AlohaCareCommercial Clinical Policy

RXMP-28 Ramucirumab (Cyramza) Form

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RXMP-28 Ramucirumab (Cyramza)

Indications

(1) Does the request meet this criterion: Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx.? 
(2) Does the request meet this criterion: No LCD/NCD/LCA found as of 9/20/2023. Review using General Coverage Criteria below. MEDICARE PART B 90-DAY TRANSITION PERIOD: For new Medicare members, a 90-day transition period applies. During this time, if a member is? 
(3) Does the request meet this criterion: For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.? 
(4) Does the request meet this criterion: No step therapy GENERAL COVERAGE CRITERIA:? 
(5) Does the request meet this criterion: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Request? 

YesNoN/A
YesNoN/A
YesNoN/A

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Effective Date

NA

Last Reviewed

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Original Document

  Reference



Page 1 of 3

AlohaCare Medical Policy ramucirumab (Cyramza)

Policy Number:
RXMP-28 Effective Date:
10/1/2023 (Medicaid), 1/1/2024 (Medicare) Review Date:
11/3/2025 Plans:
AlohaCare Medicaid & Medicare

PRODUCT(S): Cyramza (ramucirumab)

HCPCS Code HCPCS Description How Supplied J9308 Injection ramucirumab 5mg Cyramza 100mg/10mL, 500mg/50mL SDV

Formulary Status: Medical Benefit: Authorization Required
Pharmacy Benefit: Excluded to Medical Benefit Duration of Approval: Initial Request: 26 weeks COC/Reauthorization: 12 months
Quantity Limit: See dosing information

MEDICARE PART B COVERAGE CRITERIA: • Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • No LCD/NCD/LCA found as of 9/20/2023. Review using General Coverage Criteria below.

MEDICARE PART B 90-DAY TRANSITION PERIOD:
For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of- network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage.

MEDICARE PART B STEP THERAPY CRITERIA: • For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.
• No step therapy

GENERAL COVERAGE CRITERIA:  Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module.

Initial Request

  1. Member has a diagnosis of Hepatocellular Carcinoma AND all of the following: a. Member has inoperable or metastatic disease
    b. Member has had disease progression on or after prior treatment with sorafenib c. Ramucirumab is used as a single agent d. Member has a baseline serum α–fetoprotein (AFP) concentrations of ≥ 400 ng/mL at initiation of therapy OR
  2. Member has a diagnosis of Esophageal, Gastric, or Gastroesophageal Junction Adenocarcinoma AND all of the following: a. Member has advanced (non-resectable) or metastatic disease

Page 2 of 3 b. Member has had disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy c. Ramucirumab is used as a single agent or in combination with paclitaxel (J9267), or in combination with irinotecan (J9206) alone, or in combination with fluorouracil (J9190) and irinotecan (J9206). OR

  1. Member has a diagnosis of metastatic Non-Small Cell Lung Cancer (NSCLC) AND all of the following: a. Member has a test result confirming EGFR (epidermal growth factor receptor) Exon 19 deletion or Exon 21 (L858R) substitution mutation b. Ramucirumab is used as first line therapy in combination with erlotinib. OR
  2. Member has a diagnosis of metastatic Non-Small Cell Lung Cancer (NSCLC) AND all of the following:
    a. The disease has progressed on or after platinum-containing chemotherapy b. Member with EGFR and ALK genomic tumor aberrations have failed FDA-approved therapy c. Ramucirumab is used in combination with docetaxel (J9171). OR
  3. Member has a diagnosis of metastatic Colorectal Cancer AND all of the following: a. Member has had disease progression on or after prior bevacizumab-, oxaliplatin (J9263), and fluoropyrimidine-containing chemotherapy b. Ramucirumab is used in combination with irinotecan (J9206), folinic acid, and 5-fluorouracil (FOLFIRI) OR

  4. Member has a diagnosis of Mesothelioma AND all of the following: a. Member has disease progression after primary treatment. b. Ramucirumab is used in combination with gemcitabine (J9201)

    Reauthorization / Continuation of Therapy There is no evidence of unacceptable toxicity or disease progression while on the current regimen when used for one of the diagnoses above.

    EXCLUSIONS:

  5. Ramucirumab is used for colorectal cancer in combination with the same irinotecan (J9206)-based regimen that was previously used in combination with bevacizumab (or bevacizumab biosimilar).

  6. The following diagnoses: a. Breast cancer b. Metastatic melanoma c. Ovarian, fallopian tube or primary peritoneal cancer d. Renal cell cancer

    FDA INDICATIONS, DOSING & ADMINISTRATION: Indication Dosing/Administration Gastric Cancer • 8 mg/kg every 2 weeks as a single agent or in combination with weekly paclitaxel (J9267) Non-Small Cell Lung Cancer • 10 mg/kg every 2 weeks with daily erlotinib • 10 mg/kg on Day 1 of a 21-day cycle prior to docetaxel (J9171) Colorectal Cancer • 8 mg/kg every 2 weeks prior to FOLFIRI Hepatocellular Carcinoma • 8 mg/kg every 2 weeks Mesothelioma • 10 mg/kg every 3 weeks3

Page 3 of 3 REFERENCES:

  1. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. Updated periodically.
  2. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology, Plymouth Meeting, PA: NCCN. http://www.nccn.org/index.asp. a. Esophageal and Esophagogastric Junction Cancers. V3.2023. Revised August 29, 2023.
    b. Gastric Cancer. V2.2023. Revised August 29, 2023. c. Non-Small Cell Lung Cancer. V3.2023. Revised April 13, 2023. d. Colon Cancer. V3.2023. Revised September 21, 2023. e. Rectal Cancer. V5.2023. Revised September 21, 2023. f. Hepatocellular Cancers. V2.2023. Revised September 14, 2023. g. Mesothelioma: pleural. V1.2023. Revised December 15, 2022.

  3. Pinto C, Zucali PA, Pagano M, Grosso F, Pasello G, Garassino MC, Tiseo M, Soto Parra H, Grossi F, Cappuzzo F, de Marinis F, Pedrazzoli P, Bonomi M, Gianoncelli L, Perrino M, Santoro A, Zanelli F, Bonelli C, Maconi A, Frega S, Gervasi E, Boni L, Ceresoli GL. Gemcitabine with or without ramucirumab as second-line treatment for malignant pleural mesothelioma (RAMES): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2021 Oct;22(10):1438-1447. doi: 10.1016/S1470-2045(21)00404-6. Epub 2021 Sep 6. PMID: 34499874.

    CHANGE HISTORY: 10/2/2023 DS/PH: New

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