Defines prior authorization, coverage criteria, dosing limits, and renewal rules for intravenous atezolizumab (Tecentriq) for Viva Health members in North Carolina.
No material clinical or coverage changes in this revision.
6 monthsinitial prior authorization duration
504max units (most indications)
120max units (mesothelioma/thymic/CLL)
1200 mgcommon IV dose (q3w)
0-2ECOG/PS requirements
J9022
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HCPCS code
Coverage Criteria for Atezolizumab (Tecentriq)
Universal Criteria
Covered when ALL of the following are met (universal eligibility, age, prior therapy exclusions, PD-1/PD-L1 prior use restrictions).
Universal criteria: Member is at least 18 years of age (unless otherwise specified).
From Initial Approval Criteria; chunk 3
Prior PD-1/PD-L1 therapy: Member has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy, unless otherwise specified for a particular indication (exceptions noted in indication-specific criteria).
From Universal Criteria; chunk 4
Concomitant subcutaneous atezolizumab: Therapy will not be used concomitantly with subcutaneous atezolizumab (concomitant use is not allowed).
From Universal Criteria; chunk 4
Non-Small Cell Lung Cancer (NSCLC) - first-line single agent
NSCLC — recurrent, advanced, or metastatic disease. Covered when the following first-line single-agent conditions are met.
Indication and line: Used for recurrent, advanced, or metastatic NSCLC AND used as first-line therapy as a single agent.
Chunks 5
Performance status and biomarker requirements
PS 0-2 with high PD-L1: Member has ECOG/performance status (PS) 0-2; tumor is negative for actionable biomarkers (may be KRAS G12C positive); AND PD-L1 expression ≥50% (TC ≥50% or IC ≥10%).PD-L1 TC ≥50% or IC ≥10%
Chunk 5
PS 3 regardless of PD-L1 (biomarker-negative): Member has PS 3 and tumor is negative for actionable biomarkers (may be KRAS G12C positive); PD-L1 status may be any.
Non-Small Cell Lung Cancer (NSCLC) - combination and maintenance
Combination regimens for non-squamous NSCLC: Used in combination with carboplatin + paclitaxel + bevacizumab OR carboplatin + albumin-bound paclitaxel for non-squamous histology, with biomarker-guided rules (tumor negative for actionable biomarkers OR tumor positive for specified biomarkers as listed).
Chunks 5 and 6
Continuation maintenance following specified first-line regimens: Continuation maintenance allowed after response or stable disease following an initial atezolizumab-containing first-line regimen as follows: in combination with bevacizumab after atezolizumab + carboplatin + paclitaxel + bevacizumab; OR as single agent after atezolizumab + carboplatin + albumin-bound paclitaxel; OR as single agent following single-agent atezolizumab first-line.
Chunk 6
Adjuvant use: Used as adjuvant single-agent therapy when tumor expresses PD-L1 ≥1% as determined by an FDA-approved or CLIA-compliant test; adjuvant schedules and maximum durations referenced in dosing/duration section.
Small Cell Lung Cancer (SCLC)
Small Cell Lung Cancer (SCLC) — coverage logic for extensive-stage disease, maintenance, and subsequent therapy.
Extensive-stage first-line: Member has extensive-stage SCLC (ES-SCLC) AND used as first-line therapy in combination with carboplatin and etoposide.
Chunk 8
Maintenance after atezolizumab-containing regimen: Used as maintenance therapy if disease has not progressed following first-line therapy with atezolizumab (IV or subcutaneous), carboplatin, and etoposide; maintenance options include single-agent atezolizumab or combination with lurbinectedin (if not previously used).
Chunk 8
Subsequent therapy after progression/relapse: For progression or relapse after prolonged disease-free interval: used as subsequent therapy in combination with carboplatin and etoposide OR as single agent or with lurbinectedin (if not previously used); member must have at least stable disease after 4 cycles of subsequent therapy, ECOG PS 0-1, and no history of brain metastases for certain maintenance/subsequent uses.ECOG 0-1; stable disease after 4 cycles
Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) — coverage when used with bevacizumab and permitted lines of therapy.
HCC with bevacizumab: Used in combination with bevacizumab AND used as first-line therapy for unresectable or metastatic HCC; OR used as subsequent-line therapy for disease progression on or after systemic therapy.
Chunks 9 and 21
Dosing guidance for HCC: Administer IV until progression or unacceptable toxicity at one of: 840 mg q2w; 1200 mg q3w; or 1680 mg q4w for first-line; subsequent therapy dosing commonly 1200 mg q3w per dosing section.
Chunk 21
MSI-H/dMMR / POLE-POLD1 indications
Colorectal, rectal, and small bowel disease with MSI-H/dMMR or POLE/POLD1 ultra-hypermutated phenotype — coverage rules.
Biomarker requirement: Member has MSI-H/dMMR disease OR POLE/POLD1 mutation with ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb) as determined by an FDA-approved or CLIA-compliant test.TMB > 50 mut/Mb (when applicable)
Chunks 14-16
Adjuvant colon-specific use: Used as adjuvant treatment in combination with FOLFOX or CAPEOX followed by single-agent maintenance for members with stage IIC, stage III, or metastatic colon cancer.
Chunk 14
Unresectable/advanced/metastatic single-agent use: Used as a single agent for locally unresectable, medically inoperable, advanced, or metastatic disease of colon, rectum, or small bowel as specified.
Chunks 14-16
Cutaneous Melanoma
Cutaneous melanoma — coverage for BRAF V600–mutant disease with BRAF/MEK inhibitor combination sequencing rules.
BRAF V600 mutation: Member has BRAF V600 mutation detected by an FDA-approved or CLIA-compliant test; used in combination with cobimetinib and vemurafenib for unresectable or metastatic disease.
Chunk 11
Line of therapy and re-induction: Used as first-line or subsequent therapy; re-induction allowed if prior disease control on combination BRAF/MEK + PD-(L)1 therapy was achieved and progression/relapse occurs >3 months after discontinuation. Prior cobimetinib/vemurafenib lead-in regimen required per dosing guidance before PD-(L)1 initiation.>3 months for re-induction
Chunks 11 and 21-22
Alveolar Soft Part Sarcoma
Alveolar Soft Part Sarcoma (ASPS) — pediatric and adult eligibility and single-agent use.
Age and single-agent use: Member is at least 2 years of age; AND used as a single agent.Age ≥2 years
Chunk 12
Dosing guidance: Administer IV until disease progression or unacceptable toxicity per general dosing options (840 mg q2w; 1200 mg q3w; 1680 mg q4w); pediatric dosing: 15 mg/kg (up to 1200 mg) q3w.Pediatric: 15 mg/kg up to 1200 mg q3w
Chunk 22
Cervical Cancer
Cervical cancer — coverage for NECC and squamous/adenocarcinoma/adenosquamous histologies with combination and maintenance options.
NECC (small cell neuroendocrine carcinoma): Member has small cell neuroendocrine carcinoma of the cervix (NECC) AND used as first-line or subsequent therapy in combination with etoposide and either cisplatin or carboplatin; maintenance single-agent atezolizumab allowed after initial combination therapy.
Chunk 13
Squamous/adenocarcinoma/adenosquamous: Member has recurrent or metastatic adenocarcinoma, adenosquamous, or squamous cell carcinoma AND used in combination with bevacizumab, paclitaxel, and either cisplatin or carboplatin for first-line or subsequent therapy; maintenance with bevacizumab + atezolizumab allowed after initial atezolizumab + bevacizumab + paclitaxel + platinum regimen.
Chunk 13 and dosing section chunk 21
Thymic Carcinoma
Thymic carcinoma — perioperative and first-line recurrent/advanced use and duration example.
Postoperative or first-line recurrent use: Used in combination with carboplatin and paclitaxel as postoperative therapy after R1 or R2 resection OR as first-line therapy for recurrent, advanced, or metastatic thymic carcinoma.
Chunk 17
Duration example: Dosing examples include 1200 mg q3w or 1680 mg q4w; thymic carcinoma may be administered for up to 24 months in absence of progression or unacceptable toxicity per dosing section.<=24 months
Chunk 23
Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) — Richter transformation coverage logic and dosing limits.
Richter transformation indication: Used in combination with venetoclax and obinutuzumab for histologic transformation (Richter); may be used as additional therapy for partial response, refractory disease, progression on prior treatment, or as first-line for Richter if previously treated for CLL; continuation therapy allowed for complete response until progression.
Chunk 18
Dosing and maximum cycles: Administer 1200 mg IV every 3 weeks for CLL/SLL indications, up to a total of 18 cycles; note first infusion timing (day 2 of cycle 1) and subsequent cycle day 1 scheduling when applicable.up to 18 cycles
Chunk 23
Covered indications and dosing examples
Covered indications and dosing examples — general IV dosing schedules and select indication-specific dosing notes.
General IV dosing schedules: Administer intravenously until disease progression or unacceptable toxicity at one of: 840 mg every 2 weeks; 1200 mg every 3 weeks; or 1680 mg every 4 weeks. Weight-based guidance: 840 mg (15 mg/kg) q3w if ≤61 kg; 1200 mg (20 mg/kg) q4w if ≤66 kg; pediatric: 15 mg/kg (max 1200 mg) q3w for ≥2 years.See dosing thresholds
Chunks 21 and 23
CLL/SLL example: CLL/SLL dosing example: 1200 mg IV every 3 weeks for up to a total of 18 cycles; first infusion given day 2 of cycle 1 and on day 1 of subsequent 21-day cycles when applicable.up to 18 cycles
Chunk 23
Indication-specific fixed-duration examples: Some indications have fixed-duration adjuvant schedules (examples include NSCLC adjuvant up to 12 months; thymic carcinoma up to 24 months per dosing and duration guidance).
Adjuvant and maintenance coverage examples
Adjuvant and maintenance coverage examples — indication-specific duration and cycle examples (excerpted).
NSCLC adjuvant example: Adjuvant NSCLC: administer until progression or unacceptable toxicity; may continue up to a maximum of 12 months in members without disease recurrence.<=12 months
Chunk 21
Thymic carcinoma duration example: Administer IV for up to 24 months in absence of disease progression or unacceptable toxicity (example dosing: 1200 mg q3w or 1680 mg q4w referenced).<=24 months
Chunk 23
Colon and small bowel adjuvant regimens example: Example adjuvant regimens: FOLFOX combination then maintenance — 840 mg IV q2w for 12 cycles (6 months) then maintenance 840 mg q2w for 13 cycles (12 months total); OR CAPEOX combination — 1200 mg IV q3w for 8 cycles then maintenance 1200 mg q3w for 8 cycles (12 months total).
Concomitant administration of intravenous atezolizumab with subcutaneous atezolizumab is prohibited. Requests that indicate simultaneous use of the IV product with the subcutaneous formulation will not meet the universal coverage criteria and should be denied or returned for clarification.
Prior authorization renewal will not be approved if there is documentation of unacceptable toxicity attributed to atezolizumab. Examples of unacceptable toxicities include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis/renal dysfunction, myocarditis, pericarditis, vasculitis, or solid-organ transplant rejection), severe cutaneous reactions (including SJS, DRESS, or TEN), severe infusion-related reactions, or complications related to allogeneic hematopoietic stem cell transplantation. Renewal requests must attest to absence of these events to be considered.
This policy is intended to support non‑Medicare coverage determinations. When the member is covered under Medicare, applicable National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) (and any associated Local Coverage Articles) take precedence and must be followed; consult the CMS Medicare Coverage Database for current NCD/LCD/LCA guidance.
Use of intravenous atezolizumab is not permitted for members who have previously received PD‑1/PD‑L1–directed therapy, unless a specific indication or section of this policy explicitly allows prior PD‑1/PD‑L1 exposure. Requests for members with prior PD‑1/PD‑L1 therapy should reference the policy exception language when applicable.
Members who relapse within 6 months after treatment discontinuation due solely to completion of a fixed-duration course are not automatically eligible to re-initiate PD‑directed therapy. Re-initiation eligibility is generally limited to members who relapse ≥ 6 months after discontinuation, or to those with qualifying changes on re‑biopsy (for example, a new actionable mutation) that are evaluated case‑by‑case.
Covered Regimens and Combinations
Indication
Example regimen / combination
Notes
Non‑Small Cell Lung Cancer (NSCLC)
Atezolizumab monotherapy; or atezolizumab + carboplatin + paclitaxel + bevacizumab; or atezolizumab + carboplatin + albumin‑bound paclitaxel
Used for recurrent/advanced/metastatic disease as single agent (high PD‑L1) or in combination for non‑squamous disease per biomarker rules; continuation maintenance after response described.
Small Cell Lung Cancer (ES‑SCLC)
Atezolizumab + carboplatin + etoposide; maintenance single agent or in combination with lurbinectedin
First‑line combination for extensive‑stage disease; maintenance or subsequent therapy options require ECOG 0‑1 and no brain metastases for some uses.
Hepatocellular Carcinoma (HCC)
Atezolizumab + bevacizumab
Used as first‑line for unresectable/metastatic disease or as subsequent therapy after prior systemic therapy.
For unresectable/metastatic BRAF V600 disease as first‑line or subsequent therapy; re‑induction allowed >3 months after prior combination PD‑(L)1 + BRAF/MEK therapy if progression occurred.
Cervical Cancer (NECC and squamous/adenoca.)
Atezolizumab + etoposide + cisplatin or carboplatin (NECC); or atezolizumab + bevacizumab + paclitaxel + platinum (squamous/adenoca.)
Used first‑line or subsequent for persistent/recurrent/metastatic disease; maintenance single‑agent atezolizumab allowed after initial atezolizumab‑containing regimens.
Thymic Carcinoma
Atezolizumab + carboplatin + paclitaxel
Used postoperatively after R1/R2 resection or as first‑line for recurrent/advanced/metastatic disease.
Alveolar Soft Part Sarcoma (ASPS)
Atezolizumab as single agent
Used as single agent; pediatric dosing and age criteria apply (≥2 years for pediatric indications referenced elsewhere).
Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (Richter transformation)
Atezolizumab + venetoclax + obinutuzumab
Used for histologic transformation (Richter); may be additional therapy for partial response/refractory disease, first‑line for Richter if previously treated for CLL, or continuation until progression. Maximum durations specified (see dosing section).
Administer IV until disease progression or unacceptable toxicity; weight‑based guidance: 840 mg (15 mg/kg) q21d for members ≤61 kg when applicable; adjuvant/maintenance schedules may specify fixed cycle counts (examples in dosing section).
1200 mg every 3 weeks
Common IV dose for many indications including HCC (first‑line/subsequent per context), CLL/SLL (primary schedule within combination) and others
Administer IV until disease progression or unacceptable toxicity; CLL/SLL: 1200 mg IV q3w for up to a total of 18 cycles (atezolizumab given day 2 of cycle 1 and day 1 of subsequent 21‑day cycles). Weight‑based guidance: 1200 mg (20 mg/kg) q28d for members ≤66 kg when applicable.
1680 mg every 4 weeks
Alternate schedule referenced for multiple indications (NSCLC adjuvant, thymic carcinoma example dosing)
Administer IV until disease progression or unacceptable toxicity; thymic carcinoma example: 1680 mg q4w with option to administer 1200 mg q3w for up to 24 months in absence of progression or unacceptable toxicity. Dosing should be calculated using actual body weight when applicable.
Coding — HCPCS, NDC, ICD-10, and Unit Limits
HCPCS Unit LimitsHCPCS
HCPCS units
Max units per dosing interval: 120 units every 21 days for mesotheliomas (peritoneal, pericardial, & tunica vaginalis testis), thymic carcinoma, and CLL/SLL; 504 units every 84 days for all other indications
Notesmixed
Maximum billable units guidance
Maximum billable units specified by indication group as shown; providers must bill per J9022 units with these interval limits
HCPCS CodesHCPCSCovered
J9022
Injection, atezolizumab, 10 mg; 1 billable unit = 10 mg
NDCsNDC
50242-0917-xx
Tecentriq 1200 mg/20 mL solution for injection single-dose vial (NDC prefix)
50242-0918-xx
Tecentriq 840 mg/14 mL solution for injection single-dose vial (NDC prefix)
Malignant neoplasm of overlapping sites of small intestine.
C17.9
Malignant neoplasm of small intestine, unspecified.
C18.0
Malignant neoplasm of cecum.
C18.2
Malignant neoplasm of ascending colon.
C18.3
Malignant neoplasm of hepatic flexure.
C18.4
Malignant neoplasm of transverse colon.
1–10 of 120
1/12
Tumor mutational burden / MSI status — thresholds for select GI tumors
Biomarker requirementMSI-H/dMMR OR POLE/POLD1 mutation with ultra-hypermutated phenotype (e.g., TMB > 50 mut/Mb) required for select colon, rectal, and small bowel indications as determined by an FDA-approved or CLIA-compliant test
Colon adjuvant useRequired marker present AND used with FOLFOX or CAPEOX followed by single-agent maintenance for stage IIC, III, or metastatic disease
Rectal and small bowel therapyRequired marker present for single-agent use in locally unresectable, medically inoperable, advanced, or metastatic rectal disease; for small bowel may be used as adjuvant with FOLFOX/CAPEOX for specified stages
Weight-based dosing thresholds
15 mg/kg guidance (q21d)
Provider Actions, Prior Authorization, and Renewal Rules
Prior Authorization
Prior Authorization Required
Prior authorization required. Initial authorization will be provided for 6 months (180 days) and may be renewed every 6 months (180 days) thereafter unless otherwise specified in the policy (see Section I for indication-specific maximum durations).
Initial authorization: 6 months (180 days)
Renewal interval: every 6 months (180 days)
See Section I for indication-specific maximums (eg. colon cancer, small bowel adenocarcinoma, NSCLC adjuvant up to 12 months; thymic carcinoma up to 24 months; CLL/SLL up to 18 cycles).
Prior Authorization
Renewal Conditions
Renewal of prior authorization is allowed only when the member continues to meet the universal criteria and all applicable indication-specific criteria in Section III, the originally authorized duration has not been exceeded, and documentation demonstrates ongoing benefit and acceptable toxicity.
Member continues to meet universal and indication-specific criteria (including any concomitant therapy requirements and performance status)
Line of Therapy Specifications
first-line | subsequent-line
Line of therapy distinction — first-line versus subsequent-line requirements for multiple indications.
First-line uses: Multiple indications specify first-line use (examples: NSCLC, SCLC, HCC) often with combination regimens as detailed in each indication-specific criteria.
Chunks 5, 8, 9
Subsequent-line/maintenance uses: Several indications include subsequent-line or maintenance uses after progression or after initial atezolizumab-containing regimens (examples: NSCLC subsequent single-agent use; SCLC subsequent therapy and maintenance).
Chunks 5 and 8
first-line | subsequent
Single top-level line-of-therapy rule for select indications (combined first-line or subsequent use).
Biomarker and Molecular Testing Requirements
PD-L1 test thresholds
First-line single-agent NSCLC thresholdTumor cell (TC) ≥50% OR tumor-infiltrating immune cell (IC) ≥10% for certain first-line single-agent NSCLC uses
Adjuvant NSCLC thresholdPD-L1 ≥1% as determined by an FDA-approved or CLIA-compliant test for adjuvant single-agent use
Testing standardPD-L1 must be determined by an FDA-approved test or CLIA-compliant test where indicated
MSI-H / dMMR / POLE/POLD1 / TMB requirements
MSI-H/dMMR or POLE/POLD1 requirementMSI-H/dMMR OR POLE/POLD1 with ultra-hypermutated phenotype (e.g., TMB >50 mut/Mb) required for select colon, rectal, and small bowel indications
TMB descriptor
Definitions and Eligibility Details
Actionable biomarkers and testing expectations
List of actionable biomarkersEGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, and ERBB2 (HER2)
Testing expectationComplete molecular testing (biopsy and/or plasma) for these biomarkers via FDA-approved or CLIA-compliant assays is recommended where indicated
Treatment guidanceIf a clinically actionable marker is found, it is reasonable to start therapy based on the identified marker and guide treatment by available results
Relapse ≥6 months — re-initiation eligibility
Relapse ≥6 months re-initiation ruleMembers responding to therapy who relapse ≥6 months after discontinuation due to duration are eligible to re-initiate PD-directed therapy
Adjuvant-to-metastatic transition
Background
Atezolizumab is a programmed death‑ligand 1 (PD‑L1) directed immune checkpoint inhibitor used across multiple tumor types either as monotherapy or in combination regimens. It has FDA‑approved and compendia‑recommended indications that vary by cancer type, line of therapy, biomarker status, and combination partner. Coverage under this policy is determined by meeting the universal criteria (age, prior PD‑1/PD‑L1 exposure rules, and concomitant therapy restrictions) plus the indication‑specific requirements described elsewhere in the document.
NQTL checklist and rationale for prior authorization
NQTL checklist referenceAppendix A contains the Non-Quantitative Treatment Limitations (NQTL) Factor Checklist used to inform utilization management and PA decisions
PA rationalePA considered primarily due to indication and drug cost per the NQTL conclusions (cost = Yes: consider for PA)
Design considerationsChecklist lists factors considered (indication, safety/efficacy, misuse potential, cost) and conclusions for PA applicability
PS 3 with specific actionable biomarkers: Member has PS 3 and tumor is positive for one of: EGFR exon 20, BRAF V600E, NTRK1/2/3 fusion, MET exon-14 skipping, ERBB2 (HER2), or NRG1 fusion.
Chunk 5 and 6
PD-L1 ≥1%
Chunk 6 and dosing section chunk 21
Chunk 8
Small bowel adjuvant specifics: For small bowel adjuvant use: member has T4,N0,M0 or T any,N1-2 disease when used in combination with FOLFOX or CAPEOX then maintenance per protocol.
Chunk 16
Duration limits vary by indication
Chunks 21 and 23
12 months total
Chunk 22
Use 840 mg (15 mg/kg) for members receiving therapy every 21 days who weigh ≤ 61 kg
20 mg/kg guidance (q28d)Use 1200 mg (20 mg/kg) for members receiving therapy every 28 days who weigh ≤ 66 kg
Weight-based calculation noteDosing should be calculated using actual body weight and not flat dosing when applicable; member-specific variables considered
Medicare Part B Covered Diagnosis Codes
Medicare Part B covered diagnosis codesN/A
Medicare applicability noteInformation intended for non‑Medicare coverage determinations; applicable NCDs/LCDs must be followed where relevant
Reference linkSee CMS Medicare Coverage Database for NCD/LCD/LCA guidance
Duration limits have not been exceeded (refer to Section I)
Documented disease response: stabilization or decrease in tumor size or spread (unless otherwise specified)
Absence of unacceptable toxicity (examples listed in Section IV)
Note
PA Consideration (NQTL)
Prior authorization is applied primarily due to the drug indication mix and the cost of therapy as documented in the NQTL factor checklist.
Indication considered for PA = Yes
Cost of drug considered for PA = Yes
Safety/efficacy and potential for misuse were not primary drivers per the checklist
Denial Risk
Triggers for Denial or Non‑Renewal
Authorizations may be denied or not renewed if universal exclusions or indication-specific disqualifiers are present, or if required conditions are not met.
Prior PD‑1/PD‑L1 therapy present is an exclusion unless a specific exception applies (eg. switch‑therapy with subcutaneous atezolizumab)
Concomitant use with subcutaneous atezolizumab is prohibited
Renewal may be denied if duration limits have been exceeded
Renewal may be denied for unacceptable toxicity or if the member no longer meets criteria (eg. lack of response, worsened performance status)
Re‑initiation rules apply for relapse ≥ 6 months after discontinuation or changes in actionable mutations (see Notes)
First-line or subsequent:
Atezolizumab may be used as first-line or subsequent therapy depending on the specific indication and prior treatments; for Richter transformation it may be used first-line if previously treated for CLL or as additional therapy for progression on prior treatment.
Chunks 18, 21, 23
Example threshold cited as TMB > 50 mutations per megabase for ultra-hypermutated phenotype
Confirmation methodMust be determined by an FDA-approved or CLIA-compliant test
BRAF V600 — actionable mutation requirement
BRAF V600 requirementBRAF V600 mutation-positive disease must be detected by an FDA-approved or CLIA-compliant test for use of atezolizumab combined with cobimetinib and vemurafenib in unresectable/metastatic melanoma
Indication contextCombination regimen used as first-line or subsequent therapy and allowed as re-induction >3 months after prior combination therapy if disease control previously achieved
Testing standardMutation detection via FDA-approved assay or CLIA-compliant testing where indicated
Actionable mutation changes and re-initiation
Actionable mutation change permits re-initiationTumors that, upon re-biopsy, demonstrate a change in actionable mutation (e.g., initial MSS and subsequent MSI-H) may be eligible to re-initiate PD-directed therapy and will be evaluated case-by-case
Re-initiation contextApplies to members who previously discontinued therapy and show new actionable marker on subsequent biopsy
Evaluation processEligibility determined by case-by-case clinical evaluation per policy notes
Members who complete adjuvant therapy and progress ≥6 months after discontinuation are eligible to re-initiate PD-directed therapy for metastatic disease
Case evaluationRe-initiation eligibility assessed per policy criteria and documentation requirements
DefinitionNon-quantitative treatment limitations (NQTLs) are methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan (e.g., utilization review, prior authorization)
ExamplesMay include utilization review, prior authorization, and similar utilization management methods applied comparably across MH/SUD and M/S benefits
Policy roleNQTL factors were considered in designing prior authorization for this drug group (e.g., indication and drug cost cited)
NCCN compendia citationsMultiple NCCN Drugs & Biologics Compendium citations referenced (tumor-specific compendia versions 1–2.2026) as evidence support
Examples of cited compendiaThymomas and Thymic Carcinomas Compendium (Version 1.2026); CLL/SLL Compendium (Version 2.2026); Small Bowel and Rectal Cancer Compendia (Versions 1.2026)
Access noteReferenced with permission; consult NCCN.org for most recent complete compendium versions