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 is driven by #biological medicines for complex diseases, including cancer and orphan diseases, which are becoming unaffordable.
Some Facts:
- There are concerns about the 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 requested prices driven by the emotive nature of the disease area.
- Requested prices for new oncology medicines continue to increase despite often limited data and limited health gain due to cancer being an emotive disease area. The availability of biosimilars can help – along with other mechanisms for valuing them including ‘value-based pricing.
- There are similar concerns with increasing requested prices for new medicines for orphan diseases – becoming unsustainable, especially with envisaged prices for new gene therapies.
Ongoing Strategies:
The NOR-SWITCH study (MoH Norway) was seen by many as a game changer to enhance acceptance of biosimilars alongside the increasing realization that originator companies often change their manufacturing processes – so in effect #biosimilars themselves
- Increased knowledge alongside a continual physician and patient education by #health authorities and others has increased the uptake of biosimilars among some countries - enhanced by quality indicators and benchmarking. However, still concerns among some being addressed with more studies showing no concerns with switching even among biosimilars.
- Education is important to address the ‘Nocebo’ effect.
- Increased competition is driving down prices enhancing their use along with pertinent demand-side measures. However, still issues including activities of originator companies that need addressing
The NOR-SWITCH study sponsored by the Norwegian Government has enhanced the use of biosimilars by helping to dispel concerns with biosimilars in terms of their effectiveness and safety.
We increasingly know that originator companies do change their #manufacturing processes, often multiple times, so each new batch is a ‘biosimilar’.Such knowledge enhances the acceptance of biosimilars among key stakeholder groups
The UK & other countries:
Increasing competition is also helping drive down prices of biosimilars in the UK and this will continue. The UK contracted with multiple suppliers to enhance their long-term viability.
- Biosimilar infliximab took 28 months to reach 80% penetration (total infliximab) and by March 2018 accounted for 89% of total infliximab.
- Biosimilar rituximab took 10 months to reach 80% of total rituximab
- Biosimilar trastuzumab took 8 months to reach the target penetration rate (80%)
In Scotland:
- Etanercept and infliximab biosimilars reached 84% and 94% of the total utilization of these biologicals by December 2017
- Rituximab biosimilar 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 growing
Italy:
- Multiple demand-side measures among the Regions in Italy including education, benchmarking, and financial incentives have also increased biosimilar use and associated savings.
Education among key stakeholder groups including physicians and patients can help address the ‘Nocebo effect’. This can also include potential uses for the savings in order to hasten switching programs, e.g. Scotland with adalimumab
There may be increased discontinuation rates for biosimilars vs. originators if the nocebo effect is not addressed through increased physician and patient education. This may take time – but helped by an increasing number of studies confirming the effectiveness and safety of biosimilars.
Norway:
Increasing #competition has helped drive down the prices of biosimilars in Norway with annual procurements.
- In 2014, biosimilar infliximab won the contract for preferentially supplying infliximab to the hospital group in Norway - initially priced 33 – 39% lower than the reference product (originator)
- In 2015, prices of infliximab were further reduced resulting in prices of infliximab now 51 – 69% lower than the reference product
- In 2016, biosimilar infliximab was still the cheapest alternative 60% lower than the originator price
- In 2016, biosimilar etanercept was offered for tender at 47% lower than the regular price of the originator, with savings continuing
Korea:
- In Korea limited demand-side measures resulted in limited use of biosimilar infliximab versus France and the UK.
Bosnia and Herzegovina:
- There was also limited utilization of biosimilars for infliximab (27% of total infliximab by the end of 2019) in Bosnia and Herzegovina by the end of 2019 despite appreciable price reductions (up to 65%) without specific demand-side measures encouraging their greater prescribing – with a similar situation with biosimilar adalimumab (<1% in 2019). This is now being addressed
Europe:
- Variable use of biosimilar insulin glargine across Europe aided by concerns with different devices and originator companies decreasing its price/ promoting their higher strength patented formulation
In conclusion:
- More biosimilars at lower prices especially for oncology and immunological diseases are essential to help with increasing medicine expenditure with aging populations. The WHO prequalified scheme may help with competition
- There are concerns if biosimilars are not launched in a class–especially as competition helps drive down prices. Quality indicators/ other demand-side measures including prescribing restrictions for originators/ other biological medicines in the class are important to increase interest in biosimilars.
- Under VBP principles – countries should see greater discounts/price reductions for existing patented biologicals (under MEAs) that used a biological that is now a biosimilar for price justifications to help with access and affordability limited examples to date. Other approaches include disinvestment in the originator (which happened in Denmark with ARBs)/ restrictions.
*All the information in this article was collected during Biosimilars LatAm - Brazil (August 2022) and prepared by Professor Brian Godman (University of Strathclyde, UK and Sefako Makgatho Health Sciences University, South Africa Professor) - Case Study: European Market Dynamics
