CurrentUnitedHealthcarePolicy N/A

Prior authorization form for narcolepsy/cataplexy medications

A prescriber-completed prior authorization and clinical information form used by UnitedHealthcare for coverage decisions regarding medications to treat narcolepsy and/or cataplexy, including safety screening and continuation criteria. Affects prescribers and pharmacies requesting PA for these drugs.

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization form for narcolepsy/cataplexy medications

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form with beneficiary and prescriber details, drug information, safety screening responses, documentation of prior modafinil/armodafinil trial or contraindication, and prescriber signature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14clinical questions on form (including continuation items)

11initial clinical screening items

7safety/comorbidity checkbox items

1pharmacy PA call center listed

Coverage Criteria

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inv-01: Initial therapy / PA prerequisite

Covered when ALL of the following are met and documented on this form

Form completion: Beneficiary and prescriber identification, drug name/strength/quantity, length of therapy, and prescriber signature are provided

Supports PA processing; prescriber signature is mandatory (prescription signature required)

Indication: Documentation of diagnosis of narcolepsy and/or cataplexy

Form has separate checkboxes for narcolepsy and cataplexy (Questions 9 and 10)

Age: Beneficiary is 18 years of age or older

Question 1

Symptom duration: Daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least three (3) months>= 3 months

Question 2

Prior therapy: Adequate documented trial and failure of, or contraindication to, modafinil and armodafinil

Question 11; explain contraindication if applicable

Safety screening: Answers provided about concomitant sedative hypnotics, concomitant QT-prolonging drugs, concomitant H1 receptor antagonists, history of prolonged QTc, end-stage renal disease (eGFR < 15 mL/min/1.73 m2), and severe hepatic impairment

Questions 3-8

inv-02: Continuation therapy

Continuation is supported when ALL of the following are documented

Efficacy: Documented reduction in excessive daytime sleepiness from pretreatment baseline measured by a validated scale (e.g., Epworth Sleepiness Scale, Stanford Sleepiness Scale, Karolinska Sleepiness Scale, Visual Analog Scale)

Question 12

Cataplexy control: If treating cataplexy, documented reduction in frequency of cataplexy attacks from pretreatment baseline

Question 13

Safety: No treatment-restricting adverse effects since therapy initiation (examples: abnormal behavior, abnormal dreams/nightmares, anhedonia, anxiety, bipolar disorder, depression or depressed mood, nausea, QT prolongation, sleep disorder, suicide attempt or suicidal ideation)

Question 14

The clinical questions on the form specifically ask whether the beneficiary has experienced daily periods of irrepressible need to sleep or daytime lapses into sleep for at least 3 months, and they separate diagnostic confirmation of cataplexy and narcolepsy. These items establish the targeted population and establish the minimum symptom duration needed to support initial coverage requests.

The form does not include an explicit ‘not medically necessary’ statement for any particular presentation. However, failure to provide the required documentation or to meet the coverage criteria queried on the form (for example, absence of documented diagnosis, symptom duration, prior trial/failure of modafinil/armodafinil, or positive safety-risk responses) would likely result in the request being incomplete or denied. Providers should complete all items and include the prescriber signature to avoid administrative denials.

Initial Therapy Requirements

inv-13: Initial therapy requirements

Initial requests must include the following clinical and prescription details

Drug details: Drug name, strength, quantity per 30 days, and requested length of therapy are provided on the form

Drug Information section (Questions 8–11)

Indication: Checkbox confirmation of diagnosis: narcolepsy and/or cataplexy

Clinical Information Questions 9–10

Safety screening: Completed screening questions regarding age (>=18), concomitant sedative hypnotics, concomitant QT-prolonging drugs, concomitant H1 antagonists, history of prolonged QTc, end-stage renal disease (eGFR < 15 mL/min/1.73 m2), and severe hepatic impairment

Clinical Information Questions 1 and 3–8

Prior trials: Documentation of an adequate trial and failure of, or documented contraindication to, modafinil and armodafinil

Clinical Information Question 11; provide explanation if contraindicated

Prescriber attestation: Prescriber signature and date certifying accuracy and completeness of the information

Signature is mandatory on the form

Continuation Requirements

inv-14: Continuation requirements

Continuation requests must document clinical response and absence of severe adverse effects

Efficacy measure: Documented reduction in excessive daytime sleepiness from pretreatment baseline measured by a validated scale (examples listed on the form)

Question 12

Cataplexy response: If applicable, documented reduction in frequency of cataplexy attacks from pretreatment baseline

Question 13

Adverse effects: No treatment-restricting adverse effects such as abnormal behavior, abnormal dreams/nightmares, anhedonia, anxiety, bipolar disorder, depression or depressed mood, nausea, QT prolongation, sleep disorder, suicide attempt or suicidal ideation

Question 14

inv-02: Continuation therapy (duplicate placement)

Continuation is supported when ALL of the following are documented

Efficacy: Documented reduction in excessive daytime sleepiness from pretreatment baseline measured by a validated scale (e.g., Epworth Sleepiness Scale)

Question 12

Cataplexy control: If treating cataplexy, documented reduction in frequency of cataplexy attacks from pretreatment baseline

Question 13

Safety: No treatment-restricting adverse effects since therapy initiation (examples provided on the form)

Question 14

Step Therapy / Prior Trial

Prior Authorization

Prior Authorization Requirements

Prior authorization is required. Complete and submit the beneficiary clinical information form with the prior authorization request. The form must document prior therapy status including whether there has been an adequate trial and failure of, or a contraindication to, modafinil and armodafinil.

Prior authorization required before coverage will be considered.
Attach completed clinical information form to the prior authorization request.

Documentation Required

Signature, Accuracy, and Required Form Fields

Provider must complete all required fields on the clinical information form and sign to certify accuracy. At a minimum, the form must include: (1) beneficiary age (18 years or older), (2) documentation that the beneficiary has daily irrepressible need to sleep or daytime lapses into sleep for at least 3 months, (3) current use of sedative-hypnotic agents, (4) concomitant use of QT-prolonging drugs, (5) concomitant use of H1 receptor antagonists, (6) history of prolonged QTc, (7) end-stage renal disease (eGFR <15 mL/min/1.73 m2), (8) severe hepatic impairment, (9) diagnosis of cataplexy with narcolepsy, (10) diagnosis of narcolepsy, and (11) documentation that the beneficiary had an adequate trial and failure of, or a contraindication to, modafinil and armodafinil with explanation if contraindicated.

All checklist items on the clinical information form must be completed.
If the beneficiary has not tried modafinil or armodafinil, provide documentation of contraindication if applicable.
Provider signature and date required certifying that information is true and accurate.

Provider Actions & Prior Authorization Requirements

Prior Authorization

Complete full prior‑authorization form with safety screens and prior therapy

Prior authorization requests must include completion of the prescriber-completed form with drug details, indication (narcolepsy and/or cataplexy), safety screening items (age, QT risk, renal/hepatic impairment, concomitant interacting drugs), prior therapy status, and the prescriber signature.

Include drug name, strength, quantity per 30 days, and length of therapy (Question 8–11).
Answer clinical safety questions 1–10 (age, symptom duration, sedative hypnotics, QT-prolonging drugs, H1 antagonists, prior QTc, ESRD, severe hepatic impairment, diagnoses).
Document prior trial/failure or contraindication to modafinil/armodafinil (Question 11).

Documentation Required

Supply all required form fields and complete clinical questions

Provide beneficiary identification (name, beneficiary ID, date of birth, gender), prescriber NPI and requester contact information, drug name/strength/quantity and length of therapy, and complete clinical answers to Questions 1–14.

Beneficiary fields: last name, first name, beneficiary ID, DOB, gender (Questions 1–5).
Prescriber fields: prescribing provider NPI and requester contact (Questions 6–7).
Drug fields: drug name, strength, quantity per 30 days, and length of therapy (Questions 8–11).
Clinical fields: complete answers to safety screens, diagnosis, prior therapy, and continuation items (Questions 1–14).

Denial Risk

Include prescriber signature and certify accuracy

Prescriber signature and date are mandatory; a missing signature may render the request incomplete and the form includes a certification that falsification, omission, or concealment of material fact may subject the signer to civil or criminal liability.

Ensure prescriber signs and dates the form at the Signature of Prescriber line.
Do not falsify or omit information — the form includes a legal certification statement.

OpenPayer

Prior authorization form for narcolepsy/cataplexy medications

Coverage Criteria

Initial Therapy Requirements

Continuation Requirements

Step Therapy / Prior Trial

Key Coding & Clinical Durations

Provider Actions & Prior Authorization Requirements

Background

Definitions