VECAMYL, Mecamylamine HCl Form

Mecamylamine (Vecamyl®) is an oral anti-hypertension agent and ganglion blocker. FDA Approved Indication(s) Vecamyl is indicated for the management of moderately severe to severe essential hypertension and in uncomplicated cases of malignant hypertension. 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 Vecamyl is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Hypertension (must meet all):

1. Diagnosis of hypertension;
2. Age ≥ 18 years;

3. Failure of a combination of 3 formulary antihypertensive agents (see Appendix D for rationale), each from different classes at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated. Approval duration: Medicaid/HIM – 6 months Commercial – Length of Benefit B. Other diagnoses/indications (must meet 1 or 2):

   1. 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, HIM.PA.33 for health insurance marketplace, 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, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or Page 1 of 6

   CLINICAL POLICY Mecamylamine

   2. 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, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Hypertension (must meet all):
   3. 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 currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);

4. Member is responding positively to therapy. Approval duration:
   Medicaid/HIM – 12 months Commercial – Length of Benefit B. Other diagnoses/indications (must meet 1 or 2):

   1. 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, HIM.PA.33 for health insurance marketplace, 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, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. 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, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      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 policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, 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 Page 2 of 6

   CLINICAL POLICY Mecamylamine 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.
   Drug Name Dosing Regimen Dose Limit/ Maximum Dose Refer to the prescribing information Refer to the prescribing information Refer to the prescribing information Angiotensin-converting enzyme (ACE) inhibitors (e.g., lisinopril, enalapril, benazepril) Angiotensin II receptor blockers (ARBs; e.g., losartan, valsartan, candesartan) Refer to the prescribing Thiazide diuretics (e.g., information hydrochlorothiazide) Refer to the prescribing Calcium channel blockers (e.g., information amlodipine, diltiazem, verapamil) Refer to the prescribing Beta blockers (e.g., carvediolol. information metroprolol, nebivolol) Refer to the prescribing Alpha blockers (e.g., prazosin, information terazosin, doxazosin) 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. Refer to the prescribing information Refer to the prescribing information Refer to the prescribing information Refer to the prescribing information Refer to the prescribing information Appendix C: Contraindications/Boxed Warnings • Contraindication(s): concomitant antibiotics or sulfonamides, coronary insufficiency, glaucoma, mild or moderate hypertension, organic pyloric stenosis, recent myocardial infarction, renal insufficiency, uremia, and hypersensitivity to mecamylamine • Boxed warning(s): none reported Appendix D: General Information • Rationale for combination of 3 formulary antihypertensive agents: The recognition that triple-combination therapy is frequently a necessity is based on large-scale studies.
   o In the Study on Cognition and Prognosis in the Elderly (SCOPE) of 4,964 elderly patients with stage 2 hypertension (BP: 160–179⁄90–99 mm Hg), 49% of patients were receiving ≥ 3 antihypertensive agents by the end of the study.
   o Similarly, in the International Verapamil SR and Trandolapril Study (INVEST) involving patients with hypertension (mean BP: 150⁄86 mm Hg) and coronary artery disease, about half of the patients assigned to receive a calcium channel blocker or a beta blocker were receiving ≥ 3 antihypertensive medications at the end of the 2-year follow-up period.
   o In ALLHAT, ≥ 3 antihypertensive agents were necessary for 24% of black patients and 24% of nonblack patients initially assigned to receive chlorthalidone, for 41% and 31%, respectively, initially assigned to receive lisinopril, and for 28% and 25%, respectively, of those initially assigned to receive amlodipine. Page 3 of 6

   CLINICAL POLICY Mecamylamine o At study end point in ACCOMPLISH, 32% of the 11,506 patients with hypertension at high risk for cardiovascular disease were receiving at least 1 other antihypertensive agent in addition to initial therapy with either benazepril ⁄amlodipine or benazepril ⁄hydrochlorothiazide. V. Dosage and Administration
   Indication Hypertension Dosing Regimen Initiate therapy with 2.5 mg PO BID. Titrate in increments of 2.5 mg at intervals of not less than 2 days until desire blood pressure response occurs. Maximum Dose Based on individual response VI. Product Availability
   Tablet: 2.5 mg VII.