CurrentColorado Rocky Mountain Health PlansPolicy 1 = 2025 P 3050-16

Step Therapy — Insulin (UnitedHealthcare Pharmacy Clinical Pharmacy Programs)

Defines step therapy prior authorization criteria for specified insulin brands and formulations for Colorado Rocky Mountain Health Plans members under UnitedHealthcare Pharmacy Clinical Pharmacy Programs; affects prescribers and pharmacy benefit administrators requesting coverage for listed insulins.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep Therapy — Insulin (UnitedHealthcare Pharmacy Clinical Pharmacy Programs)

Policy CodePolicy 1 = 2025 P 3050-16

Change TypeNo material changes

Effective DateFeb 1, 2026

Next Review DateFeb 1, 2026

Key ActionObtain prior authorization and document a ≥3-month trial of preferred insulin(s) or a contraindication/intolerance to qualify for coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

11+listed insulin products

3 monthsrequired prior trial

Apidra, Fiasp…example covered products

Coverage Criteria — Step Therapy and Product Rules

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Initial therapy and step requirements by product

Covered when ALL of the following are met for each product-specific branch:

Novolin 70/30 approval: History of failure after at least a three month trial, contraindication, or intolerance (list reason for therapeutic failure, contraindication, or intolerance) to Humulin 70/30.3 months trial or documented contraindication/intolerance

Applies to Novolin 70/30

Apidra/Apidra SoloStar/Kirsty/Merilog/Novolog approval: History of failure after at least a three month trial, contraindication, or intolerance (list reason for therapeutic failure, contraindication, or intolerance) to Humalog or insulin lispro (unbranded Humalog).3 months trial or documented contraindication/intolerance

Applies to listed rapid-acting analogs (pens and vials)

Fiasp approval: History of failure after at least a three month trial, contraindication, or intolerance (list reason for therapeutic failure, contraindication, or intolerance) to BOTH Humalog or insulin lispro (unbranded Humalog) AND Lyumjev.3 months trial of each alternative or documented contraindication/intolerance

Fiasp requires failure of two alternatives

Novolin N approval: History of failure after at least a three month trial, contraindication, or intolerance (list reason for therapeutic failure, contraindication, or intolerance) to Humulin N.3 months trial or documented contraindication/intolerance

Applies to intermediate-acting Novolin N

Novolin R approval: History of failure after at least a three month trial, contraindication, or intolerance (list reason for therapeutic failure, contraindication, or intolerance) to Humulin R.3 months trial or documented contraindication/intolerance

Applies to regular Novolin R

Novolog Mix 70/30 approval: History of failure after at least a three month trial, contraindication, or intolerance (list reason for therapeutic failure, contraindication, or intolerance) to Humalog 75/25.3 months trial or documented contraindication/intolerance

Applies to Novolog Mix 70/30 (pens and vials)

Coverage criteria may be affected by law and by the member’s specific benefit plan. State mandates, federal regulatory requirements, and the individual member benefit plan can modify or override the criteria below. Other UnitedHealthcare policies and utilization management programs may also apply and should be checked when submitting an authorization request.

Certain products listed in this policy are noted with an asterisk to indicate they are typically excluded from coverage unless the stated criteria are met. The starred products are: Apidra, Apidra SoloStar, Fiasp, Kirsty, Merilog, Humalog vials (Humalog cartridge, Jr Pen and KwikPen not included), Novolin N, Novolin R, Novolin 70/30, Novolog, and Novolog Mix 70/30. For members in Connecticut, Kentucky, and Mississippi business, a shortened prior trial period of 30 days may apply per business exception. Review member-specific benefits and state requirements before submitting an authorization.

Prior Authorization, Documentation, and Step Therapy Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required and, when approved, will be issued for 12 months.

Documentation Required

Required Clinical Justification

Approval requires documented clinical justification that the member has a history of therapeutic failure after the required trial, or has a documented contraindication or intolerance. The provider must list the reason for therapeutic failure, contraindication, or intolerance in the clinical record.

Denial Risk

Missing Prior-Trial or Contraindication Documentation — Denial Risk

If documentation of the required prior trial or a documented contraindication/intolerance is not provided, the request is at risk for denial. For certain states or business lines shorter trial lengths apply (e.g., 30-day trial for CT, KY, MS) and state mandates or member-specific benefit plans may affect requirements—include state-specific rationale when applicable.

Step Therapy

Step Therapy Requirement

Step therapy: approval is contingent on documented failure after the required trial period or documented contraindication/intolerance to the specified preferred product(s). For example, approvals require failure (or contraindication/intolerance) to the listed comparator(s) for each product per the policy criteria.

Initial Therapy Rules — Product-Specific

Initial therapy rules

Product-specific initial coverage criteria (step therapy):

Novolin 70/30 initial: Requires history of failure after at least a three month trial, contraindication, or intolerance to Humulin 70/30; list reason for therapeutic failure, contraindication, or intolerance.3 months

See Novolin 70/30 criteria

Apidra/Apidra SoloStar/Kirsty/Merilog/Novolog initial: Requires history of failure after at least a three month trial, contraindication, or intolerance to Humalog or insulin lispro (unbranded Humalog); list reason for therapeutic failure, contraindication, or intolerance.3 months

Applies to pens and vials

Fiasp initial: Requires history of failure after at least a three month trial, contraindication, or intolerance to BOTH Humalog or insulin lispro (unbranded Humalog) AND Lyumjev; list reasons for therapeutic failure, contraindication, or intolerance.3 months each

Updated to require both alternatives for all ages

Novolin N initial: Requires history of failure after at least a three month trial, contraindication, or intolerance to Humulin N; list reason for therapeutic failure, contraindication, or intolerance.3 months

Novolin R initial: Requires history of failure after at least a three month trial, contraindication, or intolerance to Humulin R; list reason for therapeutic failure, contraindication, or intolerance.3 months

Novolog Mix 70/30 initial: Requires history of failure after at least a three month trial, contraindication, or intolerance to Humalog 75/25; list reason for therapeutic failure, contraindication, or intolerance.3 months

Applies to pens and vials

Step Therapy Operational Rules

Step	Requirement
Try preferred agent(s) for the required duration (generally at least a three-month trial)	Documentation must show history of therapeutic failure after the required trial, or document a contraindication or intolerance and the reason for the exception (e.g., failure/intolerance to Humulin 70/30 for Novolin 70/30)
If contraindicated or intolerant to the preferred agent(s), the provider must document the specific reason for the contraindication or intolerance	Examples per product: Apidra/Apidra SoloStar/Kirsty/Merilog/Novolog require failure/contraindication to Humalog or insulin lispro; Novolin N requires failure/contraindication to Humulin N; Novolin R requires failure/contraindication to Humulin R; Novolog Mix 70/30 requires failure/contraindication to Humalog 75/25
Fiasp-specific requirement	Approval requires documented failure after at least a three-month trial, contraindication, or intolerance to BOTH Humalog (or insulin lispro) AND Lyumjev; document reasons for each

Definitions

Step therapy definition

DefinitionStep therapy: requirement to try and fail preferred agents before coverage of non-preferred agents is authorized.

Required trial and failure criteriaApproval of non-preferred insulins requires documented failure after the required trial (typically >= 3 months) or documented contraindication/intolerance to the specified preferred alternative(s).

Product-specific applicationSome products (e.g., Fiasp) require failure of two alternatives (Humalog/insulin lispro AND Lyumjev) before approval of the non-preferred agent.

Documentation expectationsProvider must list the reason for therapeutic failure, contraindication, or intolerance for the preferred agent(s) tried.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep Therapy — Insulin (UnitedHealthcare Pharmacy Clinical Pharmacy Programs)

Policy CodePolicy 1 = 2025 P 3050-16

Change TypeNo material changes

Effective DateFeb 1, 2026

Next Review DateFeb 1, 2026

Key ActionObtain prior authorization and document a ≥3-month trial of preferred insulin(s) or a contraindication/intolerance to qualify for coverage.

SourceLink

On This Page

OpenPayer

Step Therapy — Insulin (UnitedHealthcare Pharmacy Clinical Pharmacy Programs)

Coverage Criteria — Step Therapy and Product Rules

Coding and Prior Trial Durations

Prior Authorization, Documentation, and Step Therapy Actions

Initial Therapy Rules — Product-Specific

Reauthorization and Continuation Rules

Step Therapy Operational Rules

Quantity Limits

Site of Care

Definitions

Background and Clinical Context