Introduction
The construction of assumption driven imaginary worlds to support incremental cost-per-quality adjusted life year (QALY) claims for pricing and access recommendations is the hallmark of the Institute for Clinical and Economic Review’s (ICER) business model. ICER’s latest evidence report on Janus Kinase (JAK) inhibitors in rheumatoid arthritis (RA)follows this model. The JAK inhibitors under review areupadacitinib (RINVOQ, AbbVie), tofacitinib (Xeljanz, Pfizer) and baricitinib (Olumiant, Lilly). In each case the modeled JAK inhibitor and adalimumab were compared as add on therapies to conventional DMARD therapy in the targetedimmune modulator (TIM) treatment arms. First released on 26 September 2019, the ICER evidence report for JAJK inhibitors was subsequently withdrawn with a revised report released on 11 October 2019, followed by a further evidence report for review by the ICER convened California Technology Assessment Forum on 26 November 2019 1,2,3. The final evidence report was released on 9 January,20204. At the same time, this commentary also considers a complementary model framework, the IVI-RA which is an on-line open source imaginary model that has been proposed to evaluate therapy sequences in similar RA populations to those considered by ICER 5,6,7.
The present commentary is concerned with the final evidence report and the modeled economic evaluation. The purpose of this commentary is to point out that the ICER model and consequent recommendations for pricing and access to JAK inhibitors fail to meet the standards of normal science. A similar conclusion applies to the IVI-RA model. They are irrelevant to formulary decisions.
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Previous commentaries have pointed out, including a previous commentary on targeted immune modifiers (TIMs) in RA that if an imaginary incremental cost per QALY model is constructed, then any number of similar models, with the same fatal flaws, can be constructed8,9,10,11,12. These commentaries made the case thatapplying the ICER methodology is an intellectual and analytical dead-end; none of the claims made for comparative cost-effectiveness are credible, evaluable and replicable. As such, formulary committees would have no idea whether ICER recommendations were right or wrong;they would never know and were never expected to know.
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The arguments against the ICER evidence report for JAK inhibitors is an exemplar of the irrelevance of a reference case methodology to support recommendations for pricing and access for any pharmaceutical product or devices. Certainly, the reference case methodology is seen as the ‘state of the art’ in health technology assessment which supports the construction of imaginary, simulated models projecting over the lifetime of a hypothetical patient cohort to generate incremental cost-per-QALY claims. These claims are set against willingness to pay thresholds to convince an audience, who are typically non-technical, to take at face value recommendations for product pricing and access based on a hypothetical world. It is acknowledged by technology assessment groupsthat these are artificial (yet ‘realistic’) but that their redeeming feature, apparently, is that they generate ‘approximate information’ for decision makers; or, more precisely, ‘imaginary’ information (or disinformation)13.
The IVI-RA model suffers from the same lack of scientific merit at the ICER JAK inhibitor model. It is, once again, best seen as pseudoscience; it fails the demarcation test. It opens up the prospect for a multiverse of more complex imaginary worlds to support the apparent need by decision makers for more hypothetical and ‘approximate information’ on an unknown future.
There are more fundamental flaws. ICER claims for product value do not reflect the interests of patients in RA. The reference case assumes that a generic measure of health related quality of life (HRQoL) is appropriate to evaluating the benefits of competing therapies. This belief has been challenged repeatedly over the past 40 years by first, the needs based framework for evaluating quality of life (QoL) and, more recently, since the late 1990s, supplementing the needs approach with the application of Rash Measurement Theory (RMT) to ensure unidimensionality with interval scoring14,15.
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As detailed below, a generic multi-attribute instrument such as the EQ-5D-3L, the backbone of the ICER cost-per-QALY imaginary worlds, fails standards for fundamental measurement. Rather than providing a unidimensional metric that supports RMT, it generates an ordinal manifest score that precludes basic arithmetic operations. This is seen, for example, if wanted to assess effect size. It would be a logically invalid measure 16,17. Despite the demonstrated disease-area specific superiority of needs base QoL instruments, ICER persists in modeling the EQ-5D-3L which, at best is a limited health related quality of life (HRQoL) instrument without a clearly defined construct. As argued here, HRQoL instruments, despite their inability to provide more than manifest ordinal scores, are not relevant if our objective is to assess the QoL impact of therapy interventions. They are clinically focused, representing the interest of physicians and not patients. They take no account of the needs fulfillment of patients with RA and the extent to which competing therapies impact the lives and needs of the patient18. This points to the relevance, not of a generic instrument but ones that are disease specific and patient centric19,20. If we want to assess patient needs, then we don’t need QALYs.
Unfortunately, as we also argue below in the case of RA, ICER has nowhere to go. If the case is made, which it has been in the literature for some 20 years and more, that ordinal measures have to be abandoned, then the ICER cost-per-QALY reference case collapses. It follows that the ICER business model also collapses; apart from the nonsense of attempting to construction imaginary lifetime reference case worlds. It is, perhaps, surprising that ICER launched itself as NICE-lite (National Institute for Health and Clinical Excellence) when the focus in QoL is away from HRQoL and towards needs based, RMT consistent, disease specific outcomes instruments. Indeed, as we also note, the debates over alternative value assessment frameworks come down to a failure to take explicit account of needs-based assessments instead of trying to ‘bolt-on’ other criteria to a core HRQoL model.
The ICER reference case model, to include the IVI-RA, is an unnecessary distraction in health system decision making. If formulary committees and insurers are considering factoring in the ICER recommendations as ‘approximate information’ to support pricing and access, they should put such claims to one side. Any formulary decision must be evidence based where the evaluation techniques meet the standards of normal science. Decisions should not be based on imaginary worlds, as attractive and ‘probably realistic’ they may be to the believer. Admitting that the focus is not on testing hypotheses for product impact and cost-effectiveness but on providing imaginary ‘approximate information’ is not an admissible defense.
Source: https://t-tees.com
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