CurrentCignaPolicy IP0110

Droxidopa (Northera) coverage policy

Defines Cigna medical necessity and coverage criteria for droxidopa (Northera) for adults with symptomatic neurogenic orthostatic hypotension, including required prior therapies, nonpharmacologic measures, and prescriber specialty. Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyDroxidopa coverage criteria (adult symptomatic neurogenic orthostatic hypotension)

Policy CodePolicy IP0110

Change TypeOperational and administrative updates (diagnostic confirmation language removedprescriber list narrowedtitle updated)

Effective DateFeb 15, 2025

Next Review DateFeb 15, 2025

Key ActionObtain prior authorization and document age >18, diagnosis of symptomatic NOH, trials of two other medications, nonpharmacologic measures, and prescriber specialty (cardiologist or neurologist).

SourceLink

POLICY UPDATE CHANGES

Removed requirement that documented diagnosis of 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.

1 yearApproval duration

>=2Required prior meds

18+Minimum age

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Preferred product exception

Preferred product rule

Coverage Criteria for Droxidopa (Northera)

FDA-Approved Indication (Neurogenic Orthostatic Hypotension)

Covered when ALL of the following are met:

Initial FDA-approved indication criteria

Diagnosis and age
- A): Patient is > 18 years of age;
- B): Patient has been diagnosed with symptomatic neurogenic orthostatic hypotension due to primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy;
Prior therapies
- C): Patient has tried two other medications (examples include atomoxetine, dihydroergotamine, fludrocortisone, indomethacin, midodrine, and pyridostigmine);
Non-pharmacologic measures
- D): Patient has initiated non-pharmacological measures including but not limited to elevation of the head of the bed, orthostatic compression garments, and appropriate physical training;
Prescriber
- E): The medication has been prescribed by or in consultation with a cardiologist or a neurologist.
Product preference
- F): Preferred product criteria is met for the product(s) as listed in the employer and individual/ family tables.
Approval duration: 1 year when criteria met

Operational notes

Any use of droxidopa for indications other than those specifically described in this policy is considered experimental, investigational, or unproven and is not covered.

Use of droxidopa for indications other than symptomatic neurogenic orthostatic hypotension is considered not medically necessary and may be denied as experimental or investigational.

Drug Products and Diagnostic Thresholds

Covered drug products (NDCs to be used per benefit)NDCCovered

Northera	droxidopa capsules - brand
droxidopa (generic)	droxidopa capsules - generic

Orthostatic hypotension diagnostic threshold (inv-05)

Diagnostic thresholdSustained fall in blood pressure: systolic drop ≥20 mmHg OR diastolic drop ≥10 mmHg within 3 minutes of standing or head-up tilt

Time windowWithin 3 minutes of standing or during head-up tilt to at least 60°

Measurement contextMeasured as a sustained reduction in SBP or DBP (not a single transient reading)

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approve for 1 year when all medical necessity criteria are met, including: patient is >18 years old, diagnosis of symptomatic neurogenic orthostatic hypotension (NOH) due to primary autonomic failure, dopamine beta-hydroxylase deficiency, or non‑diabetic autonomic neuropathy; trials of two other medications; initiation of non‑pharmacologic measures; and prescription by or in consultation with a cardiologist or neurologist. Receipt of sample product does not satisfy criteria.

Initial approval duration: 12 months
Prescriber requirement: cardiologist or neurologist

Step Therapy

Step Therapy Requirement

Patient must have tried two other medications prior to approval. Examples include atomoxetine, dihydroergotamine, fludrocortisone, indomethacin, midodrine, and pyridostigmine. Document trials of two agents and response or intolerance to those agents.

Step therapy: trial of 2 medications (documented)

Background

Neurogenic orthostatic hypotension (NOH) is a form of orthostatic hypotension caused by inadequate norepinephrine release from sympathetic vasomotor neurons and is frequently associated with conditions such as Parkinson disease, multiple system atrophy, pure autonomic failure, and certain autonomic neuropathies. Symptoms commonly include dizziness, lightheadedness, blurred vision, fatigue, and syncope on standing, and treatment aims to increase standing systolic blood pressure to maintain cerebral perfusion. Droxidopa, a norepinephrine precursor, is approved for the treatment of symptomatic NOH.

Definitions

Orthostatic hypotension (OH) — definition (inv-11)

DefinitionA sustained reduction in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of 10 mmHg within 3 minutes of standing or head-up tilt

Clinical relevanceOH may be symptomatic or asymptomatic; only symptomatic OH requires treatment

Tilt-table specificationHead-up tilt to at least 60° on a tilt table is included in the definition

Neurogenic orthostatic hypotension (NOH) — definition (inv-12)

DefinitionA subset of orthostatic hypotension due to inadequate release of norepinephrine from sympathetic vasomotor neurons leading to vasoconstrictor failure

Common associationsOften chronic and associated with Parkinson disease, multiple system atrophy, and pure autonomic failure

Policy Summary

PayerCigna

PolicyDroxidopa coverage criteria (adult symptomatic neurogenic orthostatic hypotension)

Policy CodePolicy IP0110

Change TypeOperational and administrative updates (diagnostic confirmation language removedprescriber list narrowedtitle updated)

Effective DateFeb 15, 2025

Next Review DateFeb 15, 2025

SourceLink

On This Page

Example agents: atomoxetine; dihydroergotamine; fludrocortisone; indomethacin; midodrine; pyridostigmine

Documentation Required

Required Documentation

Providers must document the following to support approval: patient age (>18), diagnosis of symptomatic NOH with the specified etiologies, documentation of trials of two other medications (including agent names, dates, and reason for failure/intolerance), initiation of non‑pharmacologic measures (e.g., head-of-bed elevation, compression garments, physical training), and that the drug was prescribed by or in consultation with a cardiologist or neurologist. If requesting brand over generic, document inability to tolerate the bioequivalent generic due to formulation differences (e.g., inactive ingredients) causing significant allergy or serious adverse reaction.

Document trials of two medications with reasons for failure/intolerance
Document non-pharmacologic interventions tried
If seeking brand (Northera) over generic, document specific formulation intolerance

Denial Risk

Non‑covered Uses / Denial Risk

Requests that do not meet the listed criteria or requests for any other indications are considered not medically necessary and will be denied. Use of droxidopa for indications other than symptomatic neurogenic orthostatic hypotension (as specified) is considered experimental, investigational, or unproven.

Denial risk: indications outside the FDA‑approved NOH criteria
Denial risk: insufficient documentation of step therapy or prescriber specialty

Typical symptomsDizziness, lightheadedness, blurred vision, fatigue, and fainting upon standing