biosimilar medicines in belgium– - fagg · • market analysis of biologics and biosimilars...
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Biosimilar medicines in Belgium–Perspective from rheumatology
Liese BarbierPhD researcherKU Leuven – MABEL Fund
FAGG Symposium Biological medicines in Belgium Brussel – 08/02/2018
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• Independent PhD researcher of the MABEL Fund
• MABEL Fund• Market Analysis of Biologics and Biosimilars following Loss of
Exclusivity• Collaboration between KU Leuven, Belgium and the Erasmus
University Medical Center, the Netherlands • Prof. I. Huys, Prof. S. Simoens, Prof. P. Declerck, Prof. A.G. Vulto • Supported by pharmaceutical companies via an unrestricted grant
• https://pharm.kuleuven.be/clinpharmacotherapy/mabel
Disclosure statement
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Experience and perception of rheumatologists in Belgium
van Overbeeke et al. (2017) BiodrugsRA: rheumatoid arthritis
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Objectives:• Investigate current knowledge and perception on originator biologicals and
biosimilars among RA patients and rheumatologists in Belgium • Identify differences in perception between RA patients and rheumatologists• Identify the factors that influence the choice between originator biological
and biosimilar
Study population: • 41 rheumatologists (24 Flanders, 8 Brussels, 10 Wallonia)• 121 RA patients (111 Flanders, 2 Wallonia, 8 undetermined)
Method:• Questionnaire per stakeholder group • Topics: knowledge, information, price, preference, biosimilar use,
interchangeability, extrapolation of indication, …
Objectives and study design
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Results rheumatologists: doubts about similarity
Q. Which elements do you think can differ between an original and a biosimilar?
0102030405060708090
100
Quality Efficacy Safety Price None of theabove
I don't know% o
f pat
ient
s an
d rh
eum
atol
ogis
ts
RA Patients (n = 121) Rheumatologists (n = 41)
* *
*
* = p < 0.05Chi-Square test
van Overbeeke et al. (2017) Biodrugs
van Overbeeke et al. (2017) BiodrugsPts: patients
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Results rheumatologists: majority would only prescribe biosimilarsin bio-naïve patients
0
10
20
30
40
50
60
% o
f rhe
umat
olog
ists
Pts with indications for whichthe biosimilar is registeredOnly in pts with indications in which efficacy and safety is proven in clinical trials
Stable pts treated withoriginator
Non-stable pts treatedwith originator
Only in biologic-naïve pts
I would not prescribe this
Q. For which patients would you prescribe a biosimilar?
Results rheumatologists: different opinions on extrapolation
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Q. Do you believe that indications can be extrapolated from the original to its biosimilar?
5%
56%
39%
n = 41
van Overbeeke et al. (2017) Biodrugs
Yes, after efficacy and safety is proven similar in one of the indications
Only if efficacy and safety is proven similar in one of the indications and if themedicine works via the same mechanismin the other indications
Never, a biosimilar should be tested for allits indications
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Results rheumatologists: price influences the preference of rheumatologists
0%
10%
20%
30%
40%
50%
60%
70%
80%
Original is more expensive (n= 40)
Equal prices (n = 41)
% o
f rhe
umat
olog
ists
Original Biosimilar No preference
*
Q. When the price of the original has decreased but is higher than the biosimilar, which one do you prefer to prescribe? And when the prices are equal?
* = p < 0.05Chi-Square test
van Overbeeke et al. (2017) Biodrugs
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Results RA patients: no difference in conditions for starting on, or switching to a biosimilar
01020304050607080
Never On doctor'sadvice
Efficacyproven in arheumaticdisorder
Efficacyproven in my
disorder
When cheaperthan original
When notsatisfied with
currenttreatment
% o
f pat
ient
s (n
= 1
20)
Switching Starting
Q. When would you switch from an original to a biosimilar, or start on a biosimilar?
van Overbeeke et al. (2017) Biodrugs
KBVR: SRBR:
Koninklijke Belgische Vereniging voor ReumatologieSociété Royale Belge de Rhumatologie
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• Switching• Should be the responsibility of the treating physician• Adequate monitoring needed, as is the case for switch originator
medicines• Not specifically advised for patient under disease control, if only for
cost savings reasons. But, the physician can decide to do so.• Decision on individual patient level
• Automatic substitution should not be allowed
• INN (VOS/DCI) prescribing is not recommended
• Cost responsibility for the use of biological medicines in order to provide optimal care for as many patients as needed
• In line with the statements of the FAGG/AFPMS
KBVR/SRBR – position Sept. 2015
1. Personal correspondence with prof. Westhovens 2. The safety of switching between reference biopharmaceuticals and biosimilars: a systematic review –
Manuscript in preparation 11
• UZ Leuven switch experience for infliximab1
• All patients switched (rheumatology, gastro-enterology etc) afterstandardised education
• Approx. 2% of RA patients refused to switch • No signs of loss of efficacy or increased immunogenicity after switch in
rheumatic patients. Some nocebo effect! • Formal evaluation of data by prof. Westhovens will follow
• Based on current evidence from RCTs, registries and real world studies no indications that switching from originator biologicals to biosimilars leads tosafety issues or loss of response2
• However, switch studies have limitations: • Not sensitive enough to identify rare safety events• Lack of comparator arm (registries)• Which type of evidence is needed to exclude any risk?
• Adequate follow up and traceability needed when switching• Avoid multiple switching
Switching from reference product to biosimilar
KBVR: SRBR:
Koninklijke Belgische Vereniging voor ReumatologieSociété Royale Belge de Rhumatologie
TARDIS: Tool for Administrative Reimbursement Drug Information Sharing 12
• A working group on biosimilars represents in all independencyand transparancy the rheumatological community at the level of companies, regulatory authorities and payers but also towardspatient organizations
• A role in evaluation via TARDIS (now still for RA patients only) promoting transparency
• Working together with gastro-enterologists and dermatologists…
KBVR/SRBR initiatives
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• Still hesitation and uncertainty among Belgian rheumatologists about biosimilars
• Continued effort towards transparent and correct information needed
• Information transfer from physician to patient: limit nocebo effect• Patient education and involvement is key
• Patient can be switched under the supervision of a physician, if • Adequate monitoring and traceability is in place• Patient is correctly informed• Decision on individual patient level needs to be possible• Time/incentive available to inform and guide the patients…!
Points to consider
NCAZ: Nationale commissie artsen ziekenfondsen 1. Het akkoord artsen-ziekenfondsen 2018-2019. http://www.riziv.fgov.be/SiteCollectionDocuments/akkoord_artsen_ziekenfondsen_2018_2019.pdf 14
• Convenant has reached its pre-set goal for infliximab biosimilar uptake in the hospital
• Biosimilar uptake other product classes remains low
• Next challenge: uptake biosimilars in ambulant care • NCAZ: incentive for physicians to prescribe a minimum quotum
anti-TNF biosimilars1
• Physician has a cost-responsibility when prescribing biologicals• Biosimilars are a qualitative alternative of the reference product • Entry of biosimilar drives down price of the reference product• Tapering of biologicals is also a possible strategy• Strategies including eventual stop of biologicals (less efficient in
rheumatology)
Points to consider
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Thank you for your attention!Questions?
