XIAFLEX, Collagenase Clostridium Histolyticum Form

Collagenase clostridium histolyticum (Xiaflex®) is a combination of bacterial collagenases.
FDA Approved Indication(s) Xiaflex is indicated for the treatment of: • Adult patients with Dupuytren’s contracture (DC) with a palpable cord • Adult men with Peyronie’s disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Xiaflex is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Dupuytren’s Contracture (must meet all):

1. Diagnosis of DC with a palpable cord;
2. Prescribed by or in consultation with a healthcare provider experienced in injection procedures of the hand and in the treatment of DC;
   
   3. Age ≥ 18 years;

3. Member has not received surgical treatment (e.g., fasciectomy, fasciotomy) on the selected primary joint within the last 90 days;

   5. If two injections (two vials) are requested, they are for one of the following (a or b): a. One cord affecting two joints in the same finger; b. Two cords affecting two joints in the same hand;
   6. Dose does not exceed 0.58 mg per injection (one vial per injection). Approval duration: 3 months (up to 2 injections)
      B. Peyronie’s Disease (must meet all):
   7. Diagnosis of PD with both of the following (a and b): a. Palpable plaque; b. Curvature deformity of ≥ 30 degrees at the start of therapy;
   8. Prescribed by or in consultation with a healthcare provider experienced in the treatment of male urological diseases;
   9. Age ≥ 18 years;
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   CLINICAL POLICY
   Collagenase Clostridium Histolyticum

   4. Dose does not exceed 0.58 mg per injection (one vial per injection). Approval duration: 3 months (up to 2 injections)
      C. Other diagnoses/indications (must meet 1 or 2):
   5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Dupuytren’s Contracture (must meet all):
   7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   8. Last treatment was ≥ 4 weeks ago;
4. Member has not received more than two total injections per affected cord;

5. Request is for one or both of the following: a. Metacarpophalangeal (MP) or proximal interphalangeal (PIP) contracture remains in affected cord since previous injection and the contracture is > 5 degrees; b. A different MP or PIP contracture will be injected;

   5. If two injections (two vials) are requested, use is for one of the following (a or b): a. One cord affecting two joints in the same finger; b. Two cords affecting two joints in the same hand;
   6. Member has not received surgical treatment (e.g., fasciectomy, fasciotomy) on the selected primary joint within the last 90 days;
   7. If request is for a dose increase, new dose does not exceed 0.58 mg per injection (one vial per injection). Approval duration: 3 months (up to 2 injections, total of 3 injections per affected cord) Page 2 of 7

   CLINICAL POLICY
   Collagenase Clostridium Histolyticum B. Peyronie’s Disease (must meet all):

   1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Documented curvature deformity of ≥ 15 degrees remaining since last treatment cycle;
   3. Last treatment cycle was ≥ 6 weeks ago;

6. Member has received < 4 treatment cycles (i.e. < 8 injections [2 injections per cycle]);

   5. If request is for a dose increase, new dose does not exceed 0.58 mg per injection (one vial per injection). Approval duration: 3 months (up to 2 injections)
      C. Other diagnoses/indications (must meet 1 or 2):
   6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
      IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key DC: Dupuytren’s contracture FDA: Food and Drug Administration MP: metacarpophalangeal joint PD: Peyronie’s disease PIP: proximal interphalangeal joint Page 3 of 7

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   Collagenase Clostridium Histolyticum Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): Peyronie’s plaques that involve the penile urethra; hypersensitivity. • Boxed warning(s): corporal rupture (penile fracture) or other serious penile injury in the treatment of Peyronie’s disease. V. Dosage and Administration
   Indication DC Dosing Regimen 0.58 mg per injection intralesionally into a palpable cord with a contracture of a MP joint or a PIP joint
   Maximum Dose 0.58 mg/dose PD 0.58 mg/dose Injections (0.58 mg) and finger extension procedures (24 hours later) may be administered up to 3 times per cord at approximately 4-week intervals. Up to 2 injections in the same hand may be performed during a treatment visit. Two palpable cords affecting 2 joints may be injected or 1 palpable cord affecting 2 joints in the same finger may be injected at 2 locations during a treatment visit. If a patient has other palpable cords with contractures of the MP or PIP joints, these cords may be injected at other treatment visits approximately 4 weeks apart. 0.58 mg per injection intralesionally administered into a Peyronie’s plaque; if more than one plaque is present, inject into the plaque causing the curvature deformity. A treatment course consists of a maximum of 4 treatment cycles. Each treatment cycle consists of two Xiaflex injection procedures and one penile modeling procedure. The second Xiaflex injection procedure is performed 1 to 3 days after the first. The penile modeling procedure is performed 1 to 3 days after the second injection of the treatment cycle. The interval between treatment cycles is approximately six weeks. The treatment course therefore, consists of a maximum of 8 injection procedures and 4 modeling procedures. If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if the healthcare provider determines that further treatment is not clinically indicated, then the subsequent treatment cycles should not be administered. The safety of more than one treatment course of Xiaflex is not known. Page 4 of 7

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   Collagenase Clostridium Histolyticum VI. Product Availability
   Lyophilized powder for reconstitution (single-use glass vials): 0.9 mg of collagenase clostridium histolyticum. VII.