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Xywav — Highmark

narcolepsy without cataplexy

Preferred products

  • generic CNS stimulant (e.g., dextroamphetamine, methylphenidate, amphetamine salts)
  • generic modafinil
  • plan-preferred sodium oxybate

Initial criteria

  • age ≥ 7 years
  • diagnosis of narcolepsy (ICD-10: G47.41)
  • meets ONE of the following diagnostic criteria: (a) multiple sleep latency test (MSLT) substantiating mean sleep latency ≤ 8 minutes AND ≥ 2 sleep-onset rapid eye movement periods (SOREMPs); OR (b) polysomnography AND MSLT substantiating mean sleep latency ≤ 8 minutes AND MSLT demonstrating ≥ one SOREMP AND polysomnography demonstrating ≥ one SOREMP; OR (c) documented hypocretin-1 deficiency defined as cerebrospinal fluid hypocretin-1 < 110 pg/mL OR < one-third of normal laboratory reference value
  • documentation of baseline excessive daytime sleepiness (EDS) via Epworth Sleepiness Scale (ESS) OR Maintenance of Wakefulness Test (MWT)
  • IF narcolepsy with cataplexy: (i) documentation of baseline number of cataplexy episodes AND (ii) therapeutic failure, contraindication, or intolerance to a plan-preferred generic CNS stimulant (e.g., dextroamphetamine)
  • IF narcolepsy without cataplexy AND age ≥ 18 years: therapeutic failure, contraindication, or intolerance to ALL of the following plan-preferred products: (A) generic modafinil AND (B) generic CNS stimulant (e.g., methylphenidate, amphetamine salts)
  • IF narcolepsy without cataplexy AND age ≤ 17 years: therapeutic failure, contraindication, or intolerance to ONE of the following plan-preferred products: (A) generic modafinil OR (B) generic CNS stimulant (e.g., methylphenidate, amphetamine salts)
  • IF request is for brand Xyrem: therapeutic failure or intolerance to sodium oxybate
  • IF request is for Xywav: (a) therapeutic failure or intolerance to plan-preferred sodium oxybate OR (b) sensitivity to sodium intake due to heart failure, hypertension, or impaired renal function

Reauthorization criteria

  • for narcolepsy with cataplexy: prescriber attests member has experienced a decrease in cataplexy episodes compared to baseline
  • prescriber attests member has experienced a decrease in daytime sleepiness as documented by improvement on Epworth Sleepiness Scale (ESS) or Maintenance of Wakefulness Test (MWT) compared to baseline
  • if request is for brand Xyrem: member has experienced therapeutic failure or intolerance to sodium oxybate

Approval duration

12 months