scholarly journals Imaginary Worlds and the Institute for Clinical and Economic Review (ICER) Evidence Report: Targeted Immune Modulators for Rheumatoid Arthritis

2017 ◽  
Vol 8 (2) ◽  
Author(s):  
Paul C Langley
Keyword(s):  
Rheumatoid Arthritis ◽  
Decision Makers ◽  
Unit Price ◽  
Value Assessment ◽  
Assessment Framework ◽  
Immune Modulators ◽  
Price Discounts ◽  
Comparative Cost ◽  
The Us ◽  
Care Decision

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

scholarly journals Transparency, Imaginary Worlds and ICER Value Assessments

2017 ◽  
Vol 8 (4) ◽  
pp. 11
Author(s):  
Paul C. Langley
Keyword(s):  
Lifetime Cost ◽  
Pharmaceutical Products ◽  
Decision Makers ◽  
Assessment Process ◽  
Value Assessment ◽  
Assessment Framework ◽  
Modeling Framework ◽  
Price Discounts ◽  
A Value ◽  
Independent Assessment

The Institute for Clinical and Economic Review (ICER) is seen as offering a credible platform for evaluating the pricing policies for pharmaceutical products and devices. Over the past few years ICER has presented a stream of reports, many of which have recommended substantial price discounts where the results of a lifetime cost-per-QALY modeling suggests they are out of line with notional willingness to pay thresholds and arbitrary budget constraints. At the same time, there have been growing concerns over the lack of transparency in the ICER value assessment process, focusing in particular on the refusal by ICER to allow access to its value assessment modeling framework. The purpose of this brief commentary is to point out that the position taken by ICER over model access is not defensible; the arguments given are specious. This ongoing refusal undercuts the ICER claim to be independent and the credibility of ICER recommendations for price discounting. The solution is for ICER to commit to a transparent process of value assessment, allowing in particular access to its models and for the ICER model to be subject to an independent assessment. At the same time, manufacturers and other stakeholders should have access to the model with the opportunity to challenge the model through developing model frameworks which they feel better represent product value. This advocacy, it should be noted, does not reflect acceptance of the ICER lifetime cost-per-QALY value assessment framework. Health care decision makers would be better served by a value assessment framework that provided short-term credible, evaluable and replicable claims, facilitating meaningful feedback to decision makers, and not on the construction of simulated imaginary worlds. Conflict of Interest: None   Type: Commentary

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
Keyword(s):  
Evaluation Framework ◽  
Value Assessment ◽  
Assessment Framework ◽  
Health Care Environment ◽  
Care Environment ◽  
Scientific Methods ◽  
The Us ◽  
Evidence Analysis ◽  
The Uk ◽  
Therapy Intervention

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

OCT retinal angiography features in patients with rheumatoid arthritis: A pilot study

2021 ◽  
pp. 112067212110356
Author(s):  
Pierluigi Iacono ◽  
Stefano Da Pozzo ◽  
Alberto Bedendo ◽  
Alessandro Arrigo ◽  
Mariacristina Parravano ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Foveal Avascular Zone ◽  
Value Assessment ◽  
Foveal Thickness ◽  
Central Foveal Thickness ◽  
Retinal Capillary ◽  
Capillary Plexus ◽  
Potential Applications ◽  
Treatment Naïve ◽  
Retinal Microcirculation

Purpose: To evaluate the superficial (SCP) and deep retinal capillary plexus (DCP) by mean of optical coherence tomography angiography (OCTA) in treatment-naïve patients affected by rheumatoid arthritis (RA). Methods: Between March 2019 and January 2020, patients with recent diagnosis of “definite RA” based on 2010 Rheumatoid Arthritis Classification Criteria were included in a Prospective, observational single center case-control study carried out at G.B. Bietti Foundation. Data were compared with those of 16 healthy age- and sex-matched subjects. Values of the vessel density (VD) of SCP and DCP, central foveal thickness (CFT), foveal avascular zone (FAZ) were collected by mean of OCTA. Main outcome measure was the VD alteration of SCP and DCP in treatment-naïve RA-patients. Results: No difference in age, sex-distribution, best-corrected visual acuity, CFT was registered between the two groups. OCTA data analysis showed in RA-patients a statistically significant reduction in the VD in the mean global area, inner ring, especially in the superior quadrant of the SCP. A trend of VD reduction was also registered in temporal, nasal, and inferior quadrants, respectively, although it did not reach a statistically significant value. Assessment of VD of DCP and FAZ area did not evidence any difference among the groups. Conclusions: OCTA allows to highlight the vascular remodeling of the retinal microcirculation in RA-patients, even in early stages of the disease, demonstrating a reduction of VD. Outcomes of the current investigation can provide new insight in the pathogenetic mechanism of RA and extend the potential applications of this diagnostic tool.

scholarly journals AB0115 COMPARISON OF ULTRASOUND FINDINGS BETWEEN TNF INHIBITORS AND NON-TNF INHIBITORS AT FIRST BIOLOGICS IN PATIENTS WITH RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1086.2-1087
Author(s):  
T. Okano ◽  
T. Koike ◽  
K. Inui ◽  
K. Mamoto ◽  
Y. Yamada ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Duration ◽  
Power Doppler ◽  
Tnf Inhibitors ◽  
Tnf Inhibitor ◽  
Significant Difference ◽  
The Us ◽  
Us Findings ◽  
Improvement Ratio

Background:In rheumatoid arthritis (RA), biologics treatment is one of the effective treatment options. Usually, there is no difference in therapeutic effect regardless of which biologics is used, but the effect for joint synovitis is unknown. Recently, ultrasound (US) has played a role of sensitive imaging modality in the diagnosis and follow-up of patients with RA.Objectives:The aim of this study was to compare the improvement of US findings between TNF inhibitors and non-TNF inhibitors at first biologics in patients with RA.Methods:Fifty-four RA patients who started the first biologics from September 2016 to December 2018 were included in this longitudinal study (SPEEDY study, UMIN000028260). All the patients were performed clinical examination, blood test and US examination at baseline, 4, 12, 24, 36 and 52 weeks. A US examination was performed at the bilateral first to fifth metacarpophalangeal (MCP) joints, first interphalangeal (IP) and second to fifth proximal interphalangeal (PIP) joints, wrist joints (three part of radial, medial and ulnar) and first to fifth metatarsophalangeal (MTP) joints, by using HI VISION Ascendus (Hitachi Medical Corporation, Japan) with a multifrequency linear transducer (18-6 MHz). The gray scale (GS) and power Doppler (PD) findings were assessed by the semi-quantitative method (0-3). GS score and PD score (both 0-108 points) were defined as the sum of each score. The change of disease activity and US findings were compared between TNF group and non-TNF group.Results:Among 54 cases, 32 patients were used TNF inhibitor and 22 were non-TNF inhibitor. Age and duration of RA were significantly higher in the non-TNF group, and MTX dose was significantly lower in the non-TNF group. The baseline inflammatory markers tended to be higher in the non-TNF group and the disease activity was also higher in the non-TNF group. However, the US findings showed no significant difference in both GS and PD between two groups at baseline. US improvement ratio was no difference between TNF group and non-TNF group at 4, 12, 24, 36 and 52 weeks in both GS and PD score. Regardless of the type of biologics, patients with long-term disease duration tended to have poor improvement in US synovial fingings.Table 1.Baseline patient and disease characteristicsTNF (n=32)non-TNF (n=22)P valueFemale patients, n (%)21 (65.6)16 (72.7)0.767Age (years)63.5±15.471.0±9.00.030Disease duration (years)6.5±8.213.0±11.70.032CRP (mg/dl)1.8±2.53.0±3.20.170DAS28-ESR5.0±1.45.8±1.20.022GS score26.1±18.831.8±21.10.313PD score17.6±11.423.1±14.60.150Figure 1.GS and PD improvement ratio at 4, 12, 24, 36 and 52 weeksConclusion:There was no difference in the US findings improvement between patients with TNF inhibitor and non-TNF inhibitor at first biologics in patients with RA.References:[1]Grassi W, Okano T, Di Geso L, Filippucci E. Imaging in rheumatoid arthritis: options, uses and optimization. Expert Rev Clin Immunol. 2015;11:1131-46.[2]Nishino A, Kawashiri SY, Koga T, et al. Ultrasonographic Efficacy of Biologic andTargeted Synthetic Disease-ModifyingAntirheumatic Drug Therapy in RheumatoidArthritis From a Multicenter RheumatoidArthritis Ultrasound Prospective Cohort in Japan. Arthritis Care Res (Hoboken). 2018;70:1719-26.Acknowledgements:We wish to thank Atsuko Kamiyama, Tomoko Nakatsuka for clinical assistant, Setsuko Takeda, Emi Yamashita, Yuko Yoshida, Rika Morinaka, Hatsue Ueda and Tomomi Iwahashi for their special efforts as a sonographer and collecting data.Disclosure of Interests:None declared

scholarly journals Drug prices in Latin American countries: the case of rheumatoid arthritis Biosimilars

2021 ◽  
Vol 61 (1) ◽  
Author(s):  
Gabriela Bittencourt Gonzalez Mosegui ◽  
Fernando Antõnanzas ◽  
Cid Manso de Mello Vianna ◽  
Paula Rojas
Keyword(s):  
Rheumatoid Arthritis ◽  
United States ◽  
Latin American ◽  
United States Of America ◽  
Purchasing Power Parity ◽  
The United States ◽  
Power Parity ◽  
Drug Prices ◽  
The Us ◽  
Latin American Countries

Abstract Background The objective of this paper is to analyze the prices of biological drugs in the treatment of Rheumatoid Arthritis (RA) in three Latin American countries (Brazil, Colombia and Mexico), as well as in Spain and the United States of America (US), from the point of market entry of biosimilars. Methods We analyzed products authorized for commercialization in the last 20 years, in Brazil, Colombia, and Mexico, comparing them to the United States of America (USA) and Spain. For this analysis, we sought the prices and registries of drugs marketed between 1999 and October 1, 2019, in the regulatory agencies’ databases. The pricing between countries was based on purchasing power parity (PPP). Results The US authorized the commercialization of 13 distinct biologicals and four biosimilars in the period. Spain and Brazil marketed 14 biopharmaceuticals for RA, ten original, four biosimilars. Colombia and Mexico have authorized three biosimilars in addition to the ten biological ones. For biological drug prices, the US is the most expensive country. Spain’s price behavior seems intermediate when compared to the three LA countries. Brazil has the highest LA prices, followed by Mexico and Colombia, which has the lowest prices. Spain has the lowest values in PPP, compared to LA countries, while the US has the highest prices. Conclusion The economic effort that LA countries make to access these medicines is much higher than the US and Spain. The use of the PPP ensured a better understanding of the actual access to these inputs in the countries analyzed.

scholarly journals Trends in hospitalizations forPneumocystis jirovecipneumonia among patients with rheumatoid arthritis in the US: 1996-2007

2010 ◽  
Vol 62 (12) ◽  
pp. 3826-3827 ◽  
Author(s):  
Grant H. Louie ◽  
Zhong Wang ◽  
Michael M. Ward
Keyword(s):  
Rheumatoid Arthritis ◽  
The Us

scholarly journals Oral Janus Kinase Inhibitor for the Treatment of Rheumatoid Arthritis: Tofacitinib

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Han Ni ◽  
Soe Moe ◽  
Kay Thi Myint ◽  
Aung Htet
Keyword(s):  
Rheumatoid Arthritis ◽  
Safety Profile ◽  
Kinase Inhibitor ◽  
Meta Analysis ◽  
Janus Kinase ◽  
Serious Adverse Events ◽  
Janus Kinase Inhibitor ◽  
Immune Modulators ◽  
Serious Infections

Since the introduction of immune modulators in the treatment of rheumatoid arthritis (RA), there has been hope that orally effective biologic agents would be developed. Tofacitinib, a Janus kinase inhibitor, has become the first oral biologic to receive approval for use in active RA patients. This paper reviews the efficacy and safety profile of Tofacitinib at dosages of 5 mg and 10 mg twice daily. Remarkable improvement in terms of ACR 20 response and HAQ-DI score was noted at month 3 and month 6. DAS 28-4 ESR < 2.6 achievement was noticeably obvious at month 6 for both dosages. No significant serious adverse events, serious infections, neutropenia, or anaemia were observed compared to placebo. In fact, Tofacitinib 5 mg was even found to have significant protective effect of anaemia in the meta-analysis (P=0.004). Tofacitinib has a noticeable efficacy in controlling disease activity in RA with a manageable safety profile. However, longer studies are needed for its long-term safety profile.

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