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Attention Deficit Hyperactivity Disorder Non-Stimulant Medications
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Defines Cigna prior authorization, medical necessity, and coverage criteria for non-stimulant ADHD medications Onyda XR (clonidine XR oral suspension) and Qelbree (viloxazine XR capsules) for members covered under Cigna benefit plans.
Added Onyda XR to the policy.
Updated the Employer Plans and Individual and Family Plans Qelbree preferred product criteria.
Onyda XR: Updated the ADHD and Pervasive Developmental Disorders medical necessity requirements.
Removed 'Long-Term Combination Therapy (for example, > 2 months) with atomoxetine (Strattera, generic) and Central Nervous System (CNS) Stimulants' from Conditions Not Covered.
Added Individual and Family Plans to the policy.
Coverage Criteria for Onyda XR and Qelbree
Onyda XR (clonidine XR oral suspension) - Initial Authorization
Onyda XR is considered medically necessary when ONE of the following are met (1 or 2):
Qelbree (viloxazine XR) - Initial Authorization
Qelbree is considered medically necessary when the following is met:
Pharmacotherapy (non-stimulant ADHD medications)
Revised medical necessity and preferred product criteria
Policy revisions updated medical necessity and preferred product criteria for Onyda XR and Qelbree and added Individual and Family Plans to the policy.
Onyda XR and Qelbree for any use not specified in this policy are considered not medically necessary. Examples include: binge-eating disorder; depression without ADHD; fibromyalgia; use to improve cognitive function / neuroenhancement; nocturnal enuresis; and weight loss.
Use of Onyda XR or Qelbree for indications outside the covered ADHD indications or the limited supportive uses listed in the policy (for example, the conditions above) is considered not medically necessary and will be denied.
The policy revisions removed previously present Conditions Not Covered language that excluded long-term combination therapy with atomoxetine and central nervous system stimulants from coverage.
An explicit Not Covered statement that previously disallowed long-term combination therapy (for example, > 2 months) of atomoxetine with CNS stimulants was removed from the Conditions Not Covered section.
Provider Requirements, Prior Authorization, and Billing
Prior authorization required
Prior authorization is required for benefit coverage of Onyda XR and Qelbree; approvals are provided for the durations noted in the criteria (typically 1 year for FDA‑approved ADHD indications).
Step/step‑therapy: required prior trial of specified agents
For Onyda XR (Employer and Individual/Family Plans) the patient must generally have tried and had inadequate efficacy or significant intolerance with clonidine ER tablets (generic of Kapvay) unless unable to swallow solids or already started on Onyda XR; similar trial requirements apply for Qelbree with atomoxetine for Employer and Individual/Family Plans. Prescriber must document prior trial and outcome when required.
- Onyda XR: trial and inadequate efficacy or significant intolerance with clonidine ER tablets unless unable to swallow solids or already on therapy (Employer & Individual/Family Plans).
- Qelbree: trial and inadequate efficacy or significant intolerance with atomoxetine unless unable to swallow solids or already on therapy (Employer & Individual/Family Plans).
Preferred product criteria updated — check plan specifics
Employer and Individual and Family Plans preferred product criteria were updated — check the plan‑specific preferred product/step therapy sequencing for Onyda XR and Qelbree and confirm any plan additions such as 'patient has already been started on therapy.'
- Review Employer and Individual/Family Plan tables for updated preferred product sequencing.
- Note added preferred‑product allowance: 'The patient has already been started on therapy with Onyda XR.'
Prior authorization & preferred‑product updates — verify per plan
Preferred product tables and medical necessity criteria for Onyda XR and Qelbree were updated for Employer and Individual and Family Plans; prior authorization requirements should be checked per the updated preferred product criteria.
Provide required documentation with PA requests
Documentation is required where noted in the criteria and may include chart notes, laboratory tests, claims records, prescription receipts and/or other information; all documentation must include patient‑specific identifying information.
- Provide chart notes or clinical documentation supporting diagnosis and symptomatology.
- Include prescription receipts or pharmacy records when documenting prior therapy.
- Ensure all documentation includes patient identifiers.
Document prior therapy failure or intolerance
When prior‑therapy failure or intolerance is part of the preferred‑product requirement, the prescriber must document the trial and the reason for failure or intolerance (e.g., inadequate efficacy or significant intolerance) as part of the prior authorization submission.
- Document agent tried (e.g., clonidine ER tablets or atomoxetine), duration of trial, and reason for discontinuation or inadequate response.
- Include clinical notes or pharmacy records to support the prescriber's statement of intolerance or lack of efficacy.
Follow updated documentation requirements in policy
Follow the revised documentation statement in the policy — providers should supply the documentation types noted in criteria and ensure submissions meet the updated documentation requirements specified in the policy.
- Adhere to the updated policy statement on documentation when preparing PA requests.
- Confirm documentation includes patient identifiers and the specific items requested in criteria.
Billing/coding: submit covered codes or claim will be denied
Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered; when billing, use the most appropriate codes as of the submission date.
- Use only covered diagnosis and procedure codes related to the approved indication.
- Claims lacking covered codes under this policy will be denied.
Uses not specified are not medically necessary — will be denied
Onyda XR and Qelbree for any use not specified in the policy are considered not medically necessary and will be denied (examples include binge‑eating disorder, depression without ADHD, fibromyalgia, neuroenhancement, nocturnal enuresis, and weight loss).
- Do not submit PA requests or claims for indications not listed as covered in the policy; these will be denied.
- If treating an off‑label condition listed in the Conditions Not Covered section, provide supporting evidence only if criteria specify otherwise — otherwise expect denial.
Potential denial risk from changed 'Conditions Not Covered' language
Removal of the prior not‑covered language on long‑term combination therapy may still trigger denials if the member's situation previously relied on that statement; review the updated Conditions Not Covered section to determine coverage for combination therapy and document rationale for therapy choices.
- Check the updated Conditions Not Covered statement before authorizing combination therapy previously excluded.
- Provide clinical justification in the record when prescribing combinations formerly listed as not covered.
Definitions and Documentation
Background
Atomoxetine and viloxazine are nonstimulant agents used in the management of attention-deficit/hyperactivity disorder in patients aged ≥ 6 years. Atomoxetine and viloxazine act as selective norepinephrine reuptake inhibitors, while clonidine and guanfacine are alpha-2 adrenergic agonists; clonidine XR (Onyda XR) is an extended-release oral suspension formulation of clonidine used in children and adolescents and may be used as monotherapy or adjunctive therapy. Evidence supports use of these agents for ADHD and, in some cases, for behavioral symptoms associated with pervasive developmental disorders, though data and response profiles differ from typically developing patients.
Policy Revision History
Added Individual and Family Plans to the policy; added Onyda XR to the policy; added a definition of documentation; updated Employer and Individual and Family Plans Qelbree preferred product criteria.
Removed 'Long-Term Combination Therapy (for example, > 2 months) with atomoxetine and CNS stimulants' from Conditions Not Covered.
Removed 'Long-Term Combination Therapy...' from Conditions Not Covered (recorded on 04/03/2025).
Updated Onyda XR ADHD and Pervasive Developmental Disorders medical necessity requirements and updated Qelbree ADHD medical necessity requirements; updated Employer and Individual and Family Plans preferred product requirements.
Added a policy statement and updated the documentation statement; updated Onyda XR and Qelbree medical necessity and preferred product requirements and updated the Conditions Not Covered statement.
Employer and Individual and Family Plans Preferred Product Tables: added 'The patient has already been started on therapy with Onyda XR.' to preferred product tables.
Policy effective date (document effective date) recorded as 2026-08-15; reflects prior revisions now in force.
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