CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 3152-5

Step therapy for Elmiron (pentosan polysulfate sodium)

This program defines step therapy requirements for coverage of Elmiron for treatment of bladder pain/discomfort associated with interstitial cystitis, requiring prior trial of amitriptyline; it applies to members under the payer's pharmacy clinical programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Elmiron (pentosan polysulfate sodium)

Policy CodePolicy 2025 P 3152-5

Change TypeAnnual reviewupdated references

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting trial and failure, contraindication, or intolerance to amitriptyline before requesting Elmiron; approvals are issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Annual review; updated references.

Program effective date listed as 6/1/2025.

12 moauthorization duration

1 agentstep therapy trial

2020-2025P&T approvals

Coverage Criteria

Initial Therapy

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Coverage of Elmiron is subject to state mandates and any applicable federal regulatory requirements. In addition, member-specific benefit plan coverage may restrict approval for this medication; providers should verify the member's benefit plan for any exclusions or limitations prior to submission. Other payer policies and utilization management programs may also apply and could affect coverage determinations.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Elmiron (pentosan polysulfate sodium). Providers must obtain prior authorization before initiating therapy.

Prior authorization required for Elmiron (Program 2025 P 3152-5).
P&T Approval Dates: 12/2020, 12/2021, 12/2022, 1/2024, 3/2025.

Step Therapy

Required Trial of Lower‑Cost Alternative

A trial of a lower-cost alternative, specifically amitriptyline, is required before Elmiron will be covered. This step therapy requirement is intended to encourage use of lower-cost alternatives.

Required trial: amitriptyline prior to Elmiron coverage.
Step therapy program applies to Elmiron for interstitial cystitis indication.

Documentation Required

Required Documentation & Duration

Providers must document the prior trial with amitriptyline, including evidence of failure, contraindication, or intolerance. Authorizations, when approved, will be issued for 12 months.

Documentation must show history of failure, contraindication, or intolerance to amitriptyline.
Authorizations valid for 12 months.
State mandates and member-specific benefit plan limits may affect coverage; federal requirements and other UM programs may also apply.

Denial Risk

Step Therapy Requirement

Coverage is contingent on a documented history of failure, contraindication, or intolerance to amitriptyline. If such documentation is not provided, coverage may be denied.

Coverage condition: history of failure, contraindication, or intolerance to amitriptyline must be documented.
Absence of required documentation may result in denial of coverage.

Initial Therapy

Initial coverage

Initial coverage requirement

Required prior agent: History of failure, contraindication, or intolerance to amitriptyline is required prior to Elmiron coverage

Authorization will be issued for 12 months; state mandates and member benefit plan may affect coverage

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization rules

Reauthorization: Authorization may be renewed for up to 12 months using automated processes or based on prior claim/medication history and diagnosis code logic

State mandates and member benefit plan coverage may impact reauthorization

Step	Required prior agent	Coverage status	Notes / documentation
1	Amitriptyline (history of failure, contraindication, or intolerance required)	Covered with criteria	Provider must document prior trial, intolerance, or contraindication to amitriptyline; approval issued for 12 months.

Background

Elmiron (pentosan polysulfate sodium) is used to relieve bladder pain or discomfort associated with interstitial cystitis. The payer requires step therapy to encourage the use of lower-cost alternatives before authorizing Elmiron; specifically, a documented history of failure, contraindication, or intolerance to amitriptyline is required. When prior authorization is granted, it will be issued for 12 months.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Elmiron (pentosan polysulfate sodium)

Policy CodePolicy 2025 P 3152-5

Change TypeAnnual reviewupdated references

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting trial and failure, contraindication, or intolerance to amitriptyline before requesting Elmiron; approvals are issued for 12 months.

SourceLink

On This Page

OpenPayer

Step therapy for Elmiron (pentosan polysulfate sodium)

Coverage Criteria

Provider Actions & Requirements

Initial Therapy

Reauthorization / Continuation Criteria

Step Therapy Requirement

Definitions

Background