Supporting adherence to oral anticancer agents : clinical practice and clues to improve care provided by physicians, nurse practitioners, nurses and pharmacists

Background: Healthcare provider (HCP) activities and attitudes towards patients strongly influence medication adherence. The aim of this study was to assess current clinical practices to support patients in adhering to treatment with oral anticancer agents (OACA) and to explore clues to improve the management of medication adherence. Methods: A cross-sectional, observational study among HCPs in (haemato-) oncology settings in Belgium and the Netherlands was conducted in 2014 using a composite questionnaire. A total of 47 care activities were listed and categorised into eight domains. HCPs were also asked about their perceptions of adherence management on the items: insight into adherence, patients' communication, capability to influence, knowledge of consequences and insight into causes. Validated questionnaires were used to assess beliefs about medication (BMQ) and shared decision making (SDM-Q-doc). Results: In total, 208 HCPs (29% male) participated; 107 from 51 Dutch and 101 from 26 Belgian hospitals. Though a wide range of activities were reported, certain domains concerning medication adherence management received less attention. Activities related to patient knowledge and adverse event management were reported most frequently, whereas activities aimed at patient's self-efficacy and medication adherence during ongoing use were frequently missed. The care provided differed between professions and by country. Belgian physicians reported more activities than Dutch physicians, whereas Dutch nurses and pharmacists reported more activities than Belgian colleagues. The perceptions of medication adherence management were related to the level of care provided by HCPs. SDM and BMQ outcomes were not related to the care provided. Conclusions: Enhancing the awareness and perceptions of medication adherence management of HCPs is likely to have a positive effect on care quality. Care can be improved by addressing medication adherence more directly e. g., by questioning patients about (expected) barriers and discussing strategies to overcome them, by asking for missed doses and offering (electronic) reminders to support long-term medication adherence. A multidisciplinary approach is recommended in which the role of the pharmacist could be expanded

Estimating VO_2peak in 18–90 Year-Old Adults:Development and Validation of the FitMáx©-Questionnaire

Purpose: Cardiorespiratory fitness (CRF) plays an essential role in health outcomes and quality of life. However, it is often not assessed nor estimated. Objective CRF assessment is costly, labour intensive and not widely available. Patient-reported outcome measures estimate CRF more cost-efficiently, but current questionnaires lack accuracy. The aim of this study is to develop a new self-reported questionnaire to estimate CRF.</p

Adherence, exposure and patients’ experiences with the use of erlotinib in non-small cell lung cancer

Purpose: Erlotinib is an orally administered tyrosine kinase inhibitor used for treatment of non-small cell lung cancer. Understanding actual use of medication is essential for optimizing treatment conditions. Methods: In this multicentre prospective observational study, patients starting erlotinib treatment were followed for 4 months. Adherence was assessed using a medication event monitoring system (MEMS). Area under the curve (AUC) was determined after 1, 2 and 4 months. Before start and at monthly intervals, patients filled out questionnaires about attitude towards medication and disease, quality of life, symptoms and use in daily practice. Results: Sixty-two patients (median age 63.5 years, 53 % male) were included of whom 15 were still on treatment after 4 months. MEMS data of 55 patients revealed a mean adherence of 96.8 ± 4.0 %. Over one-third of patients had an adherence rate ss of erlotinib was higher in patients with rash and patients with moderate–severe anorexia (both p < 0.05). Conclusion: Though adherence to erlotinib treatment is generally high, non-adherence might be an issue in a considerable number of patients. To support optimal erlotinib intake, clinicians need to take adequate measures to ameliorate symptoms and to address adherence and correct intake without food. Especially older patients and those who experience stomatitis may need extra attention

The use of erlotinib in daily practice: a study on adherence and patients' experiences

<p>Abstract</p> <p>Background</p> <p>Adherence to pharmacological therapy is a complex and multi-factorial issue that can substantially alter the outcome of treatment. It has been shown that cancer patients, especially when using long-term medication, have similar adherence rates to those of patients with other diseases. The consequences of poor adherence are poor health outcomes and increased health care costs. Only few studies have focused on the use of oral anticancer agents in daily practice. Information about the reasons for non-adherence is essential for the development of interventions that may increase adherence. This paper presents the CAPER-erlotinib protocol, which is designed to study the relationship between adherence to erlotinib and both the plasma concentration and side-effects in patients with NSCLC. Further, the relationships between patient characteristics, disease characteristics, side-effects, quality of life, patient beliefs and attitude towards disease and medication, dose adjustments, reasons for discontinuation and plasma concentration of erlotinib will be explored.</p> <p>Methods/Design</p> <p>In this prospective observational cohort study 65 NSCLC patients of 18 years or older starting treatment with erlotinib will be followed for a period up to 16 weeks. The main study parameters are adherence, the plasma concentration of erlotinib and the number and grade of side-effects. At baseline and on erlotinib treatment in weeks 3-4, 8-9, 12 and 15-16, patients will be asked to fill out a questionnaire. In weeks 3-4, 8-9 and 15-16 blood samples are collected, which will be analysed for plasma concentration of erlotinib. Adherence will be measured using a medication event monitoring system.</p> <p>Discussion</p> <p>The present study aims to get more insight into patients' experiences with the use of erlotinib in daily practice and the various aspects that govern adherence. We hypothesize that side-effects play an important role in the way patients use erlotinib. We expect that the present study will provide valuable knowledge which will be useful for health care professionals to develop interventions to support patients. This approach will improve the adherence and persistence with the use of erlotinib in order to derive optimal benefit from the medication.</p> <p>Trial Registration</p> <p><a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1830">NTR1830</a></p

The impact of an ‘evergreening’ strategy nearing patent expiration on the uptake of biosimilars and public healthcare costs:a case study on the introduction of a second administration form of trastuzumab in The Netherlands

In this paper, we explore dynamic market share and public healthcare costs of trastuzumab’s evergreening (subcutaneous) variant during introduction of trastuzumab’s competitive biosimilar variants in the Netherlands. We used a time series design to assess dynamic market share of trastuzumab’s evergreening variant after introducing trastuzumab’s biosimilar variants, focusing on the number of treatments and patients. The public healthcare costs of this evergreening strategy were estimated using administrative claims data. Our results show that the original trastuzumab was completely replaced by the subcutaneous and biosimilar variants. The uptake of the subcutaneous form peaked at 50% market share but after the introduction of biosimilars progressively reduced to a market share of 20%, resulting in a more competitive market structure. The public healthcare costs for trastuzumab significantly decreased after the introduction of the biosimilars. After the introduction of the biosimilars, a substantial price drop is visible, with the subcutaneous version, still under patent, also falling sharply in price but less strongly than the iv/biosimilar version. As the costs are publicly funded, we recommend a more explicit societal debate to consider if the potential benefits of subcutaneous Herceptin® (and other similar medicines) are worth the additional costs, and at which price it should be reimbursed as the part of the benefit package.</p

Involvement of Patients and Medical Professionals in the Assessment of Relative Effectiveness: A Need for Closer Cooperation

Objectives: Involvement of patients and medical professionals in assessment of relative effectiveness (relative effectiveness assessment) contributes to an efficient and effective health technology assessment (HTA) process and supports acceptance and implementation of the outcome. This study aimed to analyze stakeholder involvement in assessing relative effectiveness and how the parties involved value this collaboration. Methods: This is a document analysis of all drug assessments completed in 2019 (20) by the public HTA agency of The Netherlands, enriched with semistructured interviews with employees of the HTA agency (18) and representatives of patient (5) and medical (11) associations involved in these assessments. Data were analyzed, coded, and categorized. Results: In almost half of the assessments, there was no coordination with the medical associations at the start of the relative effectiveness assessment and no patient associations involved in this phase. During the assessment procedure, patient and medical associations were always asked to comment on the draft report. Nevertheless, the strict 5-day deadline that the HTA agency uses as a response period often hampered a proper response and involvement. According to interviewees of the HTA agency, this leads to a great diversity in the substantive quality of their input. Patient and medical associations indicated that the HTA agency relies too much on “paper knowledge,” which leads to a (perceived) lack of alignment with clinical practice. Conclusions: The limited involvement results in a lack of coordination and mutual trust. Optimizing involvement of patients and medical professionals in HTA practice requires effort from all parties involved. Procedural adjustments and better coordination, especially at the start of the assessment, would probably improve cooperation

Beoordeling van de prijs van een geneesmiddel: Niet alleen op basis van de waarde voor de patiënten

Voorafgaand aan toelating tot het verzekerde pakket wordt de prijs van een geneesmiddel meestal beoordeeld op basis van de waarde die het medicijn heeft voor de patiënt. Een middel met een groot effect op de gezondheid en overleving mag meer kosten dan een middel met een klein of onzeker effect. Dat lijkt een rechtvaardig uitgangspunt, maar dergelijke ‘waarde-gedreven’ modellen leiden soms tot onredelijk hoge prijzen. Dit leidt vervolgens weer tot discussies over de grenzen van de bekostiging van zorg en tot vertragingen in de toegankelijkheid van geneesmiddelen. Wij betogen dat het voor verschillende categorieën geneesmiddelen logischer zou zijn om de prijzen te baseren op gemiddelde kosten, eventueel gecombineerd met een bonus voor innovatie, de zogenoemde kostprijs-plus-methode

Beoordeling van de prijs van een geneesmiddel. Niet alleen op basis van de waarde voor de patiënten

Voorafgaand aan toelating tot het verzekerde pakket wordt de prijs van een geneesmiddel meestal beoordeeld op basis van de waarde die het medicijn heeft voor de patiënt. Een middel met een groot effect op de gezondheid en overleving mag meer kosten dan een middel met een klein of onzeker effect. Dat lijkt een rechtvaardig uitgangspunt, maar dergelijke ‘waarde-gedreven’ modellen leiden soms tot onredelijk hoge prijzen. Dit leidt vervolgens weer tot discussies over de grenzen van de bekostiging van zorg en tot vertragingen in de toegankelijkheid van geneesmiddelen. Wij betogen dat het voor verschillende categorieën geneesmiddelen logischer zou zijn om de prijzen te baseren op gemiddelde kosten, eventueel gecombineerd met een bonus voor innovatie, de zogenoemde kostprijs-plus-methode

Response and adherence to Nilotinib in daily practice (RAND-study): An in-depth observational study of patients with chronic myeloid leukemia treated with Nilotinib

Background: In chronic myeloid leukemia (CML), oral treatment needs to be taken indefinitely in the majority of patients and specifically for nilotinib, the necessity of a twice daily, fasted schedule is an extra burden. Non-adherence to CML treatment may influence plasma levels and has been recognized as a determinant of treatment failure in CML. Objectives: To gain insight into adherence with the use of nilotinib in daily clinical practice and its influence on exposures and treatment outcome. Methods: A multicentre prospective observational study conducted between August 2013-April 2017. CML patients treated with nilotinib were followed for twelve months. Achievement of a major molecular response (MMR) within the first twelve months of nilotinib treatment was assessed. Adherence was measured by three methods: medication event monitoring system (MEMS) (proportion of days covered [PDC]), pill count (adherence rate [AR]), and self-reported Medication Adherence Report Scale (MARS-5). Nilotinib trough plasma concentrations were measured at baseline, three, six, and twelve months. Results: Sixty-eight patients (57.0 ± 15.0 years;48% female) participated. At baseline, 29 patients were newly starting nilotinib (subpopulation- A) and 39 were already on treatment with nilotinib (subpopulation-B) with a median treatment duration of 39 months (range 3-92). The overall 1-year MMR rate ranged from 44-75%. Median PDC and AR were 99.6 and 100.2 in subpopulation-A and 97.6 and 98.1 in subpopulation-B, respectively. Three and five patients, respectively, had PDC and A