Subject: Vecamyl 2992-A Supplemental Specialty PA P2021

Drug

VECAMYL  (mecamylamine hydrochloride)

Policy:

I.   INDICATIONS 

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. 

FDA-Approved Indication¹
Management of moderately severe to severe essential hypertension and in uncomplicated cases of malignant hypertension. 

All other indications are considered experimental/investigational and are not a covered benefit.

II.   CRITERIA FOR INITIAL APPROVAL 

A.   Moderately severe to severe essential hypertension
      Authorization of 12 months may be granted to members who are initiating Vecamyl therapy for moderately
      severe to severe essential hypertension who have had a contraindication, intolerance or allergy to a one month
      trial of a drug combination with at least 1 medication from each of the following classes:
      1.  Diuretics
      2.  Angiotensin-converting enzyme inhibitors or Angiotensin II receptor antagonist
      3.  Calcium channel blockers
      4.  Beta Blockers

B.   Uncomplicated malignant hypertension
      Authorization of 3 months may be granted to members who are initiating Vecamyl therapy for
      uncomplicated malignant hypertension who have had a contraindication, intolerance or allergy to a one
      month trial of a drug combination with at least 1 medication from each of the following classes:
      1.   Diuretics
      2.   Angiotensin-converting enzyme inhibitors or Angiotensin II receptor antagonist
      3.   Calcium channel blockers
      4.   Beta Blockers

Place of Service:

Outpatient

The above policy is based on the following references:

1. Vecamyl [prescribing information]. New York, NY: Vyera Pharmaceuticals, LLC.; July 2018.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 12, 2021