For HIV-1–negative, at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1. See full Indication.
Find answers to common questions that may arise when getting started with APRETUDE in your practice.
Please speak with your Territory Account Manager (TAM) if you have any additional questions while prescribing or administering APRETUDE.
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Adherence to the dosing schedule is strongly recommended. APRETUDE injections can be given up to 7 days before or after the scheduled injection date (after the first injection).
Learn more about APRETUDE dosingANo, APRETUDE can be started without the use of the oral lead-in.
Oral cabotegravir is available and may be used as an oral lead-in to assess for tolerability.
Learn more about APRETUDE dosingAAdherence to the injection dosing schedule is strongly recommended. Individuals who miss a Target Injection Date visit should be clinically reassessed to ensure resumption of APRETUDE remains appropriate.
Learn more about Missed InjectionsAIndividuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir and with each subsequent injection. - Use a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection
- If an antigen/antibody test was used and was negative, confirm results with an HIV RNA test
- Results of confirmatory HIV RNA test can be pending at the time of administration
- When recent exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash) are present
- Upon diagnosis of any other sexually transmitted infection
- If positive HIV-1 status is confirmed, transition to a complete HIV-1 treatment
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ViiVConnect is a ViiV Healthcare program designed to provide information on insurance coverage and financial support programs that may help patients get their prescribed ViiV Healthcare medicine.
We have programs for eligible patients who are insured, underinsured, and uninsured. When providers enroll patients in ViiVConnect for prescribed APRETUDE, our Access Coordinators help with:- Benefit verification
- Prior authorization (PA) support
- Claim denials and appeals support
- Patient Assistance Program for patients who qualify*
- APRETUDE Patient Savings Program*
- Access Coordinators can contact health insurance plans to find out what out-of-pocket costs may be for prescribed ViiV Healthcare medicine and help patients navigate any access-related questions and concerns they may have while prescribed APRETUDE
- Access Coordinators can also enroll patients in the APRETUDE Patient Savings Program to support their co-pay costs. Eligible commercially insured patients may pay as little as $0 co-pay for APRETUDE via the Patient Savings Program* (up to $7,850 every calendar year)
- Access Coordinators can determine program eligibility for the ViiV Healthcare Patient Assistance Program and provide information on financial support programs
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Healthcare providers should complete and sign the APRETUDE Enrollment Form with their patients and submit the form via the ViiVConnect Portal or fax, and the benefit verification process will initiate automatically if the patient has insurance.† Our goal is to provide benefit verification within 48 hours of receiving a completed enrollment form. ViiVConnect may also fax a summary of benefits and call the provider's office to discuss patient coverage options.
ViiVConnect Summary of Benefits for prescribed APRETUDE will include information concerning:- Benefit status
- Product coverage
- Prior authorization (PA) requirements
- Deductible types
- Co-pay amounts
AIf a patient doesn't have insurance and is having trouble paying for their medicine, the patient may qualify for the Patient Assistance Program through ViiV Healthcare.‡
Contact your Field Reimbursement Manager (FRM) or ViiVConnect for more information.
‡Subject to eligibility and program Terms and Conditions. ViiVConnect programs do not constitute health insurance.AOut-of-pocket costs for your patients will vary depending on their insurance coverage and benefit design. Eligible commercially insured patients could pay as little as $0 for APRETUDE when using the APRETUDE Patient Savings Program§ (up to $7,850 every calendar year).
Fill out the APRETUDE Enrollment Form to get started with ViiVConnect and to enroll your patients in the Patient Savings Program. You may also enroll patients in the Patient Savings Program at APRETUDECopayProgram.com.§
ViiVConnect can provide out-of-pocket estimates for your enrolled patients, or you can determine out-of-pocket costs by contacting your patients' insurance to determine coverage.§Subject to eligibility and program Terms and Conditions. ViiVConnect programs do not constitute health insurance. AAPRETUDE can be covered under a medical benefit, as well as a pharmacy benefit. These options depend on your patient's insurance plan. It is important to note that APRETUDE may be covered under one or both benefit types.
This coverage type may influence how you choose to acquire APRETUDE. Please contact your Territory Account Manager (TAM) for more information.
Pharmacy benefit- The pharmacy benefit typically covers prescription medications that patients obtain at a retail pharmacy, specialty pharmacy, or by mail order
- The medical benefit typically covers services and medications administered in an office or hospital setting, such as lab work, x-rays, and injections
- It typically covers provider-administered drugs, such as APRETUDE
AYou can contact your Field Reimbursement Manager (FRM) or ViiVConnect Access Coordinator with any questions you may have regarding the benefit verification process, including any questions about authorization (PA) requests.
When patients are enrolled in ViiVConnect, an Access Coordinator can provide guidance on PA steps and let providers and patients know what additional information or documentation may be needed. -
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Prescribed APRETUDE can be acquired through select specialty pharmacies or via the Buy and Bill process from a specialty distributor. Your practice will select the method.
Please keep in mind that the patient's insurance plan coverage and benefit type may determine how your practice acquires APRETUDE. APRETUDE may be covered under the medical benefit or the pharmacy benefit depending on your patient's insurance plan. You may contact your authorized distributor directly with questions about customer eligibility to order APRETUDE.
You may also contact your Territory Account Manager (TAM) for more information on how to acquire APRETUDE.AYou may speak to your dedicated TAM or Field Reimbursement Manager (FRM) for your office; additionally, dedicated ViiVConnect support is available to help answer any acquisition questions you or your team may have.
ViiVConnect support can be reached toll free at 1-844-588-3288.AViiV Healthcare has partnered with a number of specialty pharmacies in the US that are experienced with injectable medications and are committed to providing APRETUDE.
You can find a list of in-network specialty pharmacies at ViiVConnect.com/APRETUDE-Ordering-Guide
If the selected specialty pharmacy doesn't carry APRETUDE, contact your FRM for assistance.AWhen ordering APRETUDE through a specialty pharmacy, you may prescribe APRETUDE through your practice's Electronic Health Records (EHR). Please note that it may take time for your EHR vendor to add APRETUDE to the drug database.
When ordering APRETUDE via the Buy and Bill acquisition option, you will purchase prescribed APRETUDE directly from a specialty distributor.
Contact your TAM for more information on how to acquire APRETUDE.AWhen ordering APRETUDE via the Buy and Bill acquisition option, you will purchase prescribed APRETUDE directly from a specialty distributor and store the medication on the premises until you prescribe and administer it. Buy and Bill allows your practice greater control over the acquisition process. Key things providers should know about Buy and Bill ordering: - Your office will need to store and track your own supply of APRETUDE
- Your practice submits a reimbursement claim for the cost of APRETUDE, the injection administration, and the office visit, if applicable, to payers
- Your practice collects the co-pay or coinsurance from each patient
AConsider the body mass index (BMI) of the individual to ensure that the needle length is sufficient to reach the gluteus muscle. Longer needle lengths (not included in the dosing kit) may be required for individuals with higher BMI (eg, >30 kg/m2) to ensure that the injection is administered intramuscularly as opposed to subcutaneously.
If you determine that a 2-inch safety needle is required for your patient, you can order by visiting http://www.fisherhealthcare.com/
2inchsafetyneedle .This information is provided for your reference only. ViiV Healthcare does not warrant or endorse ThermoFisher or its offerings.
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No, APRETUDE does not require refrigeration and should never be frozen. Store APRETUDE at 36°F to 77°F (2°C to 25°C) in the original carton until ready to use. -
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Submit the claim to your patient’s insurance provider for the cost of drug, administration of injection, and office visit (if applicable): - Be sure to include the correct coding (J code and Current Procedural Terminology [CPT] code)
- Ensure you submit a thorough claim based on the patient’s insurance requirements (eg, a description of drug/dosing, route of administration, or National Drug Code [NDC])
- Ensure reimbursement aligns with contractual amount designated
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Often, yes. Most commercial plans may cover without cost-sharing certain baseline and monitoring services related to pre-exposure prophylaxis (PrEP), including HIV testing. Individual payer policies vary and are not controlled by ViiV Healthcare. AAdherence to the dosing schedule is strongly recommended. Contact your patient and reschedule their appointment. APRETUDE can be administered 7 days before or after the Target Injection Date (after the first injection). If your patient cannot receive their APRETUDE injection during this window, oral cabotegravir can be used to replace up to one missed injection. Please see guidance on Missed Dosing. ATo 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. ANo. APRETUDE must only be administered as a gluteal intramuscular injection by a healthcare provider. AFor those individuals at continuing risk of HIV-1 acquisition, alternative forms of PrEP should be considered following discontinuation of APRETUDE and initiated within 2 months of the final APRETUDE injection.
Residual concentrations of APRETUDE may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer); therefore, you should take the prolonged-release characteristics of APRETUDE into consideration when discontinuing injections. -
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Yes. Please speak to your ViiV Healthcare Territory Account Manager (TAM), who will be able to provide resources and support to help you implement APRETUDE in your practice. AEducational resources, including injection education and informational sessions, are available to you and your practice. Speak with your TAM for more information. You may also visit APRETUDEHCP.com/resources to learn more.
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