For a long time, agencies have considered information from “comparable” markets when making their own technology decisions. However, recently, collaboration between health technology assessment (HTA) agencies has notably increased and not only do they share HTA results, but they also share their assessment methodologies. These collaborations have led to the formalization of three major international networks, the main one being the European Network for Health Technology Assessment (EUnetHTA). Their objective is to enhance the collaboration among European HTA agencies in order to contribute to the sustainability of healthcare systems. Here we discuss three reasons why the pharmaceutical industry should be mindful of international HTA agency collaboration:
1. EUnetHTA’s tools improves efficiency for HTA agencies
The main EUnetHTA output is the HTA Core Model®. It consists of a nine-module methodology for individual agencies to conduct subparts of an HTA, which are populated in a database made exclusively available to EUnetHTA’s members (agencies). The tool allows reference to the work previously conducted on the same product within the network. As a result, it provides some degree of standardization and prevents agencies from reinventing the wheel, thus improving efficiency.
2. EUnetHTA is not a European HTA agency – it’s a network of agencies
Collaborating is not merging. A closer look at the HTA and market access decision value chain helps to identify some of the limits of a pan-European HTA and market access approach. Apart from some well-documented exceptions (hepatic metabolism specificities in Asian populations involving particular cytochrome isozymes), the biomedical science is universal; what is valid in one country generally holds for another.
The context starts to play a role as soon as the sponsor pharma company wishes to design a clinical trial that compares their new drug to the standard of care which may differ between countries. As a result, outputs from relative effectiveness studies also vary. Even when assessed against the same comparator, cost-effectiveness analysis, which assesses economic data, also varies greatly. It depends on the proposed price of the new drug, the healthcare settings involved, clinical practices and guidelines and the funding system. Therefore, one cost-effectiveness analysis won’t suit all. A similar reasoning also supports country-specific budget impact models.
Thus, the access decision (yes or no) and the conditions applied (indication, price and reimbursement status) remain specific to the market being considered. Interestingly though, Belgium and the Netherlands have announced their intention to jointly negotiate the price for orphan drugs and other medicines of high value or with a high budgetary impact/a high cost-per-patient with individual pharmaceutical companies. This pilot project is expected to launch in 2016, in an effort to improve patient access by increasing their bargaining power in price negotiations.2
Avoiding the political sphere, EUnetHTA restricts its role to the most easily generalizable aspects of HTA: science and methodologies.3 EUnetHTA members benefit from the scientific assessments already carried out by another agency via the HTA Core Model; however the final HTA report, intended to inform access in a given country, will be made specific to the country’s context by the national agency itself, not the network.
3. The pharma industry should consider EUnetHTA’s approach in order to better align their operations
There is an opportunity for pharma to account for EUnetHTA’s approach in their operations: Roche has looked closely at EUnetHTA’s methodology, module by module, to identify which elements could be relevant to its activities.4 This project, which involved many affiliate representatives and benefited from EUnetHTA guidance, led to the deployment of new evidence and value-generation procedures within the firm.
This is a pioneering initiative that some observers question. However, even though the long-term benefit of such a commitment remains to be quantified, pharmaceutical companies should not overlook EUnetHTA. It’s becoming an influential player in the HTA and market access arena. Expect EUnetHTA’s work to be more systematically considered in the future, possibly informing joint price negotiations such as the recent Belgian-Dutch initiative.
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1. EUnetHTA, Work package 4 – HTA Core Model for Medical and Surgical Interventions. December 2008
2. The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). Position on joint price negotiations for Medicines. June 2015
3. STAMP European Commission expert group. EU cooperation on HTA – latest developments. PowerPoint presentation. May 2015
4. Roche Pharma. Roche Pharma Report Relating to EUnetHTA HTA Core Model® Applications for Pharmaceuticals. December 2014