CurrentMass General Brigham Health PlanPolicy N/A

Fidaxomicin (Dificid) prior authorization

Pharmacy prior authorization policy for fidaxomicin (Dificid) oral tablet and suspension for members on the Commercial/Exchange plan; governs specialty pharmacy dispensing and authorization criteria for treating C. difficile infection.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFidaxomicin (Dificid) prior authorization

Policy CodePolicy N/A

Change TypeAdministrative updatesadded suspension formulation

Effective DateOct 1, 2021

Next Review Date

Key ActionObtain prior authorization and provide documentation of a positive stool assay confirming C. difficile plus clinical justification per criteria.

SourceLink

POLICY UPDATE CHANGES

Changed diagnosis name and removed 'diarrhea-associated' wording, replacing with 'infection'.

Added Dificid oral suspension formulation to policy.

Separated MassHealth (MH) versus Commercial/Exchange criteria presentation with no clinical changes.

10 daysinitial approval duration

20 tabsqty limit (200 mg)

136 mLqty limit (susp)

Commercial/Exchangeplans covered

Policy Summary

PayerMass General Brigham Health Plan

PolicyFidaxomicin (Dificid) prior authorization

Policy CodePolicy N/A

Change TypeAdministrative updatesadded suspension formulation

Effective DateOct 1, 2021

Next Review Date

Key ActionObtain prior authorization and provide documentation of a positive stool assay confirming C. difficile plus clinical justification per criteria.

SourceLink

On This Page

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Coverage Criteria for Fidaxomicin (Dificid)

Initial Approval

Authorization may be granted when ALL the following are met:

Initial authorization: Member has Clostridioides difficile infection confirmed by a positive stool assay

Positive stool assay required

One of the following must be met: Patient requires additional medication to complete a 10-day course initiated in the hospital OR had inadequate response to oral vancomycin after at least 7 days OR has intolerance/contraindication to vancomycin

Defines acceptable clinical scenarios for approval

No explicit exclusions are listed beyond the coverage criteria above. Note that this therapy is designated as a specialty medication and must be dispensed from a contracted specialty pharmacy when required by the plan.

Use of fidaxomicin for indications other than a confirmed Clostridioides difficile infection — i.e., without documentation of a positive stool assay — or when the patient does not meet one of the listed clinical scenarios (additional medication to complete a hospital-initiated 10-day course, inadequate response to oral vancomycin after ≥7 days, or intolerance/contraindication to vancomycin) would not meet the authorization criteria.

Provider Actions, Documentation, and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for fidaxomicin (Dificid) oral tablet and suspension for Commercial/Exchange members. Initial approvals are for 10 days. This medication is specialty and must be filled at a contracted specialty pharmacy. Contact pharmacy benefit: Phone: 800-711-4555, Fax: 844-403-1029. Medical benefit contact: Phone: 833-895-2611, Fax: 888-656-6671.

Plan: Commercial/Exchange only
Program Type: Prior Authorization (Pharmacy Benefit)
Specialty fill required at contracted specialty pharmacy
Initial approval duration: 10 days
Quantity limits: Dificid 200 mg tablet — 20 tablets per 10 days; Dificid 40 mg/mL suspension — 136 mL per 10 days
Pharmacy Benefit Contact: Phone 800-711-4555; Fax 844-403-1029
Medical Benefit Contact: Phone 833-895-2611; Fax 888-656-6671

Step Therapy

Therapy Sequencing / Step Requirement

Therapy sequencing / step requirement — Patient must meet ONE of the following to qualify for authorization:

Complete a hospital-initiated 10-day course and require additional medication to finish that 10-day course
Have an inadequate response to oral vancomycin after a trial of at least 7 days
Have intolerance or contraindication to oral vancomycin

Documentation Required

Required Clinical Documentation

Required clinical documentation — Authorization requires documentation of a positive stool assay confirming Clostridioides difficile infection and evidence that the patient meets one of the therapy sequencing criteria above (hospital-initiated 10-day course needing completion, inadequate response to ≥7 days of oral vancomycin, or intolerance/contraindication to vancomycin).

Positive stool assay for C. difficile
Clinical notes supporting which therapy sequencing criterion is met (hospital course details or documentation of vancomycin trial and response/intolerance)

Denial Risk

Missing Diagnostic Confirmation or Criteria

Missing diagnostic confirmation or criteria — If documentation does not include a positive stool assay for C. difficile and evidence that the member meets one of the listed clinical criteria, the authorization cannot be approved and may be denied or returned for additional information.

Absence of positive stool assay for C. difficile
Absence of documentation showing hospital-initiated therapy needing completion, or lack of evidence of ≥7-day vancomycin trial with inadequate response, or lack of documentation of vancomycin intolerance/contraindication

Definitions

Fidaxomicin

Drug classMacrolide antibacterial

Mechanism of actionInhibits RNA synthesis by binding to RNA polymerases

Site of actionActs locally in the gastrointestinal tract against Clostridioides difficile

SourceFermentation product from Actinomycete Dactylosporangium aurantiacum

Confirmed C. difficile infection

Diagnostic criterionConfirmed Clostridioides difficile infection by a positive stool assay

Required documentationProvide documentation of a positive stool assay for C. difficile

Related therapy requirementMember must meet additional clinical criteria (see coverage guidelines) to qualify for treatment

OpenPayer

Fidaxomicin (Dificid) prior authorization

Coverage Criteria for Fidaxomicin (Dificid)

Provider Actions, Documentation, and Authorization Requirements

Definitions

Background