CurrentCareSourcePolicy N/A

y0119_ga-dsnp-m-4588238_c-step-therapy.pdf

Part 1 lists medications assigned to Step 1 and Step 2 across multiple therapeutic classes and provides the step-therapy rule: approval of a Step 2 agent requires prior trials of specified Step 1 agents (with stated exceptions). Contains multiple product-specific exceptions (e.g., prior use, age, clinical situations). This file is one segment (Part 1 of 3).

Policy Summary

PayerCareSource

Policyy0119_ga-dsnp-m-4588238_c-step-therapy.pdf

Policy CodePolicy N/A

Change TypeIndex/step-therapy summary (no material change)

Effective Date

Next Review Date

Key ActionFor listed Step 2 drugs, provider must document trials of required Step 1 agents (usually two Step 1 trials) unless an explicit exception applies (current use, prior use, or specified clinical exceptions such as palliative care for Relistor, age/special conditions for inhalers, suicidal ideation for Auvelity, swallowing difficulty for Raldesy).

POLICY UPDATE CHANGES

No material clinical/coverage changes reported

manyProducts listed (Part 1)

Step 1 & 2Step assignments present

presentSpecial-case exceptions

5Lurasidone strengths listed

Coverage Summary & Step-Therapy Scope

Part 1 lists medications assigned to Step 1 and Step 2 across multiple therapeutic classes and provides the step-therapy rule that approval of a Step 2 agent generally requires prior trials of the specified Step 1 agents (with stated exceptions). This file is Part 1 of a multi-part index and contains multiple product-specific exceptions (for example: Relistor, Auvelity, fluticasone HFA, Raldesy); product-specific exception details and additional criteria groups are listed in subsequent criteria sections of the full policy.

General Step Therapy Rule (Initial/Step Therapy Criteria)

General Step Therapy Rule (applies to listed products)

Covered when the step-therapy trial requirements below are satisfied:

ALL of the following

ANY of the following
- Step 1 trials: If the patient has tried two Step 1 drugs, approve the requested Step 2 drug2 trials
  A trial of the brand name equivalent of a generic step 1 product will also count towards this requirement
- Current/prior use exceptions
  - Current use: Approve if the patient is currently taking the requested drug
  - Prior use: Approve if the patient has taken the requested drug at any time in the past

Product-specific Exceptions (Relistor, Auvelity, Fluticasone HFA, Raldesy)

Relistor (Step exception)

Relistor injection exception for opioid-induced constipation in palliative care:

Relistor criteria

Standard rule: If the patient has tried a Step 1 drug, approve the requested Step 2 (standard rule)
Palliative-care exception: Approve Relistor injection without a trial of a Step 1 drug if being prescribed for treatment of opioid-induced constipation in an adult patient with advanced illness who is receiving palliative care

Auvelity (Step exception)

Auvelity coverage conditions:

Auvelity criteria

Listed Products & Code Groups (Index Excerpt)

Listed Step 1 products (selected examples from Part 1)NDC|drug_nameCovered

aripiprazole 10 mg disintegrating tablet
aripiprazole 1 mg/ml oral solution
asenapine 2.5 mg sublingual tablet
CAPLYTA 10.5 MG CAPSULE
lurasidone 120 mg tablet
olanzapine 10 mg disintegrating tablet
paliperidone er 1.5 mg tablet,extended release 24 hr
quetiapine 100 mg tablet
quetiapine er 150 mg tablet,extended release 24 hr

Listed Step 1 products (continued large index)NDC|drug_nameCovered

bupropion hcl 75 mg tablet
citalopram 10 mg tablet
desvenlafaxine succinate er 50 mg tablet,extended release 24 hr
duloxetine 30 mg capsule,delayed release
escitalopram 5 mg tablet
fluoxetine 20 mg capsule
fluvoxamine 25 mg tablet
nefazodone 100 mg tablet
paroxetine 20 mg tablet
sertraline 50 mg tablet

1–10 of 16

1/2

Listed Step 2 products (selected examples)NDC|drug_nameCovered

FANAPT MG TABLET
VRAYLAR 6 MG CAPSULE
ziprasidone 20 mg capsule
OPIPZA 10 MG ORAL FILM
REXULTI 0.25 MG TABLET
RELISTOR 12 MG/0.6 ML SUBCUTANEOUS SOLUTION
RELISTOR 12 MG/0.6 ML SUBCUTANEOUS SYRINGE
RELISTOR 8 MG/0.4 ML SUBCUTANEOUS SYRINGE
RALDESY 10 MG/ML ORAL SOLUTION
FLUTICASONE PROPIONATE 110 MCG/ACTUATION HFA AEROSOL INHALER

Listed drug formulations in fragmentmixed

lurasidone 20 mg tablet	listed repeatedly in index
lurasidone 40 mg tablet	listed repeatedly in index
lurasidone 60 mg tablet	listed repeatedly in index
lurasidone 80 mg tablet	listed repeatedly in index
lurasidone 120 mg tablet	listed repeatedly in index; often paired with fluvoxamine 50 mg
fluvoxamine 25 mg tablet	appears paired with fluvoxamine 50 mg and lurasidone in fragment
fluvoxamine 50 mg tablet	appears paired with lurasidone 120 mg in fragment

Indexed drugs and mapping numbers (partial)mixed

fluvoxamine 25 mg tablet	Index entry mapping to multiple numeric groups (repeated)
fluvoxamine 50 mg tablet	Index entry mapping to multiple numeric groups (repeated)
fluvoxamine 100 tablet	Index entry (OCR noisy)
lurasidone 120 mg tablet	Index entry
INHALER fluvoxamine 100 tablet mg	OCR artifact - inhaler mapping
MCGIACTUATION HFA INHALER	OCR artifact / device mapping
nefazodone 150 mg tablet	Index mapping 5,6
nefazodone 200 mg tablet	Index mapping 5,6
nefazodone 250 mg tablet	Index mapping 5,6
nefazodone 50 mg tablet	Index mapping (incomplete)

1–10 of 93

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This file is a fragmented index of product strengths and their numeric mappings and does not itself contain the full rule set; providers should use the index mapping as a lookup to determine the requirement group and then consult the full policy matrix for the final group-number to rule mapping.

Prior Authorization & Documentation Requirements

Prior Authorization

Step therapy prior authorization requirement

For any requested Step 2 agent listed on this policy, providers must document trials of the required Step 1 agents (typically two distinct Step 1 products) prior to approval. Exceptions to the trial requirement are allowed in specific, policy-defined situations (see items). A prior authorization is required when the Step 2 agent is requested and the required Step 1 trials are not documented.

Typical requirement: documentation of two distinct Step 1 trials (drug name + dates).
Exceptions include but are not limited to: palliative‑care use for Relistor, suicidal ideation for Auvelity, age or inability to use required inhaler types for fluticasone HFA, and documented inability to swallow tablets for Raldesy.
A trial of the brand‑name equivalent of a generic Step 1 product counts toward the requirement.
Current or past use of the requested Step 2 drug may satisfy the requirement (see policy details).

Background & Definitions

This part enumerates multiple medications assigned to Step 1 and Step 2, summarizes the core step-therapy rules (for Step 2 approval typically requiring trials of Step 1 agents) and lists several product-specific exceptions (including Relistor, Auvelity, fluticasone HFA, and Raldesy). It is one segment of a larger prior-authorization code matrix; note that the source is a fragmented index and contains OCR artifacts and repeated entries, so providers should treat this as a fragmentary reference and verify details in the complete policy.

Term	Definition
Step 1	First-line agents that must be tried before Step 2 agents per this policy.
Step 2	Second-line agents requiring prior trials of Step 1 agents unless specified exceptions apply (see product-specific exceptions).
Fragment	This part is a fragmented index of product strength names; not a complete policy section.

Policy Summary

PayerCareSource

Policyy0119_ga-dsnp-m-4588238_c-step-therapy.pdf

Policy CodePolicy N/A

Change TypeIndex/step-therapy summary (no material change)

Effective Date

Next Review Date

On This Page

Step 1 requirement: Approve if the patient has tried a generic SSRI OR SNRI AND separately tried bupropion (i.e., Step 1 criteria)

Suicidal ideation exception: Approve Auvelity if the patient has suicidal ideation without a trial of a Step 1 drug

Current/prior use: Approve Auvelity if the patient is currently receiving Auvelity or has taken Auvelity in the past

Fluticasone HFA (inhaler) exceptions

Fluticasone HFA Step 2 approval exceptions and special populations:

Top-level

Standard rule: If the patient has tried two Step 1 drugs, approve the requested Step 2 drug2 trials
Standard rule
Age/special circumstance exceptions
- Age 5-11 inhaler-use inability: If patient is 5 to 11 years of age and is unable to use BOTH a powder inhaler AND a breath-actuated metered-dose inhaler (e.g., QVAR Redihaler), approve fluticasone propionate HFA if the patient has tried Asmanex HFA
- Age <=4: If the patient is 4 years of age or younger, approve Step 2 drug (fluticasone propionate HFA) without a trial of a Step 1 drug
- Eosinophilic esophagitis / chronic GVHD: If the patient is being treated for eosinophilic esophagitis or chronic graft-versus-host disease with bronchiolitis obliterans syndrome involvement, approve fluticasone propionate HFA without a trial of a Step 1 drug
- Pregnancy/current use: If the patient is pregnant and is currently receiving the requested drug, approve without a trial of a Step 1 drug

Raldesy (trazodone oral solution) exception

Raldesy coverage conditions:

Raldesy criteria

Step 1 trazodone trial: If the patient has tried one Step 1 trazodone product then authorization for Raldesy (Step 2) will be given1 trazodone trial
Swallowing impairment exception: Approve Raldesy if the patient has difficulty swallowing tablets or cannot swallow tablets
Current/prior use: Approve if the patient is currently taking Raldesy or has taken Raldesy at any time in the past

Documentation Required

Document prior trials or exceptions

When requesting prior authorization, submit clear supporting documentation showing either the required Step 1 trials or a qualifying exception. Documentation must be specific and contemporaneous where applicable.

Required for trials: drug name(s) and start/end dates for each Step 1 agent trial.
Palliative‑care exception (Relistor): clinical notes indicating advanced illness, diagnosis of opioid‑induced constipation, and that the patient is receiving palliative care.
Suicidal ideation exception (Auvelity): documentation of suicidal ideation or clinical rationale for immediate use without Step 1 trial.
Inhaler age/use exceptions (fluticasone HFA): patient age and objective documentation that the patient cannot use BOTH a powder inhaler and a breath‑actuated MDI (or other qualifying clinical reason such as eosinophilic esophagitis, BOS, pregnancy when currently receiving drug).
Swallowing impairment (Raldesy): clinical documentation that the patient has difficulty swallowing tablets or cannot swallow tablets.
Documentation that the member is currently taking — or has previously taken — the requested Step 2 drug may substitute for Step 1 trials when indicated by the policy.

Note

Index mapping guidance

Use the policy index mapping to determine which numeric requirement group applies to the specific product formulation you are prescribing. The index maps each product and formulation to a numeric group (e.g., 1, 2, 3, etc.) that defines the actionable step‑therapy requirements and exceptions. Providers must consult the full prior‑authorization matrix and Part 1 of 3 of the policy to identify the exact Step 1 products and any product‑specific special‑case exceptions before submitting a request.

Index mapping ties product formulations to requirement group numbers — reference the full policy index and the prior‑authorization matrix.
Requirement groups determine how many and which Step 1 trials are required and list permitted exceptions.
Always confirm the formulation (tablet, solution, inhaler type, dispenser) in the index to ensure correct mapping.