Premera Bluecross Xiaflex Coverage Prior Auth

Coverage criteria and indications

Initial Therapy

Covered when ALL of the following are met:

Dupuytren's contracture - Initial Therapy: The individual has Dupuytren's contracture with a palpable cord AND injections may be administered up to 3 times at intervals of at least 30 days AND treatment is limited to 2 joints in the same hand per treatment visit (consistent with FDA labeling).

Peyronie's disease - Initial Therapy: The individual has a diagnosis of Peyronie's disease with a palpable plaque AND has a curvature deformity of at least 30 degrees at the start of therapy AND treatment is limited to a maximum of 4 treatment cycles (each cycle consists of 2 injection procedures).

Treatment of sexual dysfunction may be excluded by benefit plans; verify member benefits.

Re-authorization

Dupuytren's re-authorization: Re-authorization for treatment of the same palpable cord is considered investigational; re-authorization for treatment of a different palpable cord will be reviewed as a new request.

Peyronie's re-authorization: Re-authorization of Xiaflex for the treatment of Peyronie's disease is considered investigational.

Coverage by indication (summary)

Coverage referenced for specific conditions per evidence and FDA labeling

Covered indications per document: Dupuytren's contracture: considered medically necessary when policy criteria are met; Peyronie's disease: FDA-approved for men with a palpable plaque and penile curvature >30 degrees (REMS required) though evidence limitations are noted; adhesive capsulitis: evidence lacking and considered investigational.

Policy history indicates Dupuytren's covered with criteria and Peyronie’s subject to benefit and REMS; adhesive capsulitis investigational.

Coverage for treatment of Peyronie’s disease with injectable clostridial collagenase (Xiaflex) may be limited by the member’s benefit plan. Treatment of sexual dysfunction is excluded under many benefit plans; therefore, use of Xiaflex for Peyronie’s disease may not be covered. Verify member benefits and applicable plan exclusions before authorization or scheduling of treatment.

When applying benefit rules, note that injection of collagenase is an office-based procedure and some plans may require prior authorization. Providers should contact member customer service to confirm coverage terms, including any sexual-dysfunction exclusions, and submit documentation as required.

Initial authorizations for Xiaflex may vary by review type: non-formulary exception reviews can be approved up to 12 months. For other reviews, approvals are limited by indication: up to 3 months for Dupuytren’s contracture and up to 6 months for Peyronie’s disease per policy guidance.

Re-authorization rules specify that repeat treatment for the same palpable cord in Dupuytren’s contracture is considered investigational; treatment of a different palpable cord will be reviewed as a new request. Re-authorization of Xiaflex for Peyronie’s disease is considered investigational.

Historically, this policy has been updated multiple times and includes changes to coverage for Peyronie’s disease tied to member contract benefits. In 2019 the policy was renumbered and at times Xiaflex for Peyronie’s disease was designated as a plan-level non-covered exclusion; subsequent reviews restored medical-necessity coverage when the member’s contract includes a treatment-of-sexual-dysfunction benefit. Always check the member’s benefits for contractual exclusions.

The policy’s history documents repeated literature reviews and coding updates; clinicians and reviewers should refer to the benefit-specific determinations reflected in the member’s plan when assessing coverage for Peyronie’s disease.

Use of Xiaflex for indications other than Dupuytren’s contracture or Peyronie’s disease (for example, adhesive capsulitis and other listed conditions) is considered investigational / not medically necessary under this policy.

Policy history and prior reviews have consistently identified injectable clostridial collagenase as investigational for indications beyond the FDA‑approved uses; these investigational exclusions should be applied when reviewing requests for off‑label indications.

The available evidence for Peyronie’s disease shows short‑term improvements in penile curvature and symptom distress in randomized trials, but overall the literature is limited and does not establish clear improvement in long‑term health outcomes. For adhesive capsulitis, evidence is lacking and a small randomized substudy showed no benefit and increased adverse events. Accordingly, the policy concludes there is insufficient evidence to determine a net health benefit for these indications outside the specified FDA‑labeled population.

Injectable clostridial collagenase is considered investigational for indications other than Dupuytren’s contracture and Peyronie’s disease. Historical policy entries and reviewer input have affirmed that all other uses remain investigational and are not covered by this policy.

Initial therapy requirements

Initial Therapy

Dupuytren's initial: Palpable cord; up to 3 injections at ≥30-day intervals; max 2 joints treated in same hand per visit (per FDA labeling).up to 3 injections

Consistent with FDA labeling; injections at intervals of at least 30 days.

Peyronie's initial: Palpable plaque; curvature ≥30° at start of therapy; maximum 4 treatment cycles (each cycle = 2 injection procedures).maximum 4 cycles

Verify member benefit for sexual dysfunction exclusions; REMS applies for Peyronie's.

Initial therapy dosing limits (Peyronie's)

FDA-labeled cycle limits and administration notes

Criteria for continuation of therapy

Continuation Therapy

Continuation - Dupuytren's: Re-authorization for the same palpable cord is considered investigational; a different palpable cord will be reviewed as a new request.

Dosing and quantity limits

collagenase clostridium histolyticum (Xiaflex) — Quantity limits

Quantity limit (Dupuytren's)Up to 3 injections per palpable cord; injections administered at intervals of at least 30 days

Quantity limit (Peyronie's)Up to 4 treatment cycles; each cycle consists of 2 injection procedures

Per-visit joint limit (Dupuytren's)Treatment limited to 2 joints in the same hand per treatment visit

Xiaflex — Dosing and cycle limits

Peyronie's dosing limitMaximum of 4 cycles (each cycle = 2 Xiaflex injection procedures) per FDA labeling

Dupuytren's dosing limitUp to 3 injections per palpable cord at ~4-week (≥30-day) intervals

Procedure and billing codes

Procedure and HCPCS codesmixed

20527	Injection, enzyme (e.g., collagenase), palmar fascial cord (i e, Dupuytren's contracture)
26341	Manipulation, palmar fascial cord (ie, Dupuytren's cord), post enzyme injection ( e.g., collagenase), single cord
54200	Injection procedure for Peyronie disease
54205	Injection procedure for Peyronie disease; with surgical exposure of plaque
54235	Injection of corpora cavernosa with pharmacologic agent(s) (e.g., papaverine, phentolamine)
J0775	Injection, collagenase clostridium histolyticum, 0.01 mg

Non-covered CPT codes (historical changes noted)CPTNot Covered

54200	CPT code moved to non-covered coding section
54235	CPT code moved to non-covered coding section
54205	CPT code added as non-covered

Prior authorization, documentation, and provider requirements

Prior Authorization

Prior Authorization Required

Prior authorization may be required by some benefit plans before injection of clostridial collagenase (Xiaflex). Initial authorizations for non‑formulary exception reviews may be approved for up to 12 months; other initial approvals vary by indication (e.g., up to 3 months for Dupuytren's contracture, up to 6 months for Peyronie's disease).

Some plans require prior authorization—check the member's benefit plan or contact customer service using the telephone number on the member ID card.
Non‑formulary exception review authorizations for drugs listed in this policy may be approved up to 12 months.

Documentation Required

Clinical documentation submitted for review must support that medical necessity criteria are met.

Include the diagnosis/condition and history.

Key definitions

Clostridial collagenase / Xiaflex — definition

DefinitionClostridial collagenase (collagenase clostridium histolyticum, Xiaflex) is a bacterial collagenase derived from Clostridium histolyticum intended to enzymatically break down collagen in cords or plaques in fibroproliferative disorders

Primary usesEvaluated and used for Dupuytren's contracture, Peyronie's disease, and adhesive capsulitis (investigational for some indications)

Formulation noteMarketed as Xiaflex for injection per FDA-approved indications

Dupuytren's contracture — definition

DefinitionDupuytren's contracture is a progressive disorder of the palmar and digital fascia characterized by formation of palpable cords leading to finger flexion deformities

Functional threshold

Background and clinical context

Clostridial collagenase (collagenase clostridium histolyticum, Xiaflex) is an enzyme product derived from Clostridium histolyticum that enzymatically degrades collagen within palpable cords or plaques. It is used as a less‑invasive, intralesional treatment alternative for fibroproliferative disorders such as Dupuytren’s contracture and Peyronie’s disease.

In clinical practice the product is administered by injection into the cord or plaque to enzymatically break down collagen, followed by manual modeling per FDA labeling for Peyronie’s and manipulation for Dupuytren’s in appropriate cases. For Peyronie’s disease, use is subject to a FDA‑mandated REMS because of the risk of corporal rupture and hematoma, and prescribers and sites must be certified to provide the therapy.

Step therapy considerations

Step	Required prior therapy / comparator	Notes
No explicit step-therapy sequence mandated
Comparisons to surgical alternatives (per reviewer input and trials) — clinical literature includes head-to-head and comparative studies
Policy statement: reviewers and some studies compared collagenase to surgery, but this document does not require failure of a specific prior therapy before approval

Administration setting and provider training

Note

Office‑based procedure; general anesthesia not required

Xiaflex injections are office‑based procedures; general anesthesia is not required.

Plan procedures accordingly in an office setting