COVID-19 has had a significant impact on the world economy, as countries grapple with the strain on healthcare organisations at the forefront of the response to COVID – resources that were already stretched. Globally, many Health Technology Assessment (HTA) bodies are prioritising COVID-19-related solutions, in an effort to rise to the challenge of the health crisis. But what does this mean for drug programmes currently in the pipeline? For the timing of health economic outcomes research (HEOR) evidence generation? Or for the planned sequencing of reimbursement dossiers?
The requirements for global HTA/reimbursement consideration are continuing to evolve in response to the current pandemic. The following article offers suggestions for how the industry can navigate a path to reimbursement success and market access for therapies that were in development prior to the pandemic.
Altered timelines and reprioritised work programmes
HTA boards in most countries initially slowed or delayed their appraisal timelines during the early days of the pandemic, although most are now ‘back in business’, even if operating virtually. Also, some HTA boards have stated that they plan to prioritise certain products for appraisal before others. While few of these bodies have been explicit about their criteria for prioritisation, we can glean something from those that have.
The National Institute for Health and Care Excellence (NICE) in the UK, the Dental and Pharmaceutical Benefits Agency (TLV) in Sweden, and Haute Autorité de santé (HAS) in France are all fast- tracking assessment of products related to COVID-19. Additionally, HAS has clarified that it will prioritise interventions in oncology, paediatrics or any medication in a serious disease with unmet need, and products for temporary use and requests for early care funding. It is also likely to evaluate indication extensions according to a simplified procedure.
Thus, as we come to the close of 2020, we can see a significant push for approvals of vaccines and antivirals as healthcare industry and governments begin to open up the economy while preparing for future spikes or waves. We predict that HTA bodies will pivot, in the short term, toward assessing the evidence of antibodies, antivirals and vaccines. There will also be a clear focus on therapies that can free up resources that are in short supply, such as ICU (intensive care unit) beds and ventilators.
What it means for sponsors:
For products in classes to be fast tracked, sponsors should shore up their research and focus on demonstrating value within mainstream and unusual scenarios.
For products in classes that are currently deprioritised, sponsors should use this time to fill data gaps with real-world data (RWD), expert opinions, and indirect treatment comparisons that will strengthen their case when the time comes. This will be especially important as health systems will have been depleted of financial resources and potentially will need to apply more stringent assessments to counter these constraints.
Changing evidence requirements
With a priority focus on antibiotics, antivirals and vaccines for assessment, we predict potential changes to the ways products in these therapeutic areas are reimbursed in the future. Outcomes- based reimbursement will gain further traction in the days ahead, with an added need to quantify the resources that are saved by new therapeutics. The current efficacy focus will be about understanding which therapies can truly free up scarce resources. New evidence hurdles will likely lower thresholds for organisations’ willingness to pay as health systems are being hard it and are needing to make more efficient use of constrained resources. And, in countries where economic data was not part of the appraisal process, we foresee that such data will be increasingly required.
In the US, the Institute for Clinical and Economic Review (ICER), while not a government agency, is gaining influence, and this is likely to continue. Meanwhile, the US is faced with a growing number of unemployed – and therefore uninsured – people, which is placing greater burdens on the healthcare system. This may bring to the fore politically sensitive discussions on equitable access to care.
What it means for sponsors:
We advise aiming for high-priority subgroups of patients, being mindful of the overall budget and not targeting all possible indications for each new therapy. Sponsors might also need to consider the overall budget impact that improvements in population access to treatment bring. Such evidence does not necessarily require further trials (which are challenging to generate at this time). Real-world data, retrospective patient record analyses, literature reviews subject to statistical meta-analysis and expert opinion will all be valuable surrogate indicators in lieu of clinical trial extensions.
We strongly recommend early-stage interactions with HTA boards by way of the early scientific advice processes that already happen remotely. Sponsors should be mindful of the pressures facing these committees, however. Liaising through a third party who has established relationships and communication channels might be a way to approach these beleaguered bodies.
Companies operating in the US need to understand that the way of working and launching products is changing; healthcare system and payers are looking to assess the value of therapies. COVID has highlighted the inequity in the system, and there will need to be discussions on how to ensure equitable access to care.
Early-stage regulatory approval
One of the impressive outcomes of the pandemic has been the way in which pharmaceutical and medical device companies have joined forces to collaborate in developing new diagnostic kits, vaccines, and treatments through organisations such as the Coalition for Epidemic Preparedness Innovations (CEPI) and Europe’s Innovative Medicines Initiative (IMI).
It is estimated that at the time of this writing there are over 500 clinical trials for new treatments and vaccines in development for SAR-COV-2. In terms of evidence requirements at the early stage, we have already seen that drugs related to COVID-19 have understandably lower evidence methodological benchmarks, with single arm studies becoming the norm.
What it means for sponsors:
We advise that sponsors hold pragmatic discussions with regulatory boards regarding individual challenges and questions, while being mindful of the increased pressure on HTA boards.
We recommend that sponsors prepare for continued, innovative public-private partnerships and alliances.
It is essential for global pharmaceutical market access and HTA/ reimbursement directors to re-evaluate their HTA work programmes and HEOR evidence generation plans. Such re-evaluation needs to be pragmatic and nimble, as the terrain will shift frequently.
Manpreet Sidhu is the executive principal and global head of ICON’s Health Economics and Outcomes Research practice
