CurrentMass General Brigham Health PlanPolicy N/A

Osmolex ER (amantadine extended release) prior authorization

Defines prior authorization criteria and coverage rules for Osmolex ER (amantadine ER) under the commercial/exchange pharmacy benefit for adults with Parkinson's disease or drug-induced extrapyramidal symptoms.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOsmolex ER (amantadine extended release) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation of diagnosis, age, and prior trial/outcome with immediate‑release amantadine.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Prior Authprogram type

24 monthsapproval duration

≥18minimum age

30/30dqty limit (single strengths)

1-timetherapy pack

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Initial Authorization Criteria

Covered when ALL of the following are met

Indication: Member has a diagnosis of Parkinson's disease or treatment of drug-induced extrapyramidal symptoms

Age: Member is >= 18 years of age>= 18 years

Prior therapy: Member has had an inadequate response, adverse reaction, or contraindication to immediate‑release amantadine

Continuation for members already on Osmolex ER

Alternate pathway

Current therapy: Members new to the plan who are currently receiving treatment with Osmolex ER may be authorized (excludes products obtained as samples or via manufacturer's patient assistance programs)

Documentation of current treatment required

Reauthorization requirement: Reauthorization requires physician documentation of improvement in the member's condition

Authorization excludes coverage for Osmolex ER doses that were obtained as samples or provided through a manufacturer's patient assistance program. Requests relying on supply from those sources are not eligible for prior authorization approval under this policy.

Quantity Limits and Coding

Quantity limitsNDC/misc

Osmolex ER therapy pack	1 = 1-time fill
Osmolex ER 129 mg	1 = 30 tablets per 30 days
Osmolex ER 193 mg	1 = 30 tablets per 30 days
Osmolex ER 258 mg	1 = 30 tablets per 30 days

Quantity limits — therapy pack and tablet strengths

Osmolex ER therapy pack1 = 1-time fill

Osmolex ER 129 mg1 = 30 tablets per 30 days

Osmolex ER 193 mg1 = 30 tablets per 30 days

Osmolex ER 258 mg1 = 30 tablets per 30 days

What Providers Must Do

Prior Authorization

Prior authorization required for Osmolex ER

Prior authorization is required for Osmolex ER (amantadine extended release) under the commercial/exchange pharmacy benefit. Approvals may be granted for members currently receiving Osmolex ER or when all coverage criteria are met.

Step Therapy

No step therapy program

No step therapy program applies for Osmolex ER; Step Therapy is not selected for this policy.

Documentation Required

Required documentation to support authorization

Provider must supply documentation showing the member's diagnosis, age, and prior trial and outcome with immediate‑release amantadine; for reauthorization, physician documentation of clinical improvement is required.

Documentation that member has Parkinson's disease or drug‑induced extrapyramidal symptoms
Documentation that member is ≥ 18 years of age
Evidence of inadequate response, adverse reaction, or contraindication to immediate‑release amantadine
For reauthorization: physician documentation of improvement in the member's condition

Denial Risk

Denial triggers for authorization

Authorization may be denied if the member does not meet the clinical criteria: no diagnosis of Parkinson's disease or drug‑induced extrapyramidal symptoms, is under 18 years of age, or has not tried and failed (or had intolerance/contraindication to) immediate‑release amantadine.

Background

Osmolex ER is an extended‑release formulation of amantadine, a noncompetitive NMDA receptor antagonist used in the treatment of Parkinson's disease and drug‑induced extrapyramidal symptoms. Prior authorization under the commercial/exchange pharmacy benefit may be granted either for members who are already receiving Osmolex ER (with documentation of current treatment, excluding product obtained as samples or via manufacturer assistance) or for new starts when all clinical criteria are met: the member has a diagnosis of Parkinson's disease or drug‑induced extrapyramidal symptoms, is ≥ 18 years of age, and has had an inadequate response, adverse reaction, or contraindication to immediate‑release amantadine.

Definitions

Osmolex ER — definition and indication summary

DefinitionAn extended‑release formulation of amantadine, a noncompetitive NMDA receptor antagonist

IndicationsTreatment of Parkinson's disease and drug‑induced extrapyramidal symptoms

Approval durationInitial approvals and reauthorizations approved for 24 months

Coverage notePrior authorization required under the commercial/exchange pharmacy benefit; continuation allowed for members already receiving Osmolex ER (documentation required)