantly sexual mode of transmission

Z20.5 Contact with and (suspected) exposure to viral hepatitis

Z20.6 Contact with and (suspected) exposure to HIV

Z51.81 Encounter for therapeutic drug level monitoring

Z72.5 High risk sexual behavior

Z72.51 High risk heterosexual behavior

Z72.52 High risk homosexual behavior

Z72.53 High risk bisexual behavior

Z79.899 Other long term (current) drug therapy

 
 

CPT Code6

96372 Therapeutic, prophylactic, or diagnostic injection

 
 

CPT Modifier

33 When the primary purpose of the service is the delivery of an evidence-based service in accordance with a US Preventive Services Task Force A or B rating in effect and other preventive services identified in preventive services mandates (legislative or regulatory), the service may be identified by appending modifier 33, Preventive Service, to the service

 

These codes are only intended to support APRETUDE for use as PrEP. The codes in this guide are not all-inclusive and are for informational purposes only. ViiV Healthcare does not make any representation or guarantee concerning reimbursement or coverage for any service or item.

A zero is removed if a 10-digit NDC is needed. 600-mg/3-mL cabotegravir: 49702-264-23.1

List price to wholesalers and warehousing chains, not including prompt pay, stocking, or distribution allowances, or other discounts, rebates, or chargebacks. List price may not represent prices charged to other customers, including specialty distributors.

§

Modifier 33 does not guarantee coverage or zero cost-sharing. Actual reimbursement and patient cost-sharing is subject to the payer’s coverage policy. Reference payer instructions to help ensure accurate billing.

Important Safety Information (cont’d)

CONTRAINDICATIONS

Do not use APRETUDE in individuals:

ο

with unknown or positive HIV-1 status

ο

with previous hypersensitivity reaction to cabotegravir

ο

receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine

WARNINGS AND PRECAUTIONS

Comprehensive Management to Reduce the Risk of HIV-1 Infection:

Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner(s) HIV-1 status, including viral suppression status; regular testing for STIs)

Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection

When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs

If an HIV-1 test indicates possible HIV-1 infection, or if symptoms consistent with acute HIV-1 infection develop following an exposure event, additional HIV testing to determine HIV status is needed. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment

Counsel HIV-1 uninfected individuals to strictly adhere to the recommended dosing and testing schedule for APRETUDE

Potential Risk of Resistance with APRETUDE:

There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. Alternative forms of PrEP should be considered following discontinuation of APRETUDE for those individuals at continuing risk of HIV-1 acquisition and initiated within 2 months of the final injection of APRETUDE

Long-Acting Properties and Potential Associated Risks with APRETUDE:

Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence to every-2-month injections or missed doses could lead to HIV-1 acquisition and development of resistance

Hypersensitivity Reactions:

Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE

Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated

Hepatotoxicity:

Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors

Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated

Depressive Disorders:

Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE

Promptly evaluate patients with depressive symptoms

Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:

The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE

Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.

DRUG INTERACTIONS

Refer to the full Prescribing Information for important drug interactions with APRETUDE

Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir

USE IN SPECIFIC POPULATIONS

Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation

Pediatrics: Not recommended in individuals weighing less than 35 kg

Please see full Prescribing Information, including Boxed Warning, for APRETUDE.

CPT=Current Procedural Terminology; HCPCS=Healthcare Common Procedure Coding System; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification.

References: 1. APRETUDE [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021. 2. Centers for Medicare & Medicaid Services. Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Recommendations. Accessed May 18, 2022. https‌ ://www‌ .cms.‌ gov/files/document/2022-hcpcs-application-summary-quarter-1-2022-drugs-and-biologicals.‌ pdf ‌3. Truven Health Analytics Inc [database online]. Red Book Pricing. Accessed May 5, 2022. www‌ .micromedexsolutions.‌ com/home/dispatch 4. Billing ‌Coding Guide for HIV Prevention. National Alliance of State & Territorial AIDS Directors; 2018. Accessed May 5, 2022. https‌ ://nastad‌ .org/sites/default/files/2021-12/PDF_BillingCodingGuide_v5.‌ pdf ‌5. Preexposure prophylaxis for the prevention of HIV infection in the United States—2017 clinical providers’ supplement. Centers for Disease Control and Prevention. Accessed May 4, 2022. https‌ ://www‌ .cdc.‌ gov/hiv/pdf/risk/prep/cdc-hiv-prep-provider-supplement-2017.‌ pdf 6. Codify by AAPC. CPT® 96372, under therapeutic, prophylactic, and diagnostic injections and infusions (excludes chemotherapy and other highly complex drug or highly complex biologic agent administration). Accessed May 5, 2022. https‌ ://www‌ .aapc.‌ com/codes/cpt-codes/96372 7. Wilcox A. ‌Modifier 33 for preventive care. Find-A-Code. Accessed May 5, 2022. https‌ ://www‌ .findacode.‌ com/articles/modifier-33-for-preventive-care.‌ htm

Please do not reply to this email, if you require additional information or have any questions, please contact us here.

For more information go to www.APRETUDEhcp.com.

To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

ViiV Healthcare

©2022 ViiV Healthcare or licensor.
CBTEML220050 ‌ ‌May 2022
Produced in USA.

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