Patient-reported outcomes with lanreotide Autogel/Depot for carcinoid syndrome: An international observational study

Well- or moderately differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are often slow-growing, and some patients with unresectable, asymptomatic, non-functioning tumors may face the choice between watchful waiting (WW), or somatostatin analogues (SSA) to delay progression. We developed a comprehensive multi-criteria decision analysis (MCDA) framework to help patients and physicians clarify their values and preferences, consider each decision criterion, and support communication and shared decision-making. The framework was adapted from a generic MCDA framework (EVIDEM) with patient and clinician input. During a workshop, patients and clinicians expressed their individual values and preferences (criteria weights) and, on the basis of two scenarios (treatment vs WW; SSA-1 [lanreotide] vs SSA-2 [octreotide]) with evidence from a literature review, expressed how consideration of each criterion would impact their decision in favor of either option (score), and shared their knowledge and insights verbally and in writing. The framework included benefit-risk criteria and modulating factors, such as disease severity, quality of evidence, costs, and constraints. Overall and progression-free survival being most important, criteria weights ranged widely, highlighting variations in individual values and the need to share them. Scoring and considering each criterion prompted a rich exchange of perspectives and uncovered individual assumptions and interpretations. At the group level, type of benefit, disease severity, effectiveness, and quality of evidence favored treatment; cost aspects favored WW (scenario 1). For scenario 2, most criteria did not favor either option. Patients and clinicians consider many aspects in decision-making. The MCDA framework provided a common interpretive frame to structure this complexity, support individual reflection, and share perspectives. Ipsen Pharma.

/pdf/development-of-a-framework-based-on-reflective-mcda-to-362uibxv9m.pdf

Development of a Framework Based on Reflective MCDA to Support Patient–Clinician Shared Decision-Making: The Case of the Management of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) in the United States

Introduction: Lanreotide autogel is a synthetic somatostatin analogue which has been FDA and EMA approved for unresectable, well to moderately differentiated, locally advanced or metastatic gastroe...

The safety of lanreotide for neuroendocrine tumor.

Somatostatin analogs (SSAs) are used to treat neuroendocrine tumors (NETs) and acromegaly. Two first-generation SSAs, octreotide long-acting release (OCT LAR) and lanreotide autogel/depot (LAN), are available. A systematic literature review (SLR) was conducted to investigate which characteristics beyond efficacy are most important in patient and healthcare practitioner (HCP) experience of LAN and OCT when used to treat acromegaly and NETs. MEDLINE, Embase, the Cochrane Library, and Database of Abstracts of Reviews of Effect were searched from database inception to January 2019 with terms for first-generation SSAs, NETs, acromegaly, preferences, decision-making, and human factors. Key congresses in 2016–2018 and SLR bibliographies were hand-searched. Two independent reviewers screened articles at title/abstract and full-text stage. Publications fulfilling pre-specified inclusion criteria reported patient or HCP perspectives of LAN or OCT, or any factors affecting treatment perspectives for NETs or acromegaly. A total of 1110 unique records were screened, of which 21 studies were included, reporting from the perspectives of patients (n = 18) and/or HCPs (n = 9). Perspectives were collected using shared decision-making frameworks, questionnaires, informal patient opinion, and a Delphi panel. Where patient preference was specifically reported, LAN was preferred in 4/5 studies and OCT LAR in 1/5. Common factors underlying treatment experience included technical problems with injections and associated pain, emotional quality/anxiety of injections, time and convenience of treatment administration, and independence. Immediate aspects of injections appeared most important to patients, though the possibilities of extended dosing intervals and self-/partner-injection with LAN were also notable factors. Study outcomes favored LAN in this SLR, with factors surrounding injection administration most influential in treatment experience. The findings of this SLR provide a basis that could inform development of decision-making criteria, with patient and HCP treatment perspectives considered. Future studies should utilize a common method to report preference and associated drivers.

/pdf/patient-and-healthcare-provider-perspectives-of-first-44qqwoty6w.pdf

Patient and Healthcare Provider Perspectives of First-Generation Somatostatin Analogs in the Management of Neuroendocrine Tumors and Acromegaly: A Systematic Literature Review.

Acromegaly is a rare, chronic condition caused by growth hormone (GH) overproduction, usually due to a benign tumour of the pituitary gland. During the disease many complications occur, including cardiovascular disease and changes in the musculoskeletal, respiratory, and endocrine systems. Treatment includes surgery, medical therapy, and radiation. In this paper a literature review was conducted for information related to costs of management of acromegaly and its associated comorbidities using PubMed.The majority of total costs represent pharmacological treatment, especially the most common somatostatin analogues (SSA) therapy. The average reported annual cost of SSA therapy is EUR 12,000-40,000. Surgery reduces the cost of care via the possibility of avoiding lifelong pharmacological treatment. Radiotherapy is also suggested to lower the costs of therapy because about 60% of patients eventually will not require further pharmacological treatment; however, it is connected with negative outcomes like hypopituitarism, lower quality of life, and increased mortality. Cabergoline and pegvisomant are the lowest and highest priced treatments, respectively, but the overall impact on the cost of therapy is minor due to less frequent usage of these drugs. It is hard to fully estimate the impact of comorbidities of acromegaly on financial burden because patients are treated for them many years before the diagnosis of the underlying pathology. The treatment cost of comorbidities is higher in uncontrolled patients. Life-long treatment of acromegaly and its comorbidities is very expensive. Early diagnosis and successful treatment reduce direct and indirect costs.

/pdf/the-real-costs-of-acromegaly-analysis-of-different-therapies-b5bbrv7tzr.pdf

The real costs of acromegaly: analysis of different therapies.

Background Lanreotide Autogel is supplied in prefilled syringes. Therefore, it is possible for patients with neuroendocrine tumors to use self-/partner-administered injections. The primary objective of this study was to assess the proportion of patients preferring self/partner injections over injections administered by health care professionals, and to describe the impact of self/partner administration on efficacy, safety, and costs. Methods Of 62 eligible patients, 26 (42%) patients with neuroendocrine tumors treated with a stable dose of lanreotide Autogel 90 mg or 120 mg every 4 weeks agreed to participate in this Phase IV, international, open-label, crossover study, conducted at hospitals in Sweden, Norway, and Denmark. Patients were randomized to two blocks, starting with administration of lanreotide Autogel by either self/partner or a health care professional. Preference for injections administered by self/partner or health care professionals was measured, as well as efficacy, safety, and health care resource utilization (both direct and indirect costs). Results

/pdf/randomized-crossover-study-in-patients-with-neuroendocrine-170mhf8eo0.pdf

Randomized crossover study in patients with neuroendocrine tumors to assess patient preference for lanreotide Autogel(®) given by either self/partner or a health care professional.

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Randomized crossover study in patients with neuroendocrine tumors to assess patient preference for lanreotide Autogel(®) given by either self/partner or a health care professional.