Droxidopa (Northera) Form

Droxidopa (Northera®) is a synthetic amino acid precursor of norepinephrine. FDA Approved Indication(s) Northera is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non- diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of Northera should be assessed periodically. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Northera is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Neurogenic Orthostatic Hypotension (must meet all):

1. Diagnosis of symptomatic nOH caused by one of the following (a, b, or c): a. Primary autonomic failure (PD, multiple system atrophy, or pure autonomic failure); b. Dopamine beta-hydroxylase deficiency; c. Non-diabetic autonomic neuropathy;
2. Age ≥ 18 years;
   3. Failure of midodrine or fludrocortisone at up to maximally indicated doses, unless both are contraindicated or clinically significant adverse are experienced;
   4. If request is for brand Northera, member must use generic droxidopa, unless contraindicated or clinically significant adverse effects are experienced;

3. Dose does not exceed both of the following (a and b): a. 1,800 mg per day; b. 6 capsules per day.
   Approval duration: 14 days
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   Droxidopa B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.16 for Medicaid; or
5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Neurogenic Orthostatic Hypotension (must meet all):
6. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is receiving benefit from the referenced states for the applicable product and regulation (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
7. Member is responding positively to therapy;
   3. If request is for brand Northera, member must use generic droxidopa, unless contraindicated or clinically significant adverse effects are experienced;
8. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. 1,800 mg per day; b. 6 capsules per day.
   Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):
9. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.16 for Medicaid; or

10. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and CP.PMN.53 for Medicaid.
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    Droxidopa III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy – CP.CPA.09 for commercial and CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration nOH: neurogenic orthostatic hypotension PD: Parkinson’s disease
    Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Dosing Regimen Drug Name midodrine
    10 mg PO TID at 3 to 4 hour intervals (during daytime hours) 0.1 to 0.2 mg PO QD fludrocortisone
    Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. 0.2 mg/day Dose Limit/ Maximum Dose 30 mg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): history of hypersensitivity to the drug or its ingredients • Boxed warning(s): supine hypertension Appendix D: General Information • Symptoms of nOH may include lightheadedness, dizziness, visual disturbances, presyncope, and syncope in response to sudden postural change. • Effectiveness of Northera beyond two weeks of treatment has not been established. Per package labeling for Northera, continued effectiveness of Northera should be assessed periodically. • The package labeling for Northera includes a Black Box warning for reduction or discontinuation of Northera if supine hypertension cannot be managed by elevation of the head of the bed. V. Dosage and Administration
    Indication Dosing Regimen nOH 100 mg PO TID during the day Maximum Dose 1,800 mg/day
    Titrate to symptomatic response, in increments of 100 mg PO TID every 24-48 hours up to a maximum dose of 600 mg PO TID. Page 3 of 6

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    Droxidopa VI. Product Availability
    Capsules: 100 mg, 200 mg, 300 mg VII.