CurrentmhnPolicy CP.PMN.17

Droxidopa (Northera)

Defines medical necessity, prior authorization and coverage criteria for droxidopa (generic and brand Northera) for treatment of symptomatic neurogenic orthostatic hypotension (nOH) in adults; applies to commercial and Medicaid lines of business within Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyDroxidopa (Northera)

Policy CodePolicy CP.PMN.17

Change TypeClarifiedadministrative

Effective DateAug 1, 2016

Next Review Date

Key ActionProvider must submit documentation demonstrating the member meets all approval criteria, including trial and failure or intolerance to generic droxidopa before approving brand Northera when applicable.

SourceLink

POLICY UPDATE CHANGES

Policy text includes redirection to generic for brand requests and separates dosing and quantity limits into distinct requirements (noted in revision history).

1800Maximum daily dose allowed

6Maximum capsules per day

14Initial approval duration (days)

12Continued therapy duration (months)

≥18

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Medical Necessity Criteria

Initial Approval — Neurogenic Orthostatic Hypotension

Covered when ALL of the following are met:

ALL of the following

one of
- Primary autonomic failure (Parkinson's disease, multiple system atrophy, or pure autonomic failure)
- Dopamine beta-hydroxylase deficiency
- Non-diabetic autonomic neuropathy
Age is greater than or equal to 18 years
Failure of midodrine or fludrocortisone at up to maximally indicated doses, unless both are contraindicated or clinically significant adverse effects are experienced
Appendix B lists midodrine max 30 mg/day and fludrocortisone max 0.2 mg/day as reference dosing
If request is for brand Northera, patient must use generic droxidopa first unless contraindicated or clinically significant adverse effects are experienced
Dose limits (both required)
- Total daily dose does not exceed 1,800 mg per day<= 1,800 mg/day
- Total capsules per day does not exceed 6 capsules per day<= 6 capsules/day

Initial Approval — Other diagnoses/indications

If request is for an indication not covered above, follow one of the paths below:

ANY of the following

If drug had a recent label change (within 6 months) not reflected in this policy and drug is on formulary/PDL, refer to no coverage criteria policy for relevant line of business (CP.CPA.190 commercial; CP.PMN.255 Medicaid)
If drug had a recent label change and is NOT on formulary/PDL, refer to non-formulary policy for relevant line of business (CP.CPA.190 commercial; CP.PMN.16 Medicaid)
If requested use is not specifically listed under section III and above does not apply, refer to off-label use policy (CP.CPA.09 commercial; CP.PMN.53 Medicaid)

Continued Therapy — Neurogenic Orthostatic Hypotension

Covered when ALL of the following are met:

ALL of the following

ANY of the following
- Currently receiving medication via Centene benefit
- Member has previously met initial approval criteria
- Member is receiving benefit from referenced states/products and applicable state addendums apply (refer to addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
If request is for brand Northera, member must use generic droxidopa, unless contraindicated or clinically significant adverse effects are experienced

Continued Therapy — Other diagnoses/indications

If request is for an indication not covered above, follow one of the paths below:

ANY of the following

If drug had a recent label change (within 6 months) not reflected in this policy and drug is on formulary/PDL, refer to no coverage criteria policy for relevant line of business (CP.CPA.190 commercial; CP.PMN.255 Medicaid)
If drug had a recent label change and is NOT on formulary/PDL, refer to non-formulary policy for relevant line of business (CP.CPA.190 commercial; CP.PMN.16 Medicaid)
If requested use is not specifically listed under section III and above does not apply, refer to off-label use policy (CP.CPA.09 commercial; CP.PMN.53 Medicaid)

Not Authorized / Not Covered

Coverage is not authorized for:

ALL of the following

Non‑FDA approved indications that are not addressed in this policy, unless there is sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09; CP.PMN.53) or other evidence of coverage documents

Product and Presentation

Relevant product and presentationmixed

Northera	Brand name product; capsules available in 100 mg, 200 mg, 300 mg
droxidopa	Generic active ingredient

What Providers Must Do

Prior Authorization

Documentation required for prior authorization

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria.

Prior Authorization

Generic required before brand

If requesting brand Northera, provider must document trial and failure or intolerance/contraindication to generic droxidopa before approval of brand, unless contraindicated or clinically significant adverse effects occurred.

Documentation Required

Efficacy assessment for continued therapy

For continued therapy, provider must document that the member is responding positively to therapy; continued effectiveness should be assessed periodically.

Clinical Background

Droxidopa is a synthetic amino acid precursor of norepinephrine approved for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in adults. The FDA‑approved indications include nOH caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta‑hydroxylase deficiency, and non‑diabetic autonomic neuropathy.

Per the product labeling, effectiveness beyond 2 weeks of treatment has not been established and the continued effectiveness should be assessed periodically. The package insert includes a boxed warning for supine hypertension and recommends reduction or discontinuation of therapy if supine hypertension cannot be managed (for example, by elevation of the head of the bed).

Droxidopa is available as oral capsules in 100 mg, 200 mg, and 300 mg strengths.

Defined Terms

Definitions

nOHNeurogenic orthostatic hypotension

PDParkinson's disease

Numeric Limits and Key Metrics

Thresholds

Maximum daily dose1,800 mg per day

Maximum capsules per day6 capsules per day

Age limit≥ 18 years

14Initial approval duration (days)

12Continued therapy approval (months)

18Minimum age (years) = 18

1800Maximum total daily dose (mg)

Policy Update Changes

2022-07-12clarifiedLatest

Added redirection to generic for brand requests and clarified dosing and quantity limits by separating them into distinct requirements.

Droxidopa (Northera)

Medical Necessity Criteria

Product and Presentation

What Providers Must Do

Clinical Background

Defined Terms

Numeric Limits and Key Metrics

Cross-References

Policy Update Changes