As government agencies shifted their time to addressing COVID-19, there have been downstream impacts on HTAs that could extend out time to reimbursement in non-COVID indications
- Changing patterns in Health Technology Assessments during the first months of 2020
- HTA agencies have refocused to tackle COVID-19
- Evolving HTA submission processes
- Changing HTA methods
While much of the attention during COVID-19 has focused on developing treatment or a vaccine, the pandemic is already having downstream effects on countries’ assessment of drugs for pricing and reimbursement.
From data collected by Decision Resource Group’s Market Access Platform, we have seen governmental responses become much more focused on the virus than on evaluating new therapies.
Changing patterns in Health Technology Assessments during the first two thirds of 2020
While countries fought to combat the virus in the first months of 2020, there is some evidence that their time was not spent on the evidence generating process that underpins the approval of drugs for reimbursement. In particular, there was a significant decrease in Health Technology Assessments (HTAs) conducted between January and April 2020 and a particular drop off of assessments in March.
In some countries, HTA effectively stopped for several months this year. In South Korea there were no new HTAs from March through May. In Mexico there has been no HTA this year. Australia, Brazil and Canada continued to complete HTAs steadily, but at a reduced rate.
A deeper trend is seen in the number of completed HTAs in Europe as tracked by Market Access Platform. In February 2020 they were only 4% below the same point in 2019 (149 vs. 155) but that narrow gap that widened substantially the following month, to 47% below the previous year’s 158. This trend was also true more globally, where completed HTAs were off 39% from previous years in March.
Although the virus continues to spread across the world, the summer was a relative low-point in virus transmission in Europe, and that may be reflected in the overall increase in HTAs in July (72% of 2019 levels) and August (97% of 2019 levels), however, there is little chance that the levels will rebound enough to make up for the more than 250 decrease in HTAs across Europe.
Still, the summer rebound of HTA is a positive, and whether it is an adaptation to the virus’s pressures, in preparation for a second wave, or just a return to the normal business of half-finished assessments, it is a signal that HTA will continue despite COVID-19.
HTA agencies have refocused to tackle COVID-19
Agencies that have traditionally produced HTA have focused on providing reviews of therapies and testing procedures related to COVID-19. Updated processes in many countries have included requests for research topics, temporary regulations on treatment, guidelines on care, and advice on treatments such as NSAIDs, inhalers and hydroxychloroquine in countries such as Germany, France, United Kingdom, and Canada. The Institute for Clinical and Economic Review (ICER) in the US, released several ways of modeling cost effectiveness or cost recovery for remdesivir.
Countries have also streamlined the process for issuing guidance around COVID-19 procedures. The National Institute for Health and Care Excellence (NICE) has issued a streamlined interim process for rapid guidelines for COVID-19. The new process includes eliminating public consultation during the scoping process and the need for a systematic literature review (SLR).
These actions, while normally within the mandate of HTA bodies, have been broadly expanded during the course of this pandemic and demonstrate the flexibility of the agencies to respond to crises. Further, most agencies have broad toolkits that are meant to connect citizens and healthcare practitioners to resources on a variety of topics as in the case of Germany and France.
Evolving HTA submission processes
HTA bodies themselves may need to alter operations to continue the flow of reviews. NICE, which performs HTA for the United Kingdom, has given priority to review COVID-19 treatments.
On the European continent, France’s HAS implemented a paperless operation for its services, including the Transparency Commission. In an effort to free up time for health professionals who make up the committees or intervene as external experts, the country decided to prioritize and limit the number of dossiers being evaluated. In France, medical technologies intended to manage COVID-19 along with original submissions or extension of licenses for oncology, pediatrics, and serious illnesses responding to an unmet medical need will receive preference.
HAS rolled out a 7-step process detailing the collaboration of the HAS with the experts (health professionals, user associations), the restrictive selection of evidence, and the use of digital means of communication under these exceptional circumstances. Requests may originate from the Ministry of Health, health professionals, user associations, or the HAS itself. The interim process is as follows:
HAS temporary HTA process
France typically performs more reviews than other countries, owing to its use of renewals and the major impacts of this change may be that drugs are re-reviewed less frequently. However, if other countries follow France’s lead on limiting reviews, the number of drugs assessed and ultimately reimbursed may decline or at least come at a slower rate vs. earlier years across HTA markets.
Changing HTA methods
A new tool has been applied during the COVID-19 pandemic, a cost-recovery analysis, which offers a plan for covering all associated costs with the drug. The Institute for Clinical and Economic Review (ICER) employed this method in one of its analyses of Remdesivir, highlighting that a ten-day course of treatment would cost $10 to produce.
A cost-recovery analysis is meant to cover the costs of producing a drug rather than paying for its public health value, which might be unknown for some time. ICER conducted this analysis alongside a more traditional cost-effectiveness analysis, but the introduction of the tool should not be ignored.
COVID-19 represents a serious threat to the entire planet and its impact on HTA – the fourth hurdle in market access – could be far-reaching on how assessments are performed or time to reimbursements.