Outcomes and Drug Costs of Sunitinib Regimens for Metastatic Renal Cell Carcinoma: A Provincial Population-Based Study.

BACKGROUND: Conventional sunitinib dosing in metastatic renal cell carcinoma (mRCC) administers 50 mg daily on a 4 weeks on/2 weeks off (4/2) schedule. Not all patients tolerate this regimen and many undergo modifications to schedule, dose, or both. MATERIAL AND METHODS: All patients with mRCC treated with sunitinib by the Saskatchewan Cancer Agency between January 1, 2006, and January 1, 2013, were included. Regimens were categorized as standard intermittent dosing (SID), modified intermittent schedule (MIS), modified intermittent dosing (MID), combination of modified schedule and dosing (MSD), or continuous dosing (CD). The primary objective was to compare overall survival (OS) between regimens. Secondary outcomes included progression-free survival (PFS), discontinuation due to adverse effects (AE), and medication cost. RESULTS: Among 161 patients, 18.0%, 51.6%, and 30.4% had favorable, intermediate, and poor Heng risk prognoses, respectively. A total of 140 (87.0%) received sunitinib as first-line therapy. MID was associated with longer OS compared with SID (estimated median 28.4 vs. 11.2 months). PFS was longer for MID, MSD, and CD compared with SID (estimated median 12.0, 9.0, and 8.0 months vs. 3.0 months, respectively). Adjustment for potential confounders did not negate these associations. SID also had higher average monthly drug costs than MIS, MID, and MSD. Overall discontinuation rate due to AE was high (24%). CONCLUSION: An adjusted-dose sunitinib regimen is associated with improved OS and PFS over SID, with lower costs. The development of toxicities requiring dose reductions serves as a predictive biomarker for better outcomes.

Hazardous drug residue on exterior vial surfaces: evaluation of a commercial manufacturing process.

PURPOSE: Hazardous drug residue on the exterior surface of drug vials poses a potential risk for exposure of health care workers involved in handling these products. The purpose of this article is to heighten the awareness of this serious issue and to evaluate a commercial manufacturing process for removing and containing hazardous drug (HD) residue on exterior vial surfaces. Additionally, findings from this study are interpreted, incorporated into the current body of evidence, and discussed by experts in this field. METHODS: This study includes separate evaluations for the presence or absence of surface drug contamination on the vials of 3 HD products: 5-fluorouracil, cisplatin, and methotrexate. The drug products were packaged in vials using a patented prewashing/decontamination method, application of a polyvinylchloride (PVC) base, and use of clear glass vials. An additional step of encasing the vial in a shrink-wrapped sheath was used for 5-fluorouracil and cisplatin. RESULTS: Of all 5-fluorouracil (110 vials), methotrexate (60 vials), and cisplatin (60 vials) tested, only 2 had detectable amounts of surface residue. One 5-fluorouracil vial was found to have approximately 4 mg of 5-fluorouracil on the surface of the vial. The second contaminated vial was cisplatin, which was discovered to have 131 ng of platinum, equal to 200 ng of cisplatin or 0.2 µL of cisplatin solution, on the vial sheath. CONCLUSION: Using validated extraction and analytic methods, all but 2 of the 230 tested vials were found to be free of surface drug contamination. Pharmacy leaders need to take an active role in promoting the need for clean HD vials. Manufacturers should be required to provide their clients with data derived from externally validated analytic studies, reporting the level of HD contamination on the exterior of their vial products.

Reimbursement for supportive cancer medications through private insurance in Saskatchewan.

BACKGROUND: As demand for cancer treatment grows, and newer, more expensive drugs become available, public payers in Canada are finding it increasingly difficult to fund the full range of available cancer drugs. OBJECTIVE: To determine the extent of private drug coverage for supportive cancer treatments in Saskatchewan, preparatory to exploring the potential for cost-sharing. METHODS: Patients who presented for chemotherapy and who provided informed consent for participation were surveyed regarding their access to private insurance. Insurers were contacted to verify patients' level of coverage for supportive cancer medications. Groups with specified types of insurance were compared statistically in terms of age, income bracket, time required to assess insurance status, and amount of deductible. Logistic regression was used to determine the effect of patients' age and income on the probability of having insurance. RESULTS: Of 169 patients approached to participate, 156 provided consent and completed the survey. Their mean age was 58.5 years. About two-fifths of all patients (64 or 41%) were in the lowest income bracket (up to $30 000). Sixty-three (40%) of the patients had private insurance for drugs, and 36 (57%) of these plans included reimbursement for supportive cancer medications. A deductible was in effect in 31 (49%) of the plans, a copayment in 28 (44%), and a maximum payment in 8 (13%). Income over $50 000 was a significant predictor of access to drug insurance (p = 0.003), but age was not significantly related to insurance status. CONCLUSIONS: A substantial proportion of cancer patients in this study had access to private insurance for supportive cancer drugs for which reimbursement is currently provided by the Saskatchewan Cancer Agency. Cost-sharing and optimal utilization of the multipayer environment might offer a greater opportunity for public payers to cover future innovative and supportive therapies for cancer, but further study is required to determine whether a cost-sharing program would be cost-effective and in the best interest of patients.