By Jens Leutloff, Senior Consultant
Email: [email protected]
Partners4Access asked payer experts from France, Germany, Italy, Spain, and the Nordics what the key trends are for market access by 2025. Besides the financial challenge posed by high-cost innovative therapies, they will also influence how other drugs will be looked at.
- An increasing number of innovative therapies will force a ‘funding re-think’
An increasing number of high-cost innovative therapies such as CAR-T cell therapy or gene therapies, particularly for rare diseases, will be a financial challenge for many healthcare systems. To make these innovative treatments available to patients, our French payer expert assumes that savings will be required in other disease areas, to stabilize the overall budget. This will increase financial pressure on treatments for highly prevalent diseases such as Diabetes Mellitus Type 2, which have a high budget impact due to their large patient numbers and the projected growth of treatment costs.
According to our Italian and German payer experts, these innovative therapies will also require payers to re-think their position on “innovative funding” such as managed entry agreements (MEA) and risk-sharing. Currently payers across Europe are reluctant to implement such agreements, partly due to the high management effort associated with such agreements. In the case of high-cost, single-use (curative) treatments, the benefits of MEAs may outweigh the relatively high effort. This will be even more relevant if a significant percentage of patients does not respond to a certain treatment, or relapses.
Our Spanish payer expert considers payments in several yearly installments as another option for such single-use treatments to alleviate the cost pressure on the healthcare budget. This has not yet been widely discussed in financially stronger countries like Germany, but as the number of high-cost treatments increases, it could become more relevant. Also, in the context of risk-sharing, installments might be demanded by payers to take into account the probability that patients turn out to be non-responsive or relapsed.
2. More price transparency across member states
Due to the price setting mechanisms for innovative drugs in most European healthcare systems, there is a discrepancy between published list prices and the net prices which are actually paid. This makes international price referencing (IPR) difficult if not impossible. According to our payer experts, health authorities both in Italy and France are thinking about ways to increase price transparency, e.g. by collating this price information in a data base, or by obliging manufacturers to disclose net prices in other countries. Since many European healthcare systems rely on IPR, especially in smaller countries, they might support these efforts.
3. Greater use and acceptance of RWE
Our German payer expert sees an increasing acceptance of real-world evidence (RWE) in Germany by 2025. As of 2020, manufacturers can be obligated to facilitate the post-launch collection of treatment data, primarily for Orphan Drugs with limited clinical data and uncertain clinical benefit. This requires health authorities, such as the Federal Joint Committee (G-BA) and the scientific IQWiG institute, to define standards and methodological requirements for the use of RWE in G-BA’s benefit assessment. With these standards in place and with more experience, payers’ acceptance of RWE will likely increase also in non-orphan indications. Our Italian payer expert assumes that the collection of RWE in Italy (namely the AIFA Monitoring Registries) will mostly be limited to innovative drugs.
4. Greater influence of cost-effectiveness in HTA appraisals
According to our Nordics payer expert, Denmark, Norway, and Sweden are refining their assessment of new drugs. Denmark has decided to implement QALYs in the assessment of hospital products, conducted by the Danish Medicines Council (DMC). Our expert assumes that the DMC will assess an increasing number of products in the future, also for outpatient use.
Pharmacoeconomic dossiers that are submitted to AIFA in Italy can also use QALYs for the assessment of clinical benefit and cost-effectiveness, but there is no obligation to do so. While France has been considering QALY thresholds as part of their cost-effectiveness evaluations for a while now, Spain and Germany have rejected them. However, some payers in Germany are demanding stricter price regulations for new drugs, such as a price-cap for high-cost therapies. This will likely be revisited by the next government after the election in 2021.
Norway sees an increasing number of specialist products being funded on a regional level, instead by individual reimbursement. The Norwegian Medicines Agency (NoMA) will assess these products (including Orphan Drugs) on the national level, making regional assessments less important.
In Sweden, the Dental and Pharmaceutical Benefits Agency (TLV) was running a pilot project on the health economic evaluation of medical devices. This pilot has now been extended to the assessment of hospital products, which will likely influence the funding and prescription patterns of an increasing number of high price medicines by 2025, according to our expert.
The increasing number of high-cost innovative therapies will be a financial challenge for many European healthcare systems by 2025. Payers will likely consider different options to address this challenge, including the implementation of MEAs and risk-sharing. Yearly installments instead of a single upfront payment could be of interest, especially for single-use treatments. Payers will also try to increase price transparency for IPR. Some countries are refining their methodology for health economic evaluations, to make better use of RWE, or to implement the assessment of a bigger number of products on the national level.
If you would like to know about HTA and future trends, please do not hesitate to reach out to the P4A team at [email protected].