Onpattro (patisiran) coverage for hereditary transthyretin-mediated amyloidosis with polyneuropathy
Defines medical necessity and prior authorization requirements for Onpattro (patisiran) when used to treat polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. Applies to pharmacy/medical benefit administration (medical benefit per header) for the payer's Arkansas PASSE program.
Increased initial authorization duration from 6 months to 9 months.
Simplified diagnostic requirement to any method of confirmation; separated genetic testing and FAP staging into mandatory requirements (historic change noted 07/02/2020).
Replaced staging with PND score and added quantity limit (QL) for dosing.
Renewal criteria updated to require documentation of improvement or stabilization of neuropathy, speed, nutritional status, disability, or quality of life compared to baseline.
Removed liver transplant exclusion.
Updated references and removed other specialists except neurology; prescriber must be neurologist or consult with neurologist.
Medical Necessity Criteria for Onpattro (patisiran)
Initial authorization - Onpattro (patisiran) for hATTR-PN
Onpattro will be considered for coverage when ALL of the following are met:
ALL of the following
- Member is at least 18 years of age
- Medication is prescribed by or in consultation with a neurologist
Prescriber requirement restricted to neurology.
- Member has a diagnosis of hereditary transthyretin (hATTR) amyloidosis with documentation of a transthyretin (TTR) mutation confirmed by genetic testing
Genetic testing documentation required.
- Member has signs/symptoms of polyneuropathy
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