CurrentHealth NetPolicy CP CPA.273

Prednisone Delayed-Release (Rayos)

Coverage and medical necessity criteria for Rayos (prednisone delayed-release) for commercial line of business; describes initial and continued therapy requirements, dosing guidance, and exclusions for Health Net members.

Policy Summary

PayerHealth Net

PolicyPrednisone Delayed-Release (Rayos)

Policy CodePolicy CP CPA.273

Change TypeNo material changes

Effective DateNov 16, 2016

Next Review DateNov 24, 2024

Key ActionObtain prior authorization with documentation that the member meets the initial approval criteria and has tried generic immediate‑release prednisone unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsapproval duration (commercial)

1,2,5 mgtablet strengths available

try IR prednisonestep before Rayos

multipleFDA-approved indication groups

Coverage Criteria for Rayos (prednisone delayed-release)

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Initial Approval

Indication List: Member has one of the FDA‑approved indications listed in the policy (examples include: atopic dermatitis; drug hypersensitivity reactions; seasonal or perennial allergic rhinitis; congenital adrenal hyperplasia; hypercalcemia of malignancy; bullous dermatitis herpetiformis; Crohn's disease; ulcerative colitis; acute leukemia; aggressive lymphomas; autoimmune hemolytic anemia; acute exacerbations of multiple sclerosis; sympathetic ophthalmia; acute or chronic solid organ rejection; renal indications such as nephrotic syndrome due to idiopathic disease or lupus; pulmonary indications including acute COPD exacerbations, allergic bronchopulmonary aspergillosis, asthma, symptomatic sarcoidosis; rheumatologic conditions such as rheumatoid arthritis, polymyalgia rheumatica, ankylosing spondylitis; certain infectious diseases as listed)
See full policy for complete indication list and specifics

Prior therapy / step requirement: Member must have used generic immediate-release oral prednisone unless contraindicated or clinically significant adverse effects are experienced

Step therapy requirement prior to Rayos

Dosing guidance: If switching from immediate‑release prednisone/prednisolone/methylprednisolone, convert to Rayos at an equivalent dose based on relative potency; initial dose range 5–60 mg PO once daily and maintenance using the lowest effective dose

Dosing and conversion guidance per policy dosing section

Documentation: Provider must submit documentation (e.g., office chart notes, lab results) supporting that the member has met all approval criteria

Prior authorization requires supporting documentation

Continuation Therapy Criteria

Continued coverage when ONE of the following is met:

Continued therapy eligibility: Member is currently receiving Rayos via the Centene benefit or has previously met the policy's initial approval criteria

Includes members who previously met initial approval

Continuity of care: Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (see state-specific addendums)

Applies per applicable state/product continuity rules

Response requirement: Member is responding positively to therapy

Clinical response is required for continued approval

Other scenarios: For uses not covered on formulary or PDL, follow the applicable non-coverage, non-formulary, or off-label use policies (e.g., CP.CPA.190 or CP.CPA.09) as referenced in the policy

Requests for non‑FDA approved indications not addressed in this policy require documentation per off‑label policy

Documentation for continuation: Provider must submit documentation (e.g., office chart notes, lab results) demonstrating continued benefit/response to therapy

Supportive documentation required for prior authorization continuation decisions

Requests for use of Rayos (prednisone delayed‑release) for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the Health Plan's off‑label use policy CP CPA.09 or the member's applicable evidence of coverage.

Coverage and administration of Rayos are governed by the member's specific plan documents. Determinations regarding medical necessity and benefit administration are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract) and to applicable state and federal requirements. If there is any discrepancy between this clinical policy and legal or regulatory requirements, the law governs.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must submit documentation (e.g., office chart notes, lab results, imaging, and other clinical information) supporting that the member meets all approval criteria.

Affected product: Rayos (prednisone delayed‑release)

Documentation Required

Supportive Documentation Required

Requests for coverage must include supporting clinical documentation to demonstrate that the member meets the policy criteria (office notes, pertinent labs, prior therapies, and rationale for therapy choice).

Step Therapy

Step Therapy / Switching Guidance

Step therapy/switching guidance: Members must use generic immediate‑release oral prednisone (or prednisolone/methylprednisolone equivalent) prior to approval of delayed‑release prednisone (Rayos) unless there is a contraindication or clinically significant adverse effect documented.

Step: Trial of generic immediate‑release prednisone required unless contraindicated or intolerant
Switching: If switching to Rayos, use equivalent dosing based on relative potency

Denial Risk

Non‑covered Indications

Non‑FDA approved indications that are not addressed by this policy are not authorized unless the off‑label use policy (CP CPA.09) criteria are met and sufficient documentation of efficacy and safety is provided.

Note

Coverage and Provider Responsibilities

Coverage determinations are subject to all terms, conditions, exclusions, and limitations of the member's plan (evidence of coverage, certificate of coverage, policy, contract of insurance), and applicable state and federal requirements. Providers are expected to exercise professional medical judgment; this policy is a guide to medical necessity determinations.

Background

Rayos is the brand name for prednisone delayed‑release, an oral corticosteroid formulated for delayed release. It is indicated as an anti‑inflammatory and immunosuppressive agent for multiple FDA‑approved conditions across allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, neurologic, renal, respiratory, rheumatologic, infectious disease, endocrine and neoplastic disease categories. Dosing varies by condition; initial doses in the FDA‑approved labeling range approximately from 5 mg to 60 mg once daily, with maintenance use at the lowest effective dose. Tablet strengths available include 1 mg, 2 mg, and 5 mg.

Definitions and Key Terms

Rayos — Prednisone delayed‑release tablet, indications and dosing summary

Generic namePrednisone delayed-release (Rayos)

Indications (FDA-approved groups)Anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions, organ transplantation; also for certain endocrine and neoplastic conditions.

Typical initial dosingInitial dose: 5 mg to 60 mg PO once daily depending on the specific disease entity being treated.

Maintenance dosing guidanceUse the lowest dosage that will maintain an adequate clinical response.

Conversion from immediate‑release prednisonePatients on immediate‑release prednisone, prednisolone, or methylprednisolone should be switched to Rayos at an equivalent dose based on relative potency.

Tablet strengths available1 mg, 2 mg, 5 mg (per policy stats).

COPD — Definition/abbreviation

AbbreviationCOPD

DefinitionChronic obstructive pulmonary disease

Reference locationDefined in Appendix A of the policy (Appendices/General Information).

Medical necessity — Definition used for coverage decisions

Purpose in policyComponent used to assist in making coverage decisions and administering benefits.

RoleHelps determine whether a service or medication meets the Health Plan's criteria for coverage under member benefit documents.

Interaction with coverage documentsCoverage determinations are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable legal/regulatory requirements.

Health Plan — Definition of the plan adopting this clinical policy

DefinitionHealth 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.

ScopeApplies to the health plan(s) that adopt this clinical policy for use in coverage and medical necessity determinations.

Legal/administrative noteThis clinical policy is the property of the Health Plan; coverage and administration are subject to contractual terms and applicable law.