Do Health Technology Assessment organisations consider manufacturers' costs in relation to drug price? A study of reimbursement reports.

INTRODUCTION: Drug reimbursement decisions are often made based on a price set by the manufacturer. In some cases, this price leads to public and scientific debates about whether its level can be justified in relation to its costs, including those related to research and development (R&D) and manufacturing. Such considerations could enter the decision process in collectively financed health care systems. This paper investigates whether manufacturers' costs in relation to drug prices, or profit margins, are explicitly mentioned and considered by health technology assessment (HTA) organisations. METHOD: An analysis of reimbursement reports for cancer drugs was performed. All relevant Dutch HTA-reports, published between 2017 and 2019, were selected and matched with HTA-reports from three other jurisdictions (England, Canada, Australia). Information was extracted. Additionally, reimbursement reports for three cases of expensive non-oncolytic orphan drugs prominent in pricing debates in the Netherlands were investigated in depth to examine consideration of profit margins. RESULTS: A total of 66 HTA-reports concerning 15 cancer drugs were included. None of these reports contained information on manufacturer's costs or profit margins. Some reports contained general considerations of the HTA organisation which related prices to manufacturers' costs: six contained a statement on the lack of price setting transparency, one mentioned recouping R&D costs as a potential argument to justify a high price. For the case studies, 21 HTA-reports were selected. One contained a cost-based price justification provided by the manufacturer. None of the other reports contained information on manufacturer's costs or profit margins. Six reports contained a discussion about lack of transparency. Reports from two jurisdictions contained invitations to justify high prices by demonstrating high costs. CONCLUSION: Despite the attention given to manufacturers' costs in relation to price in public debates and in the literature, this issue does not seem to get explicit systematic consideration in the reimbursement reports of expensive drugs.

Around the Tables - Contextual Factors in Healthcare Coverage Decisions Across Western Europe.

BACKGROUND: Across Western Europe, procedures and formalised criteria for taking decisions on the coverage (inclusion in the benefits basket or equivalent) of healthcare technologies vary substantially. In the decision documents, which display the justification of, the rationale for, these decisions, national healthcare institutes may employ 'contextual factors,' defined here as situation-specific considerations. Little is known about how the use of such contextual factors compares across countries. We describe and compare contextual factors as used in coverage decisions generally and 4 decision documents specifically in Belgium, England, Germany, and the Netherlands. METHODS: Four group interviews with 3 experts from the national healthcare institute of each country, document and web site analysis, and a workshop with 1 to 2 of these experts per country were followed by the examination of the documents of 4 specific decisions taken in each of the 4 countries, sampled to vary widely in type of technology and decision outcome. RESULTS: From the available decision documents, we conclude that in every country studied, contextual factors are established 'around the table,' ie, in deliberation. All documents examined feature contextual factors, with similar contextual factor patterns leading to similar decisions in different countries. The Dutch decisions employ the widest variety of factors, with the exception of the societal functioning of the patient, which is relatively common in Belgium, England, and Germany. Half of the final decisions were taken in another setting, with the consequence that no documentation was retrievable for 2 decisions. CONCLUSION: First, we conclude that in these countries, contextual factors are actively integrated in the decision document, and that this is achieved in deliberation. Conceptualising contextual factors as both situation-specific and actively-integrated affords insight into practices of contextualisation and provides an encouragement for exchange between decision-makers on more qualitative aspects of decisions. Second, the decisions that lacked a publicly accessible justification of the final decision document raised questions on the decisions' legitimacy. Further research could address patterning of contextual factors, elucidate why some factors may remain implicit, and how decisions without a publicly available decision document may enable or restrain decision-making practice.

Dealing with patients facing a history of sexual abuse: A cross-sectional survey among Dutch general practitioners.

BACKGROUND: Sexual abuse (SA) is a common problem. As the primary confidant, the general practitioner (GP) has a valuable role in identifying a history of abuse, specifically with regard to the commonly performed pelvic examination for cervical cancer screening. OBJECTIVES: This study focused on GPs' practice patterns, knowledge, training need and barriers concerning asking patients about SA. Furthermore, it was investigated who performs the cervical smear within the practice and if SA is taken into consideration. METHODS: The authors constructed a 31-item questionnaire, which was sent to a group of 730 Dutch GPs in September 2012. RESULTS: The response rate was 49.3%. Half of the 357 responding GPs asked their patients about SA sometimes. The majority (76.2%) stated they had some knowledge of SA. The most important barriers for not asking were 'no angle or motive for asking' (81.6%), 'presence of third parties' (73.1%), and 'not enough training' (54.1%). In most practices (84.3%), the nurse practitioner (NP) was assigned to perform the cervical smears, of which 34.8% presumably never ask about SA in advance. Additional training was in need according to 68.6%. GPs desired a clinical practice guideline regarding the counselling of SA (83.5%). CONCLUSION: This study showed SA is an under-evaluated problem in general practice, yet GPs are motivated to improve knowledge and counselling skills. NPs perform most of the cervical smears, but the majority never or rarely asked about SA in advance. Educational training and a clinical guideline regarding SA would be appreciated and hence recommended.

Cytokeratin 17 and p63 are markers of the HPV target cell, the cervical stem cell.

BACKGROUND: Basic research on HPV has focused on identifying the genetic changes that lead to cervical carcinoma. However, while focusing on the molecular biology of the cancer, understanding of its cellular biology has lagged: the target cell of the HPV infection is unknown. MATERIALS AND METHODS: In this study we identified the stem cell population of the cervical epithelium by monoclonal antibodies against p63, a homologue of the tumor suppressor gene p53 and cytokeratin 17 (CK17). RESULTS: We noted p63 expression consistently in the nuclei of reserve cells, hyperplasia of the reserve cells and the basal layer of the ectocervical epithelium, while CK17 only stained endocervical reserve cells and reserve cell hyperplasia. CONCLUSION: We conclude that both p63 and CK17 are suitable markers for cervical stem cell identification. Both markers, therefore, qualify for the identification of the HPV target cell.