Insulin degludec (Tresiba??, Novo Nordisk A/S) for the treatment of diabetes: effectiveness, value, and value-based price benchmarks : final report

Insulin degludec (Tresiba??, Novo Nordisk A/S) for the treatment of diabetes: effectiveness, value, and value-based price benchmarks : final report

Collection:
Health Policy and Services Research
Author(s):
Tice, Jeffrey A., author
Ollendorf, Daniel A., author
Chapman, Rick, author
Shore, Karen K., author
Weissberg, Jed, author
Pearson, Steven D., author
Contributor(s):
California Technology Assessment Forum, issuing body.
Institute for Clinical and Economic Review, issuing body.
Publication:
[Boston, MA] : Institute for Clinical and Economic Review, March 14, 2016
Language(s):
English
Format:
Text
Subject(s):
Blood Glucose -- drug effects
Diabetes Mellitus, Type 1 -- drug therapy
Diabetes Mellitus, Type 2 -- drug therapy
Hypoglycemia -- prevention & control
Hypoglycemic Agents -- therapeutic use
Insulin, Long-Acting -- administration & dosage
Insulin, Long-Acting -- therapeutic use
Blood Glucose -- metabolism
Cost-Benefit Analysis
Diabetes Mellitus, Type 1 -- blood
Diabetes Mellitus, Type 1 -- complications
Diabetes Mellitus, Type 2 -- blood
Diabetes Mellitus, Type 2 -- complications
Hypoglycemia -- blood
Hypoglycemia -- chemically induced
Hypoglycemic Agents -- administration & dosage
Insulin -- adverse effects
Severity of Illness Index
Humans
United States
Genre(s):
Technical Report
Abstract:
The Centers for Disease Control and Prevention (CDC) estimates that 29.1 million Americans have diabetes and 1.7 million adults are newly diagnosed with diabetes mellitus (DM) each year. The majority of people with diabetes (~95%) have type 2 diabetes, which is characterized by resistance of tissues in the body to the effects of insulin, a hormone that helps move glucose from the bloodstream into cells in the body where it is needed to provide energy. The remaining 5% of patients have type 1 diabetes, in which an auto-immune process destroys cells in the pancreas that produce insulin, leading to more dramatic increases in blood glucose levels. The metabolic effects associated with elevated blood glucose (hyperglycemia) lead over time to increased risks for premature heart disease, strokes, blindness, peripheral nerve damage, and kidney failure. To treat diabetes, approximately 6 million Americans use insulin therapy as part of their treatment plan to control their blood glucose level. Current guidelines for managing DM of either type recommend target pre-prandial (pre-meal) blood glucose values of 80 to 130 mg per deciliter, peak post-prandial (after meal) blood glucose values <180 mg per deciliter, and hemoglobin A1c (HbA1c) levels of less than or equal 7.0%. Several large clinical trials have demonstrated the benefits of intensive management of blood glucose in reducing the likelihood of downstream complications. However, intensive management, particularly with insulins, has also been associated with an increased risk of hypoglycemia (a drop in blood glucose to abnormally low levels). Untreated, episodes of severe hypoglycemia can lead to seizure, coma, and even death. Even when treated, severe hypoglycemia may increase the risk of myocardial infarction or stroke over the long term. Topic in Context In summarizing the contextual considerations for appraisal of a health care intervention, we seek to highlight the four following specific issues: (1) Is there a particularly high burden/severity of illness? (2) Do other acceptable treatments exist? (3) Are other, equally or more effective treatments nearing introduction into practice? (4) Would other societal values accord substantially more or less priority to providing access to this treatment for this patient population? As mentioned above, chronically uncontrolled hyperglycemia leads to a wide range of adverse health outcomes including retinopathy, nephropathy, neuropathy, and cardiovascular disease. These complications result in significant morbidity and mortality for patients with diabetes. Fortunately, many treatment options exist, including a variety of oral agents that act to increase the body's sensitivity to insulin in patients with type 2 DM. As the disease progresses, however, management of blood glucose becomes more complex, and many patients require insulin to complement treatment. Earlier forms of insulin were relatively short-acting, requiring multiple injections per day and careful coordination with mealtimes to minimize the risk of hyper- and hypoglycemic episodes. Hypoglycemic episodes are the major adverse event associated with insulin therapy. Severe hypoglycemia is defined as an event that requires the assistance of another person to administer carbohydrate, glucagon, or some other form of resuscitation; as described above, severe episodes are associated with significant short- and long-term morbidity and even immediate death in some circumstances. Nonsevere events are typically defined as those with a blood glucose level <70 mg/dL, and they may or may not produce bothersome but transient symptoms (e.g., palpitations, sweating). These nonsevere events can occur during the day or at night (i.e., nocturnal hypoglycemia). The health effects of nonsevere hypoglycemia are less well-understood. Some studies have suggested that these events may be correlated with lower productivity and fatigue, while others have recorded instances of QT prolongation and arrhythmia. However, the transient episodes associated with nonsevere hypoglycemia have not been persuasively linked to adverse long-term health effects. Long-acting insulins To address the disadvantages of frequent injections and hypoglycemia often associated with shorter-acting insulins, long-acting insulins have been developed to meet the background (or "basal") insulin needs of patients with DM. The first long-acting insulin, neutral protamine Hagedorn (NPH) insulin, has a delayed onset, reaching its peak within six to seven hours. At least two injections per day are still needed, however, and insulin levels remain variable during the day. Insulin glargine U100 (Lantus??, Sanofi) and insulin detemir (Levemir??, Novo Nordisk) are newer long-acting insulins with longer half-lives that allow for once-a-day dosing. Randomized trials have demonstrated that patients treated with glargine or detemir require fewer injections and have fewer hypoglycemic episodes that those treated with NPH. Insulin glargine is the dominant long-acting insulin in the current marketplace; it was among the five best-selling pharmaceuticals in 2014, with worldwide sales in excess of $8 billion. Most patients with type 2 DM, particularly those starting insulin use for the first time, are able to achieve adequate glucose control by using long-acting insulins alone or in combination with oral agents. This treatment approach is commonly known as a "basal-only" regimen. But for all patients with type 1 DM, and for those with poorly-controlled or advanced type 2 DM, long-acting insulins are usually used in combination with a short-acting insulin to create a "basal-bolus" regimen. Patients with type 2 DM who require basal-bolus regimens commonly need much higher doses of long-acting insulin than patients on basal-only regimens. Insulin degludec (Tresiba??, Novo Nordisk A/S) Insulin degludec is a new, long-acting insulin for use in both type 1 and type 2 DM. It has a half-life of approximately 25 hours and can be detected in the blood for at least five days after the last dose. The long half-life allows for flexible dosing once a day to maintain a steady level in the blood stream. Insulin degludec comes in two formulations: U100, which contains 100 units of insulin per milliliter and U200, which contains 200 units per milliliter. The more concentrated formulation is designed to meet the needs of patients with type 2 diabetes and large insulin requirements. Insulin degludec was initially reviewed by the Food and Drug Administration (FDA) in November 2012. Approval was not granted at that time because of evidence suggesting a higher rate of major adverse cardiovascular events (MACE) with insulin degludec versus comparator therapy (see "Harms" below for detailed information). Results of an interim analysis of an ongoing trial to measure MACE were subsequently presented to the FDA by the manufacturer, and approval was granted in September 2015. Data from this interim analysis have not been made public so as not to compromise the integrity of the ongoing study. In this review, we sought to assess the comparative clinical effectiveness and comparative value of use of insulin degludec relative to that of other long-acting insulins (i.e., insulin glargine, insulin detemir) in patients with type 1 and type 2 diabetes.
Copyright:
Reproduced with permission of the copyright holder. Further use of the material is subject to CC BY license. (More information)
Extent:
1 online resource (1 PDF file (i-iv, ES1-ES13, 87 pages))
Illustrations:
Illustrations
NLM Unique ID:
101679187 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101679187