Patisiran (Onpattro)
Defines medical necessity criteria, dosing limits, concurrent therapy exclusions, approval durations, and documentation requirements for coverage of patisiran (Onpattro) for hereditary transthyretin-mediated amyloidosis with polyneuropathy across Commercial, Medicaid, and HIM/ICHRA lines of business.
Added Wainua to list of drugs that should not have been previously received or prescribed concurrently.
Removed criteria requiring no prior treatment with Amvuttra, Tegsedi, or Wainua.
Revised initial approval duration for Medicaid/HIM from 6 to 12 months and added ICHRA line of business.
Added concurrent use exclusion with Amvuttra and Tegsedi (historical) and no prior liver transplant criterion in prior revisions.