Sustainable market scorecard represents gold-standard for biosimilar sustainability

Biosimilars/General | Posted 02/10/2020 post-comment0 Post your comment

IQVIA Institute and Medicines for Europe have recently launched Country Scorecards for Biosimilar Sustainability in 12 European countries [1]. The scorecards assess the level of competition, price evolution and volume development for seven key biological molecules – adalimumab, etanercept, infliximab, insulin glargine, insulin lispro, rituximab and trastuzumab – in each country. They also present a sustainability assessment and detail positive policy elements, challenges and solutions for each country.

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There are notable differences in the healthcare systems of European countries, therefore, policy scores should not be directly compared across countries. To avoid any inaccurate comparison of countries, ‘The Sustainable Market’ scorecard was developed to act as the gold-standard market to which country scorecards can compare themselves. This scorecard represents how the ideal marketplace should perform to ensure optimal market sustainability and patient-focus, and it is depicted in the tables below.

Table 1: Contribution of biosimilars    
MOLECULE LEVEL OF
COMPETITION
PRICE
EVOLUTION
VOLUME
DEVELOPMENT
  1 = Low, 5 = High 1 = Low, 5 = High 1 = Low, 5 = High
The most recent launches in the European market An indicator of the level of competition for a molecule Evolution of price level since start of biosimilar competition An indicator of additional access generated since the start of biosimilar competition
7 molecules covering anti-TNFs (adalimumab, infliximab, etanercept), insulins (insulin glargine and lispro), and oncology (trastuzumab, rituximab) Using a Herfindahl index to evaluate the level of competition in the market for a molecule, based on competitors’ market shares Net price reduction compared to list price before biosimilar competition, collected where available Increased number of treatment days (TD) per capita in Q1 2020 versus the year before biosimilar entry
TNF: tumour necrosis factor.                      
Source: IQVIA Institute for Human Data Science.    
Table 2: Sustainability scorecard  
POLICY AREA SUSTAINABILITY MEASURE SUSTAINABLE MARKET STATUS
Regulatory environment and clinical guidelines Time from EMA approval to first biosimilars sales Instant or very short market entry after approval
Treatment guidelines for biosimilar use Publication of multiple guidelines on usage and protocols prior to first biosimilar entry
Physician switching policies Authorisation and guidance of physician-led ability to switch to a biosimilar medicine at entry of first biosimilar on the market
No biologic pharmacy substitution  No biologic pharmacy substitution allowed
Awareness and education Comprehensive training / education for patient Access to comprehensive and unbiased training or education prior to first biosimilar entry
Comprehensive training / education for physician
Incentives Patient incentives to promote biosimilar use Incentives in place to encourage use of most economically advantageous product upon introduction of competition
Prescription quotas or financial incentives for providers that do not restrict physician choice An incentive or quota that does not restrict physician choice
Pricing rules and dynamics Originator price not subject to mandatory price cuts No forced originator price cuts by central authorities required, market forces to determine price
Molecule pricing not subject to reference price No reference price determined by central authorities, market forces to determine price
Purchasing mechanisms Length of contracts 12- to 24-month contracts ensure market competitiveness and avoid patients are switched often
Tender timing relative to biosimilar availability Tender opens upon introduction of competition 
Time from tender award to delivery 4-6 months lead time to allow necessary preparations and stock build-up
Number of winners Consistently award multi-winner tenders to allow of market sustainability
Winner decision criteria beyond price Decision based on the most economically advantageous tender offers (e.g. incorporating sustainability, price, product characteristics, continuity of supply)
Source: IQVIA Institute for Human Data Science.
Table 3: The sustainable market
POSITIVE POLICY ELEMENTS
Selected country policy elements that positively influence Biosimilar Sustainability.
POLICY CHALLENGES
Most-urgent country policy challenges that require action in order to achieve Biosimilar Sustainability.
POTENTIAL POLICY SOLUTIONS
Suggested country policy actions to address challenges and improve Biosimilar Sustainability
Source: IQVIA Institute for Human Data Science.

Figure 4: A multi-stakeholder definition of sustainability for the biosimilars marketplace

Figure 4 A multi-stakeholder definition of sustainability for the biosimilars marketplace

Successful policies balance the benefits of competition, volume uptake and price discounts. By tailoring policies to local needs, governments and authorities can reduce pressure on healthcare resources to improve access and increase the sustainability of healthcare systems.

Related articles
Sustainable biosimilar policies in Europe

Optimizing the benefits of biosimilars for society

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Scorecards show biosimilar sustainability in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 2]. Available from: www.gabionline.net/Biosimilars/General/Country-scorecards-show-biosimilar-sustainability

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Source: IQVIA Institute for Human Data Science.

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