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ACCESS TO THE ACCESS TO THE BIOLOGICAL BIOLOGICAL
TREATMENT TREATMENT IN POLANDIN POLAND
ACCESS TO THE ACCESS TO THE BIOLOGICAL BIOLOGICAL
TREATMENT TREATMENT IN POLANDIN POLAND
Prof. Karina JAHNZ-RÓŻYK MD, Ph.D.Prof. Karina JAHNZ-RÓŻYK MD, Ph.D.
ISPOR POLAND CHAPTER, ATLANTA 2010ISPOR POLAND CHAPTER, ATLANTA 2010
Poland - general infoPoland - general info
8th country in Europe by area: 312,000 km2
8th country in Europe by area: 312,000 km2
Republic of PolandRepublic of Poland
6th country in Europe by population: 38,500,696 (July 2008 est.)
6th country in Europe by population: 38,500,696 (July 2008 est.)
7th country by size of pharmaceutical market: 4,8 bln EUR
7th country by size of pharmaceutical market: 4,8 bln EUR
Poland - general infoPoland - general info
Republic of PolandRepublic of Poland
GDP = 567,400 bn USD (rank 18)
GDP = 567,400 bn USD (rank 18)
GDP per capita in 2008 = 17,482 USD
(rank 50)
GDP per capita in 2008 = 17,482 USD
(rank 50)
POLAND MACROECONOMICS2009
POLAND MACROECONOMICS2009
•• GDP growth (GDP growth (annualannual) ) 3,1%3,1%
•• InflationInflation raterate 2, 6%2, 6%
•• UnemploymentUnemployment 12,912,9%%
•• SalarySalary ((meanmean) 1081,2 USD ) 1081,2 USD
E t bli h d E t bli h d
ISPOR POLAND CHAPTERISPOR POLAND CHAPTER
Polish Society of Pharmacoeconomics (PTFE)
Polish Society of Pharmacoeconomics (PTFE)
Established in January 2005
Established in January 2005
140 members 140 members
WHAT IS BIOLOGICSWHAT IS BIOLOGICS
•• BiologicBiologic-- a a medicinal product medicinal product that is synthesized from a living that is synthesized from a living organism or its productsorganism or its products
•• Small molecule drugSmall molecule drug: a drug : a drug synthesized via a chemical synthesized via a chemical processprocess
2
BIOLOGICSBIOLOGICS
StructurallyStructurally similarsimilar to to autologousautologous proteinsproteins, , largelargepeptidepeptide//proteinsproteins
AA dig t ddig t d d d dd b t t b t t t b li dt b li d
ImmuneImmune mediatedmediated effectseffects areare inherentinherent inin theirtheiractivityactivity, but , but hypersensitivitieshypersensitivities areare rarerare and and mainlymainlyduedue to to immunoglobulinsimmunoglobulins ((IgEIgE, , IgGIgG))
AreAre digesteddigested and and processedprocessed, but not , but not metabolizedmetabolized
ParenteralParenteral applicationapplication requiredrequired
BIOLOGICSBIOLOGICS
•• VACCINESVACCINES•• BLOOD & BLOOD & BLOODBLOOD COMPONENTSCOMPONENTS•• ALLERGENICSALLERGENICS•• SOMATIC CELLSSOMATIC CELLS•• GEN THERAPYGEN THERAPY•• TISSUESTISSUES•• RECOMBINANT THERAPEUTIC PROTEINSRECOMBINANT THERAPEUTIC PROTEINS
BIOLOGICALS – tools to affectinflammatory or malignat cellsBIOLOGICALS – tools to affectinflammatory or malignat cells
CYTOKINES CYTOKINES
ANTI ANTI CYTOKINESCYTOKINES
DEPLETING CELLS BY ANTIBODIESDEPLETING CELLS BY ANTIBODIES
ANTI ANTI -- CYTOKINESCYTOKINES
BLOCKING LIGANDSBLOCKING LIGANDS
KEY DIFFERENCES between BIOLOGICS and SMALL MOLECULE
DRUGS
KEY DIFFERENCES between BIOLOGICS and SMALL MOLECULE
DRUGS
A A followfollow--onon biologicbiologic cannotcannot be be exactlyexactly identicalidentical to to itsitsreferencereference products products becausebecause of of thethe largelarge sizesize and and complexitycomplexity of of thethe moleculesmolecules
BiologicsBiologics havehave specificspecific safetysafety riskrisk involvinginvolving
PricesPrices for for biologicsbiologics havehave increasedincreased moremore rapidlyrapidly thanthanpricesprices for for smallsmall moleculemolecule drugsdrugs
gg pp yy ggimmunogenicityimmunogenicity
BiologicsBiologics tendtend to be to be moremore expensiveexpensive thanthan smallsmallmoleculemolecule drugsdrugs
BIOLOGICSIMPACT ON MEDICAL FIELDS
BIOLOGICSIMPACT ON MEDICAL FIELDS
•• RHEUMATOLOGYRHEUMATOLOGY•• ONCOLOGYONCOLOGY•• CARDIOLOGYCARDIOLOGYCARDIOLOGYCARDIOLOGY•• DERMATOLOGYDERMATOLOGY•• NEUROLOGYNEUROLOGY•• PNEUMONOLOGYPNEUMONOLOGY
IMS HEALTH : Biotechnology in global pharmacutical market in 2009 (bln USD)
3
IMS HEALTH : Biologics Sales –top three categories in 2009 (blnUSD)
Monoclonal antibodies – 80% of SALES
Oncology
A ti
AI / ID
Avastin
Herceptin
Rituxan
Humira
Remicade
Rituxan
Biological agentsSubclassification of adverse side effects
based on immunopathology & actions of compounds
Biological agentsSubclassification of adverse side effects
based on immunopathology & actions of compounds
•• TypeType -- high high cytokinecytokine & & cytokinecytokine releaserelease syndromesyndrome
•• TypeType ββ –– hypersensitivityhypersensitivity (immediate & (immediate & delayeddelayed))
•• TypeType γγ –– immuneimmune oror cytokinecytokine imbalanceimbalance syndromessyndromes((e ge g a toimm nita toimm nit allergicallergic disordersdisorders))((e.ge.g autoimmunityautoimmunity, , allergicallergic disordersdisorders))
•• TypeType δδ –– crosscross--reactantreactant
•• TypeType εε –– non non -- immunologicalimmunological sideside effectseffects
Pichler, Allergy 2006
FewFew casescases of of anaphilacticanaphilactic shockshock eveneven afterafter followingfollowing dosesdoses
30 min to > 24 h 30 min to > 24 h afterafter injectioninjection
85
XolairXolair –– anaphilacticanaphilactic shockshock
LongerLonger observationobservation requiredrequired
SuitableSuitable equipmentequipment of of healthcarehealthcare insitutionsinsitutions requiredrequired
BIOLOGICS –CIS (type γγ))CytokineCytokine ImbalanceImbalance SyndromesSyndromes
BIOLOGICS –CIS (type γγ))CytokineCytokine ImbalanceImbalance SyndromesSyndromes
• They are not allergic side effects and are clinicallycharacterised by different symptoms which do notcorrespond to classical allergycorrespond to classical allergy
• Are dependent on the underlying homeostasis/immunebalance of the individual patient
Biologics – side effectscytokine storm
4
BIOLOGICS –side effectsTNF-alfa blockers
BIOLOGICS –side effectsTNF-alfa blockers
•• AllergyAllergy ((acuteacute infusioninfusion SSLR)SSLR)•• AutoimmunityAutoimmunity (pancytopenia, (pancytopenia, demyelitatingdemyelitating diseasedisease•• ImmunodeficiencyImmunodeficiency ((e.ge.g. . lossloss of of controlcontrol of of
intracellularintracellular bacteriabacteria-- MycobacteriosisMycobacteriosis))•• CutaneousCutaneous ((vasculitisvasculitis))•• MalignancyMalignancy lymphomalymphoma•• SeizureSeizure disordersdisorders•• AggravationAggravation of of heartheart failurefailure
NHF (National Health Fund)THERAPEUTIC PROGRAMS
(n=41)
NHF (National Health Fund)THERAPEUTIC PROGRAMS
(n=41)
•• Ca mammae Ca mammae -- TrastuzumabTrastuzumab•• Chronic mieloblastic leucemia Chronic mieloblastic leucemia –– ImatinibImatinib•• GIST GIST –– Imatinib or SunitinibImatinib or Sunitinib•• Multiple sclerosis Multiple sclerosis –– Interferon betaInterferon betapp•• Hepatitis B or C Hepatitis B or C –– Interferon alfaInterferon alfa•• Kidney carcinoma Kidney carcinoma -- SunitinibSunitinib•• Rheumatoid arRheumatoid artthritis hritis –– Infliximab or Etanerceptum Infliximab or Etanerceptum
or Adalimumabor Adalimumab
NHF (National Health Fund)THERAPEUTIC PROGRAMS
QUALIFICATION
NHF (National Health Fund)THERAPEUTIC PROGRAMS
QUALIFICATION
•• ApplicationApplication of National of National ConsultantConsultant ininspecialspecial field of field of medicinemedicine
•• SubmissionSubmission of of thethe applicationapplication to to thetheMinistryMinistry of Healthof HealthMinistryMinistry of Healthof Health
•• RecommendationRecommendation of HTA (AOTM) of HTA (AOTM) inincooperationcooperation withwith ConsultativeConsultative CouncilCouncil (CC) (CC) commissionedcommissioned by by thethe MinistryMinistry of Healthof Health
AOTM Recommendation
AOTM Recommendation
•• DescriptionDescription of of medicalmedical problemproblem•• DescriptionDescription of of existingexisting clinicalclinical practicepractice•• ClinicalClinical effectivenesseffectiveness•• SafetySafety analysisanalysis•• CostCost effectivenesseffectiveness•• BudgetBudget impactimpact analysisanalysis•• PriPriccee negotiationnegotiationss and and riskrisk sharingsharing recommendationsrecommendations
optionallyoptionally
Rheumatoid arthritisONE YEAR of ANTI- TNF IN POLAND (USD)
No of DOSeS/YEAR
POINTS/MG HOSPITALISATION/one day
COST /YEAR TOTAL COST
ETANERECEPT50mg/week
51 2,1 0 19 626 19 62619 626 19 626ADALIZUMAB40mg/2 weeks
26 5,3 0 20 020 20 920INFLIKSIMAB
200mg/dosis8
(3+5) 2,1 1224 12 427 13 651INFLIKSIMAB
300mg/dosis8
(3+5) 2,1 1224 18 641 19 865
CostCost--effectivenesseffectiveness analysisanalysis of of omalizumabomalizumabv.sv.s. standard . standard therapytherapy inin thethe management management of of severesevere asthmaasthma
CostCost ––effectivenesseffectiveness –– daysdays freefree of of symptomssymptoms
USD USD
250 000250 000
200 000200 000 OmalizumabOmalizumab
standardstandard
MartinezMartinez--RevellesRevelles M.etM.et allall ., ISPOR 2007, Novartis, ., ISPOR 2007, Novartis, MexicoMexico
150 000150 000
100 000100 000
50 00050 000
00280280 300300 320320 340340 360360 380 380
dnidni
5
XOLAIR XOLAIR WhatWhat was was thethe priceprice inin 2008 2008 ??
USAUSA
UKUK
1150,99 USD/1150,99 USD/ampamp (150 mg/1.2 ml)(150 mg/1.2 ml)
647 58 GBP/647 58 GBP/ampamp (180 mg/1 2 ml)(180 mg/1 2 ml)UKUK
CanadaCanada
Poland Poland
647,58 GBP/647,58 GBP/ampamp (180 mg/1.2 ml)(180 mg/1.2 ml)
971,62 USD/971,62 USD/ampamp (150 mg/1.2 ml) (150 mg/1.2 ml)
633 PLN/633 PLN/ampamp (150 mg/1,2 ml)(150 mg/1,2 ml)
Xolair – every 4 weeks
300 mg(2 amp.)
150 mg(1 amp.)
150 mg(1 amp.)
150 mg(1 amp.)
> 30 - 100
> 90 - 150> 70 - 90> 60 - 7030 - 60
Weight (kg)
Ig E level (IU/ml)
> 500 - 600
> 400 - 500
> 300 - 400
300 mg(2 amp.)
> 200 - 300
300 mg(2 amp.)
300 mg(2 amp.)
300 mg(2 amp.)
> 100 - 200
Xolair – every 2 weeks
225 mg> 100 200
Look at previous slide
> 30 - 100
> 90 - 150> 70 - 90> 60 - 7030 - 60
Weight (kg)IgE level
(IU/ml)
375 mg(2 1/2 amp.)
> 600 - 700
No treatment
375 mg(2 1/2 amp.)
300 mg(2 amp.)
> 500 - 600
375 mg(2 1/2 amp.)
300 mg(2 amp.)
300 mg(2 amp.)
> 400 - 500
300 mg(2 amp.)
225 mg(1 1/2 amp.)
225 mg(1 1/2 amp.)
> 300 - 400
300 mg(2 amp.)
225 mg(1 1/2 amp.)
225 mg(1 1/2 amp.)
> 200 - 300
g(1 1/2 amp.)> 100 - 200
One year of anti TNF-alfa and anti IgE( USD mean) v.s. GDP & Salary in Poland (2009)
NHF - costs of therapeutic programs in 2010 (PLN )
5/24/2010
1
Dr Joanna LisPresident-Elect Polish Society of Pfarmacoeconomics
200,000
250,000
300,000
9.0%
12.0%
15.0%
% % %
7% 7.4%
7.7%
8.0%
8.2% 8.7%
Expenditure
[Exch. rate, million US$]Expenditure as % GDP
0
50,000
100,000
150,000
Source: OECD Health Data 2009: data from 2007 year
0.0%
3.0%
6.0%
Poland
Slovak Rep
ublic
Hungary
Czech Rep
ublic
Greece
Finland
Ireland
Spain
Italy
Swed
en
Austria
Germany
Den
mark
France
4.6% 5.2%
5.2% 5.8%
5.8%
6.1%
6.1%
6.1% 6.
25,000
30,000
35,000
40,000
1.2%
1.4%
1.6%
1.8%
2.0%
9% 1.0%
1.2%
1.2% 1.3% 1.4% 1.5%
1.9%
Expenditure
[Exch. rate, million US$]Expenditure as % GDP
0
5,000
10,000
15,000
20,000
* expenditure on pharmaceuticals and other medical non-durables comprises pharmaceuticals such as medicinal preparations, branded and generic medicines, drugs, patent medicines, serums and vaccines, vitamins and minerals and oral contraceptives.
Source: OECD Health Data 2009, data from 2007 year
0.0%
0.2%
0.4%
0.6%
0.8%
1.0%
0.5% 0.6%
0.6% 0.7% 0.8% 0. 9
Alimentary tract and metabolism ;
15,52%
n/a ; 7,92%
Respiratory system; 1,42%
Respiratory system 14,28%
Nervous system; 16,02%
Musculo-skeletal system; 3,99%
VARIA; 1,55%
Antineoplastic and immunomodulating agents;
6,27%
Systemic hormonal preparations, excluding sex
hormones and insulins;1,23%
Genito-urinary system and sex hormones ;
3,98%
Antiparasitic products, insecticides and repellents;
0,08%
Antiinfectives for systemic use;
7,35%
Dermatologicals ; 0,71%
Cardiovascular system; 14,68%
Blood and blood forming organs; 5,02%
Source: National Health Found, Report 2008
◦ corelation betweenlevel of health careexpenditure vs qualityof diabetics health care
◦ 0,74 (p<0,05)
Wydatki na ochronę zdrowia 2006 r. (USD, ppp) a ocena systemu opieki nad pacjentami z cukrzycą
AUS
BEL
DAN
FRAHOL
IRLNIE
NOR
SZWCSZWE
UK
WŁO750
800
850
900
NA
D P
AC
JEN
TA
MI Z
AUS
BŁG
CYP
CZEEST
FIN
GRE
HISZLIT LUX
ŁOT
MAL
POL
PORRUM
SK
SLOWĘG
0 500 1000 1500 2000 2500 3000 3500 4000 4500
wydatki na ochronę zdrowia per capita 2006 (USD, ppp)
450
500
550
600
650
700
RA
NK
ING
SY
ST
EM
ÓW
OP
IEK
I NC
UK
RZ
YCĄ
Wydatki na ochronę zdrowia (OECD Health Data, 12.2008)
5/24/2010
2
Strong corelation betweenlevel of health careexpenditure vs quality of health care in cardiology
0,84 (p<0,05)Wydatki na ochronę zdrowia per capita w 2006 r. (USD, ppp) a ocena systemu opieki nad pacjentami z chorobami serca
AUS
FRA
HOL
LUX
SZW750
800
850
900
PA
CJE
NT
AM
I Z
A
BEL
CYP
CZE
DAN
EST
FIN
GRE
HISZ IRL
LIT
ŁOT
MALNIE
POL
POR
SK
SLO SZW
WĘG
UKWŁO
0 500 1000 1500 2000 2500 3000 3500 4000 4500
WYDATKI NA OCHRONĘ ZDROWIA PER CAPITA 2006 (USD, PPP)
450
500
550
600
650
700
750
RA
NK
ING
SY
ST
EM
ÓW
OP
IEK
I N
AD
C
HO
RO
BA
MI
SE
RC
A
Wydatki na ochronę zdrowia (OECD Health Data, 12.2008)
PRICE CONTROL x VOLUMEN CONTROL = SPENDING CONTROL
SSUUPPPPLLYY
PRICE REGULATIONSj, (freezing, lowering, …)
CUT TING COSTS FOR MARKETING
RSS
NATIONAL REFERENCE PRICING
International Price Comparisons
PRODUCT VOLUME CAPS
REVENUE CONTROL
"Cost-effectiveness pricing" PROFIT CONTROL
REBATES PRODUCT RENEVUE CAPS
VBPVBP
DDEEMMAANNDD
PATIENT’S COPAYMENT FOLUMULARIES PATIENT/DISEASE BUDGET
REGISTRATION & MARKET AUTHORISATION RULES
POSITIVE/NEGATIVE REIMBURSEMENT LISTS
PHYSICIAN RX BUDGET
INSURANCE SYSTEMCONTROL
PRESCRIPTIONPHUSICIAN HEALTH CARE
BUDGET
GENERIC SUBSTITIUTION TRATMENT GUIDELINES
TAXES PARALLEL TRADE
Name Merits Advance
Pharma Law
Amendment implementing EU DirImportant: introduction of 8+2+1 RDP regime
Consulted in 2009
Clinical trials
Assumptions of new Law ( single act) Important: - New (obligatory) insurance for each participant- 1 trials at a time by one investigator
Consulted in Jan’10
Registra-ti
New law on Regulatory Office Important:MA issued by President of Reg Office (not MoH)
Consulted in 2009
10
tion MA issued by President of Reg. Office (not MoH) 2009
Reimbur-sement
New reimbursement law : expected important changes: Individual decisions Fixed margins and prices Risk-sharing agreements Tax on pharma activities (Garattini tax)
Not Consultedyet
Doctors Draft law on New types of specializations Consulted Jan 2010
Clinical hospitals
New regime of clinical hospitals (erected by Medical Universities)
n/a
CompanyMoH
risk-
conditionalreimbursement
Healthoutcome
pay forperformance
Coverage with clinical evidence development
Payment for treatment continuation only
Payment for treatment outcome
Upfront payment refunded in case of
DRAFT!
11
sharing
agreem.
Financialoutcom
populationbased
individualpatient based
no treatment outcome
Defined market share and overspendings’ pay-back
Defined volume and overspendings’ pay-back
Limited no of treatment
Natural rebate
5/24/2010
3
A complete assessment of health technology comprises the following analyses:
1) Analysis of decision problem
2) Clinical effectiveness analysis
3) Economic analysis
4) Analysis of impact on health care system
Analysis of impact on health care system covers ◦ the budget impact analysis and
◦ the assessment of organizational consequences for the heath care system, and possibly the assessment of possible ethical and social implications
◦ Lantus utilization after reimbursement decision
Future expenditures on Lantus after its reimbursement are calculated based on predicted use of Lantus given in international units (IU).
Share of estimated consumption of Lantus within basal insulin market was estimated on the basis of data from European countries where Lantus is reimbursed.where Lantus is reimbursed.
◦ Lantus utilization without reimbursement decision
Values for this forecast was obtained based on the dynamics of the consumption of Lantus in Poland (IMS Health data)
◦ Insulin dosage Calculator gives the opportunity to use input data on insulin dosage
from RCTs, observational studies or market research studies
* HTA Consulting, 2010
DAILY INSULIN DOSES (IU)
Insulin RCT Observational studies Market research study
Lantus 39 23,1 27,9
NPH 37 23,1 28,3
Premixed insulin 46,5 35 41,2
Proportions of use between Lantus and other insulin
Insulin RCT Observational studies Market research study
NPH 0,94 1,00 1,01
Premixed insulin 1,19 1,59 1,48
HTA Consulting, 2010
Utilization of insulin glycaemic test strips
Comparison of use of test strips in addition to insulin therapy indicates differences between patients on Lantus, NPH and premixes.
Compared to NPH/Premixes Lantus requires less strips. ◦ The difference is 20 less strips a month for new patients starting therapy
and ◦ 13 strips a month for patients using insulin for before
Insulin prices
Perspective of the analysis: The analysis was conducted from public payer (NHF) and patient
perspective.
Time horizon The analysis was conducted in 5 years perspective.
HTA Consulting, 2010
Replacement (switching) of insulin (NPH and premixes) by Lantus
Based on the insulin utilization from European countries (analysis of the structure of insulin market relating to replacement of NPH and premixes after Lantus reimbursement)
User can choose: ◦ Selected country (choice between different EuropeanSelected country (choice between different European
countries can be made) ◦ European mean calculated as arithmetic mean◦ European mean calculated as mean weighted by
population size ◦ European mean calculated as mean weighted by
insulin utilization ◦ User prognosis – user can choose the degree of
share between NPH and Premixes which are replaced by Lantus
Data on consumption of different types of insulin, together with the characteristics that describe the dynamics of the consumption trends (for the sample country (Greece))
HTA Consulting, 2010
Insulin utilization and trends used in the prognosis in Greece
5/24/2010
4
0
5
10
15
20
acja NFZ [mln PLN
]
Reimbursement by payer – scenario with OADs
Lantus
NPH
Mieszanki
‐20
‐15
‐10
‐5
2010 2011 2012 2013 2014
Refunda
YEAR
Metformina
Glimepiryd
Paski glikemiczne
HTA Consulting, 2010
‐200
‐150
‐100
‐50
0
50
100
150
200
250
2010 2011 2012 2013 2014
Zużycie insulin [mln IU]
Rok
Insulins usage
Lantus
NPH
Mix
Reimbursement by payer – scenario without OADs
HTA Consulting, 2010
‐25
‐20
‐15
‐10
‐5
0
5
10
15
20
2010 2011 2012 2013 2014
Refundacja NFZ [mln PLN
]
Rok
Reimbursement by payer scenario without OADs
Lantus
NPH
Mieszanki
Metformina
Glimepiryd
Paski glikemiczne
ECONOMIC
SOCIAL
ETHICS
NEGOTIATIONin
RSS
ORGANIZATION
ETHICS
Individual decisions: changes to administrative procedures leading to full implementation of EU Transparency Directive No 105. Decisions are to be taken in the individual form Drugs reimbursement lists will be often updated and published in form of internal MoH
order/ not as legal Act published in Official Journal. New bodies will be introduced: Transparency Council and Economic Committee which will
conduct negotiations with pharmaceutical companies Fixe margins and prices
Rebates will be forbidden as well as all kinds of commercial practices concerning decreasing of ex-factory official price. Ph i ill b d f i b li i / f h i Pharmacy margins will be accounted from reimbursement limit/ not from the price.
Risk-sharing agreements Arrangements between a payer and a pharmaceutical, device, or diagnostic manufacturer
Tax on pharma activities („Garattini tax”) 3% of reimbursed drugs sales paid by Pharmaceutical Companies to the state budget. This money are going to be spent on independent clinical trials and registers (CER)
Others: Limits will be based on the cheapest drug with 15% market share level in therapeutic
group. Constant cost-reevaluation under reference price system
In case of lack of head to head trials comparing directly an assessed and an alternative technology, it is recommended to conduct an indirect comparison.
Health Technology Assessment
EFFI or
k?m
?
Com
EFFECT
Indirect comparisons can be performed and presented independently of direct comparisons. In the case of mixed comparisons involving both direct and indirect comparisons, the results of direct comparisons alone should be presented separately and independently from the results of the mixed comparison.
Evidence BasedMedicine
ICACy
Does
it W
oFo
r who
m mparativeCost
TIVENESS
Health Technology Assessment
EFFI W
ork?
om?
Com
EFFECTI
Evidence Based Medicine
ICACy
Does
it W
For w
ho
mparative
Cost
IVENESS
5/24/2010
5
Comparative Effectiveness is the conduct and synthesis of research comparing the benefits and harms of different interventions in a „real world” settings. The purpose of this research is to improve health outcomes
b d l i d di i ti id b dby developing and disseminating evidence – based information to patients, clinicians and other decision makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances”
Additional taxes for financing CER
CHANGES IN HEALTH CARE SYSTEMWHICH ALLOW TO GET BETTER ACCESS
WITHIN LIMITED RESOURCES
Let’s do together!
5/24/2010
1
Follow-on biologics in the Russian Federation
Prof. Pavel Vorobyev, Oleg Borisenko
ISPOR Russia ChapterXV ISPOR International Meeting
May 15-19, 2010, Atlanta, USA
Follow-on biologics in Russia
• Erythropoietins (16 items)
• Insulins (58 items)
• Somatotropins (9 items)
C l ti f t (18 it )• Coagulation factors (18 items)
• Interferons (37 items)
• Heparines (20 items)
• Granulocyte colony-stimulating factors (10 items)
Follow-on biologics market share (2009)
• Coagulation factors – 243 mln. USD (1,3%)• Epoetins alfa – 72,3 mln. USD (0,4%)• Epoetins beta – 31,7 mln. USD (0,1%)• Heparins – 46,8 mln. USD (0,2%)• Interferons – 193 mln. USD (1%)Interferons 193 mln. USD (1%)• Somatotropins – 26,4 mln. USD (0,1%)
• Total drug market of Russia – 17,9 bill. USD:• 9,6 bill. USD – pharmacy sales (53,9%),
• 1 bill. USD – biologically active additives (5,5%)IMS Health, DSM Group
Technical Regulations for drug registration of the Federal Service for the Surveillance of HealthCare and Social Development
Административный регламент Росздравнадзора по осуществлению государственной функции по государственной регистрации лекарственных средств (утв. Приказом МЗиСР №736 от 30.10.06.)
Federal Law “On Circulation of Drugs”
• Article 13. State registration of medicines • 2. The following drugs must have State
registration:• 1) original drugs;• 2) generic drugs;
3) bi ti f i l i t d• 3) new combinations of previously registered drugs;
• 4) drugs that were registered earlier, but produced in other dosage forms, have new dosing.
• 3. State registration of drugs for medical application is carried out according to the results of drug examination and ethical examination of the possibility of conducting a clinical trial
Federal Law “On Circulation of Drugs” (2)
• There is no definition of “Follow-on biologic” in this Law
• Formulary Committee of Russian Academy of Medical Science offered the followingMedical Science offered the following amendment: “Follow-on biologic – drugs, received using methods of biological technology: from human and animal tissues or tissue cultures”
5/24/2010
2
Federal Law “On Circulation of Drugs” (3)
• Formulary Committee Russian Academy of Medical Science amendment: “…as for follow-on biologics, studies of its therapeutic equivalence are carried out according to standards established by the federal executive authority”
Federal Law “On Circulation of Drugs” (4)
• There is new definition of immunobiological drug: “immunobiological drugs - drugs of biological origin, used for the diagnosis, prevention and treatment of immunological diseases”
• Accelerated program for the examination of drugs is not applied for immunobiological drugs, insulin and drugs registered for the first time in the Russian Federation.
Opinion of the Ministry of Health and Social Development Representative
• Deputy Director of the Department of Pharmaceutical and Medical Equipment Market of the Russian Ministry of Health and Social Development Marat Sakayev:“The law says that it is impossible to use accelerated program of registration for biotech drugs. The issue of registration of biotech drugs is discussed in the EU g gand the U.S.A. But in general there is no clear belief that biotech drugs should be registered using simplified program”
http://pharmvestnik.ru/text/18131.html
The Ministry of Health and Social Development does not understand the role of follow-on
biologics and the necessity of special regulation of its circulation
Scandal Stories of the follow-on biologicsInterchangeability
• 09.2009 – Federal Antimonopoly Service confirmed interchangeability of Eprex and Eralfon(Epoetin alfa )
• 12.2009 –Multiple Sclerosis Society issued a press release with the requirement to revise the results of clinical studies of Robental (Interferon beta)of clinical studies of Robental (Interferon - beta)
• 01.2010 – Russian Society of Hemophilia applied to the Minister of Health T. Golikova with requirement to suspend the registration of the Caogil-VII (eptakog alfa activated)
Studying Safety of follow-on biologics
• In the annual report of the Centre for Monitoring the Safety of Medicines of Roszdravnadzor for 2009 there is no special mention of the follow-on biologics safetysafety
• There are no follow-on biologics in the List of medicines which require special surveillance (including drugs caused great attention of patient organizations and experts)
http://www.regmed.ru/Downloads.asp?idDownload=6975
Thus, for 12 years since the adoption of the Federal Law
“On Medicines”
non-regulation of follow-on gbiologics has not changed
Who benefits from it?
5/24/2010
3
Follow-on biologics for Import Substitution
• Introduction of "The Strategy of Pharmaceutical Industry Development in the Russian Federation until 2020“ (23.10.09)
• Import substitution is its key element
• The strategy shows significant savings in case ofThe strategy shows significant savings in case of transition from foreign to domestic drugs (including follow-on biologics)
• In 2009 in terms of "7 nosologies" program cost of domestic drugs (hemophilia, multiple sclerosis , etc.) amounted to 2-7%, in program of Essential Drugs Supply – 6%
• Circulation of follow-on biologics is not regulated in Russia
• Currently the State is not interested in establishment of special (more complex) regulation of follow-on
Conclusions
complex) regulation of follow on biologics because it may hamper the program of import substitution
• We can not exclude corruption • Again we have forgotten about
patients
What Should We Do?• Continue to offer amendments for the follow-on
biologics regulation
• Carry out prospective comparative study of effectiveness (including quality of life) and safety of follow-on biologics in “real world” conditionsconditions
• Carry out monitoring of follow-on biologics effectiveness and safety
• Additional efforts of the pharmacovigilance system in collection of data on adverse reactions to new follow-on biologics
Our activities• RSPOR carries out studies the quality of
life of patients with hemophilia, inhibitor hemophilia, multiple sclerosis, chronic renal anemia
M lti l t ti bli ti i• Multiple presentations, publications in mass media
• Formulary Committee of Russian Academy of Medical Science supported manufacturers in contentious situations with Antimonopoly Service
