Central Nervous System/Behavioral Health

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.

• 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 18 or older.Prior authorization is required for all products for members under age 18.

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:

• Minimum of 30 day trial with all available Tier 2 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

tasimelteon (Hetlioz®) Approval Criteria:

• An FDA approved diagnosis of Non-24-Hour Sleep-Wake Disorder (Non-24); 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.
• 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.

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

• zolpidem tartrate (Ambien CR®)
• ramelteon (Rozerem®)

• suvorexant (Belsomra®)

*Unique dosage formulations require a special reason for use in place of Tier-1 formulations.

+ Individual criteria specific to tasimelteon.

Prior Authorization of Interferon

• Documented diagnosis of relasping remitting MS.
• Tier 2 medications require failure of the preferred tier 1 product defined as:
  • Occurrence of an exacerbation after 6 months.
  • Significant increase in MRI lesions after 6 months.
  • Adverse reactions or intolerable side effects.
• No concurrent use with other therapies.
• Compliance will be checked for continued approval every 6 months.

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

•  
• interferon β 1a (Rebif®)
• inerferon 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

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.

PA Criteria:

• Documented diagnosis of relapsing remitting MS with at least one relapse in the previous 12 months, or transitioning from existing MS therapy.
• No concurrent use with other therapies.
• Compliance will be checked for continued approval every 6 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
Consideration will be based on all of the following criteria:

• A 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 from the prescriber that member has no active infection (s); AND
  • CBC counts and verification that levels are acceptable to the prescriber; AND
• Compliance will be checked every 6 months there-after for continuation of therapy; AND
• Quantity limit of #60 tablets per 30 days applies

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 for stimulants is required for all tiers for members greater than 20 years of age and for members 0-4 years of age. All prior authorization requests for members under the age of 5 years must be reviewed by an OHCA contracted psychiatrist.

Tier 2 Prior Authorization Approval Criteria:

• FDA approved diagnosis; AND
• A trial with at least one long-acting Tier one stimulant:
  • Trials should have been within the last 180 days; AND
  • Trials should have been dosed up to maximum recommended dose or documented adverse effects at higher doses should be included; AND
  • If trials are not in member’s claim history, the pharmacy profile should be submitted or detailed information regarding dates and doses should be included along with the signature from the physician.

Tier 3 Prior Authorization Approval Criteria:

• FDA approved diagnosis; AND
• A trial with at least one long-acting Tier-1 stimulant; AND
• A trial with at least one Tier-2 medication that did not yield adequate response:
  • Trials should have been within the last 365 days; AND
  • Trials should have been dosed up to maximum recommended dose or documented adverse effects at higher doses should be included; AND
  • If trials are not in member’s claim history, the pharmacy profile should be submitted or detailed information regarding dates and doses should be included along with the signature from the physician.
• A clinical exception may apply for special formulation products when there is a patient-specific, clinically significant reason why member cannot use the available long acting capsule formulation.
• Use of Kapvay® requires:
  • An FDA approved diagnosis; AND
  • Recent trials with a long-acting Tier-1 stimulant and a long-acting Tier-2 stimulant, and a trial of Intuniv® and Strattera® within the past six months, unless contraindicated, that did not yield adequate results; AND
  • A patient-specific, clinically significant reason why member cannot use clonidine immediate release tablets.

Special Prior Authorization Approval Criteria: Desoxyn®, Dexedrine®, Dexedrine Spansules®, Evekeo™, ProCentra® Solution, and Zenzedi® Criteria:

• Covered diagnosis; AND
• A patient-specific, clinically significant reason why member cannot use all other available stimulant medications.

Daytrana®, Quillivant XR®, and Methylin® Chewable Tablets and Solution Criteria:

• FDA approved diagnosis; AND
• A patient-specific, clinically significant reason why member cannot use all other available formulations of long-acting stimulant medications that can be used for members who cannot swallow capsules/tablets.

Provigil®, Nuvigil®, and Xyrem® Criteria:

• An FDA approved diagnosis; AND
• Use of Provigil® or Nuvigil® requires a patient-specific, clinically significant reason why the member cannot use stimulant medications to improve wakefulness during the daytime.
• Use of Xyrem® requires recent trials with Tier-1 and Tier-2 stimulants from different chemical categories, and trials with both Provigil® and Nuvigil® within the past six months, unless contraindicated, that did not yield adequate results.
• The diagnosis of obstructive sleep apnea requires concurrent treatment for the obstructive sleep apnea.
• The diagnosis of shift work sleep disorder requires the member’s work schedule to be included with the prior authorization request.

ADHD & Narcolepsy Medications Additional Criteria:

• Doses exceeding 1.5 times the FDA maximum are not covered.
• Prior Authorization is required for all tiers for members greater than 20 years of age and for members 0-4 years of age. All prior authorization requests for members under the age of 5 years must be reviewed by an OHCA contracted psychiatrist.
• Vyvanse® (Lisdexamfetamine) Approval Criteria: Binge Eating Disorder (BED)
  • An FDA approved diagnosis of moderate-to-severe binge eating disorder; and
  • Member must be 18 years or older; and
  • Vyvanse® for the diagnosis of BED must be prescribed by a psychiatrist; and
  • Authorizations will not be granted for the purpose of weight loss without the diagnosis of BED or for the diagnosis of obesity alone. The safety and effectiveness of Vyvanse® for the treatment of obesity have not been established; and
  • A quantity limit of 30 capsules per 30 days will apply; and
• Initial approvals will be for the duration of three months. Continued authorization will require prescriber documentation of improved response/effectiveness of Vyvanse®.

• amphetamine (Evekeo™)
• armodafinil (Nuvigil®)
• dextroamphetamine (Dexedrine®) tabs
• dextroamphetamine (Dexedrine®)spansules
• dextroamphetamine (ProCentra®) sol
• dextroamphetamine (ZenZedi®)
• methamphetamine (Desoxyn®)
• methylphenidate (Methylin®) chew tabs
• methylphenidate (Methylin®) sol
• modafinil (Provigil®)
• sodium oxybate (Xyrem®) sol
• methylphenidate (Daytrana®)
• methylphenidate (Quillivant XR®)

• Short-Acting
• amphetamine (Adderall®)

• Long-Acting
• lisdexamfetamine (Vyvanse®)

Long-Acting

• Adderall XR® (brand only)

Long-Acting

• amphetamine/Dextroamphetamine ER capsules (generic Adderall XR®)

Short-Acting

• dexmethylphenidate (Focalin®)
• methylphenidate (Methylin®)
• methylphenidate (Ritalin®)

Long-Acting

• methylphenidate er (Metadate ER®)
• Metadate CD® (brand only)
• methylphenidate er (Methylin ER®)
• methylphenidate er (Ritalin SR®)

Long-Acting

• Ritalin LA® (brand only)
• dexmethylphenidate er (Focalin XR®)

Long-Acting

• methylphenidate CD (generic Metadate CD®)
• methylphenidate ER (Aptensio XR™)
• methylphenidate ER (Concerta®)
• methylphenidate LA (generic Ritalin LA®)

•  
• atomoxetine (Strattera®)
• guanfacine ER (Intuniv®)

• clonidine ER (Kapvay®)

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:

• 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™.

Approval Criteria for Tier 2 Medication:

• Trials of two Tier 1 products (not including clozapine), at least 14 days in duration each, titrated to recommended dose, that did not yield adequate response or resulted in intolerable adverse effects.

Approval Criteria for Tier 3 Medication:

• A trial of two Tier-1 products (not including clozapine), at least 14 days in duration, titrated to recommended dose, that did not yield adequate response or resulted in intolerable adverse effects; AND
• A trial of two 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.
• A manual prior authorization may be submitted for consideration of a Tier-3 product when the member has had at least four trials of Tier-1 and Tier-2 products (two trials must be from Tier-1) 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:

For Abilify® (aripiprazole), Rexulti® (brexipiprazole), Seroquel XR® (quetiapine extended release), or Symbyax® (olanzapine/fluoxetine): 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) 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).

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.

• clozapine (Clozaril®)*
• quetiapine (Seroquel®)
• risperidone (Risperdal®, Risperdal Consta®)
• olanzapine (Zyprexa®)
• ziprasidone (Geodon®)

• aripiprazole (Abilify®, Abilify Maintena®)
• iloperidone (Fanapt^TM)
• paliperidone (Invega®, Invega Sustena®, Invega Trinza™)∞
• lurasidone (Latuda®)
• asenapine (Saphris®)
• quetiapine ER (Seroquel XR®)

•  
• clozapine (Fazaclo®)
• brexpiprazole (Rexulti®)
• olanzapine/fluoxetine (Symbyax®)
• clozapine (Versacloz®)

* Does not count toward a Tier-1 trial.

∞ In addition to tier trials, use of Invega Trinza™ requires members to have been adequately treated with the 1-month paliperidone extended-release injection (Invega® Sustenna®) for at least four months.

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
• 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
• 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
• Additionally, Zecuity® will require a patient-specific, clinically significant reason why member cannot use all available generic formulations of sumatriptan (tablets, nasal spray, and injection)

• rizatriptan (Maxalt®, Maxalt MLT®)
• sumatriptan (Imitrex®)

• naratriptan (Amerge®)
• zolmitriptan tablets & ODTs (Zomig®, Zomig ZMT®)

• almotriptan (Axert®)
• eletriptan (Relpax®)
• frovatriptan (Frova®)
• sumatriptan injection (Imitrex®)
• sumatriptan nasal spray (Imitrex®)
• sumatriptan (Sumavel DosePro®)
• sumatriptan (Zecuity®TDS)
• sumatriptan/naproxen (Treximet®)
• zolmitriptan nasal spray (Zomig®)

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.

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

• pregabalin (Lyrica ®)

• 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.

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

For Abilify® (aripiprazole), Rexulti® (brexipiprazole), Seroquel XR® (quetiapine extended release), or Symbyax® (olanzapine/fluoxetine): 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) 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).

**Irenka™ for musculoskeletal conditions will require a patient-specific, clinically significant reason why the member cannot use two duloxetine 20mg capsules in place of the 40mg capsules.

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

• fluvoxamine (Luvox CR®)
• fluoxetine 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)

• vilazodone (Viibryd®)

• desvenlafaxine (Pristiq®, Khedezla®)
• levomilnacipran (FetzimaTM®)
• nefazodone (Serzone®)

• bupropion ER (Aplenzin®, Forfivo®)
• duloxetine (Irenka™)**
• trazodone ER (Oleptro®)
• venlafaxine extended release tablets

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

• vortioxetine (Brintellix®)

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.

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.
   • Dosepacks 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.

PA criteria:

• Diagnosis of generalized tonic, atonic or myoclonic seizures; and
• Previous failure of at least two non-benzodiazepine anticonvulsants; and
• Previous failure of clonazepam.
• For continuation prescriber must include information regarding improved response/effectiveness of this medication.

PA criteria:

• An FDA approved diagnosis of partial-onset seizures as adjunctive therapy; AND
• Member must be on current antiepileptic drug therapy (Aptiom® is only indicated for adjunctive treatment); AND
• Member must not currently be taking oxcarbazepine (concurrent use is contraindicated); AND
• A member-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).

PA criteria:

• An FDA approved diagnosis of partial onset or primary generalized tonic-clonic seizures or as adjunctive therapy in seizures associated with Lennox-Gastaut syndrome; 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 partial onset or primary generalized tonic-clonic seizures or as adjunctive therapy in seizures associated with Lennox-Gastaut syndrome; 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 (200mg).

PA Criteria

Consideration will be based on all of the following criteria:

• 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
• Members with refractory complex seizures must have previous trials of at least three other antiepileptic medications; OR
• Members with infantile spams must have had a previous trial with adrenocorticotropic hormone (ACTH) OR have a diagnosis of infantile spasms with tuberous sclerosis; AND
• Prescription must be written by a neurologist; AND
• Member, prescriber, and pharmacy must all register in the SHARE program and maintain enrollment throughout therapy

PA Criteria:

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

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:

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.

• codeine
• codeine/APAP
• hydromorphone(Dilaudid®)
• ASA/butalbital/caffeine/ codeine(Fiorinal with Codeine®)
• hydrocodone/APAP(Lortab®)
• morphine-immediate release (MSIR®)
• oxycodone-immediate release (OxylR®)
• oxycodone/APAP(Percocet®)
• oxycodone/ASA(Percodan®)
• oxycodone/ibuprofen (Combunox™)
• oxycodone ER 10mg, 15mg, 20mg only (Oxycontin®)
• tramadol/APAP (Ultracet®)
• hydrocodone/IBU (Vicoprofen®)
• tramadol
• Hycet®*

• morphine ER (MS Contin®)
• fentanyl patches (Duragesic®)
• buprenorphine (Butrans®)
• oxycodone ER (Oxycontin®)
• hydrocodone bitartrate extended-release (Hysingla™ ER)

• morphine sulfate(Avinza®)
• buprenorphine buccal film (Belbuca™)
• morphine sulfate/naltrexone(Embeda®)
• hydromorphone(Exalgo®)
• morphine sulfate(Kadian®)
• oxymorphone(Opana ER®)
• tramadol ER (Ryzolt® Ultram® ER)
• tapentadol ER(Nucynta ER®)
• hydrocodone (Zohydro ER™)

• oxycodone/APAP (Xartemis™XR)

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• tapentadol(Nucynta®)
• oxymorphone (Opana® IR)

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• Liquicet®
• oxycodone (Oxecta®)
• oxycodone/APAP (Primlev®, Xolox®,)
• Trezix®
• hydrocodone/APAP (Xodol®, Zamicet®)

• fentanyl(Abstral®, Lazanda®)
• fentanyl (Actiq®)
• fentanyl (Fentora®)
• fentanyl sublingual spray(Subsys®)

Suboxone® is the preferred product. Bunavail™ and Zubsolv® authorization requires a patient-specific, clinically significant reason why Suboxone® is not appropriate.

PA criteria:

• Products 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.
• Diagnosis of opiate abuse/dependence.
• Combination with opioids (including tramadol) will be denied.
• Approval will be for 90 days to allow for concurrent medication monitoring.
• The following limitations will apply:
  • Suboxone® 2mg/0.5mg and 8mg/2mg tablets and film: A quantity limit of 90 units per 30 days will apply.
  • Suboxone® 12mg/3mg film: A quantity limit of 60 films per 30 days will apply.
  • Subutex®2mg and 8mg tablets will only be approved if the member is pregnant (product may be used for the duration of the pregnancy only), or has a documented serious allergy or adverse reaction to naloxone.
  • Zubsolv® sublingual tablets: A quantity limit of 90 tablets per 30 days will apply.
  • Bunavail™ 2.1mg/0.3mg and 4.2mg/0.7mg buccal films: A quantity limit of 90 films per 30 days will apply.
  • Bunavail™ 6.3mg/1mg buccal films: A quantity limit of 60 films per 30 days will apply.

High Dose Buprenorphine Products Criteria:

• Each request for greater than 24mg 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.

• 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. Each product may be used for up to 180 days per calendar year.
• 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 er/donepezil (Namzaric™ ) Approval Criteria:

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

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

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.

PA criteria:

• FDA approved diagnosis.
• Member must be 18 years of age or older.
• Quantity limit of #60 tablets per 30 days will apply.
• Approvals will be for the duration of a year.