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Defines prior authorization and medical necessity criteria for Acthar Gel and Purified Cortrophin Gel for infantile spasms and opsoclonus-myoclonus syndrome, including initial approval durations and denial of reauthorization; excludes many other indications as not medically necessary.
3/2025 annual review updated background and references; removed references to OptumRx without changes to intent of criteria.
3/2022 added Purified Cortrophin Gel to program with same coverage criteria as Acthar Gel.
Defines prior authorization and medical necessity criteria for Acthar Gel and Purified Cortrophin Gel for infantile spasms and opsoclonus-myoclonus syndrome, including initial approval durations and denial of reauthorization; excludes many other indications as not medically necessary.
Initial Therapy - Infantile Spasms
Covered when ALL of the following are met:
ALL of the following
Authorization will be issued for 4 weeks.
Initial Therapy - Opsoclonus-myoclonus syndrome (OMS)
Covered when ALL of the following are met:
Authorization will be issued for 3 months.
Prior authorization required for initial therapy
Prior authorization is required and will be approved only if initial therapy criteria for infantile spasms or opsoclonus-myoclonus syndrome are met; initial approvals issued for specified durations (4 weeks for infantile spasms; 3 months for OMS).
Not Medically Necessary Indications
Use is considered not medically necessary for the following disorder categories:
ANY of the following disorders
The vendors' package inserts list multiple conditions for Acthar Gel and Purified Cortrophin Gel; however, because these agents are more costly than alternative treatments that provide equivalent therapeutic results, UnitedHealthcare restricts coverage to infantile spasms (children under 2 years) and opsoclonus-myoclonus syndrome (OMS), and considers use for the other listed categories not medically necessary.
| Infantile spasms (West Syndrome) - diagnosis referenced (no specific ICD-10 codes listed in document) | |
| Opsoclonus-myoclonus syndrome (Kinsbourne Syndrome) - diagnosis referenced (no specific ICD-10 codes listed in document) |
P&T approvals are documented from 5/2014 through 3/2025 (annual reviews). Primary references include the Acthar Gel package insert (February 2024) and the Purified Cortrophin Gel package insert (December 2024), and selected clinical studies for OMS (e.g., Pranzatelli et al. 2005; Tate et al. 2012).
Acthar Gel and Purified Cortrophin Gel are adrenocorticotropic hormone (ACTH) analogues. Because they are more costly than alternative therapies that are at least as likely to produce equivalent therapeutic results, UnitedHealthcare limits coverage to infantile spasms (monotherapy for infants and children under 2 years) and opsoclonus-myoclonus syndrome (Kinsbourne Syndrome), and deems use for multiple other disorder categories not medically necessary.
Reauthorization: Request to continue therapy after initial authorization; per policy, such requests are denied and require appeal.
3/2025 annual review updated background and references; removed references to OptumRx without changes to intent of criteria.
3/2022 added Purified Cortrophin Gel to program with same coverage criteria as Acthar Gel. (Material change)