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4. Variation in the prices of oncology medicines across Europe and the implications for the future

Author

Godman, Brian, primary, Simoens, Steven, additional, Kurdi, Amanj, additional, Selke, Gisbert, additional, Yfantopoulos, John, additional, Hill, Andrew, additional, Gulbinovic, Jolanta, additional, Martin, Antony P, additional, Timoney, Angela, additional, Gotham, Dzintars, additional, Wale, Janet, additional, Bochenek, Tomasz, additional, Selke Krulichova, Iva, additional, Allocati, Eleonora, additional, Hoxha, Iris, additional, Malaj, Admir, additional, Nachtnebel, Anna, additional, Hamelinck, Wouter, additional, Mitkova, Zornitza, additional, Petrova, Guenka, additional, Laius, Ott, additional, Sermet, Catherine, additional, Langner, Irene, additional, Joppi, Roberta, additional, Jakupi, Arianit, additional, Poplavska, Elita, additional, Greiciute-Kuprijanov, Ieva, additional, Vella Bonanno, Patricia, additional, Piepenbrink, JF Hans, additional, de Valk, Vincent, additional, Plisko, Robert, additional, Wladysiuk, Magdalene, additional, Markovic-Pekovic, Vanda, additional, Mardare, Ileana, additional, Novakovic, Tanja, additional, Parker, Mark, additional, Furst, Jurij, additional, Tomek, Dominik, additional, Banasova, Katarina, additional, Obach Cortadellas, Merce, additional, Zara, Corrine, additional, Pontes, Caridad, additional, Juhasz-Haverinen, Maria, additional, Skiold, Peter, additional, McTaggart, Stuart, additional, Wong-Rieger, Durhane, additional, Campbell, Stephen, additional, and Hill, Ruaraidh, additional

Published
2021
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6. Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications

Author

Godman, Brian, primary, Hill, Andrew, additional, Simoens, Steven, additional, Selke, Gisbert, additional, Selke Krulichová, Iva, additional, Zampirolli Dias, Carolina, additional, Martin, Antony P, additional, Oortwijn, Wija, additional, Timoney, Angela, additional, Gustafsson, Lars L, additional, Voncina, Luka, additional, Kwon, Hye-Young, additional, Gulbinovic, Jolanta, additional, Gotham, Dzintars, additional, Wale, Janet, additional, Cristina Da Silva, Wânia, additional, Bochenek, Tomasz, additional, Allocati, Eleonora, additional, Kurdi, Amanj, additional, Ogunleye, Olayinka O., additional, Meyer, Johanna C, additional, Hoxha, Iris, additional, Malaj, Admir, additional, Hierländer, Christian, additional, Sauermann, Robert, additional, Hamelinck, Wouter, additional, Petrova, Guenka, additional, Laius, Ott, additional, Langner, Irene, additional, Yfantopoulos, John, additional, Joppi, Roberta, additional, Jakupi, Arianit, additional, Greiciute-Kuprijanov, Ieva, additional, Vella Bonanno, Patricia, additional, Piepenbrink, Jf (Hans), additional, de Valk, Vincent, additional, Wladysiuk, Magdalene, additional, Marković-Peković, Vanda, additional, Mardare, Ileana, additional, Fürst, Jurij, additional, Tomek, Dominik, additional, Obach Cortadellas, Mercè, additional, Zara, Corinne, additional, Pontes, Caridad, additional, McTaggart, Stuart, additional, Laba, Tracey-Lea, additional, Melien, Øyvind, additional, Wong-Rieger, Durhane, additional, Bae, SeungJin, additional, and Hill, Ruaraidh, additional

Published
2021
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7. Pricing of oral generic cancer medicines in 25 European countries; findings and implications

Author

Godman, Brian Hill, Andrew Simoens, Professor Steven Kurdi, Amanj Gulbinovic, Jolanta Martin, Antony P. Timoney, Angela and Gotham, Dzintars Wale, Janet Bochenek, Tomasz Rothe, Celia C. Hoxha, Iris Malaj, Admir Hierlaender, Christian and Sauermann, Robert Hamelinck, Wouter Mitkova, Zornitsa and Petrova, Guenka Laius, Ott Sermet, Catherine Langer, Irene and Selke, Gisbert W. Yfantopoulos, John Joppi, Roberta and Jakupi, Arianit Poplavska, Elita Greiciute-Kuprijanov, Ieva and Bonanno, Patricia Vella Piepenbrink, J. F. (Hans) de Valk, Vincent Hagen, Carolin Ringerud, Anne Marthe Plisko, Robert and Wladysiuk, Magdalene Markovic-Pekovic, Vanda Grubisa, Natasa and Ponorac, Tatjana Mardare, Ileana Novakovic, Tanja and Parker, Mark Furst, Jurij Tomek, Dominik Cortadellas, Merce Obach Zara, Corinne Juhasz-Haverinen, Maria Skiold, Peter and McTaggart, Stuart Haycox, Alan

Subjects
health care economics and organizations
Abstract

Introduction: There are appreciable concerns among European health authorities with growing expenditure on cancer medicines and issues of sustainability. The enhanced use of low-cost generics could help. Aims: Consequently, there is a need to comprehensively document current and future arrangements regarding the pricing of generic cancer medicines across Europe, and whether these are indication specific, as well as how this translates into actual prices to provide future direction. Methodology: Mixed-method approach with qualitative research among senior health authority personnel and their advisers. Quantitative research via health authority databases to ascertain current prices for oral cancer medicines that had lost their patent and the influence of population size and economics on prices. Results: Twenty-five European countries participated. The research found the following issues: (a) variable approaches to the pricing of generic cancer medicines, which will continue; (b) no concerns with substitution for oral generic cancer medicines; (c) substantial price reductions versus originators for generic capecitabine (up to -93.1%), generic imatinib (up to -97.8%) and generic temozolomide (up to -80.7%). Prices for oncology medicines are not generally indication specific, and are not affected by population size although influenced by pricing approaches. There have also been price increases for some non-patented cancer medicines following manufacturer changes although now stabilizing. Conclusion: The considerable price reductions seen for some generics means health authorities should further encourage the use of generic oncology medicines when they become available to fund increased volumes and new valued cancer medicines. Countries are also starting to address price increases for generics following changes in the manufacturer.

Published
2019

8. Pricing of oral generic cancer medicines in 25 European countries; findings and implications

Author

Godman, Brian, primary, Hill, Andrew, additional, Simoens, Steven, additional, Kurdi, Amanj, additional, Gulbinovič, Jolanta, additional, Martin, Antony P, additional, Timoney, Angela, additional, Gotham, Dzintars, additional, Wale, Janet, additional, Bochenek, Tomasz, additional, Rothe, Celia C, additional, Hoxha, Iris, additional, Malaj, Admir, additional, Hierländer, Christian, additional, Sauermann, Robert, additional, Hamelinck, Wouter, additional, Mitkova, Zornitza, additional, Petrova, Guenka, additional, Laius, Ott, additional, Sermet, Catherine, additional, Langer, Irene, additional, Selke, Gisbert, additional, Yfantopoulos, John, additional, Joppi, Roberta, additional, Jakupi, Arianit, additional, Poplavska, Elita, additional, Greiciute-Kuprijanov, Ieva, additional, Vella Bonanno, Patricia, additional, Piepenbrink, JF (Hans), additional, de Valk, Vincent, additional, Hagen, Carolin, additional, Ringerud, Anne Marthe, additional, Plisko, Robert, additional, Wladysiuk, Magdalene, additional, Marković-Peković, Vanda, additional, Grubiša, Nataša, additional, Ponorac, Tatjana, additional, Mardare, Ileana, additional, Novakovic, Tanja, additional, Parker, Mark, additional, Fürst, Jurij, additional, Tomek, Dominik, additional, Cortadellas, Mercè Obach, additional, Zara, Corinne, additional, Juhasz-Haverinen, Maria, additional, Skiold, Peter, additional, McTaggart, Stuart, additional, and Haycox, Alan, additional

Published
2019
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10. Clinical and quantitative coronary angiographic predictors of coronary restenosis: a comparative analysis from the balloon-to-stent era

Author

Mercado, Nestor, Boersma, Eric, Wijns, William, Gersh, Bernard J, Morillo, Carlos A, de Valk, Vincent, van Es, Gerrit-Anne, Grobbee, Diederick E, Serruys, Patrick W, and Cardiology

Subjects
surgical procedures, operative, cardiovascular diseases
Abstract

OBJECTIVESWe sought to assess whether coronary stents have modified the predictive value of demographic, clinical and quantitative coronary angiographic (QCA) predictors of coronary restenosis.BACKGROUNDA systematic analysis in a large cohort of registries and randomized trials of the percutaneous transluminal coronary angioplasty (PTCA) and stent era has never been performed.METHODSA total of 9,120 treated lesions in 8,156 patients included in nine randomized trials and 10 registries, with baseline, post-procedural and six-month follow-up QCA analyses, were included in this study. Predictors of restenosis were identified with univariate and multivariate logistic regression analyses. Interaction terms were introduced in the regression equation to evaluate whether the predictors of restenosis were common to both eras or specific for either one of the revascularization techniques.RESULTSThe restenosis rate was 35% after PTCA and 19% after angioplasty with additional stenting. In the univariate analysis, favorable predictors were previous coronary artery bypass graft surgery (CABG), stent use, stent length and a large pre-procedural minimal lumen diameter (pre-MLD); unfavorable predictors were weight, body mass index, diabetes mellitus, multi-vessel disease, lesion length and a high residual post-procedural diameter stenosis (post-DS). Predictors specific for the PTCA population were a large post-procedural MLD (post-MLD) as favorable and a severe pre-procedural DS (pre-DS) as unfavorable. Favorable predictors specific for the stent population were a large post-MLD and a large pre-procedural reference diameter (pre-RD). In the multivariate analysis, the best model included the following favorable predictors: stent use, a large post-MLD, previous CABG and the interaction term between stent use and a large post-MLD; unfavorable predictors were lesion length and diabetes mellitus.CONCLUSIONSThere are no major differences in demographic and clinical predictors of coronary restenosis between PTCA and stent populations. In the modern (stent) era, a severe pre-DS is no longer an unfavorable predictor of restenosis. Still important, but more so in the stent population, is a large post-MLD (optimal result). Finally, a larger pre-RD became a favorable predictor with the advent of stenting.

Published
2001

11. Long-term effects of regulatory warnings and increased media coverage on paroxetine and other SSRIs use

Author

Sub Gen. Pharmacoepi and Clinical Pharm, Sub Pharmacoepidemiology, Sub Pharmacotherapy, Theoretical, Pharmacoepidemiology and Clinical Pharmacology, Hernandez, Juan F., Mantel-Teeuwisse, Aukje K., Van Thiel, Ghislaine, Belitser, Svetlana, Warmerdam, Jan, De Valk, Vincent, Raaijmakers, Jan, Pieters, Toine, Sub Gen. Pharmacoepi and Clinical Pharm, Sub Pharmacoepidemiology, Sub Pharmacotherapy, Theoretical, Pharmacoepidemiology and Clinical Pharmacology, Hernandez, Juan F., Mantel-Teeuwisse, Aukje K., Van Thiel, Ghislaine, Belitser, Svetlana, Warmerdam, Jan, De Valk, Vincent, Raaijmakers, Jan, and Pieters, Toine

Published
2012

13. The effect of completeness of revascularization on event-free survival at one year in the arts trial

Author

van den Brand, Marcel J.B.M, primary, Rensing, Benno J.W.M, additional, Morel, Marie-angèle M, additional, Foley, David P, additional, de Valk, Vincent, additional, Breeman, Arno, additional, Suryapranata, Harry, additional, Haalebos, Maximiliaan M.P, additional, Wijns, William, additional, Wellens, Francis, additional, Balcon, Rafael, additional, Magee, Patrick, additional, Ribeiro, Expedito, additional, Buffolo, Enio, additional, Unger, Felix, additional, and Serruys, Patrick W, additional

Published
2002
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14. Incidence, Predictors, and Significance of Abnormal Cardiac Enzyme Rise in Patients Treated With Bypass Surgery in the Arterial Revascularization Therapies Study (ARTS)

Author

Costa, Marco A., primary, Carere, Ronald G., additional, Lichtenstein, Samuel V., additional, Foley, David P., additional, de Valk, Vincent, additional, Lindenboom, Wietze, additional, Roose, Paul C.H., additional, van Geldorp, Theo R., additional, Macaya, Carlos, additional, Castanon, José L., additional, Fernandez-Avilèz, Francisco, additional, Gonzáles, Jesús Herreros, additional, Heyer, Günter, additional, Unger, Felix, additional, and Serruys, Patrick W., additional

Published
2001
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17. ATL>The effect of completeness of revascularization on event-free survival at one year in the arts trial.

Author

van den Brand, Marcel J. B. M., Rensing, Benno J. W. M., Morel, Marie-angèle M., Foley, David P., de Valk, Vincent, Breeman, Arno, Suryapranata, Harry, Haalebos, Maximiliaan M. P., Wijns, William, Wellens, Francis, Balcon, Rafael, Magee, Patrick, Ribeiro, Expedito, Buffolo, Enio, Unger, Felix, and Serruys, Patrick W.

Subjects
*MYOCARDIAL revascularization, *CORONARY arteries
Abstract

: ObjectivesWe sought to assess the relationship between completeness of revascularization and adverse events at one year in the ARTS (Arterial Revascularization Therapies Study) trial.: BackgroundThere is uncertainty to what extent degree of completeness of revascularization, using up-to-date techniques, influences medium-term outcome.: MethodsAfter consensus between surgeon and cardiologist regarding the potential for equivalence in the completeness of revascularization, 1,205 patients with multivessel disease were randomly assigned to either bypass surgery or stent implantation. All baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization.: ResultsOf 1,205 patients randomized, 1,172 underwent the assigned treatment. Complete data for review were available in 1,143 patients (97.5%). Complete revascularization was achieved in 84.1% of the surgically treated patients and 70.5% of the angioplasty patients (p < 0.001). After one year, the stented angioplasty patients with incomplete revascularization showed a significantly lower event-free survival than stented patients with complete revascularization (i.e., freedom from death, myocardial infarction, cerebrovascular accident and repeat revascularization) (69.4% vs. 76.6%; p < 0.05). This difference was due to a higher incidence of subsequent bypass procedures (10.0% vs. 2.0%; p < 0.05). Conversely, at one year, bypass surgery patients with incomplete revascularization showed only a marginally lower event-free survival rate than those with complete revascularization (87.8% vs. 89.9%).: ConclusionsComplete revascularization was more frequently accomplished by bypass surgery than by stent implantation. One year after bypass, there was no significant difference in event-free survival between surgically treated patients with complete revascularization and those with incomplete revascularization, but patients randomized to stenting with incomplete revascularization had a greater need for subsequent bypass surgery. [Copyright &y& Elsevier]

Published
2002
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18. Quantification of Adverse Drug Reactions Related to Drug Switches in The Netherlands.

Author

Glerum PJ, Maliepaard M, de Valk V, Scholl JHG, van Hunsel FPAM, van Puijenbroek EP, Burger DM, and Neef K

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Drug-Related Side Effects and Adverse Reactions etiology, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, Netherlands epidemiology, Pharmacovigilance, Retrospective Studies, Young Adult, Adverse Drug Reaction Reporting Systems statistics & numerical data, Drug Substitution adverse effects, Drug-Related Side Effects and Adverse Reactions epidemiology
Abstract

We performed a retrospective cohort study in the Dutch patient population to identify active substances with a relatively high number of adverse drug reactions (ADRs) potentially related to drug switching. For this, we analyzed drug switches and reported ADRs related to switching between June 1, 2009, and December 31, 2016, for a selection of 20 active substances. We also compared pharmacovigilance analyses based on the absolute, switch-corrected, and user-corrected numbers of ADRs. In total, 1,348 reported ADRs and over 23.8 million drug switches were obtained from the National Health Care Institute in The Netherlands and from Lareb, which is The Netherlands Pharmacovigilance Centre. There was no correlation between the number of ADRs and the number of switches, but, on average, we found 5.7 reported ADRs per 100,000 switches. The number was relatively high for rivastigmine, levothyroxine, methylphenidate, and salbutamol, with 74.9, 50.9, 47.6, and 26.1 ADRs per 100,000 switches, respectively. When comparing analyses using the absolute number and the switch-corrected number of ADRs, we demonstrate that different active substances would be identified as having a relatively high number of ADRs, and different time periods of increased numbers of ADRs would be observed. We also demonstrate similar results when using the user-corrected number of ADRs instead of the switch-corrected number of ADRs, allowing for a more feasible approach in pharmacovigilance practice. This study demonstrates that pharmacovigilance analyses of switch-related ADRs leads to different results when the number of reported ADRs is corrected for the actual number of drug switches., (© 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.)

Published
2020
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19. [Cardiovascular polypill in high risk patients].

Author

Lafeber M, Spiering W, Bots ML, de Valk V, Visseren FL, and Grobbee DE

Subjects
Cardiovascular Diseases prevention & control, Drug Combinations, Drug Therapy, Combination, Humans, Risk Factors, Treatment Outcome, Anticholesteremic Agents therapeutic use, Antihypertensive Agents therapeutic use, Cardiovascular Diseases drug therapy, Patient Compliance, Platelet Aggregation Inhibitors therapeutic use
Abstract

The initial theoretical concept of a polypill was a fixed-dosed combination pill containing an antiplatelet agent, a cholesterol-lowering agent and multiple blood pressure-lowering agents aimed at the prevention of atherosclerotic vascular disease in the population aged 55 years and up. The reduction in the risk of cardiovascular disease does not depend on the cholesterol level and blood pressure at the start of treatment. The pharmacological reduction in risk factors in individuals with a high risk of atherosclerotic vascular disease is often suboptimal, partly due to the complexity of the guidelines and low adherence to the therapy. A polypill may offer opportunities for improvement. Research has shown that the use of combination products leads to a greater reduction in risk factors than the use of separate substances, possibly through improved adherence to the therapy. The use of a polypill in the prevention of vascular disease in high-risk patients may lead to a more effective reduction in risk, a decrease in costs and a reduction in pharmacological expenditure.

Published
2011

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