CurrentCignaPolicy IP0477

Drug Coverage Policy: ADHD stimulant products medical necessity and prior authorization criteria

Cigna drug coverage policy IP0477 governing medical necessity criteria, preferred alternatives, and prior authorization applicability for a comprehensive list of ADHD stimulant products (amphetamines, methylphenidates, lisdexamfetamine, methamphetamine, transdermal systems, oral solutions, ER/IR formulations) for Employer Group/Complete Plan lines; diagnostic and step/step-down requirements vary by product and by drug list tier.

Policy Summary

PayerCigna

PolicyDrug Coverage Policy: ADHD stimulant products medical necessity and prior authorization criteria

Policy CodePolicy IP0477

Change TypePreferred product / formulary criteria updates

Effective DateJul 1, 2025

Next Review Date

Key ActionWhen prior authorization applies (Complete Plan), document the diagnostic and step therapy criteria in this policy (chart notes, lab tests, claims records or other information) and ensure required trials/failures and specialist confirmations are included.

POLICY UPDATE CHANGES

Vyvanse capsules: updated the preferred product requirements to multi-source brand criteria and extended the preferred product criteria to the Standard, Performance and Legacy formularies.

Vyvanse chewable tablets: updated the preferred product requirements to multi-source brand criteria and extended the preferred product criteria to the Standard, Performance and Legacy formularies.

Updated the preferred product requirements for Adderall, Adderall XR, Adhansia XR, Adzenys XR-ODT, Aptensio XR, Concerta, Cotempla XR ODT, Desoxyn, Dexedrine, Dyanavel XR, Evekeo, Evekeo ODT, Focalin, Focalin XR, Jornay PM, Methylin, Mydayis, Ritalin, Ritalin LA, Xelstrym and Zenzedi.

40+Stimulant products listed

Varies

Required alternative failures (per product)

Complete Plan onlyPrior auth diagnostic criteria applicability

12 monthsTypical authorization duration

3Formulary categories affected

Coverage summary

Coverage stance: covered_with_criteria. Scope: Cigna policy IP0477 governs medical necessity criteria, preferred alternatives, and prior authorization applicability for a comprehensive list of ADHD stimulant products including amphetamines, methylphenidates, lisdexamfetamine, methamphetamine, transdermal systems, oral solutions, ER/IR formulations for Employer Group/Complete Plan lines. (Policy identifier: IP0477; Effective date: 07/01/2025.)

Product groups covered include immediate- and extended-release amphetamines (Adderall, Adderall XR, Mydayis and generics), methylphenidate products (Concerta, Ritalin, Jornay PM, transdermal/patch, chewables, liquids), lisdexamfetamine (Vyvanse capsules and chewable tablets), methamphetamine (Desoxyn), transdermal dextroamphetamine (Xelstrym), oral solutions (Procentra, Dyanavel XR), and other ER/IR/formulation-specific products. Prior authorization applies to the Complete Plan; initial and reauthorization approval durations are up to 12 months.

Initial therapy — product-specific medical necessity

Product-specific preferred covered alternatives / step requirements (examples from policy)

Most branded/non-preferred products require failure, contraindication, or intolerance to specified preferred/generic alternatives; the exact number and items depend on drug and formulary tier.

Adderall (immediate-release) criteria

Top-level diagnosis: Documented diagnosis of ONE of: ADHD, Narcolepsy, Adjunctive/Augmentation for Depression (with age ≥18 and concurrent antidepressant), Fatigue associated with cancer, Idiopathic hypersomnolence (confirmed by sleep specialist)
Preferred alternatives/steps
- Trial of bioequivalent generic IR amphetamine/dextroamphetamine: Trial of amphetamine/dextroamphetamine salts immediate-release tablets (bioequivalent generic) AND cannot take due to a formulation difference in inactive ingredient(s) causing allergy/serious adverse reaction
- Failure of three alternatives: Failure, contraindication, or intolerance to THREE of: dexmethylphenidate (generic for Focalin); dextroamphetamine sulfate (generic for Zenzedi) OR Procentra (dextroamphetamine solution); methamphetamine (generic for Desoxyn); methylphenidate chewable OR methylphenidate tablet (generic for Ritalin) OR methylphenidate oral solution (generic for Methylin)

Adderall XR (extended-release) criteria

Top-level diagnosis: Documented diagnosis of ONE of: ADHD, Narcolepsy, Adjunctive/Augmentation for Depression (with age ≥18 and concurrent antidepressant), Fatigue associated with cancer, Idiopathic hypersomnolence (confirmed by sleep specialist)
Preferred alternatives/steps
- Trial of bioequivalent generic ER amphetamine/dextroamphetamine: Trial of amphetamine/dextroamphetamine salts extended-release capsules (bioequivalent generic) AND cannot take due to formulation difference in inactive ingredient(s) causing significant allergy/serious adverse reaction
- Failure of all alternatives: Failure, contraindication, or intolerance to ALL of: dexmethylphenidate ER (generic for Focalin XR); methylphenidate ER capsules/tablets (generics for Ritalin LA, Aptensio XR, Concerta); lisdexamfetamine (generic for Vyvanse)

Adhansia XR; Aptensio XR; Concerta; other methylphenidate ER products: Documented diagnosis of ONE of the general diagnoses AND product-specific preferred alternatives failure: examples include failure to dexmethylphenidate ER, dextroamphetamine/amphetamine ER (Adderall XR or Mydayis), methylphenidate ER capsules/tablets (Ritalin LA, Aptensio XR, Concerta) as required by the product and drug list tier

Formulation-specific criteria (ODT, suspension, transdermal, chewable, inability to swallow): Documented inability to swallow capsules and tablets required for some ODT or liquid/suspension products (e.g., Adzenys XR-ODT, Cotempla XR-ODT, Dyanavel XR, Evekeo ODT). Some products require inability to swallow AND failure/contraindication/intolerance to listed alternatives (varies by product and drug list).

Jornay PM specific criteria: Individual is 6 years of age or older; documented diagnosis of ONE of the general diagnoses; AND failure, contraindication, or intolerance to ALL of: dexmethylphenidate ER (Focalin XR); dextroamphetamine/amphetamine ER (Adderall XR or Mydayis); methylphenidate ER capsules (Ritalin LA or Aptensio XR) OR methylphenidate ER tablet (Concerta)

Products requiring trials of matching generic bioequivalent first: Many branded products require trial of the bioequivalent generic formulation AND inability to take due to inactive ingredient formulation difference causing allergy/serious adverse reaction; additionally, failure/contraindication/intolerance to a specified number of alternative agents (often 3 or ALL depending on product and formulary tier) is required

General medical necessity criteria for methylphenidate and related products

Methylphenidate products are considered medically necessary when the individual meets the following:

Diagnoses: Documented diagnosis of ONE of: ADHD; Narcolepsy; Adjunctive/Augmentation Treatment for Depression (meets BOTH: age ≥18 AND concurrently receiving other medication therapy for depression e.g., SSRIs); Fatigue Associated with Cancer and/or its Treatment; Idiopathic Hypersomnolence (diagnosis confirmed by a sleep specialist).
Product-specific preferred alternatives: Individual meets the preferred covered alternatives criteria as indicated for the specific product (see product-specific nodes).

Methylphenidate extended-release 45mg, 63mg, 72mg tablets: Considered medically necessary when BOTH are met: Documented diagnosis of ONE of the listed conditions AND documentation of failure, contraindication, or intolerance to ALL of: dexmethylphenidate ER (generic for Focalin XR); methylphenidate ER tablets (generic for Concerta); methylphenidate CD capsules OR methylphenidate LA capsules (generic for Ritalin LA); methylphenidate extended-release capsules (generic for Aptensio XR).

Continuation / reauthorization criteria

Non-covered / experimental indications and exclusions

Conditions listed as not covered / considered experimental or investigational include: fatigue associated with Multiple Sclerosis (MS); long-term combination therapy (> 2 months) with Strattera (atomoxetine) and CNS stimulants; neuroenhancement (use to augment cognition in otherwise healthy individuals); and weight loss except for short-term, limited amphetamine/methamphetamine use as noted. Claims for these indications may be denied per the policy's non-covered indications guidance.

Applicable codes and identifiers

Policy identifiersmixed

IP0477

Coverage Policy Number

No specific billing codes listed in this partmixed

No codes listed

Provider actions — prior authorization, documentation, and step therapy

Prior Authorization

Prior authorization required per policy

Prior authorization required per policy: When prior authorization is required for Complete Plan members, the diagnostic and step therapy criteria in this policy must be documented and met before approval. Requests should include evidence that the member meets the documented diagnosis criteria and that any required failure, contraindication, or intolerance trials for preferred/generic alternatives have been completed and recorded. Examples of required documentation are listed in the documentation callouts below.

Documentation Required

Documentation required for diagnoses and trials

Documentation required for diagnoses and trials: Providers must supply supporting clinical documentation with the prior authorization request. Acceptable documentation may include chart notes, specialist consultation notes, sleep study or sleep specialist confirmation when idiopathic hypersomnolence is claimed, laboratory tests when relevant, and prior claims or medication records showing dates and durations of prior trials. For step-therapy requirements, include clear documentation of failure, contraindication, or intolerance to each required preferred or generic alternative (including dates and reason for discontinuation).

Clinical evidence and references

Evidence references in the brief include the NCCN Cancer-Related Fatigue guideline (version 1.2021) recommending consideration of psychostimulants such as methylphenidate after other causes are ruled out, and the American Academy of Sleep Medicine (AASM) practice parameters (2007) supporting amphetamine, methamphetamine, dextroamphetamine, and methylphenidate for narcolepsy and suggesting these agents (and modafinil) may be effective for idiopathic hypersomnia. The brief does not provide trial metrics or numeric response rates.

Background and definitions

Background / purpose: This policy provides a medical necessity review framework for a comprehensive list of ADHD stimulant products and details product-specific criteria. Criteria include required diagnoses (e.g., ADHD, narcolepsy, adjunctive use in depression with age and concurrent antidepressant requirements, cancer-related fatigue, idiopathic hypersomnolence with sleep-specialist confirmation), age/stage requirements for specific products (for example, Jornay PM requires age ≥ 6 years; some amphetamine products and Mydayis have age thresholds), and specialist confirmation requirements for idiopathic hypersomnolence.

Product-specific criteria outline step or alternative failure pathways that vary by formulary tier and product (examples include required trials of bioequivalent generics, failures of specified numbers of alternatives, or documentation of inability to swallow for ODT/suspension/chewable products). Prior authorization diagnostic criteria apply to the Complete Plan / Employer Group lines and preferred product criteria changes (e.g., Vyvanse capsule and chewable updates) were implemented effective 07/01/2025.

Definitions: Documentation — may include chart notes, laboratory tests, claims records, and/or other information as noted in criteria. Beneficial response — documentation that therapy produces clinical benefit (no specific metric provided in the policy).

Revision history

07/01/2025policy updateLatest

Vyvanse capsules: updated the preferred product requirements to multi-source brand criteria and extended the preferred product criteria to the Standard, Performance and Legacy formularies.

07/01/2025policy updateLatest

Vyvanse chewable tablets: updated the preferred product requirements to multi-source brand criteria and extended the preferred product criteria to the Standard, Performance and Legacy formularies.

07/01/2025policy update

Policy Summary

PayerCigna

PolicyDrug Coverage Policy: ADHD stimulant products medical necessity and prior authorization criteria

Policy CodePolicy IP0477

Change TypePreferred product / formulary criteria updates

Effective DateJul 1, 2025

Next Review Date

On This Page

Methylphenidate transdermal system/patch: Considered medically necessary when: Documented diagnosis of ONE of the general-listed conditions.

Mixed salts single-entity amphetamine ER capsules (generic for Mydayis / Mydayis): Considered medically necessary when BOTH are met: Age ≥13 years; documented diagnosis of ONE of the general-listed conditions; AND meets preferred covered alternatives criteria (failure/contraindication/intolerance to listed alternatives as required by plan, e.g., dexmethylphenidate ER; dextroamphetamine/amphetamine ER; lisdexamfetamine; methylphenidate ER capsules/tablets).

Quillichew ER (methylphenidate ER chewable tablets): Considered medically necessary when ALL are met: Documented diagnosis of ONE of the general-listed conditions; documented inability to swallow capsules or tablets; AND failure/contraindication/intolerance to ALL of: dexmethylphenidate ER; dextroamphetamine/amphetamine ER OR mixed amphetamine salts ER; methylphenidate ER capsules (Ritalin LA or Aptensio XR).

Quillivant XR (methylphenidate ER oral suspension): Considered medically necessary when BOTH are met: Documented diagnosis of ONE of the general-listed conditions AND documented inability to swallow capsules or tablets.

Relexxii (methylphenidate ER 18mg–72mg tablets): Considered medically necessary when BOTH are met: Documented diagnosis of ONE of the general-listed conditions AND failure/contraindication/intolerance to ALL of: dexmethylphenidate ER; methylphenidate ER tablets (Concerta); methylphenidate CD OR LA capsules (Metadate CD or Ritalin LA); methylphenidate ER capsules (Aptensio XR).

Ritalin (methylphenidate immediate-release tablets): Considered medically necessary when BOTH are met (for certain drug list plans): Documented diagnosis of ONE of the general-listed conditions; Trial of methylphenidate immediate-release tablets (bioequivalent generic) AND cannot take due to formulation difference in inactive ingredients causing significant allergy/serious adverse reaction; AND failure/contraindication/intolerance to THREE of the specified alternatives (examples: amphetamine OR dextroamphetamine/amphetamine; dexmethylphenidate; dextroamphetamine sulfate OR Procentra; methamphetamine).

Ritalin LA (methylphenidate extended-release capsules): Considered medically necessary when BOTH are met (for certain drug list plans): Documented diagnosis of ONE of the general-listed conditions; Trial of methylphenidate extended-release capsules (bioequivalent generic) AND cannot take due to formulation difference in inactive ingredients causing significant allergy/serious adverse reaction; AND failure/contraindication/intolerance to BOTH: dexmethylphenidate ER and other specified alternatives depending on plan.

Vyvanse (lisdexamfetamine) capsules and chewable tablets: Capsules: Considered medically necessary when BOTH are met: Documented diagnosis of ONE of listed conditions (including binge-eating disorder in adults ≥18) AND preferred product criteria met (patient has tried lisdexamfetamine capsules bioequivalent generic AND cannot take due to inactive ingredient difference causing significant allergy/serious adverse reaction). Chewable tablets: Considered medically necessary when ALL are met: documented inability to swallow capsules/tablets; documented diagnosis (including binge-eating disorder ≥18); AND preferred product criteria met (tried lisdexamfetamine chewable generic AND cannot take due to inactive ingredient difference).

Xelstrym (dextroamphetamine): Considered medically necessary when BOTH are met: Documented diagnosis of ONE of the general-listed conditions AND failure/contraindication/intolerance to FOUR of the listed alternatives (examples: dexmethylphenidate ER; dextroamphetamine/amphetamine ER or Mydayis; dextroamphetamine ER capsules; lisdexamfetamine; methylphenidate ER capsules).

Procentra (dextroamphetamine sulfate liquid): Considered medically necessary when: Documented diagnosis of ONE of the general-listed conditions.

Zenzedi (dextroamphetamine tablets): Considered medically necessary when BOTH are met: Documented diagnosis of ONE of the general-listed conditions; Trial of dextroamphetamine tablets (bioequivalent generic) AND cannot take due to formulation difference in inactive ingredients causing significant allergy/serious adverse reaction; AND failure/contraindication/intolerance to THREE of the listed alternatives (amphetamines, dexmethylphenidate, lisdexamfetamine, methamphetamine, methylphenidate formulations, etc.).

Chart notes or clinic progress notes documenting the diagnosis and symptom history
Specialist confirmation for idiopathic hypersomnolence (sleep specialist or accredited sleep center)
Medication history or pharmacy/claims records showing prior trials, dates, dosages, and reason for failure/intolerance
Relevant lab or objective testing if applicable (e.g., sleep study reports)

Documentation Required

Inability to swallow or allergy to inactive ingredients

Inability to swallow or allergy to inactive ingredients: If approval is sought because the member cannot take the preferred/generic formulation due to inability to swallow a formulation or an allergy to an inactive ingredient, provide documentation supporting the limitation. For swallowing difficulties, include clinical notes describing the impairment and why alternative formulations are not feasible. For allergies to inactive ingredients, document the specific ingredient(s), the allergic reaction or adverse event history, and why the preferred/generic product cannot be used. Exemptions based on inactive-ingredient allergy require a clear link between the ingredient and a clinically significant reaction.

Clinical note describing inability to swallow and why alternate formulations are unsuitable
Allergy documentation naming the inactive ingredient and describing prior reaction(s) or testing
If exemption is due to inactive-ingredient allergy, note attempts (if any) to use alternative products without the offending ingredient and reasons those attempts failed

Step Therapy

Step therapy / failure trials required

Step therapy / failure trials required: Many branded or non-preferred stimulant products require documentation of prior failure, contraindication, or intolerance to specified preferred or generic alternatives before coverage is approved. The number of required prior trials varies by product and formulary tier — some products require failure of 3 alternatives, some require failure of ALL listed alternatives, and others may require up to 4 specific trials. Documentation must show dates, doses, and reasons for discontinuation for each trial.

Counts of required failures vary by product tier (examples across the policy: 3; ALL of a short list; or up to 4 required trials)
Failure, contraindication, or intolerance must be clearly documented for each required alternative
If a formulation difference (e.g., inactive ingredient) prevents use of the bioequivalent generic, include supporting documentation

Note

Approval durations

Approval durations: Initial and reauthorization approvals are up to 12 months each.

Denial Risk

Non-covered indications

Non-covered indications: The following are among the most common non-covered or denial-risk categories observed in the policy and utilization data. Requests for these indications are frequently denied when not meeting specific medical necessity criteria: multiple sclerosis–related fatigue, long-term combination use with atomoxetine (Strattera) beyond short-term/allowed durations (e.g., >2 months when the policy limits apply), use for neuroenhancement or cognitive enhancement in individuals without ADHD, and use for weight loss or appetite suppression outside of covered indications. Ensure submitted documentation clearly supports a covered diagnosis and meets the policy's required trials to reduce denial risk.

Fatigue related to multiple sclerosis (unless meeting specific covered criteria)
Long-term combination therapy with atomoxetine (Strattera) beyond policy-allowed durations
Use for neuroenhancement/cognitive enhancement without a covered diagnosis
Weight loss or appetite suppression not supported by covered indication

Documentation Required

Formulary preference changes

Formulary preference changes: Material formulary updates reflected in this policy include changes to Vyvanse (lisdexamfetamine) capsule and chewable tablet preferred-product criteria to recognize multi-source brand products and extension of those criteria to Standard/Performance/Legacy formularies. Other stimulants and preferred-product listings were updated as noted in the provider actions and the Employer Group Medical Necessity Criteria (for example, adjustments to preferred generic alternatives and required trials across Adderall, Adderall XR, Adhansia XR, and others). Review the plan-specific formulary to confirm preferred products and any recent changes before submitting a request.

Vyvanse capsule and chewable tablet preferred criteria updated to multi-source brand and extended to Standard/Performance/Legacy formularies
Other stimulant preferred-product listings and step requirements updated across the formulary — confirm plan-specific details

Updated the preferred product requirements for multiple stimulant products including Adderall, Adderall XR, Adhansia XR, Adzenys XR-ODT, Aptensio XR, Concerta, Cotempla XR ODT, Desoxyn, Dexedrine, Dyanavel XR, Evekeo, Evekeo ODT, Focalin, Focalin XR, Jornay PM, Methylin, Mydayis, Ritalin, Ritalin LA, Xelstrym and Zenzedi.