An overview of critical decision-points in the medical product lifecycle: Where to include patient preference information in the decision-making process?

Whichello, Chiara; Bywall, Karin Schölin; Mauer, Jonathan; Watt, Stephen J.; Cleemput, Irina; Pinto, Cathy Anne; Overbeeke, Eline van; Huys, Isabelle; Bekker‐Grob, Esther W. de; Hermann, Richard; Veldwijk, Jorien

doi:10.1016/j.healthpol.2020.07.007

Cited by 29 publications

(34 citation statements)

References 20 publications

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“…Techniques such as multiple criteria decision analysis (MCDA) and discrete choice experiments (DCEs) can elicit patient and stakeholder preferences to help establish the societal value of the product [ 46 ]. Furthermore, the preferences can be incorporated during technology development [ 53 ] and there is consensus from the industry, regulatory authorities, and HTA bodies to do so [ 54 ]. Thus, we encourage future go/no-go recommendations to also include patient elicitation methods and not just clinical and economic factors, such as cost effectiveness.…”

Section: Discussionmentioning

confidence: 99%

The Potential Cost-Effectiveness of a Cell-Based Bioelectronic Implantable Device Delivering Interferon-β1a Therapy Versus Injectable Interferon-β1a Treatment in Relapsing–Remitting Multiple Sclerosis

et al. 2021

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Background Current first-line disease-modifying therapies (DMT) for multiple sclerosis (MS) patients are injectable or oral treatments. The Optogenerapy consortium is developing a novel bioelectronic cell-based implant for controlled release of beta-interferon (IFNβ1a) protein into the body. The current study estimated the potential cost effectiveness of the Optogenerapy implant (hereafter: Optoferon) compared with injectable IFNβ1a (Avonex). Methods A Markov model simulating the costs and effects of Optoferon compared with injectable 30 mg IFNβ1a over a 9-year time horizon from a Dutch societal perspective. Costs were reported in 2019 Euros and discounted at a 4% annual rate; health effects were discounted at a 1.5% annual rate. The cohort consisted of 35-year-old, relapsing-remitting MS patients with mild disability. The device is implanted in a daycare setting, and is replaced every 3 years. In the base-case analysis, we assumed equal input parameters for Optoferon and Avonex regarding disability progression, health effects, adverse event probabilities, and acquisition costs. We assumed reduced annual relapse rates and withdrawal rates for Optoferon compared with Avonex. Sensitivity, scenario, value of information, and headroom analysis were performed. Results Optoferon was the dominant strategy with cost reductions (− €26,966) and health gains (0.45 quality-adjusted lifeyears gained). A main driver of cost differences are the acquisition costs of Optoferon being 2.5 times less than the costs of Avonex. The incremental cost-effectiveness ratio was most sensitive to variations in the annual acquisition costs of Avonex, the annual withdrawal rate of Avonex and Optoferon, and the disability progression of Avonex. Conclusion Innovative technology such as the Optoferon implant may be a cost-effective therapy for patients with MS. The novel implantable mode of therapeutic protein administration has the potential to become a new mode of treatment administration for MS patients and in other disease areas. However, trials are needed to establish safety and effectiveness.

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Section: Discussionmentioning

confidence: 99%

The Potential Cost-Effectiveness of a Cell-Based Bioelectronic Implantable Device Delivering Interferon-β1a Therapy Versus Injectable Interferon-β1a Treatment in Relapsing–Remitting Multiple Sclerosis

et al. 2021

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“…With this background and these especially sensitive patients it seems adequate to evaluate the factors that might have an influence and that are relevant for the different stakeholders involved in the decision-making process, from a holistic perspective. Currently the incorporation of patient preferences and the patients’ perspective is a discussion point and decision-making processes are moving forward to the implementation of this approaches [ 22 ]. Multicriteria Decision Analysis (MCDA) through the EVIDEM framework, enables the inclusion of a comprehensive group of criteria that are relevant for establishing the value of the intervention in a specific health system in an explicit, replicable, and systematic way.…”

Section: Introductionmentioning

confidence: 99%

Applying reflective multicriteria decision analysis to understand the value of therapeutic alternatives in the management of gestational and peripartum anaemia in Spain

Casellas

Hidalgo

García-Erce

et al. 2022

BMC Pregnancy Childbirth

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Background The objective of the FeminFER project was to assess the value of ferric carboxymaltose following a multicriteria decision analysis in obstetrics and gynaecology in Spain. Methods Ferric carboxymaltose (FCM) and ferrous sulphate were evaluated using the EVIDEM framework. Ten stakeholders participated to collect different perspectives. The framework was adapted considering evidence retrieved with a PICO-S search strategy and grey literature. Criteria/subcriteria were weighted by level of relevance and an evidence-based decision-making exercise was developed in each criterion; weights and scores were combined to obtain the value of intervention relative to each criterion/subcriterion, that were further combined into the Modulated Relative Benefit-Risk Balance (MRBRB). Results The most important criterion favouring FCM was Compared Efficacy/Effectiveness (0.183 ± 0.07), followed by Patient Preferences (0.059 ± 0.10). Only Direct medical costs criterion favoured FS (-0.003 ± 0.03). MRBRB favoured FCM; 0.45 ± 0.19; in a scale from -1 to + 1. Conclusions In conclusion, considering the several criteria involved in the decision-making process, participants agreed with the use of FCM according to its MRBRB.

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“…Since this implant may possibly be an addition to the current treatment landscape within the field of MS, it is expected that patients will face tough trade-offs concerning the new mode of administration, which makes it an interesting area for research into patient preferences. Furthermore, patient preference information can inform about the (unmet) needs of patients, guide the product development, cost-effectiveness analysis and market authorisation (10)(11)(12). As such, the implant can be tailored to the needs of the patient, which may enhance patient satisfaction, lead to better health and more efficient healthcare systems (13).…”

Section: Introductionmentioning

confidence: 99%

An implantable device to treat multiple sclerosis: A discrete choice experiment on patient preferences in three European countries

Visser

Huls

Groot

et al. 2021

Journal of the Neurological Sciences

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An overview of critical decision-points in the medical product lifecycle: Where to include patient preference information in the decision-making process?

Cited by 29 publications

References 20 publications

The Potential Cost-Effectiveness of a Cell-Based Bioelectronic Implantable Device Delivering Interferon-β1a Therapy Versus Injectable Interferon-β1a Treatment in Relapsing–Remitting Multiple Sclerosis

The Potential Cost-Effectiveness of a Cell-Based Bioelectronic Implantable Device Delivering Interferon-β1a Therapy Versus Injectable Interferon-β1a Treatment in Relapsing–Remitting Multiple Sclerosis

Applying reflective multicriteria decision analysis to understand the value of therapeutic alternatives in the management of gestational and peripartum anaemia in Spain

An implantable device to treat multiple sclerosis: A discrete choice experiment on patient preferences in three European countries

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