Ormalvi — Medical Mutual

Initial criteria

• Patient has a confirmed diagnosis of primary hyperkalemic periodic paralysis by meeting at least ONE of the following: (a) increase from baseline in serum potassium concentration ≥ 1.5 mEq/L during a paralytic attack; OR (b) serum potassium concentration > 5.0 mEq/L during a paralytic attack; OR (c) family history of the condition; OR (d) genetically confirmed skeletal muscle sodium channel mutation
• The prescriber has excluded other reasons for acquired hyperkalemia
• Patient has tried oral acetazolamide therapy
• According to the prescriber, acetazolamide therapy did not worsen paralytic attack frequency or severity
• The medication is prescribed by or in consultation with a neurologist or a physician who specializes in the care of patients with primary periodic paralysis (e.g., muscle disease specialist, physiatrist)
• If the request is for Keveyis or Ormalvi, either (a) patient has been established on therapy with Keveyis or Ormalvi; OR (b) patient has tried generic dichlorphenamide products AND cannot take generic dichlorphenamide tablets due to a formulation difference in the inactive ingredient(s) which would result in a significant allergy or serious adverse reaction [documentation required]

Reauthorization criteria

• Patient is currently receiving dichlorphenamide and has responded to therapy (e.g., decrease in the frequency or severity of paralytic attacks) as determined by the prescriber

Approval duration

initial 2 months; reauth 1 year