CurrentCignaPolicy IP0217

Nonstimulant ADHD medications (Onyda XR and Qelbree)

Cigna coverage policy for medical necessity review of clonidine extended-release oral suspension (Onyda XR) and viloxazine extended-release capsules (Qelbree) for treatment of ADHD; applies to Cigna-administered health benefit plans unless a customer's plan document or law supersedes.

Policy Summary

PayerCigna

PolicyNonstimulant ADHD medications (Onyda XR and Qelbree)

Policy CodePolicy IP0217

Change TypeCriteria additions and revisions

Effective DateMay 15, 2025

Next Review Date

Key ActionProvide documentation of prior therapies or documented inability to swallow tablets/solid oral forms to support medical necessity for Onyda XR or Qelbree.

SourceLink

POLICY UPDATE CHANGES

Added Individual and Family Plans to the policy.

Added Onyda XR to the policy.

Added a definition of documentation.

Removed 'Long-Term Combination Therapy (> 2 months) with atomoxetine and CNS stimulants' from Conditions Not Covered.

Updated Employer Plans and Individual and Family Plans Qelbree preferred product criteria.

2primary products with formal criteria (Onyda XR, Qelbree)

≥6minimum age for ADHD medication coverage

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Medical Necessity Criteria for Onyda XR and Qelbree

Onyda XR (clonidine extended-release oral suspension) - Initial coverage

Documentation required. Onyda XR is medically necessary when ONE of the following is met:

ANY of the following

The patient has tried clonidine ER tablets (generic of Kapvay).
The patient is unable to swallow tablets or has difficulty swallowing tablets.

Qelbree (viloxazine extended-release capsules) - Initial coverage

Documentation required. Qelbree is medically necessary when ONE of the following is met:

ANY of the following

The patient has had an inadequate response, contraindication, or is intolerant to atomoxetine (generic for Strattera).
The patient is unable to swallow or has difficulty swallowing solid oral dosage forms.

Shared ADHD diagnosis and age requirements

Applies to products when referenced preferred product criteria are met:

ALL of the following

Individual is 6 years of age or older.>= 6 years
Documented diagnosis of attention deficit hyperactivity disorder (ADHD).
Preferred product criteria is met for the product(s) as listed in the applicable table/plan section (Employer or Individual & Family Plans).

Pervasive developmental disorders (e.g., autism spectrum disorder) eligibility

When ADHD symptoms are present, coverage follows:

ALL of the following

The patient has symptoms of ADHD (e.g., inattention, hyperactivity).
Preferred product criteria is met for the product(s) as listed in the applicable table/plan section.

Reauthorization criteria (continued use)

Clonidine ER oral suspension (Onyda XR) and Viloxazine (Qelbree) are medically necessary for continued use when:

ALL of the following

Initial criteria are met.
There is documentation of beneficial response.

Policy Identifiers and Drug References

Policy identifiers / drugs namedmixed

Onyda XR	clonidine hydrochloride extended-release oral suspension (Tris)
Qelbree	viloxazine extended-release capsules (Supernus)
Kapvay (generic)	clonidine ER tablets referenced as comparators
Strattera (atomoxetine, generic)	atomoxetine referenced for step/therapy prior failure with Qelbree

What Providers Must Do / Authorization Details

Documentation Required

Provide documentation of prior therapies or swallowing difficulty

For Onyda XR, document either a trial of clonidine ER tablets (generic Kapvay) or a documented inability or difficulty swallowing tablets. For Qelbree, document prior inadequate response, contraindication, or intolerance to atomoxetine (Strattera, generic) or a documented inability or difficulty swallowing solid oral dosage forms. Documentation may include chart notes, laboratory tests, claims records, and/or other information.

Onyda XR
Qelbree
Kapvay (generic)
Atomoxetine (Strattera, generic)

Prior Authorization

Prior authorization required

Prior authorization is required; submission of documentation meeting the listed medical necessity criteria is necessary for coverage determinations. Initial and reauthorization approval durations are each up to 12 months.

Clinical and Administrative Context

Onyda XR (clonidine hydrochloride extended-release oral suspension) and Qelbree (viloxazine extended-release capsules) are nonstimulant medications approved for the treatment of attention deficit hyperactivity disorder (ADHD). Both products are named in the policy overview as covered nonstimulant options for ADHD management. (See product list in policy.)

Atomoxetine (Strattera, generic) and Qelbree are classified as selective norepinephrine reuptake inhibitors and are indicated for treatment of ADHD in patients aged ≥ 6 years, adolescents, and adults. This age threshold is applied across the policy when assessing eligibility.

Clonidine formulations (including clonidine ER tablets, Kapvay, and the clonidine ER oral suspension Onyda XR) and guanfacine ER are alpha-2 agonists approved for use in children and adolescents (typically ages 6–17) and may be used either as monotherapy or as adjunctive therapy to stimulant medications. The policy notes these agents’ roles and specifies that Onyda XR may be covered when criteria—such as prior trial of clonidine ER tablets or documented inability to swallow tablets—are met.

Defined Terms

Documentation definition

DocumentationChart notes, laboratory tests, claims records, and/or other information used to support medical necessity determinations.

Examples of acceptable sourcesChart notes, laboratory test results, and claims records may be used to demonstrate prior therapy, response, intolerance, contraindication, or swallowing difficulty.

PurposeUsed where noted in the medical necessity criteria to substantiate that one or more required criteria are met for initial or continued coverage.

When requiredDocumentation is required for initial coverage determinations and reauthorization when criteria call for evidence of prior trials or beneficial response.

SubmissionDocumentation should be submitted with prior authorization requests to support medical necessity determinations.

Policy Changes

2025-05-15removedLatest

Removed 'Long-Term Combination Therapy (> 2 months) with atomoxetine and CNS stimulants' from Conditions Not Covered.

2025-01-15added

Added Individual and Family Plans to the policy.

2025-01-15added

Nonstimulant ADHD medications (Onyda XR and Qelbree)

Medical Necessity Criteria for Onyda XR and Qelbree

Policy Identifiers and Drug References

What Providers Must Do / Authorization Details

Clinical and Administrative Context

Defined Terms

Policy Changes

Other Policies to Review