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Lung Cancer Agents – Unified Formulary

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Lung Cancer Agents – Unified Formulary bmchp.org | 888-566-0008 wellsense.org | 877-957-1300 Pharmacy Policy Lung Cancer Agents – Unified Formulary Policy Number: 9.712 Version Number: 1.1 Version Effective Date: 3/3/2021 Product Applicability All Plan+ Products Well Sense Health Plan Boston Medical Center HealthNet Plan New Hampshire Medicaid MassHealth- MCO MassHealth- ACO Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options Note: Disclaimer and audit information is located at the end of this document. Prior Authorization Policy Reference Table: Drugs that require PA No PA Alecensa® (alectinib) Alunbrig® (brigatinib) Gilotrif® (afatinib) Iressa® (gefitinib) Lorbrena® (lorlatinib) Tabrecta® (capmatinib) Tagrisso® (osimertinib) Tarceva® (erlotinib) * Vizimpro® (dacomitinib) Xalkori® (crizotinib) Zykadia® (ceritinib) *A-rated generic available. Both brand and A-rated generic require PA. + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. Lung Cancer Agents 1 of 7 Procedure: Approval Diagnosis: Advanced or metastatic non-small cell lung cancer (All agents) Advanced or metastatic pancreatic cancer (erlotinib) Stage IIB to IIIA NSCLC (Tagrisso®) Approval Criteria: Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis* Alecensa® (alectinib) 2. Prescriber is an oncologist 3. Appropriate dosing Zykadia® (ceritinib) 4. Cancer is anaplastic lymphoma kinase (ALK)-positive (Documentation must be provided on the PA request or in attached medical records) 5. ONE of the following: a. If the request is for Alecensa® (alectinib), quantity requested is ≤8 units/day b. If the request is for Zykadia® (ceritinib), quantity requested is ≤3 units/day Notes: *Please see Appendix for requests for Zykadia® (ceritinib) for the first- line treatment of ROS1-rearrangement NSCLC. Approval Criteria: Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis Alunbrig® (brigatinib) 2. Prescriber is an oncologist 3. Appropriate dosing 4. Cancer is anaplastic lymphoma kinase (ALK)-positive (Documentation must be provided on the PA request or in attached medical records) 5. ONE of the following: c. Quantity requested is ≤2 units/day (30 mg tablet) a. Quantity requested is ≤1 unit/day (90 mg, 180 mg tablets; 90 mg-180 mg tablet pack) Approval Criteria: Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis Gilotrif® (afatinib) 2. Prescriber is an oncologist 3. Appropriate dosing 4. ONE of the following: a. Member has epidermal growth factor receptor (EGFR) mutations (Documentation must be provided on the PA request or in attached medical records) b. Inadequate response or adverse reaction to at least one platinum- based chemotherapy regimen OR contraindication to the use of platinum-based chemotherapy (History of claims is not sufficient) 5. Quantity requested is ≤1 unit/day Approval Criteria: Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis Iressa® (gefitinib) 2. Prescriber is an oncologist 3. Appropriate dosing Vizimpro® 4. Member has epidermal growth factor receptor (EGFR) mutations (dacomitinib) (Documentation must be provided on the PA request or in attached medical records) + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. Lung Cancer Agents 2 of 7 5. Quantity requested is ≤1 unit/day Approval Criteria: Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis** Lorbrena® (lorlatinib) 2. Prescriber is an oncologist 3. Appropriate dosing 4. Cancer is ALK-positive (Documentation must be provided on the PA request or in attached medical records) 5. ONE of the following: a. Inadequate response or adverse reaction to Xalkori® (crizotinib) and at least one other ALK inhibitor† (History of claims is not sufficient) b. Inadequate response or adverse reaction to Alecensa® (alectinib) or Zykadia® (ceritinib) (History of claims is not sufficient) 6. Quantity requested is ≤1 unit/day Notes: **Requests for ROS1-rearrangement positive disease require clinical review (see Appendix) †ALK inhibitors include: Alecensa® (alectinib), Alunbrig® (brigatinib), Zykadia® (ceritinib). Approval Criteria: Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis Tabrecta® 2. Prescriber is an oncologist (capmatinib) 3. Appropriate dosing 4. Cancer has mutation that leads to MET exon 14 skipping (Documentation must be provided on the PA request or in attached medical records) 5. Quantity requested is ≤4 units/day Approval Criteria: Advanced or metastatic NSCLC Prescriber provides documentation of ALL of the following: Tagrisso® 1. Appropriate diagnosis (osimertinib) 2. Prescriber is an oncologist 3. Appropriate dosing 4. ONE of the following: a. Cancer displays the EGFR exon 19 deletion or exon 21 L858R mutation (Documentation must be provided on the PA request or in attached medical records) b. Cancer displays the EGFR mutation and the T790M resistance mutation (Documentation must be provided on the PA request or in attached medical records) c. Inadequate response or adverse reaction to ONE of the following or contraindication to ALL of the following (History of claims is not sufficient): a. erlotinib b. Gilotrif® (afatinib) c. Iressa® (gefitinib) d. Vizimpro® (dacomitinib) 5. Quantity requested is ≤1 unit/day + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. Lung Cancer Agents 3 of 7 Stage IIB to IIIA NSCLC Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis 2. Prescriber is an oncologist 3. Appropriate dosing 4. Cancer displays the EGFR exon 19 deletions or exon 21 L858R mutation (Documentation must be provided on the PA request or in attached medical records) 5. Member has completely resected disease 6. Quantity requested is ≤1 unit/day Approval Criteria: For advanced or metastatic non-small cell lung cancer Prescriber provides documentation of ALL of the following: Tarceva® (erlotinib) * 1. Appropriate diagnosis 2. Prescriber is an oncologist 3. Appropriate dosing *A-rated generic 4. Member has EGFR mutations (Documentation must be provided on the available. Both brand PA request or in attached medical records) and A-rated generic 5. Quantity requested is ≤1 unit/day require PA 6. If request is for BRAND NAME Tarceva® the member must meet the above criteria and the prescriber must provide medical records documenting an inadequate response or adverse reaction to generic erlotinib (as per the Brand Name Guideline) For advanced or metastatic pancreatic cancer Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis 2. Prescriber is an oncologist 3. Appropriate dosing 4. Member will be using the requested agent in combination with gemcitabine 5. Quantity requested is ≤1 unit/day 6. If request is for BRAND NAME Tarceva® the member must meet the above criteria and the prescriber must provide medical records documenting an inadequate response or adverse reaction to generic erlotinib (as per the Brand Name Guideline) 7. Approval Criteria: Prescriber provides documentation of ALL of the following: 1. Appropriate diagnosis Xalkori® (crizotinib) 2. Prescriber in an oncologist 3. Appropriate dosing 4. Cancer is anaplastic lymphoma kinase (ALK)-positive or ROS1 positive (Documentation must be provided on the PA request or in attached medical records) 5. Quantity requested is ≤2 units/day Notes: + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. Lung Cancer Agents 4 of 7 Please see appendix for patients with NSCLC with MET amplification Denial Criteria: Cases that do not meet the approval criteria will be denied. If a request is denied and the prescriber has additional clinical documentation, a new prior authorization request must be submitted. Duration/Quantity of Prior authorization may be issued for 3 months. Authorization: Recertification Resubmission by prescriber will infer a positive response to therapy and request Criteria: can be recertified for 6 months. Appendix: Stability Stability alone on the agents in this guideline is not a reason to bypass approval criteria. However, requests for members who have already started treatment on these agents should be reviewed with clinical review and approval is strongly considered for any member with any FDA-approved indication. Grandfathering N/A Additional Information Xalkori® (crizotinib) for patients with NSCLC with ROS1 rearrangements and MET amplification Although there is limited evidence, the NCCN guidelines recommend additional targeted therapies for patients with other genetic alterations, including Xalkori® (crizotinib)
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