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EndeavorRx

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Monthly starting September, 2021

FAQ

Look below for more info about some of our most common topics. Don’t see what you need?

You can always contact us directly with any questions you still have.

Clinical/Cost

How is EndeavorRx® different from a non-prescription video game?

EndeavorRx treatment is a proprietary and patented prescription digital therapeutic. The game adapts in real-time as well as between treatment sessions, continuously challenging and encouraging the patient to improve their performance—individualizing each patient’s experience.

What is Selective Stimulus Management Engine (SSME™)?

SSME is a proprietary & patented technology that presents specific sensory stimuli and simultaneous motor challenges designed to target key neural systems in the brain related to attentional control.

SSME technology implements specific closed-loop algorithms that adapt real-time and between treatment sessions to automatically adjust the difficulty level for a personalized treatment experience. The algorithms enable second by second monitoring of patient progress, and continuously challenge each patient to an optimized level, encouraging them to improve their performance.

Why is EndeavorRx only available by prescription?

EndeavorRx is a digital prescription treatment that is delivered through an action video game that was shown to improve attention function in children with ADHD. (Please see final page for full ISI and Prescribing Information.) EndeavorRx is different from other action video games that a child might play. The treatment programmed into the game was designed to challenge a child!s attentional control during gameplay, requiring focus and flexibility to manage multiple tasks at the same time. EndeavorRx has been evaluated in over 600 children with ADHD across 5 clinical studies:

  • A study of 348 children with ADHD (not receiving ADHD medication), where EndeavorRx was used for a 4-week treatment period and showed improvements in attention function (as measured by computer-based testing) and attention-related ADHD symptoms and impairments.
  • A study of 206 children with ADHD (on stimulant medication or not receiving any ADHD medication), where EndeavorRx was used for a 4-week period, followed by a treatment pause of one month and a subsequent second 4-week treatment period. Improvements in attention-related ADHD symptoms and impairments were similar in magnitude to those seen in other studies and further improved with the second treatment period in children on or off ADHD medication.
  • Three separate studies of 40, 20 and 19 children with ADHD, where EndeavorRx was used for a 4-week treatment period and showed improvements in attention measures and attention-related ADHD symptoms.

Do you have any long-term/durability data?

At this time, Akili only has the 12-week, open label, STARS Adjunct study in which participants played EndeavorRx for 4 weeks, followed by a treatment pause for 4 weeks, followed by an additional 4 weeks of EndeavorRx therapy. (Please refer to graphs of STARS Adjunct study for elaboration.)

What is the Test of Variables of Attention (TOVA®) and why did you use this measure?

The TOVA is an objective and accurate computer based test to measure the key components of attention and inhibitory control. The visual TOVA aids in the assessment of, and evaluation of treatment for, attention deficits, including ADHD. Since EndeavorRx is the first FDA-Cleared digital treatment for children with primarily inattentive-type or combined-type ADHD, it was important to have an objective measure of attention in addition to subjective measures.

Do you have any data that supports refilling Rx past the initial 96 days?

At this time, Akili has no clinical trial data that extends beyond the initial 96 day treatment period.

Does EndeavorRx have dosing strengths?

EndeavorRx does not have different ‘strengths’ that are prescribed for different patients like a pharmaceutical. The game’s difficulty will adapt according to the patient’s progress in completing missions.

How long does it take for EndeavorRx to begin to work?

EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by a child’s health care provider.

What is the cost per day for EndeavorRx?

EndeavorRx costs less than $100/month for a 3-month prescription. EndeavorRx may be covered by your health insurance and Akili is actively working to improve coverage. If your health insurance doesn’t cover EndeavorRx, a discount will be automatically applied to all prescriptions through our online pharmacy partner, reducing the regular price of $450 to less than $300 for a 3-month prescription. A Patient Assistance Program is available for those that qualify for free access to treatment.

How long does a prescription last?

EndeavorRx is available in 3-month prescriptions. It is recommended EndeavorRx should be used for approximately 25 minutes per day, 5 days per week, for 4 weeks, or as recommended by your child’s healthcare professional.

What are the side effects?

There were no serious adverse events. Of 538 participants using EndeavorRx (AKL-T01), 50 participants (9.3%) experienced treatment-related adverse events (probable, likely), and three participants experienced treatment-related adverse events with the digital control, in studies where a control was used. EndeavorRx associated adverse events included frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). All adverse events were generally transient. Only 3 events led to device discontinuation, and no subject reported lasting or irreversible effects after discontinuation.

What ages can be prescribed EndeavorRx?

EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.

What is the EndeavorRx® treatment and what is it used for?

EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, Test of Variables of Attention (TOVA®), of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. EndeavorRx is only available through a prescription, and is not a substitute for your child’s ADHD medication. You should consult with your child”’s healthcare professional and review the Instructions for Use before using the EndeavorRx treatment.

Has the EndeavorRx treatment been studied in clinical trials?

EndeavorRx has been evaluated in over 600 children with ADHD across 5 clinical studies. EndeavorRx has been shown to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD who have a demonstrated attention issue.

What are the results of clinical trials with EndeavorRx?

The EndeavorRx treatment has been evaluated in over 600 children with ADHD across 5 clinical studies:

  • A study of 348 children with ADHD (not receiving ADHD medication), where EndeavorRx was used for a 4-week treatment period, showed improvements in attention function (as measured by computer-based testing) and attention-related ADHD symptoms and impairments.
  • A study of 206 children with ADHD (on stimulant medication or not receiving any ADHD medication), where EndeavorRx was used for a 4-week period, followed by a treatment pause of one month and a subsequent second 4-week treatment period. Improvements in attention-related ADHD symptoms and impairments were similar in magnitude to those seen in other studies and further improved with the second treatment period in children on or off ADHD medication.
  • Three separate studies of 40, 20 and 19 children with ADHD, where the EndeavorRx treatment was used for a 4-week treatment period and showed improvements in attention measures and attention-related ADHD symptoms.

How should the EndeavorRx treatment be used?

EndeavorRx is available in 3-month treatment periods. It is recommended EndeavorRx should be used for approximately 25 minutes per day, 5 days per week, initially for at least 4 weeks. Unlike an action video game, there is no way to #win” EndeavorRx. The algorithm continues to challenge the child at a specific and consistent level of difficulty throughout the game. In addition, the multitasking rules get more complex as the game progresses through the four worlds. As long as the child is playing consistently and trying his/her best, the child is engaging with the treatment as intended.

Why does EndeavorRx need to be obtained through a prescription?

As an FDA-cleared medical device, EndeavorRx is designed for the treatment of a medical disorder and should be used under the supervision of a medical professional who can manage a broader treatment program and can oversee adherence and compliance with the treatment program.

Are there any side effects of EndeavorRx?

There were no serious adverse events. Of 538 participants using EndeavorRx (AKL-T01), 50 participants (9.3%) experienced treatment-related adverse events (probable, likely), and three participants experienced treatment-related adverse events with the digital control, in studies where a control was used. AKL-T01 associated adverse events included frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). All adverse events were generally transient. Only 3 events led to device discontinuation, and no subject reported lasting or irreversible effects after discontinuation.

How much does the EndeavorRx treatment cost?

EndeavorRx may be covered by health insurance and Akili is actively working to improve coverage. If health insurance doesn’t cover EndeavorRx, a discount will be automatically applied to all prescriptions through our online pharmacy partner, reducing the regular price of $450 to less than $300 for a 3-month prescription. A Patient Assistance Program is available for those that qualify for free access to treatment.

After EndeavorRx has been purchased, can it be used for more than one child?

An EndeavorRx activation code can only be used by the individual for whom it was prescribed. If multiple children in a household have been prescribed EndeavorRx, they will receive an individual activation code for each child and individual payment request emails for each activation code. It’s important to remember that the treatment’s technology adapts real-time and between treatment sessions to the individual child’s level, designed to continuously challenge and encourage them to improve their performance.

How does EndeavorRx work?

Evaluated in over 600 children with ADHD across 5 clinical studies¹, the EndeavorRx treatment uses sensory stimuli and simultaneous motor challenges designed to target areas of the brain that play a key role in attention function. ¹STARS-ADHD Pivotal Study: Kollins et al, Lancet Digital Health, 2020. STARS-Adjunctive Study: Data on File, Akili, 2020. (manuscript in progress). Proof of concept study: Davis et al, PLOS One, 2018. Pilot studies: Anguera et al., PLOS One, 2017. Yerys et al., J Autism Dev Disord, 2019G When using EndeavorRx, the goal is for the child to successfully navigate their character through a course while collecting targets and avoiding bumping into obstacles. These actions require focus and flexibility to manage multiple tasks at the same time.

Why does my child need to play 5 days per week, 25 minutes per day? Is it possible to play less or more?

EndeavorRx is recommended to be used for approximately 25 minutes per day, 5 days per week, over initially at least 4 consecutive weeks, or as recommended by your child’s healthcare professional. Your child’s healthcare professional may follow these recommendations or may make a different treatment decision suitable for your child. Always follow your child’s healthcare professionals treatment recommendations. If your child has experienced any side effects from using the EndeavorRx treatment, or if you have any questions about the benefit of continuing with the EndeavorRx treatment, please contact your child’s healthcare professional to discuss your child’s experience and determine if additional treatment cycles are warranted.

Can the patient pause during sessions?

Yes, each daily treatment can be paused at any time by tapping the upper-left corner of the screen. Note that there are built-in rest periods between sessions (every four or five minutes on average). EndeavorRx will display reminders if treatment days are missed, as well as notification when the treatment is soon to expire.

Does the caregiver need to sit with the child while using the EndeavorRx treatment?

That is a decision entirely up to the parent, but it is not necessary. However, Akili does recommend that the caregiver designates a suitable place free from distractions for the child to play, as well as a time of day. It is fine to experiment with the best time to engage with the EndeavorRx treatment. It is recommended not to play right before bedtime to avoid risk of potential reduction in sleep quality.

Technical

How can I download and access the demo?

The EndeavorRx application can be downloaded on the App Store® and on Google Play™. Once the app is downloaded, please look for the “Play Demo,” button in the top right-hand corner of the main screen.

How does a patient get access to EndeavorRx?

There are two simple ways for a patient to get a prescription for EndeavorRx. The caregiver can either schedule a virtual appointment with an independent telehealth partner on endeavorrx.com or schedule an appointment with their child’s current doctor. Once the doctor writes a prescription for EndeavorRx, Phil pharmacy will provide the patient with an access code to activate EndeavorRx on their device.

How can I get access to a live demonstration?

A free EndeavorRx demo can be downloaded from the App Store and on Google Play. This demo is for look and feel only, and does not contain any therapeutic benefit. This demo should not be used as a substitute for the actual EndeavorRx treatment.

What are the device requirements for EndeavorRx?

iOS Device Minimum Specifications are:

  • iOS version 13.0
  • iPadOS version: 13.1
  • Storage 16 GB
  • Memory 2 GB
  • Network Infrastructure: WiFi
  • Example Devices: iPad Mini 4, iPhone 7, and later models

Android Device Minimum Specifications are:

  • Android OS version: 9.0
  • Storage: 64 GB
  • Memory 4 GB
  • Network Infrastructure: WiFi
  • Example Devices: Samsung Galaxy S8™ or similar, and later models

Is this available on any EMR platform?

EndeavorRx is available on most EMR platforms. If you are unable to access EndeavorRx on your EMR platform, please reach out to phil.us/contact and Akili will work with the system to have it added.

Does data remain safe and private while the patient uses the EndeavorRx treatment?

Akili understands how important data privacy is to you. Akili uses industry standard privacy and security measures to protect the patient’s health data, in accordance with the terms of Akili’s Privacy Notice for the EndeavorRx treatment located here.

Is an internet connection required to play?

Internet or network connectivity is not required to use the EndeavorRx treatment, but it is required to download, register, activate, and start treatment. Once the patient begins treatment, he or she can use the EndeavorRx treatment online or offline. Akili recommends the patient play the EndeavorRx treatment while connected to WiFi so that the app can stay in sync with important updates.

If the patient is having problems activating the code, what should they do?

They can reach out with any technical difficulties by calling 855.977.0975 (Press 3) or visit www.phil.us/contact.

Pharmacy/Process

How do I write a prescription for EndeavorRx?

Prescriptions can be sent to PhilRx (Phil pharmacy, Inc) through your EHR found as PhilRx (Columbus, Ohio). If you cannot send prescriptions to Phil through EHR, you can call them directly at 855.977.0975 (Press 1) to provide the prescription over the phone or to obtain a form to fax to 888.975.0603. To minimize callbacks, please include:

  • Diagnosis / Primary ICD-10 code F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type; F90.2 Attention-deficit hyperactivity disorder, combined type; F90.8 Attention-deficit hyperactivity disorder, other type; F90.9 Attention-deficit hyperactivity disorder, unspecified type
  • Instructions to play EndeavorRx per the Instructions For Use (IFU)* or other frequency of time per day, days per week, number of weeks, and length of break (if any)
  • Number of refills

*IFU Recommendation: EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by a child’s health care provider.

Once EndeavorRx treatment has been prescribed for your patient, the caregiver will receive a text message from Phil pharmacy with instructions on next steps. If required prescribers should submit prior authorizations to CoverMyMeds®.

Phil pharmacy will initiate the prior authorization and send a key. Once the caregiver has processed payment, they will receive a pharmacy-issued activation code via text and email. Caregivers can download the EndeavorRx app from the App Store® or on Google Play™ and apply the activation code to begin treatment.

Please note: EndeavorRx is only available to patients through a prescription and should not be used as a stand-alone therapy or substitute for your patient’s medication.

  • EndeavorRx is available with iPhone® or iPad® iOS (Apple®) devices running iOS 13.0 and newer and on Android devices version 9.0 and newer
  • EndeavorRx may not be appropriate for patients with photosensitive epilepsy, color blindness, or physical limitations that restrict use of a mobile device; parents should consult with their child’s healthcare provider

You can find these prescribing instructions on our Healthcare Provider Website: hcpendeavorrx.com

What is the prescription journey for the treatment?

Prescriptions can be sent to Phil pharmacy through your EHR found as PhilRx (Columbus, Ohio). If you cannot send prescriptions to Phil through EHR, you can call them directly at 855.977.0975 (Press 1) to provide the prescription over the phone or to obtain a form to fax to 888.975.0603.

To minimize callbacks, please include:

  • Diagnosis / Primary ICD-10 code (F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type; F90.2 Attention-deficit hyperactivity disorder, combined type; F90.8 Attention-deficit hyperactivity disorder, other type; F90.9 Attention-deficit hyperactivity disorder, unspecified type)
  • Instructions to play EndeavorRx per the Instructions For Use (IFU)* or other frequency of time per day, days per week, number of weeks, and length of break (if any)
  • Number of refills

*IFU Recommendation: 25 mins/day, 5 days/week for 4 weeks with a break of up to 4 weeks, followed by another 4 weeks of 25 mins/day, 5 days/week.

Is the prescription for three months or for so many uses?

One EndeavorRx prescription will enable the patient to receive three months of access to the EndeavorRx treatment.

Game/Other

The EndeavorRx treatment is delivered via a digital screen. Should I be fearful of screen time risks?

Akili Interactive understands that screen time can be of concern to parents and physicians. Akili Interactive is aligned with the American Academy of Pediatrics in its policy on media use in school-age children and adolescents and the recommendation to set consistent limits on hours per day on media. The EndeavorRx treatment is limited to approximately 25 minutes of screen exposure per treatment day. This is the time it takes the child to finish the daily treatment’s five missions. The EndeavorRx treatment will automatically lock after each daily treatment session is completed. Be sure to let the child know that it is OK to occasionally take a break from treatment for a few minutes in order to avoid excess eye strain or fatigue.

Will the child enjoy playing EndeavorRx?

By design, EndeavorRx can be challenging, repetitive, and even feel discouraging to a child. EndeavorRx is different from other action video games that a child might play. The treatment programmed into the gameplay experience was designed to challenge a child’s attentional control during gameplay, requiring focus and flexibility to manage tasks at the same time.

Is there a way to test out the treatment before prescribing it?

Please visit the EndeavorRx website to learn more. A free EndeavorRx demo can be downloaded from the App Store®> or on Google Play™. This demo is for look and feel only, and does not contain any therapeutic benefit. This demo should not be used as a substitute for the actual EndeavorRx treatment.

Can the patient test out the treatment before making the purchase?

There is a brief playable demo for the patient to experience in order to get the look and feel of EndeavorRx. To access the demo, the patient should download the EndeavorRx app in the App Store® or on Google Play™ (or update the app if they have the previous version on your mobile device). Once they open the app, just click “Play Demo” to get started. Remember: this demo is for look and feel only, and does not contain any therapeutic benefit. This demo should not be used as a substitute for the actual EndeavorRx treatment.

EndeavorRx:

Indications, Safety and Cautions

Indications:
EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, Test of Variables of Attention (TOVA®), of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.

Safety:
Of 538 participants using EndeavorRx, 50 participants (9.3%) experienced treatment-related adverse events (probable, likely), and three participants experienced treatment-related adverse events with the digital control, in studies where a control was used. EndeavorRx associated adverse events included frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). There were no serious adverse events. All adverse events were generally transient. Only 3 events led to device discontinuation, and no subject reported lasting or irreversible effects after discontinuation.

Cautions:
Rx only: Federal law restricts this device to sale by or on the order of a physician. EndeavorRx should only be used by the patient for whom the prescription was written. For medical questions, please contact your child’s healthcare provider. If you are experiencing a medical emergency, please dial 911. EndeavorRx is not intended to be used as a stand-alone therapeutic and is not a substitution for your child’s medication.

If your child experiences frustration, emotional reaction, dizziness, nausea, headache, eye-strain, or joint pain while playing EndeavorRx pause the treatment. If the problem persists contact your child’s healthcare provider. If your child experiences a seizure stop the treatment and contact your child’s healthcare provider.

EndeavorRx may not be appropriate for patients with photo-sensitive epilepsy, color blindness, or physical limitations that restrict use of a mobile device; parents should consult with their child’s healthcare provider.

Please follow all of your mobile device manufacturer’s instructions for the safe operation of your mobile device. For example, this may include appropriate volume settings, proper battery charging, not operating the device if damaged, and proper device disposal. Contact your mobile device manufacturer for any questions or concerns that pertain to your device.