ModifiedCentenePolicy CP.PMN.136

Mecamylamine (Vecamyl) for hypertension

Policy governing medical necessity and prior authorization criteria for mecamylamine (Vecamyl) for management of moderately severe to severe essential hypertension and uncomplicated malignant hypertension for Centene lines of business.

Policy Summary

PayerCentene

PolicyMecamylamine (Vecamyl) for hypertension

Policy CodePolicy CP.PMN.136

Change TypeStep therapy bypass addedapproval duration extended

Effective DateJun 1, 2017

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis of hypertension, age ≥18, and failure of three different-class antihypertensives unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition and added ICHRA line of business.

12 monthsApproval duration

≥18Minimum age

3Required failed classes

2.5 mg BIDInitiation dosing

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Coverage Criteria for Mecamylamine (Vecamyl)

Initial therapy — Hypertension

Covered when ALL of the following are met for hypertension:

Hypertension initial criteria: Diagnosis of hypertension

Hypertension initial criteria: Age ≥ 18 years

Hypertension initial criteria: Failure of a combination of 3 formulary antihypertensive agents, each from different classes at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated3 agents from different classes

Approval duration: 12 months

Continued therapy

Continuation therapy (must meet all):

Continuation criteria: Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; or (b) currently receiving medication and is enrolled in a state/product with continuity of care regulations

Continuation criteria: Member is responding positively to therapypositive response

Approval duration: 12 months

Other diagnoses/indications

Other/Unlisted uses:

Label changes or unlisted uses: If the drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, follow the listed no-coverage or non-formulary policies for the relevant line of business (see policy references);refer to listed policies

See CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable

Off-label uses: If the requested use is not specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for HIM/ICHRA, CP.PMN.53 for Medicaid).refer to off-label policies

Coverage for uses of mecamylamine that are not FDA‑approved and not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy for the member's line of business (see CP.CPA.09 for Commercial, HIM.PA.154 for HIM/ICHRA, and CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

Mecamylamine has specific contraindications that must be considered prior to approval. Documented contraindications include concomitant use with certain antibiotics or sulfonamides, coronary insufficiency, glaucoma, mild or moderate hypertension, organic pyloric stenosis, recent myocardial infarction, renal insufficiency, uremia, and hypersensitivity to mecamylamine. There are no boxed warnings reported for this product.

All coverage determinations for mecamylamine are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract), as well as applicable state and federal requirements and Health Plan administrative policies. Providers should verify benefits and applicable exclusions in the member's coverage documents when requesting authorization.

Requests for off‑label use of mecamylamine will not be authorized without provision of adequate supporting clinical documentation. Providers must follow the appropriate off‑label use policy for the member's line of business and supply evidence demonstrating efficacy and safety for the requested non‑FDA indication.

This clinical policy is intended as a guide to medical necessity and coverage determinations and does not replace individualized clinical judgment. It does not constitute medical advice or dictate treatment; providers are expected to exercise professional judgment in the care of members and remain solely responsible for medical decisions.

Coding

No specific codes listedmixed

No procedure or billing codes listed in this document.

Eligibility age

Minimum age for coverage>= 18 years

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vecamyl. Providers must request authorization before initiating therapy and include clinical information demonstrating that the member meets the policy criteria.

Authorization requests must include supporting documentation such as office chart notes, relevant lab results, medication history, and documentation of prior therapy failures or contraindications.

Note

Authorization Governed by Plan Documents

Authorization and coverage determinations are governed by the member's specific Health Plan and the terms of the member's coverage documents (e.g., evidence of coverage, certificate of coverage, policy or contract). Providers should verify member benefits and limitations prior to prescribing.

Coverage is subject to plan exclusions, limitations, and state/federal requirements; medical necessity determinations are made in accordance with the applicable Health Plan documents.

Definitions

Mecamylamine (Vecamyl) definition

Drug name (brand/generic)Vecamyl (mecamylamine)

Drug classOral ganglion-blocking antihypertensive agent

FDA-approved indicationsManagement of moderately severe to severe essential hypertension and uncomplicated malignant hypertension

Health Plan definition

Definition'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates, as applicable.

Policy roleGoverns adoption and application of the clinical policy for coverage determinations and benefit administration

Background

Mecamylamine (Vecamyl) is an oral ganglion‑blocking antihypertensive agent indicated for management of moderately severe to severe essential hypertension and in uncomplicated cases of malignant hypertension. As a ganglion blocker, mecamylamine lowers blood pressure by interrupting sympathetic ganglionic transmission. The clinical policy and coverage criteria for mecamylamine are intended to guide use for these specific indications and to support prior authorization decisions; they do not replace provider clinical judgement.