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Blog
Finding a workable solution to the HTA backlog in England
Jun 18, 2021
HTA backlog: The numbers
Over the last 12 months, the National Institute for Health and Care Excellence (NICE) has been faced with a significant decision problem of its own – publishing COVID-19 rapid guidelines whilst continuing to issue pathways, guidance and quality indicators. The UK has seen a 25% drop in HTA publications in 2020 vs 2015-2019 average*. The number of new prescription medicine entrants to the market has not been impacted by the pandemic - New Active Substances (NAS) in 2020 vs. the 2015-2019 average was 31 and 32, respectively.
HTA backlog: The Associated consequences
It is fair to conclude that COVID-19 has led to delays on publishing a final HTA decision. Delays in the HTA process create a challenge for access, as commissioners are highly unlikely to fund any product that is currently in the NICE HTA process. To address the HTA publication backlog caused by COVID-19, NICE will need to consider selection based on priority with preference presumably for new active substances and areas of high unmet need.
Where does this leave patients, health care professionals (HCPs) and industry whilst NICE manage the HTA backlog? What happens to treatments already in the submission process that don’t meet the priority criteria? Will medicines that improve quality of life and provide incremental benefits to patients be delayed?
The NHS is addressing the challenges associated with non-COVID treatment backlog and successfully managing a national vaccination programme. An additional challenge of slowdown for patients accessing improved treatments would be unfortunate, and, if not resolved rapidly, would become more prominent. In the current situation where vaccination and addressing the treatment backlog are priorities, the HTA backlog may seem less crucial. However, the HTA backlog will become critical if in the longer term, UK patients wait longer for access to medicines. HCPs could become restricted in their treatment choice and lose the benefit of alternative treatment options should the current standard of care be insufficient or contra-indicated for their patient(s).
The UK is attempting to position itself as a pro-innovation market for the launching of new medicines. This is evident from the new initiatives such as the Innovative Licensing and Access Pathway (ILAP) and Project Orbis International. However, it would be challenging for industry to engage with novel access routes if the critical and essential step in the process, the HTA submission, is delayed because of factors outside of their control.
HTA backlog: Potential solutions
We must collectively find a solution that tackles the backlog of submissions. NHS England (NHSE) recently published their commercial framework, which describes how the NHS will engage with commercial activity to support the reimbursement of new medicines. There is potential for commercial access agreements (CAAs) to be adapted to solve the HTA backlog. For example, conditional approval could be granted by NHSE, allowing reimbursement for the product on the condition that the company return the cost should NICE issue a negative TA in the future. CAAs can be combined with a simple discount to ensure that the price is within a ‘cost-effective threshold’, whilst further data is collected.
Albeit a bold move, this strategy would minimise the financial risk of providing access prior to NICE decision; and also provides patients with timely access to novel therapies that have a licence, avoiding the financial risk to commissioners and encouraging sponsors to launch innovation in England. The financial risk to payers is further reduced if the delayed compounds are ‘me-too’ therapies with clinical equivalence, as the originator product will have already been deemed cost-effective.
If responding to the pandemic has taught us one thing, it’s that at times like this we must be bold and act fast. We welcome the debate around how the HTA backlog should be resolved - feel free to contact us for further discussion.
*Source: IQVIA HTA Accelerator, includes single drug assessments only.