Biosimilars are essential to help contain medicine costs and treat patients well with biologicals

Godman, Brian

University of Strathclyde Institutional Repository

WHF Biosimilars 20211Improving medicines value for money in the NHS and the role of biosimilars - assessing progress so far Prepared by Professor Brian GodmanWHF Biosimilars 202121. Introduction 2. Current situation biosimilars3. Conclusion WHF Biosimilars 20213▪ There is growing expenditure on medicines worldwide, estimated to reach US$1.5 trillion by 2023, with implications for affordability even in high income countries. This increase will be driven by biological medicines for complex diseases including cancer and orphan diseases exacerbated by their high costs, which are becoming unaffordable ▪ The costs even for the anti-TNFs has resulted in their limited prescribing among Central and Eastern European countries, which is difficult to sustain▪ Biosimilars offer a way forward to improve the care of patients with proven similar effectiveness and safety between originators and biosimilars, e.g. NOR-SWITCH study in Norway. As a result:❑ More patients can be treated with biologicals as lower co-pays -especially important for CEE countries❑ More patients can be treated within the same overall expenditure❑ Services can be enhanced with realised savings, e.g. employing extra staff in rheumatology as seen with adalimumab in Scotland❑ Lower cost biosimilars puts pressure on patented biologicals that used the originator to help justify premium pricesBiosimilars are essential to help contain medicine costs and treat patients well with biologicals4There are concerns with rising prices of new oncology medicines and their value, e.g. the median annual cost for new oncology medicines exceeded US$150,000 per person per year in 2017 compared with US$79,000 in 2013, with continuing increases in costs/ LYS driven by the emotive nature of the disease area. Biosimilars can helpWHF Biosimilars 20215▪ There has been variable use of biological medicines to treat patients with rheumatoid arthritis across Europe in recent years driven by their higher costs versus traditional disease modifying therapies▪ Putrik at al in 2014 showed considerable variation in the use of biologicals across Europe depending on issues including socioeconomic status, co-payments and disease severity ▪ Overall, low use of anti-TNFs to treat patients with rheumatoid arthritis among Central and Eastern European (CEE) countries versus Western European countries▪ Biosimilars can help redress the balance and increase the ability of patients with rheumatoid arthritis to access biologicals to improve their careBiosimilars can enhance the use of biological medicines in RA and IBD among CEE countriesRef: Putrik et al 2014WHF Biosimilars 20216▪ There was also considerable variation in the use of biologicals to treat patients with inflammatory bowel disease (IBD) across Europe ▪ This ranged from appreciable use in France and Spain to limited or no use in Latvia, Poland and Romani (Pentek et al - 2017)▪ Kostic et al (2017) also found limited use of biologicals to manage patients with IBD in Serbia due to high patient co-payments ▪ Biosimilars can again help enhance access to biologicals for patients with IBD among CEE and other countriesBiosimilars can enhance the use of biological medicines in RA and IBD among CEE countries (cont.)Ref: Kostic et al 2017; Pentek et al 2017; Baumgart et al 2019WHF Biosimilars 202171. Introduction 2. Current situation biosimilars3. Conclusion WHF Biosimilars 20218▪ NOR-SWITCH study organised by Ministry of Health in Norway was seen by many as a game changer to enhance acceptance of biosimilars among key stakeholder groups across Europe and wider. In addition increasing realisation that originator companies often change their manufacturing processes▪ Studies such as these have typically resulted in more rapid uptake of biosimilars in the UK enhanced by quality indicators and benchmarking▪ Demand-side measures essential else limited use biosimilars, e.g. Korea. This is not an issue in countries such as the UK▪ Increased competition helps drive down prices as seen with infliximab in Norway and adalimumab in Denmark and the UK▪ There have been issues with biosimilar insulin glargine with different devices and originator company activities to reduce biosimilar use/availability although not universalThere is increasing use of biosimilars across countries with increasing evidence and measures WHF Biosimilars 20219The NOR-SWITCH study sponsored by the Norwegian Government helped cement biosimilarsWHF Biosimilars 202110We also know that originator companies do change their manufacturing processes, often multiple times, so each new batch is a ‘biosimilar’. Suck knowledge helps enhance the acceptance of biosimilarsWHF Biosimilars 202111Can local policies on biosimilars optimize the use of freed resources – experiences from ItalyGenerics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(4):183-7.Originators do change their manufacturing process without the need to re-do clinical studies as commented on by us and othersWHF Biosimilars 202112▪ In England:❑ Biosimilar infliximab took 28 months to reach 80% penetration (total infliximab)❑ Biosimilar rituximab took 10 months to reach 80% of total rituximab❑ Biosimilar trastuzumab took 8 months to reach target penetration rates (80%)▪ In Scotland:❑ Etanercept and infliximab biosimilars reached 84% and 94% of total utilisation of these biologicals by December 2017❑ Rituximab 74% - its first year of availability ❑ By December 2019, biosimilars for trastuzumab had accounted for 92% of all trastuzumab and biosimilar adalimumab 87% of all adalimumab and growingQuality targets for new and switched patients plus benchmarking has accelerated biosimilar uptake in UKRef: Godman et al submitted/ re-submitted WHF Biosimilars 202113This compares with Korea where limited use of biosimilars with limited demand-side measuresWHF Biosimilars 202114Increasing competition is helping drive down the prices of biosimilars – this will continueRef: Davio 2018WHF Biosimilars 202115Costs of adalimumab decreased by over 82% among hospitals in Denmark following successful tendering –benefitting both patients and the healthcare systemWHF Biosimilars 202116Concurrent with this, Abbvie decreased the price of HUMIRA by 89% in some European countries to try and reduce biosimilar use/ availability – not universal thoughWHF Biosimilars 202117There has been variable use of biosimilar insulin glargine across Europe exacerbated by concerns with different devices and the originator company decreasing its price/ promoting higher strength patented formulationNB: No or very limited biosimilar insulin glargine in Austria, Albania, Estonia, Kosovo, Latvia, Malta or Romania. This situation may deter biosimilar companies from developing biosimilars for other long-acting insulin analogues unless addressedRef: Godman et al submitted/ re-submitted WHF Biosimilars 2021181. Introduction 2. Current situation biosimilars3. ConclusionWHF Biosimilars 202119▪ More biosimilars at lower prices especially for oncology and immunological diseases are essential to help with increasing medicine expenditure with ageing populations ▪ There are concerns if biosimilars are not launched in a class –especially as competition helps drive down prices without compromising care to the benefit of key stakeholders▪ Quality indicators/ other demand-side measures can alleviate discussions especially in US that originators should automatically drop their prices once patent loss negating the need for biosimilars (only short term gains). UK is showing the way▪ Under VBP principles – countries should see greater discounts/ price reductions for existing patented biologicals that used a biological that is now a biosimilar for price justifications to help with access and affordability – limited examples to dateIn conclusion:WHF Biosimilars 202120Thank YouAny Questions!Brian.Godman@strath.ac.uk briangodman@outlook.com; brian.godman@smu.ac.za

Improving medicines value for money in the NHS and the role of biosimilars - assessing progress so far

https://strathprints.strath.ac.uk/76364/1/Godman_WHF_2021_Improving_medicines_value_for_money_in_the_NHS.pdf

Improving medicines value for money in the NHS and the role of biosimilars - assessing progress so far

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