Dave Nellesen

Comorbidities in Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation: A Review of the Literature From the Past Decade

Abstract Background: Irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) are common functional bowel disorders. Patients with IBS-C or CIC often present with ≥ 1 comorbidity that coincides with either of these conditions. These comorbidities may make underappreciated contributions to the patients overall disease burden. Objective: To identify the comorbidities that are the most frequently reported in patients with IBS-C or CIC in the medical literature. Methods: A literature search (January 2001–March 2012) was performed using the Medline and Medline In-Process databases. Studies of adult patients with IBS-C or CIC were selected, and the prevalence rates of the comorbidities were extracted and analyzed according to the body system affected. Results: A total of 70 distinct comorbidities were identified from 35 published studies. These comorbidities involved several body systems, including the gastrointestinal, genitourinary, psychiatric, endocrine, and allergic or immunologic systems. Functional dyspepsia and depression were the most common comorbidities in patients with IBS-C, whereas functional dyspepsia, diabetes, and depression were the most common comorbidities in patients with CIC. Conclusion: Patients with IBS-C or CIC frequently experience a wide range of comorbidities that contribute to their disease burden. Thus, we believe that medical professionals should consider common comorbidities when diagnosing and treating patients with IBS-C or CIC.

Perspectives on comparative effectiveness research: views from diverse constituencies.

Healthcare sector participants in the US and worldwide offer a rich diversity of views on comparative effectiveness research (CER). CER has been defined – and redefined – by separate stakeholders for various purposes in the context of its potential to help address problems in the healthcare systems of the US and other countries. The demand for evidence about treatment alternatives in terms of both clinical and cost effectiveness in actual clinical practice has stimulated the development and dissemination of comparative effectiveness studies. Many participants in these discussions anticipate that the information these studies provide will, at a minimum, support better decision making and more rational allocation of scarce resources to fund healthcare, with fewer dollars allocated to (relatively) ineffective treatments. The more hopeful believe that evidence from comparative effectiveness studies will directly translate into real improvements in the quality and safety of the healthcare provided to patients. While the implementation of CER has implications across global healthcare systems, theUS focus on CER points to the growing influence of payers and their desire to control spending. Significant funding of the CER initiative from the American Recovery and Reinvestment Act of 2009 indicates that an expected return on investment should be new clinical and economic evidence that will yield better value. In addition, the Patient Protection and Affordable Care Act of 2010 establishes a private, nonprofit entity to oversee publicly financed comparative effectiveness studies, the PatientCentered Outcomes Research Institute (PCORI), whose core mission will be to identify priorities for CER, fund these studies and support improvements in CER methodology. A key measure of PCORI’s potential impact is its substantial funding: a trust fund with amounts provided from the general fund that will grow to at least

Budget impact of pasireotide for the treatment of Cushing’s disease, a rare endocrine disorder associated with considerable comorbidities

US150 million in fiscal 2012, with additional funding based on the size of the Medicare population and from new taxes on insurance policies. Altogether, public funding for CER may exceed

Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies

US500 million per year by 2014. Thus, not only will the focus on CER likely change established priorities in the outcomes research arena, but the funding associated with this shift will likely add to the body of analytical evidence alongside existing manufacturer-funded studies that together will describe the key features of alternative medical interventions. In the future, as the voice of the payer grows louder, both health outcomes research and product development are likely to evolve to address new cost-effectiveness objectives, with implications for those conducting research and developing healthcare technologies. In an era marked by increasing prominence of CER evidence, successful pharmaceutical, biotechnology and medical device manufacturers will need to develop products with unambiguous evidence of economic as well as clinical value relative to alternatives. The goal of this editorial is to highlight important issues raised by an increased reliance on CER evidence and how they could have an EDITORIAL Pharmacoeconomics 2010; 28 (10): 789-798 1170-7690/10/0010-0789/

Budget impact of pasireotide LAR for the treatment of acromegaly, a rare endocrine disorder.

49.95/0

Economic burden of multiple chronic comorbidities associated with Cushing’s disease, a rare endocrine disorder

Abstract Objectives: Cushing’s disease (CD) is a rare condition with a prevalence of roughly 39 cases per million in the general population. Healthcare costs are substantial for CD patients with either untreated or inadequately controlled disease. This study assesses the 3-year budget impact of pasireotide on a US managed care health plan following pasireotide (Signifor) availability. Methods: Two scenarios were evaluated to understand the differences in costs associated with the introduction of pasireotide. The first scenario evaluates the budget impact of pasireotide from the perspective of an entire health plan (total budget impact) and the second from the perspective of the pharmacy budget (pharmacy budget impact). Both scenarios evaluate the annual incremental budget impact with and without pasireotide. Scenario 1 includes costs for medical procedures, drug therapies, monitoring, surgical complications, comorbidities for patients with controlled or uncontrolled CD, and adverse events. Procedures include transsphenoidal surgery, bilateral adrenalectomy, radiotherapy and radiosurgery. Drugs include pasireotide (indicated for CD), mifepristone (indicated to control hyperglycemia secondary to hypercortisolism in patients with Cushing’s syndrome) as well as several off-label treatments (ketoconazole, cabergoline, mitotane). Scenario 2 considers costs solely from the perspective of a health plan pharmacy. Costs are in

Perspectives of Comparative Effectiveness Research from the World of Decision Making

2013. Results: The estimated total budget impact is

Budget impact of everolimus for the treatment of progressive, well-differentiated, non-functional neuroendocrine tumors of gastrointestinal or lung origin that are advanced or metastatic

0.0115 per-member per-month (PMPM) in the first year following FDA approval,

PIH4 PERSONALIZED MEDICINE: TRENDS IN CLINICAL STUDIES BASED ON NATIONAL REGISTRY DATA

0.0184 in the second year, and

A Systematic Review of the Economic and Humanistic Burden of Illness in Irritable Bowel Syndrome and Chronic Constipation

0.0194 in the third year. Introduction of pasireotide is expected to increase the pharmacy budget by