We examined the minimum extent of dependency of UK patient organisations on pharmaceutical industry funding using drug company disclosure reports and patient organisation financial accounts from 2012 ...to 2016. We used linear regression to explain the overall share of industry funding (‘general dependency’) and top donor funding (‘company‐specific dependency’) in organisations’ income. Predictors included patient organisations’ goal; having members and volunteers; geographical scope of activity; headquarter location; expenditure/income ratio; and disease area. The prevalent low levels of general dependency (IQR, 0.1%–6.0%) and company‐specific dependency (IQR, 0.1%–4.3%) made a widespread capture of patient organisations unlikely, though only if one excludes the possibility of significant payment under‐reporting. However, organisations with considerably higher dependency than others might be more prone to co‐optation by industry. Of the 398 organisations, 18 (4.5%) and 8 (2.0%) had general and company‐specific financial dependency over 50%, respectively. However, the shares of outliers exceeding the third quartile plus 1.5 times IQR were 51 (12.8%) and 56 (14.1%) for each dependency type. Certain characteristics including activity profile (advocacy) or indicating limited access to resources (remote location) made organisations vulnerable to developing financial dependency. Future research should examine both financial and non‐financial links between the two sides and their impact on patient organisations’ activity.
This paper explores policy mechanisms behind New Zealand's remarkable track record of cost containment in public pharmaceutical spending, contrasting with most other advanced economies. We drew on a ...review of official policy documents and 28 semi-structured expert interviews. We found that decision making in pricing and reimbursement policy was dominated by a small group of managers at the Pharmaceutical Management Agency (PHARMAC), the country's drug reimbursement and Health Technology Assessment Agency, who negotiated pharmaceutical prices on behalf of the public payer. In formal negotiation over patented pharmaceutical prices these managers applied an array of pricing strategies, most notably, ‘bundling’ consisting of discounted package deals for multiple pharmaceuticals, and ‘play-off tenders’, whereby two or more pharmaceutical companies bid for exclusive contracts. The key pricing strategy for generic drugs, in contrast, was ‘blind-tenders’ taking the form of an annual bidding process for supply contracts. An additional contextual condition on bargaining over pharmaceutical prices was an indirect strategy that involved the cultivation of the PHARMAC's ‘negotiation leverage’. We derived two cost containment mechanisms consisting in the relationship between pricing strategy options and various reimbursement actors. Our findings shed light on aspects of the institutional design of drug reimbursement that may promote the effective use of competitive negotiations of pharmaceutical prices, including specific pricing strategies, by specialist public payer institutions. On this basis, we formulate recommendations for countries seeking to develop or reform policy frameworks to better meet the budgetary challenge posed by pharmaceutical expenditure.
Drug company payments to health care organizations can create conflicts of interest. However, little is known about such financial relationships, especially outside the United States.
To examine the ...concentration and patterns of drug company payments to health care organizations in the United Kingdom.
This cross-sectional study examined nonresearch payments reported in the industry-run Disclosure UK database. Companies participating in Disclosure UK in 2015 and health care organizations receiving their payments were included in the analysis. The data were analyzed descriptively at the health care organization, payment, and donor levels, considering health care organization categories, payment categories, and companies from February 5 through May 28, 2017, with follow-up checks from June 1 through August 31, 2018. Analysis was conducted from July 10 through December 20, 2018.
Share of funding and the Gini index (GI) to measure payment concentration (0 indicates perfect deconcentration eg, all drug companies provide the same value of payments; 1, perfect concentration eg, 1 company provides the entire value of payments) and median and interquartile range (IQR) to measure payment patterns.
A total of 4028 health care organizations received 19 933 payments, worth US $72 110 156.6, from 100 companies. This study identified 11 categories of health care organizations, with 3-public-sector secondary and tertiary care providers, education and research providers, and professional organizations-accumulating 67.2% of funding. The health care organization categories had varying GIs (range, 0.65-0.92), medians (range, $750.3-$45 862.4), and IQRs (range, $389.1-$1843.9 to $3104.4-$199 868.2). Of 4 payment categories, the top category-donations and grants-captured 50.6% of funding. Joint working (collaborative projects with nonindustry partners) had a lower GI (0.64) than other payment categories (range, 0.79-0.84). The median and IQR were the lowest for contributions to costs of events ($366.8; IQR, $229.3-611.3) and highest for joint working ($14 903.7; IQR, $3185.0-34,748.4). The top 10 firms (58.6% of funding) had payments with varying medians (from $366.8 IQR, $244.5-611.3 to $9781.3 IQR, $1834.0-48 906.7).
Although organizations from across the health care system received funding, the payments were concentrated on a few large donors, payments, and recipients. Different payment and recipient categories had different patterns of payment values, suggesting that the industry has diversified its funding strategies across different parts of the health care system. These results suggest that Disclosure UK requires improved transparency, particularly by including built-in recipient categories, and that organizational conflicts of interest need more policy attention, including disclosure of payments independent of the industry.
Abstract Background Chemotherapy with lomustine is widely considered as standard treatment option for progressive glioblastoma. The value of adding radiotherapy to second-line chemotherapy is not ...known. Methods EORTC-2227-BTG (LEGATO, NCT05904119) is an investigator-initiated, pragmatic (PRECIS-2 score: 34 out of 45), randomized, multicenter phase III trial in patients with first progression of glioblastoma. A total of 411 patients will be randomized in a 1:1 ratio to lomustine (110 mg/m 2 every 6 weeks) or lomustine (110 mg/m 2 every 6weeks) plus radiotherapy (35 Gy in 10 fractions). Main eligibility criteria include histologic confirmation of glioblastoma, isocitrate dehydrogenase gene ( IDH ) wild-type per WHO 2021 classification, first progression at least 6 months after the end of prior radiotherapy, radiologically measurable disease according to RANO criteria with a maximum tumor diameter of 5 cm, and WHO performance status of 0–2. The primary efficacy endpoint is overall survival (OS) and secondary endpoints include progression-free survival, response rate, neurocognitive function, health-related quality of life, and health economic parameters. LEGATO is funded by the European Union’s Horizon Europe Research program, was activated in March 2024 and will enroll patients in 43 sites in 11 countries across Europe with study completion projected in 2028. Discussion EORTC-2227-BTG (LEGATO) is a publicly funded pragmatic phase III trial designed to clarify the efficacy of adding reirradiation to chemotherapy with lomustine for the treatment of patients with first progression of glioblastoma. Trial registration ClinicalTrials.gov NCT05904119. Registered before start of inclusion, 23 May 2023
To examine the under-reporting of pharmaceutical company payments to patient organisations by donors and recipients.
Comparative descriptive analysis of payments disclosed on drug company and charity ...regulator websites.
UK.
87 donors (drug companies) and 425 recipients (patient organisations) reporting payments in 2012-2016.
Number and value of payments reported by donors and recipients; differences in reported payments from/to the same donors and recipients; payments reported in either dataset but not the other one; agreement between donor-recipient ties established by payments; overlap between donor and recipient lists and, respectively, industry and patient organisation data.
Of 87 donors, 63 (72.4%) reported payments but 84 (96.6%) were mentioned by recipients. Although donors listed 425 recipients, only 200 (47.1%) reported payments. The number and value of payments reported by donors were 259.8% and 163.7% greater than those reported by recipients, respectively. The number of donors with matching payment numbers and values in both datasets were 3.4% and 0.0%, respectively; for recipients these figures were 7.8% and 1.9%. There were 24 and 3 donors missing from industry and patient organisation data during the entire study period, representing 38.1% and 3.6% of those in the respective datasets. The share of donor-recipient ties in which industry and patient organisation data agreed about donors and recipients was 38.9% and 68.4% in each dataset, respectively. Of 63 donors reporting payments, only 3 (4.8%) had their recipient lists fully overlapping with patient organisation data. Of 200 recipients reporting industry funding, 102 (51.0%) had their donor lists fully overlapping with industry data.
Both donors and recipients under-reported payments. Existing donor and recipient disclosure systems cannot manage potential conflicts of interest associated with industry payments. Increased standardisation could limit the under-reporting by each side but only an integrated donor-recipient database could eliminate it.
AbstractBackgroundSocial scientists have paid increasing attention to health technology assessment (HTA). This paper provides an overview of existing social scientific literature on HTA, with a focus ...on sociology and political science and their subfields. MethodsNarrative review of key pieces in English. ResultsThree broad themes recur in the emerging social science literature on HTA: the drivers of the establishment and concrete institutional designs of HTA bodies; the effects of institutionalized HTA on pricing and reimbursement systems and the broader society; and the social and political influences on HTA decisions. ConclusionSocial scientists bring a focus on institutions and social actors involved in HTA, using primarily small-N research designs and qualitative methods. They provide valuable critical perspectives on HTA, at times challenging its otherwise unquestioned assumptions. However, they often leave aside questions important to the HTA practitioner community, including the role of culture and values. Closer collaboration could be beneficial to tackle new relevant questions pertaining to HTA.
We examined the effects of the COVID-19 pandemic on the screening, diagnosis and treatment of breast cancer in Hungary based on administrative data until June 2021, covering three pandemic waves. ...After correcting for trend and seasonality, the number of mammography examinations decreased by 68% in 2020q2, was around its usual level in 2020q3 and was reduced by 20–35% throughout 2020q4-2021q2. The reduction was caused by a combination of supply-side (temporary suspensions of screening) and demand-side (lower screening participation during the pandemic waves) factors. The number of new breast cancer diagnoses and mastectomy surgeries responded with a lag, and were below their usual level by 15-30% in all quarters between 2020q2 and 2021q2, apart from 2020q4, when there was no significant difference. Using a regression discontinuity framework, we found that the partial mastectomy rate (indicative of early diagnosis) dropped more substantially in 2020q2 in the 61–65 years old age group that was just below the age cut-off of organized screening than in the 66–70 years old age group, and this difference was partially offset in 2021q1. We suggest that policymakers need to motivate the target population (by providing both information and incentives) to catch up on missed screenings.
OnkoNetwork is a patient navigation program established in the Moritz Kaposi General Hospital to improve the timeliness and completeness of cancer investigations and treatment. The H2020 SELFIE ...consortium selected OnkoNetwork as a promising integrated care initiative in Hungary and conducted a multicriteria decision analysis based on health, patient experience, and cost outcomes. In this paper, a more detailed analysis of clinical impacts is provided in the largest subgroup, non-small cell lung cancer (NSCLC) patients. A retrospective cohort study was conducted, enrolling new cancer suspect patients with subsequently confirmed NSCLC in two annual periods, before and after OnkoNetwork implementation (control and intervention cohorts, respectively). To control for selection bias and confounding, baseline balance was improved via propensity score weighting. Overall survival was analyzed in univariate and multivariate weighted Cox regression models and the effect was further characterized in a counterfactual analysis. Our analysis included 123 intervention and 173 control NSCLC patients from early to advanced stage, with significant between-cohort baseline differences. The propensity score-based weighting resulted in good baseline balance. A large survival benefit was observed in the intervention cohort, and intervention was an independent predictor of longer survival in a multivariate analysis when all baseline characteristics were included (HR = 0.63, p = 0.039). When post-baseline variables were included in the model, belonging to the intervention cohort was not an independent predictor of survival, but the survival benefit was explained by slightly better stage distribution and ECOG status at treatment initiation, together with trends for broader use of PET-CT and higher resectability rate. In conclusion, patient navigation is a valuable tool to improve cancer outcomes by facilitating more timely and complete cancer diagnostics. Contradictory evidence in the literature may be explained by common sources of bias, including the wait-time paradox and adjustment to intermediate outcomes.