Coverage stance: covered_with_criteria. Policy number: CP PMN.17. Effective date: 2016-08-01. Last review date: 2024-11-01.
Scope summary: Defines medical necessity criteria, prior authorization requirements, dosing/quantity limits, continuation criteria, contraindications, and formulary/generic redirection for droxidopa (Northera) for commercial and Medicaid lines of business.
Medical necessity / key criteria: Northera is medically necessary when the patient has symptomatic neurogenic orthostatic hypotension (nOH) due to one of the specified causes (primary autonomic failure including Parkinson's disease, multiple system atrophy, or pure autonomic failure; dopamine beta-hydroxylase deficiency; or non‑diabetic autonomic neuropathy), has failed midodrine or fludrocortisone at up to maximally indicated doses unless contraindicated or they caused clinically significant adverse effects, and dosing/quantity limits are observed.
Prior authorization and provider requirements: Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria. Prior authorization requires documentation of failure of midodrine or fludrocortisone at up to maximally indicated doses unless both are contraindicated or cause clinically significant adverse effects. For brand Northera requests, members must use generic droxidopa unless contraindicated or clinically significant adverse effects are experienced.
Dosing, quantity, and continuation limits: Initial and continued therapy limits require total daily dose not to exceed 1800 mg/day and dose not to exceed 6 capsules/day. Initial approval duration is 14 days. For continued therapy, the member must be currently receiving the medication via the benefit or have previously met initial criteria and must be responding positively to therapy; dose increases must not exceed the stated limits.
Contraindications and safety redirection: Contraindication includes history of hypersensitivity to the drug or its ingredients; boxed warning for supine hypertension and guidance to manage or discontinue if supine hypertension cannot be managed. The policy includes redirection to generic droxidopa for brand requests unless contraindicated or clinically significant adverse effects are experienced.