Clinical Policy: No Coverage Criteria, Recent Label Changes Pending Form

**CENTENE Corporation**

**Clinical Policy: No Coverage Criteria, Recent Label Changes Pending**
Clinical Policy Update
Reference Number: HIM.PA.33
Effective Date: 05.01.16
Last Review Date: 11.25
Line of Business: HIM                                 **Revision Log**

See Important Reminder at the end of this policy for important regulatory and legal
information.

**Description**
This policy is to be used for formulary drugs that:*
• Require prior authorization where there are no specific guidelines or coverage criteria.
• Have drug specific clinical policies that are pending updates as a result of recent (within the
last 6 months) label changes (e.g., newly approved indications, age expansions, new dosing
regimens).

*All requests for non-formulary drugs, under the pharmacy benefit, should be reviewed against HIM.PA.103 –
Brand Name Override and Non-Formulary Medications or medication specific prior authorization criteria when
available

**FDA Approved Indication(s)**
Varies by drug product.

**Policy/Criteria**
Provider must submit documentation (such as office chart notes, lab results or other clinical
information) supporting that member has met all approval criteria.

It is the policy of health plans affiliated with Centene Corporation® that all medical necessity
determinations for formulary drug therapy without Centene® coverage criteria or pending
clinical policy updates as a result of recent label changes be considered on a case-by-case basis
by a physician, pharmacist, or ad hoc committee, using the guidance provided within this policy.

*All requests for non-formulary drugs, under the pharmacy benefit, should be reviewed against HIM.PA.103 –
Brand Name Override and Non-Formulary Medications or medication specific prior authorization criteria when
available

**I. Initial Approval Criteria***
*For members in Nevada, medical management techniques, including quantity management, beyond step
therapy is not allowed for medication-assisted treatment (MAT)/withdrawal, HIV, and hepatitis C drugs
**A. Pharmacy Benefit: No Drug-specific Coverage Criteria or Pending Clinical Policy
Updates as a Result of Recent Label Changes (must meet all):**
1. Request is for a drug on the formulary*;
*Requests for formulary contraceptives should be reviewed against HIM.PA.100 Non-formulary and
Formulary contraceptives
*Requests for non-formulary drugs, under the pharmacy benefit, should be reviewed against
medication-specific prior authorization criteria when available; if there are no medication-specific
criteria, refer to HIM.PA.103 – Brand Name Override and Non-Formulary Medications
2. Request is not for a benefit excluded use (e.g., cosmetic);
3. One of the following (a or b):
a. Requested drug does not have a drug-specific clinical policy or custom coverage
criteria;
b. Requested drug has a drug-specific clinical policy that is pending clinical policy
updates as a result of recent (within the last 6 months) label changes (e.g., newly
approved indications, age expansions, new dosing regimens);

5. 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, when such agents
exist, at maximum indicated doses, unless one of the following (a, b, or c):*
*Generic is preferred, if available generically
^For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB
5395
a. Clinically significant adverse effects are experienced or all are contraindicated;
b. 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);
c. Request is for the treatment of a member in a State with limitations on step
therapy in certain mental health settings (see Appendix F);
6. For combination product or alternative dosage form or strength of existing drugs, one
of the following (a, b, or c):*
*For Illinois HIM requests, the step therapy requirements below do not apply as of 1/1/2026 per IL HB
5395
a. Medical justification* supports inability to use the individual drug products
concurrently or alternative dosage forms or strengths (e.g., contraindications to
the excipients of all alternative products);
*Use of a copay card or discount card does not constitute medical necessity
b. 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);
c. Request is for the treatment of a member in a State with limitations on step
therapy in certain mental health settings (see Appendix F);
7. Member has no contraindications to the prescribed agent per the prescribing
information;
8. If applicable, prescriber has taken necessary measures to minimize any risk associated
with a boxed warning in the product information label;

Approval duration: Duration of request or 12 months, whichever is less
**B. Medical Benefit: No Drug-specific Coverage Criteria or Pending Clinical Policy
Updates as a Result of Recent Label Changes (must meet all):**
1. Request is not for a benefit excluded use (e.g., cosmetic);
2. One of the following (a or b):
a. Requested drug does not have a drug-specific clinical policy or custom coverage
criteria;
b. Requested drug has a drug-specific clinical policy that is pending clinical policy
updates as a result of recent (within the last 6 months) label changes (e.g., newly
approved indications, age expansions, new dosing regimens);
3. Diagnosis of one of the following (a or b):
a. A condition for which the product is FDA-indicated and -approved;
b. A condition supported by one of the following (i, ii, iii, or iv):
i. The National Comprehensive Cancer Network (NCCN) Drug Information and
Biologics Compendium level of evidence 1, 2A, or 2B (see Appendix D);
ii. Evidence from at least two high-quality, published studies in reputable peer-
reviewed journals or evidence-based clinical practice guidelines that provide
all of the following (1 – 4):
1) Adequate representation of the member’s clinical characteristics, age, and
diagnosis;
2) Adequate representation of the prescribed drug regimen;
3) Clinically meaningful outcomes as a result of the drug therapy in question;
4) Appropriate experimental design and method to address research questions
(see Appendix F for additional information);
iii. Micromedex DrugDex® with strength of recommendation Class I or IIa (see
Appendix D);
iv. For state(s) with state-specific regulations for supportive evidence for requests
in pediatrics where member’s age is beyond the FDA labeled indication and
prescribing information, refer to Appendix G for supportive references by
State;
4. 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, when such agents exist, at
maximum indicated doses, unless one of the following (a, b, or c):*
*For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB
5395
a. Clinically significant adverse effects are experienced or all are contraindicated;
b. 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);
c. Request is for the treatment of a member in a State with limitations on step
therapy in certain mental health settings (see Appendix F);
5. For combination product or alternative dosage form or strength of existing drugs, one
of the following (a, b, or c):*
*For Illinois HIM requests, the step therapy requirements below do not apply as of 1/1/2026 per IL HB
5395
a. Medical justification* supports inability to use the individual drug products
concurrently or alternative dosage forms or strengths (e.g., contraindications to
the excipients of all alternative products);
*Use of a copay card or discount card does not constitute medical necessity
b. 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) ;
c. Request is for the treatment of a member in a State with limitations on step
therapy in certain mental health settings (see Appendix F);
6. Member has no contraindications to the prescribed agent per the prescribing
information;
7. If applicable, prescriber has taken necessary measures to minimize any risk associated
with a boxed warning in the product information label;

Approval duration: Duration of request or 12 months, whichever is less
**II. Continued Therapy***
*For members in Nevada, medical management techniques, including quantity management, beyond step
therapy is not allowed for medication-assisted treatment (MAT)/withdrawal, HIV, and hepatitis C drugs
**A. Pharmacy or Medical Benefit: No Drug-specific Coverage Criteria or Pending
Clinical Policy Updates as a Result of Recent Label Changes (must meet all):**
1. Member meets one of the following (a, b, or c):
a. Currently receiving medication via Centene benefit;
b. Member has previously met initial approval criteria;
c. State or Health plan continuity of care programs apply to the requested drug and
indication (e.g., seizures, heart failure, human immunodeficiency virus infection,
psychotic disorders [e.g., schizophrenia, bipolar disorder], oncology, depression,
transplant) with documentation that supports that member has received this
medication for at least 30 days (refer to state specific addendums for
CC.PHARM.03A and CC.PHARM.03B);
2. Member is responding positively to therapy;
3. If request is for a dose increase, request meets one of the following (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).
Approval duration: Duration of request or 12 months, whichever is less
**III. Diagnoses/Indications for which coverage is NOT authorized**
**A.** Non-FDA approved indications, which are not addressed in this policy, unless there is
sufficient documentation of efficacy and safety according to the off-label use policy –
HIM.PA.154 for health insurance marketplace or evidence of coverage documents;
**B.** Indications or diagnoses in which the drug has been shown to be unsafe or ineffective.
**IV. Appendices/General Information**
Appendix A: Abbreviation/Acronym Key
FDA: Food and Drug Administration
NCCN: National Comprehensive Cancer Network

Appendix B: Therapeutic Alternatives
Not applicable

Appendix C: Contraindications/Boxed Warnings
Varies by drug product.

Appendix D: General Information
These criteria are to be used only when specific prior authorization criteria do not exist.

Appendix E: States with Regulations against Redirections in Cancer
| State | Step Therapy Prohibited? | Notes |
|-------|-------------------------|-------|
| FL    | Yes                     | For stage 4 metastatic cancer and associated conditions. |
| GA    | Yes                     | For stage 4 metastatic cancer. Redirection does not refer to review of medical necessity or clinical appropriateness. |
| IA    | Yes                     | For standard of care stage 4 cancer drug use, supported by peer-reviewed, evidence-based literature, and approved by FDA. |
| IN    | Yes                     | For advanced, metastatic cancer and associated conditions |
| LA    | Yes*                    | For stage 4 advanced, metastatic cancer or associated conditions. *Exception if clinically equivalent therapy, contains identical active ingredient(s), and proven to have same efficacy. |
| MS    | Yes                     | For advanced metastatic cancer and associated conditions |
| NV    | Yes                     | Stage 3 and stage 4 cancer patients for a prescription drug to treat the cancer or any symptom thereof of the covered person |
| OH    | Yes                     | For stage 4 metastatic cancer and associated conditions |
| OK    | Yes                     | For advanced metastatic cancer and associated conditions |
| PA    | Yes                     | For stage 4 advanced, metastatic cancer |
| TN    | Yes^                    | For stage 4 advanced metastatic cancer, metastatic blood cancer, and associated conditions <br> ^Exception if step therapy is for AB-rated generic equivalent, interchangeable biological product, or biosimilar product to the equivalent brand drug |
| TX    | Yes                     | For stage 4 advanced, metastatic cancer and associated conditions |

Appendix F: States with Limitations against Redirections in Certain Mental Health Settings
| State | Step Therapy Prohibited? | Notes |
|-------|-------------------------|-------|
| AR    | Yes                     | For the treatment of psychosis and serious mental illness through antipsychotic prescription drugs, no step therapies allowed. |
| TX    | No                      | For the treatment of psychosis and serious mental illness (e.g., depression), step therapy is limited to one drug (excluding the generic or pharmaceutical equivalent of the prescribed drug). |

Appendix G: Supportive References by State in Pediatrics Where Request is for a Member with Age Beyond the FDA Labeled Indication and Prescribing Information
| State | Supportive References |
|-------|----------------------|
| LA    | The drug has been recognized for the treatment of the disease or condition in pediatric application by one of the following: <br> • The American Medical Association Drug Evaluations <br> • The American Hospital Formulary Service (AHFS) Drug Information <br> • The United States Pharmacopeia Dispensing Information, Volume 1, "Drug Information for the Health Care Professional" <br> • Recognized in two articles from major peer-reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed journal |

**V. Dosage and Administration**
Varies by drug product.

**VI. Product Availability**
Varies by drug product.


| Added step therapy bypass for IL HIM per IL HB 5395. <br> For Appendix E, added state IN. | 03.30.26 |  |

**Important Reminder**
This clinical policy has been developed by appropriately experienced and licensed health care
professionals based on a review and consideration of currently available generally accepted
standards of medical practice; peer-reviewed medical literature; government agency/program
approval status; evidence-based guidelines and positions of leading national health professional
organizations; views of physicians practicing in relevant clinical areas affected by this clinical
policy; and other available clinical information. The Health Plan makes no representations and
accepts no liability with respect to the content of any external information used or relied upon in
developing this clinical policy. This clinical policy is consistent with standards of medical
practice current at the time that this clinical policy was approved. “Health Plan” means a health
plan that has adopted this clinical policy and that is operated or administered, in whole or in part,
by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a
component of the guidelines used to assist in making coverage decisions and administering
benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage
decisions and the administration of benefits are subject to all terms, conditions, exclusions, and
limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy,
contract of insurance, etc.), as well as to state and federal requirements and applicable Health
Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting
may not be the effective date of this clinical policy. This clinical policy may be subject to
applicable legal and regulatory requirements relating to provider notification. If there is a
discrepancy between the effective date of this clinical policy and any applicable legal or
regulatory requirement, the requirements of law and regulation shall govern. The Health Plan
retains the right to change, amend or withdraw this clinical policy, and additional clinical
policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment, or medical care. It is
not intended to dictate to providers how to practice medicine. Providers are expected to exercise
professional medical judgment in providing the most appropriate care, and are solely responsible
for the medical advice and treatment of members. This clinical policy is not intended to
recommend treatment for members. Members should consult with their treating physician in
connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent
judgment and over whom the Health Plan has no control or right of control. Providers are not
agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and
distribution of this clinical policy or any information contained herein are strictly
prohibited. Providers, members, and their representatives are bound to the terms and conditions
expressed herein through the terms of their contracts. Where no such contract exists, providers,
members and their representatives agree to be bound by such terms and conditions by providing
services to members and/or submitting claims for payment for such services.