What information should be included in a prior authorization request for an adult patient with attention deficit hyperactivity disorder (ADHD) to approve Vyvanse (lisdexamfetamine) chewable for twice-daily dosing, given their metabolic benefits from this regimen?

Prior Authorization Strategy for Vyvanse Chewable Twice-Daily Dosing in Adults

Standard FDA-approved dosing for Vyvanse (lisdexamfetamine) is once-daily administration with demonstrated efficacy up to 14 hours post-dose, and twice-daily dosing is not supported by FDA labeling or clinical guidelines—however, your prior authorization should emphasize documented inadequate duration of effect with once-daily dosing and functional impairment during late-day hours despite optimization attempts. 1, 2

Critical Elements to Include in Your Prior Authorization

1. Document Inadequate Duration of Standard Once-Daily Dosing

• Specify that the patient experiences symptom return before end of day (e.g., "Patient reports ADHD symptoms return by 2-3 PM despite taking maximum-dose Vyvanse 70 mg at 7 AM, causing functional impairment at work/home during afternoon/evening hours") 1, 2
• Include objective evidence such as workplace performance issues, missed deadlines, or family/relationship problems occurring specifically during late-day hours when medication effect wanes 3
• Note that lisdexamfetamine provides 13-14 hour coverage in clinical trials, but individual pharmacokinetic variation means some patients metabolize the prodrug more rapidly 2, 4

2. Document Trials and Failures of Alternative Long-Acting Formulations

• State that patient has tried and failed other long-acting stimulants that provide extended coverage, specifically:
  • OROS-methylphenidate (Concerta) 12-hour formulation 3, 5
  • Extended-release mixed amphetamine salts (Adderall XR) 8-9 hour formulation 5
  • Other methylphenidate extended-release options (Ritalin LA, Metadate CD) 5, 6
• For each failed trial, document specific reasons: inadequate efficacy, intolerable side effects, or insufficient duration despite maximum dosing 3, 7

3. Explain Why Chewable Formulation is Medically Necessary

• Document specific medical reason requiring chewable formulation (e.g., dysphagia, severe pill-swallowing difficulty, gastrointestinal absorption issues with capsules) 6
• Note that chewable formulation allows for split dosing that capsule formulation does not, as capsules cannot be opened and divided reliably for twice-daily administration 5

4. Provide Clinical Rationale for Twice-Daily Dosing Pattern

• Emphasize that functional impairment occurs specifically during afternoon/evening hours (1 PM onward) when once-daily morning dose wears off, affecting work productivity, family responsibilities, and quality of life 3, 1
• Reference that methylphenidate guidelines support divided dosing 2-3 times daily for adults when extended-release formulations provide inadequate coverage, establishing precedent for split stimulant dosing 3
• Note that adding afternoon immediate-release stimulant supplementation (common clinical practice) would result in higher total daily stimulant dose than proposed twice-daily chewable regimen 3, 7

5. Specify Proposed Dosing Regimen with Safety Monitoring

• Provide exact proposed dosing schedule: "Vyvanse chewable 30 mg at 7 AM and 20 mg at 1 PM (total daily dose 50 mg, within FDA-approved maximum of 70 mg)" 1
• Commit to regular monitoring of blood pressure, pulse, weight, sleep quality, and appetite at monthly intervals during initial 3 months, then quarterly 3, 7
• Document that total daily amphetamine dose remains within recommended maximum range of 40-70 mg for adults 7, 1

6. Address Abuse Potential Concerns Proactively

• Emphasize that lisdexamfetamine is a prodrug with lower abuse potential compared to immediate-release amphetamines due to requirement for enzymatic conversion in red blood cells 2, 8, 9
• Document negative substance abuse screening and absence of personal/family history of stimulant misuse 3
• Commit to controlled substance agreement and regular urine drug screening if required by insurance 3

Common Pitfalls to Avoid

• Do not request twice-daily dosing without documenting failed trials of alternative long-acting formulations—insurers will deny if standard extended-release options haven't been attempted 3, 5
• Do not use vague language like "patient prefers" or "works better"—use specific functional outcomes (e.g., "unable to complete work tasks after 2 PM, resulting in written warnings from employer") 3
• Do not exceed FDA maximum daily dose of 70 mg total—proposed twice-daily regimen must stay within this limit 1
• Do not ignore the fact that twice-daily lisdexamfetamine dosing lacks clinical trial support—acknowledge this explicitly but justify based on individual patient pharmacokinetics and functional impairment 1, 2

Alternative Strategy If Denial Occurs

• If prior authorization is denied, pivot to requesting OROS-methylphenidate (Concerta) with supplemental immediate-release methylphenidate 5-10 mg at 1-2 PM, which has stronger guideline support for divided dosing in adults 3, 5
• This approach provides 12-hour coverage from Concerta plus targeted afternoon supplementation, achieving similar functional goal with better evidence base 3, 5
• Methylphenidate divided dosing is explicitly recommended in guidelines for adults requiring extended symptom control throughout the day 3