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Health Economics Models and Interchangeability of Drugs
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Goran Medić, MSc. Pharm. Spec.6th November 2015
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Agenda
Introduction: Basics of Health economics models
Biosimilars and biobetters Conclusions
Introduction: Basics of health economics models
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Before and now
Drug approval and “game over”
Before
New hurdles:• Safety, quality and efficacy … and … • Cost-effectiveness analysis • Health economics analyses
Now
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Models
Cost-effectiveness analysis (Analiza isplativosti)
Cost-utility analysis (Analiza odnosa troškova i korisnosti)
Cost-minimization analysis (Analiza minimizacije troškova)
Cost-benefit analysis (Analiza odnosa troškova i koristi)
Budget Impact Model (BIM)
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Different types of health economics modelsModel type Costs Consequences ResultCost Minimization
Money Same in all aspects (safety, efficacy)
The cheapest alternative
Cost Effectiveness
Money Different magnitude of a common measure i.e., LY’s gained, blood pressure reduction.
Cost per unit of consequence i.e. cost per LY gained.
Cost Utility Money Single or multiple effects not necessarily common. Valued as “utility” i.e. QALY
Cost per unit of consequence i.e. cost per QALY.
Cost Benefit Money As for CUA but valued in money
Net € Cost-benefit ratio.
Biosimilars and biobetters
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Biosimilars vs. biobetters
Biosimilars1 are designed to be similar to an approved originator biologic product, and are expected to demonstrate comparability to the originator product in terms of quality, safety and efficacy.
Biobetters2 incorporate intentional modifications to the originator molecular profile with the aim of producing an improved product.
Interchangeability3 of medicinal products refers to the situation where one product is “switched” for another equivalent product in a clinical setting, without a risk of an adverse health outcome.
1EMA. Biosimilar Medicines. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp 2014; Accessed October 27, 2014.
2 Generics and Biosimilars Initiative. http://gabionline.net/Biosimilars/Research/Biosimilars-or-biobetters-what-does-the-future-hold 2011; Accessed October 27, 2014.
3 EuropaBio & Biosimilar Medicines. http://www.europabio.org/sites/default/files/biosimilar_factsheet_december_2008.pdf. Accessed October 2015.
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Examples of products1
Filgrastims Epoetins Insulins Growth hormones Alfa interferons Monoclonal antibodies Beta interferons Follitropins Low-molecular-weight heparins (LMWH)
1EMA. Biosimilar medicinal products. http://www.ema.europa.eu/docs/en_GB/document_library/Brochure/2011/03/WC500104228.pdf. Accessed October 2015.
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Regulatory implications and example Biosimilars follow class-specific guidance whereas biobetters
are considered innovator drugs.
Neupogen® (filgrastim) – originator drug.
Filgrastim1 – a recombinant granulocyte-colony stimulating factor – an example of a biologic drug for which there are biosimilar products.
Biobetters: pegfilgrastim and lipegfilgrastim Pegylated forms of filgrastim.2,3 Long-acting versions that require a lower frequency of
administration compared with originator filgrastim.4
1EMA Filgrastim. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124&source=homeMedSearch&keyword=filgrastim&category=human&isNewQuery=true 2014; Accessed October 20152. Satterwhite, C. Assessing Development Needs for Biobetters and Biosimilars. http://www.biopharminternational.com/biopharm/ArticleStandard/Article/detail/804371 2013; Accessed October 20153. Biosimilar News. Teva receives EU nod for Neulasta biosimilar. http://www.biosimilarnews.com/teva-receives-eu-nod-for-neulasta-biosimilar 2013; Accessed October 20154 EMA. Lonquex; Summary for the public. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002556/WC500148383.pdf 2013; Accessed October 2015
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Biosimilar vs. biobetterBiosimilar Biobetter
Completely new drug No Yes
Abbreviated regulatory approval pathway
Yes No
Market exclusivity No Yes
Research and development costs Lower than the originator biologic
Lower than the originator biologic
Indication(s) Same as the originator biologic
All indications for which it is approved by the Regulatory agency
Sample size Smaller Larger
Interchangeability(originator vs. biosimilar/biobetter) – EMA perspective1
No recommendation No recommendation
1EMA. Questions and answers on biosimilar medicines (similar biological medicinal products). http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500020062.pdf. Accessed October 2015.
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Price and reimbursement
Biobetters = price premium? Convenience of use, but no demonstrated improvements in
therapeutic effect (pegfilgrastim) Cost savings were demonstrated only in certain
circumstances as the price was higher than for biosimilars, and is therefore recommended in multiple countries for restricted use only.
Lipegfilgrastim (follow-on version of pegfilgrastim) – offers lower drug acquisition costs – reimbursed in multiple countries.
Peginterferon alfa (biobetter of interferon alfa) – offers improved efficacy and cost-effectiveness was considered in their reimbursement.
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HTA agencies in different countries
France – HAS (Haute Autorité de Santé) www.has-sante.fr Netherlands – ZIN (Zorginstituut Nederland)
www.zorginstituutnederland.nl Scotland – SMC (Scottish Medicines Consortium)
www.scottishmedicines.org.uk Sweden – SBU (Statens beredning för medicinsk och social
utvärdering) www.sbu.se Wales – AWMSG (All Wales Medicines Strategy Group)
www.awmsg.org England – NICE (The National Institute for Health and Care
Excellence) www.nice.org.uk
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Clinical decision factors in HTA appraisals of biosimilars
France Scotland Sweden Wales England
Clinical comparability demonstrated to reference product X X X X XSafety profile demonstrated to be comparable to reference product X X X X XLong term safety data for biosimilars potentially desired for certain indications
X
Post-marketing pharmacovigilance due to the potential for minor variation from reference product
X
Clinical analyses of all patient subgroups XClinical analyses performed on all administrations
X X XRarity of disease and/or prevalence of disease X
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Economic decision factors in HTA appraisals of biosimilars
France Scotland Sweden Wales England
Provide a cost-minimization analysis X X X XCost-effectiveness / cost-utility analysis preferred XProvide a budget impact analysis X X XDifference in administration versus reference product (more or less frequent affecting cost)
X X
Economic analyses performed on all administrations X X XInclude potential comparators beyond reference product X XSimultaneous launching of another biosimilar in the same class reduces the budget impact savings
X
Extrapolation of analyses allowed for other indications X X X
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Overview table of biosimilars/biobettersBiosimilar / Biobetter
Active substance
EU approval date
France Netherlands Scotland Sweden Wales England
Biograstim® Filgrastim 2008
Ratiograstim® Filgrastim 2009
Tevagrastim® Filgrastim 2008
Zarzio® Filgrastim 2009
Filgrastim Hexal®
Filgrastim 2009
Nivestim® Filgrastim 2010
Grastofil® Filgrastim 2013
Neulasta® Pegfilgrastim 2009
Lonquex® Lipegfilgrastim 2013
Recommended Not appraised Not recommended
Conclusions
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Conclusions
Appraisals are based on efficacy, safety and cost-effectiveness of biosimilars to the reference product.
Economic evidence for biosimilars, to date, was provided mainly in the form of cost-minimization analyses.
NICE has a short guidance in place on the appraisal of biosimilars or biobetters.
More guidelines will be issued for the assessment of biosimilars.
Biologic agents will continue to outpace overallpharmaceutical spending growth and are expected torepresent 19-20% of the total market value by 2017.1
Biologics growth is driven by monoclonal antibodies and human insulin. 1
1The Global Use of Medicines: Outlook through 2017. https://www.imshealth.com/deployedfiles/imshealth/Global/Content/Corporate/IMS%20Health%20Institute/Reports/Global_Use_of_Meds_Outlook_2017/IIHI_Global_Use_of_Meds_Report_2013.pdf. Accessed October 2015
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