CurrentCignaPolicy N/A

Antibiotics (Inhaled) - Tobramycin Products Preferred Specialty Management - (CNF258)

Defines Cigna's Preferred Specialty Management program for inhaled tobramycin products (Bethkis, TOBI generics, TOBI Podhaler, Kitabis Pak) including preferred vs non-preferred designation, exception (prior authorization) criteria for non-preferred products, approval durations, and routing to preferred products when exception criteria are not met.

Policy Summary

PayerCigna

PolicyAntibiotics (Inhaled) - Tobramycin Products Preferred Specialty Management - (CNF258)

Policy CodePolicy N/A

Change TypeAddition/Clarification/Removal (generics added; some coverage conditions removed; continuation added)

Effective Date

Next Review Date

Key ActionRequests for Non-Preferred tobramycin products require meeting the Non-Preferred Product Exception Criteria and the standard Tobramycin Inhalation Solution PA criteria; approvals granted per criteria durations (1 year or 1 month).

SourceLink

POLICY UPDATE CHANGES

Generic to Bethkis was added to the policy and to the Preferred Products list.

Policy statement clarified that Kitabis Pak brand is not targeted in the PSM program.

Initial therapy and certain 'patient currently taking' conditions for Bethkis and other non-CF bronchiectasis were removed due to availability of the generic product.

Continuation of therapy condition for Bethkis was added.

Preferred Products list updated to include generics for Bethkis, Kitabis Pak, and TOBI and TOBI Podhaler; Preferred Products do not require PA.

3Named branded products

Preferred product groupings

1Typical approval duration (year)

1 moContinuation approval duration

Coverage Summary

Defines Cigna's Preferred Specialty Management program for inhaled tobramycin products used in the management of cystic fibrosis with Pseudomonas aeruginosa. The program designates Preferred Products (generics for Bethkis, Kitabis Pak, and TOBI, and TOBI Podhaler) that do not require prior authorization and Non-Preferred Products (branded Bethkis and TOBI and other non-preferred tobramycin products) that require meeting exception (prior authorization) criteria and, when applicable, documentation of a trial of a Preferred Product.

Policy facts

PayerCigna

PolicyAntibiotics (Inhaled) - Tobramycin Products Preferred Specialty Management (CNF258)

Coverage Stancemixed

Typical Approval Duration1 year

Continuation Approval Duration1 month (30 days where specified)

Prior Authorization & Exception Criteria

General Preferred Product Policy

Preferred Products do not require Prior Authorization; Non-Preferred products require meeting exception criteria.

Preferred Products (tobramycin inhalation solution generics for Bethkis, Kitabis Pak, and TOBI; and TOBI Podhaler) do not require Prior Authorization

All approvals for Preferred and Non-Preferred Products are provided for 1 year unless otherwise noted; where approval is authorized in months, 1 month = 30 days

Non-Preferred products require meeting the Non-Preferred Product Exception Criteria to be covered

Non-Preferred Product Exception Criteria - Bethkis (tobramycin inhalation solution branded)

Bethkis is covered as medically necessary ONLY when one of the following exception pathways is met; any other exception is not medically necessary.

ONE of

1. Cystic Fibrosis - Initial/Standard Approval

Products addressed (drug names)

Products addressed in policy (drug names)mixed

Bethkis	tobramycin inhalation solution (Chiesi, brand)
TOBI (brand)	tobramycin inhalation solution (Mylan, brand)
TOBI Podhaler	tobramycin inhalation powder (Novartis)
Kitabis Pak (brand)	tobramycin inhalation solution (authorized generic) - note: branded Kitabis Pak not targeted in policy
tobramycin inhalation solution (generic)	generics for Bethkis, Kitabis Pak, and TOBI

Actionable Provider Requirements

Prior Authorization

Prior Authorization required for Non-Preferred products

Requests for Non-Preferred tobramycin products (branded Bethkis or TOBI) require meeting the Non-Preferred Product Exception Criteria and the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution prior authorization criteria. The Preferred Products (tobramycin inhalation solution generics for Bethkis, Kitabis Pak, and TOBI, and TOBI Podhaler) do not require prior authorization. Approvals for non-preferred products are granted per the exception criteria durations (typically 1 year or as specified).

Documentation Required

Trial of Preferred Product required

For approval of most non-preferred exceptions, documentation must show the patient has tried the specified Preferred Product (tobramycin inhalation solution generic or TOBI Podhaler as indicated). If the required trial of the preferred product is not documented, the non-preferred exception will not be met.

Background & Evidence

Tobramycin inhalation products are indicated for management of cystic fibrosis with Pseudomonas aeruginosa; TOBI (generic) is specifically indicated for patients ≥ 6 years of age. Inhalation solutions (e.g., TOBI [generic], Kitabis Pak [authorized generic], Bethkis) are administered by nebulization using specified PARI nebulizers and compressors over approximately 15 minutes, while TOBI Podhaler is a dry powder formulation for oral inhalation using the Podhaler device.

The policy distinguishes product designations for coverage: Preferred Products include tobramycin inhalation solution generics for Bethkis, Kitabis Pak, and TOBI and TOBI Podhaler (these do not require prior authorization). Non-Preferred Products include branded Bethkis and branded TOBI (and other non-preferred tobramycin products) which require meeting the Non-Preferred Product Exception Criteria and the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution PA criteria. Kitabis Pak (brand only) is not targeted by this PSM program.

Source	Notes
Prescribing information references	Multiple manufacturer PI documents cited (Dr. Reddy, Mylan, Chiesi, Novartis, Genericus) with dates Feb 2023 - Jan 2024

Definitions

Preferred Products: Tobramycin inhalation solution generics for Bethkis, Kitabis Pak, and TOBI, and TOBI Podhaler – products that do not require prior authorization under this PSM.

Non-Preferred Products: Branded bethkis and TOBI (and other non-preferred tobramycin products) which require meeting exception criteria and PA for coverage.

Revision History

03/27/2024added (material)

Generic to Bethkis was added to the policy and to the Preferred Products list. Clarification added that tobramycin inhalation solution includes generics for Bethkis, Kitabis Pak, and TOBI.

03/27/2024clarified

Policy statement clarified that Kitabis Pak (brand only) is not targeted in the PSM program.

03/27/2024removed (material)

Initial therapy and several 'patient currently taking Bethkis' conditions of coverage (including bronchiectasis and other conditions) were removed due to availability of the generic product.

Policy Summary

PayerCigna

PolicyAntibiotics (Inhaled) - Tobramycin Products Preferred Specialty Management - (CNF258)

Policy CodePolicy N/A

Change TypeAddition/Clarification/Removal (generics added; some coverage conditions removed; continuation added)

Effective Date

Next Review Date

SourceLink

On This Page

Patient meets the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution Prior Authorization (PA) criteria
Patient has tried tobramycin inhalation solution (generic) or TOBI Podhaler

2. Bronchiectasis, Non-Cystic Fibrosis - Initial/Standard Approval

Patient meets the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution PA criteria
Patient has tried tobramycin inhalation solution (generic)

3. Continuation of Therapy

Patient meets the standard Antibiotics (Inhaled) - Tobramycin Inhaled Solution PA criteria
Patient has tried tobramycin inhalation solution (generic)

Denial / Alternative when exception criteria not met: If patient meets PA criteria but has NOT tried required preferred product (per above), Bethkis is NOT approved; When Bethkis not approved per above, approve tobramycin inhalation solution (generic) or TOBI Podhaler as applicable

Non-Preferred Product Exception Criteria - TOBI (tobramycin inhalation solution branded)

TOBI is covered as medically necessary ONLY when one of the following exception pathways is met; any other exception is not medically necessary.

ONE of

1. Cystic Fibrosis - Initial/Standard Approval
- Patient meets the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution Prior Authorization (PA) criteria
- Patient has tried tobramycin inhalation solution (generic) or TOBI Podhaler
2. Bronchiectasis, Non-Cystic Fibrosis - Initial/Standard Approval
- Patient meets the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution PA criteria
- Patient has tried tobramycin inhalation solution (generic)
3. Continuation of Therapy
- Patient meets the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution PA criteria
- Patient has tried tobramycin inhalation solution (generic)

Denial / Alternative when exception criteria not met: If patient meets PA criteria but has NOT tried required preferred product (per above), TOBI inhalation solution is NOT approved; When TOBI not approved per above, approve tobramycin inhalation solution (generic) or TOBI Podhaler as applicable

Denial Risk

Denial if preferred product not tried

If the patient meets the standard PA criteria for a non-preferred product but has not documented trial of the required preferred product, the non-preferred product (e.g., Bethkis or TOBI) will not be approved. In such cases, coverage will be provided for the applicable preferred product (tobramycin inhalation solution generic or TOBI Podhaler) instead.

Billing Rule

Approval durations

Approvals are typically issued for 1 year unless otherwise noted. When continuation approvals are authorized, they may be for 1 month (30 days). Bethkis and TOBI exception criteria specify 1-year approvals for initial indications and 1-month approvals for continuation of therapy when applicable.

03/27/2024added (material)

Continuation of therapy condition for Bethkis was added: Bethkis is approved for 1 month for continuation if PA criteria are met and patient has tried tobramycin inhalation solution (generic).

03/27/2024revised (material)Latest

Policy updated to direct patients to try at least one Preferred Product prior to approval of a Non-Preferred Product; Preferred Products (generics for Bethkis, Kitabis Pak, and TOBI, and TOBI Podhaler) do not require prior authorization.