CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Osphena (ospemifene) coverage criteria

Policy governing coverage and prior authorization requirements for Osphena (ospemifene) for members of Neighborhood Health Plan of Rhode Island, including step therapy requirements relative to formulary vaginal estradiol products.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOsphena (ospemifene) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date02/01/2020

Next Review DateN/A

Key ActionProvide documentation of trial and inadequate response or intolerance to a formulary vaginal estradiol product (Yuvafem or estradiol cream) within the prior 365 days when submitting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsCoverage duration when approved

365 daysPrior lookback

2019–2025Review history

Coverage Criteria for Osphena (ospemifene)

Initial therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Step requirement: Member has trialed and experienced an inadequate treatment response or intolerance to formulary estradiol (Yuvafem vaginal tablet) or estradiol vaginal cream (generic Estrace)evidence of at least one claim within prior 365 days

Osphena will be paid if there is at least one claim within the last 365 days for the listed estradiol products or if Osphena was previously paid

Coverage duration: If approved, coverage duration is 12 months12 months

Use of Osphena (ospemifene) for investigational purposes is excluded. Neighborhood Health Plan of Rhode Island does not provide coverage when a drug is used at a dose or for a condition that is not recognized as a medically accepted indication in standard reference compendia or peer-reviewed literature.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOsphena (ospemifene) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date02/01/2020

Next Review DateN/A

SourceLink

On This Page

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Initial Therapy

Initial therapy — Initial coverage criteria (detailed logic for starting therapy)

Initial coverage criteria

Required prior therapy: Member must have trialed and experienced an inadequate treatment response or intolerance to formulary estradiol (Yuvafem vaginal tablet) or estradiol vaginal cream (generic Estrace)evidence of at least one claim within prior 365 days

Documentation should demonstrate trial and inadequate response or intolerance; a prior claim within 365 days satisfies the step

Continuation / Renewal Criteria

Continuation therapy — Renewal/continuation criteria

Renewal/continuation

Continuation: Coverage may be renewed for 12 months when approved; continuation may require evidence of ongoing clinical benefit12 months

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation that the member has trialed and experienced an inadequate treatment response or intolerance to at least one formulary estradiol product (Yuvafem vaginal tablet or estradiol vaginal cream — generic Estrace) prior to approval of Osphena.

Coverage Duration: 12 months
Coding logic: Step therapy — at least one claim within the last 365 days for a formulary estradiol product (Yuvafem vaginal tablet or estradiol vaginal cream) or prior Osphena paid claim

Step Therapy

Step Therapy Requirement

Member must have trialed at least one formulary estradiol product (Yuvafem vaginal tablet or estradiol vaginal cream — generic Estrace) and had an inadequate response or intolerance to that product before Osphena will be considered for coverage.

Required trial products: Yuvafem vaginal tablet; estradiol vaginal cream (generic Estrace)
Trial window: evidence of a claim within the past 365 days

Documentation Required

Required Trial Documentation

Documentation submitted with the prior authorization must include evidence of trial and inadequate response or intolerance to a formulary estradiol product (Yuvafem vaginal tablet or estradiol vaginal cream). Acceptable documentation includes medical records, prescription fill history, and clinician notes indicating lack of efficacy or intolerance.

Include dates of trial, medication name, dose, duration, and reason for discontinuation (inadequate response or intolerance)
Pharmacy claim history showing at least one fill within the last 365 days may be used as evidence

Denial Risk

Investigational Use — Denial Risk

Osphena will be denied when used for investigational purposes — i.e., at a dose or for a condition not recognized as a medically accepted indication in standard reference compendia (AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs) or supported by peer-reviewed published medical literature.

Neighborhood does not provide coverage for investigational uses or non–medically accepted indications

Step Therapy Requirements

Requirement	Details
Step therapy requirement	Member must have trialed at least one formulary estradiol product (Yuvafem vaginal tablet or estradiol vaginal cream [generic Estrace]) with inadequate response or intolerance within the prior 365 days before Osphena will be covered; a prior claim for those agents within 365 days or prior payment for Osphena satisfies the requirement.

Coding / Lookback

inv-03: Prior claim lookback — at least one claim within the last 365 days

Lookback periodAt least one claim for a formulary estradiol product (Yuvafem vaginal tablet or estradiol vaginal cream) or Osphena within the prior 365 days

PurposeSatisfies step-therapy requirement prior to coverage of Osphena

Applies toFormulary vaginal estradiol products: Yuvafem (vaginal estradiol tablet) or estradiol vaginal cream (generic Estrace)

Coding logic noteOsphena will pay if there is at least one claim within the last 365 days for the listed estradiol products or if Osphena was previously paid

Definitions

inv-09: Investigational use — use at a dose or for a condition not recognized as medically accepted indications in standard compendia or peer-reviewed literature

DefinitionInvestigational use: use at a dose or for a condition other than those recognized as medically accepted indications in standard compendia or peer‑reviewed literature

Coverage stanceNeighborhood does not provide coverage for drugs when used for investigational purposes

Reference compendiaIncludes AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs, or peer‑reviewed published medical literature

Implication for OsphenaRequests will be excluded if Osphena is used at an unapproved dose or for an unapproved condition

Background

Osphena (ospemifene) is a selective estrogen receptor modulator indicated for treatment of dyspareunia due to vulvar and vaginal atrophy associated with menopause. The policy requires a trial of local vaginal estradiol formulations (such as Yuvafem vaginal tablet or estradiol vaginal cream [Estrace]) with documented inadequate response or intolerance prior to coverage of Osphena. When approved, coverage duration is 12 months, and step-therapy is satisfied if there is evidence of at least one claim for a formulary vaginal estradiol product within the prior 365 days or if Osphena was previously paid.