CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Osphena (ospemifene) coverage

Defines prior authorization and coverage criteria for Osphena (ospemifene) for members of Neighborhood Health Plan of Rhode Island, including required step therapy with formulary vaginal estradiol products. Affects prescribers and pharmacy benefit administrators.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOsphena (ospemifene) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization showing trial and inadequate response or intolerance to a formulary vaginal estradiol product before Osphena is approved.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthscoverage duration

365 dayslook-back

1required prior trials

Coverage Criteria

Initial therapy

Covered when ALL of the following are met

Initial coverage criteria: Member has trialed and experienced an inadequate treatment response or intolerance to formulary estradiol/Yuvafem vaginal tablet or estradiol vaginal cream (generic Estrace)1 trial

Plan will pay if there is at least one paid claim within the last 365 days for a listed comparator or Osphena

Neighborhood Health Plan of Rhode Island does not provide coverage for drugs when used for investigational purposes. Therapies are considered investigational when used at a dose or for a condition other than those recognized as medically accepted indications in standard compendia (for example, AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) or when peer‑reviewed literature does not demonstrate sufficient evidence to support the use.

Initial Therapy

Initial therapy — Initial authorization requires

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOsphena (ospemifene) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization showing trial and inadequate response or intolerance to a formulary vaginal estradiol product before Osphena is approved.

SourceLink

On This Page

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Required prior trial: Trial and inadequate response or intolerance to formulary estradiol/Yuvafem vaginal tablet or estradiol vaginal cream (generic Estrace)1 trial

Evidence may be shown by a paid claim within the last 365 days

Continuation / Renewal Criteria

Continuation therapy

Continuation/renewal

Renewal: Coverage duration is 12 months per approval12 months

Step Therapy Requirements

Requirement	Details
Step therapy prerequisite	Member must have trialed and experienced an inadequate treatment response or intolerance to a formulary estradiol/Yuvafem vaginal tablet or estradiol vaginal cream (generic Estrace).
Step therapy look-back	At least one paid claim for a listed comparator (formulary estradiol/Yuvafem vaginal tablet or estradiol vaginal cream [generic Estrace]) or Osphena within the last 365 days.
Coverage duration upon approval	Authorization is granted for 12 months.

Drugs and Coding

Drugs referenced for coverage and step therapyNDC|brand

Osphena (ospemifene)	Brand/generic drug name referenced in policy
Yuvafem	Formulary estradiol vaginal tablet referenced for step therapy
Estrace (estradiol vaginal cream)	Estradiol vaginal cream (generic) referenced for step therapy

Step therapy look-back

Look-back periodAt least one paid claim within the last 365 days for a listed comparator or Osphena

Comparator products countedFormulary estradiol/Yuvafem vaginal tablet or estradiol vaginal cream (generic Estrace)

Purpose of look-backEvidence of prior paid claim is used to satisfy the step-therapy requirement for Osphena coverage

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Osphena (ospemifene). Providers must document a trial and inadequate response or intolerance to a formulary vaginal estradiol product (Yuvafem vaginal tablet or estradiol vaginal cream, e.g., generic Estrace) before approval.

Formulary alternatives: Yuvafem vaginal tablet or estradiol vaginal cream (generic Estrace)
Coverage duration: 12 months

Step Therapy

Step Therapy and Claim Look-back

Osphena is subject to step therapy. Coverage will be approved only after the member has tried a formulary estradiol/Yuvafem vaginal tablet or estradiol vaginal cream and experienced inadequate response or intolerance.

Step therapy look-back: paid claim for formulary estradiol/Yuvafem vaginal tablet, estradiol vaginal cream (generic Estrace), or Osphena within the last 365 days satisfies coding logic for step therapy.

Documentation Required

Required Medical Information

Document in the prior authorization request that the member trialed and experienced an inadequate treatment response or intolerance to a formulary estradiol/Yuvafem vaginal tablet or estradiol vaginal cream (generic Estrace). Include dates, medications tried, doses, duration, and reason for discontinuation or failure.

Required elements: medication name, start and stop dates, dose, duration of trial, clinical reason for inadequate response or intolerance (e.g., side effects, lack of efficacy)

Denial Risk

Step Therapy Prerequisite — Denial Risk

Coverage may be denied if there is no record of a trial and inadequate response or intolerance to a formulary estradiol/Yuvafem vaginal tablet or estradiol vaginal cream (generic Estrace). Neighborhood does not cover investigational uses or uses outside recognized indications.

Denial risk: absent documentation of step therapy trial and failure/intolerance
Investigational use: not covered if used at dose or for condition not recognized in standard compendia

Definitions

Step therapy prerequisite for Osphena

Step therapy requirementMember must trial and have inadequate response or intolerance to a formulary estradiol/Yuvafem vaginal tablet or estradiol vaginal cream (generic Estrace) prior to Osphena

Evidence acceptedDocumentation may include a paid claim for the comparator product within the last 365 days

Required trial countOne trial of a formulary estradiol product is required

Coverage consequencePlan may deny coverage if there is no record of trial and inadequate response or intolerance to the formulary estradiol product

Background

Osphena (ospemifene) is an oral selective estrogen receptor modulator indicated for treatment of moderate‑to‑severe dyspareunia due to vulvar and vaginal atrophy associated with menopause. Prior authorization for Osphena requires documentation that the member has trialed and experienced an inadequate treatment response or intolerance to a formulary vaginal estradiol product (formulary estradiol/Yuvafem vaginal tablet or estradiol vaginal cream, generic Estrace). Authorization, when approved, is granted for 12 months and coverage is subject to step therapy and claim look‑back requirements described in this policy.