CurrentCentenePolicy HIM.PA.33

No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update

Policy governing authorization and medical necessity review for requests of formulary drugs that lack drug-specific coverage criteria or have pending clinical policy updates due to recent label changes; applies to pharmacy and medical benefit requests with state-specific exceptions for step therapy/redirection.

Policy Summary

PayerCentene

PolicyNo Coverage Criteria, Recent Label Changes Pending Clinical Policy Update

Policy CodePolicy HIM.PA.33

Change TypePeriodic annual reviews and targeted revisions (added exceptions, appendices, and clarifications)

Effective DateMay 1, 2016

Next Review Date

Key ActionProvider must submit documentation (e.g., office notes, lab results) supporting that member has met all approval criteria for medical necessity determinations.

POLICY UPDATE CHANGES

4Q 2020 annual review: added NCCN 2B as acceptable level of evidence for off-label use and added criteria for combination products and alternative dosage forms/strengths; added requirement for redirection to two preferred.

4Q 2021 annual review: added exclusion for indications shown to be unsafe or ineffective and revised reference to off-label policy HIM.PA.154.

01.06.22: Added criteria set for requests through the medical benefit and added redirection bypass for states with regulations against redirections in cancer (Appendix E).

06.09.22: Clarified that formulary contraceptives should be reviewed against HIM.PA.100.

07.05.23–07.19.23: Added bypass of preferred drugs and combination products redirection for states with limitations in certain mental health settings and updated Appendices E and F to include additional states (OK, TX); added NV SB 439 disclaimer.

06.05.24: Added allowance for continuation of care for depression and transplant; added NV quantity management limitation note.

4Q 2024 annual review: no significant changes; references reviewed and updated.

2Required failed preferred agents (minimum)

Coverage Summary

Policy HIM.PA.33 governs authorization and medical necessity review for requests of formulary drugs that lack drug-specific coverage criteria or have pending clinical policy updates due to recent label changes; it applies to both pharmacy and medical benefit requests and includes state-specific exceptions for step therapy/redirection. Effective date: 2016-05-01. Last review date: 2024-07-29. Policy number: HIM.PA.33.

Key policy facts

Required failed preferred agents (minimum)2

Maximum approval duration12 months

State exceptions for redirection/step therapyAppendices E-F

Drugs covered (varies by product)N/A

Effective Date2016-05-01

Last Review2024-07-29

Medical-Necessity Criteria

Initial Approval Criteria - Pharmacy Benefit (Labeled Use without Drug-specific Coverage Criteria or Pending Clinical Policy Updates)

Must meet ALL of the following:

ALL of the following

ALL of the following
- Request is for a drug on the formulary*
- Request is not for a benefit excluded use (e.g., cosmetic)
- ONE of the following (a or b)
  - a: A condition for which the product is FDA-indicated and -approved

Definitions & Evidence

This Centene clinical policy applies when no specific authorization criteria exist for formulary drugs or when clinical policy updates are pending because of recent label changes; it is used to guide case-by-case medical necessity determinations for formulary drug therapy across both the pharmacy and medical benefits. The policy requires providers to submit supporting documentation for medical necessity and generally requires failure of an adequate trial of at least two preferred FDA‑approved drugs at maximum indicated doses unless exceptions apply. It also references state-specific continuity of care addenda (CC.PHARM.03A and CC.PHARM.03B) and identifies state limitations or prohibitions on redirection/step therapy (see Appendices E and F) that may bypass redirection requirements for oncology or certain mental health settings.

Definitions

Formulary*Drugs included on the health plan's formulary; policy applies to formulary drugs unless otherwise noted.

Redirection/step therapyRequirement to trial preferred products prior to approval of requested drug unless exceptions apply or state law prohibits.

Evidence

Acceptable off-label evidence levels

Provider Actions

Documentation Required

Submit documentation to support criteria

Provider must submit documentation (e.g., office notes, lab results) supporting that member has met all approval criteria for medical necessity determinations.

Step Therapy

Redirection/step therapy requirements

Requests typically require failure of at least two preferred FDA-approved drugs at maximum indicated doses unless an exception applies. Exceptions include clinically significant adverse effects or contraindications to all preferred agents, and state-specific prohibitions or limitations on step therapy/redirection as described in Appendices E and F.

Appendix E: States with regulations against redirections in cancer (see chunk 15 and 16)
Appendix F: States with limitations against redirections in certain mental health settings (see chunk 16)

Policy References & Appendices (Codes)

Policy-level codes referenced / applicable appendicesmixed

HIM.PA.33	Reference Number for this clinical policy
HIM.PA.103	Brand Name Override and Non-Formulary Medications
HIM.PA.100	Non-formulary and Formulary contraceptives
HIM.PA.154	Off-label use policy referenced
CC.PHARM.03A	State continuity of care addendum A
CC.PHARM.03B	State continuity of care addendum B

Revision History

4Q 2020 (P&T 11.20)added

Added NCCN level 2B as an acceptable level of evidence for off-label use; added criteria for combination products and alternative dosage forms/strengths; added requirement for redirection to two preferred.

4Q 2021 (P&T 11.21)revised

Section III updated to add exclusion for indications or diagnoses shown to be unsafe or ineffective and revised off-label policy reference to HIM.PA.154; references reviewed and updated.

01.06.22revised

Added criteria set for requests through the medical benefit (adapted from CP PMN.255) and added redirection bypass for states with regulations against redirections in cancer (Appendix E).

ALL of the following

Failure of an adequate trial of at least two preferred* FDA-approved drugs for the indication and/or drugs that are considered the standard of care, at maximum indicated doses, unless one of the listed exceptions applies
Minimum = 2 failed preferred agents
Exceptions to step therapy/redirection (a, b, or c)
- a: Clinically significant adverse effects are experienced or all are contraindicated
- b: Request is for the treatment of a member in a State with limitations on step therapy in certain mental health settings (see Appendix F)
- c: Request is for a product for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E)
For combination product or alternative dosage form or strength of existing drugs: medical justification supports inability to use the individual drug products concurrently or alternative dosage forms or strengths (e.g., contraindications to excipients) OR state redirection exceptions apply
Use of a copay card or discount card does not constitute medical necessity
Member has no contraindications to the prescribed agent per the prescribing information
Prescriber has taken necessary measures to minimize any risk associated with a boxed warning in the product information label, if applicable
Dose requirement (a or b)
- a: Dose does not exceed the FDA-approved maximum recommended dose for the relevant product and indication
- b: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Initial Approval Criteria - Medical Benefit (Labeled Use without Drug-specific Coverage Criteria or Pending Clinical Policy Updates)

Must meet ALL of the following:

ALL of the following

Request is not for a benefit excluded use (e.g., cosmetic)
One of the following (a or b)
- a: Requested does not have a drug-specific clinical policy or custom coverage criteria
- b: Requested has a drug-specific clinical policy that is pending clinical policy updates as a result of recent (within the last 6 months) label changes
Diagnosis requirement (a or b)
- a: A condition for which the product is FDA-indicated and -approved
- b: A condition supported by the NCCN Drug Information and Biologics Compendium level of evidence 1, 2A, or 2B
Failure of an adequate trial of at least two FDA-approved drugs for the indication and/or drugs that are considered the standard of care, at maximum indicated doses, unless an exception applies (a, b, or c)
Minimum = 2 failed agents
For combination product or alternative dosage form or strength of existing drugs: medical justification supports inability to use individual drug products concurrently or alternative forms/strengths
Use of a copay card or discount card does not constitute medical necessity
Member has no contraindications to the prescribed agent per the prescribing information
Dose requirement (a or b)
- a: Dose does not exceed the FDA-approved maximum recommended dose for the relevant indication
- b: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Continued Therapy Criteria - Pharmacy or Medical Benefit

Must meet ALL of the following:

ALL of the following

Member must meet one of (a, b, or c)
- a: Member has previously met initial approval criteria
- b: Member is currently receiving medication via Centene benefit
- c: State or Health plan continuity of care programs apply to the requested drug and indication with documentation that member has received this medication for at least 30 days (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
Dose increase requirement (a or b)
- a: New dose does not exceed the FDA-approved maximum recommended dose for the relevant indication
- b: New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)