Drug Therapy Guidelines Pemetrexed (Alimta®, PemfexyTM)
Applicable* Medical Benefit x Effective: 5/28/2021 Pharmacy- Formulary 1 Next Review: 3/22 Pharmacy- Formulary 2 Date of Origin: 1/16 Pharmacy- Formulary 3/Exclusive Review Dates: 9/15, 3/16, 3/17, 3/18, 3/19, 3/20, 3/21 Pharmacy- Formulary 4/AON
I. Medication Description
Pemetrexed is a pyrimidine-based antifolate that suppresses tumor growth by inhibiting both DNA synthesis and folate metabolism at multiple target enzymes. This multiple enzyme inhibition is unique, as methotrexate inhibits only dihydrofolate reductase, and 5-fluorouracil and raltitrexed inhibit only thymidine synthetase. Thus, pemetrexed may be useful for 5-fluorouracil-, methotrexate-, and raltitrexed-resistant cancers. Folic acid and vitamin B12 supplementation is needed to reduce hematologic and gastrointestinal toxicity and enable therapy continuation; dexamethasone is also required to mitigate cutaneous toxicity.
II. Position Statement
Coverage is determined through a prior authorization process with supporting clinical documentation for every request.
III. Policy
Coverage of Alimta or Pemfexy is available when the following criteria have been met: • Member is at least 18 years of age AND • The medication is prescribed by a hematologist/oncologist AND • The requested use is supported by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (NCCN Guidelines®) and/or NCCN Drugs & Biologics Compendium (NCCN Compendium®) with a recommendation of category level 1 or 2A.
IV. Quantity Limitations
Coverage is available for FDA-approved and/or NCCN Guidelines-supported dosing regimens, dependent upon diagnosis and body surface area.
V. Coverage Duration
Coverage is approved for up to 6 months and may be renewed.
VI. Coverage Renewal Criteria
Coverage can be renewed based upon the following criteria: • Stabilization of disease or in absence of disease progression AND
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Drug Therapy Guidelines Pemetrexed (Alimta®, PemfexyTM) Last Review Date: 3/2021
• Absence of unacceptable toxicity from the drug.
VII. Billing/Coding Information
• Alimta is available as 100 mg and 500 mg single-dose vials for injection • Pemfexy is available as 500 mg/20 ml (25 mg/ml) in a single-dose vial • J9305: Injection, pemetrexed, not otherwise specified, 10 mg o 1 billable unit is 10mg • J9304: Injection, pemetrexed (pemfexy), 10 mg o 1 billable unit is 10mg • Pertinent indications: o Bladder cancer: C61, C65.1, C65.2, C65.9, C66.1, C66.2, C66.9, C67.0-C67.9, C68.0, D09.0, Z85.51, Z85.59 o Cervical cancer: C53.0, C53.1, C53.8, C53.9, C79.89, C79.9 o CNS cancer: C83.30, C83.31, C83.39, C83.80, C83.81, C83.89 o Mesothelioma: C38.4, C45.0, C45.1 o NSCLC: C33, C34.00-C34.02, C34.10-C34.12, C34.2, C34.30-C34.32, C34.80-C34.82, C34.90-C34.92, Z85.118 o Ovarian cancer: C48.1, C48.2, C48.8, C56.1, C56.2, C56.9, C57.00-C57.02, C57.10-C57.12, C57.20- C57.22, C57.3, C57.4, C57.7-C57.9, Z85.43 o Thymomas and Thymic Carcinomas: C37, D15.0
VIII. Summary of Policy Changes
• 1/1/16: new policy • 3/15/16: no policy changes • 4/5/17: no policy changes • 5/1/18: coverage criteria updated to allow use as supported by current NCCN guidelines • 5/15/19: updated billing/coding information • 5/1/20: changed policy name from “Alimta” to “Pemetrexed;” added Pemfexy to policy • 10/1/20: updated billing/coding information • 5/28/21: no policy changes
IX. References
1. Prescribing Information: Alimta®. Eli Lilly and Company. Indianapolis, IN 46285. Revised 1/2019. 2. Prescribing information: Pemfexy. Woodcliff Lake, Indianapolis, IN: Eagle Pharmaceuticals, Inc.; Revised 2/2020. 3. NCCN Drugs & Biologics Compendium®: Pemetrexed. Reviewed 1/2021. 4. Clinical Pharmacology. Gold Standard: Pemetrexed. Reviewed 1/2021. 5. National Comprehensive Cancer Network Guidelines [database online]. Fort Washington, PA: National Comprehensive Cancer Network, Inc.; 2021. URL: https://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site. Updated January, 2021. Page 2 of 3
Drug Therapy Guidelines Pemetrexed (Alimta®, PemfexyTM) Last Review Date: 3/2021
6. Centers for Medicare and Medicaid Services. Medicare Benefit Policy Manual: Chapter 15. (CMS Publication No. 100-02). Retrieved from http://www.cms.hhs.gov.
The Plan fully expects that only appropriate and medically necessary services will be rendered. The Plan reserves the right to conduct pre-payment and post-payment reviews to assess the medical appropriateness of the above-referenced therapies.
The preceding policy is a guideline to allow for coverage of the pertinent medication/product, and is not meant to serve as a clinical practice guideline.
*These guidelines are not applicable to benefits covered under Medicare Advantage. Medicare Advantage benefit coverage requests are reviewed in accordance with the guidance set forth in Chapter 15 Section 50 of the Centers for Medicare & Medicaid Services Medicare Benefit Policy Manual.
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