Find policies, billing codes, payers, states, and providers
Antibody-Drug Conjugates
Customize your policy alerts
Sign up for Premera Bluecross Policy 5.01.582 alerts
Get alerted when Policy 5.01.582 changes without checking for updates manually.
Monitor payer policy activity
Defines medical necessity criteria, coding, documentation, and authorization lengths for specific antibody-drug conjugate (ADC) therapies under the medical benefit for Premera Bluecross members.
Updated coverage criteria for Padcev (enfortumab vedotin-ejfv) to include combination with pembrolizumab and berahyaluronidase alfa‑pmph and neoadjuvant/adjuvant use in certain muscle invasive bladder cancer settings.
Added coverage criteria for Datroway (datopotamab deruxtecan-dlnk) and expanded indications including unresectable/metastatic TNBC and other tumor types over 2025-2026 updates.
Clarified that non-formulary exception review authorizations may be approved up to 12 months and that medications are subject to FDA dosing and administration.
Moved Adcetris (brentuximab vedotin) and Polivy (polatuzumab vedotin-piiq) from a monoclonal antibody policy into this ADC policy and added associated HCPCS codes.
Coverage Criteria and Medical Necessity
Drug-specific medical necessity indications
Covered when ALL specified drug-specific criteria are met (age, diagnosis, prior therapies, biomarker status or combination regimen as applicable).
Extracted from policy listed indications.
Age and diagnosis required.
Multiple tumor-specific branches summarized.
FRα-positive and prior therapy required.
Biomarker-specified coverage.
Age distinctions present in policy.
Multiple indications and combination regimens included.
Regimen- and prognostic-index-specified coverage.
Post-chemotherapy progression required.
Line-of-therapy requirement specified.
Investigational/Not covered uses
All other uses of the medications listed in this policy:
Policy statement on investigational uses.
Pivotal-trial derived clinical populations and outcomes
Clinical trial eligibility and primary efficacy outcomes used to support coverage for individual ADC indications (agent-specific criteria summarized):
Study population median prior therapies and demographics provided in chunks 22-23.
Patients required CR, PR, or SD to most recent pre-auto-HSCT salvage therapy per trial design.
Key efficacy and biomarker threshold noted.
Trial-derived efficacy informs coverage branches.
Prior bevacizumab required in trial.
Assay confirmation in subset; prior systemic therapy required.
Safety signals and trial evolution summarized.
Combination and neoadjuvant/adjuvant data described.
Trial-aligned coverage criteria
Coverage considerations when treatment aligns with pivotal trial populations and endpoints
Cohort 1 data from EV-201 available; comparator context with erdafitinib for FGFR-altered disease.
Cohort K randomized data available; details limited to trial populations.
Trial excluded non-bladder primary urothelial cancers and patients with recent systemic immunosuppression or active autoimmune disease.
Dosing: 2 mg/kg IV every 3 weeks until progression or unacceptable toxicity.
Dosing schedule per LOTIS-2.
General coverage rule
Coverage is provided when FDA-approved indications and any product-specific criteria are met; specific additions and expansions have been applied to individual ADC products over time.
Policy ties coverage to product labeling, prior authorization, and applied updates (e.g., Padcev combinations, Datroway additions).
Uses not explicitly listed as medically necessary for the antibody-drug conjugates named in this policy are considered investigational and not covered. The policy further notes that medications are subject to the product's FDA dosing and administration prescribing information when determining coverage.
Certain patient conditions were excluded from pivotal trials and may inform coverage determinations. For example, Study 0417 for Elahere excluded individuals with corneal disorders or ocular conditions requiring ongoing treatment, those with Grade >1 peripheral neuropathy, and individuals with noninfectious interstitial lung disease.
Datroway (datopotamab deruxtecan) TNBC trial eligibility excluded individuals with ongoing or steroid‑requiring interstitial lung disease/pneumonitis, those with clinically significant corneal disease at screening, and individuals with ECOG performance status >1; these exclusions may be considered when evaluating requests outside the trial populations.
Several trials listed exclusion criteria that could inform noncoverage decisions. EV-303 (PADCEV + pembrolizumab in MIBC) excluded individuals with non‑bladder primary urothelial cancers and those with active autoimmune disease requiring systemic therapy or conditions requiring immunosuppression within 2 years. InnovaTV‑204 (Tivdak) excluded individuals with active ocular surface disease or a history of cicatricial conjunctivitis/Stevens‑Johnson syndrome; such trial exclusions are relevant when assessing coverage for similar clinical scenarios.
This medical policy applies to the Company’s commercial medical benefit populations but does not apply to Medicare Advantage. Coverage remains subject to member benefit plan limits and conditions; providers and members should verify individual benefit plan applicability before initiating treatment.
An important historical safety signal is documented for gemtuzumab ozogamicin: the SWOG S0106 trial found increased fatal toxicity without improved disease‑free survival when gemtuzumab ozogamicin was added to a particular induction regimen, a finding that led to voluntary market withdrawal in 2010 and informs cautious use and indication‑specific coverage.
Use that is inconsistent with studied populations or lacks documentation of required prior therapies may be considered not medically necessary. For example, PADCEV (enfortumab vedotin) pivotal studies and labeling reference patients previously treated with platinum chemotherapy and anti‑PD‑1/PD‑L1; omitting documentation of prior platinum and PD‑1/PD‑L1 exposure when required by the indication may render the use non‑covered. Additionally, serious safety risks noted in the evidence base (e.g., risk of Stevens‑Johnson syndrome/toxic epidermal necrolysis with PADCEV and corneal toxicity with Tivdak) require adherence to trial‑aligned populations and monitoring.
When the policy’s specified criteria are not met, treatment with the ADCs listed is considered investigational. Historical context in the policy emphasizes that agents (for example, Besponsa and gemtuzumab ozogamicin) are treated as medically necessary only when explicit criteria are satisfied and as investigational when those criteria are not documented.
Coding and Billing
| C9174 | Injection, datopotamab deruxtecan-dlnk (Datroway), 1 mg (code termed 10/01/25) |
| C9306 | Injection, telisotuzumab vedotin-tllv (Emrelis), 1 mg (code termed 01/01/26) |
| J9011 | Injection, datopotamab deruxtecan-dlnk (Datroway), 1 mg (new code effective 10/01/25) |
| J9042 | Injection, brentuximab vedotin (Adcetris), 1 mg |
| J9063 | Injection, mirvetuximab soravtansine-gynx (Elahere), 1 mg |
| J9177 | Injection, enfortumab vedotin-ejfv (Padcev), 0.25 mg |
| J9203 | Injection, gemtuzumab ozogamicin (Mylotarg), 0.1 mg |
| J9229 | Injection, inotuzumab ozogamicin (Besponsa), 0.1 mg |
| J9273 | Injection, tisotumab vedotin-tftv (Tivdak), 1 mg |
| J9309 | Injection, polatuzumab vedotin-piiq (Polivy), 1 mg |
| J9326 | Injection, telisotuzumab vedotin-tllv, 1 mg (new code effective 01/01/26) |
| J9359 | Injection, loncastuximab tesirine-lpyl (Zynlonta), 0.075 mg |
| J9229 | HCPCS code added effective 1/1/19 (referenced in historical changes) |
| J3590 | HCPCS code referenced and later removed/modified across updates |
| C9084 | HCPCS code removed (termed) per document history |
| J9177 | HCPCS code added for Adcetris |
| J9042 | HCPCS code added for Adcetris |
| J9309 | HCPCS code added for Polivy |
| C9174 | HCPCS code added then later termed/removed (Datroway/C9174 historic) |
| J9063 | HCPCS code added (coding update) |
| C9146 | HCPCS code added then removed in later update |
| C9306 | HCPCS code added; later termed |
Prior Authorization, Documentation, and Provider Requirements
Prior authorization required; approval lengths are drug-specific
Prior authorization is required for ADCs in this policy. Initial approvals for Besponsa (inotuzumab ozogamicin) and Mylotarg (gemtuzumab ozogamicin) may be approved up to 3 months; many other agents have drug-specific re-authorization intervals (agents such as Adcetris, Datroway, Elahere, Emrelis, Padcev, Polivy, Tivdak, and Zynlonta may be re-authorized up to 6 months and, where continued clinical response is documented, may be approved up to 12 months).
- Initial authorization: Besponsa and Mylotarg up to 3 months [[chunk 10]].
- Re-authorization: many agents up to 6 months; continued response may permit approval up to 12 months [[chunk 11]].
- Non-formulary exception authorizations may be approved up to 12 months when granted [[chunk 61]].
Confirm indication and biomarker/assay results match trial populations
Prior authorization requests must confirm the indication and any biomarker requirements match the pivotal trial populations—e.g., CD22 ≥70% by flow cytometry for INO‑VATE ALL (Besponsa), FRα positivity by VENTANA FOLR1 RxDx Assay for Elahere, or high c‑Met overexpression (≥50% 3+ IHC) for Emrelis.
- INO‑VATE ALL entry required ≥70% leukemic blasts expressing CD22 by flow cytometry (inotuzumab) [[chunk 26]].
- Elahere Study 0417 required FRα positivity by VENTANA FOLR1 (FOLR1‑2.1) RxDx Assay and prior bevacizumab exposure [[chunk 31]].
- Emrelis LUMINOSITY required c‑Met high overexpression (≥50% tumor cells with strong 3+ staining) as defined on assay testing [[chunk 33]].
Use prior authorization to confirm trial-aligned indication (ADC examples)
Prior authorization should confirm the requested ADC indication aligns with clinical trial populations—examples include enfortumab vedotin after prior platinum and PD‑1/PD‑L1 therapy and PADCEV use per EV‑303 neoadjuvant/adjuvant criteria.
- EV‑201 and other enfortumab trials enrolled patients previously treated with platinum chemotherapy and anti‑PD‑1/PD‑L1 agents for metastatic urothelial carcinoma [[chunk 36]].
- EV‑303 specified neoadjuvant PADCEV + pembrolizumab for cisplatin‑ineligible MIBC with continuation as adjuvant per trial dosing and schedule [[chunk 38]].
- EV103/Keynote‑869 enfortumab + pembrolizumab cohorts evaluated combination in cisplatin‑ineligible first‑line populations [[chunk 37]].
Non-formulary/prior authorization duration and adherence to FDA PI
When a non-formulary exception or prior authorization is granted, approvals may be issued for up to 12 months; all treatments must follow the product's FDA dosing and administration prescribing information.
- Clarified that non-formulary exception authorizations for drugs in this policy may be approved up to 12 months [[chunk 61]].
- Medications listed are subject to the product's FDA dosage and administration prescribing information [[chunk 61]].
- Re-authorization intervals vary by drug and documented continued clinical response is required for extended approvals [[chunk 11]].
Document prior required therapies before ADC authorization
Some ADC indications require prior therapy(s) before use; prior authorization must document that these prerequisite systemic or targeted therapies were received as specified in the indication.
- Padcev monotherapy indications require prior platinum chemotherapy and prior PD‑1/PD‑L1 inhibitor exposure in certain metastatic urothelial cancer branches [[chunk 9]].
- Datroway NSCLC indication requires prior EGFR‑directed therapy and platinum-based chemotherapy in the NSCLC branch [[chunk 28]].
Document prior sequence of therapies when sequencing matters
When agents were studied in sequence with other therapies, document the prior sequence of systemic regimens (for example, Padcev authorization should document prior platinum and anti‑PD‑1/PD‑L1 therapy when applicable).
- EV‑201 and related enfortumab evidence evaluated individuals after platinum and anti‑PD‑1/PD‑L1 exposure; chart notes should show prior lines and timing [[chunk 36]].
- Datroway breast and NSCLC trials specify prior endocrine/chemotherapy or EGFR‑directed therapy in the respective branches and should be documented [[chunk 28]].
Consider alternative approved targeted therapies when sequencing
If alternative approved targeted therapies exist for a biomarker-defined population (e.g., erdafitinib for FGFR2/3‑altered urothelial carcinoma), authorization decisions may consider sequencing and guideline-referenced therapy choices.
- Padcev efficacy context is compared to erdafitinib for FGFR2/3‑altered disease in trial discussions, which may inform sequencing [[chunk 36]].
- NCCN therapy sequencing for AML and targeted agents is referenced elsewhere as contextual guidance for sequencing decisions [[chunk 54]].
Use guideline-referenced therapy sequencing (NCCN examples)
Use NCCN-referenced therapy sequencing and guideline examples to inform authorization for relapsed/refractory AML and other contexts (e.g., targeted agents such as gilteritinib for FLT3 mutations).
- Table 2 (NCCN Guidelines) lists targeted therapy sequences for r/r AML, including gilteritinib for FLT3 mutations, which may inform ADC sequencing decisions [[chunk 54]].
Submit office visit notes, diagnosis, history, physical, and medication history
Submit medical records demonstrating medical necessity: office visit notes must include the diagnosis, relevant history, physical examination, and a medication history.
- Office visit notes must document the diagnosis, relevant history, physical evaluation, and medication history for all prior authorization reviews [[chunk 12]].
Provide diagnostic test results and assay identification for biomarker-directed indications
Document diagnostic test results and the specific assay used when biomarker-directed eligibility is required (e.g., CD22 % by flow cytometry for inotuzumab; FRα by VENTANA FOLR1 assay for Elahere; VENTANA MET (SP44) assay confirmation for c‑Met).
- INO‑VATE ALL required ≥70% leukemic blasts expressing CD22 by flow cytometry—document percentage and method [[chunk 26]].
- Elahere required FRα positivity determined by the VENTANA FOLR1 (FOLR1‑2.1) RxDx Assay—document the assay result [[chunk 31]].
- Emrelis high c‑Met OE definition was confirmed on VENTANA MET (SP44) RxDx Assay in retrospective testing—document assay and result if applicable [[chunk 33]].
Document prior therapies and treatment intent (neoadjuvant/adjuvant vs metastatic)
Document prior therapies and the treatment intent (neoadjuvant, adjuvant, or metastatic) where relevant—e.g., for PADCEV + pembrolizumab neoadjuvant then adjuvant use around cystectomy, document cisplatin ineligibility and neoadjuvant/adjuvant intent.
- EV‑303 required cisplatin‑ineligibility and specified neoadjuvant PADCEV + pembrolizumab followed by adjuvant therapy—document intent and eligibility for cystectomy pathways [[chunk 38]].
- For metastatic indications, document prior systemic therapies and whether treatment is palliative or curative intent as applicable [[chunk 36]].
Adhere to FDA dosing/administration; non-formulary exceptions up to 12 months
Medications are subject to the product's FDA dosing and administration; non-formulary exception authorizations may be approved for up to 12 months when granted.
- Policy clarifies that listed medications must follow FDA dosing and administration prescribing information and that non-formulary exceptions may be approved up to 12 months [[chunk 61]].
Denial risk if medical necessity documentation is incomplete
Failure to document that medical necessity criteria are met—including office visit notes with diagnosis, relevant history, physical evaluation, and medication history—may result in denial of coverage.
- Denial risk arises if medical records do not demonstrate the coverage criteria are satisfied per documentation requirements [[chunk 12]].
Denial risk if required biomarker/testing absent or thresholds not met
Required biomarker or expression testing must be present in the medical record (e.g., CD22 ≥70% by flow cytometry for inotuzumab, FRα positive by VENTANA FOLR1 assay for Elahere); absence of documented testing or failure to meet specified thresholds may trigger coverage denial.
- INO‑VATE ALL required CD22 ≥70% by flow cytometry—lack of this documentation risks denial [[chunk 26]].
- Elahere required FRα positivity by VENTANA FOLR1 assay—document assay results to support coverage [[chunk 31]].
- Emrelis defined high c‑Met OE as ≥50% strong (3+) IHC staining—document assay and result if claiming eligibility [[chunk 33]].
Risk of non-coverage for use outside trial‑specified populations
Use outside the trial‑specified populations—such as neoadjuvant/adjuvant PADCEV + pembrolizumab for MIBC without meeting EV‑303 eligibility (e.g., cisplatin ineligibility, bladder primary histology)—may not align with trial inclusion criteria and could be non‑covered.
- EV‑303 excluded non‑bladder primary urothelial cancers and individuals with recent systemic immunosuppression or active autoimmune disease requiring therapy—use outside these criteria may be non‑covered [[chunk 38]].
Coverage contingent on member benefit limits; Medicare Advantage excluded
Coverage is subject to member benefit plan limits and conditions; this policy does not apply to Medicare Advantage. Lack of applicable member benefits or specific plan exclusions may result in denial.
- The policy states coverage is subject to member benefit limits and conditions and that it does not apply to Medicare Advantage [[chunk 72]].
- Operational notes clarify non-formulary exception durations and that approvals are contingent on coverage terms [[chunk 61]].
Agents, Dosing Regimens, and Covered Combinations
| Regimen | Indication / Key details | Coverage status |
|---|---|---|
| Brentuximab vedotin (Adcetris) in combination with multi-agent chemotherapy | ||
| Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL) — Adcetris may be used in combination with chemotherapy as first-line therapy; trial regimens used brentuximab vedotin 1.8 mg/kg IV every 3 weeks (30-minute infusion) in relapsed and sALCL trials and combination regimens described for frontline use. | ||
| covered |
| Regimen | Indication / Key details | Coverage status |
|---|---|---|
| Enfortumab vedotin-ejfv (Padcev) + pembrolizumab (± berahyaluronidase alfa) — neoadjuvant then adjuvant around cystectomy | ||
| Neoadjuvant PADCEV 1.25 mg/kg Days 1 & 8 + pembrolizumab 200 mg Day 1 q21d for 3 cycles prior to radical cystectomy in cisplatin-ineligible adults with muscle-invasive bladder cancer (MIBC), followed by adjuvant PADCEV (up to 6 cycles) and pembrolizumab (up to 14 cycles) as studied in EV-303; trial showed significant improvements in event-free survival and overall survival. | ||
| covered |
| Regimen / Dose | Trial context / Indication | Coverage status |
|---|---|---|
| Brentuximab vedotin 1.8 mg/kg IV every 3 weeks (administered over ~30 minutes) | ||
| Used in pivotal trials for relapsed classical Hodgkin lymphoma (Study 1) and relapsed systemic ALCL (Study 2); dosing 1.8 mg/kg IV q3wk with efficacy outcomes reported (e.g., ORR 73% in Study 1). | ||
| neutral |
| Regimen / Dose | Trial context / Indication | Coverage status |
|---|---|---|
| Inotuzumab ozogamicin total 1.8 mg/m2 per cycle (fractionated schedule: 0.8 mg/m2 Day 1; 0.5 mg/m2 Days 8 and 15) | ||
| INO-VATE ALL phase III trial in adult relapsed/refractory B-cell precursor ALL with ≥70% CD22-expressing leukemic blasts by flow cytometry; compared to intensive chemotherapy with primary endpoints CR/CRi and overall survival. | ||
| neutral |
| Regimen / Dose | Indication / Trial context | Coverage status |
|---|---|---|
| Enfortumab vedotin 1.25 mg/kg IV on Days 1, 8, and 15 of a 28-day cycle | ||
| Dose and schedule used in EV-201 and other pivotal urothelial carcinoma trials for adults with locally advanced or metastatic urothelial carcinoma previously treated with platinum chemotherapy and anti–PD-1/PD-L1 agents; also referenced in combination regimens for cisplatin-ineligible and neoadjuvant/adjuvant MIBC cohorts. | ||
| covered |
| Regimen / Dose | Indication / Notes | Coverage status |
|---|---|---|
| Mirvetuximab soravtansine 6 mg/kg IV every 3 weeks (based on adjusted ideal body weight) | ||
| Dosing used in Study 0417 for adults with FRα-positive, platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received up to three prior lines of systemic therapy; FRα positivity determined by VENTANA FOLR1 RxDx Assay. | ||
| neutral |
| Regimen / Dose | Indication / Notes | Coverage status |
|---|---|---|
| Datopotamab deruxtecan 6 mg/kg IV every 3 weeks (maximum 540 mg) | ||
| Recommended dosing per pivotal Datroway trials (TROPION program) for breast cancer and used in NSCLC cohorts; approved dosing given q3wk until progression or unacceptable toxicity. | ||
| covered |
| Regimen / Dose | Trial combinations / Context | Coverage status |
|---|---|---|
| Enfortumab vedotin 1.25 mg/kg IV Days 1, 8, 15 q28d (EV-201); enfortumab vedotin combined with pembrolizumab per EV103/Keynote-869; PADCEV neoadjuvant regimen 1.25 mg/kg Days 1 & 8 + pembrolizumab 200 mg Day 1 q21d (EV-303) | ||
| EV-201 used single-agent PADCEV in previously treated mUC (ORR ~44%). Combination regimens (EV103/Keynote-869) showed higher ORR (~68% in cohorts). EV-303 evaluated neoadjuvant PADCEV+pembrolizumab followed by adjuvant PADCEV and pembrolizumab in cisplatin-ineligible MIBC, demonstrating significant EFS and OS benefits versus immediate surgery. | ||
| covered |
| Regimen / Dose | Trial context / Indication | Coverage status |
|---|---|---|
| Tisotumab vedotin 2 mg/kg IV every 3 weeks; Loncastuximab tesirine schedule: 0.15 mg/kg q3wk for 2 cycles then 0.075 mg/kg q3wk thereafter | ||
| Tisotumab vedotin dosing per innovaTV 204 for recurrent/metastatic cervical cancer after ≤2 prior systemic regimens (including at least one platinum); Loncastuximab dosing per LOTIS-2 for relapsed/refractory large B-cell lymphoma after ≥2 prior regimens. | ||
| covered |
| Regimen / Combination | Indication / Notes | Coverage status |
|---|---|---|
| Enfortumab vedotin-ejfv + pembrolizumab (± berahyaluronidase alfa) | ||
| Documented for locally advanced or metastatic urothelial carcinoma and described for neoadjuvant/adjuvant use in cisplatin-ineligible MIBC; policy updates through 2026 added combinations with pembrolizumab and berahyaluronidase alfa to coverage criteria. | ||
| covered |
| Regimen / Reference | Indication / Key details | Coverage status |
|---|---|---|
| Gemtuzumab ozogamicin per FDA prescribing information (Mylotarg) | ||
| Covered indication includes newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric individuals ≥1 month; NCCN and prescribing information referenced in policy updates (pediatric expansion noted in 2020 update). | ||
| covered |
| Regimen / Reference | Indication / Notes | Coverage status |
|---|---|---|
| Loncastuximab tesirine dosing per prescribing information (Zynlonta) | ||
| LOTIS-2 dosing used 0.15 mg/kg q3wk for two cycles followed by 0.075 mg/kg q3wk thereafter for relapsed/refractory large B-cell lymphoma after ≥2 prior systemic regimens; policy lists PI-based dosing and indication. | ||
| covered |
| Regimen / Reference | Indication / Notes | Coverage status |
|---|---|---|
| Mirvetuximab soravtansine per FDA prescribing information (Elahere) — 6 mg/kg IV q3wk (adjusted ideal body weight) | ||
| Indicated for FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who have received 1–3 prior systemic regimens; Study 0417 required FRα positivity by VENTANA FOLR1 RxDx Assay and prior bevacizumab exposure. | ||
| covered |
| Regimen / Dose | Indication / Notes | Coverage status |
|---|---|---|
| Datopotamab deruxtecan per PI: 6 mg/kg IV q3wk (max 540 mg) | ||
| Approved dosing from Datroway trials (TROPION program) and policy updates added multiple Datroway indications across 2025–2026 including TNBC and NSCLC cohorts; use per PI and trial-specific eligibility. | ||
| covered |
Line of Therapy and Treatment Intent
Salvage
Clinical context: post-transplant consolidation or salvage therapy per labeled indications.
Later-line
Documentation of prior lines required for authorization decisions.
Various
Trial-specific prior therapy requirements inform coverage determinations.
Mixed
Mixed-line trial designs may require specific documentation of treatment intent and eligibility.
Second-line
Refer to product labeling and guideline tables for specific line-of-therapy placement.
Biomarker and Diagnostic Test Requirements
Definitions and Key Terms
Background and Rationale
Antibody‑drug conjugates (ADCs) are therapeutics composed of a monoclonal antibody chemically linked to a cytotoxic payload that targets tumor‑associated antigens to deliver cytotoxic agents directly to cancer cells. After antigen binding and internalization, linker cleavage (proteolytic or acid‑labile mechanisms) releases the cytotoxic payload intracellularly, producing tumor cell death while limiting systemic exposure compared with unconjugated cytotoxic chemotherapy. The policy references multiple ADCs and payload mechanisms as the rationale for agent‑specific indications and safety monitoring.
Policy Changes and Revision History
Interim review approved updates to Padcev coverage (include combination with pembrolizumab and berahyaluronidase alfa and neoadjuvant/adjuvant use in certain MIBC) and added/updated Datroway coverage criteria for specified TNBC and other indications across 2025–2026 updates.
HCPCS coding changes effective October 1, 2025: added/adjusted codes including removal/terming of C9174 and references to C9306 and J9011 as noted in coding history.
Effective January 1, 2026, added new HCPCS code J9326 and indicated C9306 as termed per document coding history.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.