Patent expiry and costs for anticancer medicines for clinical use

Godman, Brian; Wild, Claudia; Haycox, Alan

doi:10.5639/gabij.2017.0603.021

Cited by 25 publications

(29 citation statements)

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“…Such activities are essential to raise the profile of mental health including those patients with BP-II as well as discussions about the appropriate management within countries, building on the success of the WHO in raising the profile of AMR and NCDs such as hypertension and diabetes. In addition, counteracting the activities of pharmaceutical companies and others raising the focus on for instance cancer, which is reflected by governments in highincome countries paying very high prices for new cancer medicines with often limited health gain resulting in reduced funding for other disease areas [102,104,243,244].…”

Section: Botswanamentioning

confidence: 99%

Pharmacotherapeutic interventions for bipolar disorder type II: addressing multiple symptoms and approaches with a particular emphasis on strategies in lower and middle-income countries

Godman

Grobler

Van-De-Lisle

et al. 2019

Expert Opinion on Pharmacotherapy

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Introduction: Appropriately managing mental disorders is a growing priority across countries in view of the impact on morbidity and mortality. This includes patients with bipolar disorders (BD). Management of BD is a concern as this is a complex disease with often misdiagnosis, which is a major issue in lower and middleincome countries (LMICs) with typically a limited number of trained personnel and resources. This needs to be addressed. Areas covered: Medicines are the cornerstone of managing patients with Bipolar II across countries including LMICs. The choice of medicines, especially antipsychotics, is important in LMICs with high rates of diabetes and HIV. However, care is currently compromised in LMICs by issues such as the stigma, cultural beliefs, a limited number of trained professionals and high patient co-payments. Expert opinion: Encouragingly, some LMICs have introduced guidelines for patients with BD; however, this is very variable. Strategies for the future include addressing the lack of national guidelines for patients with BD, improving resources for mental disorders including personnel, improving medicine availability and patients' rights, and monitoring prescribing against agreed guidelines. A number of strategies have been identified to improve the treatment of patients with Bipolar II in LMICs, and will be followed up.

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Section: Botswanamentioning

confidence: 99%

Pharmacotherapeutic interventions for bipolar disorder type II: addressing multiple symptoms and approaches with a particular emphasis on strategies in lower and middle-income countries

Godman

Grobler

Van-De-Lisle

et al. 2019

Expert Opinion on Pharmacotherapy

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“…It has been suggested that pharmaceutical companies take the price of other approved medicines for the same diagnosis to set increasingly higher launch prices for their new medicines, which for instance has been leading to increasing costs for drugs for cancer treatment over the years [8,12,115,116]. The process in which the manufacturers base the prices of new medicines on the price of already marketed medicines rather than associate it to the therapeutic benefit was described by Howard et al [10] as reference pricing.…”

Section: Considerations About the Use Of Thresholds In Health Technolmentioning

confidence: 99%

“…The centerpiece of a cost-effectiveness analysis (CEA) is the incremental cost-effectiveness ratio (ICER), which measures the differential cost for a unit of extra benefit gained from a new therapeutic strategy [2,4,5,6,7]. In most cases, new technologies that apply for public funding present higher costs and effectiveness than the technologies currently in use [8,9,10,11,12,13]. For a new technology to be recommended based on economic assessments, several authorities have argued that the ICER must be compared to a cost-effectiveness threshold (CET) value that should represent the highest acceptable cost for an extra unit of benefit [2,5,7,14,15,16,17,18].…”

Section: Introductionmentioning

confidence: 99%

Cost-effectiveness thresholds: methods for setting and examples from around the world

Santos

Guerra

Godman

et al. 2018

Expert Review of Pharmacoeconomics & Outcomes Research

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Cost-effectiveness thresholds (CETs) are used to judge if an intervention represents sufficient value for money to merit adoption in healthcare systems. The study was motivated by the Brazilian context of HTA, where meetings are being conducted to decide on the definition of a threshold. Areas covered: An electronic search was conducted on Medline (via PubMed), Lilacs (via BVS) and ScienceDirect followed by a complementary search of references of included studies, Google Scholar and conference abstracts. Cost-effectiveness thresholds are usually calculated through three different approaches: the willingness-to-pay, representative of welfare economics; the precedent method, based on the value of an already funded technology; and the opportunity cost method, which links the threshold to the volume of health displaced. An explicit threshold has never been formally adopted in most places. Some countries have defined thresholds, with some flexibility to consider other factors. An implicit threshold could be determined by research of funded cases. Expert commentary: CETs have had an important role as a 'bridging concept' between the world of academic research and the 'real world' of healthcare prioritization. The definition of a cost-effectiveness threshold is paramount for the construction of a transparent and efficient Health Technology Assessment system.

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“…They have all improved progression-free survival (PFS) in patients with mCRC; however, there have been concerns expressed regarding the extent of their effectiveness with improving OS [14] and their cost-effectiveness [25, 26]. Theoretically, payers of healthcare should not grant high prices for new cancer medicines that improve PFS but have limited or no improvement on OS, as this will affect available resources for other high-priority disease areas [27]. However, this has to be balanced against the emotive nature of the disease and the anxiety that patients with cancer have [28].…”

Section: Introductionmentioning

confidence: 99%

“…We believe the updated review will help people better understand the benefits and harms of the different treatments in heterogeneous populations in the ‘real world,’ reflecting conditions in routine clinical practice [50, 51]. This is important given the increasing costs of treatments for cancer, increasing pressure on available resources [26, 27, 34, 52–54], and the extent of current litigation surrounding these three MoAbs in Brazil.…”

Section: Introductionmentioning

confidence: 99%

Comparative Effectiveness and Safety of Monoclonal Antibodies (Bevacizumab, Cetuximab, and Panitumumab) in Combination with Chemotherapy for Metastatic Colorectal Cancer: A Systematic Review and Meta-Analysis

Silva

Araújo

Lima³

et al. 2018

BioDrugs

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BackgroundThe last decade has seen the increasing use of biological medicines in combination with chemotherapy containing 5-fluorouracil/oxaliplatin or irinotecan for the treatment of metastatic colorectal cancer (mCRC). These combinations have resulted in increased progression-free survival (PFS) in patients with mCRC; however, there are remaining concerns over the extent of their effect on overall survival (OS). Published studies to date suggest no major differences between the three currently available monoclonal antibodies (MoAbs); however, there are differences in costs. In addition, there is rising litigation in Brazil in order to access these medicines as they are currently not reimbursed.ObjectiveThe aim was to investigate the comparative effectiveness and safety of three MoAbs (bevacizumab, cetuximab and panitumumab) associated with fluoropyrimidine-based chemotherapy regimens and compared to fluoropyrimidine-based chemotherapy alone in patients with mCRC, through an updated systematic review and meta-analysis of concurrent or non-concurrent observational cohort studies, to guide authorities and the judiciary.MethodA systematic review and meta-analysis was performed based on cohort studies published in databases up to November 2017. Effectiveness measures included OS, PFS, post-progression survival (PPS), Response Evaluation Criteria In Solid Tumors (RECIST), response rate, metastasectomy and safety. The methodological quality of the studies was also evaluated.ResultsA total of 21 observational cohort studies were included. There were statistically significant and clinically relevant benefits in patients treated with bevacizumab versus no bevacizumab mainly around OS, PFS, PPS and the metastasectomy rate, but not for the disease control rates. However, there was an increase in treatment-related toxicities and concerns with the heterogeneity of the studies.ConclusionThe results pointed to an advantage in favor of bevacizumab for OS, PFS, PPS, and metastasectomy. Although this advantage may be considered clinically modest, bevacizumab represents a hope for increased survival and a chance of metastasectomy for patients with mCRC. However, there are serious adverse events associated with its use, especially severe hypertension and gastrointestinal perforation, that need to be considered.Electronic supplementary materialThe online version of this article (10.1007/s40259-018-0322-1) contains supplementary material, which is available to authorized users.

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Patent expiry and costs for anticancer medicines for clinical use

Cited by 25 publications

References 0 publications

Pharmacotherapeutic interventions for bipolar disorder type II: addressing multiple symptoms and approaches with a particular emphasis on strategies in lower and middle-income countries

Pharmacotherapeutic interventions for bipolar disorder type II: addressing multiple symptoms and approaches with a particular emphasis on strategies in lower and middle-income countries

Cost-effectiveness thresholds: methods for setting and examples from around the world

Comparative Effectiveness and Safety of Monoclonal Antibodies (Bevacizumab, Cetuximab, and Panitumumab) in Combination with Chemotherapy for Metastatic Colorectal Cancer: A Systematic Review and Meta-Analysis

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