CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Fidaxomicin (Dificid) coverage

Defines coverage, prior authorization and quantity limits for fidaxomicin 200 mg tablets and Dificid 40 mg/mL suspension for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFidaxomicin (Dificid) coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization with documentation showing trial and inadequate response or intolerance to formulary vancomycin or metronidazole.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20 tabs / 136 mlquantity limit per 10-day course

2fills allowed per year

12 mocoverage duration

vancomycin or metronidazolerequired prior trial

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Approval

Step Therapy Claim Evidence: At least one paid claim of at least a 10-day supply within the last 365 days for formulary metronidazole tablet (250mg or 500mg), first-metronidazole suspension, or vancomycin oral solution (25mg/ml or 50mg/ml)10 days within 365 days
Claim-level verification may be used to satisfy prior trial requirement.

Neighborhood does not provide coverage for drugs when used for investigational purposes. Therapies are considered investigational when used at a dose or for a condition other than those recognized as medically accepted indications in standard reference compendia. Examples of accepted compendia include AHFS‑DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs, or peer‑reviewed published medical literature that establishes sufficient evidence. Coverage will be declined for fidaxomicin when the requested use or dosage is investigational or not recognized as medically accepted per these sources.

Coding and Lookback

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFidaxomicin (Dificid) coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization with documentation showing trial and inadequate response or intolerance to formulary vancomycin or metronidazole.

SourceLink

On This Page

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Referenced comparator formulations for step therapymixed

metronidazole 250mg	formulary metronidazole tablet strength referenced in step therapy logic
metronidazole 500mg	formulary metronidazole tablet strength referenced in step therapy logic
metronidazole suspension	first-metronidazole suspension referenced in step therapy logic
vancomycin oral solution 25mg/ml	formulary vancomycin oral solution strength referenced in step therapy logic
vancomycin oral solution 50mg/ml	formulary vancomycin oral solution strength referenced in step therapy logic

Step therapy paid claim lookback

Lookback period365 days

Minimum paid claim requirementAt least one paid claim of at least a 10-day supply

Acceptable comparator formulations (examples)Formulary metronidazole tablets (250 mg or 500 mg), first‑line metronidazole suspension, or vancomycin oral solution (25 mg/mL or 50 mg/mL)

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Documentation must show the member has trialed and experienced an inadequate treatment response or intolerance to formulary vancomycin or metronidazole before fidaxomicin will be approved.

Required: evidence of trial and inadequate response or intolerance to formulary vancomycin or metronidazole.

Step Therapy

Step Therapy Coding Logic

Fidaxomicin will be approved under step therapy when there is at least one paid claim for a comparator of at least a 10‑day supply within the prior 365 days. This verifies the member trialed an appropriate formulary alternative before coverage.

Acceptable comparator claims: metronidazole tablets 250mg or 500mg, metronidazole suspension (first‑line suspension), vancomycin oral solution 25mg/mL or 50mg/mL.
Required claim lookback period: 365 days.
Required minimum claim supply: ≥ 10 days.

Documentation Required

Required Clinical Documentation

Submit clinical documentation demonstrating the prior trial with and inadequate response or intolerance to formulary vancomycin or metronidazole. Include medication name, dose, dates of therapy, duration (days), reason for discontinuation (inefficacy or adverse reaction), and supporting clinical notes or lab results when applicable.

Documentation must include medication name, dose, start and stop dates, duration, and reason for failure or intolerance.
Attach relevant clinical progress notes or test results supporting lack of response or intolerance.

Denial Risk

Investigational Use Exclusion

Fidaxomicin is not covered for investigational uses or for dosing/conditions not recognized as medically accepted indications in standard compendia.

Investigational exclusion applies when used at doses or for conditions not supported by AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs, or peer‑reviewed literature.

Background

Fidaxomicin (available as Fidaxomicin 200 mg tablets and Dificid 40 mg/mL suspension) is an antibiotic indicated for treatment of Clostridioides difficile infection. This policy requires prior evidence that the member has trialed and experienced an inadequate treatment response or intolerance to formulary oral vancomycin or metronidazole before fidaxomicin will be approved.

Step‑therapy coding logic permits claim‑level verification of prior therapy: fidaxomicin will be paid when there is at least one paid claim for a minimum 10‑day supply within the last 365 days for formulary metronidazole tablet (250 mg or 500 mg), first‑metronidazole suspension, or vancomycin oral solution (25 mg/mL or 50 mg/mL). Quantity limits are set at 20 tablets or 136 mL per 10‑day course, with up to 2 fills per year, and approved coverage duration is 12 months once criteria are met.

OpenPayer

Fidaxomicin (Dificid) coverage

Coverage Criteria

Coding and Lookback

Provider Actions & Requirements

Background

Initial Therapy

Continuation / Duration Criteria

Step Therapy Requirements

Quantity Limits