Value Evidence Generation

Services

• Health Economic Models: Cost-Effectiveness & Budget Impact

  Most HTA agencies require some form of cost-effectiveness and/or budget impact analysis, either as the part of their formal decision-making (e.g. NICE, SMC, TLV, CADTH, PBAC) or to inform their decision-making (e.g. HAS, AIFA). Several organizations in the US use cost-effectiveness analysis to make recommendations on treatment (e.g. ICER, IVI). We build CE & BIM models to the highest methodological standards (i.e. NICE), but easily adaptable for all countries which require economic models as part of their pricing, reimbursement and funding submissions. The health economists building the model will have NICE ERG experience, and the models critically evaluated by external experts. With an increasing focus on regenerative medicines and rare diseases in Pharma and Biotech pipelines, the robustness of economic model methodology is coming under increasing scrutiny, which is why we never rest until we are sure the method for each brand is the best it can possible be.

  Economic models can also be developed for assets very early in development to support pricing and market access scenario planning, or can be used to assess the likely price and cost-effectiveness assumptions for licensing candidates to help determine their commercial value.

• Systematic Literature Reviews

  Systematic Literature Reviews (SLRs) are a key foundation in the evidence supporting Market Access, and are used extensively by Health Technology Assessment (HTA) Agencies. We have been conducting SLRs to exacting National Institute for Health and Care Excellence (NICE) Decision Support Unit (DSU) standards for many years, which have provided major supporting studies to support the successful pricing and reimbursement of our Clients brands. Subjects range from burden of disease/burden of illness (BoD/BoI) to the statistical relationship between early and mature outcomes in a range of different disease areas, but particularly in oncology where mature overall survival (OS) may take several years to mature. Our SLR on the positive relationship between PFS and OS in pancreatic cancer was published at ASCO in 2017. We deliver SLRs conducted to the highest standards, publishable in a peer reviewed setting, as a core foundation to the evidence set required by Payers for successful pricing and reimbursement approval.

• Indirect Treatment Comparisons – Network Meta-Analyses – Matched Adjusted Indirect Comparisons

  The clinical development program cannot cover every head to head comparison demanded by Payers whether they be European HTA agencies or US insurers and CMS. To satisfy Payer requirements to understand comparisons outside the clinical program, we conduct robust Indirect Treatment Comparisons (ITCs) and Network Meta-Analyses (NMAs) to demonstrate the relative value of our Clients brands. Despite the variable acceptance of this methodology by some Payers, it is increasingly accepted as a valid method of informing comparative effectiveness and cost effectiveness decisions. Where only single arm studies are available, techniques such as a Match Adjusted Indirect Comparison (MAIC) can be used.

• Retrospective Real World Evidence

  Real World Evidence is becoming increasingly important. While prospective studies are ideal, they can take a long time, and are often very expensive. One way of building real world evidence is to conduct retrospective chart reviews of medical records to understand how patients were treated, and the outcomes associated with those treatment decisions. This type of research can also help support the applicability of the Client’s clinical trial setting with a more heterogeneous patient population, through analysis of ‘real-life’ treatment pathways and patient types.

• Health Economics & Outcomes Research Publications

  In the hierarchy of evidence used, for example by the Cochrane Collaboration, your HEOR evidence needs to be published, preferably in a peer-reviewed setting, to be of value in market access/HTA decision-making. It is also critical that these publications are made in time for the market access decisions being made. Therefore we develop HEOR publications and publication plans for our Clients to ensure the robust evidence developed to support the value of the brand is available and in the public domain in time for key market access decisions. We have already published key HEOR research for our Clients at ASCO, ESMO & ISPOR.