Collagenase Clostridium Histolyticum (Xiaflex) coverage and prior authorization
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Defines medical benefit coverage, prior authorization, dosing limits, and approval/renewal criteria for Xiaflex (collagenase clostridium histolyticum) for Dupuytren's contracture and Peyronie's disease for Aloha Care members.
No material clinical or coverage changes in this revision.
Coverage Criteria by Indication
Initial Therapy Rules
Continuation / Renewal Criteria
Coding and Billable Units
| J0775 | Injection, collagenase, clostridium histolyticum, 0.01 mg |
Quantity Limits and Dosing
Provider Requirements and Prior Authorization
Prior authorization required; pharmacy benefit not covered
Medical benefit requires prior authorization; pharmacy benefit is not covered. Authorization durations and quantity limits are specified per indication (Dupuytren's: 58 billable units per cord, up to 3 injections per cord, ~4 weeks apart, max 12 weeks; Peyronie's: 58 billable units every 2 days on two days 1–3 days apart, up to 4 treatment cycles).
- Medical benefit: Authorization Required; Pharmacy benefit: Not Covered.
- Dupuytren's: 58 billable units per cord; up to 3 injections per cord; no more than 2 injections in the same hand; approvals granted up to 12 weeks per cord.
- Peyronie's: 58 billable units dosed on two days 1–3 days apart; treatment cycles per policy (maximum 4 cycles).
Administer only by REMS‑certified, experienced clinicians
Xiaflex must be administered only by clinicians experienced with the specific injections who have completed Xiaflex REMS certification: hand-injection–experienced clinicians for Dupuytren's and urologists for Peyronie's disease.
- Administer only by clinicians experienced with hand injections for Dupuytren's contracture.
- Administer by urologists for Peyronie's disease.
- Clinicians must have received certification in the Xiaflex REMS Program.
90‑day Medicare transition for members already on treatment
New Medicare members have a 90‑day transition period during which coverage rules and step therapy do not apply if the member is currently on an active course of the requested treatment; after 90 days standard criteria apply.
- Transition period applies even if treatment is furnished by an out‑of‑network provider.
- After 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage.
Administration Setting
Office administration by trained, REMS‑certified clinicians
Administer Xiaflex in an appropriate specialty setting (office) by trained, REMS‑certified clinicians as specified for each indication.
- Site of care: office setting is acceptable when performed by qualified, REMS‑certified personnel.
- For Dupuytren's, a clinician experienced with hand injections; for Peyronie's, a urologist.
Key Definitions and Administration Details
Step Therapy Requirements
| Step | Requirement |
|---|---|
| 1 | No step therapy |
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