Prescribing Information
Full Prescribing Information, including Boxed Warning, for APRETUDE.
Dosing and Administration Guide
Dosing and administration information.
Healthcare Provider Brochure
Background for healthcare providers on APRETUDE efficacy, safety, and more.
APRETUDE Patient Discussion Guide
This guide can assist you in explaining PrEP with APRETUDE to your patients.
PrEP=pre-exposure prophylaxis.
Preparing and administering APRETUDE
APRETUDE – Administration Animation Storyboard
Scene: Opening
Voice over
Visual text
Description of the scene: APRETUDE logo elements appear. ViiV Healthcare logo is displayed.
Scene: Opening
Voice over
This is an instructional video for the administration of APRETUDE.
Visual text
Description of the scene: APRETUDE logo elements join to recreate the APRETUDE logo. The APRETUDE tradename appears. ViiV Healthcare logo is displayed.
Scene: Indication
Voice over
INDICATION
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.
Visual text
INDICATION
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.
Description of the scene: Indication will be displayed.
Scene: Important Safety Information
Voice over
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-1while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
Visual text
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-1while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
Description of the scene: ISI will be displayed.
Scene: Important Safety Information continued
Voice over
CONTRAINDICATIONS
- Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
Please see additional Important Safety Information for APRETUDE later in this video.
Please see link to full Prescribing Information, including Boxed Warning, for APRETUDE on this website.
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IMPORTANT SAFETY INFORMATION CONTINUED
CONTRAINDICATIONS
- Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
Please see additional Important Safety Information for APRETUDE later in this video.
Please see link to full Prescribing Information, including Boxed Warning, for APRETUDE on this website.
Description of the scene: ISI will be displayed.
Scene: Opening
Voice over
Two topics will be reviewed in this video: Chapter 1 explains the preparation steps for APRETUDE, with Chapter 2 focusing on the steps for injection.
Please read the full Instructions for Use (IFU) contained in the APRETUDE Dosing Kit and available in the Prescribing Information at APRETUDEHCP.com.
Visual text
Administration Video
Chapter 1 – Preparation
Chapter 2 – Injection
Please read the full Instructions for Use (IFU) contained in the APRETUDE Dosing Kit and available in the Prescribing Information at APRETUDEHCP.com.
Description of the scene: This scene will outline the purpose of the video, its objectives, and the chapters.
Scene: Opening
Voice over
The information in this video is based on the APRETUDE Instructions for Use leaflet.
However, where supplementary information is provided, which is not contained in the Instructions for Use leaflet, a light bulb icon will appear to signify that this is the case.
Visual text
The information in this video is based on the APRETUDE IFU leaflet.
However, where supplementary information is provided, which is not contained in the IFU leaflet, a light bulb icon will appear to signify that this is the case.
Description of the scene: Light bulb icon explanation.
Scene: Opening
Voice over
APRETUDE is available in a kit that includes a single-use vial of cabotegravir 600-milligrams per 3-milliliters extended-release injectable suspension. APRETUDE is for gluteal intramuscular use only and must be administered by a healthcare provider.
Visual text
600-mg/3-mL Dosing Kit
Description of the scene: Dimensions of the outer boxes are shown to support HCPs considering the storage space they may require.
Scene: Opening
Voice over
A complete dose of APRETUDE requires 1 injection: 600-milligrams per 3-milliliters of cabotegravir. It does not need further dilution or reconstitution.
Visual text
600-mg/3-mL Dosing Kit
Cabotegravir 600-mg/3-mL
Description of the scene: Vial information is shown. The vial will be rotating.
Scene: Opening
Voice over
APRETUDE should be stored in its original packaging at 36 degrees Fahrenheit to 77 degrees Fahrenheit until ready to use. APRETUDE does not require refrigeration.
Visual text
Store in the original packaging at 36°F to 77°F (2°C to 25°C) until ready to use. Do not freeze.
Description of the scene: Storage information is shown.
Chapter: Preparation
Scene: Cover
Voice over
Visual text
CHAPTER 1
Preparation
Description of the scene: Chapter 1 – Preparation cover appears
Chapter: Preparation
Scene: Take the Dosing Kit
Voice over
When removing the Dosing Kit out of your office storage, you will find the following:
Visual text
Remove Dosing Kit from office storage
Description of the scene: The office storage containing the Dosing Kits is displayed. The camera zooms in, a hand takes one of the 600-mg/3-mL Dosing Kits to start the preparation.
Chapter: Preparation
Scene: Your Dosing Kit contains
Voice over
- An Instructions for Use leaflet
- One single-dose vial containing 600-milligrams per 3-milliliters of cabotegravir
This vial has a brown tint to the glass with an orange cap
- One 23-gauge, 1½-inch injection needle
- One syringe and
- One vial adapter
Visual text
Instructions for Use leaflet
APRETUDE vial
Injection needle (23G, 1½-inch)
Syringe
Vial adapter
The APRETUDE vial has a brown tint to the glass.
Description of the scene: The Dosing Kit contents are collected on a table covered by a medical paper sheet. Each component will be highlighted one at a time, with information call-outs.
Chapter: Preparation
Scene: Needle’s length
Voice over
While the Dosing Kit contains a 23-gauge, 1½-inch needle, you should consider the patient’s build and use medical judgment to select an appropriate needle length.1-3
Visual text
Consider the patient’s build and use medical judgment to select an appropriate injection needle length. See Prescribing Information for further details.
Description of the scene: Text appears showing needle's length information.
Chapter: Preparation
Scene: Needle’s length
Voice over
If 2-inch safety needles are required to reach the gluteus muscle, please order by visiting fisherhealthcare.com/2inchsafetyneedle.
Visual text
If 2-inch safety needles are required to reach the gluteus muscle, please order by visiting www.fisherhealthcare.com/2inchsafetyneedle.
Description of the scene: Text appears showing needle's length information.
Chapter: Preparation
Scene: You will also need
Voice over
You will also require additional supplies, not included in the packaging:
- Non-sterile gloves
- 2 alcohol wipes
- 2 gauze pads
- and a suitable sharps container.
Visual text
Non-sterile gloves (not included)
2 alcohol wipes (not included)
2 gauze pads (not included)
Sharps container (not included)
Description of the scene: The camera moves on the right revealing the other components needed (not included) collected on the same table. Call-outs and a pop-up with information appear.
Chapter: Preparation
Scene: You will also need
Voice over
An adhesive bandage may be used if bleeding occurs.
Visual text
Non-sterile gloves (not included)
2 alcohol wipes (not included)
2 gauze pads (not included)
Sharps container (not included)
Adhesive bandage may be used if bleeding occurs.
Description of the scene: The call-out moves to reveal the sharps disposal container.
Chapter: Preparation
Scene: Allow vial to come to room temperature
Voice over
If the pack has been stored in the refrigerator, the vial should be brought to room temperature before you are ready to give the injection, but make sure the vial does not get above 86 degrees Fahrenheit. Do not use any heating methods, other than using the warmth of your hands.
Visual text
If you choose to store APRETUDE in the refrigerator, allow the vial to come to room temperature prior to administration (not to exceed 86° F or 30° C).
Description of the scene: A pop-up appears to advise taking out of fridge when patient checks in to your clinic.
Chapter: Preparation
Scene: Inspect vial
Voice over
Before proceeding, inspect the vial. If the expiration date has passed,
Visual text
Check the expiration date and medicine
Do not use if the expiration date has passed or you can see foreign matter in the vial.
Description of the scene: The hand enters the scene with the vial upside down. A balloon with the zoomed vial pops up showing the expiration date. Then it disappears.
Chapter: Preparation
Scene: Inspect vial
Voice over
or if you can see foreign matter in the vial, do not use.
Visual text
Check the expiration date and medicine
Do not use if the expiration date has passed or you can see foreign matter in the vial.
Description of the scene:
The hand turns the vial to better see the medicine inside the vial. A balloon with the zoomed vial pops
up showing the medicine.
Chapter: Preparation
Scene: Shake vigorously
Voice over
Visual text
Description of the scene: The hand takes the vial.
Chapter: Preparation
Scene: Shake vigorously
Voice over
Hold it firmly and vigorously shake for a full 10 seconds as demonstrated to resuspend the contents.
Visual text
10 secs
Description of the scene:
The hand shakes the vial vigorously for a full 10 seconds.
Chapter: Preparation
Scene: Inspect Medicine
Voice over
Next, invert the vial and check the suspension. Confirm the suspension is uniform. If it is not, shake the vial again. It is normal to see some small air bubbles.
Visual text
Correct suspension
Description of the scene: Zoom in to show the medicine inspection. The zoomed balloon shows the correct suspension.
Chapter: Preparation
Scene: Allow accumulated bubbles to subside
Voice over
In order to accurately administer the exact dose, allow for any excessive bubbles accumulated to subside.
Visual text
Allow accumulated bubbles to subside
Description of the scene: The hand positions the vial on the table to allow accumulated bubbles to subside.
Chapter: Preparation
Scene: Remove vial cap
Voice over
Next, remove the cap from the vial.
Visual text
Description of the scene: The hands remove vial cap.
Chapter: Preparation
Scene: Wipe rubber stopper
Voice over
Clean the rubber stopper with an alcohol wipe and do not allow anything to touch it afterwards.
Visual text
Do not allow anything to touch the rubber stopper after wiping it.
Description of the scene: The hands clean the rubber stopper.
Chapter: Preparation
Scene: Peel open vial adapter
Voice over Peel off the paper backing from the vial adapter in preparation for the next step.
Visual text
Keep the adapter in place in the packaging for the next step.
Description of the scene: The hand takes the vial adapter and opens it.
Chapter: Preparation
Scene: Peel open vial adapter
Voice over
With the vial resting in an upright position on a flat surface,
Visual text
Description of the scene: The hand takes the vial adapter and opens it.
Chapter: Preparation
Scene: Attach vial adapter
Voice over
press the vial adapter straight down onto the vial using the packaging, as shown.
The vial adapter should snap securely into place.
Visual text
Description of the scene: The hand takes the vial adapter and attaches it to the vial.
Chapter: Preparation
Scene: Attach vial adapter
Voice over
When you are ready, lift off the vial adapter packaging.
Visual text
Description of the scene: The hand takes the packaging off the vial adapter.
Chapter: Preparation
Scene: Prepare syringe withdrawing air
Voice over
Remove the syringe from the packaging and draw 1 milliliter of air into the syringe.
This will make it easier to draw up the medicine later. If this step is not completed, some medicine may flow back into the vial unintentionally, leaving less than intended in the syringe.
Visual text
1 mL of air
Description of the scene: The hands take the syringe and withdraw 1 mL of air.
Chapter: Preparation
Scene: Attach syringe and push air
Voice over
With the vial on a flat surface, hold the vial adapter and vial firmly, as shown. Screw the syringe securely onto the vial adapter. Press the plunger all the way down
Visual text
Description of the scene: The hands attach the syringe to vial adapter by screwing the syringe firmly.
Chapter: Preparation
Scene: Attach syringe and push air
Voice over
to push the air into the vial.
Visual text
Description of the scene: The hand presses the plunger to push air into the vial.
Chapter: Preparation
Scene: Slowly draw up dose
Voice over
Invert the syringe and vial and slowly withdraw as much of the medicine as possible into the syringe. It is worth noting that there will be more medicine than the dose amount.
Visual text
Description of the scene: The hands invert syringe and vial together and withdraw all the medicine possible.
Chapter: Preparation
Scene: Unscrew syringe
Voice over
Holding the vial and vial adapter, keep the syringe upright to avoid leakage and unscrew the syringe from the vial adapter. Check again that the medication looks uniform and milky white.* Once the medication has been drawn into the syringe, it is best to inject as soon as possible.
Visual text
Keep the syringe upright to avoid leakage.
Check that the medication looks uniform and milky white.*
*The liquid in the syringe may appear as a white to light pink, free-flowing suspension.
Description of the scene: The hands unscrew the syringe from vial adapter.
Chapter: Preparation
Scene: Unscrew syringe
Voice over
However, the medication can remain in the syringe for up to 2 hours before injecting. You must discard the medicine, syringe, and needle if this time limit is exceeded. The filled syringe should not be placed in the refrigerator.
Visual text
The medication can remain in the syringe for up to 2 hours before injecting. Discard if this time limit is exceeded.
Description of the scene: The hand holds the syringe.
Chapter: Preparation
Scene: Peel open needle packaging
Voice over
Now, peel open the needle packaging part way to expose
Visual text
Description of the scene: The hands peel open the needle packaging partway to expose the needle base.
Chapter: Preparation
Scene: Peel open needle packaging
Voice over
the needle hub.
Visual text
Description of the scene: The needle is positioned with its packaging on the table for later.
Chapter: Preparation
Scene: Attach needle
Voice over
While keeping the syringe upright, firmly twist the needle onto the syringe,
Visual text
Description of the scene: The hands take the needle with its packaging and attach the needle, firmly twisting the syringe onto the needle.
Chapter: Preparation
Scene: Attach needle
Voice over
then finally remove the needle from its packaging.
Visual text
Description of the scene: The needle packaging is removed.
Chapter: Injection
Scene: Cover
Voice over
Now you're ready for the injection steps.
Visual text
CHAPTER 2
Injection
Description of the scene: Chapter 2 – Injection cover appears
Chapter: Injection
Scene: Site injections
Voice over
The first step is to identify the injection site. It is important to note that this injection is for gluteal intramuscular use only. Do not administer intravenously.
There are two possible sites for injection: the ventrogluteal and the upper outer quadrant of the dorsogluteal site. The injection should not be administered in any other site.1-7
Visual text
The first step is to identify the injection site. Injections of APRETUDE are for gluteal intramuscular use only. Do not inject intravenously.
Description of the scene: A neutral torso appears. The torso turns on itself while explanations of the correct injection site appear.
Chapter: Injection
Scene: Ventrogluteal site
Voice over
The ventrogluteal site is recommended because it is located away from major nerves and blood vessels.1-7
Visual text
The ventrogluteal site is recommended.
Description of the scene: The torso turns on itself to show both sides of the body (left and right), while the ventrogluteal site explanation appears.
Chapter: Injection
Scene: Dorsogluteal site pop-up
Voice over
You may also consider the upper outer quadrant of the dorsogluteal injection site, shown here, if preferred.1-3
Visual text
You may also consider the upper outer quadrant of the dorsogluteal injection site.
Description of the scene: A pop-up appears to explain the dorsogluteal alternative.
Chapter: Injection
Scene: Patient injection position pop-up
Voice over
To receive an injection at the ventrogluteal site, the patient can lie in one of two positions. The first option for the patient is to lie on their side, with the knee bent. The second option is to lie face down.1-6
Regardless of the patient's body position, it is important to make sure that the muscle is relaxed prior to injection.4-6
Visual text
To receive an injection at the ventrogluteal site, the patient can lie in one of two positions: On their side (with the knee bent) Lying prone (face down)
Make sure that the muscle is relaxed prior to injection
Description of the scene: A pop-up appears to explain the options for the patient position during the injection.
Chapter: Injection
Scene: Identify injection site pop-up
Voice over
To locate the injection site,
Visual text
Description of the scene: We now see the patient lying face-down.
Chapter: Injection
Scene: Identify injection site pop-up
Voice over
place the heel of the hand over the patient's Greater trochanter
Visual text
Greater trochanter of femur
Gluteus medius
Iliac crest
Anterior superior iliac spine
Description of the scene: The x-ray view becomes more prominent and call-outs appear to identify landmarks.
Chapter: Injection
Scene: Identify injection site pop-up
Voice over
using the left hand for the patient's right hip or the right hand for the patient's left hip. Position the index finger on or toward the Anterior superior iliac spine. Stretch the middle finger away from the index finger, creating a "V" or triangle.1-5
Visual text
Greater trochanter of femur
Iliac crest
Anterior superior iliac spine
Description of the scene: The muscle disappears to let the bones be visible and permit the hand to enter the scene and start the identification of the injection site. The hand is semi-transparent to allow the bones to be seen under it.
Chapter: Injection
Scene: Identify injection site pop-up
Voice over
The injection site is located within the triangle created by the index finger, the middle finger, and the iliac crest.1-6
Visual text
Greater trochanter of femur
Iliac crest
Anterior superior iliac spine
Description of the scene: The injection area is now selected and an “x” appears to mark the site.
Chapter: Injection
Scene: Clean injection site
Voice over
Clean the injection site with an alcohol wipe. Allow the skin to air dry before continuing.1-2 Once the site has been identified and the patient is in the correct position, you can proceed to administer the injection.
Visual text
Clean the injection site with an alcohol wipe.
Allow the skin to air dry before continuing.
Description of the scene: We now see the right hand entering the scene with an alcohol swab to clean
the injection site.
Chapter: Injection
Scene: Removing needle cap
Voice over
Fold the needle guard away from the needle
Visual text
Description of the scene: Holding the syringe upright, the left hand takes the needle guard and folds it away from the needle.
Chapter: Injection
Scene: Remove needle cap
Voice over
and pull off the needle cap.
Visual text
Description of the scene: The needle cap is removed.
Chapter: Injection
Scene: Remove extra medicine
Voice over
Hold the syringe with the needle pointing up. Press the plunger to the 3-milliliter mark to remove extra medicine and any air bubbles, ensuring you have the correct dose prepared.
Visual text
3 mL
Description of the scene: The camera zooms in to show the correct 3-mL dosage.
Chapter: Injection
Scene: Z-track injection technique
Voice over
Use the Z-track injection technique to minimize medication leakage from the injection site.1-4
Visual text
Skin
Subcutaneous tissue
Muscle
Description of the scene: A cross-section pop-up of the skin will appear to show Z-track mechanism following the procedure in the scene.
Chapter: Injection
Scene: Z-track injection technique
Voice over
Firmly drag the skin covering the injection site, displacing it by about an inch.1 Keep it held in this position for the injection.
Visual text
1 inch (2.5 cm)
Skin
Subcutaneous tissue
Muscle
Description of the scene: The left hand stretches the skin about 1 inch to show Z-track technique.
Chapter: Injection
Scene: Insert needle
Voice over
Insert the needle to its full depth, or deep enough to reach the muscle.1-2
Visual text
Skin
Subcutaneous tissue
Muscle
Description of the scene: X-ray vision appears. While the left hand keeps the skin stretched to maintain the Z-track, the right hand inserts the needle perpendicularly.
Chapter: Injection
Scene: Inject the dose
Voice over
Still holding the stretched skin, slowly press the plunger all the way down and ensure that the syringe is empty.1-3
Visual text
Skin
Subcutaneous tissue
Muscle
Medication
Description of the scene: The thumb slowly presses the plunger down to inject the dose.
Chapter: Injection
Scene: Withdraw needle and release skin
Voice over
Withdraw the needle and release the stretched skin immediately.1-2
Visual text
Skin
Subcutaneous tissue
Muscle
Medication
Description of the scene: The right hand withdraws the needle and the left one releases the skin immediately. Then the cross-section pop-up will disappear.
Chapter: Injection
Scene: Assess injection site pop-up
Voice over
Once the needle has been removed, apply pressure to the injection site using gauze. Do not massage the area. A small adhesive bandage may be used if bleeding occurs.1-3
Visual text
Do not massage the area.
Description of the scene: We now see the right hand entering the scene with gauze, to apply pressure on the injection site.
Chapter: Injection
Scene: Make needle safe
Voice over
Fold the needle guard over the needle. Gently apply pressure using a hard surface to lock the needle guard in place.
Visual text
Description of the scene: The right hand, holding the syringe with needle, applies pressure on the table to make the needle guard fold again and make needle safe.
Chapter: Injection
Scene: Make needle safe
Voice over
The needle guard will make a click when it locks.
Visual text
click
Description of the scene: The right hand, holding the syringe with needle, applies pressure on the table to make the needle guard fold again and make needle safe.
Chapter: Injection
Scene: Dispose safely
Voice over
Dispose of the used needle, syringe, vial, and adapter1-2
Visual text
Description of the scene: The right hand enters the scene with syringe and needle to insert them into the sharps disposal container,
Chapter: Injection
Scene: Dispose safely
Voice over
according to local health and safety laws.1-2
Visual text
Description of the scene:
then also disposes the vial with vial adapter.
Scene: Important Safety Information continued
Voice over
IMPORTANT SAFETY INFORMATION CONTINUED
Visual text
IMPORTANT SAFETY INFORMATION CONTINUED
Description of the scene: ISI will be displayed.
Scene: Important Safety Information continued
Voice over
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 (for example, consistent and correct condom use; knowledge of partner(s) HIV-1 status, including viral suppression status; regular testing for STIs)
Visual text
IMPORTANT SAFETY INFORMATION CONTINUED
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 (for example, consistent and correct condom use; knowledge of partner(s) HIV-1 status, including viral suppression status; regular testing for STIs)
Description of the scene: ISI will be displayed.
Scene: Important Safety Information continued
Voice over
- 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 (for example, 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
Visual text
IMPORTANT SAFETY INFORMATION CONTINUED
WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
- 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 (for example, 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
Description of the scene: ISI will be displayed.
Scene: Important Safety Information continued
Voice over
- 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
Visual text
IMPORTANT SAFETY INFORMATION CONTINUED
WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of 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
Description of the scene: ISI will be displayed.
Scene: Important Safety Information continued
Voice over
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 should be initiated within 2 months of the final injection of APRETUDE
Visual text
IMPORTANT SAFETY INFORMATION CONTINUED
WARNINGS AND PRECAUTIONS
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
Description of the scene: ISI will be displayed.
Scene: Important Safety Information continued
Voice over
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
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IMPORTANT SAFETY INFORMATION CONTINUED
WARNINGS AND PRECAUTIONS
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.
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Voice over
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
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IMPORTANT SAFETY INFORMATION CONTINUED
WARNINGS AND PRECAUTIONS
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
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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
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IMPORTANT SAFETY INFORMATION CONTINUED
WARNINGS AND PRECAUTIONS
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
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Voice over
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
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IMPORTANT SAFETY INFORMATION CONTINUED
WARNINGS AND PRECAUTIONS
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
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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
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IMPORTANT SAFETY INFORMATION CONTINUED
WARNINGS AND PRECAUTIONS
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
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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.
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IMPORTANT SAFETY INFORMATION CONTINUED
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.
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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
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IMPORTANT SAFETY INFORMATION CONTINUED
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
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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 link to full Prescribing Information, including Boxed Warning, for APRETUDE on this website.
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IMPORTANT SAFETY INFORMATION CONTINUED
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 link to full Prescribing Information, including Boxed Warning, for APRETUDE on this website.
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Voice over
Thank you for watching this step-by-step guide for the preparation and injection of APRETUDE. For more information, visit APRETUDEHCP.com
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For additional resources and support, visit APRETUDEHCP.com
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References
– Greenway K. Using the ventrogluteal site for intramuscular injection. Nursing Standard. 2004;18(25):39-42.
– Hunt C.W. Which site is best for an I.M. injection? Nursing. 2008;38(11):62.
– Kara D., Uzelli D., Karaman D. Using ventrogluteal site in intramuscular injections is a priority or an alternative?
International journal of caring science.2015;8(2):507-513.
– Ogston-Tuck S. Intramuscular injection technique: an evidence-based approach. Nursing Standard.2014;29(4):52- 59.
– Pullen R.L. Jr. Administering medication by the Z-track method. Nursing 2005. 2005;35(7):24.
– Rodger M.A., King L. Drawing up and administering intramuscular injections: a review of the literature.
Journal of advanced nursing. 2000;31(3):574-582.
– Wynaden D., Landsborough I., Chapman R., McGowan S., Lapsley J., Finn M. Establishing best practice
guidelines for administration of intra muscular injections in the audit: a systematic review of the literature. Contemporary nurse. 2005;20(2):267-277.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2022 ViiV Healthcare or licensor.
CBTVID210001 February 2022
Produced in USA.
Description of the scene: References will be displayed.
What is a specialty drug?
What is a Specialty Drug? Manuscript
SUPER: The Access and Acquisition Series: WHAT IS A SPECIALTY DRUG?
VISUAL: A park appears onscreen. A leaf enters the frame. The leaf sweeps across the park to
the right.
VO: The HIV landscape has broadened in recent years to include long-acting specialty drugs.
VISUAL: A healthcare professional's (HCP's) office forms. An HCP works at her desk. The HCP
continues working.
VO: Understanding how to integrate these specialty drugs into your practice can help meet the
ever-changing needs of your patients.
VISUAL: The camera’s view pans past the HCP. The HCP's hand is shown scribbling notes on a
piece of paper. The shot moves past a series of plants. The camera zooms out, showing the HCP
in profile as the words "What is a specialty drug?" appear on screen.
VO: Before discussing how to prepare your practice for accessing these drugs in other videos,
let's first discover what defines a specialty drug.
VISUAL: The HCP and their office space slide off to the left; only the copy remains on the
screen. "Rare, chronic, complex diseases” appears on the screen.
VO: Specialty drugs often treat or prevent rare, chronic, and complex diseases.
VISUAL: "A specialty drug may require specific” appears on the screen, with a hand adjacent.
The hand draws a box to the right of the copy. Copy populates beneath the phrase "A specialty
drug may require specific" as the VO reads the words off. The box opens and a vial lifts out of it.
The vial rotates. The copy continues cycling. The box closes and slides off the screen to the
right.
VO: They differ from traditional medication in that they often have specific storage, handling,
and administration requirements.
VISUAL: The vial appears at the center of the screen. The vial is shown.
VO: Many specialty drugs are injectable medications.
VISUAL: The vial is shown. A hand appears from the bottom of the frame, grabbing the vial. The
camera zooms out, showing an HCP grabbing the vial while her patient sits behind her. The
doctor looks at her patient.
VO: While some are self-administered, other specialty injectable drugs must be administered in
a clinical setting by a healthcare professional.
VISUAL: The view slides right past the doctor and patient, beginning to reveal a container with
boxes inside. The container continues moving into the frame. The container slides out of the
frame to the left as the thermometer slides in from the right. The camera zooms in on the
thermometer.
VO: Some specialty injectable drugs may also require precise temperature control throughout
shipment and storage until it is time to administer them to your patient.
VISUAL: The thermometer slides off to the left as the exterior of a retail pharmacy slides in
from the right. The retail pharmacy holds on the screen. A shopper exits the store with a bag.
The camera slides past the pharmacy, revealing an HCP's office.
VO: Because of these key differences, your patients cannot acquire physician-administered
specialty drugs through a retail pharmacy in the same way they can go and pick up a traditional
oral medication.
VISUAL: The camera holds on the HCP office. The camera zooms in on the window of the HCP
office, revealing a doctor and patient having a conversation. The camera slides to the right of
the window. A sign is revealed. The sign comes into focus, revealing iconography for "specialty
pharmacy" and "specialty distributor."
VO: To acquire a specialty injectable drug, your practice will either coordinate with a specialty
pharmacy or a specialty distributor.
VISUAL: The iconography animates. The sign slides off to the left as papers slide in from the
right.
VO: Your patient's insurance coverage often determines how you will acquire the drug.
VISUAL: The paper checklist and hand come into view.
VO: Acquiring specialty injectable drugs is different from traditional oral medication.
VISUAL: The camera moves out, showing an office manager’s hand using the pen on a piece of
paper. The office manager is shown at their desk with a patient. The Access and Acquisition
Series appears on their screen. The camera zooms out and more patients populate the screen.
The office manager sits facing the patients. The office manager addresses the patients. The
camera travels through the patients and the doors, revealing an outdoor setting.
VO: Yet, as the HIV landscape evolves, understanding specialty injectable drug acquisition is
important so you can continue to support your patients' experience with their prescribed HIV
medications. Contact your ViiV Team or visit ViiVinjectables.com to learn more.
SUPER: ViiVinjectables.com
VISUAL: The camera pans to show people at a picnic. The camera pans to reveal the ending
frame with the words: "THE ACCESS AND ACQUISITION SERIES"
[ViiV Logo]
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2022 ViiV Healthcare or licensor.
CBTVID220013 September 2022 Produced in USA.
VO: And for more on acquiring specialty injectable drugs, continue watching the videos in this series.
Specialty injectable drug coverage options
Specialty Drug Coverage Transcript
SUPER: The Access and Acquisition Series: Specialty injectable drug coverage options
VISUAL: The Access and Acquisition Series: Specialty injectable drug coverage options
VISUAL: A vial appears on the screen with the text "Acquire, handle, and administer. " The vial
remains as the copy "Specialty drugs" slides in. The vial and "specialty drugs" remain.
VO: The way you acquire, handle, and administer specialty drugs can differ from oral
medications available at traditional retail pharmacies.
VISUAL: The hand grabs the vial. The hand holds the vial.
VO: How your patients' insurance covers these drugs also differs. Let's learn about the various
ways payers can cover these specialty injectable drugs.
VISUAL: Icons begin flying in. Icons continue flying in. A piece of paper flies off the clipboard.
The paper and the clipboard remain in the frame. The paper and clipboard remain in place
while a hand and the word “Medicaid” appear on the right.
VO: As you may know, commercial insurance, Medicare, and Medicaid structure their benefits
differently.
VISUAL: The clipboard moves to the back of the screen as the other icons fade away. The paper
comes to the front of the frame, while a hand holding a vial comes in from the left.
VO: This can impact how you acquire these drugs. These payers may cover drugs, services, and
treatments through different benefits. Depending on how your patients’ insurance policies are
written,
VISUAL: The paper and the hand remain, while a gloved hand holding a syringe comes in from
the right. As the paper moves, it flips, revealing “Insurance Policy” written across the top.
Hands appear from the edges of the screen. The hands appear on screen. The paper moves off
the screen, while a doctor comes in from the lower right. "Medical benefit" appears on the
screen. "Pharmacy benefit" appears, shifting "medical benefit" to the left. A plus animates
between the medical and pharmacy benefit iconography.
VO: and whether their drugs are self-administered or administered by a healthcare provider,
their specialty injectable drugs may be covered under a medical benefit, meaning their medical
insurance, a pharmacy benefit, or some combination of the two. A benefit verification will
detail your patient’s specific coverage—and remember, no matter what coverage your patient
has,
VISUAL: A check mark appears above the iconography.
VO: these drugs may require a prior authorization before approval.
VISUAL: The hand sweeps across the screen and sweeps away the iconography. The hand
continues sweeping across the screen, revealing the copy "What does it mean for your
practice?" The hand exits the frame; the text remains. The "medical benefit" iconography
appears with a medical building and doctor. The shot pans to reveal a warehouse. "Specialty
Distributor" appears next to the warehouse as the door opens.
VO: So, what does this all mean for your practice working to acquire a specialty injectable drug?
If the payer covers your patient’s drug under their medical benefit, it may be acquired through
a specialty distributor,
VISUAL: A truck drives out of the open door with the words "Buy & Bill" on it. The truck drives
toward the foreground of the shot. A container forms. The doctor, taking notes, appears to the
right of the container.
VO: via a process commonly known as Buy & Bill. This is when your practice purchases and
stores the drug until you administer it to a patient.
VISUAL: The doctor and container sweep off the screen to the left and a hand holding a vial
swings in from the right. The hand lands center screen and places the vial down as the copy
"pharmacy benefit" appears adjacent to it.
VO: If the payer covers your patient’s drug under their pharmacy benefit,
VISUAL: Vials and a mortar and pestle appear on the screen alongside a call center operator as
the words "specialty pharmacy" populate. The "specialty pharmacy" icon begins moving off the
screen to the left as a paper moves into the shot from the right. The paper is revealed to be a
prescription pad with a doctor's handwriting on it. The hand moves off the screen and a vial
slides out from behind the pad.
VO: it may be acquired through a specialty pharmacy. With a specialty pharmacy, a prescription
is written for that patient and the drug is sent to your practice
VISUAL: The paper continues moving around the vial. The vial and prescription paper fall into
the bag. The vial and prescription paper enter the bag. The bag’s top is closed. “White Bagging”
copy appears.
VO: when it is nearing the time of administration. This is also called "white-bagging."
VISUAL: The shot pans out to reveal the doctor holding the bag. The doctor and a medical
building appear on screen. The "medical benefit" and "specialty pharmacy" iconography
appear, with an unidentified link shown between them. The unidentified link is populated with
“assignment of benefits (AOB)” iconography.
VO: If your patient’s insurance covers the drug under the medical benefit, but you and your
practice would prefer working with a specialty pharmacy instead of a specialty distributor, your
practice may have the option to acquire the drug through an Assignment of Benefits, or AOB.
VISUAL: The screen splits, revealing a call center operator and a health care professional (HCP)
on the phone. The split screen collapses, leaving the HCP onscreen. A door appears.
VO: You will determine if working with a specialty pharmacy is possible given your patient's
coverage.
VISUAL: The doctor begins speaking to a patient. The shot continues moving; the doctor and
patient move off the screen to the left. An office manager at her desk begins appearing from
the window.
VO: Please note that this process varies by payer and will not be an option in all cases. As you
can see, specialty injectable drugs are covered differently and may require adopting a new
process in your practice.
VISUAL: A patient is shown sitting across from the office manager. More patients populate
behind the seated patient. Camera pans right to show more patients onscreen. More patients
are revealed as the camera continues to pan right. Camera zooms in through doors, revealing a
park where various activities are taking place.
VO: To help more people access HIV medications, assistance from ViiVConnect is available.
ViiVConnect is committed to helping inform healthcare providers about the options available
for acquiring ViiV medicines so you can continue to support your appropriate patients. Contact
your ViiV Team or visit ViiVinjectables.com to learn more.
SUPER: ViiVinjectables.com
VISUAL: Camera continues to pan to reveal people taking part in various activities, like walking
a dog.
VO: Be sure to watch other videos within the ViiV Access and Acquisition series to learn more
about working with specialty distributors and specialty pharmacies.
VISUAL: The camera pans to reveal the final frame, which says: The Access and Acquisition
Series
[ViiV Logo]
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2022 ViiV Healthcare or licensor.
CBTVID220014 September 2022 Produced in USA
Specialty pharmacy acquisition process
Specialty Pharmacy Manuscript
SUPER: The Access and Acquisition Series: Specialty pharmacy acquisition process
SUPER: Specialty Drugs
VISUAL: A park appears with a person walking through it. A leaf floats off to the right. The leaf moves across the screen. "Specialty Drugs" appears on the screen along with a vial. An HCP sits at their desk with a patient across from them. The text "Specialty Drugs" and vial continue floating above the HCP and patient.
VO: Accessing specialty drugs may be a new experience for your practice, but learning to integrate these drugs can provide additional options for your patients.
SUPER: Differs from traditional oral medication
SUPER: Insurance Coverage
VISUAL: The HCP walks out of their office toward a filing cabinet. The HCP reviews a paper from the filing cabinet. The HCP continues reviewing the paper. “Pharmacy Benefit” appears on the screen.
VO: The way your practice acquires specialty injectable drugs differs from traditional oral medication. This acquisition method is highly dependent on your patient’s insurance coverage. Let’s discuss the details of acquiring a specialty injectable drug when the patient’s insurance covers it under the pharmacy benefit.
SUPER: Pharmacy Benefit
VISUAL: The HCP and text slide down off the screen. The specialty pharmacist appears with a paper that reads “Specialty Pharmacy.”
VO: When covered under a patient's pharmacy benefit, you will acquire the drug through a specialty pharmacy.
SUPER: Specialty Pharmacy A Specialty Pharmacy is not a standard "walk-in" retail pharmacy. They:
- Help coordinate several aspects of patient care
- Deliver medications with special handling, storage, and distribution requirements
VISUAL: The “Specialty Pharmacy” definition begins animating in. The definition and icon remain on the screen.
VO: A specialty pharmacy is not a standard "walk-in" retail pharmacy. They coordinate several aspects of patient care and deliver medications with special handling, storage, and distribution requirements.
SUPER: Benefit Verification The process of verifying the patient’s current medical coverage with the insurance company.
VISUAL: The HCP appears onscreen from the right as the paper flies off. The paper reappears from the top of the screen. “Benefit Verification” animates onto the paper. The HCP rotates as the Benefit Verification definition animates in. The clipboard grows closer as the pages are rifled through. A page of the clipboard reveals a checkbox with the word "Coverage" next to it. The pages of the clipboard return back down.
VO: Once an appropriate patient is identified for the prescription of a specialty injectable, your practice will conduct a benefit verification to confirm your patient’s coverage and detail any prior authorization requirements. Please remember that prior authorizations are rather common for these drugs.
VISUAL: The clipboard and definition move off the screen to the left as a specialty pharmacy storefront slides in from the right. The specialty pharmacy centers on the screen. The camera zooms out as additional specialty pharmacy storefronts appear. The storefronts line up across the screen. Various storefronts are highlighted. The storefronts remain. The shot pans out to reveal the specialty pharmacy character. The highlighted storefronts rise. The man circles the selected storefronts. The man and storefronts remain.
VO: Once the patient’s insurer confirms that the drug is covered under the pharmacy benefit, your practice should inquire about which specialty pharmacies are in-network with the patient’s insurance, and then select the ones your practice would like to work with. Remember that the choice of pharmacy is sometimes dictated by the patient's insurance and the availability of the drug.
SUPER: Prior Authorization
The approval from a health plan that may be required before a patient receives a service or a therapy.
VISUAL: The person slides off the screen to the right, along with all but one specialty pharmacy storefront. An HCP begins appearing from the left. The HCP comes fully into the frame with the specialty pharmacy storefront. A piece of paper from the HCP flies off toward the specialty pharmacy. A paper with a patient photo appears on the left of the storefront. Checkboxes populate below the patient photo. The patient photo disappears as “Prior Authorization” replaces it. The Prior Authorization definition appears along with a checkbox with the word “Approved” below it. The shot pans in on the specialty pharmacy, the definition disappearing behind it. The camera continues panning in on the pharmacy. The shot pans into the pharmacy, revealing a technician on the phone at a desk. An exclamation mark is revealed to emphasize importance.
VO: Your ViiV Team can supply you with a list of specialty pharmacies to work with. Once verified, you can send a prescription to the specialty pharmacy for the drug. They may require additional details, like information regarding the patient's diagnosis. The specialty pharmacy will confirm any outstanding items, including whether a prior authorization is needed, and coordinate a shipment date for the drug so it arrives around the time of the patient’s injection appointment. The specialty pharmacy may contact the patient to obtain permission to bill their insurance company, discuss co-payment or other financial responsibilities, as well as gain their consent to ship the medication.
VISUAL: The shot reveals a staff member in the specialty pharmacy from the right, opening a package. The staff member picks up the phone. The patient is shown receiving the call on the right. The pharmacy tech slides off the screen.
VO: It is very important that the patient answers any communications from the specialty pharmacy to ensure their shipment isn’t delayed. The specialty pharmacy will then ship the drug
SUPER: White Bagging
An arrangement between payers and specialty pharmacies to ship a patient’s medication directly to the physician’s office.
VISUAL: The pharmacy tech and patient move off the screen as a box and the "white bagging" definition slide in from the top. A physician's office facade slides in from the right. The box begins moving into the physician's office. The box enters the office through the doors. A staff member receives the box. The staff member receives the box and verifies the information on it. The staff member holds the box. The camera rotates around the staff member. The staff member places the box in a container. The container moves across the screen to the left as an HCP enters from the right. The container moves off the screen to the left as a calendar appears to the right of the HCP. The HCP and calendar move off the screen to the left.
VO: to your practice, commonly referred to as “white bagging.” Keep in mind that specialty injectable drugs obtained through a specialty pharmacy are for a specific patient and should not be administered to other patients. Once received, be sure to store and handle the drug as required, and finally administer the injection at the patient’s scheduled appointment.
VISUAL: An office is shown, with papers flying into an envelope on top of a desk. The shot pans in on the papers sliding into the envelope. A stamp appears on the desk. A hand presses the stamp onto the envelope. The stamp is removed, revealing the “specialty pharmacy” icon. The envelope remains in the shot. The “specialty pharmacy” icon remains on the screen.
VO: Unlike medications acquired under buy-and-bill, when submitting claims for specialty pharmacy-acquired drugs, you may be able to bill for administration, but not the cost of the drug. Billing for the specialty drug is handled by the specialty pharmacy, so your patient will pay any drug-related co-pays or coinsurance directly to the specialty pharmacy.
VISUAL: The “specialty pharmacy” icon remains on the screen. The "specialty pharmacy" icon remains center screen. The "specialty distributor" icon joins, moving the "specialty pharmacy" icon to the left. The icons begin moving off the screen to the right.
VO: Please note that not all patients’ insurers will cover acquisition through the pharmacy benefit and specialty pharmacy, so it is important to understand the different types of acquisition methods available.
VISUAL: A doctor’s office waiting room is revealed, showing patients sitting in chairs. The seated patients continue moving across the screen to the left. The shot pans in on a seated patient. The shot further tightens on the patient. Leaves begin flying by the patient.
VO: Remember, your ViiV Team is available to support you throughout the entire acquisition process, and ViiVConnect is here for your practice—and most importantly your patients—regarding appropriate access, if you choose to utilize the service.
SUPER: ViiVinjectables.com
SUPER: The Access and Acquisition Series
VISUAL: The shot pans out, revealing people having a picnic outside. The shot continues panning out, revealing a person biking by. "The Access and Acquisition Series" appears onscreen and then swipes away, fading to white.
VO: Contact your ViiV Team or visit ViiVinjectables.com to learn more. For more on accessing and acquiring specialty injectable drugs, review the other videos in this series.
VISUAL:
[ViiV Logo]
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2022 ViiV Healthcare or licensor.
CBTVID220016 October 2022 Produced in USA.
Buy & Bill acquisition process
Video 3: Specialty Distributor with Buy & Bill Transcript
SUPER: The Access and Acquisition Series: Buy & Bill acquisition process
SUPER: Specialty Drugs
VISUAL: A park scene appears, with the wind blowing. A leaf blows into the frame. The leaf blows past
faces of patients and the words Specialty Drugs slide in from the right. The words Specialty Drugs are
now in full view, while the figures continue to slide to the left. The people continue to slide to the left.
The people slide off to the left as a clipboard animates in.
VO: Accessing specialty drugs may be a new experience for your practice, but understanding how to
integrate these specialty drugs into your practice can help provide additional options for your patients.
Obtaining these drugs requires processes that may differ from oral medications.
SUPER: Commercial Insurance, Medicare, Medicaid
SUPER: Medical Benefit
VISUAL: Supers appear onscreen with their corresponding icons. The icons fall off the screen. The HCP
animates in. The Medical Benefit iconography animates in. The Medical Benefit icon and words swoop
up out of the frame.
VO: The method you will use to acquire these drugs is dependent on your patient’s insurance coverage.
In this video, we’ll discuss the specifics of acquiring a specialty injectable drug when your patient’s
insurance covers it under the medical benefit.
SUPER: 3 options
SUPER: Buy & Bill
SUPER: AOB Assignment of Benefits
SUPER: ASA Alternative Site of Administration
VISUAL: Paper swirls around a vial that spins and comes into the frame, and the words 3 options appear.
Buy & Bill and its icon appear in the center of the screen. AOB Assignment of Benefits and its icon
appear in the center of the screen. ASA Alternative Site of Administration and its icon appear in the
center of the screen.
VO: Under the medical benefit, there are three options: the Buy & Bill process with a specialty
distributor, an Assignment of Benefits, or "AOB," or through an "ASA," which stands for Alternative Site
of Administration.
SUPER: Buy & Bill
SUPER: Specialty Distributor
VISUAL: The Buy & Bill icon is at the center of the frame. The Buy & Bill text and icon shift to the left as a
woman on the phone comes in from the right. A cube comes in from the left, shifting focus away from
the woman on the phone. The building increases in detail revealing the specialty distributor building
with the words Specialty Distributor appearing next to the building.
VO: Let’s begin with Buy & Bill. Buy & Bill is the most common acquisition method under the medical
benefit. The process is known as Buy & Bill as your practice will purchase the drug directly from a
specialty distributor and bill the payer for reimbursement.
SUPER: 5 Key Steps
SUPER: 1 - Benefit Verification and Payer Contract Review
2 - Prior Authorization
3 - Purchasing and Stocking the Drug
4 - Administration
5 - Billing and Reimbursement
VISUAL: Copy appears onscreen. A piece of paper is seen with the words Benefit Verification on it. Two
icons appear on either side. A hand checks a box on the piece of paper. The icons all shift clockwise and
an image of vials in a box appears; one is out of the box more than the others. The images shift again—
clockwise—and a vial and syringe take the center of the frame. The image shifts clockwise again while a
hand appears with a bill. The syringe and paper disappear and only the box with vials and a bill are
onscreen. The bill swoops away from the rest of the imagery on the frame.
VO: There are five key steps in the Buy & Bill process: benefit verification and payer contract review,
prior authorization, purchasing and stocking the drug, administration, and finally, billing and
reimbursement.
SUPER: Medical Benefit
VISUAL: A piece of paper swirls onscreen. A hand reaches for the swirling paper and writes on it. Two
healthcare professionals (HCPs) stand looking over the paper. One HCP slides off screen to the right; the
other remains. The HCP receives a clipboard. The Medical Benefit iconography reappears. The Medical
Benefit icon shifts as a manila folder with Prior Authorization appears.
VO: First, your practice will conduct a benefit verification. This step is always needed to confirm your
patient’s coverage and detail any prior authorization requirements. For drugs covered under the medical
benefit, a prior authorization is usually needed.
VISUAL: The manila folder shifts to the left and paperwork comes in from the right. The paperwork goes
into the folder. A doctor writing a letter appears from the right. The doctor fades away and the letter
goes into the manila envelope. Charts appear from the right. The charts go into the manila folder. A
paper with Test Results appears from the right. The test results go into the manila folder. A paper and a
vial appear from the right. The paper and vial go into the manila folder. A checklist and hand appear
from the right. A stamp appears and the paper swoops up.
VO: To obtain a prior authorization, some payers require the completion of a specific form, and others
require documentation such as a letter of medical necessity, chart notes, test results, or the Prescribing
Information for the drug. Your patient’s payer should supply you with a list of requirements to properly
complete their prior authorization process.
VISUAL: The prior authorization folder returns to the center of the frame and the stamp presses on the
folder leaving an approval check. The stamp increases in size. The stamp moves out of the frame. A bill
comes out of the folder. Another bill comes out of the folder and sits below the first bill. The folder now
says Payer Contract. The papers return to the folder and fall on the HCP's desk. The shot zooms in on the
folder as the papers file into it. The folder swirls on the screen.
VO: While verifying your patient’s benefits, your practice should confirm contract details with the payer
to understand reimbursement for the administration and product costs for the drug. These contracts
should be in place for all the payers your practice works with.
SUPER: Specialty Distributor
VISUAL: A hand holding a checklist appears. Another hand with a pen appears. A large box animates
above the paper. The hand checks off boxes on the paper. The paper floats out of the hands and swirls
upward. The Specialty Distributor icon appears. A truck pulls out of the Specialty Distributor warehouse.
The truck drives away from the Specialty Distributor warehouse. The box opens and a vial rises out.
VO: Once the payer contract is confirmed and prior authorization is approved, your practice will contact
a specialty distributor to acquire the drug. Your ViiV team can supply you with a list of specialty
distributors to work with.
VISUAL: The vial rotates above the box. The vial returns and the box closes. The box appears in its
storage container. The HCP is shown to the right of the container.
VO: Your practice will then place an order for the specialty injectable drug to stock on site so it is
available when needed.
SUPER: What are the return or payment terms with the specialty distributor?
When will the product be shipped?
Is the patient scheduled for administration after the shipment arrives?
Does the product require special handling or storage?
VISUAL: The HCP reviews the boxes in the container. Papers begin swirling around the HCP. Papers
begin swirling around the HCP. A paper sits on the left of the screen with a list of questions beginning to
appear on the right. The paper is replaced with a calendar and a hand truck with a box. Another
question appears to the right. The hand truck disappears and a person in a chair appears behind the
calendar. Another question appears on the right. A thermometer, vial, and box appear on the left.
Another question appears on the right.
VO: There are a few key questions to keep in mind as you’re working with the specialty distributor on
your order. What are the return or payment terms with the specialty distributor? When will the product
be shipped? Is the patient scheduled for administration after the shipment arrives? Does the product
require special handling or storage?
VISUAL: A calendar appears. A syringe lands on a day on the calendar. The calendar page turns to reveal
a patient sitting across from an HCP. The patient and HCP slide offscreen to the right and an envelope
and bill appear on the left. The bill is now in the center of the screen. The bill starts to go into the
envelope.
VO: Once your practice has ordered or stocked the drug, you can schedule an administration
appointment for your patient. After administration, your practice will bill the patient's insurance to get
reimbursed for the administration and product costs for the specialty injectable drug.
SUPER: Product
SUPER: Administration
VISUAL: The bill folds into the envelope. The envelope seals and a hand remains in the frame. A
magnifying glass looks at the barcode on the bottom right corner of the envelope. A billing code is
revealed.
VO: Your practice is responsible for collecting any co-pays or coinsurance for the product, office visit, or
additional administration fees from the patient. To facilitate accurate reimbursement, ensure your
billing codes are correct.
VISUAL: A woman appears on the phone. Between the woman on the phone and the bill, a man in a call
center appears in the center of the screen, dividing the frame into three parts. The bill on the left side of
the frame swoops to the right of the screen over the two people on the phone. An office setting
appears. The envelope continues off the screen and a check mark appears to the right of the man in the
office. The envelope flies into another office with another person working on a computer. The envelope
swoops past the man on the computer and another check mark appears on screen.
VO: You can contact your ViiV team to support you with billing information before submission to the
payer. Some provider offices even assign specific individuals within the practice to own different steps of
this process. Working as a team can help with accountability and efficiency for the Buy & Bill process.
SUPER: Buy & Bill
VISUAL: The man in an office and man in a call center appear in the background as a doctor appears in
the center of the screen with a barcode and the words Buy & Bill in the top right. The doctor moves to
the left of the screen while a cell phone with the word ViiV moves to the center. The frame transitions
with the flip of a page from the top right. A container appears next to the barcode. A box is removed
from the container and a vial comes out of the box. The box returns to the container. The container
slides off the screen to the left and the barcode moves into a person's hand to the right.
VO: If it is your practice’s first time doing the Buy & Bill process, we recommend connecting with a
member of your ViiV Team before beginning to help prepare your practice. The Buy & Bill process allows
your practice to have the specialty injectable available on site and ready for appropriate patients.
SUPER: You may have other options
SUPER: Medical Benefit
SUPER: Assignment of Benefits (AOB)
SUPER: Assignment of Benefits (AOB), Specialty Pharmacy, Specialty Distributor, Specialty Drugs
VISUAL: The hand gestures to the right and the hand and barcode move off screen. The camera zooms
out from the hand revealing the Medical Benefit icon. The camera pans around the HCP. The Assignment
of Benefits icon appears. The specialty pharmacy and specialty drug icons begin forming. The screen fills
with the flow chart of assignment of benefits to specialty pharmacy to specialty drug. The camera
continues to pan, revealing the flow chart of assignment of benefits to a specialty pharmacy to specialty
drug. Specialty distributor is crossed out in the background.
VO: Another method that may be covered by your patient's insurance under the medical benefit is
Assignment of Benefits, or AOB. An Assignment of Benefits is a process under the medical benefit that
may allow you to access a drug through a specialty pharmacy instead of a distributor.
VISUAL: The Specialty Distributor icon fades away. The Alternative Site of Administration icon begins to
come into the frame and the other icons fade away to the left.
VO: Please note that this process varies by payer and will not be an option if your patient's plan does not
allow for assignment of benefits for a specialty pharmacy under a medical benefit.
SUPER: Alternative Site of Administration (ASA)
VISUAL: The Alternative Site of Administration icon takes center frame. The camera zooms out,
revealing an HCP holding a screen with a map on it. The camera zooms out further to reveal an HCP
showing the screen to a patient. The setting changes and the patient is now at the alternative site of
administration shaking a doctor’s hand. A paper swooshes across the screen. The paper comes to the
center of the frame with the words Benefits Verification across it. The page peels back, revealing a
doctor with a box, a thermometer, and a vial next to them. The doctor turns and moves to the left as a
bill is being inserted into an envelope on the right. The screen is split between the doctor with the bill
and an HCP with a clipboard.
VO: An additional option is utilizing an alternative site of administration, or ASA. This is a facility,
oftentimes an infusion center, that can conduct a patient’s benefit verifications, acquire and administer
the specialty injectable drug, and handle the billing and reimbursement instead of your practice.
VISUAL: The split screen transitions to focus on the HCP in their office. The camera pans around the HCP
revealing their laptop screen. The HCP sits in front of her laptop. Another HCP appears. The laptop
screen displays the ViiV Healthcare logo. The three people and laptop slide to the left and a doctor's
office slides in from the right with patients sitting in a waiting room. The patients sitting in the waiting
room continue to slide to the left.
VO: In summary, learning to navigate the medical benefit is vital to bringing specialty injectable drugs to
your patients. Your ViiV Team is available to support you throughout the entire acquisition process, and
ViiVConnect is available to help further support you and your staff through working with payers if you
choose to utilize the service.
SUPER: ViiVinjectables.com
SUPER: The Access and Acquisition Series
SUPER:
[ViiV Logo]
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2022 ViiV Healthcare or licensor.
CBTVID220015 October 2022 Produced in USA.
VISUAL: The camera zooms in on a person in front of a computer. The woman in front of a computer
comes into the frame. The camera pans around the woman at her desk. The camera continues to pan
around the woman at her desk. The woman is shown at their desk with a patient. Additional individuals
populate around the seated patient. The camera shows a group of patients. A leaf blows past the patient
and the background shifts to an outdoor space revealing a patient walking with his partner and dog. The
camera pans to reveal the ending frame with the words The Access and Acquisition Series.
VO: For more on accessing and acquiring specialty injectable drugs, review the other videos in this
series. And, if you have questions about acquiring specialty injectable drugs covered under the medical
benefit, or how ViiVConnect can support you and your patients in this process, please reach out to your ViiV Team or visit ViiVinjectables.com to learn more
