CurrentmhnPolicy CP.PMN.92

ADHANSIA XR (PDF)

Defines medical necessity and prior authorization criteria for multiple extended-release CNS stimulant products (methylphenidate- and amphetamine-based) for treatment of ADHD across Commercial, HIM and Medicaid lines of business, including age limits, failure requirements, generic-first requirement, dose/quantity limits, exclusions, approval durations, and product-specific maximum doses.

Policy Summary

Payermhn

PolicyADHANSIA XR (PDF)

Policy CodePolicy CP.PMN.92

Change TypeAnnual reviews and additions

Effective Date03.01.18

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria and obtain prior authorization for listed CNS stimulants.

SourceLink

POLICY UPDATE CHANGES

Added requirement: If request is for a brand product, member must use the generic equivalent, if available, unless contraindicated or clinically significant adverse effects are experienced.

1Q 2026 annual review: added requirement that 'Request does not exceed health plan-approved quantity limit, if applicable'; references reviewed and updated.

1Q 2025 annual review: removed Adzenys ER; updated Adhansia XR quantity limit to 3 tablets per day; split Adzenys XR-ODT dosing by age groups; references updated.

1Q 2024 annual review: updated boxed warnings to include 'abuse, misuse, and addiction' for multiple agents; updated contraindications for Daytrana per PI.

16Listed CNS stimulant agents in policy

12Medicaid/HIM approval duration (months)

12Commercial approval duration (months)

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Coverage Summary

This policy defines medical necessity and prior authorization criteria for multiple extended‑release CNS stimulant products (methylphenidate‑ and amphetamine‑based) for treatment of ADHD and is covered with criteria. It is applicable across Commercial, HIM and Medicaid lines of business and is CURRENT. Typical approval durations are Commercial: 12 months or duration of request and Medicaid/HIM: 12 months. The criteria require failure of 2 formulary extended‑release products from the same therapeutic class (unless exception applies) and include product‑specific dosing/age limits, generic‑first and plan‑approved quantity limit requirements.

Quick facts / thresholds

Age for MydayisMydayis: Age ≥ 13 years

Age for other productsAll other requests: Age ≥ 6 years

Listed CNS stimulant agents in policy16 agents listed (methylphenidate- and amphetamine-based products)

Typical approval duration (Medicaid/HIM)12 months

Commercial approval duration12 months or duration of request, whichever is less

Formulary ER failures required (unless exception)Failure of two formulary extended‑release products at maximally indicated doses from same therapeutic class (2)

Medical Necessity Criteria

III. Other diagnoses/indications

If request does not fit criteria above, follow one of the below:

ANY of the following

If drug label changed within last 6 months and policy not updated: follow no coverage criteria policy or non-formulary policy for relevant line of business (references: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If requested use not listed under section III and criterion 1 above does not apply: refer to off-label use policy for relevant line of business (references: CP.CPA.09, HIM.PA.154, CP.PMN.53)

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Provider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria; prior authorization required for listed CNS stimulants.

Documentation Required

Failure documentation or formulation inability

Provider must document either failure of two formulary extended-release products at maximally indicated doses from same therapeutic class of the requested product, or document inability to use formulary dosage forms for specified products (e.g., inability to swallow tablets or capsules).

Product-Specific Dose / Quantity Limits

Product‑specific maximum doses and per‑day quantity limits are required for both initial and continued therapy and are listed within the criteria. The policy also enforces any applicable health plan‑approved quantity limits (requests exceeding plan limits will not meet criteria).

Product	Maximum dose / quantity (per day)
Adhansia XR
85 mg per day; 3 tablets per day
Adzenys XR-ODT (Age 6-12 years)
18.8 mg per day; 1 tablet per day
Adzenys XR-ODT (Age > 13 years)
12.5 mg per day; 1 tablet per day
Azstarys
52.3 mg/10.4 mg per day
Cotempla XR-ODT
51.8 mg per day; 2 tablets per day
Daytrana
30 mg per day; 1 patch per day
Dyanavel XR
20 mg per day; 1 tablet per day
Evekeo ODT
40 mg per day; 2 tablets per day
Focalin XR (Pediatric)
30 mg per day; 1 capsule per day
Focalin XR (Adult)
40 mg per day; 1 capsule per day
Jornay PM
100 mg per day; 1 capsule per day
Mydayis
50 mg per day; 1 capsule per day
Quillichew ER / Quillivant XR / Aptensio XR
60 mg per day; 1 tablet or capsule per day
Relexxii (Age 6-12 years)
54 mg per day; 1 tablet per day
Relexxii (Age ≥ 13 years)
72 mg per day; 1 tablet per day
Xelstrym
18 mg per day; 1 patch per day

Coding

No CPT/HCPCS/ICD-10/Modifiers specified in policymixed

No codes listed

Background / Rationale

This Centene clinical policy lists CNS stimulants that require prior authorization and provides medical necessity criteria for extended‑release methylphenidate and amphetamine products indicated for ADHD. It includes product‑specific dosing maxima and age limits, boxed warnings and contraindications, therapeutic alternatives, and documentation/step‑therapy requirements for prior authorization of the listed agents.

Supporting evidence includes multiple FDA prescribing information documents cited in the references and guideline recommendations such as the AACAP practice parameter and the AAP 2019 clinical practice guideline.

Revision History

1Q 2024 annual review (Date = 11.08.23 / P&T Approval Date = 02.24)revised

Updated boxed warnings to add 'abuse, misuse, and addiction' for multiple agents; updated Daytrana contraindications per prescribing information; references reviewed and updated.

1Q 2025 annual review (Date = 01.08.25 / P&T Approval Date = 02.25)revised

Removed Adzenys ER from criteria as discontinued; updated Adhansia XR quantity limit to 3 tablets per day; split Adzenys XR-ODT dosing by age groups; references reviewed and updated.

03.03.26added