Real Medical Benefit Assessed by Indirect Comparison

Abstract

-Frequently, in data packages submitted for Marketing Approval to the CHMP, there is a lack of relevant head-tohead comparisons of medicinal products that could enable national authorities responsible for the approval of reimbursement to assess the Added Therapeutic Value (ASMR) of new clinical entities or line extensions of existing therapies. Indirect or mixed treatment comparisons (MTC) are methods stemming from the field of meta-analysis that have been designed to tackle this problem. Adjusted indirect comparisons, meta-regressions, mixed models, Bayesian network analyses pool results of randomised controlled trials (RCTs), enabling a quantitative synthesis. The REAL procedure, recently developed by the HAS (French National Authority for Health), is a mixture of an MTC and effect model based on expert opinions. It is intended to translate the efficacy observed in the trials into effectiveness expected in day-to-day clinical practice in France.

Assessing key assumptions of network meta‐analysis: a review of methods

“…In total, 116 articles were included (Abdelhamid et al ., ; Achana et al ., ; Ades, ; Ades et al ., ; Ades et al ., ; Ballesteros, ; Bucher et al ., ; Buti et al ., ; Caldwell et al ., ; Caldwell et al ., ; Caldwell et al ., ; Caldwell et al ., ; Chaimani & Salanti, ; Chootrakool & Qing shi, ; Chung & Lumley, ; Cipriani et al ., ; Cipriani et al ., ; Coleman et al ., ; Cooper et al ., ; Cooper et al ., ; Coory & Jordan, ; Dakin et al ., ; Del Giovane et al ., ; Dewilde & Hawkins, ; Dias et al ., ; Dias et al ., ; Dias et al ., ; Dias et al ., ; Dias et al ., ; Dias et al ., ; Ding & Fu, ; Donegan et al ., ; Donegan et al ., ; Donegan et al ., ; Eckermann et al ., ; Edwards & Borrill, ; Edwards et al ., ; Fadda et al ., ; Falissard et al ., ; Franchini et al ., ; Gartlehner & Moore, ; Glenny et al ., ; Govan et al ., ; Griffin et al ., ; Haute Autorite De Sante, ; Hawkins et al ., ; Hawkins et al ., ; Hawkins et al ., ; Higgins et al ., ; Hoaglin et al ., ; Hong et al ., ; Ioannidis, ; Ioannidis, ; Jansen & Cope, ; Jansen, ; Jansen, ; Jansen et al ., ; Jansen et al ., ; Jansen et al ., ; Jonas et al ., ; Jones et al ., ; Julious & Wang, ; Li et al ., …”

“…Interactions can be studied using patient‐level covariate values or trial‐level covariate values. Many articles have mentioned this approach, (Ades et al ., ; Coleman et al ., ; Dias et al ., ; Falissard et al ., ; Gartlehner & Moore, ; Haute Autorite De Sante, ; Hawkins et al ., ; Hawkins et al ., ; Hawkins et al ., ; Hoaglin et al ., ; Hong et al ., ; Jansen et al ., ; Jansen et al ., ; Jansen et al ., ; Lu et al ., ; Mills et al ., ; Mills et al ., ; Naci & Fleurence, ; Ouwens et al ., ; Salanti, ; Salanti et al ., ; Signorovitch et al ., ; Song et al ., ; Sturtz & Bender, ; Sutton et al ., ; Thorlund et al ., ; Welton et al ., ; Xiong et al ., ) and various articles have applied such models including trial‐level covariates, (Cooper et al ., ; Cooper et al ., ; Dias et al ., ; Jansen & Cope, ; Jonas et al ., ; Nixon et al ., ; Salanti et al ., ) patient‐level covariates (Donegan et al ., ; Tudur Smith et al ., ) or a combination of trial‐level and patient‐level covariates (Donegan et al ., ; Jansen, ; Saramago et al ., ). Three model specifications regarding the treatment by covariate interactions have been described in the literature: independent interactions, exchangeable interactions and common interactions (Cooper et al ., ; Donegan et al ., ; Donegan et al ., ).…”

GetReal in network meta‐analysis: a review of the methodology

“…In particular, NMA allows an increase in the precision of estimates of relative effects (as compared with estimates based on direct evidence alone), and it can be used to compare interventions that have never been compared directly, head‐to‐head. This is especially valuable when active agents are only compared with placebo or standard care for regulatory purposes but not to each other (Falissard et al ., ). In addition, NMA can support (policy‐related) decision making by explicitly providing a ranking of all competing interventions (Salanti et al ., ) and to reduce the uncertainty in input parameters for subsequent formal cost‐effectiveness models (Thorlund et al ., ).…”

Network meta-analysis in health psychology and behavioural medicine: a primer

“…Additionally, many health outcomes targeted by health behaviour change interventions (e.g., blood pressure reduction) are often managed, first, through medical treatment (e.g., anti-hypertensive medication). Typically, behavioural interventions are not included as comparators in clinical trials of medical interventions, as regulatory bodies only require that they are compared with placebo conditions or treatment-as-usual/standard care (Falissard et al, 2009;Song, Altman, Glenny, & Deeks, 2003;Sutton & Higgins, 2008). For example, there is very limited evidence comparing physical activity interventions to drug interventions in those with illnesses related to cardiovascular disease, as this is often not required for licensing (Naci & Ioannidis, 2013).…”