By Chloe Sheppard, Analyst
The issue of affordability and access to medicines has been brought to the forefront of policymakers’ and payers’ attention in Europe thanks to the COVID-19 pandemic. Summarised below are some recent changes to HTA and pricing processes and discussions from payers across Italy, Germany and Spain, which highlight how payers are slowly evolving their methods to address the challenge of healthcare system sustainability.
Italy: AIFA’s new pricing and reimbursement decree1
In Italy, the introduction of a new decree will overhaul how manufacturers must approach pricing and access in this market. On 16th September, AIFA published its new guidelines for pricing and reimbursement dossiers. The basis of P&R decisions will now be made based on the scientific evidence of a drug’s additional therapeutic value versus appropriate comparator therapies, which bears great similarity to Franco-German methods of HTA. If the drug is not clinically superior over the appropriate comparator, the manufacturer must offer an economic advantage to the National Health System.
In addition, AIFA will request information on the drug’s marketing, consumption and price and reimbursement data in other European countries, including the details of any negotiated agreements. The company must also declare the public investment and incentives related to R&D and provide information on its manufacturing capability and ability to manage drug supply.
Germany: IQWiG suggest inclusion of cost-effectiveness analyses in the AMNOG process2
In the recent AMNOG 2020 report, the absence of a systematic method to assess the costs of new therapies was highlighted. Editor of the AMNOG report 2020 and CEO of DAK-Gesundheit (one of Germany’s largest sick funds), Andreas Storm, noted: “We have to openly discuss how we will not only systematically assess the benefits of a therapy in the future, but also the associated costs in the case of high-priced drugs. That is the challenge of the future.”
Interestingly, IQWiG suggested that cost-effectiveness modelling could be a positive addition to the AMNOG process, to evaluate the economic efficiency of new drugs, particularly high-cost therapies. However, in the report, the G-BA did not appear as open to the idea and particularly opposed the idea of using the quality-adjusted life year (QALY) as a measure of cost-effectiveness.
While cost-effectiveness analyses are not anticipated to become part of HTA in Germany in the near future, these discussions indicate that payers are considering the adaptations to HTA and pricing procedures required to provide access to high-cost therapies in a sustainable manner.
Spain: New multi-stakeholder network to conduct evaluations for Therapeutic Positioning Reports3
The Spanish National Health System will be revamping the process for conducting Therapeutic Positioning Reports (IPTs). A new network, called Revalmed, composed of the Spanish Medicines Agency (AEMPS), the Ministry of Health and the autonomous regions of Spain, will together evaluate IPTs, whereas previously this has been the responsibility of the Spanish Medicines Agency alone.
There are also plans to update the methodology for conducting evaluations to be more rigorous and detailed. This would include implementing a follow-up procedure for IPTs, but the details of these plans are yet to be published. The new IPT process is expected to be implemented soon and will affect all new drug products.
Overall, the recent changes to the process of HTA and pricing in Italy and Spain are clear signals that payers are taking measures at a policy- and process-level to manage the financial sustainability of healthcare systems. In Germany, while there are no concrete changes as yet, the 2020 AMNOG report indicates that payers in this market are discussing measures towards the same drug affordability challenge. It will be imperative for the pharma industry to monitor these changes and build strategies into their market access plans accordingly, to ensure successful product launches into cash-strapped healthcare systems in the years to come.
If you would like to understand more about how these changes in Europe will impact your company’s assets and to tailor your PRMA strategy accordingly, please reach out to the P4A team at firstname.lastname@example.org