Table 50: Narcolepsy and Miscellaneous Sleep Disorder Therapy Agents
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Central Nervous System (CNS)
Medication Class/Individual Agents: Narcolepsy and Sleep Disorder
I. Prior-Authorization Requirements
Narcolepsy and Miscellaneous Sleep Disorder Therapy Agents – Modafinil Agents |
Clinical Notes |
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Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
Clinical trials for solriamfetol did not evaluate its use in combination with other medications that could affect excessive sleepiness, including cerebral stimulants, modafinil agents, or sodium oxybate. |
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Narcolepsy and Miscellaneous Sleep Disorder Therapy Agents – Not Otherwise Classified |
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| # | This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent. |
| BP | Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent. |
| A90 | Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply. |
II. Therapeutic Uses
FDA-approved, for example:
- cataplexy associated with narcolepsy - sodium oxybate, Wakix, Xywav
- excessive daytime sleepiness (EDS) associated with narcolepsy - sodium oxybate, Sunosi, Wakix, Xywav
- EDS associated with obstructive sleep apnea (OSA) - Sunosi
- idiopathic hypersomnia - sodium oxybate, Xywav
- non-24-hour sleep-wake disorder - tasimelteon
- Smith-Magenis syndrome (SMS) - tasimelteon
Non-FDA approved, for example:
- EDS associated with OSA - sodium oxybate, Wakix, Xywav
Note: The above lists may not include all FDA-approved and non-FDA approved indications.
III. Evaluation Criteria for Approval
Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
- All PA requests must include clinical diagnosis, drug name, dose, and frequency.
- Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
- A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
- For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
- Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.
armodafinil and modafinil exceeding quantity limits
- Documentation of all of the following is required:
- appropriate dosing; and
- medical necessity for exceeding the quantity limits.
concomitant use of modafinil and armodafinil (a history of at least one paid MassHealth pharmacy claim for the other agents within the last 30 days)
- For all requests, individual drug PA criteria must be met first where applicable.
- Documentation of all of the following is required:
- appropriate diagnosis; and
- medical necessity for concomitant use of modafinil and armodafinil.
tasimelteon capsule
- Documentation of all of the following is required for non-24 hour sleep wake disorder:
- appropriate diagnosis; and
- member is totally blind; and
- member is ≥ 18 years of age; and
- prescriber is a sleep specialist, or consult notes from a sleep specialist are provided; and
- inadequate response (defined as at least 28 days of therapy), adverse reaction, or contraindication to melatonin; and
- requested quantity is ≤ one unit/day.
- Documentation of all of the following is required for SMS:
- appropriate diagnosis; and
- prescriber is a sleep specialist or consult notes from a sleep specialist are provided; and
- member is ≥ three years of age; and
- inadequate response (defined by at least 28 days of therapy), adverse reaction, or contraindication to melatonin; and
- requested quantity is ≤ one unit/day.
tasimelteon suspension
- Documentation of all of the following is required for SMS:
- appropriate diagnosis; and
- prescriber is a sleep specialist or consult notes from a sleep specialist are provided; and
- member is ≥ three years of age; and
- inadequate response (defined by at least 28 days of therapy), adverse reaction, or contraindication to melatonin; and
- medical necessity for use instead of capsule formulation; and
- requested quantity is ≤ five mL/day.
Sunosi
- Documentation of all of the following is required for a diagnosis of EDS associated with narcolepsy:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- medical records documenting the results of the sleep study used to confirm narcolepsy [polysomnogram (PSG) or Multiple Sleep Latency Test (MSLT)]; and
- inadequate response or adverse reaction to one, or contraindication to all cerebral stimulant agents; and
- inadequate response or adverse reaction to one, or contraindication to both of the following: armodafinil, modafinil; and
- one of the following:
- the requested medication will not be used in combination with stimulants or stimulant-like agents; or
- clinical rationale for use of the requested agent in combination with other stimulants or stimulant-like agents; and
- requested quantity is ≤ one unit/day.
- Documentation of all of the following is required for a diagnosis of EDS associated with obstructive sleep apnea (OSA):
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- medical records of the sleep study used to diagnose OSA (PSG); and
- one of the following:
- medical records documenting the member is utilizing CPAP/BiPAP, an oral appliance, or has undergone successful surgical treatment for OSA; or
- contraindication to CPAP/BiPAP or an oral appliance; and
- inadequate response or adverse reaction to one, or contraindication to both of the following: armodafinil, modafinil; and
- one of the following:
- the requested medication will not be used in combination with stimulants or stimulant-like agents; or
- clinical rationale for use of the requested agent in combination with other stimulants or stimulant-like agents; and
- requested quantity is ≤ one unit/day.
Wakix
- Documentation of all of the following is required for a diagnosis of cataplexy associated with narcolepsy:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- medical records documenting the results of the sleep study used to confirm narcolepsy (PSG or MSLT); and
- prescriber is a neurologist or sleep specialist, or consult notes from a neurologist or sleep specialist are provided; and
- inadequate response or adverse reaction to one, or contraindication to all of the following: atomoxetine, SSRI, tricyclic antidepressant, venlafaxine; and
- inadequate response or adverse reaction to one, or contraindication to all oxybate products; and
- requested quantity is ≤ two units/day.
- Documentation of all of the following is required for a diagnosis of EDS associated with narcolepsy (without cataplexy):
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- medical records documenting the results of the sleep study used to confirm narcolepsy (PSG or MSLT); and
- prescriber is a neurologist or sleep specialist or consult notes from a neurologist or sleep specialist are provided; and
- inadequate response or adverse reaction to three, or contraindication to all of the following: armodafinil or modafinil, cerebral stimulant agent, sodium oxybate, Sunosi; and
- requested quantity is ≤ two units/day.
- Documentation of all of the following is required for a diagnosis of EDS associated with OSA:
- appropriate diagnosis; and
- medical records of the sleep study used to diagnose OSA (PSG); and
- medical records documenting the member is utilizing CPAP/BiPAP, an oral appliance, or has undergone successful surgical treatment for OSA; and
- inadequate response or adverse reaction to one or contraindication to both of the following: armodafinil, modafinil; and
- inadequate response, adverse reaction, or contraindication to Sunosi; and
- inadequate response or adverse reaction to one or contraindication to both of the following: sodium oxybate, Xywav; and
- requested quantity is ≤ two units/day.
sodium oxybate and Xywav
- Documentation of all of the following is required for a diagnosis of cataplexy associated with narcolepsy:
- appropriate diagnosis; and
- medical records documenting the results of the sleep study used to confirm narcolepsy (PSG or MSLT); and
- prescriber is a neurologist or sleep specialist, or consult notes from a neurologist or sleep specialist are provided; and
- inadequate response or adverse reaction to one, or contraindication to all of the following: atomoxetine, SSRI, tricyclic antidepressant, venlafaxine; and
- requested dose is ≤ nine grams (18 mL)/day; and
- for Xywav, clinical rationale for use instead of sodium oxybate.
- Documentation of all of the following is required for a diagnosis of EDS associated with narcolepsy (without cataplexy):
- appropriate diagnosis; and
- medical records documenting the results of the sleep study used to confirm narcolepsy (PSG or MSLT); and
- prescriber is a neurologist or sleep specialist, or consult notes from a neurologist or sleep specialist are provided; and
- inadequate response or adverse reaction to one or contraindication to all cerebral stimulant agents; and
- inadequate response or adverse reaction to one or contraindication to both of the following: armodafinil, modafinil; and
- requested dose is ≤ nine grams (18 mL)/day; and
- for Xywav, clinical rationale for use instead of sodium oxybate.
- Documentation of all of the following is required for a diagnosis of idiopathic hypersomnia:
- appropriate diagnosis; and
- medical records documenting the results of the PSG ruling out other causes; and
- medical records documenting the results of the MSLT; and
- prescriber is a neurologist or sleep specialist, or consult notes from a neurologist or sleep specialist are provided; and
- member does not have hypersomnia due to another medical, behavioral, or psychiatric disorder; and
- member is not currently utilizing a drug that can cause EDS; and
- inadequate response or adverse reaction to one or contraindication to all cerebral stimulant agents; and
- inadequate response or adverse reaction to one or contraindication to both of the following: armodafinil, modafinil; and
- requested dose is ≤ nine grams (18 mL)/day; and
- for Xywav, clinical rationale for use instead of sodium oxybate.
- Documentation of all of the following is required for a diagnosis of EDS associated with OSA:
- appropriate diagnosis; and
- medical records of the sleep study used to diagnose OSA (PSG); and
- medical records documenting the member is utilizing CPAP/BiPAP, an oral appliance, or has undergone successful surgical treatment for OSA; and
- inadequate response or adverse reaction to one or contraindication to both of the following: armodafinil, modafinil; and
- inadequate response, adverse reaction, or contraindication to Sunosi; and
- requested dose is ≤ nine grams (18 mL)/day; and
- for Xywav, clinical rationale for use instead of sodium oxybate.
In addition to individual drug PA criteria where applicable, some behavioral health medications are subject to additional polypharmacy and age limit restrictions.
Behavioral Health Medication Polypharmacy (pharmacy claims for any combination of four or more behavioral health medications [i.e., alpha2 agonists, antidepressants, antipsychotics, armodafinil, atomoxetine, benzodiazepines, buspirone, cerebral stimulants, donepezil, hypnotic agents, memantine, modafinil, mood stabilizers (agents considered to be used only for seizure diagnoses are not included), naltrexone, and viloxazine] within a 45-day period) for members < 18 years of age
- For all requests, individual drug PA criteria must be met first where applicable.
- For regimens including ≤ two mood stabilizers (also includes regimens that do not include a mood stabilizer), documentation of the following is required:
- one of the following:
- member had a recent psychiatric hospitalization (within the last three months); or
- member has a history of severe risk of harm to self or others; or
- all of the following:
- appropriate diagnoses; and
- treatment plan including names of current behavioral health medications and corresponding diagnoses; and
- prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided.
- one of the following:
- For regimens including ≥ three mood stabilizers, documentation of the following is required:
- one of the following:
- member had a recent psychiatric hospitalization (within the last three months); or
- member has a history of severe risk of harm to self or others; or
- all of the following:
- appropriate diagnoses; and
- treatment plan including names of current behavioral health medications and corresponding diagnoses; and
- prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
- one of the following:
- member has a seizure diagnosis only; or
- member has an appropriate psychiatric diagnosis, with or without seizure diagnosis, and one of the following:
- cross-titration/taper of mood stabilizer therapy; or
- inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate; or
- member has a diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain), with or without seizure diagnosis, and that other clinically appropriate therapies have been tried and failed; therefore, multiple mood stabilizers are needed; or
- member has psychiatric and comorbid diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain), with or without seizure diagnosis, and that other clinically relevant therapies have been tried and failed; therefore, multiple mood stabilizers are needed, and one of the following:
- cross-titration/taper of mood stabilizer therapy; or
- inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate.
- one of the following:
armodafinil and modafinil for members < six years of age
- For all requests, individual drug PA criteria must be met first where applicable.
- Documentation of the following is required:
- one of the following:
- member had a recent psychiatric hospitalization (within the last three months); or
- member has a history of severe risk of harm to self or others; or
- all of the following:
- appropriate diagnosis; and
- treatment plan including names of current alpha agonist(s) and corresponding diagnoses; and
- prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided.
- one of the following:
† Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.
Original Effective Date: 11/2010
Last Revised Date: 03/2024
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Last updated 04/01/24