Berotralstat (Orladeyo) and assorted pharmacy prior authorization updates
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Covers prior authorization, coding, and coverage-related updates for multiple pharmacy policies with a primary heading of Berotralstat (Orladeyo); affects Ambetter Georgia providers requesting pharmacy-covered medications listed in the document.
Updated to reflect pediatric extension down to 2 years of age and added new oral pellet dosage form.
Removed HCPCS code J1572 (and other specific HCPCS removals noted per policy).
Added multiple HCPCS code additions across policies (examples: J9256, J0013, J9282, J9326, C9307, Q5160).
Extended initial approval durations from 6 to 12 months for some maintenance medications and Medicaid/HIM populations.
For brand Mavenclad requests, added redirection to generic per SDC request.
Coverage Criteria & Policy-wide Updates
Policy-wide coverage updates (summary)
Selected policy-level coverage clarifications and changes
Applied across multiple listed policies per RT4 revision notes
Examples include retifanlimab (Zynyz) and other maintenance meds as noted in RT4
Per updated prescribing information in RT4
Use of Collagenase Clostridium Histolyticum (Xiaflex®) for the treatment of Peyronie's Disease is a benefit exclusion for New York Essential Plans and New York Medicaid (including CHIP) and will NOT be authorized per state regulations. Providers should not submit authorization requests for Xiaflex for Peyronie's Disease for members covered under these New York products, as approvals are prohibited by state-specific coverage rules.
Coding / HCPCS Changes
| J9256 | HCPCS code added (listed in RT4 for select policy updates) |
| J0013 | HCPCS code added (ophthalmic injection updates) |
| J9282 | HCPCS code added (mitomycin/Prademagene entries) |
| J9326 | HCPCS code added (telisotuzumab vedotin) |
| C9307 | HCPCS code added (linvoseltamab) |
| Q5160 | HCPCS code added (bevacizumab biosimilars) |
| J1572 | HCPCS code removed (example listed in revision notes) |
| J0172 | HCPCS code removed (example listed in revision notes) |
| J9999 | HCPCS code removed (example listed in revision notes) |
| C9399 | HCPCS code removed (example listed in revision notes) |
Provider Actions, Prior Authorization & Operational Notes
Obtain prior authorization for listed pharmacy products; note HCPCS and approval-duration updates
Multiple pharmacy‑covered products listed in this set require prior authorization. Revision notes across affected policies record HCPCS code additions and removals (examples: added J9256, J0013, J9282, J9326, C9307, Q5160; removed J1572, J0172, J9999, C9399, C9305, C9306) and also extended initial approval durations from 6 to 12 months for certain maintenance medications and Medicaid/HIM populations.
- Prior authorization is required for the listed pharmacy products identified in the policies referenced in these revision notes.
- Be aware that HCPCS code lists were updated per RT4 (multiple additions and removals); use the policy-specific code section when submitting PA requests.
- Some policies extend initial approval duration to 12 months — confirm applicable duration per specific drug policy.
Document prior covalent BTK inhibitor exposure for pirtobrutinib (Jaypirca)
For pirtobrutinib (Jaypirca) when requested for CLL/SLL, the prior‑therapy requirement has been simplified: the member must have received prior treatment with a covalent BTK inhibitor; initial approval durations were also extended to 12 months for all indications per the RT4 revision.
- Document prior exposure to a covalent BTK inhibitor in the member's medication history when requesting pirtobrutinib for CLL/SLL.
- Verify and record the updated approval duration (12 months) on the authorization request where applicable.
Expect redirection of Mavenclad (brand) requests to generic per SDC
Requests for brand Cladribine (Mavenclad) will be operationally redirected to the generic formulation per SDC request; submitters should expect routing to the generic product.
- When initiating a PA for Mavenclad, indicate whether a generic is available — the request will be redirected to the generic as noted in the RT4 revision.
- Do not submit requests that assume brand‑only coverage when a generic equivalent is available and SDC redirection is in effect.
Do not request Xiaflex for Peyronie's Disease for NY Essential Plans or NY Medicaid/CHIP
Use of Collagenase Clostridium Histolyticum (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); do not submit PA requests for these New York populations.
- Do not submit prior authorization requests for Xiaflex for Peyronie's Disease for members covered by New York Essential Plans or New York Medicaid (including CHIP); such requests will be denied per state regulations.
- Confirm the member's plan type and state coverage before initiating any authorization for Xiaflex.
Initial Therapy Criteria & Approval Durations
Initial therapy duration changes
Examples of initial therapy policy adjustments
RT4 revision applied to Medicaid/HIM and maintenance therapy policies (e.g., Retifanlimab/Zynyz)
Step Therapy Requirements
| Step | Prior therapy requirement | Indication / notes |
|---|---|---|
| 1 | ||
| Member has received prior treatment with a covalent BTK inhibitor | ||
| Pirtobrutinib (Jaypirca) for chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) — prior therapy simplified per updated prescribing information; initial approval duration extended to 12 months for applicable indications |
Key Drug Definitions
Policy Background & Scope
This document is a compilation of RT4 revision notes and brief descriptions applied across multiple Ambetter Georgia pharmacy policies. It records administrative and clinical updates including pediatric age extensions (notably extension down to 2 years where applicable), additions and removals of HCPCS codes, and changes to initial approval durations for certain maintenance medications. Revision notes also include state-specific clarifications such as the New York exclusion for Xiaflex in Peyronie's Disease and operational routing instructions (for example, required redirection to generic products in some cases).
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