Banbury Forum Consensus Statement on the Path Forward for Digital Mental Health Treatment.

A major obstacle to mental health treatment for many Americans is accessibility: the United States faces a shortage of mental health providers, resulting in federally designated shortage areas. Although digital mental health treatments (DMHTs) are effective interventions for common mental disorders, they have not been widely adopted by the U.S. health care system. National and international expert stakeholders representing health care organizations, insurance companies and payers, employers, patients, researchers, policy makers, health economists, and DMHT companies and the investment community attended two Banbury Forum meetings. The Banbury Forum reviewed the evidence for DMHTs, identified the challenges to successful and sustainable implementation, investigated the factors that contributed to more successful implementation internationally, and developed the following recommendations: guided DMHTs should be offered to all patients experiencing common mental disorders, DMHT products and services should be reimbursable to support integration into the U.S. health care landscape, and an evidence standards framework should be developed to support decision makers in evaluating DMHTs.

Reaching a shared understanding of shared decision making in health care: NICE's experience of scoping the shared decision making guideline.

NICE's guideline on shared decision making, currently under development, endeavours to support shared decision making as part of routine health care practice. In this article, we summarize our learning to date, gained through the scoping of the guideline, on the key challenges that need to be addressed in the guideline. The production of a scope is the first stage in the development of a NICE guideline, setting the parameters for what will be considered in the guideline. The process for scoping the shared decision making guideline involved discussion with early recruited committee members and engagement with registered stakeholders, through both a workshop and formal consultation. Important, and sometimes divergent, viewpoints about shared decision making were revealed through this process. The key challenges centred on the issues of a need for a common definition of shared decision making, measurability, opportunities, barriers to implementation, and feasibility. Recognizing these challenges aided the refinement of the scope in terms of what the guideline will cover, draft questions and main outcomes for consideration.

Fosaprepitant and aprepitant: an update of the evidence for their place in the prevention of chemotherapy-induced nausea and vomiting.

INTRODUCTION: The selective neurokinin-1 receptor antagonist aprepitant is effective in the treatment of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with both moderately and highly emetogenic chemotherapy. Fosaprepitant has been developed as an intravenous prodrug of aprepitant. AIMS: To update the evidence underlying the use of fosaprepitant to prevent CINV. EVIDENCE REVIEW: Aprepitant in combination with a serotonin antagonist and a corticosteroid controls acute and delayed symptoms of CINV in patients receiving moderately to highly emetogenic chemotherapy. Bioequivalence of fosaprepitant with aprepitant has recently been demonstrated, which has led to its inclusion in clinical guidelines for treatment of acute CINV with highly, and some regimens of moderately, emetogenic chemotherapy. Early studies of the clinical efficacy of fosaprepitant have shown improvement over treatment with ondansetron. Both aprepitant and fosaprepitant are well tolerated with most adverse events observed of mild or moderate intensity. Conflicting economic evidence has shown that whilst aprepitant provides an increased quality of life in patients treated for CINV, there are differing views over its absolute cost in relation to standard therapy. The incremental cost-effectiveness ratio of aprepitant, however, appears to lie within acceptable bounds. PLACE IN THERAPY: Fosaprepitant and aprepitant are recommended in guidelines for preventing CINV due to moderately and highly emetogenic chemotherapy. Fosaprepitant is bioequivalent to aprepitant, and could offer potential benefits for patients who may be unable to tolerate oral administration of antiemetics during an episode of nausea or vomiting.

Rimonabant: the evidence for its use in the treatment of obesity and the metabolic syndrome.

INTRODUCTION: Obesity and overweight affect over 1 billion people worldwide and are leading causes of morbidity and mortality. Clinical features of obesity converge with those of the metabolic syndrome and type 2 diabetes, greatly increasing the risk of long-term adverse outcomes. AIMS: To review the evidence on rimonabant, a novel CB1 receptor antagonist, for the treatment of obese and overweight patients. EVIDENCE REVIEW: There is clear evidence that rimonabant 20 mg/day in conjunction with a hypocaloric diet causes a mean weight loss of 4.6 kg in obese and overweight patients after 1 year's treatment, with approximately 50% of patients achieving a weight loss of ≥5%. One study demonstrated that weight loss is maintained for up to 2 years. The drug also improves lipid and glycemic cardiovascular risk factors, including high-density lipoprotein cholesterol and insulin resistance, and reduces waist circumference, thus reducing the prevalence of metabolic syndrome. Treatment of obese and overweight diabetic patients with rimonabant decreases glycosylated hemoglobin (HbA(1c)), including patients previously untreated for diabetes. The effect of rimonabant appears to be partly independent of weight loss. Rimonabant 20 mg/day is generally well tolerated, with mild to moderate transient adverse effects including nausea, diarrhea, dizziness, and anxiety. Approximately 14% of patients receiving rimonabant 20 mg/day discontinued due to adverse effects, primarily depressed mood, although overall rates of depression did not differ significantly compared with placebo. PLACE IN THERAPY: The evidence supports the use of rimonabant 20 mg/day along with dietary modification to reduce cardiovascular risk factors in obese and overweight patients, including those with diabetes. The drug is contraindicated in patients receiving antidepressants. Long-term data on cardiovascular outcomes, morbidity, and mortality are eagerly awaited.

Vildagliptin: the evidence for its place in the treatment of type 2 diabetes mellitus.

INTRODUCTION: Type 2 diabetes is increasing in prevalence worldwide and is a leading cause of morbidity and mortality, mainly due to the development of complications. Vildagliptin is an inhibitor of dipeptidyl peptidase 4 (DPP-4), a new class of oral antidiabetic agents. AIMS: To evaluate the role of vildagliptin in the management of type 2 diabetes. EVIDENCE REVIEW: Clear evidence shows that vildagliptin improves glycemic control (measured by glycosylated hemoglobin and blood glucose levels) more than placebo in adults with type 2 diabetes, either as monotherapy or in combination with metformin. Vildagliptin is as effective as pioglitazone and rosiglitazone, and slightly less effective than metformin, although better tolerated. Further glycemic control is achieved when adding vildagliptin to metformin, pioglitazone, or glimepride. There is evidence that vildagliptin improves beta-cell function and insulin sensitivity. Vildagliptin does not appear to be associated with weight gain or with a higher risk of hypoglycemia than placebo or other commonly used oral antidiabetic agents. Economic evidence is currently lacking. PLACE IN THERAPY: Vildagliptin improves glycemic control with little if any weight gain or hypoglycemia in adult patients with type 2 diabetes when given alone or in combination with metformin, thiazolidinediones, or sulfonylureas. Since many diabetic patients require combination therapy, the complementary mechanism of action of vildagliptin and other commonly prescribed antidiabetic drugs represents an important new therapeutic option in diabetes management.

Lumiracoxib: the evidence of its clinical impact on the treatment of osteoarthritis.

INTRODUCTION: The symptoms of osteoarthritis (OA) include joint pain, stiffness, and a reduced ability to perform normal daily activities, which result in decreased quality of life. There is currently no known cure or means of preventing the progression of joint damage due to OA. Therefore, treatment focuses on the control of symptoms, including the use of various agents [including nonselective and selective nonsteroidal antiinflammatory drugs (NSAIDs)] to provide pain relief and reduce inflammation. Lumiracoxib is a selective cyclooxygenase-2 (COX-2) inhibitor for the treatment of OA. AIMS: To review the evidence for the treatment of OA with lumiracoxib. EVIDENCE REVIEW: There is evidence that lumiracoxib reduces the pain and stiffness associated with OA, and is as effective as nonselective NSAIDs, and the COX-2 inhibitor celecoxib. There is some evidence that lumiracoxib treatment results in a lower incidence of upper gastrointestinal (GI) ulcer complications compared with nonselective NSAIDs. However, evidence suggests that there is no GI benefit in patients receiving concomitant aspirin medication. With the exception of GI ulcers, the evidence indicates that lumiracoxib has a tolerability profile similar to nonselective NSAIDs: low risk of cardiovascular (CV) events and a low incidence of edema. Changes in liver function occur in some patients, largely at doses >100 mg. The cost effectiveness of lumiracoxib compared with nonselective NSAIDs remains to be determined. CLINICAL VALUE: Lumiracoxib is an alternative treatment option for OA which provides effective pain relief without the GI complications associated with nonselective NSAIDs, and with a low risk of CV events. Lumiracoxib is contraindicated in patients with current, previous, or at risk of, hepatic impairment.

Aprepitant: the evidence for its place in the prevention of chemotherapy-induced nausea and vomiting.

INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) represents a significant burden on patients and healthcare systems. Despite the introduction of serotonin antagonists, many patients still experience CINV, particularly delayed symptoms occurring more than 24 hours after chemotherapy. Aprepitant is a selective neurokinin-1 (NK(1)) receptor antagonist approved for use with other antiemetics to prevent CINV caused by moderately to highly emetogenic chemotherapy. AIMS: To review the evidence underlying the use of aprepitant to prevent CINV. EVIDENCE REVIEW: In patients receiving moderately and highly emetogenic chemotherapy, adding aprepitant to standard antiemetic therapy with dexamethasone and a serotonin antagonist significantly improved control of CINV. The degree of control of delayed CINV was particularly pronounced, and effectiveness was more likely to be maintained in multiple cycles compared with standard therapy. Nausea was generally less frequent among patients taking aprepitant. More patients receiving aprepitant were satisfied with their treatment and reported minimal/no impact of CINV on daily activities. Aprepitant appears to be well tolerated, with fatigue being the most commonly reported adverse event. The drug is an inhibitor and inducer of cytochrome P450 (CYP) 3A4, resulting in contraindications and caution with some concomitant medication. Limited economic evidence suggests that a proportion of the acquisition cost of aprepitant may be offset by savings in overall direct costs of managing CINV. PLACE IN THERAPY: The evidence supports the recommended use of aprepitant in clinical guidelines for the prevention of CINV due to highly emetogenic chemotherapy, and its recently approved role in regimens with moderate risk. It is particularly useful for delayed symptoms.

Bevacizumab: the evidence for its clinical potential in the treatment of nonsmall cell lung cancer.

INTRODUCTION: Lung cancer is the leading cause of cancer-related mortality. Platinum-based chemotherapy is the usual first-line treatment for advanced nonsmall cell lung cancer (NSCLC), although an efficacy plateau has been reached with this approach. Bevacizumab is a recombinant, humanized, monoclonal antibody to vascular endothelial growth factor, which inhibits tumor angiogenesis and is being evaluated as a different mechanism to improve outcomes in patients with stage IIIB/stage IV (metastatic) NSCLC. AIMS: To review the emerging evidence for the potential use of bevacizumab in stage IIIB/IV NSCLC. EVIDENCE REVIEW: Adding bevacizumab to carboplatin plus paclitaxel improves response rates and significantly prolongs time to disease progression, which translates into a significant extension of overall survival (median 2.3 months in one key study). Low levels of intracellular adhesion molecule-1 are associated with better response. Preliminary evidence suggests that combining bevacizumab with erlotinib could improve outcomes in patients relapsing following platinum-based chemotherapy. Episodes of bleeding (particularly pulmonary hemorrhage) are the predominant adverse events associated with bevacizumab, probably a result of tumor disintegration. There is limited evidence that the high acquisition cost of bevacizumab unfavorably affects assessment of its cost effectiveness, although there are few other treatment options in these patients with poor prognosis. PLACE IN THERAPY: The encouraging results obtained with bevacizumab in patients with NSCLC are leading to its adoption in some treatment guidelines. Emerging evidence indicates improved outcomes when bevacizumab is added to carboplatin/paclitaxel in previously untreated patients with NSCLC, and when used with erlotinib in patients who have relapsed following platinum-based chemotherapy.

Aripiprazole: the evidence of its therapeutic impact in schizophrenia.

INTRODUCTION: An ideal antipsychotic would rapidly stabilize acute psychotic symptoms and maintain the patient, without relapse, for prolonged periods in the absence of extrapyramidal, endocrine, diabetic, or cardiovascular side effects, and without weight gain. The dopamine partial agonist aripiprazole is compared with this ideal and with conventional antipsychotics, such as haloperidol, and with atypical antipsychotics. AIMS: To review the evidence for the clinical impact of aripiprazole in the treatment of patients with schizophrenia. EVIDENCE REVIEW: There is clear evidence that aripiprazole is as effective as haloperidol in reducing the positive and negative symptoms of schizophrenia and schizoaffective disorder. In patients with schizophrenia, aripiprazole has been shown to stabilize acute psychotic symptoms, prevent relapse in stabilized patients, and maintain patients with schizophrenia following acute relapse. Furthermore, in common with other atypical antipsychotics, aripiprazole appears to be associated with a lower incidence of side effects than typical antipsychotics and may reduce discontinuation of drug therapy. Evidence also suggests that aripiprazole may be associated with a lower incidence of extrapyramidal symptoms than conventional antipsychotics, but further long-term studies concerning tardive dyskinesia are required. Studies on the cost effectiveness of aripiprazole, as well as the quality of life and general functioning of patients taking the drug are still required, although there is some evidence of improved quality of life. Further evidence comparing aripiprazole with other atypical antipsychotics would be welcome. CLINICAL VALUE: In conclusion, aripiprazole is an atypical antipsychotic suitable for first-line use in patients with schizophrenia. Its clinical value in relation to other atypical antipsychotics remains to be elucidated.

Ciclesonide in persistent asthma: the evidence of its therapeutic value.

INTRODUCTION: Asthma, a respiratory disease associated with airway inflammation and hyperresponsiveness, is one of the most prevalent chronic diseases worldwide affecting both children and adults. Inhaled corticosteroids are considered to be the cornerstone of asthma management. Ciclesonide, an airway-activated inhaled corticosteroid, has been developed for the management of persistent asthma. Its once-daily administration and airway activation may be advantageous in the treatment of asthma. AIMS: The purpose of this article is to review the place in therapy of ciclesonide in the management of patients with persistent asthma based on the available clinical evidence. EVIDENCE REVIEW: The available evidence indicates that ciclesonide has an effect on pulmonary function (forced expiratory volume in 1 s, forced vital capacity, and peak expiratory flow), as well as producing improvements in patient-reported symptoms that are equivalent to those achieved with other inhaled corticosteroids. A few studies have focused on health-related quality of life and have demonstrated a positive effect with ciclesonide treatment. Its pharmacokinetic profile may offer advantages in terms of adverse effects, both local and systemic, although most of the data come from 12-week studies. PLACE IN THERAPY: The current evidence shows that ciclesonide offers another alternative among inhaled corticosteroids, with the potential for fewer adverse effects. The unique pharmacokinetic profile of ciclesonide allows once-daily administration and the airway activation of the drug appears to confer clinical benefit in the treatment of asthma. Its lack of systemic adverse effects make it a viable option for pediatric use.