Neighborhood Health Plan RI CGRP Coverage & Prior Auth

Coverage Criteria for CGRP Monoclonal Antibodies

inv-01: Initial authorization — Chronic migraine

Covered when ALL of the following are met

Age and prescriber: Patient is 18 years of age or older AND medication is prescribed by, or in consultation with a neurologist or headache specialist.

Headache frequency: Patient is experiencing at least 15 headache days per month (tension-type-like and/or migraine-like) for at least 3 months.

Abortive therapy: Patient has been fully equipped with abortive migraine therapy, if appropriate, and has had inadequate relief.

Prophylactic medication trials: Patient has documented trial and failure of a 3-month trial of any 2 prophylactic medications from the following classes: antidepressants (e.g., amitriptyline, venlafaxine), beta blockers (e.g., propranolol, metoprolol, timolol, atenolol), or anti-epileptics (e.g., valproate, topiramate).

Botulinum toxin trial (chronic only): Patient has documented trial and failure to a minimum of 2 quarterly injections (6 months) of botulinum toxin (e.g., onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB).

Concomitant CGRP or botulinum toxin use: Patient is not using medication in combination with other injectable or oral CGRP antagonists (e.g., Ajovy, Emgality, Vyepti, Ubrelvy) for migraine prevention unless oral agents are used only for acute treatment; combination with botulinum toxin is permitted only when specific exceptions apply as described in policy.

inv-02: Initial authorization — Episodic migraine

Covered when ALL of the following are met

Age and prescriber: Patient is 18 years of age or older AND medication is prescribed by, or in consultation with a neurologist or headache specialist.

Headache frequency: Patient experiences at least 4 but not more than 14 headache days per month, with disability on some days.

Abortive therapy: Patient has been fully equipped with abortive migraine therapy, if appropriate, and has had inadequate relief.

inv-03: Continuation authorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Prior approval or initial documentation: If member has not been approved for this drug by Neighborhood in the past, clinician must submit documentation that initial criteria are met.

Clinical response: Patient has experienced a positive clinical response to therapy as demonstrated by a reduction in headache frequency, duration and/or severity from baseline.

Combination with botulinum toxin: If patient is using medication in combination with a botulinum toxin, the patient must have shown a clinically meaningful incremental benefit from using both products and, for chronic migraine, have had a clinically significant response to botulinum toxin after 2 quarterly injections alone.

The policy excludes use of fremanezumab (Ajovy) or galcanezumab (Emgality) in combination with other CGRP antagonists for migraine prevention. Specifically, combination with other injectable CGRP antagonists (for example, Ajovy, Emgality, Vyepti) or oral CGRP antagonists (for example, Ubrelvy, Nurtec ODT) for prevention is not permitted unless the oral agent (Nurtec ODT or Ubrelvy) is being used solely for acute treatment rather than prevention (see exceptions below).

Combination use with a botulinum toxin (for example, onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB) is also excluded for routine prevention. An exception is allowed only when the patient has had a clinically significant response to botulinum toxin after 2 quarterly injections alone and, if both products are continued, there must be documentation of a clinically meaningful incremental benefit from using both agents together.

Therapy is considered not medically necessary when the policy’s required entry criteria are not met. Examples include failure to meet the defined headache-frequency thresholds (see definitions) for chronic or episodic migraine, lack of required prior trials of prophylactic medications, or missing required botulinum toxin trials for chronic migraine.

For chronic migraine, authorization requires documentation of a minimum of 15 headache days per month for at least 3 months plus a documented trial and failure of two 3-month prophylactic medication trials from the listed classes and a documented trial and failure of at least two quarterly (6 months total) botulinum toxin injections. Absence of these prior treatment trials makes therapy not medically necessary.

For episodic migraine, authorization requires documentation of 4–14 headache days per month and failure of two 3-month prophylactic medication trials. If these frequency or prior-treatment requirements are not met, the use of Ajovy or Emgality is considered not medically necessary.

Additionally, use in combination with other CGRP antagonists or with botulinum toxin for prevention without meeting the policy’s exception criteria (acute-use exception for certain oral agents or documented incremental benefit when combined with botulinum toxin) is also considered not medically necessary and may be denied.

Covered Agents and Headache Frequency Thresholds

Covered agents by brand namemixedCovered

AJOVY	fremanezumab (brand name referenced in policy)
EMGALITY	galcanezumab (brand name referenced in policy)

Headache frequency thresholds

Chronic migraine≥15 headache days per month

Episodic migraine4–14 headache days per month

Chronic duration qualifierAt least 3 months of these headache days (chronic only)

Prescriber Requirements, Step Therapy, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for preventative treatment of chronic and episodic migraine. Requests must document patient age, prescriber specialty, headache frequency and duration, prior adequate abortive therapy (when appropriate), prior prophylactic medication trials, and prior botulinum toxin use when applicable. If the member has not previously been approved by Neighborhood, submit supporting documentation that all initial criteria are met.

Age: 18 years or older
Prescriber: prescribed by or in consultation with a neurologist or headache specialist
Headache frequency: chronic = ≥15 headache days/month for ≥3 months; episodic = 4–14 headache days/month with some disability
Abortive therapy: member must be fully equipped with appropriate abortive migraine therapy with inadequate relief
Concomitant therapy: not to be used in combination with other injectable or preventive CGRP antagonists for prevention; limited combination with botulinum toxin only after demonstrated response to botulinum toxin alone or meaningful incremental benefit
If not previously approved by Neighborhood: submit documentation that initial criteria are met

Background

Fremanezumab (Ajovy) and galcanezumab (Emgality) are monoclonal antibodies that target the calcitonin gene-related peptide (CGRP) pathway and are indicated in this policy for the preventive treatment of migraine. The policy addresses both chronic migraine (defined as ≥15 headache days per month for ≥3 months) and episodic migraine (4–14 headache days per month) and sets prior authorization requirements accordingly.

Authorization criteria require that patients be ≥18 years old, have the medication prescribed by or in consultation with a neurologist or headache specialist, and have been adequately equipped with abortive migraine therapy with inadequate relief. In addition, patients must have documented trials and failures of two 3-month prophylactic medication trials from the specified classes (antidepressants, beta blockers, or anti-epileptics); for chronic migraine, a documented trial and failure of at least two quarterly botulinum toxin injections (6 months) is required before fremanezumab or galcanezumab will be authorized.

Key Definitions

Chronic migraine — definition

DefinitionChronic migraine: Patient is experiencing at least 15 headache days per month (tension-type-like and/or migraine-like) for at least 3 months.

Age requirementApplies to patients 18 years of age or older.

SpecialistMedication must be prescribed by, or in consultation with, a neurologist or headache specialist.

Episodic migraine — definition

DefinitionEpisodic migraine: Patient experiences at least 4 but not more than 14 headache days per month, with disability on some days.

Age requirementApplies to patients 18 years of age or older.

Revision History

2019-03-01effective_date

Policy effective date established for AJOVY (fremanezumab) and EMGALITY (galcanezumab).

2019-02review

Policy reviewed (February 2019).

2020-01review

Policy reviewed (January 2020).

OpenPayer

Preventative Treatment with CGRP Monoclonal Antibodies (Ajovy, Emgality) for Migraine

Coverage Criteria for CGRP Monoclonal Antibodies

Covered Agents and Headache Frequency Thresholds

Prescriber Requirements, Step Therapy, and Documentation

Background

Key Definitions

Revision History