CurrentmhnPolicy CP.PMN.121

VYVANSE - HNMC (PDF)

Clinical policy defining medical necessity criteria, prior authorization requirements, quantity/dosing limits, continuation criteria, and excluded indications for lisdexamfetamine (Vyvanse, Arynta) for Medicaid line of business.

Policy Summary

Payermhn

PolicyVYVANSE - HNMC (PDF)

Policy CodePolicy CP.PMN.121

Change TypeFormulation additionapproval duration and redirection clarifications

Effective DateFeb 1, 2009

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

RT4 added newly approved Arynta dosage formulation (oral solution 10 mg/mL) to criteria and expanded initial approval durations to 12 months.

Removed redirection from Vyvanse chewable tablet to Vyvanse capsule for all indications (per Dec SDC).

Updated boxed warning to include 'addiction' to align with prescriber information.

Multiple annual reviews noted 'no significant changes'; references reviewed and updated across 2022-2026.

2FDA-approved indications covered

70 mg/dayMaximum daily dose

12 monthsApproval duration (initial/continued)

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Arynta bottles per 30 days limit

2Vyvanse chewable tablets per day limit

Coverage Summary

Coverage stance: covered with criteria for FDA-approved indications. The policy aligns coverage to FDA indications for lisdexamfetamine (Vyvanse, Arynta) — ADHD in patients ≥ 6 years and moderate to severe binge eating disorder (BED) in adults — and requires documentation of prior therapies, enforces formulation-specific quantity/dose limits, and specifies approval durations. Prior therapy requirements include behavioral and pharmacologic trials for BED (e.g., ≥ 3 months CBT, ≥ 3 months topiramate, and ≥ 6 weeks of an SSRI) and trials of an extended release amphetamine and an extended release methylphenidate for ADHD. Quantity/dose limits include a maximum daily dose of 70 mg/day, Vyvanse chewable tablet limit of 2 tablets/day (or 1 capsule/day), and Arynta limit of 3 bottles/30 days. Approval durations for both initial and continued therapy for the FDA-approved indications are set to 12 months.

Thresholds and Limits (summary)

Maximum daily dose70 mg per day

Vyvanse chewable tablet limit2 tablets per day

Vyvanse capsule daily option1 capsule per day

Arynta supply limit3 bottles per 30 days

CBT trial duration for BED>= 3 months

Topiramate trial for BED>= 3 months (up to maximally indicated doses)

SSRI trial for BED>= 6 weeks (citalopram, sertraline, or escitalopram)

Approval duration12 months

Covered FDA indications (count)2

Initial Therapy Criteria

A. Binge Eating Disorder (Initial Therapy)

Must meet ALL of the following:

ALL of the following

ALL of the following
- Diagnosis of BED
- Age ≥ 18 years
- Prescribed by or in consultation with a psychiatrist
- Failure of ≥ 3 month trial of cognitive behavioral therapy (CBT) with supporting documentation

Continuation Therapy Criteria

II. Continued Therapy (All indications)

Must meet ALL of the following:

ALL of the following

Member status
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
If request is for Arynta, member must use generic lisdexamfetamine unless contraindicated, clinically significant adverse effects are experienced, or documentation supports inability to swallow capsules or chew tablets

Unapproved / Not Authorized Indications

III. Diagnoses/Indications Not Authorized

ALL of the following

Non-FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation per off-label use policy CP.PMN.53 or evidence of coverage documents

Applicable Codes & Policy References

Relevant policy referencesmixed

CP.PMN.121	Reference number for this clinical policy
CP.PMN.255	No coverage criteria policy (Medicaid formulary) referenced for label changes
CP.PMN.16	Non-formulary policy referenced for label changes
CP.PMN.53	Off-label use policy for Medicaid
CC.PHARM.03A	State-specific continuity of care addendum A
CC.PHARM.03B	State-specific continuity of care addendum B

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required

Coverage requires meeting the listed initial or continued therapy criteria; approval durations specified (12 months).

Documentation Required

Submit documentation supporting approval criteria

Provider must submit office chart notes, lab results or other clinical information supporting that member has met all approval criteria.

Documentation Required

Therapy failure documentation

Provider must document trials and reasons for failure or intolerance of required prior therapies (e.g., cognitive behavioral therapy, topiramate, an extended-release amphetamine, an extended-release methylphenidate, or a selective serotonin reuptake inhibitor such as citalopram, sertraline, or escitalopram).

Clinical Evidence & References

Evidence/sources: Vyvanse Prescribing Information (2025) and Arynta Prescribing Information (2025) are referenced as source documents. The policy aligns coverage criteria to FDA-approved indications and the relevant prescriber information in these references.

Background

Background: Lisdexamfetamine dimesylate (Vyvanse, Arynta) is a central nervous stimulant FDA-indicated for treatment of attention deficit hyperactivity disorder in patients aged 6 years and older and for moderate to severe binge eating disorder in adults. The clinical policy aligns coverage to the FDA indications and to prescriber-directed requirements, including specified prior therapy trials, quantity/dose limits (maximum 70 mg/day, Vyvanse chewable tablet limit 2/day, Arynta 3 bottles/30 days), and continuation criteria. The policy also incorporates the addition of the Arynta oral solution 10 mg/mL formulation per recent updates.

Definitions

BEDBinge eating disorder

ADHDAttention deficit hyperactivity disorder

CBTCognitive behavioral therapy

MAOMonoamine oxidase

Revision History

2025-06-26material

RT4 added the newly approved Arynta oral solution formulation (10 mg/mL) to the criteria and expanded initial approval durations to 12 months for BED and ADHD (maintenance medication for a chronic condition).

2024-12-02material

Per December SDC, removed the prior requirement redirecting Vyvanse chewable tablets to Vyvanse capsules for all indications (change reflected in 1Q2025 review).

2025-01-01administrative

Policy Summary

Payermhn

PolicyVYVANSE - HNMC (PDF)

Policy CodePolicy CP.PMN.121

Change TypeFormulation additionapproval duration and redirection clarifications

Effective DateFeb 1, 2009

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member has met all approval criteria.

SourceLink

On This Page

Failure of ≥ 3 month trial of topiramate at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced

ONE of

citalopram
sertraline
escitalopram

ALL of the following

If request is for Arynta, member must use generic lisdexamfetamine unless contraindicated, clinically significant adverse effects are experienced, or documentation supports inability to swallow capsules or chew tablets
If request is for brand Vyvanse, member must use generic lisdexamfetamine unless contraindicated or clinically significant adverse effects are experienced

ALL of the following

Dose does not exceed 70 mg per day<= 70 mg/day
AND one of
- Vyvanse: 1 capsule or 2 chewable tablets per day
  tablet quantity limit = 2 per day
- Arynta: 3 bottles per 30 days
  liquid/oral solution quantity limit

B. Attention Deficit Hyperactivity Disorder (Initial Therapy)

Must meet ALL of the following:

ALL of the following

Diagnosis of ADHD
Age ≥ 6 years
Failure of one extended release amphetamine at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated
Failure of one extended release methylphenidate at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated
If request is for Arynta, member must use generic lisdexamfetamine unless contraindicated, clinically significant adverse effects are experienced, or documentation supports inability to swallow capsules or chew tablets
If request is for brand Vyvanse, member must use generic lisdexamfetamine unless contraindicated or clinically significant adverse effects are experienced
ALL of the following
- AND one of
  - Vyvanse: 1 capsule or 2 chewable tablets per day
    tablet quantity limit = 2 per day
  - Arynta: 3 bottles per 30 days

C. Other diagnoses/indications (Initial Therapy)

Must meet ONE of the following:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to: CP.PMN.255 (Medicaid formulary) or CP.PMN.16 (non-formulary) as applicable
If the requested use is NOT specifically listed under section III and criterion 1 above does not apply, refer to the off-label use policy CP.PMN.53 for Medicaid

If request is for brand Vyvanse, member must use generic lisdexamfetamine unless contraindicated or clinically significant adverse effects are experienced

ALL of the following

AND one of
- Vyvanse: 1 capsule or 2 chewable tablets per day
- Arynta: 3 bottles per 30 days

Approval durations for approved indications (both initial and continued therapy) are specified as 12 months.

Billing Rule

Quantity/dose limits enforced

Claims exceeding 70 mg/day or exceeding formulation-specific quantity limits are not authorized.

Maximum daily dose: 70 mg per day
Vyvanse: 1 capsule or 2 chewable tablets per day (chewable tablet limit = 2/day)
Arynta: 3 bottles per 30 days

1Q2025 annual review: Appendix C boxed warning language updated to include 'addiction' to align with prescriber information; references reviewed and updated. Also documented removal of chewable-to-capsule redirection.

2022-2026administrativeLatest

Multiple template and reference updates across annual reviews (1Q2022–1Q2026); administrative changes and references reviewed/updated with no clinical policy statement changes noted in annual reviews.