Gregory Hess

Sirolimus use and cancer incidence among US kidney transplant recipients.

Sirolimus has anti‐carcinogenic properties and can be included in maintenance immunosuppressive therapy following kidney transplantation. We investigated sirolimus effects on cancer incidence among kidney recipients. The US transplant registry was linked with 15 population‐based cancer registries and national pharmacy claims. Recipients contributed sirolimus‐exposed time when sirolimus claims were filled, and unexposed time when other immunosuppressant claims were filled without sirolimus. Cox regression was used to estimate associations with overall and specific cancer incidence, excluding nonmelanoma skin cancers (not captured in cancer registries). We included 32 604 kidney transplants (5687 sirolimus‐exposed). Overall, cancer incidence was suggestively lower during sirolimus use (hazard ratio [HR] = 0.88, 95% confidence interval [CI] = 0.70–1.11). Prostate cancer incidence was higher during sirolimus use (HR = 1.86, 95% CI = 1.15–3.02). Incidence of other cancers was similar or lower with sirolimus use, with a 26% decrease overall (HR = 0.74, 95% CI = 0.57–0.96, excluding prostate cancer). Results were similar after adjustment for demographic and clinical characteristics. This modest association does not provide strong evidence that sirolimus prevents posttransplant cancer, but it may be advantageous among kidney recipients with high cancer risk. Increased prostate cancer diagnoses may result from sirolimus effects on screen detection.

The disease burden of pertussis in adults 50 years old and older in the United States: a retrospective study

BackgroundWhile the incidence of pertussis has increased in adolescents and adults in recent years in the U.S., little is known about the incidence and economic burden of pertussis in older adults. This study provides evidence of the incidence of pertussis and direct medical charges associated with pertussis episodes of care (PEOCs) in adults aged 50 years and older in the U.S.MethodsPEOCs were divided into periods before and after the initial pertussis diagnosis was made (i.e., the index date) to capture any conditions immediately preceding the pertussis diagnosis that may have represented misdiagnoses and subsequent conditions that may have represented sequelae. Data were extracted from IMSs recently acquired SDI databases of longitudinal, patient-level practitioner claims and hospital operational billing records collected from private practitioners and hospitals, respectively, across the U.S. Patients 50 years and older with one or more ICD-9-CM diagnoses for pertussis/whooping cough and/or a laboratory test positive for Bordetella pertussis between 1/1/2006 and 10/31/2010 were eligible for study inclusion. Resource utilization and charges (i.e., unadjudicated claims) associated with the patients physician and hospital care were analyzed. The nationally projected incidence of pertussis was estimated using a subsample of patients with the required data necessary for projection.ResultsEstimated incidence of diagnosed pertussis ranged from 2.1-4.6 cases per 100,000 people across the two age groups (50–64 and [greater than or equal to] 65) during the years 2006 to 2010. The analysis of charges included 5,748 patients [greater than or equal to] 50 years of age with pertussis. Average charges across the entire episode of care were

Pharmacogenomic and pharmacogenetic-guided therapy as a tool in precision medicine: current state and factors impacting acceptance by stakeholders

1,835 and

Cost of palliative radiation to the bone for patients with bone metastases secondary to breast or prostate cancer

14,428 per patient in the outpatient and inpatient settings, respectively. The average number of outpatient (i.e., private practitioner) visits was 2 per patient in both the pre-index and post-index periods.ConclusionsIn the U.S., the incidence of diagnosed pertussis in adults 50 years and older has increased between 2006 and 2010. Healthcare utilization and charges associated with pertussis are substantial, suggesting the need for additional prevention and control strategies and a higher degree of clinical awareness on the part of health care providers. Additional research regarding pertussis in older populations is needed to substantiate these findings.

Effect of reimbursement changes on erythropoiesis-stimulating agent utilization and transfusions†‡

Summary Pharmacogenetic/pharmacogenomic (PGx) testing is currently available for a wide range of health problems including cardiovascular disease, cancer, diabetes, autoimmune disorders, mental health disorders and infectious diseases. PGx contributes important information to the field of precision medicine by clarifying appropriate treatments for specific disease subtypes. Tangible benefits to patients including improved outcomes and reduced total health care costs have been observed. However, PGx-guided therapy faces many barriers to full integration into clinical practice and acceptance by stakeholders, whether practitioner, patient or payer. Each stakeholder has a unique perspective on the role of PGx testing, although all are similarly challenged with demonstrating or appraising its cost-to-benefit value. Coverage by insurers is a critical step in achieving widespread adoption of PGx testing. The acceleration of adoption of precision medicine in general and for PGx testing in particular will be determined by how quickly robust evidence can be accumulated that shows a return on investment for payers in terms of real dollars, for clinicians in terms of patient clinical responses, and for patients in terms of economic, health and quality of life outcomes. Trends in PGx testing utilization and uptake by payers in real-world practice are discussed; the role of pharmacoeconomics in assessing cost-effectiveness is highlighted using a case study in psychiatric care, and several issues that will affect adoption of PGx testing in the United States (US) over the next few years are reviewed.

The importance of clinical variables in comparative analyses using propensity-score matching: the case of ESA costs for the treatment of chemotherapy-induced anaemia.

BackgroundTo estimate the costs (paid amounts) of palliative radiation episodes of care (REOCs) to the bone for patients with bone metastases secondary to breast or prostate cancer.MethodsClaims-linked medical records from patients at 98 cancer treatment centers in 16 US states were analyzed. Inclusion criteria included a primary neoplasm of breast or prostate cancer with a secondary neoplasm of bone metastases; ≥2 visits to ≥1 radiation center during the study period (1 July 2008 through 31 December 2009) on or after the metastatic cancer diagnosis date; radiation therapy to ≥1 bone site; and ≥1 complete REOC as evidenced by a >30-day gap pre- and post-radiation therapy.ResultsThe total number of REOCs was 220 for 207 breast cancer patients and 233 for 213 prostate cancer patients. In the main analysis (which excluded records with unpopulated costs) the median number of fractions per a REOC for treatment of metastases was 10. Mean total radiation costs (i.e., radiation direct cost + cost of radiation-related procedures and visits) per REOC were

Treatment Patterns: Targeted Therapies Indicated for First-Line Management of Metastatic Renal Cell Carcinoma in a Real-World Setting

7457 for patients with breast cancer and

Survival Implications of Opioid Use Before and After Liver Transplantation

7553 for patients with prostate cancer. Results were consistent in sensitivity analyses excluding patients with unpopulated costs.ConclusionsIn the US, current use of radiation therapy for bone metastases is relatively costly and the use of multi-fraction schedules remains prevalent.

Comparative antibiotic failure rates in the treatment of community-acquired pneumonia: Results from a claims analysis

Cancer patients frequently develop chemotherapy‐induced anemia, which can be treated with erythropoiesis‐stimulating agents. These agents have shifted the standard of chemotherapy‐induced anemia treatment away from the previous mainstay of red blood cell transfusions. In July 2007, the Centers for Medicare and Medicaid Services issued a National Coverage Decision restricting reimbursement for erythropoiesis‐stimulating agents to those chemotherapy patients who have hemoglobin levels <10 g/dL at initiation of therapy. This decision was hypothesized to place a greater reliance on transfusions for chemotherapy‐induced anemia treatment. This observational study examined transfusions and erythropoiesis‐stimulating agent utilization rates within defined episodes of chemotherapy care using electronic medical records from seven practices consisting of 39 sites of care across seven states. We compared the frequency of myelosuppressive chemotherapy treatment, erythropoiesis‐stimulating agent administrations, and red blood cell transfusions before and after the National Coverage Decision in oncology patients with chemotherapy‐induced anemia. Although exposure to myelosuppressive chemotherapy was not different, erythropoiesis‐stimulating agent administrations significantly decreased and blood transfusions significantly increased after implementation of the National Coverage Decision. The 31% increase in transfusions for patients aged 65 years and older was significant (P = 0.007) and higher than the 8% increase for patients younger than 65 years (P = 0.358). Changes in practice patterns for chemotherapy‐induced anemia treatment that followed the Centers for Medicare and Medicaid Services reimbursement decision for erythropoiesis‐stimulating agents seem to be impacting practice patterns. Further research is necessary to determine whether these changes represent a widespread and durable shift in patient treatment. Am. J. Hematol., 2010.

Lipid attainment among patients newly treated with lipid-altering drugs

BackgroundThe erythropoiesis-stimulating agents (ESAs) epoetin alfa (EA) and darbepoetin alfa (DA) have comparable efficacy in treating chemotherapy-induced anaemia (CIA). Therapy choice depends on many factors, including cost. Previous estimates of ESA cost differences have been derived from claims data. These data lack clinical variables, such as baseline haemoglobin (Hb) level, which are likely to influence choice of ESA, dosing and costs. We estimated cost differences between DA and EA in patients with cancer receiving chemotherapy, using a propensity-score matched analysis of baseline patient characteristics with and without Hb values to assess the effect of this clinical variable on ESA cost estimates.MethodsData were extracted from electronic medical records in two US databases between January 2004 and December 2006. The study sample included 6743 patients receiving chemotherapy, with one or more visits during the study period, who received an ESA during a chemotherapy episode. Episodes of chemotherapy care were constructed using a 90-day gap in administration to identify the start and end. Patients receiving both DA and EA during their initial chemotherapy episode or with missing data were excluded, representing 42% of patients with CIA receiving an ESA. Drug costs were calculated from the cumulative dose multiplied by 106% of the average sales price (ASP) for DA or EA. Two propensity-score matches were conducted: first using variables available in administrative billing claims systems, then adding the baseline Hb test result. Regression-adjusted cost differences were estimated with and without baseline Hb, using generalized linear models.ResultsUsing baseline Hb levels resulted in a better match of the baseline characteristics for the EA and DA treatment groups than the original sample or the matched sample without Hb variables. Mean ESA costs (year 2007 values) for the original sample were