CurrentMass General Brigham Health PlanPolicy N/A

Zelapar (selegiline) ODT prior authorization and coverage

Defines prior authorization, quantity/benefit limits, and clinical coverage criteria for Zelapar (selegiline) orally disintegrating tablet for members of the Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyZelapar (selegiline) ODT prior authorization and coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective Date04/17/2019

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation showing the member was started and stabilized on Zelapar within the past 180 days.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard approval duration

180 daysstabilization window

MassHealth UPPLprogram referenced

Coverage Criteria for Zelapar (selegiline) ODT

Initial Authorization

Covered when ALL of the following are met:

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Overall

Concurrent therapy or administration issues: Member is currently taking carbidopa/levodopa OR member is unable to swallow or use a conventional oral solid dosage form (and is not currently receiving other oral solid dosage forms).
Indication: Zelapar is being used as adjunct therapy for patients with Parkinson disease who are being treated with levodopa/carbidopa and exhibit deterioration in the quality of their response to therapy.

Documentation note: Physician samples are not considered adequate justification for 'started & stabilized' status; documentation must be submitted to support the above criteria.

Physician-provided samples cannot be used as the sole evidence that a member was "started and stabilized" on Zelapar. Started and stabilized status must be documented in the medical record (for example, clinic notes or medication administration records) and demonstrate the member began Zelapar therapy and achieved a stable therapeutic response within the past 180 days. Authorization decisions may be denied if adequate documentation is not submitted.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required; approvals valid 12 months

Prior authorization is required for Zelapar (selegiline) ODT. Approvals, when granted, are valid for 12 months.

Step Therapy

Step therapy designation

This drug is listed under Program Type as Step Therapy (Step Therapy program applies).

Documentation Required

Required documentation for authorization

Submit documentation showing the member was started and stabilized on Zelapar within the past 180 days and evidence that the member is taking carbidopa/levodopa or is unable to swallow or use a conventional oral solid dosage form.

Evidence of initiation and stabilization on Zelapar within 180 days (physician samples are not adequate justification)
Medication history showing concurrent carbidopa/levodopa use OR clinical documentation that the member cannot swallow or use conventional oral solids

Denial Risk

Denial risk for missing stabilization or documentation

Authorization may be denied if the member has not been started and stabilized on Zelapar within the past 180 days or if required documentation is not submitted.

Physician samples do not qualify as proof of 'started & stabilized' status
Lack of documentation showing concurrent carbidopa/levodopa use or inability to use oral solid dosage forms risks denial

Indications and Definitions

Indication — Zelapar (selegiline) ODT

IndicationAdjunct therapy for management of patients with Parkinson disease who are being treated with levodopa/carbidopa and exhibit deterioration in quality of response.

Therapeutic roleUsed as an add-on (adjunct) to levodopa/carbidopa therapy to address worsening response quality.

Target populationPatients with Parkinson disease currently receiving levodopa/carbidopa who experience clinical deterioration in response to that therapy.

Background

Zelapar (selegiline) orally disintegrating tablet is used as adjunct therapy for patients with Parkinson disease who are being treated with levodopa/carbidopa and have experienced a deterioration in the quality of response. Coverage is contingent on documentation that the member was started and stabilized on Zelapar within the past 180 days, and that either the member is currently taking carbidopa/levodopa or is unable to swallow or use a conventional oral solid dosage form. Prior authorization is required and approvals are granted for a defined period when these criteria are met.