Download Impact of market access factors in the adoption of biosimilar anti

Impact of market access factors
in the adoption of biosimilar
anti-TNFs across Europe
A PRECISION BRIEF
Introduction
The recent entry of biosimilar anti-TNFs
into the European marketplace has
attracted considerable attention. Much
Figure 1.
Biosimilar infliximab discount vs uptake
Country averages, based on data reported by respondents, N=54
of the commentary to date has centered
100%
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.
Reported biosimilar UPTAKE
(% total infliximab)
on price: how competitive discounting
80%
60%
40%
20%
0%
0%
20%
40%
60%
80%
100%
Reported average biosimilar NET discount
(vs Remicade’s list price)
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,
54
The number
of in-depth
interviews
across 9
European
markets
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.
Figure 2.
Likelihood of infliximab biosimilar prescribing
Average answers based on 1-5 rating, payers and physicians answers, N=54
Market
Naïve patients
Switch patient
stable on Remicade
Switch patient stable
on other anti-TNF
80%
2
of respondents claim that infliximab-naïve, eligible,
patients receive an infliximab biosimilar exclusively
*France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Spain, UK.
20%
of respondents note
widespread switching
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.
Figure 3.
Biosimilar decision points
Guidelines and
recommendations
Tendering and
contracting
Rx quotas
Automatic
substitution policies
Purchasing
Prescribing
Dispensing
PAYER TOOLS
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.
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.
3
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.
Figure 4.
Tender types and implications for formulary inclusions
Nonexclusive Tender
Formulary
inclusion
Implications
Exclusive Tender
Class Tender
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
Physicians 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
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.
Figure 5.
Guidelines and recommendations
Payer driven
Regional variation
Regional variation
Local variation
Physician
driven
Conservative
4
Progressive
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).
Figure 6.
Case Study: Biosimilar prescription quotas exist in Germany and Italy, but are set
up and enforced differently
Similar levels of discount
(~40% vs Remicade list price)
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 2016
Level of switching correlated to quota level
Physicians fearful of audits and subjected to
financial penalties if quotas are not met
Incentive 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 comply
No financial rewards or penalties in place
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 nationallevel 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.
5
Figure 7.
Automatic substitution rules across markets
Low
High
Discount Potential
Law Prohibits
Automatic
Substitution
Guidelines
Recommend
Against Automatic
Substitution
High
No Law/Guidelines
But Automatic
Substitution
Occurring
Conditional
Automatic
Substitution
Automatic
Substitution
Low
Physician Control
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.
Figure 8.
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
Uptake
Physician
How savings generated by
biosimilar use are shared
among stakeholders will
define the strength of the
incentives for biosimilar
adoption
6
Market
Access
Incentive required to establish
new policy, pathways, and
processes, and impact the
interaction with other stakeholders
Budget
Hospital
Reimbursement
Savings
Sharing
Savings
Payer
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.
7
Translating Insights Into Strategy
Segmenting your customers beyond discount level, across and within markets,
is essential for a successful biosimilar market access strategy
Figure 9.
Biosimilar Manufacturers
Originator Manufacturers
Avoid over-discounting with
late adopters as this may be
a blunt instrument
Avoid reactionary
discounting in
conservative, slow-toswitch markets
Use evidence from early
adopters to communicate
best practices
Look for opportunities to
partly offset discounts
with increased volumes
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
Alex Grosvenor
[email protected]
Andre Vidal Pinheiro
[email protected]
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