A formal determination process has been developed to supplement the long-standing evidence-based process by AHFS for evaluation of off-label cancer uses of drugs and biologics.
A Final Determination Report for each off-label use will be published on the AHFS website and will reflect the consensus vote of the members of the AHFS Oncology Expert Committee.
Determinations that appeared on this portion of the website prior to January 1, 2010, have been incorporated into the respective drug monographs in the AHFS DI database. Determinations subject to CMS’ revised definition of medically accepted indications, related to Section 182(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) and effective as of January 1, 2010, will be posted on this portion of the website as they are finalized.
Final Determination Reports
Listed below are the Final Determination Reports published for each off-label use. These reports reflect the consensus vote of the members of the AHFS Oncology Expert Committee.
- Off-label Use of Bevacizumab in Combination with Paclitaxel for the First-line Treatment of Metastatic Breast Cancer
- Off-label Use of Bevacizumab in Combination with Chemotherapy for the Treatment of Metastatic Breast Cancer Previously Treated with Cytotoxic Chemotherapy
- Off-label Use of Bortezomib in Combination with Cyclophosphamide and Dexamethasone as Induction Therapy for Newly Diagnosed Multiple Myeloma in Transplant-eligible Patients
- Off-label Use of Bortezomib in Combination with Dexamethasone as Induction Therapy for Newly Diagnosed Multiple Myeloma in Transplant-eligible Patients
- Off-label Use of Bortezomib in Combination with Doxorubicin and Dexamethasone as Induction Therapy for Newly Diagnosed Multiple Myeloma in Transplant-eligible Patients
- Off-label Use of Bortezomib in Combination with Thalidomide and Dexamethasone as Induction Therapy for Newly Diagnosed Multiple Myeloma in Transplant-eligible Patients
- Off-label Use of Capecitabine in Combination with Oxaliplatin for the Adjuvant Treatment of Stage III Colon Cancer
- Off-label Use of Cetuximab in Combination with Chemotherapy for the First-line Treatment of Advanced Non-small Cell Lung Cancer
- Off-label Use of Endocrine Therapy in Combination with Ovarian Suppression for the Adjuvant Treatment of Early-stage Hormone Receptor-positive Breast Cancer in Premenopausal Women
- Off-label Use of Exemestane for Initial Adjuvant Treatment of Early-stage Breast Cancer
- Off-label Use of Exemestane for Extended Adjuvant Treatment of Early-stage Breast Cancer
- Off-label Use of Gemcitabine and Cisplatin Therapy for Unresectable Biliary Tract Cancer
- Off-label Use of Lenalidomide in Transfusion-dependent Low-risk or Intermediate-1 Risk Myelodysplastic Syndrome without the Deletion 5q Chromosomal Abnormality
- Off-label Use of Rituximab in Combination with Bendamustine for Previously Untreated Indolent Non-Hodgkin’s Lymphoma or Mantle Cell Lymphoma
- Off-label Use of Rituximab in Combination with Bendamustine for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma or Mantle Cell Lymphoma
- Off-label Use of Sequential IV Paclitaxel, Intraperitoneal Cisplatin, and Intraperitoneal Paclitaxel for Initial Adjuvant Treatment of Optimally Debulked Stage III Epithelial Ovarian Cancer
- Off-label Use of Zoledronic Acid for the Prevention of Aromatase Inhibitor-associated Bone Loss
- Off-label Use of Zoledronic Acid in Combination with Systemic Therapy for the Adjuvant Treatment of Early or Locally Advanced Breast Cancer
