CurrentmhnPolicy CP.PHAR.82

XIAFLEX (PDF)

Defines medical necessity criteria, initial and continued therapy requirements, exclusions, dosing, and coding implications for Xiaflex for Dupuytren's contracture and Peyronie's disease across Centene-affiliated lines of business (Commercial, HIM, Medicaid). Includes a state-specific exclusion for New York Essential Plans and New York Medicaid/CHIP for Peyronie's disease.

Policy Summary

Payermhn

PolicyXIAFLEX (PDF)

Policy CodePolicy CP.PHAR.82

Change TypeClarified state-specific exclusion; routine reviews

Effective DateOct 1, 2011

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added clarification that Xiaflex for treatment of Peyronie's Disease is a benefit exclusion and will NOT be authorized for New York Essential Plans and New York Medicaid (including CHIP) per state regulations.

Multiple annual reviews (2021-2025) noted 'no significant changes' with references updated.

2FDA-approved indications covered

1State-specific exclusion (NY) for PD

0.58 mgMax dose per injection

3 monthsTypical approval duration

Coverage Summary

This policy covers Xiaflex (collagenase clostridium histolyticum) consistent with FDA-approved indications: adult Dupuytren's contracture with a palpable cord and adult men with Peyronie's disease with palpable plaque and curvature ≥30°. Coverage is implemented as covered_with_criteria requiring prescriber experience, age ≥18 years, dosing limits (≤ 0.58 mg per injection), injection limits, and surgical exclusion windows (no surgery on the selected primary joint within the last 90 days). Note: per state regulation, Xiaflex for Peyronie's disease is a benefit exclusion and will NOT be authorized for New York Essential Plans and New York Medicaid (including CHIP).

Quick thresholds

Age>= 18 years

Maximum dose per injection<= 0.58 mg per injection (one vial)

Surgical exclusion windowNo surgery on selected primary joint within last 90 days

Dupuytren's - continued curvature threshold> 5 degrees (MP or PIP contracture remains)

Peyronie's - initial curvature threshold>= 30 degrees at start of therapy

Peyronie's - continued curvature threshold>= 15 degrees remaining since last treatment cycle

Minimum intervals between treatmentsDC: >= 4 weeks; PD: >= 6 weeks

Initial Therapy Criteria

I. Initial Approval Criteria - Dupuytren's Contracture

Must meet ALL of the following:

ALL of the following

Diagnosis of Dupuytren's contracture (DC) with a palpable cord
Prescribed by or in consultation with a healthcare provider experienced in injection procedures of the hand and in the treatment of DC
Age ≥ 18 years>= 18 years
Member has not received surgical treatment (e.g., fasciectomy, fasciotomy) on the selected primary joint within the last 90 days<= 90 days since surgery

Continuation Therapy Criteria

II. Continued Therapy - Dupuytren's Contracture

Must meet ALL of the following:

ALL of the following

Member must meet one of
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)
Last treatment was ≥ 4 weeks ago>= 4 weeks

Diagnoses / Indications Not Authorized

III. Diagnoses/Indications NOT authorized

Non-FDA approved indications that are not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Xiaflex for Peyronie's Disease will NOT be authorized for New York Essential Plans and New York Medicaid (including CHIP) per state regulations.

Provider Actions / Prior Authorization Requirements

Prior Authorization

Documentation required for approval

Provider must submit documentation (office notes, lab results or other clinical information) supporting that member has met all approval criteria.

Prior Authorization

Prescriber qualification requirement

Dupuytren's: prescribed by or in consultation with a provider experienced in injection procedures of the hand and in the treatment of Dupuytren's contracture. Peyronie's: prescribed by or in consultation with a provider experienced in the treatment of male urological diseases.

Applicable Codes

HCPCS - Drug J-codeHCPCS

J0775

Injection, collagenase, clostridium histolyticum, 0.01 mg

Clinical Evidence

Key evidence sources include the Xiaflex Prescribing Information (Endo Pharmaceuticals; July 2023 label cited, available via FDA) and guideline evidence such as the American Urological Association Peyronie's disease guideline (Nehra et al., J Urol. 2015).

Full citations and dates for the prescribing information and guideline references are listed in the policy references (see Xiaflex Prescribing Information, July 2023; AUA guideline Nehra et al., 2015).

Background

Xiaflex is indicated for adult patients with Dupuytren's contracture with a palpable cord and for adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. The policy aligns coverage to these FDA indications.

Prescriber qualifications, age requirements (≥ 18 years), dosing guidance (≤ 0.58 mg per injection), injection limits (treatment courses and cycles as described in the label), and surgical exclusion windows (no fasciectomy/fasciotomy on the selected primary joint within the last 90 days) are specified in the policy; dosing and cycle details for Dupuytren's and Peyronie's follow the prescribing information, and postmarketing/prescriber experience is acknowledged in the references.

Definitions

DCDupuytren's contracture

PDPeyronie's disease

MPmetacarpophalangeal joint

PIPproximal interphalangeal joint

Revision History

01.16.26clarificationLatest

Added clarification that use of Xiaflex for treatment of Peyronie's Disease is a benefit exclusion and will NOT be authorized for New York Essential Plans and New York Medicaid (including CHIP) per state regulations.

10.12.22template_change

Template changes applied to other diagnoses/indications and continued therapy section.

04.15.25annual_review

3Q 2025 annual review: no significant changes; references reviewed and updated.

Policy Summary

Payermhn

PolicyXIAFLEX (PDF)

Policy CodePolicy CP.PHAR.82

Change TypeClarified state-specific exclusion; routine reviews

Effective DateOct 1, 2011

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

If two injections (two vials) requested, must be one of

One cord affecting two joints in the same finger
Two cords affecting two joints in the same hand

Dose does not exceed 0.58 mg per injection (one vial per injection)<= 0.58 mg per injection

I. Initial Approval Criteria - Peyronie's Disease

Must meet ALL of the following. Note: Does NOT apply to New York Essential Plans and New York Medicaid (including CHIP) where PD treatment is excluded.

ALL of the following

Diagnosis requires both
- Palpable plaque
- Curvature deformity of ≥ 30 degrees at the start of therapy>= 30 degrees
Prescribed by or in consultation with a healthcare provider experienced in the treatment of male urological diseases
Age ≥ 18 years>= 18 years
Dose does not exceed 0.58 mg per injection (one vial per injection)<= 0.58 mg per injection

I. Initial Approval Criteria - Other diagnoses/indications

Must meet one of the following:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, follow relevant formulary/no coverage or non-formulary policies referenced
Policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
If requested use is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business
Policies: CP.CPA.09, HIM.PA.154, CP.PMN.53

Member has not received more than two total injections per affected cord<= 2 injections per affected cord (prior to continued therapy limits)

Request is for one or both of

MP or PIP contracture remains in affected cord since previous injection and the contracture is > 5 degrees> 5 degrees
A different MP or PIP contracture will be injected

If two injections (two vials) requested, use is for one of

One cord affecting two joints in the same finger
Two cords affecting two joints in the same hand

Member has not received surgical treatment (e.g., fasciectomy, fasciotomy) on the selected primary joint within the last 90 days<= 90 days since surgery

If request is for a dose increase, new dose does not exceed 0.58 mg per injection (one vial per injection)<= 0.58 mg per injection

II. Continued Therapy - Peyronie's Disease

Must meet ALL of the following:

ALL of the following

Member must meet one of
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)
Documented curvature deformity of ≥ 15 degrees remaining since last treatment cycle>= 15 degrees
Last treatment cycle was ≥ 6 weeks ago>= 6 weeks
Member has received < 4 treatment cycles (i.e., < 8 injections [2 injections per cycle])< 4 cycles; < 8 injections total
If request is for a dose increase, new dose does not exceed 0.58 mg per injection (one vial per injection)<= 0.58 mg per injection

II. Continued Therapy - Other diagnoses/indications

Must meet one of the following:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, follow relevant formulary/no coverage or non-formulary policies referenced
Policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
If requested use is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business
Policies: CP.CPA.09, HIM.PA.154, CP.PMN.53

Denial Risk

State-specific exclusion - New York Medicaid/Essential Plans

Xiaflex for treatment of Peyronie's Disease will not be authorized for New York Essential Plans and New York Medicaid (including CHIP) per state regulations.

Documentation Required

Curvature documentation

For Peyronie's disease: for initial therapy document curvature deformity of ≥ 30 degrees at the start of therapy; for continued therapy document remaining curvature deformity of ≥ 15 degrees since last treatment cycle and that the last treatment cycle was ≥ 6 weeks ago. For Dupuytren's continued therapy: document that the MP or PIP contracture remains in the affected cord and is > 5 degrees, or that a different MP or PIP contracture will be injected; ensure last treatment was ≥ 4 weeks ago.

Billing Rule

Dose reporting

Dose must not exceed 0.58 mg per injection (one vial per injection). Billing uses HCPCS J0775 (Injection, collagenase, clostridium histolyticum, 0.01 mg) as the unit-level code reference.

05.13.24annual_review

3Q 2024 annual review: no significant changes; references reviewed and updated.

04.24.23annual_review

3Q 2023 annual review: no significant changes; references reviewed and updated.

05.03.22annual_review

3Q 2022 annual review: no significant changes; references reviewed and updated.

04.12.21annual_review

3Q 2021 annual review: no significant changes; references reviewed and updated.