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Prior Authorization Protocol

APTENSIO XR™ (methylphenidate hydrochloride extended-release) 


HNMC

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • For the treatment of Attention Deficit/Hyperactivity Disorder (ADHD)
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of attention deficit hyperactivity disorder

    AND

    • Failure or clinically significant adverse effects to two formulary alternatives (immediate release methylphenidate and extended release methylphenidate)
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    This field intentionally left blank.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    methylphenidate extended release (Ritalin LA, Concerta, Metadate CD)

    Ritalin LA: 20 mg
    Concerta: 18 - 36 mg PO QD
    Ritalin LA, Metadate CD: 20 mg PO QD

    Concerta: 72 mg/day
    Ritalin LA, Metadate CD: 60 mg/day

    methylphenidate immediate release (Ritalin)

    Initial: 5 mg PO BID before breakfast and lunch; increase by 5 to 10 mg daily at weekly intervals

    60 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Aptensio XR

    Patients 6 years and above:
    10 mg PO QD

    Dose may be increased weekly in increments of 10 mg to a maximum of 60 mg/day. Capsules may be swallowed whole or opened and contents sprinkled onto applesauce.

    Length of Benefit

  7. Product Availability:

    Extended-release capsules: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg

  8. References:

    1. Aptensio XR [package insert]. Greenville, NC: Rhodes Pharmaceuticals: May 2015.
    2. MicromedexR DrugDEX, (online database). Truven Health Analytics, Greenwood Village, Colorado, USA. Accessed: October 10, 2015.

The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.