Impact of market access factors in the adoption of biosimilar anti-TNFs across Europe

A PRECISION BRIEF

2

Introduction

The recent entry of biosimilar anti-TNFs

into the European marketplace has

attracted considerable attention. Much

of the commentary to date has centered

on price: how competitive discounting

threatens pharma company revenue

streams and will drive significant cost

savings for payers. But price only

tells part of the story. Structural and

perceptual differences have led to

considerable heterogeneity in the levels

of discounting and uptake across – and

even within – European markets. Our

research explores the market access

considerations other than price that

play an important role in biosimilar

adoption rates.

To support this research, we conducted a total of 54 in-depth interviews, across 9

European markets,* targeting a mix of payer and clinicians who play an influential

role in decision making for anti-TNF biosimilars in their respective markets (detailed

sample available on request).

Prescribing Behavior With Biosimilar Anti-TNFs

Initiating naïve patients on a biosimilar anti-TNF is widely accepted, but attitudes

toward switching vary considerably across markets. In the case of infliximab,

clinicians in Norway and Poland have now switched the majority of their stable

Remicade patients to the cheaper Remsima or Inflectra biosimilar. In Germany,

Netherlands, Spain, and the UK, many of the more progressive centers have also

now switched, but clinicians in France, Italy, and Portugal remain largely resistant.

*France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Spain, UK.

54

80% 20%

The number of in-depth interviews across 9 European markets

Biosimilar infliximab discount vs uptakeCountry averages, based on data reported by respondents, N=54

0%

20%

40%

60%

80%

100%

0% 20% 40% 60% 80% 100%

Rep

orte

d bi

osim

ilar U

PTAK

E(%

tota

l infl

ixim

ab)

Reported average biosimilar NET discount (vs Remicade’s list price)

Market

Naïve patients

Switch patient stable on Remicade

Switch patient stable on other anti-TNF

Likelihood of infliximab biosimilar prescribingAverage answers based on 1-5 rating, payers and physicians answers, N=54

of respondents claim that infliximab-naïve, eligible, patients receive an infliximab biosimilar exclusively

of respondents note widespread switching

Figure 1.

Figure 2.

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Purchasing – Tendering and Contracting

Tendering and contracting represent important means of driving discounts and uptake

of biosimilars. With some exceptions in Germany and France, anti-TNFs are classed

as hospital products in most markets, with local payers incentivized to seek favorable

discounts as they keep the difference between the negotiated net price and the formal

reimbursement price.

But price is not the main barrier to switching (only 14% of respondents say it is). Most (54%) cite the need

for more data and experience with biosimilar infliximab, because biosimilars are not identical to the originator

product in the same way that small molecules are. This leads to clinical and ethical concerns with switching

a stable patient to a biosimilar purely for economic reasons. The outcomes of the NOR-SWITCH study

are expected to address these concerns, providing increased confidence in the safety of switching. But

for ethical reasons, most clinicians would never switch a patient stable on a different anti-TNF to infliximab

biosimilar based solely on cost.

Prescribing practices for the subcutaneous biosimilar anti-TNFs (ie, etanercept and adalimumab)

are expected to follow a similar pattern. However, switching may come sooner as etanercept has low

immunogenicity rates; by the time biosimilar adalimumab becomes available, switching is likely to be

accepted.

The Role of Market Access Tools in Biosimilar Adoption

Although discounting plays an important role in biosimilar adoption rates, without the right initiatives to

incentivize their implementation, it can be a blunt instrument. Payers (and manufacturers) have a number

of tools at their disposal to influence the adoption of biosimilars – and these can be exerted at different

points in the decision-making chain.

NOR-SWITCH is a randomized double-blind, parallel-group study to evaluate the safety and efficacy of switching from originator to biosimilar infliximab compared with continued treatment with originator infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, and chronic plaque psoriasis.

Biosimilar decision points

Purchasing Prescribing Dispensing

Tendering and contracting

Guidelines and recommendations

Rx quotas Automatic substitution policies

PAYER TOOLS

Figure 3.

4

However, because authorities have yet to advocate the interchangeability of biosimilar anti-TNFs, most

markets are still using nonexclusive tenders, allowing clinicians to retain their freedom to prescribe

(limiting biosimilars to naïve patients only in many cases).

Class tenders are only used in cost-conscious markets (eg, Norway and the UK), where anti-TNFs

are considered undifferentiated. However, these contracts only apply to treatment-naïve patients,

and clinicians are not forced to switch patients. Exclusive tenders are uncommon outside Poland.

Prescribing – Guidelines and Recommendations

National payer guidelines remain heavily influenced by clinicians, with medical societies

devoted to specific diseases tending to form the basis for their recommendations.

However, regional and local payers tend to be more progressive in their guidance, either

recommending or enforcing the use of infliximab biosimilars in naïve patients. Payers seldom

actively recommend switching patients – although, again, there is considerable intra-market variability in

this. Regions such as Andalucia in Spain, Tuscany in Italy, and Southampton in the UK are all engaged

in driving biosimilar adoption, working closely with clinicians to create mechanisms that allow effective

switching programs.

Nonexclusive Tender Exclusive Tender Class Tender

Formulary inclusion

Both originator and typically one biosimilar on formulary

Only one product per INN in formulary for both naïve and switch patients

All products within class are included in formulary but sorted by cost

ImplicationsPhysicians will prescribe based on personal choice, guidelines, and controls

All legacy patients are switched to tender winner

Prescribing order determined for class; physicians hold option to deviate from guidance

Applicable Markets

Tender types and implications for formulary inclusions

Paye

r driv

enPh

ysic

ian

driv

en

Regional variation

Regional variation

Local variation

Conservative Progressive

Guidelines and recommendations

Figure 4.

Figure 5.

5

Prescribing – Quotas

Biosimilar prescribing quotas are employed in Germany and Italy (and to a lesser extent

in Spain), and are considered more flexible than some of the other controls (eg, exclusive

tenders, automatic pharmacy substitution) as they do not restrict clinician prescribing

decisions at the individual patient level. But to be effective, the authorities need to implement

the right accompanying incentives and penalties for adherence (see case study below).

Dispensing – Automatic Substitution Policies

Automatic substitution is seen as the most extreme tool available to payers and is unlikely

to be implemented over the short-to-medium term (three to five years). As a national-

level tool, its implementation would require a strong consensus of originator-to-biosimilar

interchangeability among key decision makers, not just with a specific INN but across all

biosimilars. To date, only France has implemented an automatic pharmacy substitution policy for biologics,

but this only applies to naïve patients and is almost never enforced.

Germany High Incentive to meet/ surpass Rx quota

Biosimilar infliximab quotas introduced in 2 of 17 regions (from 10%-40%); expected to expand to 15 regions in 2016Level of switching correlated to quota level

Physicians fearful of audits and subjected to financial penalties if quotas are not metIncentive contracts between KKs and physicians stipulating savings sharing if quotas are surpassed

Italy Low Incentive to meet/ surpass Rx quota

Some regions introduced target infliximab biosimilar quotas, but are currently low (~10%)Physicians reach target quotas with naïve patients only

Payers track prescription levels and demand explanations from physicians that fail to complyNo financial rewards or penalties in place

Similar levels of discount(~40% vs Remicade list price)

Case Study: Biosimilar prescription quotas exist in Germany and Italy, but are set up and enforced differently

Figure 6.

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Discount PotentialLow High

Physician ControlHigh Low

Law Prohibits Automatic

Substitution

Guidelines Recommend

Against Automatic Substitution

No Law/Guidelines But Automatic Substitution Occurring

Conditional Automatic

SubstitutionAutomatic

Substitution

Automatic substitution rules across markets

Structural Considerations in the Adoption of Biosimilars

Each market operates a different framework for funding and decision making, and this structural

variability can lead to important differences in the influences and incentives for biosimilar adoption.

The way in which cost savings are realized across the different stakeholders is a central consideration.

Clinicians and local payers recognise the need to generate savings for their healthcare systems, but

unless those savings can be retained – or partially retained – in their organization, there is little incentive

to change existing practices.

HospitalPhysician PayerMarket Access

UptakeBudget

Reimbursement

Savings

Savings Sharing

Incentive required to overcome risk of using less established biosimilar and added effort to

educate patients

Incentive required to convince physicians to change established

processes and share responsibility on use of biosimilars

Incentive required to establish new policy, pathways, and processes, and impact the

interaction with other stakeholders

How savings generated by biosimilar use are shared among stakeholders will define the strength of the incentives for biosimilar

adoption

Figure 7.

Figure 8.

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In many organizations, savings-sharing mechanisms are already in place (eg, in the UK), but their

effectiveness varies – depending on the extent to which the savings are realized “on the ground.” In Italy and

Spain, fixed drug budgets are aligned with biosimilar adoption as the savings can be used to fund additional

staff, equipment, treatment of additional patients, or the use of innovative new therapeutics. By contrast, in

France, where SC anti-TNFs are hospital-prescribed but dispensed and funded outside of the hospital, there

are no incentives for clinicians to prescribe the biosimilar alternative, as their institution in no way benefits

from the resulting cost savings.

Key Insights

Price sensitivity to biosimilars currently applies mostly to the naïve-patient segment.

■ This is the segment that physicians and payers see as being in the target position for recently

launched biosimilars

■ Lack of experience and data on the safety and efficacy when patients stable on the originator are

switched to a biosimilar version, not price, is the main barrier to widespread switching

Lack of consensus on the interchangeability between originator and biosimilar is reflected across the market access tools employed by payers to drive biosimilar use.

■ In most markets, nonexclusive tenders are conducted where biosimilars only compete for naïve

patients, with payers actively guiding use in this patient population

■ While a few more progressive organizations are already conducting “winner-takes-all” exclusive

tenders, others opt for alternative market access tools such as prescribing quotas that give

physicians greater power of choice on an individual patient basis

■ Automatic pharmacy substitution is seen as a very effective tool for biosimilar adoption but requires

national-level consensus on the interchangeability between originator and biosimilar irrespective of

the INN; thus it is not likely to be implemented in the near to medium term

Structural factors impact how savings generated are distributed across stakeholders, and thus how incentives for biosimilar adoption vary between stakeholder types, impacting uptake.

Translating Insights Into Strategy

Avoid reactionary discounting in conservative, slow-to-switch marketsLook for opportunities to partly offset discounts with increased volumes

Avoid over-discounting with late adopters as this may be a blunt instrumentUse evidence from early adopters to communicate best practices

Originator ManufacturersBiosimilar Manufacturers

Segmenting your customers beyond discount level, across and within markets, is essential for a successful biosimilar market access strategy

Alex Grosvenor

Alexander.Grosvenor@precisionforvalue.com

Andre Vidal Pinheiro

Andre.Pinheiro@precisionforvalue.com

© 2016. All rights reserved.

Figure 9.

Precision for Value supports resourcing decisions and commercial excellence for global pharmaceutical and life sciences clients through the demonstration and communication of product value and outcomes. Precision has assembled a global team of industry-leading evidence, pricing and market access experts with decades of combined experience in advising clients on their payer strategy across the product life cycle. Combining this experience with our wide-ranging integrated services offers healthcare innovators uniquely robust global pricing, health economics, and market access services. Visit www.precisionforvalue.com for more information.

Authors: Andre Vidal Pinheiro, Mansi Vithlani, Kyle Sarnataro, and Alex Grosvenor