Agents for Parkinson’s Disease – NC Standard

• Gocovri (amantadine ER capsule)
• Nourianz (istradefylline tablet)
• Ongentys (opicapone capsule)
• Osmolex ER (amantadine ER tablet)
• Xadago (safinamide tablet)

FDA Approved Use:

Gocovri:

• For the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.
• For the adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.

Ongentys:

• For the adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes.

Osmolex ER:

• For Parkinson’s disease.
• For the treatment of drug induced extrapyramidal reactions in adult patients.

Nourianz:

• For the adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes. Xadago
• For the adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes.

Criteria for Approval of Restricted Product(s):

1. The request is for Gocovri; AND
   1. The patient has a diagnosis of Parkinson’s disease; AND
   2. The patient has at least mild functional impact due to dyskinesia; AND
      1. The patient is currently on a levodopa-based therapy; AND
      2. The patient has experienced adverse effects while taking immediate release amantadine; OR
   3. The patient is experiencing “off” or breakthrough episodes of motor dysfunction that cannot be further managed through the titration of current therapy; AND
      1. The patient is currently on carbidopa/levodopa therapy without titration for the past 30 days; AND
      2. The patient has tried and failed or has a clinical intolerance/contraindication to monoamine oxidase type B inhibitors (MAOB-I) (ex. selegiline, rasagiline) other than safinamide (Xadago); AND
      3. The patient has tried and failed or has a clinical intolerance/contraindication to catachol-O-methyl transferase inhibitors (COMT-I) (ex. entacapone); AND 
      4. The patient has tried and failed or has a clinical intolerance/contraindication to Ongentys; OR
2. The request is for Osmolex ER; AND
   1. The patient has a diagnosis of Parkinson’s disease; OR
   2. The patient is suffering from drug induced extrapyramidal symptoms; AND
   3. The patient has experienced adverse effects while taking immediate release amantadine; AND
      1. The provider believes the adverse effects will be mitigated through once daily dosing; OR
3. The request is for Nourianz, Ongentys, or Xadago; AND
   1. The patient has a diagnosis of Parkinson’s disease; AND
   2. The patient is currently on carbidopa/levodopa therapy without titration for the past 30 days; AND
   3. The patient is experiencing “off” or breakthrough episodes of motor dysfunction that cannot be further managed through the titration of current therapy; AND
   4. The patient has tried and failed or has a clinical intolerance/contraindication to monoamine oxidase type B inhibitors (MAOB-I) (ex. selegiline, rasagiline) other than safinamide (Xadago); AND 
   5. The patient has tried and failed or has a clinical intolerance/contraindication to catachol-O-methyl transferase inhibitors (COMT-I) (ex. entacapone); AND
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 
Gocovri:  24 weeks
Ongentys:  365 days (1 year)
Osmolex ER:  24 weeks
Nourianz:  365 days (1 year)
Xadago:  365 days (1 year)

Continuation Coverage Criteria

1. The patient’s request is for Gocovri or Osmolex ER; AND
2. The patient was approved through Blue Cross NC initial coverage criteria; AND
3. The patient has shown improvement of symptoms since initiation of therapy.   

Duration of Approval: 365 days (1 year)

Quantity Limitations:

quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.
 

Pringsheim T, Day GS, et al; Guideline Subcommittee of the AAN. Dopaminergic Therapy for Motor Symptoms in Early Parkinson Disease Practice Guideline Summary: A Report of the AAN Guideline Subcommittee. Neurology. 2021 Nov 16;97(20):942-957.

National Institute for Health and Care Excellence. (2017). Parkinson’s Disease in adults. (NICE guideline NG71). https://www.nice.org.uk/guidance/ng71

Grimes D, Fitzpatrick M, Gordon J, et al. Canadian guideline for Parkinson disease. CMAJ. 2019;191(36):E989-E1004. doi:10.1503/cmaj.181504 

Policy Implementation/Update Information:

May 2024: Criteria update: Annual criteria review. Updated references.

March 2022: Criteria update: Annual criteria review. Updated duration of approval to 1 year for initial coverage of Ongentys, Nourianz, and Xadago.

February 2021: Criteria update: Added new indication and criteria for Gocovri for patients with Parkinson’s disease (PD) experiencing “off” episodes.

February 2021:  Criteria update: Added new 25mg strength of Ongentys to the policy.  January 2021: Criteria update: Removed Kynmobi from policy.

September 2020:  Criteria update: Ongentys added to the policy.

June 2020: Criteria update: Kynmobi added to the policy.

April 2020:  Criteria update:  Osmolex pak added to the policy. 

February 2020: Criteria change: Removed requirement of baseline assessment via the Unified Dyskinesia Rating Scale (UdysRS) or Abnormal Involuntary Movement Scale (AIMS),provider awareness of the transient effectiveness of Amantadine and requirement of adjunctive therapy to levodopa.

October 2019: Original utilization management criteria issued. Combined Gocovri, Osmolex ER, and Xadago with new to market – Nourianz to create Parkinson’s Disease Agents policy.  Discontinued the individual policies.