Safety of Cancer Therapies: At What Cost?

The cost of cancer drugs has increased concurrently with drug safety resulting in both increased survivorship and increased out-of-pocket costs and co-payments for patients. This article evaluates the interplay between patient safety and cancer drug costs to determine how cancer drug costs affect patient safety and well-being. A literature review was performed that identified the main drivers of drug safety costs: drug-drug interactions, adverse drug events, medication errors, and nonadherence. Three main types of costs were identified: out-of-pocket spending, drug cost growth, and safety-related costs. Insured patients receiving chemotherapy pay an average of $10,000/month on out-of-pocket expenses. Annual drug cost growth has been as much as 21% in recent years. Over a span of 13 years, 1999-2013, insurance premiums and out-of-pocket payments have increased by 182% and 200%, respectively. Safety-related concerns include the high cost of developing a new drug, estimated at $5 billion. The cost of development is reflected in the cost of the 12 new cancer drugs that received Food and Drug Administration approval in 2012; 11 were priced at 6 figures. Although advances in pharmaceutical technology and research have yielded effective cancer therapies that reduce physical or treatment-related toxicity, patients have had to face worsening financial uncertainty both during and after treatment. Actions are needed to achieve financial safety, as well as therapeutic and clinical safety, for cancer patients.

Granulocyte colony--stimulating factor for chemotherapy-induced neutropenia in patients with small cell lung cancer : the 40% rule revisited.

Recombinant granulocyte colony-stimulating factor (G-CSF) [filgrastim and lenograstim] and pegylated G-CSF (pegfilgrastim) have been shown to reduce the severity and duration of chemotherapy-associated febrile neutropenia (FN) when administered prophylactically to cancer patients receiving chemotherapeutic regimens. The American Society of Clinical Oncology (ASCO) evidence-based clinical guidelines published in 1994, 1996 and 1997 recommended primary prophylaxis with G-CSF for cancer patients. The 2000 ASCO update, with the same recommendation, highlights the importance of economic considerations in decision making for CSFs. This paper reviews the available cost-effectiveness evidence on the use of G-CSF as primary prophylaxis against FN in patients with small cell lung cancer (SCLC).Cost-effectiveness ratios from a healthcare payer perspective supported the use of filgrastim as primary prophylaxis for people with SCLC, on the basis of both clinical and economic benefits, treated with chemotherapeutic regimens that have an FN rate in the range of 40-60%. However, when indirect and patient out-of-pocket costs attributable to severe FN are included, available evidence suggests that the risk threshold may be reduced by more than half. Given that FN rates associated with chemotherapeutic regimens for SCLC are generally <40%, then few circumstances would warrant the use of G-CSFs (filgrastim and lenograstim) under the current rule. However, inclusion of indirect costs would lower the cost-effectiveness threshold. Future cost-effectiveness studies of medications such as pegfilgrastim should attempt to capture the societal perspective by incorporating productivity-related costs and using base-case rates of FN reported in the literature.

Are telehealth technologies for hypertension care and self-management effective or simply risky and costly?

Hypertension is a prevalent chronic disease that requires ongoing management and self-care. The disease affects 31% of American adults and contributed to or caused the deaths of 348,000 Americans in 2008, fewer than 50% of whom effectively self-managed the disease. However, self-management is complex, with patients requiring ongoing support and easy access to care. Telehealth may help foster the knowledge and skills necessary for those with hypertension to engage in successful self-management. This paper considers the applicability, efficacy, associated risks, and cost-effectiveness of telehealth for individuals and populations with hypertension. Telehealth is a broad term, encompassing telemedicine and mobile health that is used for physician-patient interactions, diagnostics, care delivery, education, information sharing, monitoring, and reminders. Telemedicine may have considerable utility for people diagnosed with hypertension who have poor access or social barriers that constrain access, but potential risks exist. Telehealth technology is evolving rapidly, even in the absence of fully proven cost-effectiveness and efficacy. Considering the cost of inpatient and emergency department care for patients with hypertension, telehealth is a highly attractive alternative, but there are risks to consider. Incorporating telehealth, which is increasingly characterized by mobile health, can increase both the capacity of health care providers and the reach of patient support, clinical management, and self-care. Telehealth studies need improvement; long-term outcome data on cardiovascular events must be obtained, and robust risk analyses and economic studies are needed to prospectively evaluate the safety and cost savings for hypertension self-management.

The financial burden of cancer: estimates from a study of insured women with breast cancer.

The financial impact of cancer can be large, even among persons with comprehensive health insurance policies. Prior studies have found that women with cancer are especially likely to suffer financial hardship. Although controversial, cancer insurance policies are designed to reduce the financial burden of cancer. In this study, we provide estimates of the costs incurred by a cohort of breast cancer patients who were covered by private, Medicare, or Medicaid health insurance. In all, 156 women were interviewed about cancer-related out-of-pocket costs and their knowledge and use of cancer insurance policies. Out-of-pocket expenditures and lost income costs averaged $1,455 per month and varied widely. The majority of out-of-pocket costs were for co-payments for hospitalizations and physician visits. The financial burden of breast cancer accounted for a mean of 98%, 41%, and 26% of monthly income among female breast cancer patients with annual household income levels of < or = $30,000, $30,001-$60,000, and > $60,000, respectively. Cancer insurance policies provided reimbursement for out-of-pocket expenditures for 3% of the women in our study. Our data indicate that even among women with comprehensive health insurance policies, the financial burden of breast cancer can be substantial. Affordable programs that provide reimbursement for medical and nonmedical costs incurred following a diagnosis of breast cancer should be developed, especially for lower income women.

Telehealth technologies: changing the way we deliver efficacious and cost-effective diabetes self-management education.

Nearly 26 million people diagnosed with diabetes mellitus in the U.S. must actively engage in self-management of the disease. Telehealth is a population-based approach with the potential to optimize resources and increase access to diabetes self-management education/training (DSME/T). We conducted a systematic literature review on diabetes education and telehealth (2009­April 2014) to determine whether remote DSME/T sufficiently improves behavioral, clinical, and economic outcomes and access. Twenty-five out of 213 identified systematic literature reviews or meta-analyses (two on mobile health were identified via a Google search) met our criteria and were fully reviewed; 22 additional studies and reports of diabetes-related technologies and interventions were also identified. Telemedicine has the potential to offer great utility, but guidelines for high research standards must be introduced, adopted, and proactively refined to determine the strengths of this technology for DSME/T, behavioral change, cost-effective care, and improved access in chronic disease self-management.

Sample size calculation and power analysis: a quick review.

Diabetes educators conducting research need a basic understanding of statistical concepts so study findings are useful and can be read with confidence. Selecting an adequate sample size is a key step that needs to be considered early in the process of designing a research study. A sample size too small will not provide reliable answers to the study questions asked or research hypotheses needing to be tested. A sample size that is too big can make the study unwieldy, wasting both time and effort. An adequate sample size uses resources and time in the most cost-effective manner and is essential to producing useful research findings. The purpose of this article is to understand the importance of selecting an adequate sample size in gaining information from a small group (sample) that can be generalized to a larger group (population) along with discussing power analyses.