scholarly journals Resolving Lingering Problems or Continued Support for Pseudoscience? The ICER Value Assessment Update

2017 ◽  
Vol 8 (4) ◽  
pp. 7
Author(s):  
Paul C. Langley

The Institute for Clinical and Economic Review (ICER) released its updated value assessment framework in mid-2017. This included refinements to its conceptual structure and modifications to methods of collecting and assessing evidence. Consequent to this release, a number of authors have commented on the updated value framework, addressing the question of whether the latest framework represents a major revision or merely attempts to resolve lingering problems. The purpose of this commentary is twofold: (i) to revisit what are considered to be fundamental flaws in the ICER value assessment framework and (ii) to question whether or not post-release critiques of the value framework address the fundamental weaknesses in the ICER approach: the absence of credible, evaluable and replicable claims for the benefits and harms of a therapy intervention. The commentary argues that while ICER sees the purpose of its value assessment framework as forming ‘the backbone of rigorous, transparent evidence reports’ in placing ‘scientific methods of evidence analysis at the heart of a clearer and more transparent process’ it falls far short of these ideals. Rather, in attempting to replicate in the US health care environment the evaluation framework mandated by the National Institute for Health and Care Excellence (NICE) in the UK, the ICER falls into the trap of generating value claims for product impact that fail to meet the standards of normal science.   Type: Commentary

2020 ◽  
Vol 11 (2) ◽  
pp. 19
Author(s):  
Paul Langley ◽  
Stephen McKenna

The purpose of this anniversary supplement for Innovations in Pharmacy is to consider and / or propose modern, scientific methods for determining the evidence base for the fair pricing and accessibility of pharmaceutical products and medical devices. At present, such decisions are based on the construction of imaginary value assessment models that fail to meet the standards of normal science. Such a business model has been adopted by the Institute for Clinical and Economic Review (ICER) in the US, NICE in the UK and in a number of other countries.   Article Type: Call for Papers


2018 ◽  
Vol 14 (7) ◽  
pp. e412-e420 ◽  
Author(s):  
M. Kelsey Kirkwood ◽  
Amy Hanley ◽  
Suanna S. Bruinooge ◽  
Elizabeth Garrett-Mayer ◽  
Laura A. Levit ◽  
...  

[Media: see text] Purpose: To describe the US hematology and medical oncology practice landscape and to report findings of the sixth annual ASCO Oncology Practice Census survey. Participants and Methods: ASCO used Medicare Physician Compare data to characterize oncology practices in the United States. Practice size, number of care sites, and geographic distribution were determined. Trends in the number and size of practices from 2013 to 2017 were examined. All US oncology practices were targeted for the survey; survey responses were linked to the practices identified from Physician Compare to augment results and assess generalizability. Results: More than 2,200 hematology/oncology practices provided care to adult patients in 2017. We observed annual decreases in the number of practices and annual increases in practice size. Of the 2017 practices, 394 (18%) completed the survey and accounted for 58% of the US hematologist/oncologist workforce (n = 7,203). Respondents tended to be larger and encompass more sites of care than nonrespondents. Surveyed practices cited payers (58%), competition (38%), and staffing (37%) as primary sources of strain. Prior authorization was dominant among payer pressures (78%). Electronic health records remained a burden on practices, with only 15% reporting full interoperability. Conclusion: The results of ASCO’s 2017 survey indicate that oncology practices are challenged by day-to-day operations, often related to payment, reimbursement, and competition. Our findings likely represent conservative estimates of such burdens because they are driven by responses from midsized to large-sized organizations, which have lower relative administrative burden, greater market influence, and potentially better ability to adapt in a changing health care environment.


2017 ◽  
Vol 8 (2) ◽  
Author(s):  
Paul C Langley

In April 2017, the Institute for Clinical and Economic Review (ICER) issued its evidence report on the value of targeted immune modulators (TIMs) in rheumatoid arthritis. The report made the case that for the TIMs to be accepted for formulary placement in the US, where notional willingness-to-pay thresholds are the ICER gateway criteria, manufacturers should be prepared to offer substantial unit price discounts. The purpose of this commentary is to make the case that the methodology underpinning the ICER claims for value assessment does not meet the required standards of normal science. None of the claims made for clinical and comparative cost-effectiveness are credible, evaluable and replicable. As such, formulary committees have no idea whether ICER recommendations are right or even if they are wrong. They are, in fact, immune to failure and should be rejected. Utilizing ICER claims generated by simulated projections, this review points out that it is entirely possible to justify the current WAC or net pricing structure of TIMS. The review concludes that if ICER is to contribute to the successful formulary placement of drugs and devices the methodology for pricing recommendation should be re-assessed. As it stands, questions must be raised regarding recommendations for, possibly unnecessary, price discounts. ICER needs to develop an assessment framework that focuses on developing claims for competing therapies that are robust, evaluable and replicable together with recommendations on how these claims are to be evaluated in a timeframe meaningful to health care decision makers.   Type: Commentary


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