In the US, the Institute for Clinical and Economic Review (ICER) occupies a special, if not a unique position in promoting economic evaluations of pharmaceutical products that are entirely imaginary. This is not an unusual event. Through ICER’s embrace of the approximate information meme that has dominated health technology assessment for the last 30 years, it is merely trying to emulate agencies in single payer health systems such as the National Institute for Health and Care Excellence (NICE) in the UK who have bought into the approximate information meme lock, stock, and barrel.
Despite repeated criticism of its endorsement of imaginary claims, driven by its belief in the QALY, ICER maintains that health economists have confidence in the ratio properties of multiattribute preference scores when it is obvious that they have only ordinal properties; even pointing out that the preference score algorithms can yield negative values for health states has had no impact on ICER. The belief in the approximate information meme holds steadfast. A cynic might comment that if ICER admitted that the preference scores were actually ordinal, and not ratio measures in disguise, then the ICER reference case model collapses and with it the business case for pricing and access recommendations that ICER has promoted for some ten years.
ICER’s continued pre-eminence should not come as a surprise. Objections to the ICER modeling are muted, typically through a lack of appreciation of its manifest deficiencies as an assumption driven simulation. Media reports which do nothing but mirror ICER press release, dutifully report the recommendations, emphasizing the need for significant price discounting, without the faintest idea of the manifest deficiencies of the modeling in is a rejection of the standards of normal science and the role of assumptions to open up an imaginary future. To the media should be added groups that should know better in their support; four are noteworthy: the Academy of Managed Care Pharmacy, Department of Veterans Affairs (US Government), the National Pharmaceutical Council (NPC) and CVS Pharmacy.
Recently, the NPC has underwritten a review of uncertainty in imaginary constructs; the solutions, apparently, is to ‘tweak’ assumptions and produce a range of competing outcomes to inform formulary committees of the range of possible claims for cost-effectiveness. In fact, all this goes to show is that if you can build on assumption driven set of imaginary value claims there is no limit to the number of competing value claims and prices that can be created. It simply cuts the ground from under the approximate information meme where ICERAnalytics now allows the construction by varying its model assumptions to create any number of competing value claims. .
The ICER economic models, which are the centerpiece of their draft and final evidence reports are typically formulaic. Produced by academic research groups at selected institutions, the models are off-the-shelf each repeating variations on the assumption driven simulation structure of the preceding ones. There are no surprises, let alone any acknowledgment that what they are producing is an assumption driven figment of the imagination; different assumptions would produce different results and recommendations. They are in a real sense barren; oblivious to the challenge of an unknown future reality where progress is defined by the exploration of discoveries which, provisionally, are attempting to uncover new facts regarding therapy choice and therapy impact in target patient populations.
ICER’s influence extends beyond contracting out consultants to produce imaginary value claims. The cost-per-incremental QALY model sets the stage for claims for social pricing and the claims for limited access due to notional budget constraints. The notion of social pricing is driven entirely by impossible cost-per-QALY thresholds and the equally impossible incremental-cost-per-QALY modeled lifetime or similar value claims as to value based prices. The favored imaginary cost per QALY threshold is $150,000.
Yet the fantasy continues; a stage production which perseveres despite being panned by the critics. Perhaps one reason for this is that too many critics just miss the point regarding the standards of normal science and accept the ICER reference case focusing on assumptions; a sad commentary on health technology assessment.
Langley P. Nonsense on Stilts – Part 1: The ICER 2020-2023 value assessment framework for constructing imaginary worlds. Inov Pharm. 2020;11(1):No. 12 https://pubs.lib.umn.edu/index.php/innovations/article/view/2444/2348
Langley P. Peter Rabbit is a Badger in Disguise: Deconstructing the Belief System of the Institute for Clinical and Economic Review in Health Technology Assessment. InovPharm. 2021; 12(2): No.20 https://pubs.lib.umn.edu/index.php/innovations/article/view/3992/2855
Langley P. Let a Thousand Models Bloom: ICER Analytics Opens the Floodgates to Cloud Pseudoscience. InovPharm. 2021;12(1): Mo. 5 https://pubs.lib.umn.edu/index.php/innovations/article/view/3606/2668
Langley P. A Failure of Pharmacy Practice: The Academy of Managed Care Pharmacy Format for Formulary Submissions (Version 4.1). Maimon Working Papers. No. 26, December 2021 https://maimonresearch.com/a-failure-of-pharmacy-practice-the-academy-of-managed-care-pharmacy-format-for-formulary-submissions-version-41
Langley P. Without a Clue: The National Pharmaceutical Council and Imaginary Cost-Effectiveness Claims. https://maimonresearch.com/without-a-clue-the-national-pharmaceutical-council-and-imaginary-cost-effectiveness-claims
Langley P. Damaged Goods: Imaginary ICER value assessments and the Veterans Administration. Maimon Working Papers. No. 16, July 2020 https://maimonresearch.com/damaged-goods-imaginary-icer-value-assessments-and-the-veterans-administration
Langley P. The National Pharmaceutical Council: Endorsing the construction of imaginary worlds in health technology assessment. Pharmacy. 2020;8(119);doi:10.3390/pharmacy8030119 https://maimonresearch.com/the-national-pharmaceutical-council-endorsing-the-construction-of-imaginary-worlds-in-health-technology-assessment
Langley PC. CVS Health and the imaginary worlds of the Institute for Clinical and Economic Review (ICER). Inov Pharm. 2018; 9(4):No. 4 https://pubs.lib.umn.edu/index.php/innovations/article/view/1461/1344