In Europe, the pandemic has revealed problems within health care systems and the need to increase access to biosimilars and reform health care policies.
The coronavirus disease 2019 (COVID-19) pandemic has stretched health care systems but may also create room for improving utilization of biosimilars, according to a presentation at the Terrapinn Festival of Biologics Basel 2020.
“Interestingly, for 2020, this crisis is also the greatest opportunity we have to rethink, rebuild, and reshape. We have a new normal to face, and I think that's what we need to consider,” said Julie Maréchal-Jamil, director of Biosimilar Policy & Science at Medicines for Europe and an advisory board member for The Center for Biosimilars®.
In the presentation, Maréchal-Jamil discussed what steps need to be taken to develop policies that will foster sustainable access to the biosimilars market for patients and allow European health care systems to get the greatest benefit from biosimilar use.
She laid out 3 things that regulators should consider to achieve these goals, including developing a vision where savings are reinvested into measures that improve health by improving access for patients; targeting policy frameworks to individual countries; and incorporating components to make sure the policies function efficiently.
Determining a Vision for Health
A vision for health involves addressing health and access needs by developing roadmaps to achieve objectives, which is what France and the United Kingdom have done, explained Maréchal-Jamil.
She said the United Kingdom implemented a policy to expand access to off-patent biologics. The policy allows for reference products to compete alongside biosimilars for market access, meaning that patients exclusively use whatever product is deemed to be the “best value biologic.”
According to Maréchal-Jamil, in the United Kingdom, targets for adoption of the best value biologic are 90% for new patients within 3 months of a biosimilar launch and 80% for existing patients within 12 months.
The French implemented a policy to increase the development of innovative biologics by encouraging that 80% of existing patients transition to a biosimilar by 2022. The French theorize this would encourage innovator companies to develop new medicines once they lose patent protection for older ones.
Maréchal-Jamil said Norway and Poland also have unique strategies for how they increase biosimilar utilization.
In Norway, biosimilars were widely used in the hospital setting but rarely used in the community pharmacy setting. Maréchal-Jamil said Norway had reflect on how to adjust its framework to achieve mass use.
Maréchal-Jamil also said the Poland’s baseline biosimilar access rate is lower than the average for the European Union despite having good use rates for some biosimilars, suggesting that reforming drug programs or imposing budget caps would be more effective in addressing biosimilar use than implementing biosimilar regulatory policies.
Additionally, Maréchal-Jamil said that originators that are expected to lose patent exclusivities in the future will require policy adjustments and new policies to be added over time.
Core Policy Components
Maréchal-Jamil said that successful policy changes must build awareness, trust, and confidence, drive biosimilar use, and translate cost efficiency gains to better health.
To increase awareness, trust, and confidence in biosimilars, Maréchal-Jamil suggested that easy-to-understand educational information must be given and made continuously available to the public. Additionally, trust can be built by continuously involving stakeholders in policymaking.
According to Maréchal-Jamil, nearly half of medicines agencies in Europe still do not have biosimilar educational resources listed on their websites, even though Europe as a whole has 20 years of experience using biosimilars.
Maréchal-Jamil said that studying what other countries have done could inspire policies that drive biosimilar use. Maréchal-Jamil mentioned that IQVIA’s country scorecards published in June would be a good source of inspiration because they detail the policies of 12 European countries regarding biosimilar switching, tender systems, utilization incentives, and pricing regulations.
Lastly, Maréchal-Jamil mentioned Germany as an example of how to translate cost efficiency to impact treatment access to biologics. The Bavaria study on treatments for rheumatoid arthritis found that the introduction of biosimilar competition to the market decreased the amount of time before a patient could get access from 7.4 years to just 4 months, suggesting competition can play a major role in increasing access for patients.