CurrentAmbetter NevadaPolicy CP.PMN.312

Centanafadine (Simtriyo) Coverage Criteria

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Prior authorization and medical-necessity coverage for Simtriyo (centanafadine) in Ambetter commercial, HIM/ICHRA, and Medicaid lines of business, primarily for ADHD in adults and pediatric members meeting age, weight, treatment-trial, dosing, and documentation requirements.

Policy Summary

PayerAmbetter Nevada

PolicyCentanafadine (Simtriyo) Coverage Criteria

Policy CodePolicy CP.PMN.312

Change TypeNo material change

Effective DateDecember 1, 2026

Last ReviewNov 1, 20265d

Next Review DateNot specified

Key ActionSubmit documentation confirming ADHD, age of at least 6 years, weight of at least 20 kg, required treatment trials or a qualifying exception, and compliance with dose and capsule limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ADHDFDA-approved covered indication

6+ yearsMinimum age

20 kgMinimum weight

12 monthsApproval duration

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CurrentAmbetter NevadaPolicy CP.PMN.312

Centanafadine (Simtriyo) Coverage Criteria

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Policy Summary

PayerAmbetter Nevada

PolicyCentanafadine (Simtriyo) Coverage Criteria

Policy CodePolicy CP.PMN.312

Change TypeNo material change

Effective DateDecember 1, 2026

Last ReviewNov 1, 20265d

Next Review DateNot specified

Key ActionSubmit documentation confirming ADHD, age of at least 6 years, weight of at least 20 kg, required treatment trials or a qualifying exception, and compliance with dose and capsule limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ADHDFDA-approved covered indication

6+ yearsMinimum age

20 kgMinimum weight

12 monthsApproval duration

Coverage Criteria

Initial therapy for ADHD

Covered when all of the following are met for initial ADHD therapy:

Initial ADHD criteria

Diagnosis and eligibility
- Member has a diagnosis of ADHD; is at least 6 years old; current weight is documented in kilograms; and weight is at least 20 kg.Age ≥ 6 years; weight ≥ 20 kg
ONE of the following
- Atomoxetine has been tried and failed at up to maximally indicated doses, unless it was contraindicated or caused clinically significant adverse effects.Up to maximally indicated doses
- Documentation supports inability to swallow capsules.
Both stimulant classes required
- An amphetamine-based stimulant has been tried and failed at up to maximally indicated doses, unless clinically significant adverse effects occurred with any amphetamine product or all amphetamine products are contraindicated.Up to maximally indicated doses
- A methylphenidate-based stimulant has been tried and failed at up to maximally indicated doses, unless clinically significant adverse effects occurred with any methylphenidate product or all methylphenidate products are contraindicated.Up to maximally indicated doses
ONE applicable dose-limit pathway
- Pediatric members age 6 to 12 years
  - ONE weight-based maximum
    Weight is 20 kg to less than 35 kg and the dose does not exceed 140 mg per day.140 mg/day
    Weight is 35 kg to 50 kg and the dose does not exceed 210 mg per day.210 mg/day
    Weight is greater than 50 kg and the dose does not exceed 280 mg per day.280 mg/day
  - The dose does not exceed 1 capsule per day.

Continuation therapy for ADHD

Covered when all continuation requirements are met:

Continuation ADHD criteria

ONE existing-therapy or continuity-of-care pathway
- ONE existing-therapy condition
  - Member is currently receiving the medication through the Centene benefit.
  - Member previously met the initial approval criteria.
- Member is currently receiving the medication and is enrolled in a state and product subject to continuity-of-care regulations.
  Refer to the applicable state-specific continuity-of-care addendum.
Member is responding positively to therapy.

Non-FDA-approved indications not addressed by this policy are not authorized unless sufficient documentation of efficacy and safety supports review under the applicable off-label use policy or evidence-of-coverage documents. The applicable off-label policies are CP.CPA.09 for commercial members, HIM.PA.154 for Health Insurance Marketplace/ICHRA members, and CP.PMN.53 for Medicaid members.

Provider Actions and Authorization Requirements

Prior Authorization

Initial Authorization Requirements

For initial authorization, submit documentation showing that the member has ADHD, is at least 6 years old, has a documented current weight in kilograms of at least 20 kg, and meets the required treatment-history and dosing criteria.

Diagnosis: Attention Deficit Hyperactivity Disorder.
Age: ≥ 6 years.
Weight: Current weight documented in kg and ≥ 20 kg.
Dose: Requested dose and capsule quantity must remain within the age- and weight-based limits below.

Prior Authorization

Continuation Authorization

For continuation authorization, document that the member is currently receiving centanafadine through the Centene benefit or previously met initial approval criteria, or is receiving the medication under applicable state and product continuity-of-care regulations. The member must also be responding positively to therapy.

Continuation may be supported by current Centene benefit coverage or prior satisfaction of initial criteria.

Drug and Policy Background

Centanafadine (Simtriyo) is a norepinephrine-dopamine-serotonin reuptake inhibitor and central nervous system stimulant. Its FDA-approved use is the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older who weigh at least 20 kg. Use is not recommended in children younger than 6 years or weighing less than 20 kg because of weight-loss risk or insufficient data.

Definitions

ADHDAttention-deficit and hyperactivity disorder

Definitions

FDAFood and Drug Administration

ADHD Initial Therapy

ADHD Continuation Therapy

ADHD continuation

Continuation approval requires all of the following:

ONE existing-therapy or continuity-of-care pathway
- Member is currently receiving medication through the Centene benefit or previously met the initial approval criteria.
- Member is currently receiving medication and is enrolled in a state and product subject to continuity-of-care regulations.
  Refer to the applicable state-specific continuity-of-care addendum.
Member is responding positively to therapy.
ONE applicable dose-increase limit
- Pediatric members age 6 to 12 years

Required Treatment Trials

Step	Therapy or pathway	Requirement
1	Atomoxetine or capsule-swallowing exception	Fail atomoxetine at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; or document inability to swallow capsules.
2	Amphetamine-based stimulant	Fail an amphetamine-based stimulant at up to maximally indicated doses, unless clinically significant adverse effects are experienced to any amphetamine product or all are contraindicated.
3	Methylphenidate-based stimulant	Fail a methylphenidate-based stimulant at up to maximally indicated doses, unless clinically significant adverse effects are experienced to any methylphenidate product or all are contraindicated.

Dose and Quantity Limits

Simtriyo (centanafadine) Quantity Limits

Patients aged 6 to 12 years, weight 20 kg to less than 35 kgMaximum 140 mg per day; 1 capsule per day

Patients aged 6 to 12 years, weight 35 kg to 50 kgMaximum 210 mg per day; 1 capsule per day

Patients aged 6 to 12 years, weight greater than 50 kgMaximum 280 mg per day; 1 capsule per day

Adults and patients aged 13 to 17 yearsMaximum 280 mg per day; 1 capsule per day

Policy Summary

PayerAmbetter Nevada

PolicyCentanafadine (Simtriyo) Coverage Criteria

Policy CodePolicy CP.PMN.312

Change TypeNo material change

Effective DateDecember 1, 2026

Last ReviewNov 1, 20265d

Next Review DateNot specified

Key ActionSubmit documentation confirming ADHD, age of at least 6 years, weight of at least 20 kg, required treatment trials or a qualifying exception, and compliance with dose and capsule limits.

SourceLink

On This Page

Adults and pediatric members aged 13 to 17 years

The dose does not exceed 280 mg per day.280 mg/day
The dose does not exceed 1 capsule per day.1 capsule/day

ONE applicable dose-increase pathway

Pediatric members age 6 to 12 years
- ONE weight-based maximum
  - Weight is 20 kg to less than 35 kg and the new dose does not exceed 140 mg per day.140 mg/day
  - Weight is 35 kg to 50 kg and the new dose does not exceed 210 mg per day.210 mg/day
  - Weight is greater than 50 kg and the new dose does not exceed 280 mg per day.280 mg/day
- The new dose does not exceed 1 capsule per day.1 capsule/day
Adults and pediatric members aged 13 to 17 years
- The new dose does not exceed 280 mg per day.280 mg/day
- The new dose does not exceed 1 capsule per day.1 capsule/day

Continuity-of-care requests must reference applicable state-specific addenda for CC.PHARM.03A and CC.PHARM.03B.

For dose increases, the new dose must meet the applicable age-, weight-, and capsule-limit requirements.

Documentation Required

Continuation Documentation

For continuation requests, include documentation of current therapy or prior approval, positive clinical response, and the requested dose. Dose increases require confirmation that the new dose remains within policy limits.

Document current use through the Centene benefit, prior approval, or qualifying continuity-of-care status.
Document that the member is responding positively to therapy.
For pediatric members age 6 to 12 years: 1 capsule daily and no more than 140 mg/day at 20 to <35 kg, 210 mg/day at 35 to 50 kg, or 280 mg/day at >50 kg.
For adults and members age 13 to 17 years: 1 capsule daily and no more than 280 mg/day.

Step Therapy

Required ADHD Treatment Trials

Before initial approval, document the required ADHD treatment trials unless an applicable exception is met. Illinois HIM step-therapy requirements do not apply as of January 1, 2026, under Illinois HB 5395; this exception does not alter the requirements for Ambetter Nevada requests.

Atomoxetine: failure at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects occurred, or documentation supports inability to swallow capsules.
Amphetamine-based stimulant: failure at up to maximally indicated doses, unless clinically significant adverse effects occurred with any amphetamine product or all amphetamine products are contraindicated.
Methylphenidate-based stimulant: failure at up to maximally indicated doses, unless clinically significant adverse effects occurred with any methylphenidate product or all methylphenidate products are contraindicated.

Documentation Required

Clinical Documentation Required

The provider must submit office chart notes, laboratory results, or other clinical information supporting that the member meets all applicable approval criteria.

Include records supporting the ADHD diagnosis, age, current weight in kg, treatment history, applicable exceptions, current response, and requested dose.
Documentation must be sufficient to establish medical necessity for the requested authorization.

Step Therapy

Atomoxetine or Capsule-Swallowing Exception

If atomoxetine was not tried, document either a contraindication or clinically significant adverse effects, or the member’s inability to swallow capsules. Otherwise, document failure of atomoxetine at up to maximally indicated doses.

Acceptable exceptions include contraindication, clinically significant adverse effects, or inability to swallow capsules.
Documentation should identify the treatment outcome or the specific clinical reason the trial cannot be completed.

Step Therapy

Stimulant Step-Therapy Documentation

Document failure of both required stimulant classes at up to maximally indicated doses, unless the policy’s adverse-effect or contraindication exception applies.

Amphetamine-based stimulant: document failure, clinically significant adverse effects to any amphetamine product, or contraindication to all amphetamine products.
Methylphenidate-based stimulant: document failure, clinically significant adverse effects to any methylphenidate product, or contraindication to all methylphenidate products.

Documentation Required

Continuation Documentation Checklist

Continuation requests must include evidence of current therapy or prior approval, a positive response to treatment, and the requested dose when a dose increase is requested.

Identify current Centene-benefit therapy, prior satisfaction of initial criteria, or applicable continuity-of-care status.
Document positive response to centanafadine.
For dose increases, document that the requested dose complies with the applicable pediatric or adult/adolescent limits.

Unsupported block type: denial_risk

Denial Risk

Unmet Approval Criteria

Requests may be denied when required approval criteria are not documented or are not met, including the diagnosis, minimum age or weight, required treatment failures or exceptions, or dose and capsule limits.

ADHD diagnosis is absent or unsupported.
Member is younger than 6 years or weighs less than 20 kg, or current weight in kg is not documented.
Atomoxetine or both required stimulant-class trials are not documented, and no applicable exception is established.
Requested dose exceeds the applicable age- and weight-based maximum or exceeds 1 capsule per day.

Denial Risk

Clinical Contraindications

Do not use Simtriyo when the member has a listed contraindication, including known hypersensitivity to centanafadine or any excipient, monoamine oxidase inhibitor use within the prior 14 days, or pheochromocytoma or a history of pheochromocytoma.

Known hypersensitivity to centanafadine or any Simtriyo excipient.
Taking an MAOI or within 14 days of stopping an MAOI.
Pheochromocytoma or history of pheochromocytoma.

Denial Risk

Contraindications and Use Restrictions

Coverage and use remain subject to the listed contraindications and boxed warnings. Providers should assess these restrictions and document clinically relevant findings before requesting or continuing therapy.

Contraindicated use must not be authorized when a listed contraindication is present.
Monitor and counsel regarding suicidal ideation and behaviors in pediatric patients age 6 years and older.
Assess and address risks of abuse, misuse, and addiction.

ONE weight-based maximum
- Weight is 20 kg to less than 35 kg and the new dose does not exceed 140 mg per day.140 mg/day
- Weight is 35 kg to 50 kg and the new dose does not exceed 210 mg per day.210 mg/day
- Weight is greater than 50 kg and the new dose does not exceed 280 mg per day.280 mg/day
The new dose does not exceed 1 capsule per day.1 capsule/day

Adults and pediatric members aged 13 to 17 years

The new dose does not exceed 280 mg per day.280 mg/day
The new dose does not exceed 1 capsule per day.1 capsule/day