ModifiedCentenePolicy CP PMN.83

Short Ragweed Pollen Allergen Extract (Ragwitek)

Policy governing medical necessity and prior authorization criteria for Ragwitek (short ragweed pollen sublingual immunotherapy) for members of Centene-affiliated health plans across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyShort Ragweed Pollen Allergen Extract (Ragwitek)

Policy CodePolicy CP PMN.83

Change TypeAge indication expandedcommercial approval duration revised

Effective DateNov 16, 2021

Next Review DateAug 25, 2025

Key ActionObtain prior authorization with documentation of diagnosis, confirmatory testing, allergist/immunologist involvement, step-therapy trials, and planned dose ≤1 tablet/day.

SourceLink

POLICY UPDATE CHANGES

Age restriction revised from 18-65 years to 5-65 years per FDA indication.

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

References updated and template changes applied to continued therapy section and other diagnoses/indications.

5–65FDA approved age range

1/tab/dayMaximum daily dose

12 moCommercial approval max

Commercial, HIM, MedicaidLines of business

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Coverage and Medical Necessity Criteria

inv-01: Initial Approval Criteria

Covered when ALL of the following are met:

Initial Approval: 1) Diagnosis of short ragweed pollen–induced allergic rhinitis.

Initial Approval: 2) Prescribed by or in consultation with an allergist or immunologist.

Initial Approval: 3) Member age is between 5 and <65 years.

Initial Approval: 4) Confirmation of a positive skin test or in vitro testing for short ragweed pollen–specific IgE antibodies.

Initial Approval: 5) Failure of one intranasal corticosteroid unless clinically significant adverse effects are experienced or all intranasal corticosteroids are contraindicated.

Initial Approval: 6) Failure of one oral antihistamine at maximally indicated doses unless clinically significant adverse effects are experienced or all oral antihistamines are contraindicated.

Initial Approval: 7) Requested dose does not exceed 1 tablet per day.

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

inv-02: Continued Therapy

Covered when ANY of the following pathway criteria are met (member must meet A or B):

Continued Therapy: A) Member currently receiving medication via Centene benefit or member has previously met initial approval criteria AND member is responding positively to therapy.

If request is for dose increase, new dose must not exceed 1 tablet per day.

Continued Therapy: B) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state-specific addendums).

inv-03: General coverage criteria and governance

Policy coverage and medical necessity decisions

Policy application: Coverage decisions require adherence to the member's plan benefit documents and to applicable state and federal laws and regulations.

For Medicaid members, when state Medicaid coverage provisions conflict with this clinical policy, state Medicaid provisions take precedence; refer to the state Medicaid manual.

Documentation and medical necessity: Providers must document medical necessity consistent with generally accepted standards of medical practice and retain supporting documentation (e.g., office notes, lab results).

Requests lacking documentation that the member has met all approval criteria or requests for non–FDA approved indications without adequate off‑label justification may be denied.

Policy scope and limitations: This clinical policy is a guide to medical necessity determinations and does not constitute a guarantee of payment; coverage is subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable Health Plan administrative policies.

Non–FDA approved indications for Ragwitek are not authorized under this clinical policy unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid, or unless there is an existing evidence of coverage document that permits the requested indication.

When a state Medicaid program’s coverage provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence. Providers should follow the applicable state Medicaid manual for any coverage determinations or exceptions that apply to Medicaid members.

Requests for Ragwitek for non–FDA approved indications that do not include adequate off‑label justification or documentation of efficacy and safety per the referenced off‑label policies may be considered not medically necessary and denied. Providers must supply the specific supporting clinical documentation required by the applicable off‑label policy to demonstrate medical necessity.

This clinical policy is a guide to assist in medical necessity determinations and does not guarantee payment. Coverage and payment remain subject to all terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, or policy), as well as applicable state and federal requirements and other Health Plan administrative policies and procedures.

Billing and Product Codes

Codes mentionedmixed

N/A	No explicit CPT/HCPCS/ICD-10/NDC codes listed in this document portion

Product availability / HCPCS-like descriptormixed

12 Amb a 1-Unit (Amb a 1-U)

Tablet product strength/availability (Ragwitek)

Treatment initiation timing

Recommended initiation timingStart treatment at least 12 weeks before the expected onset of ragweed pollen season and continue through the season.

Maintenance duration guidanceContinue therapy throughout the ragweed pollen season once started.

Dosing frequency constraintMaximum dose: 1 tablet per day.

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation of diagnosis, confirmatory positive skin test or in vitro pollen-specific IgE testing for short ragweed pollen, and evidence that an allergist/immunologist is prescribing or was consulted.

Prior authorization required with documentation of diagnosis and positive confirmatory testing
Prescribed by or in consultation with an allergist or immunologist

Prior Authorization

Prior Authorization and Approval Duration

Commercial approvals are limited to 12 months or the duration of the request, whichever is less. Health plans may require prior authorization continuation per their procedures.

Commercial: 12 months or duration of request, whichever is less
Medicaid/HIM: 12 months

Policy Background and Context

Ragwitek is a sublingual tablet formulation of a short ragweed pollen allergen extract indicated as immunotherapy for the treatment of short ragweed pollen–induced allergic rhinitis, with or without conjunctivitis, for patients within the FDA‑approved age range of 5 through 65 years. The product is intended to be started prior to ragweed season and continued through the season as part of allergen immunotherapy.

Terms and Product Definitions

Ragwitek

DefinitionRagwitek is a short ragweed pollen allergen extract formulated as a sublingual tablet for immunotherapy of short ragweed pollen–induced allergic rhinitis (with or without conjunctivitis).

Age indicationApproved for use in persons 5 through 65 years of age.

Diagnostic confirmationIndicated when allergic rhinitis is confirmed by positive skin test or in vitro testing for short ragweed pollen–specific IgE antibodies.

Safety considerationsNot indicated for immediate symptom relief; carries boxed warning for severe allergic reactions and has contraindications including severe uncontrolled asthma and history of eosinophilic esophagitis.

Ragwitek Tablet

Product form and strengthTablet formulation: 12 Amb a 1-Unit (Amb a 1-U).