Wednesday, Jun 30, 2021

How biosimilars could help healthcare get back on track

HLTH

The efforts of health and care workers, governments, scientists, private and public institutions in tackling the pandemic and developing a vaccine in less than a year pay testament to our collaborative human grit, determination, and ingenuity. 


At the same time, however, the pandemic has also pushed our healthcare systems to the brink and exacerbated pre-existing inefficiencies. The challenge was daunting even before a global pandemic emerged where critical decisions impacting healthcare access and sustainability needed to be made. But with an estimated 2 million people in backlog for cancer care in UK alone1 and similar situations in other countries worldwide, as well as a global accumulated debt of 17.5 trillion dollars2 and counting, healthcare systems face insurmountable pressures in the days ahead. Conversations about how to invest and where we invest to build a better and more equitable healthcare system have never been more urgent. 


Some of these changes that need to be made at a macro level are already underway – such as changes in planning and delivery of care, greater use of data and digital tools like artificial intelligence and telemedicine. However, there is an opportunity to examine other areas already available, that could help deliver efficiencies while protecting - and in some cases even improving - patient outcomes.


How biosimilars could help to deliver more sustainable healthcare 


Biologic medicines—produced by a complex process involving living organisms—have transformed the treatment of severe conditions like cancer, colitis and rheumatoid arthritis positively impacting millions of patient lives. In the future too, we see an increasing role of biologics3. If we look at Europe, today, over 30% of all drug spend is on biological medicines4, and in the US, according to 2017 data from the IQVIA Institute, biologics represented 37% of net drug spending but 2% of all US prescriptions.5


Biosimilars, follow-on medicines after the patent expires, match the reference medicine in terms of quality, efficacy and safety. They can expand access by providing a number of affordable therapeutic options. The savings thus generated from their use can be redeployed to other areas like providing access to new therapies, helping support vital changes within the system and contributing towards long-term sustainability across the healthcare system.  


The world’s first biosimilar was approved in Europe in April 2006. Over the last fifteen years, over 60 biosimilars have been approved by the European Commission for use, which today account for 10% of the total biologics market. Since their introduction, biosimilars have not only brought clinical benefits to patients but have also generated substantial savings for healthcare systems. 


For example, Bavaria, Germany, biosimilars have helped to reduce the treatment waiting time for rheumatoid arthritis patients from 7.4 years in 2015 to a few months.6 A very recent example from the UK, where patients with rheumatoid arthritis are now able to access biologics treatments earlier due to biosimilars.

 

Despite the proven benefits and years of clinical use, there is inconsistent adoption of biosimilars both between, and even within, countries.  


Turning the tide to create a sustainable environment for biosimilars


Between now and 2025, biosimilars are expected to generate savings of USD 285 billion, this is a substantial sum when we take into account that this is nearly twice the amount that will be spent on COVID-19 vaccines (estimated at USD 157 billion) over the same time period.7 With an increasing number of biologics coming off patent, there is a huge potential and opportunity for biosimilars to bring value for patients and healthcare systems, especially in newer therapy areas for biosimilars like multiple sclerosis, ophthalmology, and immuno-oncology.


As some countries emerge from the other side of the pandemic, we find ourselves at a critical juncture where the future of our healthcare systems rests on the decisions that we make now. In order to successfully deliver a sustainable model that meets the needs of patients, national regulators, policymakers and healthcare stakeholders, we must work together in four core areas to address barriers to biosimilar adoption and improve access for patients worldwide. 


Acceptability


Confidence amongst patients and physicians plays a key role in the acceptance of biosimilar medicines. Supporting better education for physicians and patients with unbiased information on biosimilars, stimulates choice, allowing the treating physician to choose the most appropriate treatment for their patient, and at the same time, instills confidence in the patient about the use of biosimilars.


Accessibility 


Increasing access to affordable medicines and reducing inequalities in healthcare provision have become a central objective of policymaking in recent years – as evidenced by Europe’s Pharmaceutical Strategy and Beating Cancer Plan, both of which identify increased use of biosimilars and generics as important tools in achieving their goals. These policies are very encouraging but need a concerted effort to ensure that they are reflected in national guidelines, encouraging clinical use. Meanwhile in the US, policymakers should authorize a temporary add-on payment to health care providers in Medicare Part B to increase prescribing and use of biosimilars (as opposed to the current system, which encourages prescribing the most expensive option).


Availability


To ensure that biosimilars remain available and viable for the long-term, there needs to be a sustainable market that supports and incentivizes manufactures to deliver biosimilars. Suggested measures could include: gain-sharing and smart procurement practices like employing a multi-tender approach which encourages healthy competition. There is also a need to continue to streamline regulatory measures to enable biosimilar use from day one of expiry of the exclusivity period. 


Affordability 


By adopting common sense policies that encourage competition between biosimilars and reference biologics, governments and healthcare systems can reduce their medicines expenditure and increase uptake significantly.  


Taking action to create more sustainable healthcare 


When thinking of the challenges ahead, we must remind ourselves that nothing will change if nothing changes. In order to create more sustainable healthcare, where patients have access to the right treatment, we need to not only reflect on how we plan and deliver healthcare services, but also support the interventions that can help deliver the biggest impact. Biosimilars have shown they have the potential to deliver better outcomes for patients and the future of our healthcare systems. However, it’s now time to turn that potential into reality.



(1) Over 2 million people in backlog for cancer care. Available from: https://news.cancerresearchuk.org/2020/06/01/over-2-million-people-in-backlog-for-cancer-care/. Accessed June 2021

(2) The International Monetary Fund Annual Report 2020. Available from: https://www.imf.org/external/pubs/ft/ar/2020/eng/. Accessed June 2021

(3) Untangling Biosimilars. Available from: Untangling Biosimilars (acs.org). Accessed June 2021  

(4) The impact of biosimilar competition in Europe. Available from : https://ec.europa.eu/docsroom/documents/31642/attachments/1/translations/en/renditions/native. Last Accessed: June 2021 

(5) Medicine Use and Spending in the U.S. A Review of 2017 and Outlook to 2022 – IQVIA. Available at https://www.iqvia.com/insights/the-iqvia-institute/reports/medicine-use-and-spending-in-the-us-review-of-2017-outlook-to-2022. Accessed June 2021.

(6) ProBiosimilars. New study shows: Rheumatoid patients have faster access to biological therapy since biosimilars exist. Available from: https://probiosimilars.de/presse/versorgung/studie-biologika-und-rheuma-patienten/. Accessed June 2021.  

(7) Global Medicine Spending to Reach $1.6 trillion in 2025 Excluding Spending on COVID-19 Vaccines, According to IQVIA Institute for Human Data Science Study. Available from: Global Medicine Spending to Reach $1.6 Trillion in 2025 Excluding Spending on COVID-19 Vaccines, According to IQVIA Institute for Human Data Science Study (yahoo.com). Accessed June 2021 


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