CNS Stimulants Form

The following are central nervous system (CNS) stimulants requiring prior authorization: methylphenidate extended-release (Adhansia XR™, Aptensio XR™, Jornay PM™, Relexxii®), methylphenidate transdermal system (Daytrana®), methylphenidate extended-release chewable tablets (Quillichew ER®), methylphenidate extended-release oral suspension (Quillivant XR®), methylphenidate extended-release orally disintegrating tablets (Cotempla XR-ODT®), amphetamine orally disintegrating tablets (Evekeo ODT™), amphetamine extended-release orally disintegrating tablets (Adzenys XR-ODT™), amphetamine extended-release oral suspension (Adzenys ER™, Dyanavel XR®), amphetamine-dextroamphetamine extended-release (Mydayis®), dexmethylphenidate hydrochloride (Focalin XR®), dextroamphetamine patches (Xelstrym™), and serdexmethylphenidate-dexmethylphenidate capsules (Azstarys™). FDA Approved Indication(s) Extended-release methylphenidate and amphetamine products are indicated for attention- deficit/hyperactivity disorder (ADHD). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Adhansia XR, Adzenys ER, Adzenys XR-ODT, Aptensio XR, Azstarys, Cotempla XR-ODT, Daytrana, Dyanavel XR, Evekeo ODT, Focalin XR, Jornay PM, Mydayis, Quillichew ER, Quillivant XR, Relexxii, and Xelstrym are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Attention Deficit Hyperactivity Disorder (must meet all):

1. Diagnosis of ADHD;
   2. One of the following (a or b): a. Mydayis: Age ≥ 13 years; b. All other requests: Age ≥ 6 years;

2. Member meets one of the following (a or b):
   a. Failure of two formulary extended-release products at maximally indicated doses from the same therapeutic class of the requested product (i.e., amphetamine or methylphenidate), unless clinically significant adverse effects are experienced or all are contraindicated; Page 1 of 12

   CLINICAL POLICY CNS Stimulants b. Request is for Adzenys ER, Adzenys XR-ODT, Cotempla XR-ODT, Daytrana, Dyanavel XR, Evekeo ODT, Quillichew ER, Quillivant XR, or Xelstrym, and documentation supports inability to use dosage forms available on the formulary (e.g., inability to swallow tablets or capsules);

3. Dose does not exceed any of the following: a. Adhansia XR (both i and ii):
   i. 85 mg per day;
   ii. 1 tablet per day; b. Adzenys ER: 15 mL per day (age 6-12 years) or 10 mL per day (age 13-17 years); c. Adzenys XR-ODT (both i and ii):
   i. 12.5-18.8 mg per day;
   ii. 1 tablet per day; d. Azstarys (both i and ii):
   i. 52.3 mg/10.4 mg per day; ii. 1 capsule per day; e. Cotempla XR-ODT (both i and ii):
   i. 51.8 mg per day;
   ii. 2 tablets per day; f. Daytrana (both i and ii):
   i. 30 mg per day;
   ii. 1 patch per day; g. Dyanavel XR (both i and ii):
   i. 20 mg per day; ii. 1 tablet per day; h. Evekeo ODT (both i and ii):
   i. 40 mg per day;
   ii. 2 tablets per day; i. Focalin XR (i or ii):
   i. Pediatric (both 1 and 2):
   1) 30 mg per day; 2) 1 capsule per day; ii. Adult (both 1 and 2): 1) 40 mg per day; 2) 1 capsule per day; j. Jornay PM (both i and ii):
   i. 100 mg per day;
   ii. 1 capsule per day; k. Mydayis (both i and ii):
   i. 50 mg per day; ii. 1 capsule per day; l. Quillichew ER, Quillivant XR, Aptensio XR (both i and ii):
   i. 60 mg per day;
   ii. 1 tablet or capsule per day; m. Relexxii (i or ii):
   i. Age 6-12 years (both 1 and 2): 1) 54 mg per day; Page 2 of 12 CLINICAL POLICY CNS Stimulants 2) 1 tablet per day; ii. Age ≥ 13 years (both 1 and 2):
4. 72 mg per day;
   2. 1 tablet per day; n. Xelstrym (both i and ii):
      i. 18 mg per day;
      ii. 1 patch per day. Approval duration:
      Medicaid/HIM – 12 months
      Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):
5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Attention Deficit Hyperactivity Disorder (must meet all):

7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);

   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed any of the following: a. Adhansia XR (both i and ii):
      i. 85 mg per day;
      ii. 1 tablet per day; b. Adzenys ER: 15 mL per day (age 6-12 years) or 10 mL per day (age 13-17 years); c. Adzenys XR-ODT (both i and ii):
      i. 12.5-18.8 mg per day;
      ii. 1 tablet per day; Page 3 of 12

   CLINICAL POLICY CNS Stimulants d. Azstarys (both i and ii): i. 52.3 mg/10.4 mg per day; ii. 1 capsule per day; e. Cotempla XR-ODT (both i and ii):
   i. 51.8 mg per day;
   ii. 2 tablets per day; f. Daytrana (both i and ii):
   i. 30 mg per day;
   ii. 1 patch per day; g. Dyanavel XR (both i and ii):
   i. 20 mg per day; ii. 1 tablet per day; h. Evekeo ODT (both i and ii):
   i. 40 mg per day;
   ii. 2 tablets per day; i. Focalin XR (i or ii):
   i. Pediatric (both 1 and 2): 1) 30 mg per day; 2) 1 capsule per day; ii. Adult (both 1 and 2): 1) 40 mg per day; 2) 1 capsule per day; j. Jornay PM (both i and ii):
   i. 100 mg per day;
   ii. 1 tablet per day; k. Mydayis (both i and ii):
   i. 50 mg per day; ii. 1 capsule per day; l. Quillichew ER, Quillivant XR, Aptensio XR (both i and ii):
   i. 60 mg per day; ii. 1 tablet or capsule per day; m. Relexxii (both i and ii):
   i. Age 6-12 years (both 1 and 2): 1) 54 mg per day; 2) 1 tablet per day; ii. Age ≥ 13 years (both 1 and 2): 1) 72 mg per day; 2) 1 tablet per day;
   n. Xelstrym (both i and ii):
   i. 18 mg per day; 7 ii. 1 patch per day. Approval duration:
   Medicaid/HIM – 12 months
   Commercial – 12 months or duration of request, whichever is less Page 4 of 12

   CLINICAL POLICY CNS Stimulants B. Other diagnoses/indications (must meet 1 or 2):

8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

9. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ADHD: attention-deficit and hyperactivity disorder CNS: central nervous system FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen Dose Limit/ Maximum Dose Concerta: 72 mg/day Ritalin LA, Metadate CD: 60 mg/day 30 mg/day Concerta: 18 – 36 mg PO QD Ritalin LA, Metadate CD: 20 mg PO QD
   Patients 6-17 years: 10 mg PO QD Adults: 20 mg PO QD
   5 mg PO QD/BID
   methylphenidate extended release (Ritalin LA®, Concerta®, Metadate CD®) amphetamine (Adderall XR®) dextroamphetamine (Dexedrine SR®)
   Vyvanse® (lisdexamfetamine) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. 30 mg PO QAM 70 mg/day 60 mg/day Page 5 of 12

   CLINICAL POLICY CNS Stimulants Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
   o Hypersensitivity; use with monoamine oxidase (MAO) inhibitor, or within 14 days of last MAO inhibitor dose o Azstarys: known hypersensitivity to serdexmethylphenidate, methylphenidate, or product components o Relexxii: known hypersensitivity to methylphenidate or other components of Relexxii • Boxed warning(s):
   o Abuse and dependence (Adzenys ER and Adhansia XR) o Abuse, misuse, and addiction (Adzenys XR-ODT, Aptensio XR, Azstarys, Cotempla XR-ODT, Daytrana, Dyanavel XR, Evekeo ODT, Focalin XR, Jornay PM, Mydayis, Quillichew ER, Quillivant XR, Relexxii, Xelstrym) V. Dosage and Administration
   Drug Name Adhansia XR (methylphenidate ER capsule) Adzenys ER (amphetamine ER oral suspension) Adzenys XR-ODT (amphetamine ER orally disintegrating tablet) Aptensio XR (methylphenidate hydrochloride ER capsule) Azstarys (serdexmethylphenid ate- dexmethylphenidate capsule) Evekeo ODT (amphetamine orally disintegrating tablet) Dosing Regimen 25 mg PO QD Patients 6 to 17 years: 6.3 mg PO QD Adults: 12.5 mg PO QD Patients 6 to 17 years: 6.3 mg PO QD Adults: 12.5 mg PO QD 10 mg PO QD
   Maximum Dose 6 to 17 years: 70 mg Adults: 85 mg 6 to 12 years: 15 ml/day
   13 year and older: 10 ml/day 6 to 12 years: 18.8 mg/day
   13 to 17 years, Adults: 12.5 mg/day 60 mg/day Patients 6 to 12 years: 39.2 mg/7.8 mg PO in the morning. Dosage may be increased to 52.3 mg/10.4 mg daily or decreased to 26.1 mg/5.2 mg daily after one week 52.3 mg/10.4 mg/day Adults and pediatric patients 13-17 years: 39.2 mg/7.8 mg PO in the morning. Increase the dosage after one week to 52.3 mg/10.4 mg once daily Patients 6 to 17 years: 5 mg PO QD or BID. Titrate daily dose in increments of 5 mg at weekly intervals. 40 mg/day Page 6 of 12

   CLINICAL POLICY CNS Stimulants Drug Name Methylphenidate ER (Adhansia XR) Methylphenidate ER (Aptensio XR) Methylphenidate ER (Jornay PM) Cotempla XR-ODT (methylphenidate ER orally disintegrating tablet)
   Dexmethylphenidate (Focalin XR) Methylphenidate Transdermal System (Daytrana) Dyanavel XR (amphetamine oral suspension/tablet) amphetamine- dextroamphetamine ER (Mydayis) Quillichew ER (methylphenidate chewable tablet) Quillivant XR (methylphenidate oral suspension) Relexxii (methylphenidate hydrochloride ER) Xelstrym (dextroamphetamine transdermal patch) Dosing Regimen Patients 6 and older: 25 mg PO QD. Dose may be increased in increments of 10 to 15 mg at intervals of at least 5 days. 10 mg PO QD Starting dose 20 mg PO QHS, dose may be increased weekly in increments of 20 mg/day
   Patients 6 to 17 years: 17.3 mg PO QD Maximum Dose 85 mg/day 60 mg/day 100 mg/day 51.8 mg/day Pediatric patients: 5 mg PO QD, dose may be titrated weekly in increments of 5 mg Adult patients: 10 mg PO QD, dose may be titrated weekly in increments of 10 mg 10 mg applied to the hip area (using alternating sites) 2 hours before an effect is needed and should be removed 9 hours after application 2.5 – 5 mg PO QD 12.5 mg PO QD 20 mg PO QD Pediatric: 30 mg per day Adults: 40 mg per day 30 mg/9-hour patch per day 20 mg/day Adults: 50 mg/day Pediatrics (13 to 17 years): 25 mg/day 60 mg/day 20 mg PO QD 60 mg/day Pediatric patients 6-17 years: starting dose 18 mg PO QD, dose may be titrated by 18 mg once per day at weekly intervals Adult patients: starting dose 18 mg or 36 mg PO QD, dose may be titrated by 18 mg once per day at weekly intervals • Patients 6-17 years: Recommended starting dose is 4.5 mg/9 hours, dose may be titrated in weekly increments of 4.5 mg • Adults: Recommended starting dose is 9 mg/9 hours Pediatrics (6-12 years): 54 mg/day Pediatrics (13-17 years) and adults: 72 mg/day 18 mg/9-hour patch per day Page 7 of 12

   CLINICAL POLICY CNS Stimulants Drug Name Dosing Regimen Maximum Dose Apply one patch at a time for not more than 9 hours. Use only one patch per 24 hours. VI. Product Availability
   Drug Name Availability Extended-release capsules: 25 mg, 35 mg, 45 mg, 55 mg, Adhansia XR (methylphenidate) 70 mg, 85 mg Adzenys ER (amphetamine) Extended-release oral suspension: 1.25 mg/mL Adzenys XR-ODT (amphetamine) Extended-release orally disintegrating tablets: 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg Orally disintegrating tablets: 5 mg, 10 mg, 15 mg, 20 mg Extended-release capsules: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg Capsules: 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, 52.3 mg/10.4 mg Aptensio XR (methylphenidate ER) Azstarys (serdexmethylphenidate- dexmethylphenidate capsule) Evekeo ODT (amphetamine orally disintegrating tablet) Methylphenidate ER (Adhansia XR) Methylphenidate ER (Aptensio XR) Methylphenidate ER (Jornay PM) Cotempla XR-ODT (methylphenidate ER orally disintegrating tablet) Dexmethylphenidate (Focalin XR) Methylphenidate Transdermal System (Daytrana) Dyanavel XR (amphetamine) Extended-release oral suspension: 2.5 mg/mL Extended-release capsules: 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg Extended-release capsules: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg Extended-release capsules: 20 mg, 40 mg, 60 mg, 80 mg, 100 mg Extended-release orally disintegrating tablets: 8.6 mg, 17.3 mg, 25.9 mg Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg Transdermal patch: 10 mg/9 hours, 15 mg/9 hours, 20 mg/9 hours, and 30 mg/9 hours amphetamine- dextroamphetamine ER (Mydayis) Quillichew ER (methylphenidate chewable) Quillivant XR (methylphenidate oral suspension) Relexxii (methylphenidate hydrochloride ER) Extended-release tablets: 5 mg, 10 mg, 15 mg, 20 mg Extended-release capsules: 12.5 mg, 25 mg, 37.5 mg, 50 mg Extended-release chewable tablets, scored: 20 mg, 30 mg Extended-release chewable tablets, not scored: 40 mg Extended-release oral suspension: 25 mg/5 mL (5 mg/mL) Extended-release tablets: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, 72 mg Page 8 of 12

   CLINICAL POLICY CNS Stimulants Drug Name Xelstrym (dextroamphetamine) Availability Transdermal patch: 4.5 mg/9 hours, 9 mg/9 hours, 13.5 mg/9 hours, 18 mg/9 hours VII.