CurrentCignaPolicy IP0110

Droxidopa (Northera) for Neurogenic Orthostatic Hypotension

This Cigna coverage policy governs prior authorization and medical necessity criteria for droxidopa (Northera) for treatment of symptomatic neurogenic orthostatic hypotension in adults and applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyDroxidopa (Northera) for Neurogenic Orthostatic Hypotension

Policy CodePolicy IP0110

Change TypeAnnual revision with material coverage and documentation clarifications

Effective Date

Next Review Date

Key ActionObtain prior authorization and document trials of two other NOH medications and required supporting records.

SourceLink

POLICY UPDATE CHANGES

Removed 'Documented diagnosis of Neurogenic Orthostatic Hypotension (NOH) is confirmed by a sustained decrease in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg within 3 minutes of standing OR during a head-up tilt-table test'.

Removed nephrologist from list of specialist prescribers.

Policy name changed from Northera to Droxidopa.

Documentation: Documentation is required where noted in the criteria as [documentation required] and must include patient-specific identifying information.

Clarified requirement from 'Patient has tried two other medications' to 'Patient has tried two other medications for the treatment of neurogenic orthostatic hypotension.'

Prior Authorization requiredadministrative requirement

Age >18minimum patient age for FDA indication

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Coverage and Medical Necessity

Medical necessity criteria (initial authorization)

Droxidopa is considered medically necessary when ALL of the following are met:

FDA-Approved Indication: Patient has symptomatic neurogenic orthostatic hypotension due to primary autonomic failure (Parkinson's disease, multiple system atrophy, pure autonomic failure), dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy.

Age: Patient is > 18 years of age.>18

Prior medication trials: Patient has tried two other medications for the treatment of neurogenic orthostatic hypotension.2 agents

Examples include atomoxetine, dihydroergotamine, fludrocortisone, indomethacin, midodrine, pyridostigmine.

Non-pharmacologic measures: Patient has initiated non-pharmacological measures.

Examples include elevation of the head of the bed, orthostatic compression garments, and appropriate physical conditioning; listed as a Note in policy.

Prescriber specialty: Medication prescribed by or in consultation with a cardiologist or neurologist.

Nephrologist removed as acceptable prescriber in revision.

Preferred product criteria: For brand Northera: patient has tried the bioequivalent generic droxidopa capsules (documentation required) and cannot take the generic due to inactive ingredient differences causing a significant allergy or serious adverse reaction per the prescriber.

Applies to Employer and Individual/Family plans as specified; documentation required.

Northera (droxidopa) for any other use is considered not medically necessary.

Use of Northera for indications other than neurogenic orthostatic hypotension is considered not medically necessary.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of droxidopa. All approvals are provided for the duration noted in the policy (approve for 1 year if criteria met). Because of the specialized skills required for evaluation and diagnosis of patients treated with droxidopa as well as the monitoring required for adverse events and long-term efficacy, approval requires droxidopa to be prescribed by or in consultation with a physician who specializes in the condition being treated. Documentation is required where noted in the criteria as [documentation required]. Documentation may include, but is not limited to, chart notes, laboratory tests, claims records, and/or other information. All documentation must include patient-specific identifying information.

Prior authorization required: Approvals provided for up to 1 year when criteria are met.
Prescriber requirement: Must be prescribed by or in consultation with a specialist (e.g., cardiologist or neurologist) as noted in the criteria.
Documentation required: Provide chart notes, lab tests, claims records, or other patient-specific documentation where indicated in criteria.

Key Definitions

Orthostatic hypotension (OH) — definition and diagnostic threshold

DefinitionOrthostatic hypotension (OH) is a sustained reduction in systolic blood pressure (SBP) of at least 20 mmHg or diastolic blood pressure (DBP) of 10 mmHg within 3 minutes of standing or head-up tilt to at least 60°.

Diagnostic thresholdDecrease in SBP ≥ 20 mmHg or DBP ≥ 10 mmHg within 3 minutes of standing (or on head-up tilt to ≥ 60°).

Symptomatic vs asymptomaticOH may be symptomatic or asymptomatic; only symptomatic OH requires treatment.

Treatment goalFor symptomatic OH, aim to increase standing systolic blood pressure into compensatory cerebrovascular autoregulation range (~50–150 mmHg).

Neurogenic Orthostatic Hypotension (NOH) — definition and associated conditions

Definition

Clinical Background

Neurogenic orthostatic hypotension (NOH) is a form of orthostatic hypotension caused by failure of sympathetic norepinephrine release, leading to symptomatic drops in blood pressure on standing with symptoms such as dizziness, lightheadedness, blurred vision, and syncope. Treatment goals are to raise standing systolic blood pressure into the autoregulatory range and reduce symptom burden; pharmacologic options include droxidopa and midodrine, with nonpharmacologic measures and other agents used as adjuncts.

Billing Rule

Preferred Product / Brand Override

Employer, Individual and Family Plans require trial of the bioequivalent generic droxidopa capsules before coverage of the brand (Northera) will be approved. If the generic was tried, documentation is required showing the trial of the bioequivalent generic product. An override to the brand is allowed only when the prescriber documents that the patient cannot take the bioequivalent generic due to a formulation difference in inactive ingredient(s) (e.g., dyes, fillers, preservatives) that would, per the prescriber, result in a significant allergy or serious adverse reaction. Receipt of sample product does not satisfy trial requirements.

Employer Plans: Trial of bioequivalent generic droxidopa capsules required; provide documentation of trial and prescriber statement that inactive ingredient difference prevents use of generic.
Individual & Family Plans: Same requirement as Employer Plans; documentation required.
Sample products: Receipt of samples does NOT satisfy the trial requirement.

Step Therapy

Step Therapy Requirement

For FDA-approved indication of neurogenic orthostatic hypotension, patient must have tried two other medications for treatment of neurogenic orthostatic hypotension prior to authorization of droxidopa. Examples of other medications include atomoxetine, dihydroergotamine, fludrocortisone, indomethacin, midodrine, and pyridostigmine. Patient must have initiated appropriate non-pharmacologic measures and the medication must be prescribed by or in consultation with a cardiologist or neurologist.

Step therapy: Patient must have tried two other medications for neurogenic orthostatic hypotension (examples listed in policy).
Non-pharmacologic measures: Patient should have attempted measures such as elevation training, head-of-bed elevation, and compression garments.
Specialist prescriber: Medication must be prescribed by or in consultation with a cardiologist or neurologist.