Pharmacy Prior Authorization Criteria

Anti-Parkinson’s Agents

Indications for Prior Authorization

Rytary (carbidopa and levodopa) extended-release capsules

• For diagnosis of Parkinson’s disease
  Indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication

Duopa (carbidopa and levodopa) enteral suspension

• For diagnosis of Advanced Parkinson's disease
  Indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.

Xadago (safinamide) tablets

• For diagnosis of Parkinson’s disease
  Indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.

Gocovri (amantadine) extended-release capsules

• For diagnosis of Dyskinesia in Parkinson's disease
  Indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.

• For diagnosis of "Off" Episodes in Parkinson's Disease
  Indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

Osmolex ER (amantadine) extended-release tablets

• For diagnosis of Parkinson's Disease
  Indicated for the treatment of Parkinson's disease.

• For diagnosis of Drug-Induced Extrapyramidal Reactions
  Indicated for the treatment of drug-induced extrapyramidal reactions in adult patients.

Dhivy (carbidopa-levodopa)

• For diagnosis of Parkinson's Disease
  Indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

Crexont (carbidopa and levodopa) extended-release capsules

• For diagnosis of Parkinson's Disease
  Indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults.

Ongentys (opicapone)

• For diagnosis of Parkinson’s Disease
  Indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.

Vyalev (foscarbidopa and foslevodopa) subcutaneous injection

• For diagnosis of Advanced Parkinson’s disease
  Indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.

Criteria

Rytary

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply) of ONE of the following:
• Generic carbidopa-levodopa immediate release
• Generic carbidopa-levodopa extended release

Crexont

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• BOTH of the following:
• Trial and failure (of a minimum 30-day supply) of ONE of the following:
• Generic carbidopa-levodopa immediate release
• Generic carbidopa-levodopa extended release
AND
• Trial and failure (of a minimum 30-day supply) to Rytary

Xadago

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply) of BOTH of the following:
• rasagiline mesylate
• selegiline

Duopa

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of Parkinson's disease
AND
• Patient is levodopa-responsive [A, B]
AND
• Patient experiences disabling “Off” periods for a minimum of 3 hours/day [B]
AND
• Disabling “Off" periods occur despite therapy with both of the following: [A, C]
• Oral levodopa-carbidopa
• One drug from a different class of anti-Parkinson's disease therapy (e.g., COMT inhibitor [entacapone, tolcapone], MAO-B inhibitor [selegiline, rasagiline], dopamine agonist [pramipexole, ropinirole])
AND
• Prescribed by or in consultation with a neurologist

Duopa

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy

Gocovri

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Dyskinesia in Parkinson’s Disease

• Diagnosis of Parkinson's disease
AND
• Patient is experiencing dyskinesia
AND
• Patient is receiving concurrent levodopa-based therapy [5, D]
AND
• Trial and failure or intolerance to amantadine immediate release
AND
• Prescribed by or in consultation with a neurologist

Gocovri

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of "Off" Episodes in Parkinson's Disease

• Diagnosis of Parkinson's disease
AND
• Patient is experiencing "off" episodes [E, 6]
AND
• Used in combination with levodopa/carbidopa therapy [1]
AND
• Both of the following:
• Trial and failure, or intolerance to amantadine immediate release
AND
• Trial and failure, contraindication or intolerance to one of the following:
• MAO-B inhibitor (e.g., rasagiline, selegiline)
• Dopamine Agonist (e.g., pramipexole, ropinirole)
• COMT inhibitor (e.g., entacapone)
AND
• Prescribed by or in consultation with a neurologist

Gocovri

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications

• Patient demonstrates positive clinical response to therapy (e.g., decreased "off" periods, decreased "on" time with troublesome dyskinesia) [D]

Osmolex ER

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Parkinson's Disease

• Diagnosis of Parkinson's disease
AND
• Trial and failure, contraindication or intolerance to BOTH of the following:
• amantadine immediate release
AND
• ONE of the following: [9]
• carbidopa-levodopa
• MAO-B Inhibitor (e.g., rasagiline, selegiline)
• Dopamine Agonist (e.g., pramipexole, ropinirole)
AND
• Prescribed by or in consultation with a neurologist

Osmolex ER

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Drug-Induced Extrapyramidal Reactions

• Patient is experiencing drug-induced extrapyramidal reactions
AND
• One of the following: [10]
• Patient has persistent extrapyramidal symptoms despite a trial of dose reduction, tapering, or discontinuation of the offending medication
OR
• Patient is not a candidate for a trial of dose reduction, tapering, or discontinuation of the offending medication
AND
• Trial and failure or intolerance to amantadine immediate release
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist

Osmolex ER

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Parkinson's Disease, Drug-Induced Extrapyramidal Reactions

• Patient demonstrates positive clinical response to therapy

Dhivy

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply) of both of the following:
• Generic carbidopa-levodopa immediate release (IR)
• Generic carbidopa-levodopa oral disintegrating tablet (ODT)

Ongentys

Step Therapy

Length of Approval: 12 Month(s)
For diagnosis of Parkinson's Disease

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (to a minimum 30 day supply), contraindication, or intolerance to entacapone

Vyalev

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of Parkinson's disease
AND
• Patient is levodopa-responsive
AND
• Patient experiences disabling “Off” periods for a minimum of 2.5 hours/day
AND
• Disabling “Off" periods occur despite therapy with both of the following:
• Oral levodopa-carbidopa
• One drug from a different class of anti-Parkinson's disease therapy (e.g., COMT inhibitor [entacapone, tolcapone], MAO-B inhibitor [selegiline, rasagiline], dopamine agonist [pramipexole, ropinirole])
AND
• Prescribed by or in consultation with a neurologist

Vyalev

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2024-12-02, 2024-10-22, 2024-10-02, 2024-02-09, 2023-09-05, 2023-05-16, 2023-02-10, 2022-01-25, 2022-01-11, 2021-09-28, 2021-05-20, 2021-03-30, 2021-01-28, 2020-05-11, 2020-02-12

References

1. Duopa Prescribing Information. AbbVie Inc. North Chicago, IL. December 2019.
2. Olanow CW, Kieburtz K, Odin P, et al. Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson’s disease: a randomised, controlled, double-blind, double-dummy study. Lancet Neurol. 2014 Feb;13(2):141-9.
3. Rytary Prescribing Information. Amneal Pharmaceuticals LLC. Bridgewater, NJ. December 2019.
4. Xadago Prescribing Information. US WorldMeds, LLC. Louisville, KY. August 2021.
5. Gocovri Prescribing Information. Adamas Pharma, LLC. Emeryville, CA. January 2021.
6. Pahwa R, Tanner CM, Hauser RA, et al. ADS-5102 (Amantadine) Extended- Release Capsules for Levodopa-Induced Dyskinesia in Parkinson Disease (EASE LID Study): A Randomized Clinical Trial. JAMA Neurol. 2017 Aug:1;74(8): 941-949.
7. Pahwa R, Tanner CM, Hauser Ra, et al. Amantadine Extended Release for Levodopa-Induced Dyskinesia in Parkinson’s Disease (EASED Study). Mov Disorder. 2015 May; 30(6):788-95.
8. Osmolex ER Prescribing Information. Vertical Pharmaceuticals, LLC. Bridgewater, NJ. March 2021.
9. National Institute of Health and Clinical Excellence (NICE). Parkinson's disease in adults. NICE guideline [NG71]. July 2017. Available at: https://www.nice.org.uk/guidance/ng71/chapter/Recommendations. Accessed January 28, 2021.
10. Muench J, Hamer AM. Adverse effects of antipsychotic medications. Am Fam Physician. 2010 Mar 1;81(5):617-622.
11. Oertel W, Eggert K, Pahwa R, et al. Randomized, placebo-controlled trial of ADS-5102 (amantadine) extended-release capsules for levodopa-induced dyskinesia in Parkinson's disease (EASE LID 3). Mov Disord. 2017;32(12):1701-1709.
12. Dhivy Prescribing Information. Riverside Pharmaceuticals Corporation. Washington, DC. November 2021.
13. Zahoor, I., Shafi, A., Ehtishamul, H. Pharmacological Treatment of Parkinson’s Disease. Available at: https://www.ncbi.nlm.nih.gov/books/NBK536726/. Accessed February 9, 2024.
14. UpToDate. Initial pharmacologic treatment of Parkinson disease. Available at: https://www.uptodate.com/contents/initial-pharmacologic-treatment-of-parkinson-disease?search=parkinsons%20disease%20adult%20treatment&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. Accessed February 9, 2024.
15. Crexont Prescribing Information. Amneal Pharmaceuticals LLC. Bridgewater, NJ. August 2024.
16. Ongentys prescribing information. Neurocrine Biosciences, Inc. San Diego, CA. April 2020.
17. Vyalev Prescribing Information. AbbVie Inc. North Chicago, IL. October 2024.

---

End Notes

1. The efficacy of Duopa was established in a randomized, double-blind, double-dummy, active controlled, parallel group, 12-week study in patients with advanced Parkinson's disease who were levodopa-responsive and had persistent motor fluctuations while on treatment with oral immediate-release carbidopa-levodopa and other Parkinson's disease medications. [2, 3]
2. Patients were eligible for participation in the studies if they were experiencing 3 hours or more of “Off” time on their current Parkinson's disease drug treatment and they demonstrated a clear responsiveness to treatment with levodopa. [2, 3]
3. Most patients (89%) were taking at least one concomitant medication for Parkinson’s disease (e.g., dopaminergic agonist, COMT-inhibitor, MAO B inhibitor) in addition to oral immediate-release carbidopa-levodopa. [2, 3]
4. The efficacy of Gocovri was established in two Phase III randomized, double-blind, placebo-controlled trials, a 12 week and 24 week study in patients with Parkinson's disease were treated with levodopa. Both studies demonstrate statistically significant and clinically relevant reduction in dyskinesia compared to placebo. Also, both studies showed that Gocovri-treated patients experienced an increase in functional time daily (defined as ON time without troublesome dyskinesia) compared to placebo-treated patients. [6, 7]
5. “Off” time is defined as the amount of time the Parkinson’s Disease medication was not controlling motor symptoms. [6]

---

Revision History

• 2024-12-02: update guideline
• 2024-10-22: update guideline
• 2024-10-02: update guideline
• 2024-02-09: 2024 Annual Review
• 2023-09-05: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-05-16: update guideline
• 2023-02-10: 2023 Annual Review
• 2022-01-25: 2022 Annual Review
• 2022-01-11: 2022 UM Update ST criteria for Dhivy
• 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-30: Program update.
• 2021-01-28: Annual Review
• 2020-05-11: Program Update
• 2020-02-12: Annual Review

---