Pharmacy Prior Authorization Criteria

Apomorphine Products

Indications for Prior Authorization

Apokyn (apomorphine injection)

• For diagnosis of Parkinson’s Disease
  Indicated for the acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) in patients with advanced Parkinson’s disease. Apokyn has been studied as an adjunct to other medications.

Onapgo (apomorphine injection)

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

Criteria

Brand Apokyn, Generic Apomorphine Hydrochloride Inj

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of Parkinson’s disease
AND
• Patient is experiencing intermittent OFF episodes
AND
• One of the following:
• Patient is receiving drug in combination with carbidopa/levodopa at a maximally tolerated dose
OR
• Patient has a contraindication or intolerance to carbidopa/levodopa
AND
• Trial and failure (of a minimum 30 day supply), contraindication or intolerance to two of the following: [A]
• MAO-B Inhibitor (e.g., rasagiline, selegiline)
• Dopamine Agonist (e.g., pramipexole, ropinirole)
• COMT Inhibitor (e.g., entacapone)
AND
• Both of the following:
• Trial and failure (of a minimum 30 day supply), contraindication or intolerance to generic apomorphine (Applies to Brand Apokyn only)
AND
• One of the following:
• Trial and failure (of a minimum 30 day supply), contraindication or intolerance to Inbrija (levodopa) inhalation powder
OR
• For continuation of prior therapy
AND
• Not used with any 5-HT3 antagonist (e.g., ondansetron, granisetron, dolasetron, palonosetron, alosetron)
AND
• Prescribed by or in consultation with a neurologist

Brand Apokyn, Generic Apomorphine Hydrochloride Inj

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy

Onapgo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of Parkinson’s disease
AND
• Patient is experiencing motor fluctuations
AND
• One of the following:
• Patient is receiving drug in combination with carbidopa/levodopa at a maximally tolerated dose
OR
• Patient has a contraindication or intolerance to carbidopa/levodopa
AND
• Trial and failure (of a minimum 30 day supply), contraindication or intolerance to two of the following: [A]
• MAO-B Inhibitor (e.g., rasagiline, selegiline)
• Dopamine Agonist (e.g., pramipexole, ropinirole)
• COMT Inhibitor (e.g., entacapone)
AND
• Not used with any 5-HT3 antagonist (e.g., ondansetron, granisetron, dolasetron, palonosetron, alosetron)
AND
• Prescribed by or in consultation with a neurologist

Onapgo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2025-05-01, 2025-04-15, 2024-03-05, 2023-09-13, 2023-07-26, 2023-02-03, 2022-03-23, 2022-01-26, 2021-03-12, 2020-11-25, 2020-09-30, 2020-07-27, 2020-03-05

References

1. Apokyn prescribing information. US WorldMeds, LLC. Louisville, KY. June 2022.
2. Obering CD, Chen JJ, Swope DM. Update on apomorphine for the rapid treatment of hypomobility ("off") episodes in Parkinson's disease. Pharmacotherapy. 2006;26(6):840-852.
3. Per clinical consult with neurologist, March 27, 2019.
4. Onapgo prescribing information. MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc. Rockville. Feb 2025.

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End Notes

1. Primary treatment options for patients experiencing intermittent OFF episodes depends on the severity of the episodes. The easiest options include: shortening the dosing interval of levodopa, advising patient to take levodopa on an empty stomach if possible, or crushing the tablet and ingesting it with carbonated water for more predictable and faster absorption. Following the trial of the above options, entacapone, MAO-B Inhibtors or Dopamine Agonists may be added to the patient's therapy to enhance dopamine levels. [3]

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Revision History

• 2025-05-01: Annual review: No criteria changes.
• 2025-04-15: Added Onapgo to guideline
• 2024-03-05: Annual Review - No criteria changes
• 2023-09-13: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-07-26: Update Guideline
• 2023-02-03: 2023 Annual Review
• 2022-03-23: Update Product List
• 2022-01-26: 2022 Annual Review
• 2021-03-12: Program Update to add step through Kynmobi and Inbrija for Apokyn
• 2020-11-25: Program Update: OFF episode criterion simplified, and embedded step revised
• 2020-09-30: Program Update
• 2020-07-27: Program Update: added new product Kynmobi to GL, renamed GL Apomorphine Products
• 2020-03-05: Annual Review

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