Currentsierra health and lifePolicy N/A

Dificid (fidaxomicin) prior authorization/notification

Defines prior authorization and notification requirements for Dificid (fidaxomicin) for treatment of Clostridium difficile–associated diarrhea (CDAD) for Sierra Health and Life members under UnitedHealthcare Pharmacy - Nevada Clinical Pharmacy Programs.

Policy Summary

Payersierra health and life

PolicyDificid (fidaxomicin) prior authorization/notification

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization showing diagnosis of CDAD and evidence of failure, intolerance, or contraindication to oral vancomycin (or request is for continuation of prior Dificid therapy).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10 daysauthorization duration

6 months+age indication

Prior Auth/Notificationprogram type

12/2019, 12/2020approval history

Coverage Criteria for Dificid (fidaxomicin)

Policy Summary

Payersierra health and life

PolicyDificid (fidaxomicin) prior authorization/notification

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization showing diagnosis of CDAD and evidence of failure, intolerance, or contraindication to oral vancomycin (or request is for continuation of prior Dificid therapy).

SourceLink

On This Page

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Initial and continuation therapy criteria

Covered when ALL of the following are met

Primary diagnosis: Diagnosis of Clostridium difficile-associated diarrhea (CDAD)

Prior therapy or continuation: One of: a) history of failure, contraindication, or intolerance to Firvanq (vancomycin oral solution); OR b) history of failure, contraindication, or intolerance to vancomycin (Vancocin) oral capsules if prescriber documents reason patient cannot use Firvanq; OR c) continuation of prior Dificid therapy (authorization issued for 10 days).

Use of Dificid (fidaxomicin) is limited to infections that are proven or strongly suspected to be caused by Clostridium difficile. This restriction is intended to reduce the development of drug‑resistant bacteria and to preserve the effectiveness of Dificid and other antibacterial agents.

Initial Dificid Therapy

Initial Dificid therapy

Initial authorization criteria

Diagnosis requirement: Diagnosis of Clostridium difficile-associated diarrhea (CDAD)

Prior therapy requirement: History of failure, contraindication, or intolerance to Firvanq (vancomycin oral solution) OR to Vancocin (vancomycin oral capsules) if prescriber documents why Firvanq cannot be used.

Continuation of Prior Dificid Therapy

Continuation of prior Dificid therapy

Continuation authorization rule

Continuation: Authorization for continuation of prior Dificid therapy will be issued for 10 days.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Dificid (fidaxomicin). Approval is granted only for treatment of documented Clostridium difficile-associated diarrhea (CDAD).

Medication: Dificid (fidaxomicin)
Authorization duration: 10 days

Step Therapy

Step Therapy Requirement

Step therapy: a trial and history of failure, contraindication, or intolerance to preferred oral vancomycin therapy (Firvanq oral solution) is required prior to approval of Dificid unless the prescriber documents a specific reason the patient cannot use Firvanq.

Preferred agent: Firvanq (vancomycin) oral solution
Alternative: Vancocin (vancomycin) oral capsules only if prescriber documents reason patient cannot use Firvanq

Documentation Required

Required documentation: Provider must document the diagnosis of CDAD and evidence of history of failure, intolerance, or contraindication to the preferred agents (Firvanq or Vancocin) or document clinical justification for use (including reasons Firvanq cannot be used), or documentation supporting continuation of prior Dificid therapy.

Documented diagnosis: Clostridium difficile-associated diarrhea (CDAD)
Documented treatment history: failure, intolerance, or contraindication to Firvanq or Vancocin, or rationale for exception
For continuation requests: documentation of prior Dificid therapy and clinical rationale

Denial Risk

Denial Risk — Missing Documentation

Potential denial triggers: requests lacking documentation of a CDAD diagnosis, missing evidence of required prior trial/failure/intolerance/contraindication to preferred agents, or absence of a documented clinical justification for exceptions may be denied.

No documented CDAD diagnosis
No documentation of prior trial or contraindication to Firvanq (vancomycin) oral solution
No prescriber justification when Firvanq cannot be used

Step Therapy Requirements

Step	Requirement	Notes
1	Trial and failure, contraindication, or intolerance to Firvanq (vancomycin oral solution)	Firvanq is the preferred vancomycin formulation prior to Dificid
1	History of failure, contraindication, or intolerance to Vancocin (vancomycin oral capsules) when prescriber documents why Firvanq cannot be used	Vancocin acceptable only with documented reason patient cannot use Firvanq
1	Continuation of prior Dificid therapy	Authorization for continuation will be issued for 10 days

Diagnosis Codes and Automated Logic

Diagnosis codes referenced in automated approval logicmixed

ICD-10

Diagnosis codes may be used to support automated approval/re-approval per program logic

Quantity and Supply Limits

Dificid (fidaxomicin) — Quantity / supply limits

Quantity limit statusSupply limits may be in place for Dificid (fidaxomicin).

ApplicabilitySupply limits apply per course as determined by the program's additional clinical rules.

Program variabilityUse of automated approval/re-approval processes varies by program and therapeutic class and may affect supply limits.

Site-of-Care and Automated Approvals

Note

Automated approvals may be used based on claims/diagnosis codes

The program may use automated approval or reauthorization based on previous claim/medication history, diagnosis codes (ICD-10), and claim logic; no specific site-of-care restriction is specified.

Use of automated approval and re-approval processes varies by program and/or therapeutic class.

Background

Dificid (fidaxomicin) is indicated for treatment of Clostridium difficile–associated diarrhea (CDAD) in adults and pediatric patients aged 6 months and older. The prescribing guidance emphasizes limiting use to infections proven or strongly suspected to be caused by C. difficile to help prevent emergence of resistance.

Definitions

CDAD definition

DefinitionClostridium difficile–associated diarrhea (CDAD): diarrhea caused by infection with Clostridium (Clostridioides) difficile.

Indication contextDificid is indicated for treatment of CDAD in adults and pediatric patients 6 months and older; use should be limited to infections proven or strongly suspected to be caused by C. difficile.

Documentation relevanceDiagnosis of CDAD is a required element for prior authorization/notification and continued therapy determinations.