There is little evidence that current Health Technology Assessment (HTA) processes make a difference in terms of speeding up patients’ access to medicines, or that they result in better rewards for medicines with higher therapeutic value, says a new report.
Moreover, recommendations from HTA bodies are not always implemented by pricing and reimbursement authorities, and the overall link between HTA and pricing and reimbursement is still unclear in many cases, according to the study, which was commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio, Medicines Australia and the Pharmaceutical Research and Manufacturers of America (PhRMA).
"On the current data, we do not find that the application of HTA per se systematically lowered prices," add the researchers, from Charles River Associates. They also note that there is no clear evidence that the impact of HTA is being monitored, and that this makes it difficult to assess whether the process improves allocation of resources or offers value for money.
The study examined 15 nations where HTA is in use or under development - Australia, Brazil, Canada, England, France, Germany, Italy, the Netherlands, New Zealand, Poland, Scotland, South Korea, Spain, Sweden and Turkey. They found wide varieties between these nations in the objectives which they seek for HTA - in some countries the processes focus predominantly on assessing medicines in terms of therapeutic value, while others incorporate economic factors, through an assessment of value for money and budget impact, and regional disparities.
The range of evidence accepted by different HTA systems also varies across countries, although randomised controlled trials remain the gold standard, the researcher note. They also found that only two of the countries systematically integrate a societal perspective in economic evaluation and that there is little evidence of social value - which remains controversial – generally being taken into account.
Scientific advice to manufacturers was found to be officially available in only three of the 15 countries, although informal interactions between manufacturers and agencies are available in most processes.
An analysis of the relationship between the length of time between marketing authorisation (MA) and announcement of the HTA decision found that Scotland, France, Australia and the Netherlands are "systematically faster" that the other 11 countries examined. And only in the case of Scotland was there found to be a relationship between the product's therapeutic value and the speed of HTA review, with higher-value medicines progressing more quickly through the process.
The study identifies a number of areas where it believes HTA processes can be improved, bringing benefits to all stakeholders, including: - improving the information available, with HTA agencies publishing performance metrics; - improving areas where intention and application appear to differ, such as the use of HTA for re-assessments; - and the relationship between the assessment and the speed of review, freedom in terms of pricing and reimbursement and, ultimately, how the medicine is used, needs to be made more explicit, say the researchers.
Finally, they point out that HTA submissions "often run into thousands of pages" and impose significant cost, yet there is little or no evidence looking at whether HTA has improved the allocation of scarce health care resources and whether this depends on the different HTA models. Much more work is needed to look at whether the benefits of HTA exceed costs to different stakeholders, they suggest.
The four industry groups say the report "sets the foundation for a regular exercise," to which they will give continuous support. "Such regular exercise has the potential to allow consistent assessments of the impact of HTA to be efficiently captured over time, taking into account the impact of current reforms and cross-border activities on access to innovative medicines and the move towards truly patient-centred healthcare systems," they add.