FOLOTYN® (pralatrexate injection) Coverage and Payment
Coverage, coding and payment guidelines vary by payer, plan, setting of care and patient. The following information provides a general framework of the coverage and payment environment for each payer segment. Please reference the state-by-state map, or contact your ASAP representative at 1-877-ASAP102 for more information on FOLOTYN coverage.
Medicare
FOLOTYN is eligible for Medicare Part B coverage for the treatment of its FDA-approved indication of relapsed or refractory peripheral T-cell lymphoma (PTCL), when meeting the general requirements of being “incident to” a physician’s service1, and when reasonable and necessary for the individual patient.
In the physician office setting, Part B claims are submitted to the local Part B carrier or A/B Medicare Administrative Contractor (MAC). Payment for most covered Part B drugs is based on the average sales price (ASP) + 6%. The Centers for Medicare and Medicaid Services (CMS) updates Part B drug payment allowables on a quarterly basis.
In the hospital outpatient setting, claims are submitted to the local fiscal intermediary or A/B MAC. CMS granted FOLOTYN transitional pass-through status under the Medicare Outpatient Prospective Payment System (OPPS), effective April 1, 20102. Payment for covered transitional pass-through drugs is based on ASP + 6%. CMS updates OPPS payment rates quarterly, which are available through OPPS Addendum A or B.
Please refer to the state-by-state map for additional information.
Medicaid
Medicaid coverage and payment for FOLOTYN varies by state. Patients and providers should review the information at the state-by-state map below to determine if published coverage information is available, or contact the ASAP program to inquire about FOLOTYN coverage for a specific patient.
Commercial Payers
Coverage and payment guidelines vary significantly by commercial payer, plan, setting of care, and patient. Patients and providers should verify patient-specific benefits to determine if FOLOTYN is covered under each specific commercial insurance plan. The ASAP program can assist patients and providers in verifying insurance benefits.
- Sample CMS-1450 for Outpatient Hospital - 2011 dates of service
- Sample CMS-1500 for Physician Office - 2011 dates of service
- View/download a sample letter of medical necessity
- View/download a sample letter of appeal
- State-by-State Coverage, Coding, and Payment Map - At a Glance
- Link to Medicare Part B Reimbursement Allowances ( ASP+6) Pricing
- Link to Medicare OPPS APC Reimbursement Rates
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1Centers for Medicare and Medicaid Services (CMS), Medicare Benefit Policy Manual: Chapter 15 – Covered Medical and Other Health Services; §§50.1 and 50.4.1
2CMS, April 2010 Update of the Hospital Outpatient Prospective Payment Systems (OPPS). Transmittal 1924; February 26, 2010.
Allos Therapeutics, Inc. does not guarantee coverage and/or reimbursement for FOLOTYN. Coverage, coding, and reimbursement policies vary significantly by payer, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. Allos strongly recommends verifying coverage, coding, and reimbursement guidelines on a payer and patient-specific basis.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
- FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities.
- Mucositis may occur. If ≥Grade 2 mucositis is observed, omit or modify dose. Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis.
- Fatal dermatologic reactions may occur. Dermatologic reactions may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued.
- Tumor lysis syndrome may occur. Monitor patients and treat if needed
- FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN and pregnant women should be informed of the potential harm to the fetus.
- Use caution and monitor patients when administering FOLOTYN to patients with moderate to severe renal function impairment.
- Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are ≥Grade 3, omit or modify dose.
Adverse Reactions
- The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.
Use in Specific Patient Population
- Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.
Drug Interactions
- Co-administration of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal clearance.
