HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-74-004
Topic:
Pemetrexed (Alimta®)
Section:
Injections
Effective Date:
November 27, 2017
Issued Date:
November 27, 2017
Last Revision Date:
July 2017
 
 

Pemetrexed is a folate analog metabolic inhibitor that is indicated for the use to treat certain cancers.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

FDA Approved Indications
The use of pemetrexed (Alimta®) may be considered medically necessary when used in the treatment of the following conditions:

  • Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer as:
    • Initial treatment in combination with cisplatin; or
    • Maintenance treatment of patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy; or
    • After prior chemotherapy as a single-agent; or
  • Mesothelioma: in combination with cisplatin.

The use of pemetrexed (Alimta®) for any other indication not listed on this policy will be considered not medically necessary, and therefore, non-covered.

NCCN Approved Indications

Bladder Cancer

The use of pemetrexed (Alimta®) may be considered medically necessary when used in the treatment of bladder cancer when:

  • Used as a single agent for clinical stage T4b or T2-4a, N1-3 disease, or for recurrence post cystectomy, or for metastatic disease as subsequent systemic therapy.

The use of pemetrexed (Alimta®) may be considered medically necessary when used in the treatment of bladder cancer- primary carcinoma of the urethra when:

  • Used as a single agent as subsequent systemic therapy for recurrent or metastatic disease.

Note: Chemotherapy regimen based on histology. See Non-Urothelial and Urothelial with Variant Histology (BL-D) if appropriate.

The use of pemetrexed (Alimta®) may be considered medically necessary when used in the treatment of bladder cancer/ upper GU tract tumors when:

  • Used as a single agent as subsequent systemic therapy for metastatic disease.

The use of pemetrexed (Alimta®) may be considered medically necessary when used in the treatment of bladder cancer- urothelial carcinoma of the prostate when:

  • Used as a single agent as subsequent systemic therapy for metastatic disease.

The use of pemetrexed (Alimta®) for any other indication not listed on this policy will be considered not medically necessary, and therefore, non-covered.

Central Nervous System Cancers - Primary CNS Lymphoma

The use of pemetrexed (Alimta®) may be considered medically necessary when used in the treatment of Central Nervous System Cancers - Primary CNS Lymphoma when used as a:

  • Single-agent treatment for progressive or recurrent disease in patients who have received prior methotrexate-based regimen without prior radiation therapy (RT):
    • After prolonged (equal or greater than 12 months) response to prior regimen; or
    • In combination with RT after short (less than 12 months) or no response to prior regimen; or
  • Systemic treatment as a single agent for progressive or recurrent disease;
    • May be considered in patients with prior whole brain radiation therapy; or
    • In patients who received prior high-dose chemotherapy with stem cell rescue after a prolonged response (greater than or equal to 12 months).

The use of pemetrexed (Alimta®) for any other indication not listed on this policy will be considered not medically necessary, and therefore, non-covered. 

Cervical Cancer

The use of pemetrexed (Alimta®) may be considered medically necessary when used in the treatment of cervical cancer as a:

  • Second-line therapy as a single agent for:
    • Local/regional recurrence; or
    • Distant metastases.

The use of pemetrexed (Alimta®) for any other indication not listed on this policy will be considered not medically necessary, and therefore, non-covered.

Malignant Pleural Mesothelioma

The use of pemetrexed (Alimta®) may be considered medically necessary when used in the treatment of malignant pleural mesothelioma when used as:

  • Induction chemotherapy in combination with cisplatin for medically operable clinical stage I-III disease; or
  • Used as a single agent or in combination with carboplatin or cisplatin as treatment of:
    • Unresectable clinical stage I-III disease and tumors of epithelial histology; or
    • Resected clinical stage I-III disease in patients not treated with induction chemotherapy; or
    • Clinical stage IV disease, tumors of sarcomatoid or mixed histology, or medically inoperable tumors in patients with performance status (PS) 0-2; or
  • Used in combination with bevacizumab and cisplatin as treatment of:
    • Unresectable clinical stage I-III disease and tumors of epithelial histology: or
    • Clinical stage IV disease, tumors of sarcomatoid or mixed histology, or medically inoperable tumors in patients with performance status (PS) 0-2; or
  • Second-line chemotherapy as a single agent:
    • If not administered first-line; or
    • As rechallenge if good sustained response at the time initial chemotherapy was interrupted (if administered first-line).

The use of pemetrexed (Alimta®) for any other indication not listed on this policy will be considered not medically necessary, and therefore, non-covered.

Non-Small Cell Lung Cancer (NSCLC)

The use of pemetrexed (Alimta®) may be considered medically necessary when used in the treatment of NSCLC when used as:

  • Preoperative concurrent chemoradiation in combination with carboplatin or cisplatin for:
    • Resectable or possibly resectable superior sulcus tumors (T3 invasion or T4 extension, N0-1); or
    • T3 invasion or resectable T4 extension, N0-1 disease in the chest wall, proximal airway, or mediastinum; or
  • Combination with cisplatin:
    • May be used as induction chemotherapy for operable stage IB (peripheral T2a, N0), stage I (central T1ab-2a, N0), stage II (T1ab-2ab, N1 or T2b, N0), stage IIB (T3, N0), or stage IIIA (T3, N1) with negative mediastinal nodes as an alternative for patients likely to receive adjuvant chemotherapy; or
    • As neoadjuvant chemotherapy for T3 invasion or resectable T4 extension, N0-1 disease in the chest wall, proximal airway, or mediastinum; or
    • As induction chemotherapy with or without radiation for T1-2 or T3 (other than invasive) N2, M0; or
    • May be used as induction chemotherapy for T1-3, N0-1 (including T3 with multiple nodules in the same lobe) as an alternative for patients likely to receive adjuvant chemotherapy; or
  • Initial treatment as definitive concurrent chemoradiation in combination with carboplatin or cisplatin (with or without an additional 4 cycles of pemetrexed after concurrent chemoradiation if given with cisplatin) for:
    • Medically inoperable stage IB (peripheral T2a, N0), stage I (central T1ab-2a, N0), stage II (T1ab-2ab, N1 or T2b, N0), stage IIB (T3, N0), or stage IIIA (T3, N1) with negative mediastinal nodes and N1 disease; or
    • Unresectable superior sulcus tumors (T4 extension, N0-1); or
    • Unresectable stage IIIA (T4, N0-1); or
    • T1-2 or T3 (other than invasive), N2 nodes positive, M0; or
    • T3 invasion, N2 nodes positive, M0; or
    • Stage IIIB (T1-3, N3 positive, M0); or
    • Contralateral or ipsilateral mediastinal node-positive stage IIIB (T4 extension, N2-3); or
    • Stage IV, M1b disease and limited non-brain metastases confirmed, if definitive therapy for thoracic disease is feasible; or
  • Adjuvant chemotherapy in combination with cisplatin:
    • May be considered following definitive radiation therapy in medically inoperable high-risk stage IB (peripheral T2a, N0), stage I (central T1ab-2a, N0), stage II (T1ab- 2ab, N1; T2b, N0), stage IIB (T3, N0), or stage IIIA (T3, N1) with negative mediastinal nodes and N0 disease; or
    • For high-risk, margin-negative stage IB (T2a, N0) and IIA (T2b, N0); or
    • For margin-positive stage IB (T2a, N0) and IIA (T2b, N0); or
    • For margin-positive stage IIA (T2b, N0) following radiation; or
    • For stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1); or
    • For margin-negative stage IIIA (T1-3, N2; T3, N1); or
    • For resectable superior sulcus tumors (T3 invasion or T4 extension, N0-1); or
    • For T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall, proximal airway, or mediastinum if not given as initial treatment; or
    • For clinical stage IIIA disease (T1-3, including T3 with multiple nodules in the same lobe) that was clinically N2 but has negative N2, N3 nodes on mediastinal biopsy and negative margins post-surgery; or
    • For clinical stage IIIA disease (T1-2, T3 other than invasive, N2 nodes positive, M0) with no apparent progression or local progression after induction chemotherapy; or
    • For separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral non-primary lobe (T4), N0-1; or
    • For margin-negative or margin-positive, R1 separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral non-primary lobe (T4), N2; or
  • Adjuvant concurrent chemoradiation in combination with carboplatin or cisplatin (with or without an additional 4 cycles of pemetrexed after concurrent chemoradiation if given with cisplatin) for:
    • Margin-positive stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1); or
    • Margin-positive stage IIIA (T1-3, N2; T3, N1); or
    • Margin-positive T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall, proximal airway, or mediastinum if not given as initial treatment; or
    • Clinical stage IIIA disease (T1-3, including T3 with multiple nodules in the same lobe) that was clinically N2 but has negative N2, N3 nodes on mediastinal biopsy and positive margins post-surgery; or
    • Margin-positive separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral non-primary lobe (T4), N2; or
  • Concurrent chemoradiation in combination with carboplatin or cisplatin (with or without an additional 4 cycles of pemetrexed after concurrent chemoradiation if given with cisplatin) if radiation not previously given for locoregional recurrence in the mediastinal lymph nodes or for superior vena cava obstruction; or
  • Treatment for recurrence or metastasis for tumors of nonsquamous cell histology as a single agent for patients with performance status (PS) 2, in combination with cisplatin for (PS) 0-1, or in combination with carboplatin for (PS) 0-2 as:
    • First-line therapy for EGFR, ALK, ROS1, and PD-L1 negative or unknown; or
    • Subsequent therapy for sensitizing EGFR mutation-positive tumors and prior erlotinib, afatinib, gefitinib, or osimertinib therapy; or
    • Subsequent therapy for ALK rearrangement-positive tumors and prior crizotinib, ceritinib, or alectinib therapy; or
    • Subsequent therapy for ROS1 rearrangement-positive tumors and prior crizotinib therapy; or
    • Subsequent therapy for PD-L1 expression-positive (greater than or equal to 50%) and EGFR, ALK, and ROS1 negative tumors and prior pembrolizumab therapy; or
  • Treatment for recurrence or metastasis in combination with bevacizumab and cisplatin or carboplatin for patients with performance status 0-1, tumors of nonsquamous cell histology, and no history of recent hemoptysis as:
    • First-line therapy for EGFR, ALK, ROS1, and PD-L1 negative or unknown; or
    • Subsequent therapy for sensitizing EGFR mutation-positive tumors and prior erlotinib, afatinib, gefitinib, or osimertinib therapy; or
    • Subsequent therapy for ALK rearrangement-positive tumors and prior crizotinib, ceritinib, or alectinib therapy; or
    • Subsequent therapy for ROS1 rearrangement-positive tumors and prior crizotinib therapy; or
    • Subsequent therapy for PD-L1 expression-positive (greater than or equal to 50%) and EGFR, ALK, and ROS1 negative tumors and prior pembrolizumab therapy; or
  • Treatment for recurrence or metastasis of nonsquamous cell histology in patients with performance status 0-2 who achieve tumor response or stable disease following chemotherapy:
    • As a single agent for continuation maintenance therapy if previously used with a first-line chemotherapy regimen; or
    • In combination with bevacizumab if bevacizumab previously used with a first-line pemetrexed/platinum chemotherapy regimen; or
    • As a single agent for switch maintenance; or 
  • Single agent (if not already given) as subsequent therapy for metastatic disease in patients with performance status 0-2 and tumors of nonsquamous cell histology:
    • Following progression on a first-line cytotoxic regimen; or
    • For further progression on a systemic immune checkpoint inhibitor or other systemic therapy.

The use of pemetrexed (Alimta®) for any other indication not listed on this policy will be considered not medically necessary, and therefore, non-covered.

Ovarian Cancer - Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer

The use of pemetrexed (Alimta®) may be considered medically necessary when used in the treatment of ovarian cancer - epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer when used as a:

  • Single-agent therapy for persistent disease or recurrence.

The use of pemetrexed (Alimta®) for any other indication not listed on this policy will be considered not medically necessary, and therefore, non-covered.

Thymomas and Thymic Carcinomas

The use of pemetrexed (Alimta®) may be considered medically necessary when used in the treatment of thymomas and thymic carcinomas when used as a:

  • Second-line therapy as a single agent.

The use of pemetrexed (Alimta®) for any other indication not listed on this policy will be considered not medically necessary, and therefore, non-covered.

J9305



Related Policies

NOTE: Dosage recommendations per the FDA label.


Place of Service: Outpatient

Pemetrexed (Alimta®) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances including, but not limited to the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.



The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.



Links






This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.





    Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

    Discrimination is Against the Law
    The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.