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Article ; Online: 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.

Kirshner, Ghyli / Makai, Peter / Brouns, Chiara / Timmers, Lonneke / Kemp, Ron

The European journal of health economics : HEPAC : health economics in prevention and care

2024

Abstract: 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 ... ...

Abstract	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
Language	English
Publishing date	2024-01-08
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2045253-6
ISSN	1618-7601 ; 1618-7598
ISSN (online)	1618-7601
ISSN	1618-7598
DOI	10.1007/s10198-023-01648-w
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Article ; Online: Involvement of Patients and Medical Professionals in the Assessment of Relative Effectiveness: A Need for Closer Cooperation.

Lips, Paulus / Timmers, Lonneke / Bal, Roland / Delnoij, Diana

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

2022 Volume 25, Issue 9, Page(s) 1480–1488

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	Humans ; Netherlands ; Technology Assessment, Biomedical/methods
Language	English
Publishing date	2022-05-09
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1471745-1
ISSN	1524-4733 ; 1098-3015
ISSN (online)	1524-4733
ISSN	1098-3015
DOI	10.1016/j.jval.2022.03.021
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Article ; Online: The Beneluxa Initiative domain task force health technology assessment: a comparison of member countries' past health technology assessments.

Vreman, Rick A / van Hoof, Daan / Nachtnebel, Anna / Daems, Joël / van de Casteele, Marc / Fogarty, Emer / Adams, Roisin / Timmers, Lonneke

International journal of technology assessment in health care

2023 Volume 39, Issue 1, Page(s) e44

Abstract: Objective: This study aimed to compare assessments between Beneluxa Initiative member countries' assessments and identify alignments and divergences.: Methods: A retrospective comparative analysis was performed that investigated (i) number and type ... ...

Abstract	Objective: This study aimed to compare assessments between Beneluxa Initiative member countries' assessments and identify alignments and divergences. Methods: A retrospective comparative analysis was performed that investigated (i) number and type of assessed indications (for Austria (AT), Belgium (BE), Ireland (IE), and the Netherlands (NL)); (ii) added benefit conclusions (for BE, IE, and NL); and (iii) the main arguments underlying differences in conclusions (for BE, IE, and NL). Data were retrieved directly from agency representatives and from public HTA reports. European Medicines Agency approved indications were included for drugs assessed between 2016 and 2020, excluding veterinary drugs, generics, and biosimilars. Results: Only 44 (10 percent) of the 444 included indications were assessed by all four member countries. Between any pair of two countries, the overlap was higher, from 63 (AT-NL) to 188 (BE-IE). Added benefit conclusions matched exactly in 62-74 percent of the indications, depending on the countries compared. In the remaining cases, most often a difference of one added benefit level was observed (e.g., higher vs. equal relative effect). Contradictory outcomes were very rare: only three cases were observed (lower vs. higher effect). When assessing the underlying arguments for seven cases with different outcomes, differences were attributable to slight differences in weighing of evidence and uncertainties rather than disagreement on aspects within the assessment itself. Conclusions: Despite high variability in European HTA procedures, collaboration on HTA between the Beneluxa Initiative member countries is very feasible and would likely not result in added benefit conclusions that would be very different from added benefit conclusions in national procedures.
MeSH term(s)	Technology Assessment, Biomedical/methods ; Biosimilar Pharmaceuticals ; Retrospective Studies ; Netherlands ; Austria
Chemical Substances	Biosimilar Pharmaceuticals
Language	English
Publishing date	2023-06-15
Publishing country	England
Document type	Journal Article
ZDB-ID	632573-7
ISSN	1471-6348 ; 0266-4623
ISSN (online)	1471-6348
ISSN	0266-4623
DOI	10.1017/S0266462323000338
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Article ; Online: Systemic anticancer treatment in the Netherlands: Few hospitals treat many patients, many hospitals treat few patients.

Peeters, Niels W L / Vreman, Rick A / Cirkel, Geert A / Kersten, Marie José / van Laarhoven, Hanneke W M / Timmers, Lonneke

Health policy (Amsterdam, Netherlands)

2023 Volume 135, Page(s) 104865

Abstract: Introduction: The correlation between patient volume and clinical outcomes is well known for various oncological treatments, especially in the surgical field. The current level of centralisation of systemic treatment of (hemato-)oncology indications in ... ...

Abstract	Introduction: The correlation between patient volume and clinical outcomes is well known for various oncological treatments, especially in the surgical field. The current level of centralisation of systemic treatment of (hemato-)oncology indications in Dutch hospitals is unknown. Objectives: The aim of this study was to gain insight in patient volumes per hospital of patients treated with systemic anticancer treatment in the Netherlands. Methods: National claims data (Vektis) of all 73 Dutch hospitals that provide systemic anticancer medication in the Netherlands for the time period 2019 were used. The distribution of volumes of patients treated with anticancer medication for 38 different haematological or oncological indications was analysed. Hospitals were categorized into academic/specialised, general, and top clinical. Two volume cut off points (10 and 30 patients) were used to identify hospitals treating relatively few patients with anticancer medication. Four indications were investigated in more detail. Results: A wide distribution in patient volumes within hospitals was observed. Top clinical hospitals generally treated the most patients per hospital, followed by general and academic/specialised oncology hospitals. The volume cut off points showed that in 19 indications (50%) the majority (>50%) of all hospitals treated less than 10 patients and in 25 indications (66%) the majority of all hospitals treated less than 30 patients with anticancer medication. Four case studies demonstrated that relatively few hospitals treat many patients while many hospitals treat few patients with anticancer medication. Conclusion: In the majority of oncology indications, a large proportion of Dutch hospitals treat small numbers of unique patients with anticancer medication. The high level of fragmentation gives ground for further exploration and discussion on how the organisation of care can support optimization of the efficiency and quality of care. Professional groups, policy makers, patients, and healthcare insurers should consider per indication whether centralisation is warranted.
MeSH term(s)	Humans ; Netherlands ; Hospitals ; Antineoplastic Agents/therapeutic use ; Delivery of Health Care ; Medical Oncology
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2023-06-30
Publishing country	Ireland
Document type	Journal Article
ZDB-ID	605805-x
ISSN	1872-6054 ; 0168-8510
ISSN (online)	1872-6054
ISSN	0168-8510
DOI	10.1016/j.healthpol.2023.104865
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Zs.B 2250: Show issues

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Article ; Online: Adjuvant immune checkpoint blockade revisited.

van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh / Huisman, Atse / Roy, Anke Pisters-van / Koole, Simone / Timmers, Lonneke / Blank, Christian / Gelderblom, Hans

The Lancet. Oncology

2023 Volume 24, Issue 7, Page(s) 717–719

MeSH term(s)	Humans ; Immune Checkpoint Inhibitors ; Antibodies, Monoclonal ; Immunotherapy/adverse effects
Chemical Substances	Immune Checkpoint Inhibitors ; Antibodies, Monoclonal
Language	English
Publishing date	2023-07-07
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	2049730-1
ISSN	1474-5488 ; 1470-2045
ISSN (online)	1474-5488
ISSN	1470-2045
DOI	10.1016/S1470-2045(23)00233-4
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Zs.A 5696: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Lessons learned from postmarketing withdrawals of expedited approvals for oncology drug indications.

Koole, Simone N / Huisman, Atse H / Timmers, Lonneke / Westgeest, Hans M / van Breugel, Edwin / Sonke, Gabe S / van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh

The Lancet. Oncology

2024 Volume 25, Issue 3, Page(s) e126–e135

Abstract: In the past decade, there have been a record number of oncology therapy approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Besides the EMA's conditional marketing authorisation programme and the FDA's ... ...

Abstract	In the past decade, there have been a record number of oncology therapy approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Besides the EMA's conditional marketing authorisation programme and the FDA's Accelerated Approval Program, we observe a tendency towards fast approval for exploratory studies with non-randomised, uncontrolled designs and surrogate endpoints. This issue raises concerns about the robustness and effectiveness of accepted treatments, leaving patients and health-care professionals in a state of uncertainty. A substantial number of accelerated approvals have recently been withdrawn in the USA, with some still authorised in Europe, emphasising discrepancies in regulatory standards that affect both patients and society as a whole. We highlight examples of drugs, authorised on the basis of surrogate endpoints, that were later withdrawn due to an absence of overall survival benefit. Our findings address the challenges and consequences of accelerated approval pathways in oncology. In conclusion, this Policy Review calls for regulatory bodies to better align their procedures and insist on robust evidence, preferably through unbiased randomised controlled trials. Drug approval processes should prioritise patient benefit, overall survival, and quality of life to minimise risks and uncertainties for patients.
MeSH term(s)	Humans ; Drug Approval ; Europe ; Medical Oncology ; Product Surveillance, Postmarketing ; Safety-Based Drug Withdrawals
Language	English
Publishing date	2024-02-02
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2049730-1
ISSN	1474-5488 ; 1470-2045
ISSN (online)	1474-5488
ISSN	1470-2045
DOI	10.1016/S1470-2045(23)00592-2
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Zs.A 5696: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Beoordeling van de prijs van een geneesmiddel.

Hollak, Carla E M / van den Berg, Sibren / Timmers, Lonneke / Canoy, Marcel

Nederlands tijdschrift voor geneeskunde

2021 Volume 165

Abstract: Before admission to the insured package, the price of a medicine is usually assessed on the basis of the value of the medicine for the patient: a large effect size on health and survival may cost more than a small or uncertain effect. That seems like a ... ...

Title translation	The assessment of the price of a medicine: not only on the basis of the value for the patient.
Abstract	Before admission to the insured package, the price of a medicine is usually assessed on the basis of the value of the medicine for the patient: a large effect size on health and survival may cost more than a small or uncertain effect. That seems like a fair starting point, but such 'value-driven' models sometimes lead to unreasonably high prices. This in turn leads to discussions about limitations within the healthcare budget and to delays in the accessibility of medicines. We argue that it would be more logical for different categories of medicines to base prices on average costs, possibly combined with a bonus for innovation: the so-called cost-plus method.
MeSH term(s)	Drug Costs ; Humans
Language	Dutch
Publishing date	2021-09-09
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	82073-8
ISSN	1876-8784 ; 0028-2162
ISSN (online)	1876-8784
ISSN	0028-2162
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Article ; Online: Author Reply.

van den Berg, Sibren / de Visser, Saco J / Timmers, Lonneke / Hollak, Carla E M

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

2021 Volume 25, Issue 1, Page(s) 158–159

Language	English
Publishing date	2021-09-21
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	1471745-1
ISSN	1524-4733 ; 1098-3015
ISSN (online)	1524-4733
ISSN	1098-3015
DOI	10.1016/j.jval.2021.08.005
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Article: Manufacturers' views on outcome-based agreements.

Barjestehvan Waalwijk van Doorn-Khosrovani, Sahar / Timmers, Lonneke / Pisters-van Roy, Anke / Gijzen, Joël / Blijlevens, Nicole M A / Bloemendal, Haiko

Journal of market access & health policy

2021 Volume 9, Issue 1, Page(s) 1993593

Abstract: Introduction: Outcome-based agreements (OBAs) are occasionally deployed to relieve the burden of high drug prices on healthcare budgets. However, it is not clear when manufacturers are willing to collaborate in establishing such agreements. Therefore, ... ...

Abstract	Introduction: Outcome-based agreements (OBAs) are occasionally deployed to relieve the burden of high drug prices on healthcare budgets. However, it is not clear when manufacturers are willing to collaborate in establishing such agreements. Therefore, we explored the feasibility of OBAs from the manufacturer's point of view. Methods: Dutch market-access experts from eight major pharmaceutical companies, globally active in the field of oncology, were interviewed. Opinions were compiled, and interviewees and their colleagues were then given the chance to review the manuscript for additional comments. Results: Most interviewees believe that OBAs can be useful in providing access to off-label use of authorised medicines, especially when no alternative treatment is available for seriously ill patients. For the licenced indications, manufacturers seem to be more inclined to collaborate when there is a potential incentive to improve market-access (e.g., if the product is not used because of concerns regarding its effectiveness). However, manufacturers are less likely to collaborate when there are greater financial risks for the company. Further concerns were definition of outcome or performance, the impact of compliance on the effectiveness of a drug, administrative burden, uncertainty regarding revenue recognition and the challenges of reimbursing combination therapies. Discussion: Market-access interviewees were generally positive about OBAs, however they were more reluctant towards OBAs for registered indications with low response-rate. The definition of performance or outcome and its clinical relevance and validity, the feasibility of OBAs and their administrative burden are relevant aspects that need to be addressed in advance. Ideally, countries should collaborate to share the outline of OBAs and create shared databases to accumulate evidence.
Language	English
Publishing date	2021-10-29
Publishing country	United States
Document type	Journal Article
ISSN	2001-6689
ISSN	2001-6689
DOI	10.1080/20016689.2021.1993593
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Article ; Online: Patient experiences and views on pharmaceutical care during adjuvant endocrine therapy for breast cancer: A qualitative study.

En-Nasery-de Heer, Selma / Tromp, Vashti N M F / Westerman, Marjan J / Konings, Inge / Beckeringh, Jan Jacob / Boons, Christel L M / Timmers, Lonneke / Hugtenburg, Jacqueline G

European journal of cancer care

2022 Volume 31, Issue 6, Page(s) e13749

Abstract: Objective: The use of adjuvant endocrine therapy (AET) after primary treatment of hormone receptor-positive breast cancer reduces the risk of recurrence and mortality. However, non-adherence is still common. Limited consideration has been given to how ... ...

Abstract	Objective: The use of adjuvant endocrine therapy (AET) after primary treatment of hormone receptor-positive breast cancer reduces the risk of recurrence and mortality. However, non-adherence is still common. Limited consideration has been given to how users deal with AET and the role of pharmaceutical care. Therefore, this study aims to obtain insight into the needs and wishes of women using AET regarding pharmaceutical care and eHealth. Methods: This is a qualitative explorative study comprising semi-structured interviews (n = 16) and a focus group (n = 5) among women who use or used AET after primary early-stage breast cancer (EBC) treatment using a thematic analysis approach. Results: Three themes emerged from the interviews and focus group: (1) experiences with AET use, (2) experiences with provided information and (3) needs and wishes regarding pharmaceutical care. Most women were highly motivated to use AET and indicated to have received useful information on AET. However, many expressed a strong need for more elaborate tailored and timely provided information on AET. They acknowledged the accessibility of pharmacists but reported that currently, pharmacists are hardly involved in AET care. Several women considered eHealth useful to obtain counselling and reliable information. Conclusion: Women need more comprehensive information and follow-up in primary setting after initial cancer treatments. A more elaborate role for the pharmacy and eHealth/mHealth, especially with regard to counselling on side effects and side effect management, could potentially improve pharmaceutical care.
MeSH term(s)	Female ; Humans ; Breast Neoplasms/drug therapy ; Chemotherapy, Adjuvant ; beta-Aminoethyl Isothiourea/therapeutic use ; Medication Adherence ; Pharmaceutical Services ; Patient Outcome Assessment ; Antineoplastic Agents, Hormonal/therapeutic use
Chemical Substances	beta-Aminoethyl Isothiourea (151-16-6) ; Antineoplastic Agents, Hormonal
Language	English
Publishing date	2022-10-27
Publishing country	England
Document type	Journal Article
ZDB-ID	1303114-4
ISSN	1365-2354 ; 0961-5423 ; 1360-5801
ISSN (online)	1365-2354
ISSN	0961-5423 ; 1360-5801
DOI	10.1111/ecc.13749
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