Introduction
2020 was dominated by the COVID-19 pandemic, but with the prospect of vaccines coming ever closer, what does 2021 hold for pricing and market access (PMA)? We believe that these are the 5 key PMA trends that could shape the industry in 2021:
- COVID-19 Pandemic delays for Health Technology Assessments (HTA)
- Is the UK still an early launch country given Brexit?
- Affordability of cell and gene therapies
- Parallel EMA/EUNetHTA early dialogue consultations
- Joint EU HTA procedure.
COVID-19 pandemic delays for Health Technology Assessments (HTA)
The short-term impact of COVID-19 on HTA processes was significant, with several agencies (NICE, SMC etc) temporarily halting assessments. Our survey of manufacturers and ISPOR poster highlights the impact to both the industry and patient access.
As 2020 has progressed, the consequences have been mixed, dependent on how severely affected the working processes of the HTA agency has been.
Some countries have continued unaffected (the G-BA in Germany increased their output by 7% in 2020) while others (e.g. UK and France) have focused only on critical medicines.
France and the UK have reduced the number of HTA publications in March-June 2020 (down 30% and 31% respectively compared to the 2015-19 average in the same months).
2021 Trends:
- In countries affected by a slowdown in HTA activities, a backlog of applications in 2021 is likely to slow the market access of drugs deprioritised as being non-critical.
- In the less affected markets, payer price pressure and budgetary concerns are likely to be of more importance, as pressure mounts to begin recouping the costs of the COVID-19 pandemic.
Is the UK still an early launch country given Brexit?
Brexit is finally happening. In the short term, there are limited changes to the UK’s position as an early launch country. Our recent article discusses the temporary changes planned for 2021.
The split from the European Medicines Agency (EMA) will result in pharmaceutical countries submitting separate regulatory dossiers to the EMA and the Medicines and Healthcare products Regulatory Agency (MHRA).
2021 Trends:
- Given the significant cost and time resource involved in a regulatory submission, small pharmaceutical and biotech companies may prioritise an EMA submission over the MHRA
- An altered launch sequence will impact on international reference pricing (IRP), given that the UK is referenced by many countries within Europe
- The UK may lose status as an early launch country, with NHS patients facing delayed access to innovative medicines. While this is unlikely to happen in 2021, companies will still have to carefully consider the impact of Brexit on European-wide pricing and launch strategies.
Affordability of cell and gene therapies
One of the hottest topics of the pharmaceutical industry is the price of one-off cell therapies, with articles on the first $3m list price drug capturing headlines.
While upfront affordability is an obvious issue, payers will have to ensure the level of long-term clinical benefit is proportional to the extremely high cost of the drug.
2021 Trends:
- As a result, new approaches to reimbursement will be required. New payment models will need to both reduce the upfront cost, and guarantee that payments are closely related to the level of clinical benefit. This could take the form of milestone-based payments, or innovative models such as the ‘Netflix’ subscription model (in which a fixed budget is used to treat an unlimited number of patients)
- Nevertheless, it is likely that payers will still consider such therapies as unaffordable and limit patient access significantly
- Given the likely rise of cell therapies in the next few years, if implemented successfully models will likely be copied and become the cornerstone for reimbursement for other indications.
Parallel EMA/EUNetHTA early dialogue consultations
Early payer dialogue or payer scientific advice is critical for many companies to enhance their clinical development program, as discussed in our 2017 article.
The funding for EUNetHTA ran out in 2020, forcing the parallel EMA/EUNetHTA consultation to be suspended temporarily in mid-2020. Commitment has been made to continue these consultations until May 2021 in the form of additional funding.
2021 Trends:
- It is unclear in what capacity early dialogue activities will continue past the EUNetHTA prolongation period
- With the wider EUNetHTA project proposed to shut down in 2021, it is likely that manufacturers will lose the possibility of accessing this vital opportunity to engage with both regulators and HTA bodies at the European level
- Companies may be forced to rely on early dialogue processes within each individual country, rather than at the joint EU level.
Joint EU HTA procedure
The efforts to implement EU-joint HTA and align the HTA processes of all member states into a single process, as discussed in our article earlier this year, appears to have slowed over the last year.
This is not only due to the pandemic, but also significant internal resistance led by France and Germany over several key issues (e.g. whether recommendations should be mandatory).
The German presidency of the EU council has published a proposal to overcome some of these issues. This includes:
- Clear wording that the reimbursement decision remains up to individual countries
- A proposed “non-duplication” approach, in which the individual countries are not to request or assess evidence already presented during the EU Joint Clinical Assessment (JCA)
- The suggestion that the JCA should first focus on oncology drugs, followed by orphan drugs and advanced therapy medicinal products (ATMPs). This could be difficult given that these are all drug types with heterogenous assessment procedures within the EU member states.
2021 Trends:
- While the guarantee of non-binding assessment decisions is likely to please EU member states, no decision is expected in 2021, due to ongoing negotiations
- The implications of implementing a joint EU HTA process would be hugely significant in the European HTA landscape. Given the complexity of aligning all member states to a single HTA process, the possibility of closer European collaboration on HTA remains faint, especially within the next few years.
Do you agree that these are the key trends for 2021? Do you anticipate other topics will be more important? We would love to hear your thoughts – contact us at contact@remapconsulting.com