CurrentHealth NetPolicy CP PMN.17

Clinical Policy: Droxidopa (Northera)

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.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Droxidopa (Northera)

Policy CodePolicy CP PMN.17

Change TypeClarifiedrevised references

Effective DateAug 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

4Q 2022 annual review added redirection to generic for brand requests and clarified dosing and quantity limits by separating into separate requirements.

4Q 2020-2024 annual reviews: references reviewed and updated; no significant clinical changes for 2020, 2021, 2023, and 2024.

1FDA approved indication group (nOH)

2Required prior therapies

1800 mg/dayMax total daily dose

6Max capsules/day

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Initial approval duration (days)

Coverage Summary

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.

Initial Therapy Criteria

Prior Authorization

Requirement to try alternatives; Submit documentation to support criteria

Prior authorization requires documentation that the member has failed therapy with midodrine or fludrocortisone at up to maximally indicated doses unless both agents are contraindicated or cause clinically significant adverse effects. The PA must also include supporting clinical documentation such as office chart notes and relevant laboratory results demonstrating the trial and failure or contraindication of these alternatives.

Requirement to try alternatives: failure of midodrine or fludrocortisone at maximally indicated doses unless contraindicated or significant adverse effects
Submit documentation to support criteria: office chart notes, lab results, other clinical information

Billing Rule

Brand-to-generic redirection

Approval Duration

Approval duration: 14 days

Continuation Therapy Criteria

Continued Therapy (Renewal) Criteria

Continued therapy is authorized when ONE of the following is met and dosing limits are observed:

ONE of

Member is currently receiving medication via Centene benefit or member has previously met initial approval criteria
Member is responding positively to therapy (member is receiving benefit)
Member is receiving benefit from the referenced states for the applicable product and regulation (refer to state specific addendums)

Continued dose limits (if request is for dose increase)

Total daily dose does not exceed 1,800 mg per day

Other Diagnoses / Off-Label Use

Other Diagnoses/Indications

For indications not specified in initial/continued therapy sections, ONE of the following must apply:

ONE of

If drug is on the formulary (commercial/marketplace) or PDL (Medicaid), follow the no coverage criteria policy for the relevant line of business (CP.CPA.190 for commercial; CP PMN.255 or other referenced for Medicaid)
If drug is NOT on the formulary or PDL, follow the non-formulary policy for the relevant line of business (CP CPA.190 for commercial; CP PMN.16 for Medicaid)
If requested use is not listed under section III and initial criteria do not apply, refer to off-label use policy (CP CPA.09 for commercial; CP PMN.53 for Medicaid)

Diagnoses/Indications Not Authorized

Provider Actions

Prior Authorization

Submit documentation to support criteria

Submit clinical documentation to support that the member meets all approval criteria. Acceptable documentation includes office chart notes, relevant laboratory results, and other clinical information demonstrating diagnosis, prior therapy trials or contraindications, and clinical status.

Office chart notes
Laboratory results
Other clinical information supporting diagnosis and prior therapy trials/contraindications

Prior Authorization

Requirement to try alternatives

Prior authorization requires documented failure of midodrine or fludrocortisone at up to maximally indicated doses unless both agents are contraindicated or cause clinically significant adverse effects. Document the dosing and outcomes of these trials in the chart.

Failure of midodrine or fludrocortisone at maximally indicated doses required unless contraindicated
Document dosing and outcomes of prior therapy trials

Applicable Codes & Product Strengths

Product NDC / strengths availableNDC

N/A	Capsules available: 100 mg, 200 mg, 300 mg (no specific NDCs listed in policy)

Clinical Evidence & Safety Notes

Droxidopa is a synthetic amino acid precursor of norepinephrine indicated for symptomatic neurogenic orthostatic hypotension (nOH) in adults.

Package labeling note: Effectiveness beyond 2 weeks not established; continued effectiveness should be assessed periodically.

Boxed warning: Supine hypertension.

Definitions

nOH: neurogenic orthostatic hypotension — symptomatic orthostatic dizziness, lightheadedness, or the feeling that you are about to black out in adult patients with neurogenic causes (see approved causes in policy).

PD: Parkinson's disease — listed as a primary autonomic failure cause of nOH in the indication criteria.

Revision History

11/07/2022material_change

Template changes applied to Other diagnoses/indications and Continued therapy sections (template changes to other diagnoses/indications and continued therapy section applied).

07/12/2022material_change

4Q 2022 annual review: added redirection to generic for brand requests and clarified dosing and quantity limits by separating into separate requirements; references reviewed and updated.

11/22/2022material_change

Policy Summary

PayerHealth Net

PolicyClinical Policy: Droxidopa (Northera)

Policy CodePolicy CP PMN.17

Change TypeClarifiedrevised references

Effective DateAug 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria.

SourceLink

On This Page

Brand Northera requests will be redirected to generic droxidopa; approval requires use of generic droxidopa unless the generic is contraindicated or produces clinically significant adverse effects for the member.

Brand-to-generic redirection: brand requests require generic droxidopa unless contraindicated or AE

Dose does not exceed 6 capsules per day<= 6 capsules/day

If request is for brand Northera, member must use generic droxidopa unless contraindicated or clinically significant adverse effects are experienced

Brand-to-generic redirection for renewals

Documentation Required

Demonstrate continued benefit for renewal

For renewal/continued therapy, document that the member is responding positively to droxidopa or that the member previously met the initial approval criteria. Include objective or subjective evidence of benefit in the chart (e.g., improvement in symptoms, clinician assessment) to support continued authorization.

Demonstrate continued benefit for renewal: document positive response or prior meeting of initial criteria

Billing Rule

Dose and quantity limits enforcement

Dose and quantity limits are enforced: total daily dose must not exceed 1,800 mg/day and dosing must not exceed 6 capsules per day. Requests that exceed these limits are not allowed and dose increases must remain within these specified limits.

Dose limit: <= 1,800 mg/day
Quantity limit: <= 6 capsules/day
Requests exceeding limits are not allowed; dose increases must not exceed limits

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety per off-label use policy is provided

Refer to CP.CPA.09 for commercial and CP.PMN.53 for Medicaid

Billing Rule

Brand-to-generic redirection

For brand Northera requests, require the use of generic droxidopa unless the generic is contraindicated for the member or results in clinically significant adverse effects. Indicate contraindication or adverse reaction in submitted documentation if brand use is requested.

Brand-to-generic redirection: require generic droxidopa for brand requests unless contraindicated or AE

Documentation Required

Demonstrate continued benefit for renewal

For renewals, document that the member is responding positively to therapy or that the member previously met the initial approval criteria. Provide clinical notes showing ongoing benefit or prior evidence that met initial requirements.

Document positive response to therapy
Or document that initial approval criteria were previously met

Billing Rule

Dose and quantity limits enforcement

Enforce dosing/quantity limits: total daily dose must be <= 1,800 mg/day and dosing must not exceed 6 capsules per day. Requests exceeding 1,800 mg/day or more than 6 capsules/day are not allowed; dose increases must not exceed these limits. Exceptions require documentation per plan policy.

Total daily dose limit: <= 1,800 mg/day
Maximum capsules per day: <= 6 capsules/day
Requests exceeding limits are not allowed; exceptions require plan documentation/process

4Q 2022 P&T approval for annual review changes (redirection to generic and separation/clarification of dosing and quantity limits).

08/21/2020routine_update

4Q 2020 annual review: no significant changes; references reviewed and updated.

11/20/2020routine_update

4Q 2020 P&T approval noted for annual review.

08/01/2021routine_update

4Q 2021 annual review: no significant changes; references reviewed and updated.

11/21/2021routine_update

4Q 2021 P&T approval noted for annual review.

08/07/2023routine_update

4Q 2023 annual review: no significant changes; references reviewed and updated.

07/19/2024routine_update

4Q 2024 annual review: no significant changes; references reviewed and updated.

11/24/2024routine_updateLatest

4Q 2024 P&T approval noted for annual review (no significant clinical changes; references reviewed and updated).