Narissa J. Nonzee

Evaluating the supportive care costs of severe radiochemotherapy-lnduced mucositis and pharyngitis results from a northwestern university costs of cancer program pilot study with head and neck and nonsmall cell lung cancer patients who received care at a county hospital, a veterans administration hospital, or a comprehensive cancer care center

Few studies have examined the costs of supportive care for radiochemotherapy‐induced mucosits/pharyngitis among patients with head and neck cancer (HNC) or lung cancers despite the documented negative clinical impact of these complications.

Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs or Early Release of Unsafe and Ineffective Drugs?

PURPOSE Accelerated approval (AA) was initiated by the US Food and Drug Administration (FDA) to shorten development times of drugs for serious medical illnesses. Sponsors must confirm efficacy in postapproval trials. Confronted with several drugs that received AA on the basis of phase II trials and for which confirmatory trials were incomplete, FDA officials have encouraged sponsors to design AA applications on the basis of interim analyses of phase III trials. METHODS We reviewed data on orphan drug status, development time, safety, and status of confirmatory trials of AAs and regular FDA approvals of new molecular entities (NMEs) for oncology indications since 1995. RESULTS Median development times for AA NMEs (n = 19 drugs) and regular-approval oncology NMEs (n = 32 drugs) were 7.3 and 7.2 years, respectively. Phase III trials supported efficacy for 75% of regular-approval versus 26% of AA NMEs and for 73% of non-orphan versus 45% of orphan drug approvals. AA accounted for 78% of approvals for oncology NMEs between 2001 and 2003 but accounted for 32% in more recent years. Among AA NMEs, confirmatory trials were nine-fold less likely to be completed for orphan drug versus non-orphan drug indications. Postapproval, black box warnings were added to labels for four oncology NMEs (17%) that had received AA and for two oncology NMEs (9%) that had received regular approval. CONCLUSION AA oncology NMEs are safe and effective, although development times are not accelerated. A return to endorsing phase II trial designs for AA for oncology NMEs, particularly for orphan drug indications, may facilitate timely FDA approval of novel cancer drugs.

Costs and Cost-Effectiveness of a Low-Intensity Patient-Directed Intervention to Promote Colorectal Cancer Screening

PURPOSE Colorectal cancer (CRC) screening is the most underused evidence-based cancer screening test in the United States. Few studies have reported the cost-effectiveness of CRC screening promotional efforts. In a recent randomized controlled trial, a patient-directed intervention for average-risk patients who had been referred for screening colonoscopy led to a 12% increase in CRC screening rates. The objective of this secondary analysis is to assess the cost-effectiveness of this intervention. PATIENTS AND METHODS Patients in the intervention arm received a customized mailed brochure that included a reminder to schedule a screening colonoscopy and general information about CRC, the importance of CRC screening, and how to prepare for the procedure. The end point was completion of screening colonoscopy. The costs and incremental cost-effectiveness ratio of this patient-directed intervention were derived. Sensitivity analyses were based on varying the costs of labor and supplies. RESULTS Rates of CRC screening for the intervention (n = 386 patients) versus control (n = 395) arms were 71% and 59%, respectively (P = .001). The total cost of the intervention was

Costs and Cost Effectiveness of a Health Care Provider–Directed Intervention to Promote Colorectal Cancer Screening

1,927 and the incremental cost-effectiveness ratio was

Patient Navigators’ Reflections on the Navigator-Patient Relationship

43 per additional patient screened (

Design of a prostate cancer patient navigation intervention for a Veterans Affairs hospital

38 to

Heeding Our Words: Complexities of Research Among Low-Literacy Populations

47 in a sensitivity analysis). CONCLUSION An intervention based on mailing a customized brochure to patients who were referred for a screening colonoscopy improved CRC screening rates at a university-based general medicine clinic. This intervention was comparable in effectiveness and cost-effectiveness to a similar recently reported low-intensity patient-directed CRC screening intervention, and markedly more affordable and cost-effective than a previously reported physician-directed CRC screening promotion intervention.

Community–Campus Partnership in Action: Lessons Learned From the DuPage County Patient Navigation Collaborative

PURPOSE Colorectal cancer (CRC) screening remains underutilized in the United States. Prior studies reporting the cost effectiveness of randomized interventions to improve CRC screening have not been replicated in the setting of small physician practices. We recently conducted a randomized trial evaluating an academic detailing intervention in 264 small practices in geographically diverse New York City communities. The objective of this secondary analysis is to assess the cost effectiveness of this intervention. METHODS A total of 264 physician offices were randomly assigned to usual care or to a series of visits from trained physician educators. CRC screening rates were measured at baseline and 12 months. The intervention costs were measured and the incremental cost-effectiveness ratio (ICER) was derived. Sensitivity analyses were based on varying cost and effectiveness estimates. RESULTS Academic detailing was associated with a 7% increase in CRC screening with colonoscopy. The total intervention cost was

Evaluating a Bilingual Patient Navigation Program for Uninsured Women With Abnormal Screening Tests for Breast and Cervical Cancer: Implications for Future Navigator Research

147,865, and the ICER was

What Women Want: Patient Recommendations for Improving Access to Breast and Cervical Cancer Screening and Follow-up

21,124 per percentage point increase in CRC screening rate. Sensitivity analyses that varied the costs of the intervention and the average medical practice size were associated with ICERs ranging from