Central Nervous System/Behavioral Health 2019

Members 19 Years and Older will not require a petition

1). Quantity limits apply on all benzodiazepine anxiolytic products.
2). No request for dosing greater than 3 times daily will be approved unless a specific diagnosis exists; for these diagnoses the maximum allowed dosing is 4 times daily.
3). The maximum covered dosing of benzodiazepine therapy is three times a day if a hypnotic medication is also prescribed.

Members 0-18 Years of Age will require a petition:

1). No concurrent stimulant ADHD medications, and
2). No Contraindicated Conditions, and
3). Maximum dosing of 3 times daily.

• For Members 12 or younger the same criteria applies and prescriptions for psychiatric conditions must originally be written by a psychiatrist.

Prior Authorization form

• lorazepam (Ativan®)
• chlordiazepoxide (Librium®)
• oxazepam (Serax®)
• clorazepate dipotassium (Tranxene®)
• diazepam (Valium®)
• alprazolam (Xanax®)
• alprazolam XR (Xanax XR®)

Prior Authorization required.

• alprazolam rapdis (Niravam®)

Tier 1 products are available without prior authorization for members age 19 or older.

Prior authorization is required for all products for members under age 19.

Tier 2 approval Criteria:

• Minimum of 30 day trial with at least two Tier 1 products and clinical documentation of attempts to correct any primary cause for insomnia.
• FDA approved diagnosis.
• Approvals granted for 6 months.
• No current anxiolytic benzodiazepine therapy greater than TID

Tier 3 approval Criteria:

• An FDA approved diagnosis; AND
• A minimum of a 30-day trial with at least two Tier-1 medications and clinical documentation of attempts to correct any primary cause for insomnia; AND
• A minimum of a 30-day trial with at least two Tier-2 medications; AND
  
  • If only one Tier-2 medication is available, a minimum of a 30-day trial with one Tier-2 medication will be required; AND  
• No concurrent anxiolytic benzodiazepine therapy greater than three times daily dosing; AND
• Approvals will be granted for the duration of six months.

ramelteon (Generic Rozerem®) Approval Criteria:  

• A patient-specific, clinically significant reason why the member cannot use the brand formulation (Rozerem®) of ramelteon. 

tasimelteon (Hetlioz®) Approval Criteria: 

• An FDA approved diagnosis of Non-24-Hour Sleep-Wake Disorder (Non-24) confirmed by a sleep specialist; AND  
• Member must be 18 years of age or older; AND
• Member must be totally blind; AND
• A failed trial of appropriately timed doses of melatonin; AND
• A failed trial of Rozerem® (ramelteon); AND
• Initial approvals will be for the duration of 12 weeks. For continuation, the prescriber must include information regarding improved response/effectiveness of this medication.
• A quantity limit of 30 capsules for 30 days will apply. 

Prior Authorization form

Tier 1

Tier 2

Tier 3

Special PA*

• zolpidem tartrate (Ambien®)
• flurazepam (Dalmane®)
• triazolam (Halcion®)
• eszopiclone (Lunesta®)
• estazolam (ProSom®)
• temazepam (Restoril®) 15mg & 30mg
• ramelteon (Rozerem®) BRAND Preferred
• zaleplon (Sonata®)

• zolpidem tartrate (Ambien CR®)

• suvorexant (Belsomra®)

• zolpidem SL tabs (Edluar®)
• tasimelteon (Hetlioz®)+
• zolpidem SL tabs (Intermezzo®)
• temazepam (Restoril®) 7.5mg & 22.5mg
• doxepin (Silenor®)
• Zolpidem Oral Spray (Zolpimist®)

• An FDA approved diagnosis of clinically isolated syndrome, relapsing forms of MS, and secondary progressive forms of MS; AND
• Tier 2 medications require failure of the preferred tier 1 product defined as:
• Occurrence of an exacerbation after 6 months.; OR
• Significant increase in MRI lesions after 6 months; OR
• Adverse reactions or intolerable side effects; AND
• No concurrent use with other therapies; AND
• Compliance will be checked for continued approval every 6 months.

Tier 1

Tier 2

• interferon β 1a (Avonex®)
• interferon β 1b (Betaseron®)

• interferon β 1a (Rebif®)
• interferon β 1b (Extavia®)
• peginterferon β – 1a (Plegridy™)

PA Criteria:

• Member must have a diagnosis of Multiple Sclerosis
• Kurtzke Expanded Disability Status Scale (EDSS) score between 3 and 7.5
• A 90 day trial will be approved. If member has responded well to treatment and physician states that the member has shown improvement or the drug was effective, member may receive authorization for one year.
• Quantity Limit of 60 for 30 days

 Prior Authorization form

PA Criteria:

• An FDA approved diagnosis of relapsing, remitting Multiple Sclerosis; AND
• Approvals will not be granted for concurrent use with other disease modifying therapies; AND
• Approvals for the 40mg strength of Copaxone® will require a patient-specific, clinically significant reason why the member cannot use the 20mg strength; AND
• Compliance will be checked for continued approval every six months.
• Copaxone 20mg and 40 mg will be Brand preferred. Approvals for the generic formulation of either strength of Copaxone®, including Glatopa®, require a patient-specific, clinically signification reason why the member cannot use the brand formulation.

PA Criteria:

• An FDA approved diagnosis of relapsing forms of Multiple Sclerosis (MS); AND
• Approvals will not be granted for concurrent use with other disease-modifying therapies; AND
• The first dose should be observed in the doctor’s office for signs and symptoms of bradycardia for six hours after first dose; AND  
• Verification from the prescriber that member has no active infection(s); AND
• Complete blood counts (CBC) and verification that levels are acceptable to the prescriber; AND
• Liver function tests and verification that levels are acceptable to the prescriber; AND
• Compliance will be checked for continued approval every six months. 

PA Criteria
Consideration will be based on all of the following criteria: 

• Documented diagnosis of relapsing forms of Multiple Sclerosis; AND
• All of the following will be required for initiation of treatment:
  • No concurrent use with other disease modifying therapies; AND
  • Verification that female members are not pregnant and currently on a reliable contraceptive; AND
  • Verification that member has no active infection(s); AND
  • CBC counts and verification that levels are acceptable to the prescriber; AND
  • Liver function tests and verification that levels are acceptable to the prescriber; AND
  • Blood pressure measurement and verification that blood pressure is being monitored; AND
  • Verification that members do not have tuberculosis, or completion of standard medical treatment for patients with tuberculosis; AND
   
• Approval of Aubagio will be initially for 6 months, after which time, all of the following will be required for further approval:
  • Medication compliance; AND
  • Repeat CBC counts and verification that counts are acceptable to the prescriber; AND 
  • Repeat liver function tests and verification that levels are acceptable to the prescriber; AND
  • Verification that female members are not pregnant and still on reliable contraceptive; AND
  • Verification that blood pressure and symptoms of renal failure are being monitored; AND
   
• Compliance will be checked every 6 months there-after for continuation of therapy; AND
• Quantity limit of #30 tablets per 30 days applies. 

PA Criteria: 

• An FDA approved diagnosis of clinically isolated syndrome, relapsing forms of Multiple Sclerosis (MS), and secondary progressive forms of MS; AND
• No concurrent use with other disease-modifying therapies; AND
• Verification from the prescriber that member has no active infection(s); AND
• Recent CBC counts and verification that levels are acceptable to the prescriber; AND
• Serum aminotransferase, alkaline phosphatase, and total bilirubin levels and verification that levels are acceptable to the prescriber; AND
• Compliance will be checked for continued approval every six months; AND
• A quantity limit of 60 tablets per 30 days will apply. 

PA Criteria
Consideration will be based on all of the following criteria:

• FDA approved diagnosis of relapsing forms of Multiple Sclerosis; AND
• Member must have had an inadequate response to two or more drugs indicated for the treatment of Multiple Sclerosis; AND
• Lemtrada™ must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. The prescriber must agree that the member will be monitored for two hours after each infusion; AND
• The prescriber must agree to monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine counts at periodic intervals for 48 months after the last dose of Lemtrada™; AND
• The prescriber must agree that baseline and yearly skin examinations will be performed while the member is utilizing Lemtrada™ therapy; AND
• Member, prescriber, pharmacy, and healthcare facility must all enroll in the Lemtrada™ REMS Program and maintain enrollment throughout therapy.

Prior Authorization form

ocrelizumab (Ocrevus™)

PA Criteria: 

• An FDA approved diagnosis of relapsing or primary progressive forms of Multiple Sclerosis (MS); AND
• Approvals will not be granted for concurrent use with other disease modifying therapies; AND  
• Ocrevus™ must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. The prescriber must agree that the member will be monitored for one hour after each infusion; AND  
• Prescriber must verify hepatitis B virus (HBV) testing has been performed prior to initiating Ocrevus™ therapy and member does not have active HBV; AND  
• Verification from the prescriber that member has no active infection(s); AND
• Verification from the prescriber that female members are not currently pregnant and will use contraception while receiving Ocrevus™ therapy and for six months after the last infusion of Ocrevus™; AND
• Compliance will be checked for continued approval.  

Seconal Sodium™ (Secobarbital Sodium Capsule) Approval Criteria:   

• An FDA approved indication for 1 of the following:
  • The short-term treatment of insomnia; OR
  • A preanesthetic; AND  
• A patient-specific, clinically significant reason why the member cannot use other cost-effective therapeutic alternatives must be provided; AND
  or the short-term treatment of insomnia, a quantity limit of 1 capsule per day not to exceed 14 capsules per 30 days will apply.  

PA criteria:

• Diagnosis of Parkinson's Disease, and
• Clinically significant reason why the immediate release products cannot be used.

PA criteria:

• An FDA approved diagnosis of symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy; AND
• Member must be 18 years of age or older; AND
• Member must have tried and failed two of the following medications at recommended dosing within the last 90 days:
• Midodrine; OR
• Fludrocortisone; OR
• Pyridostigmine; OR
• Have a contraindication to all preferred medications.
• Initial approval will be for the duration of two weeks of treatment only. 
• Continued approval will require the prescriber to provide information regarding improved member response/effectiveness of this medication to determine whether Northera™ is continuing to provide a benefit.
• Continued approval will be for the duration of three months.  Each approval will require prescriber documentation of member response/effectiveness to Northera™.

 Prior Authorization form  

Tier-1 products are available without prior authorization for members age five years and older.  Prior authorization requests for members younger than five years of age are reviewed by an OHCA-contracted child psychiatrist.

aripiprazole oral solution (Abilify® Oral Solution) Approval Criteria:

• Members older than 7 years of age require a patient-specific, clinically significant reason why the oral tablet formulation cannot be used. 

 Approval Criteria for Tier 2 Medication: 

• A trial of a Tier 1 medication at least 14 days in duration, titrated to recommended dose, that did not yield adequate response or resulted in intolerable adverse effects.
• Clozapine does not count towards a Tier 1 trial. 

Atypical Antipsychotic Tier-3 Approval Criteria:  

• A trial of a Tier 1 medication at least 14 days in duration, titrated to recommended dose, that did not yield adequate response or resulted in intolerable adverse effects. 
• Clozapine does not count towards a Tier 1 trial.; AND  
• Trials of all oral Tier-2 medications, at least 14 days in duration each, titrated to recommended dose, that did not yield adequate response or resulted in intolerable adverse effects.; OR
• A manual prior authorization may be submitted for consideration of a Tier-3 medication when the member has had at least four trials of Tier-1 and Tier-2 medications that did not yield an adequate response or resulted in intolerable adverse effects.  
• Use of Versacloz™ (clozapine oral suspension) and Fazaclo® (clozapine orally disintegrating tablet) requires a patient-specific, clinically significant reason why the member cannot use the oral tablet formulation.  

Approval Criteria for Atypical Antipsychotics as Adjunctive Treatment for Major Depression Disorder: 

• Authorization of Symbyax® (olanzapine/fluoxetine) or Rexulti® (brexpiprazole) for a diagnosis of major depressive disorder requires current use of an antidepressant, and previous trials with at least two other antidepressants from both categories (an SSRI and duloxetine) and a trial of aripiprazole tablets that did not yield adequate response. Tier structure applies. 

Clinical Exceptions:

• Members currently stabilized on a higher tiered medication defined by paid claim(s) for the higher tiered medication in the past 90 days will be approved. 
• Members being released from a hospital and stabilized on a higher tiered medication will be approved.
• Approvals will be granted for members with clinical conditions for which lower tiered drugs are contraindicated.
• Approvals will be granted for members whose current regimen includes drugs known to adversely interact with all lowered tiered drugs.
• Lurasidone (Latuda®) may be approved for pregnant women with appropriate diagnosis.

Abilify MyCite® (Aripiprazole Tablet with Sensor) Approval Criteria:

• An FDA approved diagnosis; AND
  
• Member must not have dementia-related psychosis; AND
  
• A patient-specific, clinically significant reason why the member cannot use all oral or injectable Tier-1 or Tier-2 medications. Tier structure rules continue to apply. Please note, the ability of Abilify MyCite® to improve patient compliance or modify aripiprazole dosage has not been established; AND
  
• Previous use of aripiprazole tablets and a patient-specific, clinically significant reason why the Tier-1 aripiprazole tablets are no longer appropriate for the member must be provided; AND
  
• The prescriber agrees to closely monitor patient adherence; AND
  
• Patients should be capable and willing to use the MyCite® App and follow the Instructions for Use and ensure the MyCite® App is compatible with their specific smartphone; AND
  
• Approvals will be for the duration of 3 months. For continuation consideration, documentation demonstrating positive clinical response and patient compliance greater than 80% with prescribed therapy must be provided. In addition, a patient-specific, clinically significant reason why the member cannot transition to oral aripiprazole tablets or to any of the oral or injectable Tier-1 or Tier-2 medications must be provided. Tier structure rules continue to apply.
  

Tier 1

Tier 2

Tier 3

• aripiprazole (Abilify®)¥
• aripiprazole solution (Abilify®)#
• aripiprazole (Abilify Maintena®)
• aripiprazole lauroxil (Aristada™)
• aripiprazole lauroxil (Aristada® INITIO™)
• clozapine (Clozaril®)*
• olanzapine (Zyprexa®)
• paliperidone (Invega Sustena®, Invega Trinza™)∞
• quetiapine (Seroquel®)
• quetiapine ER (Seroquel XR®)
• risperidone (Risperdal®, Risperdal Consta®)
• ziprasidone (Geodon®)

• asenapine (Saphris®)
• lurasidone (Latuda®)ψ 

• aripiprazole tablet with sensor (Abilify MyCite®)~
• brexpiprazole (Rexulti®)
• cariprazine (Vraylar™)
• clozapine (Fazaclo®)
• clozapine oral suspension (Versacloz®)
• iloperidone (Fanapt^TM)
• olanzapine/fluoxetine (Symbyax®)£
• paliperidone (Invega®)
• risperidone extended-release injectable (Perseris™)

Children less than 5 years of age will require a "second opinion" prior authorization to be reviewed by an OHCA-contracted child psychiatrist. Current users will be allowed to remain on current medication until the petition is submitted and reviewed. The second opinion process is as follows:

• Clinical pharmacist reviews petition for necessary information including diagnosis and behavioral information to submit to on-call OHCA psychiatrist.
• On-call psychiatrist at OHCA reviews submitted prior authorization request.
• OHCA faxes response back within 24 hours.
• Clinical pharmacist issues appropriate response for petition based on the results
  

PA Criteria:

Tier 1 products are covered with no authorization necessary.

Tier 2 authorization requires:

• Trial of all available Tier 1 products with inadequate response or a patient-specific, clinically significant reason why a Tier-1 product is not appropriate for the member, OR
• Documented adverse effect to all the Tier 1 products, OR
• Previous success with a Tier 2 product within the last 60 days.

Tier 3 authorization requires:

• Trial of all available Tier 1 and Tier 2 products with inadequate response or a patient-specific, clinically significant reason why a lower tiered product is not appropriate for the member, OR
• Documented adverse effect to all the Tier 1 and Tier 2 products, OR
• Previous success with a Tier 3 medication within the last 60 days
• Use of any non-oral formulation will require a patient-specific, clinically significant reason why member cannot use the oral tablet formulation.

Anti-Migraine Medications Special Prior Authorization Approval Criteria:

• Use of any non-oral sumatriptan formulation will require a patient-specific, clinically significant reason why the member cannot use the oral tablet formulation or lower-tiered triptan products. 
• Use of Zembrace™ SymTouch™ will require a patient-specific, clinically significant reason why the member cannot use all available generic formulations of sumatriptan (tablets, nasal spray, and injection) or lower-tiered triptan products. 
• Use of dihydroergotamine injection (D.H.E. 45®) will require a patient-specific, clinically significant reason why the member cannot use lower-tiered triptan products. 
• Use of dihydroergotamine nasal spray (Migranal®) will require a patient-specific, clinically significant reason why the member cannot use lower-tiered triptan products and dihydroergotamine injection (D.H.E. 45®). 
• Use of ergotamine sublingual tablets (Ergomar®) will require a patient-specific, clinically significant reason why the member cannot use lower-tiered triptan medications; AND
  • Member must not have any of the contraindications for use of Ergomar® (e.g., coadministration with a potent CYP 3A4 inhibitor, women who are or may become pregnant, peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function, sepsis, hypersensitivity to any of the components); AND
  • A quantity limit of 20 tablets per 28 days will apply.

 Prior Authorization form  

Approval Criteria for the Butalbital Medications [Dolgic Plus® (butalbital-acetaminophen-caffeine, 50-750-40 mg), Phrenilin Forte® (butalbital-acetaminophen 50-650 mg), Orbivan® (butalbital- acetaminophen-caffeine 50-300-40 mg), Orbivan® CF (butalbital-acetaminophen 50-300 mg), Esgic-Plus® (butalbital-acetaminophen-caffeine 50-500-40 mg), Allzital® (butalbital/acetaminophen 25mg/325mg)]:

• An FDA approved indication for the treatment of tension-type headache; AND
• Member must be 12 years of age or older; AND
• Failure within the previous 60 days of the following:
  
  • All available formulations of butalbital/acetaminophen medications that do not require prior authorization (medications available without prior authorization contain butalbital/acetaminophen/caffeine in the standard 50mg/325mg/40mg dose); AND
  • Trials of at least two nonsteroidal anti-inflammatory drugs (NSAIDs), unless contraindicated.

Esgic® capsules (butalbital/acetaminophen/caffeine 50mg/325mg/40mg) approval criteria:

• A patient-specific, clinically significant reason why the member cannot use Fioricet® tablets (butalbital/acetaminophen/caffeine 50mg/325mg/40mg). 
  

PA Criteria:

Tier 1 products are covered with no authorization necessary.

Tier-2 Approval Criteria:

• A documented, recent (within the last six months) trial of two Tier-1 medications (must include one trial with duloxetine) at least three weeks in duration that did not provide an adequate response or resulted in intolerable adverse effects; OR
• Contraindication(s) to all available lower tiered medications; OR
• Current stabilization on a Tier-2 medication.

Tier-3 Approval Criteria:

• A documented, recent (within the last six months) trial of two Tier-1 medications (must include one trial with duloxetine) and all available Tier-2 medications at least three weeks in duration that did not provide an adequate response OR resulted in intolerable adverse effects; OR
• Contraindication(s) to all available lower tiered medications; OR
• Current stabilization on a Tier-3 medication.   

pregabalin (Generic Lyrica® Immediate-Release) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use the brand formulation (Lyrica®) of immediate-release pregabalin. 

pregabalin extended-release (ER) (Lyrica® CR ) Approval Criteria:

• An FDA approved diagnosis of one of the following:
  • Neuropathic pain associated with diabetic peripheral neuropathy (DPN); OR
  • Neuropathic pain associated with postherpetic neuralgia (PHN). 
• A patient-specific, clinically significant reason (beyond convenience) the member cannot use the immediate-release formulation (brand formulation preferred); AND
• For a diagnosis of DPN, current Lyrica® immediate-release criteria will also apply; AND
• Requests exceeding once daily dosing will not be approved.

Prior Authorization form

Tier 1

Tier 2

• amitriptyline
• cyclobenzaprine
• duloxetine HCI (Cymbalta ®)
• fluoxetine
• pregabalin (Lyrica®)
• tramadol 

• milnacipran (Savella ®)

PA Criteria:

Tier 1 products available with no authorization necessary
Tier 2 Authorization Criteria:

• A documented, recent (within six months) trial of two Tier-1 medications at least four weeks in duration and titrated to recommended dosing, that did not provide an adequate response. Tier-1 selection must include at least one medication from the SSRI category and one trial with duloxetine; OR
• Prior stabilization on the Tier-2 medication documented within the last 100 days. A past history of success on the Tier-2 medication will also be considered with adequate documentation; OR
• A unique FDA-approved indication not covered by Tier-1 products or other products from a different therapeutic class; OR
• A petition may be submitted for consideration whenever a unique patient-specific situation exists.
  

Tier 3 Authorization Criteria

• A documented, recent (within six months) trial with two Tier-1 medications (one medication from the SSRI category and one trial with duloxetine) and a Tier-2 medication at least four weeks in duration and titrated to recommended dose, that did not provide an adequate response; OR
• Prior stabilization on the Tier-3 medication documented within the last 100 days.  A past history of success on the Tier-3 medication will also be considered with adequate documentation; OR
• A unique FDA-approved indication not covered by a lowered tiered product or other products from a different therapeutic class; OR
• A petition may be submitted for consideration whenever a unique patient-specific situation exists.
  

Special Criteria:

• Use of any Special PA product will require a patient-specific, clinically significant reason why the member cannot use other available generic Tier-1 products; OR
• A petition may be submitted for consideration whenever a unique patient-specific situation exists.
• Tier structure rules still apply.
• When Irenka™ (duloxetine 40mg) is being requested for non-depression related diagnoses, the criteria below will apply:  
  • An FDA approved diagnosis of diabetic peripheral neuropathy or chronic musculoskeletal pain; AND
  • A patient-specific, clinically significant reason why the member cannot use two duloxetine 20mg capsules in place of Irenka™ 40mg capsules; AND    
  • A quantity limit of 30 capsules per 30 days will apply. 
• Marplan® (Isocarboxazid) Approval Criteria: 
  • A patient-specific, clinically significant reason why the member cannot use any of the Tier-3 monoamine oxidase inhibitors (MAOIs) or other cost-effective, lower tiered alternatives in place of Marplan®. Tier structure rules still apply. 
• Desyrel® (Trazodone 300mg Tablets) Approval Criteria:  
  • A patient-specific, clinically significant reason why the member cannot use other available generic Tier-1 products including two trazodone 150mg tablets or three trazodone 100mg tablets to achieve a 300mg dose. 
• Fluoxetine capsules will be preferred over fluoxetine tablets.
  
  • Fluoxetine capsules will be available without a prior authorization. The tablet formulation will require prior authorization and reasoning why the tablet formulation is required in place of the capsule formulation.  

Approval Criteria for Atypical Antipsychotics as Adjunctive Treatment for Major Depression Disorder:

Authorization of Rexulti® (brexipiprazole) or Symbyax® (olanzapine/fluoxetine) for a diagnosis of major depression disorder requires current use of an antidepressant, and previous trials with at least two other antidepressants from both categories (an SSRI and duloxetine) and a trial of aripiprazole tablets that did not yield adequate response. Tier structure rules still apply (the member would have needed to try the Tier-2 atypical antipsychotics indicated for adjunctive treatment of MDD before trying a Tier-3).                

 Prior Authorization form

Tier 1

Tier 2

Tier 3

Special PA

• citalopram (Celexa®)
• escitalopram (Lexapro®)
• fluoxetine (Prozac®)
• fluvoxamine (Luvox®)
• paroxetine (Paxil®)
• sertraline (Zoloft®) 

• fluvoxamine (Luvox CR®)
• fluoxetine 10mg, 20mg, & 60mg tablets
• fluoxetine DR (Prozac weekly®)
• paroxetine CR (Paxil CR®)
• paroxetine (Pexeva®) 

• bupropion (Wellbutrin®, Wellbutrin SR®,  Wellbutrin XL®)
• duloxetine HCI (Cymbalta ®)
• mirtazapine (Remeron®, Remeron SolTab®)
• trazodone (Desyrel®)
• venlafaxine (Effexor®, Effexor XR® capsules) 

• desvenlafaxine (Pristiq®)

• desvenlafaxine (Khedezla®)
• levomilnacipran (Fetzima®) 
• nefazodone (Serzone®)
• vilazodone (Viibryd®)
  

• bupropion ER (Aplenzin®, Forfivo®)
• duloxetine (Irenka™)**
• trazodone 300mg tablet (Desyrel®)
• venlafaxine extended release tablets

• phenelzine (Nardil®)
• selegiline transderm (Emsam®)
• tranylcypromine(Parnate®)

• isocarboxazid (Marplan®)

• vortioxetine (Trintellix®) 

PA Criteria:

• An FDA approved diagnosis of moderate to severe vasomotor symptoms associated with menopause; AND
• Approvals for Brisdelle® will not be granted for psychiatric indications; AND
• Member must not have any of the contraindications for use of Brisdelle®; AND
• Two previous trials with either a selective serotonin reuptake inhibitor (SSRI) or a selective serotonin norepinephrine reuptake inhibitor (SNRI) or both, or a patient-specific, clinically significant reasoning why a SSRI or SNRI is not appropriate for the member; AND
• Authorization requires a patient-specific, clinically significant reason why paroxetine 10mg is not appropriate for the member; AND  
• A quantity limit of 30 capsules per 30 days will apply.
  

 Prior Authorization form

 1.) Anticonvulsants will be included in the current mandatory generic plan.

• All brand-name anticonvulsants (with a generic equivalent) will require prior authorization.

2.) Prior authorization will be required for certain non-standard dosage forms of medications when the drug is available in standard dosage forms.

• Members 12 and older must have a documented medical reason demonstrating need for non-standard dosage forms.
• Criteria for approval of extended-release formulation.
  • Previously stabilized on the short-acting formulation.
  • Dosing is not more than once daily.
  • Member must provide a reason why the short-acting formulation is not adequate.
   
• Dose packs will not be approved if standard dosage forms are available.

3.) Quantity limit restrictions will be placed on lower strength tablets and capsules. The highest strengths will continue to have no quantity restrictions unless a maximum dose is specified for a particular medication.

Prior Authorization form

PA Criteria:

• An FDA approved indication for the treatment of partial-onset seizures; AND
• Initial prescription must be written by a neurologist; AND
• Member must have failed therapy with at least three other medications commonly used for seizures. 
• Members currently stable on Briviact® and who have a seizure diagnosis will be grandfathered; AND
• For Briviact® oral solution, an age restriction of 12 years and younger will apply. Members older than 12 years of age will require a patient-specific, clinically significant reason why the member cannot take the oral tablet formulation; AND
• Approval length for Briviact® injection will be for a maximum of seven days of therapy.  Further approval may be granted if prescriber documents an ongoing need for Briviact® intravenous (IV) therapy over oral Briviact® formulations.

Prior Authorization form

cannabidiol Oral Solution (epidiolex®)

PA Criteria:

• An FDA approved diagnosis of 1 of the following:
  
  • Lennox-Gastaut syndrome (LGS); OR  
  • Dravet syndrome; AND  
   
• Member must be 2 years of age or older; AND
• Initial prescription must be written by, or in consultation with, a neurologist; AND  
• For a diagnosis of Dravet syndrome, the member must have failed or be inadequately controlled with at least 1 anticonvulsant; OR  
• For a diagnosis of LGS, the member must have failed therapy with at least 3 other anticonvulsants; AND
• Members currently stable on Epidiolex® and who have a seizure diagnosis will be grandfathered; AND
• The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling; AND
• Initial approvals will be for the duration of 3 months.  For continuation, the prescriber must include information regarding improved response/effectiveness of the medication.

Prior Authorization form

clobazam Oral Film (Sympazan™)

PA Criteria:

• An FDA approved indication of adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in members 2 years of age and older; AND
• Previous failure of at least 2 non-benzodiazepine anticonvulsants; AND
• Previous failure of clonazepam; AND
• A patient-specific, clinically significant reason why the member cannot use clobazam oral tablets or clobazam oral suspension must be provided; AND
• Initial approvals will be for the duration of 3 months.  For continuation, the prescriber must include information regarding improved response/effectiveness of the medication.

Prior Authorization form

PA criteria:

• An FDA approved diagnosis of partial-onset seizures; AND
• Member must not currently be taking oxcarbazepine (concurrent use is contraindicated); AND
• A patient-specific, clinically significant reason why member cannot use oxcarbazepine.
• A quantity limit of 30 per 30 days will apply on the lower strength tablets (200mg and 400mg) and 60 per 30 days on the higher strength tablets (600mg and 800mg). 

erolimus (Afinitor®)

Approval Criteria [Tuberous Sclerosis Complex (TSC)-Associated Partial-Onset Seizures Diagnosis]:

• An FDA approved diagnosis of TSC-associated partial-onset seizures; AND
• Initial prescription must be written by a neurologist; AND
• Member must have failed therapy with at least three other medications commonly used for seizures; AND
• Afinitor® must be used as adjunctive treatment; AND
• The member must not be taking any P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) concurrently with Afinitor®; AND
• The member must not be taking St. John’s wort concurrently with Afinitor®; AND
• The prescriber must verify that Afinitor® trough levels and adverse reactions (e.g., non-infectious pneumonitis, stomatitis, hyperglycemia, dyslipidemia, thrombocytopenia, neutropenia, febrile neutropenia) will be monitored, and dosing changes or discontinuations will correspond with recommendations in the drug labeling; AND
• Verification from the prescriber that female members will use contraception while receiving Afinitor® therapy and for eight weeks after the last dose of Afinitor® and that male members with female partners of reproductive potential will use contraception receiving Afinitor® therapy and for four weeks after the last dose of Afinitor®; AND
• The member’s recent body surface area (BSA) must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling. 
• Initial approvals will be for the duration of three months. For continuation, the prescriber must include information regarding improved response/effectiveness of the medication.

Prior Authorization - Afinitor PA

Approval Criteria:

• An FDA approved diagnosis of the treatment of partial-onset seizures; AND
• Initial prescription must be written by a neurologist; AND
• Member must have failed therapy with at least one other medications commonly used for seizures.
• Members currently stable on Vimpat® who have a seizure diagnosis will be grandfathered. 

Prior Authorization form

PA Criteria:

• An FDA approved diagnosis of partial-onset seizures, myoclonic seizures, or primary generalized tonic-clonic (PGTC) seizures; AND
• A patient-specific, clinically significant reason why the member cannot use generic formulations of levetiracetam. 
• A quantity limit of 60 tablets per 30 days will apply. 

Prior Authorization form

 PA Criteria:

• An FDA approved indication of adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut Syndrome; AND
• Initial prescription must be written by a neurologist; AND
• Member must have failed therapy with at least three other medications commonly used for seizures. 
• Members currently stable on Banzel® and who have a seizure diagnosis will be grandfathered. 

Prior Authorization form

stiripentol (Diacomit®)

PA Criteria:

• An FDA approved indication of adjunctive therapy in the treatment of seizures associated with Dravet syndrome in members 2 years of age and older; AND
• Initial prescription must be written by, or in consultation with, a neurologist; AND
• Member must have failed or be inadequately controlled with clobazam and valproate; AND
• Member must take clobazam and valproate concomitantly with Diacomit® or a reason why concomitant clobazam and valproate are not appropriate for the member must be provided; AND
• Members currently stable on Diacomit® and who have a seizure diagnosis will be grandfathered; AND
• The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling; AND
• For Diacomit® powder for oral suspension, an age restriction of 12 years and younger will apply.  Members older than 12 years of age will require a patient-specific, clinically significant reason why the member cannot take the oral capsule formulation; AND
• Initial approvals will be for the duration of 3 months.  For continuation, the prescriber must include information regarding improved response/effectiveness of the medication.

Prior Authorization form

PA criteria:

•  An FDA approved diagnosis of one of the following:
  • partial onset or primary generalized tonic-clonic seizures; OR  
  • As adjunctive therapy in seizures associated with Lennox-Gastaut syndrome; OR
  • Prophylaxis of migraine headache; AND  
• A member-specific, clinically significant reason why member cannot use the short-acting formulation, Topamax® (topiramate).
• A quantity limit of 30 per 30 days will apply on the lower strength capsules (25mg, 50mg, and 100mg) and 60 per 30 days on the higher strength capsules (150mg and 200mg).
  

PA criteria:

• An FDA approved diagnosis of one of the following:
  • partial onset or primary generalized tonic-clonic seizures; OR  
  • As adjunctive therapy in seizures associated with Lennox-Gastaut syndrome; OR
  • Prophylaxis of migraine headache; AND
• A member-specific, clinically significant reason why member cannot use the short-acting formulation, Topamax® (topiramate); AND
• A patient-specific, clinically significant reason why the member cannot use Qudexy® XR (topiramate ER) must be provided; AND
  
• Members currently stable on Trokendi XR® (topiramate ER) and who have a seizure diagnosis will be grandfathered; AND
• A quantity limit of 30 per 30 days will apply on the lower strength capsules (25mg, 50mg, and 100mg) and 60 per 30 days on the higher strength capsules (200mg).
  

PA Criteria:

Consideration will be based on all of the following criteria (Brand Name Preferred): 

• FDA approved diagnosis of refractory complex seizures in adults, and pediatric patients 10 years or older, OR infantile spasms in children ages 1 month to 2 years of age; AND
• Authorization of generic vigabatrin (in place of brand Sabril®) will require a patient-specific, clinically significant reason why the member cannot use the brand formulation (brand formulation is preferred); AND  
• Members with refractory complex seizures must have previous trials of at least three other antiepileptic medications; OR
• Prescription must be written by a neurologist; AND
• Member, prescriber, and pharmacy must all register in the SABRIL REMS program and maintain enrollment throughout therapy 

PA Criteria:

Only one long-acting and one short-acting agent can be used concurrently.

An age restriction for all tramadol and codeine liquid and solid dosage form products for members younger than 12 years of age will apply.  Authorization would require a patient-specific, clinically significant reason for use of these products despite the medication being contraindicated for the member’s age.

Tier 1 medications are available without prior authorization.

Tier 2 authorization requires:

• Documented 30-day trial/titration period with at least one Tier-1 medication(s) within the last 90 days is required for a Tier-2 long-acting medication, or documented 30-day trial with at least two Tier-1 short-acting medications within the last 90 days is required for a Tier-2 short-acting medication, OR
• Clinically appropriate pain therapy requiring time-released medication.
  

 Tier 3 authorization requires:

• documented 30 day trial with at least two Tier-2 long acting medications within the last 90 days is required for a Tier-3 long acting medication and documented 30 day trial with at least two Tier-2 short acting medications within the last 90 days is required for a Tier-3 short acting medication, OR
• documented allergy or contraindication to all Tier 2 medications

Special PA Criteria:

ConZip® (tramadol ER capsules) Approval Criteria:

• Authorization would require a patient-specific, clinically significant reason why the member could not use the extended-release tablet formulation. Tier structure rules would apply.

Levorphanol Tartrate Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use alternative treatment options for pain (e.g., non-opioid analgesics, lower-tiered opioid analgesics) must be provided. 

Opana® ER (oxymorphone ER) Approval Criteria:

• Authorization would require a patient-specific, clinically significant reason why the member could not use any other available extended-release opioid analgesic.

Xartemis™ XR approval criteria:

• An acute pain condition requiring around-the-clock opioid treatment; AND
• A patient-specific, clinically significant reason for the following:
  • Why the member cannot use any other opioid medication for treatment of acute pain; AND
  • Why the member requires a long-acting medication for an acute pain condition; AND
  • Why the member cannot use Oxycontin® (oxycodone ER) and OTC acetaminophen individual products in place of this combination product. 
• A quantity limit of 4 tablets per day will apply with a maximum approval duration of 10 days; AND
• The member must not exceed 3,250mg of acetaminophen per day from all sources.
• Tier structure rules still apply. 

Oncology Only Products:

• Members with an oncology-related diagnosis are exempt from the prior authorization process, and do not require pain contracts, although quantity and dosage limits still apply. Actiq®, Fentora®, Onsolis®, Abstral®, Lanzanda® and Subsys™ are approved only for oncology-related diagnoses.

Prior Authorization form

naloxone auto-injector (Evzio®) is currently not covered.

Suboxone® (Buprenorphine/Naloxone Sublingual Tablets and Film), Subutex® (Buprenorphine Sublingual Tablets), Zubsolv® (Buprenorphine/Naloxone Sublingual Tablets), Bunavail™ (Buprenorphine/Naloxone Buccal Films), and Cassipa® (Buprenorphine/Naloxone SL Films) Approval Criteria:  

• Brand formulation Suboxone® and generic buprenorphine/naloxone SL tablets are the preferred products. Bunavail™, Zubsolv®, Cassipa®, and generic Suboxone® films authorization requires a patient-specific, clinically significant reason why Suboxone® films or generic buprenorphine/naloxone SL tablets are not appropriate.
• Subutex® (buprenorphine) 2mg and 8mg tablets will only be approved if the member is pregnant, or has a documented serious allergy or adverse reaction to naloxone.
• For Cassipa®, the member must have been titrated to a dose of 16mg buprenorphine using another buprenorphine product prior to approval; AND
• Buprenorphine products FDA approved for a diagnosis of opioid abuse/dependence must be prescribed by a licensed prescriber who qualifies for a waiver under the Drug Addiction Treatment Act (DATA) and has notified the Center for Substance Abuse Treatment of the intention to treat addiction patients and has been assigned a Drug Enforcement Agency (DEA) X number; AND
• Member must have an FDA approved diagnosis of opioid abuse/dependence; AND  
• Concomitant treatment with opioids (including tramadol) will be denied; AND  
• Approvals will be for the duration of 90 days to allow for concurrent medication monitoring; AND  
• The following limitations will apply:
  • Suboxone® 2mg/0.5mg and 4mg/1mg SL tablets and films: A quantity limit of 90 units per 30 days will apply.
  • Suboxone® 8mg/2mg SL tablets and films: A quantity limit of 60 SL units per 30 days will apply.
  • Suboxone® 12mg/3mg films: A quantity limit of 30 SL films per 30 days will apply.
  • Subutex® 2mg tablets: A quantity limit of 90 SL tablets per 30 days will apply.
  • Suboxone® 8mg/2mg SL tablets and films: A quantity limit of 60 SL units per 30 days will apply.
  • Zubsolv® 1.4mg/0.36mg and 2.9mg/0.71mg sublingual tablets: A quantity limit of 90 tablets per 30 days will apply.
  • Zubsolv® 5.7mg/1.4mg SL tablets: A quantity limit of 60 SL tablets per 30 days will apply.
  • Zubsolv® 8.6mg/2.1mg and 11.4mg/2.9mg SL tablets: A quantity limit of 30 SL tablets per 30 days will apply.
  • Bunavail™ 2.1mg/0.3mg buccal films: A quantity limit of 90 films per 30 days will apply.
  • Bunavail® 4.2mg/0.7mg buccal films: A quantity limit of 60 buccal films per 30 days will apply.
  • Bunavail™ 6.3mg/1mg buccal films: A quantity limit of 30 films per 30 days will apply. 
  • Cassipa® 16mg/4mg SL films: A quantity limit of 30 SL films per 30 days will apply.  

High Dose Buprenorphine Products Criteria:

• Each request for greater than 16mg bioequivalent buprenorphine per day should be evaluated on a case-by-case basis.
• A taper schedule should be documented on the petition or dates of an attempted taper with reason for failure should be documented or a patient-specific, clinically significant reason a taper schedule or attempt is not appropriate for the member; AND
• Opioid urine drug screens should be submitted with high-dose requests that plan to continue high-dose treatment longer than the duration of one month.
  • Urine drug screens must show the absence of opioid medications other than buprenorphine products for continued approval; OR
  • Prescriber must document a patient-specific reason the member should continue therapy, reason for opioid use, and document a plan for member to discontinue opioid use; AND
• Symptoms associated with withdrawal at lower doses or symptoms requiring high doses should be listed on petition; AND
• Each approval will be for the duration of one month. If urine drug screen and other documentation are submitted indicating high-dose therapy is necessary an approval can be granted for the duration of three months.
• Continued high-dose authorization after the three month approval will require a new (recent) urine drug screen.

buprenorphine implant (Probuphine®) Approval Criteria:

• An FDA approved diagnosis of maintenance treatment of opioid dependence; AND
• Members must be currently on a maintenance dose of 8mg per day or less of a Subutex® or Suboxone® sublingual tablet or its transmucosal buprenorphine product equivalent; AND
• Member must have been stable on current transmucosal buprenorphine dose (of 8mg per day or less) for three months or longer without any need for supplemental dosing or adjustments; AND
• Members must have had no positive urine toxicology results or paid claims for opioids for the last three months. Concomitant treatment with opioids (including tramadol) will be denied; AND
• Probuphine® must be prescribed by a licensed physician who qualifies for a waiver under the Drug Addiction Treatment Act (DATA) and has notified the Center for Substance Abuse Treatment of the intention to treat addiction patients and has been assigned a DEA (X) number; AND
• Prescribers must verify they have considered the following factors in determining clinical stability and suitability for Probuphine®:
  • Period free from illicit opioid drug use 
  • Stability of living environment 
  • Participation in a structured activity/job 
  • Consistency in participation in recommended behavioral therapy/peer support program 
  • Consistency in compliance with clinic visit requirements 
  • Minimal to no desire or need to use illicit opioids 
  • Period without episodes of hospitalizations (addiction or mental health issues), emergency room visits, or crisis interventions 
  • Social support system 
• The prescriber must verify enrollment in the Probuphine® Risk Evaluation and Mitigation Strategy (REMS) program; AND
• Approvals will be for one kit (four implants) per six months. Reauthorizations for an additional six months may be granted if the member does not have ongoing use of supplemental dosing with transmucosal buprenorphine or opioid analgesics while utilizing Probuphine®.

lofexidine (Lucemyra™) Approval Criteria:

• An FDA approved indication for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults; AND
• Date of opioid discontinuation must be listed on the prior authorization request; AND
• Prescriber must verify member has been screened for hepatic and renal impairment and that dosing is appropriate for the member’s degree of hepatic and renal function; AND
• Prescriber must verify member’s vital signs have been monitored and that the member is capable of and has been instructed on self-monitoring for hypotension, orthostasis, bradycardia, and associated symptoms; AND
• Member must not have severe coronary insufficiency, a recent myocardial infarction, cerebrovascular disease, chronic renal failure, or marked bradycardia; AND
• Member must not have congenital long QT syndrome; AND
• Prescriber must verify Lucemyra™ will be used in conjunction with a comprehensive management program for the treatment of opioid use disorder; AND  
• A patient-specific, clinically significant reason why clonidine tablets or patches cannot be used in place of Lucemyra™ to mitigate opioid withdrawal symptoms must be provided; AND
• Approvals will be for a maximum duration of 14 days; AND  
• A quantity limit of 12 tablets daily will apply.

buprenorphine extended-release (Sublocade™) Injection] Approval Criteria:

• Sublocade™ must be prescribed by a licensed physician who qualifies for a waiver under the Drug Addiction Treatment Act (DATA) and has notified the Center for Substance Abuse Treatment of the intention to treat addiction patients and has been assigned a Drug Enforcement Agency (DEA) X number; AND
• An FDA approved diagnosis of moderate-to-severe opioid use disorder; AND
• Member must have initiated treatment with a transmucosal buprenorphine-containing product for a minimum of seven days; AND
• Concomitant treatment with opioids (including tramadol) will be denied; AND
• Sublocade™ should only be prepared and administered by a health care provider; AND
• A patient-specific, clinically significant reason why the member cannot use the preferred buprenorphine product(s) (Suboxone®) must be provided; AND
• Approvals will be for the duration of 90 days to allow for concurrent medication monitoring; AND
• A quantity limit of one dose (300mg or 100mg) per 28 days will apply. 

Prior Authorization form   

• Smoking cessation products no longer require a prior authorization. 
• Smoking cessation products do not count against the 6 prescriptions/month limit.
• Smoking cessation products are available without a co-pay. 
• All nicotine replacement products (patches, gum, lozenges, inhalers), Zyban®, and Chantix® do not require prior authorization.
• Chantix® may be used for up to 180 days per calendar year. Chantix is not covered for members younger than 16 years of age.
• Oklahoma Tobacco Helpline - Smoking Cessation Program 

PA criteria:

• Prior Authorization is required for the following special formulation products:  
  • donepezil (Aricept®) and 23 mg tablets
  • rivastigmine (Exelon®) solution and patch
  • memantine (Namenda®) solution and tablets
  • galantamine (Razadyne®) solution and extended release capsules
   
• Member must have a documented reason why the special formulation is clinically necessary over the regular formulation
• Application of Age Restriction for ages 0-50 with the following approval criteria.  
• FDA approved diagnosis

memantine extended-release (ER) capsules (Namenda XR®) Approval Criteria:

• An FDA approved diagnosis for the treatment of moderate-to-severe Alzheimer’s type dementia; AND
• A patient-specific, clinically significant reason why the member cannot use memantine immediate-release tablets.

memantine er/donepezil (Namzaric™ ) Approval Criteria:

• Member must have a patient-specific, clinically significant reason why the separate immediate release products which do not require a prior authorization cannot be used in place of this combination product; AND
• A quantity limit of 30 capsules per 30 days will apply.
  

 Prior Authorization form  

Parkinson's Disease

• FDA approved indication for the treatment of signs and symptoms of Parkinson's Disease
• Must be 18 years old or older
• Failed treatment, intolerance, or clinically significant reason why member cannot use oral dopamine agonists

Restless Leg Syndrome

• FDA approved indication of Restless Leg Syndrome
• Must be 18 years or older
• Must provide documented treatment attempts at recommended dose with at least two of the following that did not yield adequate relief:
• • carbidopa/levodopa
  • pramipexole
  • ropinirole

Prior Authorization form

PA criteria:

• FDA-approved indication of postherpetic neuralgia.
• Must provide documented treatment attempts at recommended dosing or contraindications to at least one agent from two of the following drug classes:
  • Tricyclic antidepressants
  • Anticonvulsants
  • Topical or oral analgesics
   
• Must provide a clinically significant reason why the member cannot take the immediate-release formulation of gabapentin.

 Prior Authorization form

PA criteria:

• An FDA approved diagnosis of Pseudobulbar Affect (PBA) secondary to a neurological condition (e.g., ALS, MS, Parkinson’s disease, stroke, traumatic brain injury); AND  
• Documentation of the neurological condition must be submitted; AND
• Member must be 18 years of age or older; AND
  Nuedexta® must be prescribed by, or in consultation with, a neurologist or psychiatrist (or be an advanced care practitioner with a supervising physician who is a neurologist or psychiatrist); AND
• Member must not have a contraindication to therapy [e.g., concomitant use with quinidine, quinine, or mefloquine; history of quinidine, quinine, or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions; known hypersensitivity to dextromethorphan; use with a monoamine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI; prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure; complete atrioventricular (AV) block without implanted pacemaker, or at high risk of complete AV block; currently taking other drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine or pimozide)]; AND
• Prescriber must document baseline number of PBA laughing or crying episodes per day; AND
• A quantity limit of 60 capsules per 30 days will apply; AND
• Initial approvals will be for the duration of one year 12 weeks. Reauthorizations may be granted if the prescriber documents the member is responding well to treatment as indicated by a reduction in the number of PBA episodes of laughing or crying per day compared to baseline. Current users must meet the revised approval criteria when reapplying for prior authorization continuation. 

Prior Authorization form   

PA criteria:

amantadine extended-release (ER)(Gocovri™) Approval Criteria:

• An FDA approved indication for the treatment of dyskinesia in patients with Parkinson’s disease (PD) receiving levodopa-based therapy; AND
• Member must use Gocovri™ concomitantly with levodopa therapy; AND
• Member must not have end-stage renal disease (ESRD, CrCl <15mL/min/1.73m2); AND
• A minimum of a six-month trial of amantadine immediate-release (IR) that resulted in inadequate effects or intolerable adverse effects that are not expected to occur with amantadine ER; AND
• A patient-specific, clinically significant reason why amantadine IR products cannot be used must be provided; AND
• A patient-specific, clinically significant reason why Osmolex ER™ (amantadine ER) cannot be used must be provided; AND
• A quantity limit of one 68.5mg capsule or two 137mg capsules per day will apply.

amantadine extended-release (ER) (Osmolex ER™) Approval Criteria:

• An FDA approved indication for the treatment of Parkinson’s disease (PD) or drug-induced extrapyramidal reactions in adults patients; AND
• Member must not have end-stage renal disease (ESRD) [creatinine clearance (CrCl) <15mL/min/1.73m2]; AND
• A minimum of a 6-month trial of amantadine immediate-release (IR) that resulted in inadequate effects or intolerable adverse effects that are not expected to occur with amantadine ER; AND
• A patient-specific, clinically significant reason why amantadine IR products cannot be used must be provided; AND
• A quantity limit will apply based on FDA approved dosing regimen(s). 

carbidopa/levodopa enteral suspension (Duopa™) Approval Criteria:

• An FDA approved diagnosis of advanced Parkinson’s disease; AND
• For long-term administration, member or caregivers must be willing and able to administer Duopa® through a percutaneous endoscopic gastrostomy; AND
• Patients must be experiencing three hours or more of “off” time on their current Parkinson's disease drug treatment and they must have demonstrated a clear responsiveness to treatment with levodopa;  AND
• Approvals will be for a quantity of one cassette per day

carbidopa/levodopa extended-release capsules (Rytary™) Approval Criteria:

• An FDA approved diagnosis of Parkinson’s disease, post-encephalitic parkinsonism, or parkinsonism that may follow carbon monoxide intoxication or manganese intoxication; AND
• A patient-specific, clinically significant reason why the member cannot use other generic carbidopa/levodopa combinations including Sinemet® CR (carbidopa/levodopa extended-release tablets).

levodopa Inhalation (Inbrija™) Approval Criteria:

• An FDA approved indication for the treatment of “off” episodes in patients with Parkinson’s disease (PD) treated with carbidopa/levodopa; AND
• Member must be taking levodopa/carbidopa in combination with Inbrija™. Inbrija™ has been shown to be effective only in combination with carbidopa/levodopa; AND
• The member must be experiencing motor fluctuations with a minimum of 2 hours of “off” time and demonstrate levodopa responsiveness; AND
• Member must not be taking nonselective monoamine oxidase inhibitors (MAOIs) concomitantly with Inbrija™ or within 2 weeks prior to initiating Inbrija™; AND
• A previous failed trial of immediate-release (IR) carbidopa/levodopa formulations alone or in combination with long-acting carbidopa/levodopa formulations or a reason why supplementation with IR carbidopa/levodopa formulations is not appropriate for the member must be provided; AND
• A quantity limit of 10 capsules for inhalation per day will apply. 

pimavanserin (Nuplazid™) Approval Criteria:  

• An FDA approved diagnosis of hallucinations and delusions associated with Parkinson’s disease psychosis; AND
• Member must have concomitant diagnosis of Parkinson’s disease; AND
• Member must not be taking concomitant medications known to prolong the QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin, moxifloxacin); AND
  
• The member must not have a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia, hypomagnesemia, and the presence of congenital prolongation of the QT interval; AND
• Nuplazid™ will not be approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis; AND
• Initial approvals will be for the duration of three months. For continuation, the prescriber must include information regarding improved response/effectiveness of this medication.
• A quantity limit of one tablet daily will apply.

safinamide (Xadago®) Approval Criteria:  

• An FDA approved diagnosis of adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes; AND
• Member must be taking levodopa/carbidopa in combination with safinamide. Safinamide has not been shown to be effective as monotherapy for the treatment of PD; AND
• A patient-specific, clinically significant reason why the member cannot use rasagiline or other lower cost monoamine oxidase type B (MAO-B) inhibitors must be provided; AND
• Member must not have severe hepatic impairment; AND
• Member must not be taking any of the following medications concomitantly with safinamide:
  • Monoamine oxidase inhibitors (MAOIs); OR
  • Linezolid; OR
  • Opioid analgesics (including tramadol); OR
  • Selective norepinephrine reuptake inhibitors (SNRIs); OR
  • Tri- or tetra-cyclic or triazolopyridine antidepressants; OR
  • St. John’s wort; OR
  • Cyclobenzaprine; OR
  • Methylphenidate and its derivatives; OR
  • Amphetamine and its derivatives; OR
  • Dextromethorphan; AND 
• Prescriber must verify member has been counseled on avoiding foods that contain a large amount of tyramine while taking safinamide; AND
• A quantity limit of one tablet daily will apply.

Prior Authorization form

PA criteria:

• An FDA approved diagnosis of infantile spasms; AND  
  • Member must be two years of age or younger; AND
  • Must be prescribed by, or in consultation with, a neurologist or an advanced care practitioner with a supervising prescriber that is a neurologist; OR  
• An FDA approved diagnosis of multiple sclerosis (MS); and a. Member is experiencing an acute exacerbation; AND
  • Must be prescribed by, or in consultation with, a neurologist or an advanced care practitioner with a supervising prescriber that is a neurologist or a physician that specializes in MS; AND
  • Prescriber must rule out pseudo-exacerbation from precipitating factors (e.g., pain, stress, infection, premenstrual syndrome); AND  
  • Symptoms of acute exacerbation last at least 24 hours; AND
  • Member must be currently stable within the last 30 days on an immunomodulator agent, unless contraindicated; AND  
  • A patient-specific, clinically significant reason why the member cannot use alternative corticosteroid therapy (e.g. IV methylprednisolone, IV dexamethasone, oral prednisone). 
  • A quantity limit of daily doses of up to 120 units for up to 3 weeks for acute exacerbation will apply; OR 
• An FDA approved diagnosis of nephrotic syndrome without uremia of the idiopathic type or that is due to lupus erythematosus to induce a diuresis or a remission; and a. Must be prescribed by, or in consultation with, a nephrologist or an advanced care practitioner with a supervising prescriber that is a nephrologist; AND
  • A patient-specific, clinically significant reason why the member cannot use alternative corticosteroid therapy (e.g., prednisone); OR 
• An FDA approved diagnosis of the following disorders and diseases: rheumatic; collagen; dermatologic; allergic states; ophthalmic; respiratory; and edematous states; and a. A patient-specific, clinically significant reason why the member cannot use alternative corticosteroid therapy.

Prior Authorization form

deutetrabenazine (Austedo™) Approval Criteria [Huntington's Disease Diagnosis]:

• An FDA approved diagnosis of chorea associated with Huntington’s disease; AND
• Austedo™ must be prescribed by a neurologist, or a mid-level practitioner with a supervising physician that is a neurologist; AND
• A previous trial of Xenazine® (tetrabenazine) or a patient-specific, clinically significant reason why the member cannot use brand Xenazine® (tetrabenazine); AND
• Member must not be actively suicidal or have uncontrolled depression and prescriber must verify member will be monitored for depression prior to starting Austedo™ therapy and throughout treatment; AND
• Member must not have hepatic impairment; AND
• Member must not be taking monoamine oxidase inhibitors (MAOIs) or have taken an MAOI within the last 14 days; AND
• Member must not be taking reserpine or have taken reserpine within the last 20 days; AND
• Member must not use another vesicular monoamine transporter-2 (VMAT2) inhibitor (e.g., tetrabenazine, valbenazine) concurrently with Austedo™; AND
• For members requiring doses of Austedo® above 24mg per day, who are using Austedo® concomitantly with other medications that are known to prolong the QTc interval [antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, or any other medications known to prolong the QTc interval] the prescriber must agree to assess the QTc interval before and after increasing the dose of Austedo® or other medications that are known to prolong the QTc interval; AND
• The member must not have congenital long QT syndrome or a history of cardiac arrhythmias; AND
• The daily dose of Austedo™ must not exceed 36mg per day if the member is taking strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) or if they are a known poor CYP2D6 metabolizer; AND
• Approvals will be for the duration of six months at which time the prescriber must document that the signs and symptoms of chorea have decreased and the member is not showing worsening signs of depression.

deutetrabenazine (Austedo®) Approval Criteria [Tardive Dyskinesia Diagnosis]:   

• An FDA approved diagnosis of tardive dyskinesia meeting the following DSM-5 criteria:
  • Involuntary athetoid or choreiform movements; AND  
  • History of treatment with dopamine receptor blocking agent (DRBA); AND
  • Symptom duration lasting longer than 4 to 8 weeks; AND 
• Member must be 18 years of age or older; AND
• Austedo® must be prescribed by a neurologist or psychiatrist, or a mid-level practitioner with a supervising physician that is a neurologist or psychiatrist; AND
• Member must not be actively suicidal or have uncontrolled depression and prescriber must verify member will be monitored for depression prior to starting Austedo® therapy and throughout treatment; AND
• Member must not have hepatic impairment; AND
• Member must not be taking monoamine oxidase inhibitors (MAOIs) or have taken an MAOI within the last 14 days; AND
• Member must not be taking reserpine or have taken reserpine within the last 20 days; AND
• Member must not use another vesicular monoamine transporter 2 (VMAT2) inhibitor (e.g., tetrabenazine, valbenazine) concurrently with Austedo®; AND  
• For members requiring doses of Austedo® above 24mg per day, who are using Austedo® concomitantly with other medications that are known to prolong the QTc interval [antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, or any other medications known to prolong the QTc interval] the prescriber must agree to assess the QTc interval before and after increasing the dose of Austedo® or other medications that are known to prolong the QTc interval; AND  
• The member must not have congenital long QT syndrome or a history of cardiac arrhythmias; AND
• The daily dose of Austedo® must not exceed 36mg per day if the member is taking strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) or if they are a known poor CYP2D6 metabolizer; AND
• Female members must not be pregnant or breastfeeding; AND
• Prescriber must document a baseline evaluation using the Abnormal Involuntary Movement Scale (AIMS); AND
• Approvals will be for the duration of six months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment as indicated by an improvement from baseline in the AIMS total score (a negative change in score indicates improvement) or documentation of a positive clinical response to therapy.  

tetrabenazine (Xenazine®) Approval Criteria:

• Authorization of generic tetrabenazine (in place of brand Xenazine®) will require a patient-specific, clinically significant reason why the member cannot use the brand formulation (brand formulation is preferred); AND
• A diagnosis of one of the following: 
  •  Chorea associated with Huntington’s disease; OR
  • Tardive dyskinesia; OR
  • Tourette syndrome; AND 
• Xenazine® must be prescribed by a neurologist, or a mid-level practitioner with a supervising physician that is a neurologist; AND
• Member must not be actively suicidal or have uncontrolled depression and prescriber must verify member will be monitored for depression prior to starting Xenazine® therapy and throughout treatment; AND
• Member must not have hepatic impairment; AND
• Member must not be taking monoamine oxidase inhibitors (MAOIs) or have taken an MAOI within the last 14 days; AND
• Member must not be taking reserpine or have taken reserpine within the last 20 days; AND
• Member must not use another vesicular monoamine transporter-2 (VMAT2) inhibitor (e.g., deutetrabenazine, valbenazine) concurrently with Xenazine®; AND
• Member must not be taking medications that are known to prolong the QTc interval concomitantly with Xenazine® [antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, or any other medications known to prolong the QTc interval]; AND
• Patients who require doses of tetrabenazine greater than 50mg per day must be tested and genotyped to determine if they are poor metabolizers (PMs), intermediate metabolizers (IMs), or extensive metabolizers (EMs) by their ability to express the drug metabolizing enzyme, CYP2D6. The following dose limits will apply based on patient metabolizer status: 
  • Extensive and Intermediate CYP2D6 Metabolizers: 100mg divided daily; OR
  • Poor CYP2D6 Metabolizers: 50mg divided daily; AND 
• The daily dose of Xenazine® must not exceed 50mg per day if the member is taking strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion); AND
• Approvals will be for the duration of six months at which time the prescriber must document that the signs and symptoms of chorea, tardive dyskinesia, or Tourette syndrome have decreased and the member is not showing worsening signs of depression. 

valbenazine (Ingrezza™) Approval Criteria:

• An FDA approved diagnosis of tardive dyskinesia meeting the following DSM-5 criteria:
  • Involuntary athetoid or choreiform movements; AND
  • History of treatment with dopamine receptor blocking agent (DRBA); AND
  • Symptom duration lasting longer than 4 to 8 weeks; AND  
• Member must be 18 years of age or older; AND
• Ingrezza™ must be prescribed by a neurologist or psychiatrist, or a mid-level practitioner with a supervising physician that is a neurologist or psychiatrist; AND
• The daily dose of Ingrezza™ must not exceed 40mg per day if the member is taking strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, clarithromycin); AND
• Member must not be taking monoamine oxidase inhibitors (MAOIs); AND
• Member must not be taking other vesicular monoamine transporter 2 (VMAT2) inhibitors (e.g., tetrabenazine, deutetrabenazine); AND
• The daily dose of Ingrezza® must not exceed 40mg per day for members with moderate or severe hepatic impairment (Child-Pugh score 7 to 15); AND
• The member must not have congenital long QT syndrome or a history of arrhythmias associated with a prolonged QT interval; AND
• Female members must not be pregnant or breastfeeding; AND
• Prescriber must document a baseline evaluation using the Abnormal Involuntary Movement Scale (AIMS); AND
• A quantity limit of two 40mg capsules or a total dose of 80mg per day will apply; AND
• Approvals will be for the duration of six months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment as indicated by an improvement from baseline in the AIMS total score (a negative change in score indicates improvement) or documentation of a positive clinical response to therapy. 

Prior Authorization form

edaravone (Radicava™) Approval Criteria:

• An FDA approved diagnosis of amyotrophic lateral sclerosis (ALS); AND
• Member must have been evaluated by a physician specializing in the treatment of ALS within the last three months; AND
• Disease duration of two years or less (for initial approval); AND
  
  • A prior authorization request with patient-specific information may be submitted for consideration of edaravone for members with disease duration greater than two years, including but not limited to disease progression, specific symptoms related to the disease, activities of daily living currently affected by the disease, or prognosis; AND

• Approvals will be for the duration of six months.  For each subsequent approval, the prescriber must document that the member is responding to the medication, as indicated by a slower progression in symptoms and/or slower decline in quality of life compared to the typical ALS disease progression. 

Prior Authorization form