Sustainable market scorecard represents gold-standard for biosimilar sustainability

Biosimilares/General | Posted 02/10/2020 post-comment

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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.

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
Awareness and education	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
Incentives	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
Pricing rules and dynamics	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

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.