CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy and prior authorization criteria for methyldopa

Defines prior authorization and step therapy requirements for coverage of methyldopa under the payer's clinical pharmacy programs; applies to members seeking methyldopa therapy (exceptions for pregnancy).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy and prior authorization criteria for methyldopa

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Next Review DateMay 20, 2025

Key ActionObtain prior authorization and document trials (name and date) of ACE inhibitor, ARB, calcium channel blocker, and diuretic unless the patient is pregnant.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Step Therapyprogram type

12 monthsauthorization duration

Methyldopamedication

Yespregnancy exception

Coverage criteria overview

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Pregnancy: Patient is pregnant

Direct approval for pregnancy

Prior therapy failure/contraindication/intolerance: History of failure, contraindication or intolerance to all of the following (provider must document name and date tried): ACE inhibitor (e.g., lisinopril); ARB (e.g., valsartan); calcium channel blocker (e.g., amlodipine); diuretic (e.g., hydrochlorothiazide).

Document name and date tried for each agent

Coverage decisions for methyldopa are subject to applicable state mandates, any relevant federal regulatory requirements, and the member's individual benefit plan provisions. These requirements may modify or supersede the criteria described in this policy and should be checked before authorizing therapy.

Other payer policies and utilization management programs may also apply and could affect coverage. When there is a conflict between this clinical policy and a mandated requirement (state or federal) or the member’s benefit plan, the mandate/benefit plan takes precedence.

Initial therapy criteria for methyldopa

Initial therapy — top-level initial coverage criteria

Initial coverage criteria

Pregnancy exemption: Patient is pregnant.

Pregnancy allows approval without prior trials

Required prior agents: Documented failure, contraindication, or intolerance to all of: ACE inhibitor (e.g., lisinopril); ARB (e.g., valsartan); calcium channel blocker (e.g., amlodipine); diuretic (e.g., hydrochlorothiazide). Provider must document name and date tried for each agent.

All four classes required unless pregnancy

Provider actions and documentation requirements

Prior Authorization

Prior authorization required

Prior authorization is required for methyldopa unless the patient is pregnant. Approval is granted when the patient is pregnant or when the provider documents failure, contraindication, or intolerance to all required lower-cost alternatives.

Prior authorization required unless patient is pregnant
Approval criteria: patient is pregnant OR documented failure/contraindication/intolerance to all required agents
Authorization duration: 12 months
State mandates, federal requirements, and member-specific benefit plan coverage may affect coverage

Step Therapy

Step therapy requirements

A trial of lower-cost alternative antihypertensive agents is required prior to coverage of methyldopa unless the patient is pregnant. Providers must document the specific agents tried and the dates of the trials.

Required prior trials (name and date tried must be documented): ACE inhibitor (e.g., lisinopril); ARB (e.g., valsartan); Calcium channel blocker (e.g., amlodipine); Diuretic (e.g., hydrochlorothiazide)
Pregnancy exemption: no prior trials required if patient is pregnant

Documentation Required

Prior trial documentation required

When requesting prior authorization, the provider must document the name of each required prior agent and the date it was tried. If claiming a contraindication or intolerance, the provider must include supporting documentation specifying the nature of the contraindication or intolerance.

Document for each required agent: drug name and date(s) tried
If not tried, provide documentation of contraindication or intolerance with specifics

Denial Risk

Missing prior trials may lead to denial

Failure to document prior trials or to provide evidence of contraindication/intolerance to the required agents may result in denial of the request for methyldopa coverage.

Missing documentation of trials, contraindications, or intolerances may trigger denial
Verify records include dates and agent names to avoid denial

Step therapy requirements

Requirement	Details
Step therapy requirement	Trial of lower-cost alternatives required prior to methyldopa unless the patient is pregnant: documented trial (or documented contraindication/intolerance) of an ACE inhibitor (e.g., lisinopril), an ARB (e.g., valsartan), a calcium channel blocker (e.g., amlodipine), and a diuretic (e.g., hydrochlorothiazide). Provider must document name and date tried for each agent.
Pregnancy exception	If the patient is pregnant, methyldopa may be approved without trials of the required prior agents.
Documentation required	Provider must document the name and date tried for each required prior agent when requesting approval based on prior failure, contraindication, or intolerance.
Denial risk	Failure to document trials, contraindications, or intolerances to the ACE inhibitor, ARB, CCB, and diuretic may result in denial of coverage.

Reauthorization and continuation criteria

Authorization duration — reauthorization rules and duration (e.g., 12 months)

Reauthorization rules

Reauthorization duration: Authorization will be issued for 12 months.12 months

Reauthorize based on standard program rules

Key definitions

inv-08: Methyldopa — definition and short description

Drug classAromatic-amino-acid decarboxylase inhibitor

IndicationHypertension

Pregnancy guidanceRecommended as a first-line option for hypertension in pregnancy by the American Heart Association

Program noteStep therapy required — lower-cost alternatives must be tried before methyldopa unless the patient is pregnant

Background and clinical context

Methyldopa is authorized under this program with an issuance period of 12 months. Providers should confirm any state-specific mandates, federal requirements, or member benefit limitations that could alter authorization duration or coverage prior to prescribing.

If other utilization management policies apply to the member (for example, step therapy or prior authorization rules from another program), those rules must be followed in addition to the criteria specified here.