biosimilar medicines - a cost-effective move towards patient access · 2019-06-24 · health...
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patients • quality • value • sustainability • partnership
Biosimilar medicines:a cost-effective move towards patient access
Diogo Piedade
Health Economics Advisor – Medicines for Europe
patients • quality • value • sustainability • partnership
Better Access, Better Health
Med
icin
es fo
r Eu
rop
eGeneric Medicines
Biosimilar Medicines
Value Added Medicines
Our Vision: Provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership.
Our Members: • Employ 160,000 people at over 350 manufacturing
and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation.
• Increase access to medicines and drive improved health outcomes.
Our collective expertise: off-patent medicines which have proven clinically useful over the years, are effective in the largest
part of the population; their development & manufacturing, their regulation, their market dynamics
Biosimilar Medicines Group MembershipC
OM
PAN
IES
ASS
OC
IATI
ON
S
The biosimilar medicines’ landscape
Over 50 EU authorised* biosimilar medicines
Active substance Reference product Biosimilar medicines
Adalimumab (8) Humira® Amgevita®, Solymbic®, Cytelzo®, Imraldi®, Halimatoz®, Hyrimoz®, Hefiya®, Hulio®
Bevacizumab (1) Avastin® Mvasi®
Enoxaparin sodium (2) Lovenox® Inhixa®, Thorinane®
Epoetin (5) Erypo®/Eprex® Abseamed®, Binocrit®, Epoetin Alfa Hexal®, Retacrit®, Silapo®
Etanercept (2) Enbrel® Benepali®, Erelzi®
Filgrastim (7) Neupogen® Accofil®, Filgrastim Hexal®, Grastofil®, Nivestim®, Ratiograstim®, Tevagrastim, Zarzio®
Follitropin alfa (2) Gonal-f® Bemfola®, Ovaleap®
Infliximab (4) Remicade® Flixabi®, Inflectra®, Remsima®, Zessly®
Insulin glargine (3) Lantus® Abasaglar®, Lusduna®, Semglee®
Insulin Lispro (1) Humalog® Insulin Lispro Sanofi®
Pegfilgrastim (5) Neulasta® Fulphila®, Pelgraz®, Pelmeg®, Udenyca®, Ziextenzo®
Rituximab (6) MabThera® Blitzima®, Ritemvia®, Rituzena®, Rixathon®, Riximyo®, Truxima®
Somatropin (1) Genotropin® Omnitrope®
Teriparatide (2) Forsteo® Movymia®, Terrosa®
Trastuzumab (5) Herceptin® Ontruzant®, Herzuma®, Kanjinti®, Trazimera®, Ogivri®Source: European Medicines Agency (October 2018) - *positive recommendation from EMA, EC decision might be pending
patients • quality • value • sustainability • partnership
35 different approved indications
Cardiology 1%
Dermatology 18%
Endocrinology 5%
Gastroenterology 11%
Haematology 7%
Immunology 6%
Infectious diseases 3%
Oncology 21%
Rheumatology 20%
Transplantation 4%
Urology 3%
Gynaecology 1%
Therapeutic Area
Source: European Medicines Agency (October 2018)
patients • quality • value • sustainability • partnership
Biologics growth continues to outstrip total pharma and impact expenditure
Biologics account for over ¼ of European sales
0%
1%
2%
3%
4%
5%
6%
7%
8%
9%
10%
-
10
20
30
40
50
60
2012 2013 2014 2015 2016 2017 2018
Bio
logi
cal s
ales
, EU
R, B
n
DEU FRA ITA
GBR ESP Rest of Europe
Europe GrowthP
PG
%
Europe biologic market dynamics, €54Bn
Such a trend is putting additional financial pressure on healthcare budgets
0%
10%
20%
30%
40%
50%
60%
70%
80%
0.0
0.5
1.0
1.5
2.0
2.5
3.0
2012 2013 2014 2015 2016 2017 2018
Bio
logi
cal s
ales
, EU
R, B
n
DEU FRA ITA
GBR ESP Rest of Europe
Europe Growth
PP
G%
Europe biosimilar market dynamics, €2.7Bn
Biosimilars only account for 5.0%
Source: IQVIA
Important Biologics have already lost or are about to lose exclusivity
Biologic sales (Bn)EU Protection
expiry dateUS Protection
expiry date
2018 (2023)
Expired Expired
Expired 2022
Expired 2018
Expired 2018
Expired Expired
Expired 2019
2019 2019
2024 2027
Expired Expired5.1
2.7
2.9
2.6
5.3
3.9
5.4
8.6
9.1
16.1
0.4
2.0
1.8
1.9
0.6
1.8
1.8
1.8
1.0
3.5
0.3
1.2
1.7
1.8
0.8
1.6
2.2
1.4
2.1
2.4
0 5 10 15 20 25US Europe ROW
Rituximab (Mabthera)
Insulin glargine (Lantus)
Insulin aspart (Novorapid)
Etanercept (Enbrel)
Infliximab (Remicade)
Adalimumab (Humira)
Insulin Lispro (Humalog)
Immunoglobulin base (Privigen)
Bevacizumab (Avastin)
Trastuzumab (Herceptin)
Global Top 10 Biologics SalesUS$ MAT Q3 2017
Source: IQVIA MIDAS MAT Q3 2017; IQVIA Institute Jan 2018
patients • quality • value • sustainability • partnership
Biosimilar medicines experience EU at the forefront
• 9 out of 10 biosimilar medicines sales take place in EU (2016)
• 60% of overall biological medicines sales occur in US (2016)
• Over the last 10 years, EU cumulates nearly 100% of the use and experience with biosimilar medicines
Source: IMS Health MIDAS MAT Q4 2016; Europe does not include Russia and Turkey
All Others Europe Japan US Global
Biologic vs Biosimilar Medicines Sales (USD)
Non-biosimilars Biosimilars
European markets
patients • quality • value • sustainability • partnership
Use of biosimilar medicines varies greatly by country and therapeutic area
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Biosimilar penetration vs reference product (12/2017)
Market share TD (2017) - Anti-TNF Market share TD (2017) - EPO Market share TD (2017) - Folitropin alfa
Market share TD (2017) - G-CSF Market share TD (2017) - HGH Market share TD (2017) - Rituximab
Market share TD (2017) - Insulins
Source: IQVIA. The Impact of Biosimilar Competition in Europe. (2018).
patients • quality • value • sustainability • partnership
Infliximab High variation in biosimilar use
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
M0 M4 M8 M12 M16 M20 M24 M28 M32 M36 M40 M44 M48 M53
Infl
ixim
ab
bio
sim
ilar
up
take (
treatm
en
t d
ays)
Europe*: Infliximab biosimilar market share in treatment days
Norway Finland Poland Spain Germany France Sweden Denmark Italy UK
100%
100%
70%
90%
51%
53%
50%
EU5
100%
44%
Notes: *High uptake countries and EU5, Latvia and Bulgaria excluded because only biosimilar manufacturers present in market; Source: IQVIA MIDAS Restricted MTH April 2018
patients • quality • value • sustainability • partnership
InfliximabIncrease in treatment days reveals unmet needs
100%100%
100%96%
74%
55%42%
3%15%
24%
27%
0%1%
11%21% 29%
1%
2%
0
5
10
15
20
25
30
35
40
Q1 2012 Q1 2013 Q1 2014 Q1 2015 Q1 2016 Q1 2017 Q1 2018
Trea
tmen
t d
ays
(Mn
)
Europe: Treatment increase as a result of biosimilar usage
Remicade Remsima Inflectra Flixabi
21 Mn
31 Mn
22 Mn
34 Mn
19 Mn
24 Mn
28 Mn
Infliximab TD % growth increase
Country Q1 2014-Q1 2016 Q1 2016-Q1 2018
France 41% 55%
Germany 27% 34%
Italy 4% 37%
Spain 31% 51%
UK 28% 33%
Finland 62% 43%
Poland -5% 52%
Europe 33% 44%
Notes: Infliximab unknown has been excluded; Source: IQVIA MIDAS Restricted QTR Q1 2018
patients • quality • value • sustainability • partnership
Uptake is faster with newer launchesas trust in biosimilars increases
Notes: each curve represents the biosimilar uptake for one EU5 country (FR, DE, IT, ES, UK)Source: IQVIA MIDAS Restricted MTH Apr 2018
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
80.00%
90.00%
100.00%
M0 M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12
Bio
sim
ilar
shar
e (T
reat
men
t d
ays)
Infliximab Rituximab
Time to marketbig discrepancies across Europe
0 5 10 15 20 25 30 35 40 45
GERMANY
FINLAND
IRELAND
UK
SWEDEN
ITALY
NORWAY
SPAIN
AUSTRIA
FRANCE
POLAND
NETHERLANDS
Average product delay
ROMANIA
DENMARK
CZECH
HUNGARY
SLOVENIA
SWITZERLAND
PORTUGAL
BULGARIA
SLOVAKIA
BELGIUM
GREECE
Months
Note: Time lapse between EMA approval and first recorded sale. Averaged per country for the products available.Source: IQVIA. The Impact of Biosimilar Competition in Europe. (2018).
Biosimilar medicines policies - What are the existing incentives ?
patients • quality • value • sustainability • partnership
What’s in it for me?Making benefits tangible
Incentives
Patients
Physicians
Hospitals
Payers
Pharmacists
Industry
patients • quality • value • sustainability • partnership
Information and education: EU initiatives on biosimilar medicines
What you need to know about biosimilar medicinal
productsEuropean Commission, 2013
(link)
What I need to know about biosimilar medicines –
Information for patientsEuropean Commission, 2016
(link)
Biosimilars in the EU –Information guide for
healthcare professionalsEMA, 2017
(link)
The impact of biosimilar competition in Europe
QuintilesIMS, 2018(link)
NEW
Patients Physicians Payers
patients • quality • value • sustainability • partnership
Information and education: EU initiatives on biosimilar medicines
An animated video for patients explains key facts on biosimilar medicines and how EMA works to ensure that they are as safe and effective as their reference biological medicines.The video is also available in the following European languages: Dutch, English, French, German, Italian, Polish, Portuguese and Spanish. EMA plans to publish further language versions when available.
Patients Physicians Payers
patients • quality • value • sustainability • partnership
Information and education: biosimilar medicines as therapeutic alternative
National Position on Physician-led switching
National/Targeted Information campaign
National Plan/Ambition
Link: Overview of positions on EU physician-led switching for biosimilar medicines
UK: https://www.england.nhs.uk/wp-content/uploads/2017/09/biosimilar-medicines-commissioning-framework.pdfFR: http://solidarites-sante.gouv.fr/IMG/pdf/dossier_sns_2017_vdef.pdfDK: http://ec.europa.eu/docsroom/documents/26630
Patients Physicians Payers
patients • quality • value • sustainability • partnership
Revising Prescribing/Clinical GuidelinesClear positioning is essential
• The originator was authorised however not used in a certain indication (in the label)
Acknowledging revised cost-effectiveness of a given treatment
• Prescription subject to authorisation
• Failure of another treatment (secondary treatment)
Remove existing prescription limitations / Introduce authorisation process for less cost-effective option
Southern healthcare
region
Patients Physicians Payers
patients • quality • value • sustainability • partnership
Biosimilar medicinesincrease patient access
▪ After biosimilar launch in 2008, NICE guidelines were updated to reflect the improved cost-effectiveness of biosimilar filgrastim vs. alternative treatments
▪ As a result, G-CSF restrictions have been relaxed and usage is now also recommended for primary prophylaxis of neutropenia (before: secondary prophylaxis only)
▪ As a consequence, overall consumption of filgrastim short-acting increased by 104% between 2009 and 2014
▪ One can conclude that the launch of biosimilar G-CSF also led to improved patient outcomes, by enabling greater numbers of patients to access these treatments at an earlier stage of the therapy cycle
0
200
400
600
800
1,000
1,200
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Short acting GCSFs Long acting GCSFs
Biosimilar launch
+ 104%
- 18%
Filgrastim uptake in the UK Standard Units (K)
Changes in developments depicted as overall change in % between 2008–2014 (short acting) and 2010–2014 (long acting)
Source: Simon-Kucher & Partners, IMS Health, MIDAS, IMS Consulting Group, Nov 2015
Patients Physicians Payers
patients • quality • value • sustainability • partnership
Biosimilar medicinesincrease patient access
Previous situation prior to availability of filgrastim biosimilars
• In order to be allowed to initiate the treatment with filgrastim originator, the opinion / formal approval of three physicianshas to be awaited
Current situation with filgrastim biosimilars available
• Launch of filgrastim biosimilars and the associated reduction in treatment costs for G-CSF treatment of febrile neutropenia prompted the regional authorities to relax restrictions on prescribing
• Prescription does not need further authorization
• Clinical use of G-CSF increased five-fold in the Southern Healthcare Region, driven by usage of biosimilar filgrastim
Southern healthcare
region
Source: Simon-Kucher & Partners, IMS Health
Patients Physicians Payers
patients • quality • value • sustainability • partnership
Revising Prescribing/Clinical GuidelinesClear positioning is essential
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
Jun-18 Jul-18 Aug-18 Sep-18 Oct-18 Nov-18 Dec-18 Jan-19 Feb-19 Mar-19 Apr-19 May-19 Jun-19
Rit
uxi
mab
bio
sim
ilar
up
take
(Tr
eatm
ent
day
s)
New biosimilars guideline
Source: Infarmed, website accessed 19.10.2018; CNFT, website accessed 19.10.18
Patients Physicians Payers
scientific evidence driving
the update of clinical guideline
biosimilars increase patient
access
support of medical
switching
promotes switching in all clinically stable
patients
includes a Q&A for patients
Hospitals
patients • quality • value • sustainability • partnership
HCP Initiatives: supporting patient-HCP dialogue
Hospital Pharmacists guideline on introducing biosimilar medicines in the hospital
• Link: http://nvza.nl/wp-content/uploads/2017/04/NVZA-Toolbox-biosimilars_7-april-2017.pdf
European Specialised Nurses guideline on introducing biosimilar medicines in the hospital
• Published in June 2018: http://www.esno.org/assets/biosimilar-nurses-guideline-final.pdf
Patients Physicians Hospitals
patients • quality • value • sustainability • partnership
Market Access & Procurement mechanisms
Internal reference pricing (price based on originator)
Best-value biologic (preferred biologic)
HospitalsPayersIndustry
patients • quality • value • sustainability • partnership
Supporting the Clinical Use of biosimilar medicines
• Voluntary
• Mandatory
Quotas/ Target Agreements
Prescription monitoring
Benefit-sharing schemes
Hospitals Physicians Payers
patients • quality • value • sustainability • partnership
Benefit sharing models: successful driver of biosimilar medicines use in clinical practice
University Hospital Southampton NHS Foundation Trust – Managed Switching
▪ Managed switching program – Biosimilar infliximab for IBD
▪ Team discussions with physicians – agreement with entire medical staff
▪ Additional staffing to implement and monitor a safe switch
▪ Proposed switching program discussed in detail with IBD patient panel
▪ Additional clinical monitoring and surveillance included at the request of patient panel
▪ Some of cost-savings being reinvested in improvements of patients’ care
▪ Continuous communication with patients during switch
▪ 134 patients switched from originator to biosimilar infliximab, only 2 patients have requested review of the switch on medical grounds
▪ Estimated savings after 4 months: £293,000
patients • quality • value • sustainability • partnership
Norway – National tenders with direct benefits for stakeholders
▪ National Committee (LIS) providing the basis to, and specification for, purchase and delivery agreements
▪ KOL from different medical specialties included in decision making process
▪ Recommendations for use of drug with lowest cost, not compulsory
▪ Norwegian government invested heavily in physician and patient education on biosimilar medicines
▪ Investment by government in NOR-SWITCH to reassure physicians’ concerns
▪ Financial incentive to use lowest-cost biosimilar throughDRG payment in hospitals
▪ Immediate and fast use of biosimilar medicine in clinical practice (≈100%)
▪ Attractive prices offered by companies
Ori
gin
al
DRG price
Bio
sim
ilar
Bio
sim
ilar
Ori
gin
al
Year 1 Year 2
Hospitals earn
money
Hospitals earn
money
Hospitals lose money
Benefit sharing models: successful driver of biosimilar medicines use in clinical practice
patients • quality • value • sustainability • partnership
Denmark – Good communication and direct benefits for hospitals
▪ All 5 regions group their tenders National tender
▪ Council for Use of Expensive Hospital Medicine (RADS) makes recommendation to national tender body AMGROS
▪ Expert physicians in their field included in RADS
▪ Savings from biosimilar medicines go back to the regional hospitals
▪ Clear information for patients developed by government in consultation with payers, regulators and physicians
▪ Attractive prices offered by companies biosimilar infliximab wonthe national tender
▪ Change of RADS guidelines: biosimilar infliximab now first-line product for biological treatment in rheumatology/gastroenterology
▪ Immediate uptake of biosimilar medicine in clinical practice
Benefit sharing models: successful driver of biosimilar medicines use in clinical practice
A sustainable biosimilar market should deliver:
1. Long-term-savings for healthcare systemdue to fair erosion with adequate volume ofprescribed biosimilar medicines
2. Viable business through healthy competitionof several manufacturers
1. Limited changes to pricing & market access policies over time reduce payers’ efforts and increase predictability for the industry
2. Procurement practices allow several manufacturers in the same market (e.g. by regional differentiation or multiple tender lots)
3. Physician education, communication and incentivization to ensure appropriate but cost-conscious prescribing
Delivering on the biologic medicines promise requires a sustainable policy framework
Source: Simon-Kucher – Policy requirements for a sustainable biosimilar market
patients • quality • value • sustainability • partnership
Sustainability requires accommodation and balancing of all stakeholders’ needs
Concluding Remarks
Optimal biosimilar medicines policy setup
What generally works
What conditions the success
Multi-stakeholder policy platform – incl. education, information
Comprehensive policies with defined ambition
– i.e. more than 1 measure + objective
Implementation schemes
Benefit-sharing
Clear Medicines Agency position
CountryHealth Care
system & budget
Acute vs
ChronicTreatment
Hospital vs
Outpatientvs
Retail
Today vs Tomorrow
National, Regional or
Local
Revision of guidelines after
entry of biosimilar: cost- effectiveness
consideration
Set the ambition first, then take a first concrete step
“The best time to plant a tree was 20 years ago. The second best time is now”.
Chinese proverb
patients • quality • value • sustainability • partnership
THANK YOU!
For more information: https://www.medicinesforeurope.com/biosimilar-medicines/
Contact: [email protected]
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patients • quality • value • sustainability • partnership
Useful resources
• Biosimilar medicines reading list – online
• Biosimilar medicines handbook – online
• Overview of positioning Statements on Physician-led Switching – online
• Biosimilar policy:
• Medicines for Europe Market Review – online
• Biosimilar sustainability:
• 2014 – Factors Supporting a Sustainable European Biosimilar Medicines Market, GfK – online
• 2016 – Payers’ price & market access policies supporting a sustainable biosimilar medicines market, SKP – online
• 2018 – Advancing Biosimilar Sustainability in Europe, IQVIA – online