Compendia Transparency
Through the process established by the Centers for Medicare and Medicaid Services (CMS), Thomson Reuters DRUGDEX® is recognized as a compendium for the determination of payment for medically-accepted off-label indications for anti-cancer regimens. Effective January 1, 2010, new requirements were added to the CMS compendia evaluation process that require compendia to utilize transparent processes to evaluate therapies and to identify potential conflicts of interest. Specifically, with respect to an internal or external "request" for inclusion of a therapy in a compendium, publishers of compendia must now make the following information available via their public Web sites1:
1. Criteria used to evaluate the request (therapy)
2. Evidentiary materials reviewed or considered
3. Names of individuals who have substantively participated in the review or disposition of the request
4. Meeting minutes and records of votes for disposition of the request (therapy)
In addition, certain information regarding direct or indirect financial relationships or ownership and investment interests between an individual (or their spouse or minor child) who substantively participates in the development or disposition of compendia recommendations and the manufacturer or seller of a drug or biological being reviewed must be made publicly available in response to a public request for such information.
To meet these requirements, documents detailing this information for each drug/indication pair published on or after January 1, 2010 are posted on this site. Information is organized by drug name, with the document title indicating the off-label indication.
1Federal Register 2009;74(226):61901-61904.
http://edocket.access.gpo.gov/2009/pdf/E9-26502.pdf(accessed March 8, 2010).
Acitretin
Prophylaxis of skin cancers, in high-risk renal transplant recipients PDFAlemtuzumab
Primary Cutaneous T-Cell Lymphoma PDFBendamustine
Metastatic Breast Cancer PDFBevacizumab
Colon cancer, adjuvant therapy in combination with fluorouracil, leucovorin, and oxaliplatin PDF
Metastatic Breast Cancer HER2 Negative PDF
Metastatic breast cancer, HER2-negative, first-line therapy in combination with chemotherapy (except paclitaxel) PDF
Metastatic breast cancer, HER2-negative, first-line therapy in combination with paclitaxel PDF
Nonsquamous non-small cell lung cancer, advanced or recurrent, first-line therapy in combination with cisplatin and gemcitabine PDFCapecitabine
Stage III colon cancer, adjuvant, in combination with oxaliplatin PDFCarboplatin
Metastatic breast cancer, HER2 overexpression, first-line therapy in combination with a taxane and trastuzumab PDF
Ovarian cancer, early stage epithelial, adjuvant PDF
Testicular seminoma, stage I, adjuvant, monotherapy PDFCelecoxib
Prevention of sporadic colorectal adenomas, in high-risk patients PDFCisplatin
Non-Hodgkin Lymphoma Relapse Refractory PDF
Pancreatic Cancer, locally advanced or metastatic, first-line therapy in combination with gemcitabine PDF
Thyroid Cancer Advanced Combo Doxorubicin PDFDasatinib
Chronic Phase Chronic Myeloid Leukemia Philadelphia Chromosome Positive PDF
Exemestane
Breast cancer, Neoadjuvant therapy for hormone receptor-positive disease in postmenopausal women PDF
Prevention of invasive breast cancer in postmenopausal women at increased risk PDFGefitinib
Head and Neck Cancer PDF
Gemcitabine
Mantle Cell Lymphoma PDF
Ovarian Cancer PDFLenalidomide
Myelofibrosis PDFOxaliplatin
Pancreatic cancer, advanced or metastatic, second-line therapy in combination with 5-fluorouracil and leucovorin PDFRituximab
Mantle cell lymphoma, untreated, induction therapy, in combination with anthracycline based regimens PDFSorafenib
Non-small Cell Lung Cancer Advanced PDFToremifene citrate
Prophylaxis of vertebral fracture, Secondary to androgen deprivation therapy in patients with prostate cancer PDFVandetanib
Non-small cell lung cancer, locally advanced or metastatic, after failure of first- or second-line chemotherapy PDF
Feedback