019 Form

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Pharmacy Medical Policy CNS Stimulants and Psychotherapeutic Agents Table of Contents • Related Polices

• Prior Authorization Information

• Summary • Policy

• Provider Documentation

• Individual Consideration • Policy History

• Forms

• References Policy Number: 019 BCBSA Reference Number: N/A Related Policies • Quality Care Dosing guidelines may apply to the following medications and can be found in Medical Policy #621A.

Prior Authorization Information Policy ☒ Prior Authorization ☐ Step Therapy ☒ Quantity Limit ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 Policy Effective Date 7/2025 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☐ MED To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy applies to Commercial Members:
• Managed Care (HMO and POS),
• PPO and Indemnity • MEDEX with Rx plan • Managed Major Medical with Custom BCBSMA Formulary • Comprehensive Managed Major Medical with Custom BCBSMA Formulary • Managed Blue for Seniors with Custom BCBSMA Formulary Policy does NOT apply to: • Medicare Advantage

Summary This is a comprehensive policy covering prior authorization and quantity limit requirements for CNS Stimulants and Psychotherapeutic Agents.

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Formulary status/requirements of medications affected by this policy are provided in below: Drug Formulary Status (BCBSMA Commercial Plan) Requirement amphetamine
Covered, PA PA required. See criteria below armodafinil Covered, PA dextroamphetamine Covered, PA dextroamphetamine ER Covered, PA Desoxyn ® (methamphetamine) Covered, PA Lumryz ™ (Sodium Oxybate) Covered, PA, QCD Methamphetamine Covered, PA modafinil Covered, PA Wakix ® (pitolisant) Covered, PA, QCD Xywav ™ (oxybates) Covered, PA, QCD Zenzedi ® (dextroamphetamine) Covered, PA

Dexedrine ® (dextroamphetamine) NFNC, PA PA required and meet Non- formulary exception criteria Dexedrine Spansules ® (dextroamphetamine) NFNC, PA Evekeo ™ (amphetamine sulfate) NFNC, PA Evekeo ODT ™ (amphetamine sulfate) NFNC, PA Sodium Oxybate NFNC, PA, QCD Sunosi ® (solriamfetol) NFNC, PA PA – Prior Authorization; NFNF – Non-formulary, non-covered; QCD – Quality Care Dosing (refer to policy #621b) Policy Length of Approval 12 months Formulary Status All requests must meet the Prior Authorizations requirement. For non-covered medications, the member must also have had a previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available. See section on individual consideration for more information if you require an exception to any of these criteria requirements for an atypical patient.
Member cost share consideration A higher non-preferred cost share may be applied if an exception request is approved for coverage of a non-preferred or a non-formulary/non-covered drug.

Prior Authorization Criteria
Amphetamine, Dexedrine ®/Dexedrine ® Spansules, Desoxyn ®, and Zenzedi ® Amphetamine, Dexedrine /Dexedrine Spansules, Desoxyn, Zenzedi and their generic alternatives may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met:

1. Age < 17 years, OR
2. Age ≥ 17 years WITH a diagnosis of attention-deficit hyperactivity disorder (ADHD) or narcolepsy, OR
3. Prescribed by a board certified/board eligible Psychiatrist, Neurologist, Oncologist, or Sleep Medicine specialist, OR
4. Prior use of amphetamine, dextroamphetamine or methamphetamine
   NOTE: Amphetamine is NOT covered for Exogenous Obesity according to our subscriber certificates.

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Evekeo ™and Evekeo ODT Evekeo and Evekeo ODT tablets may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met:

1. Diagnosis of attention-deficit hyperactivity disorder (ADHD) or Narcolepsy, AND
2. Prescribed by a board certified/board eligible Psychiatrist, Neurologist, Oncologist, or Sleep Medicine specialist, AND
3. Previous use of TWO covered formulary alternatives (ex: amphetamine salt combination, dextroamphetamine, methylphenidate, Metadate ER) NOTE: Evekeo is NOT covered for Exogenous Obesity according to our subscriber certificates Modafinil Modafinil may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met:
4. Age >18 years; AND
5. A diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome, or shift work sleep disorder, AND
6. Prescribed by a board certified/board eligible Psychiatrist, Neurologist, Oncologist, or Sleep Medicine specialist, OR
7. Prior claim history of modafinil Armodafinil Armodafinil may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met:
8. Age >18 years; AND
9. A diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome, or shift work sleep disorder, AND
10. Prescribed by a board certified/board eligible Psychiatrist, Neurologist, Oncologist, or Sleep Medicine specialist,
    OR
11. Prior claim history of armodafinil Sunosi Sunosi may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met:
12. Age > 18 years, AND
13. A diagnosis of narcolepsy or obstructive sleep apnea/hypopnea syndrome, AND
14. Prescribed by a board certified/board eligible Psychiatrist, Neurologist, Oncologist, or Sleep Medicine specialist, AND
15. Prior claim history of modafinil AND armodafinil Wakix, Lumryz, and Xywav Wakix, Lumryz or Xywav may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met:
16. Age > 6 years for Wakix or > 7 years for Lumryz or Xywav, AND
17. A diagnosis of narcolepsy or cataplexy OR for Xywav only a diagnosis of Idiopathic Hypersomnia if applicable, AND

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3. Prescribed by a board certified/board eligible Psychiatrist, Neurologist, Oncologist, or Sleep Medicine specialist, AND

4. For diagnosis of narcolepsy only, prior claim history of modafinil AND armodafinil Note: * Diagnosis of cataplexy diagnosis does NOT require the prior use of modafinil and armodafinil

   Sodium Oxybate Sodium Oxybate may be considered MEDICALLY NECESSARY and may be covered when ALL of the following criteria are met:

5. Age > 7 years, AND
6. A diagnosis of narcolepsy or cataplexy, AND
7. Prescribed by a board certified/board eligible Psychiatrist, Neurologist, Oncologist, or Sleep Medicine specialist, AND
8. For diagnosis of narcolepsy only, prior claim history of modafinil AND armodafinil

9. For diagnosis of cataplexy only, prior claim history of two of the following: Wakix, Lumryz, or Xywav. Note: * Diagnosis of cataplexy diagnosis does NOT require the prior use of modafinil and armodafinil

   Prior Use Criteria The plan uses prescription claim records to support criteria for prior use within previous 130 days or the trial and failure of formulary alternatives when available. Additional documentation will be required from the provider when historic prescription claim data is either not available or the medication fill history fails to establish criteria for prior use or trial and failure of formulary alternatives. Documentation will also be required to support any clinical reasons preventing the trial and failure of formulary alternatives. Please see the section on documentation requirements for more information.

   Provider Documentation Requirements
   Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason.
   Individual Consideration (For Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
   If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
   Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
   To facilitate a thorough and prompt review of an exception request, we encourage the provider to include

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additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines.

Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to:

Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Phone: 1-800-366-7778 Fax: 1-800-583-6289

We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or that step therapy criteria has been met.
Policy History

Date Action 7/2025 Updated to add Xywav, Lumryz and Sodium Oxybate to the Policy. 10/2024 Updated to include Wakix’ s new age. 4/2024 Update criteria for armodafinil and modafinil. 1/2024 Clarified coding for Wakix and Sunosi. 11/2023 Reformatted Policy. 10/2023 Reformatted Policy and updated IC to align with 118E MGL § 51A. 7/2023 Reformatted Policy. 4/2022 Updated armodafinil criteria to remove trial of modafanil and removed Nuvigil & Provigil as they will be handled with Formulary Exception criteria. 1/2021 Updated to add new indication for Wakix®. 1/2020 Updated to remove PA on atomoxetine and Straterra™ and make Straterra™ not covered and add Wakix® and Sunosi™ to the policy. 2/2019 Updated to add Amphetamine to the policy. 7/2018 Clarified coding for Provigil. 1/2018 Updated to include atomoxetine & criteria for Straterra™. 6/2017 Update address for Pharmacy Operations. 11/2016 Updated to include armodafinil and Evekeo. 7/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/2015. 4/2014 Updated to include Sleep Medicine specialists. 2/2014 Updated ExpressPAth language, remove Blue Value and added Zenzedi. 6/2012 Updated to include coverage criteria for new generic modafanil. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
2/2012 Reviewed – Medical Policy Group – Psychiatry and Ophthalmology.
No changes to policy statements. 1/2012 Reviewed - Medical Policy Group - Neurology and Neurosurgery. No changes to policy statements.

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5/2011 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 2/2011 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. No changes to policy statements. 1/2011 Reviewed - Medical Policy Group - Neurology and Neurosurgery. No changes to policy statements. 5/2010 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 2/2010 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. No changes to policy statements. 1/2010 Reviewed - Medical Policy Group - Neurology and Neurosurgery. No changes to policy statements. 11/2009 Updated to include authorization requirements for Nuvigil™.
9/2009 Policy updated to change 180 day look back period to 130 days, update sample language, define coverage for new starts, and to remove Medicare Part D criteria from Medical Policy.
5/2009 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 2/2009 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. No changes to policy statements. 1/2009 Reviewed - Medical Policy Group - Neurology and Neurosurgery. No changes to policy statements. 5/2008 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 2/2008 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. No changes to policy statements. 1/2008 Reviewed - Medical Policy Group - Neurology and Neurosurgery. No changes to policy statements. 5/2007 Reviewed - Medical Policy Group - Pediatrics and Endocrinology. No changes to policy statements. 2/2007 Reviewed - Medical Policy Group - Psychiatry and Ophthalmology. No changes to policy statements. 1/2007 Reviewed - Medical Policy Group - Neurology and Neurosurgery. No changes to policy statements. 11/2004 New policy, effective 11/2004, describing covered and non-covered indications.

Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical-policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434

References

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4. American Academy of Pediatrics. Subcommittee on Attention-Deficit/Hyperactivity Disorder and Committee on Quality Improvement. Clinical practice guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001;108:1033-1044.

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51. Sunosi ™ [package insert]. Palo Alto, CA; Jazz Pharmaceuticals, Inc.; June 2019.
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