ispor serbia chapter introduction the impact of health economy on reimbursement decisions –...

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THE IMPACT OF HEALTH ECONOMY ON REIMBURSEMENT DECISIONS –

CENTRAL/EASTERN EUROPE PERSPECTIVE

SERBIA

AgendaAgenda

ISPOR Serbia Chapter IntroductionISPOR Serbia Chapter Introduction

Current State of AffairsCurrent State of Affairs

Learning ProcessLearning Process

Health Technology Assessment (HTA)Health Technology Assessment (HTA)

ISPOR Serbia Chapter ISPOR Serbia Chapter

IntroductionIntroduction

PresidentPresidentVladimir ZahVladimir Zah, K.C. B.Sc., Health Economics Consultant, Belgrade, , K.C. B.Sc., Health Economics Consultant, Belgrade,

Serbia (and Toronto, Canada)Serbia (and Toronto, Canada)

ViceVice--PresidentPresidentT j N k iT j N k i M S Ph G l ik d P id t fM S Ph G l ik d P id t f

ISPOR Serbia Officers (2007ISPOR Serbia Officers (2007--2009)2009)

Tanja NovakovicTanja Novakovic, M.Sc. Pharm., Galenika a.d., President of , M.Sc. Pharm., Galenika a.d., President of Pharmacoeconomic Section of Pharmaceutical Society of Serbia Pharmacoeconomic Section of Pharmaceutical Society of Serbia (FDS), Belgrade(FDS), Belgrade

Secretary / TreasurerSecretary / TreasurerNatasa BogavacNatasa Bogavac--Stanojevic, Stanojevic, D.Sc. Pharm. Spec., Assoc. Professor, D.Sc. Pharm. Spec., Assoc. Professor,

Faculty of Pharmacy, University of BelgradeFaculty of Pharmacy, University of Belgrade

DirectorsDirectors

Dr sci. med. Ana SaboDr sci. med. Ana Sabo, Professor, , Professor, Medical Faculty, University of Novi SadMedical Faculty, University of Novi Sad

Dr Predrag DjukicDr Predrag Djukic ConsultantConsultant

ISPOR Serbia DirectorsISPOR Serbia Directors

Dr Predrag DjukicDr Predrag Djukic, Consultant, , Consultant, Project Coordination Unit, Ministry of Health, BelgradeProject Coordination Unit, Ministry of Health, Belgrade

Dr Dragana AtanasijevicDr Dragana Atanasijevic, , Consultant, Project Coordination Unit, Ministry of Health, BelgradeConsultant, Project Coordination Unit, Ministry of Health, Belgrade

Doc.dr sci.ph Vesela RadonjicDoc.dr sci.ph Vesela Radonjic, Director, , Director, National Information Center for Medicine and Medical Devices National Information Center for Medicine and Medical Devices (ALIMS), Belgrade(ALIMS), Belgrade

DirectorsDirectors

M.Sc. Pharm.M.Sc. Pharm. Danka StefanovicDanka Stefanovic, , National Information Center for National Information Center for Medicine and Medical DevicesMedicine and Medical Devices (ALIMS), Belgrade(ALIMS), Belgrade

M Sc PharmM Sc Pharm Danka TesicDanka Tesic National Information Center for National Information Center for

ISPOR Serbia DirectorsISPOR Serbia Directors

M.Sc. Pharm.M.Sc. Pharm. Danka TesicDanka Tesic, , National Information Center for National Information Center for Medicine and Medical DevicesMedicine and Medical Devices (ALIMS)(ALIMS), Belgrade, Belgrade

M.Sc. Pharm.M.Sc. Pharm. SSpecpec. Dragana Sovtic. Dragana Sovtic, , Independent advisor for pharmaceutical issues, The Independent advisor for pharmaceutical issues, The Pharmaceutical Chamber of SerbiaPharmaceutical Chamber of Serbia

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New Drug /Medical Device

Medicines and MedicalDevices Agency of Serbia

(ALIMS)

seek approval

Approved?No

Yes

Reimbursement Approved?

No / Partial

Yes

negotiate Pricingseek Reimbursement

Serbian Health Insurance Office (RZZO)

Patient pays full price or % that is not reimbursed

End Government can intervene, override andstipulate price of medicines

Medicines and Medical Devices Agency Medicines and Medical Devices Agency of Serbia (ALIMS) of Serbia (ALIMS)

As a result of harmonisation process with the EU As a result of harmonisation process with the EU directives, based on which the whole process of directives, based on which the whole process of regulating medicines in Serbia has been developed regulating medicines in Serbia has been developed up to current EU standards, the Medicines and up to current EU standards, the Medicines and Medical Devices Agency of Serbia (ALIMS) was Medical Devices Agency of Serbia (ALIMS) was g y ( )g y ( )established in 2004 by the Law on Medicines and established in 2004 by the Law on Medicines and Medical Devices. Although the introduction of a Medical Devices. Although the introduction of a completely new regulatory system was not an easy completely new regulatory system was not an easy task, ALIMS has grown into a professional, task, ALIMS has grown into a professional, independent regulatory body recognized as the key independent regulatory body recognized as the key one in the Balkans region.one in the Balkans region.


As defined by the Law, As defined by the Law, ALIMS mission is to upgrade ALIMS mission is to upgrade public health in Serbia through regulation of public health in Serbia through regulation of marketing and consumption of all healthcare marketing and consumption of all healthcare products. products. In sake of enabling this task to be In sake of enabling this task to be performed, there were grouped three main activities in performed, there were grouped three main activities in ALIMSALIMS doc mentation assessment laboratordoc mentation assessment laboratorALIMS: ALIMS: documentation assessment, laboratory documentation assessment, laboratory quality control, and information collecting and quality control, and information collecting and processing with the aim the rational use of processing with the aim the rational use of healthcare products to be promoted. healthcare products to be promoted. Serbian experts Serbian experts assess documentation on chemical drug active assess documentation on chemical drug active substances, biological and blood products, phyto substances, biological and blood products, phyto medicinal products, homeopathic medicines, medicinal products, homeopathic medicines, radiopharmaceuticals, vaccines, sera, as well as radiopharmaceuticals, vaccines, sera, as well as documentation on new production technologies. documentation on new production technologies.


ALIMS has established its mission and vision in the ALIMS has established its mission and vision in the Quality Policy Mission Statement. This was Quality Policy Mission Statement. This was acknowledged throughacknowledged through the certification of the the certification of the Quality Management System Quality Management System (ISO 9001:2008) and the (ISO 9001:2008) and the EnvironmetEnvironmetal Mal Management anagement SSystem (ISO 14001:2004) ystem (ISO 14001:2004) by the international certification body.by the international certification body.by the international certification body.by the international certification body.

ALIMS representatives participate in the ALIMS representatives participate in the EDQM & EDQM & HealthCare HealthCare work on regular basis. As a member of work on regular basis. As a member of the Official Medicines Control Laboratory (OMCL) the Official Medicines Control Laboratory (OMCL) Network, the National Control Laboratory (NCL) of Network, the National Control Laboratory (NCL) of ALIMS has established the highALIMS has established the high--level cooperation level cooperation with the other European laboratories, contributing to with the other European laboratories, contributing to the work quality improvement and services provision the work quality improvement and services provision to ALIMS clients. to ALIMS clients.


Quality of work in the NCL is also verified by the Quality of work in the NCL is also verified by the regular participation in the Proficiency Test Studies regular participation in the Proficiency Test Studies (PTS) and the highly ranked results. ALIMS is also (PTS) and the highly ranked results. ALIMS is also going to be included in the IPA (Instrument for Pre going to be included in the IPA (Instrument for Pre Accession) of the European Commission that will be Accession) of the European Commission that will be performed by the EMEA between 2009 and 2011performed by the EMEA between 2009 and 2011performed by the EMEA between 2009 and 2011.performed by the EMEA between 2009 and 2011.

ALIMS closely cooperates with Uppsala Monitoring ALIMS closely cooperates with Uppsala Monitoring Centre (UMC), World Health Organization (WHO), Centre (UMC), World Health Organization (WHO), which is reflected through the active participation of which is reflected through the active participation of the National Pharmacovigilance Center (NCF) in the the National Pharmacovigilance Center (NCF) in the system of spontaneous reporting, collecting and system of spontaneous reporting, collecting and monitoring of adverse drug reactions. monitoring of adverse drug reactions.

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In the perspective of European Union accession, In the perspective of European Union accession, building up a new regulatory framework and building up a new regulatory framework and establishing the ALIMS was supported by several EU establishing the ALIMS was supported by several EU projects in the period from 2002projects in the period from 2002--2006. Recently, 2006. Recently, there has been finished the Twinning Project (2007there has been finished the Twinning Project (2007--2009) between the Medicines and Medical Devices2009) between the Medicines and Medical Devices2009) between the Medicines and Medical Devices 2009) between the Medicines and Medical Devices Agency of Serbia (ALIMS) and the French Health Agency of Serbia (ALIMS) and the French Health Products Safety Agency (AFSSAPS) and the French Products Safety Agency (AFSSAPS) and the French National Agency for Veterinary Medicinal products National Agency for Veterinary Medicinal products (ANMV). (ANMV).


The challenges to be faced in the forthcoming period The challenges to be faced in the forthcoming period are related to the several important regulatory are related to the several important regulatory aspects: aspects:

Further improvement of marketing authorization Further improvement of marketing authorization performance;performance;

Professionally and scientifically based decision Professionally and scientifically based decision making process;making process;

Transparency;Transparency; Market balance in terms of medicinal products Market balance in terms of medicinal products

availability.availability.

The additional information on the Medicines and The additional information on the Medicines and Medical Devices Agency of Serbia could be found Medical Devices Agency of Serbia could be found on the official website on the official website http://www.alims.gov.rs.http://www.alims.gov.rs.

Government can intervene, override and stipulate price of medicines

Proposes new pricing

Ministry of Trade, Tourism and Services


Evaluates and passes on for Government Decision

Passes legislature on revised pricing/ rejects

Medicines Pricing Revised

Government

Ministry of Health

Imported medicines go down in price by 5.3%*

Belgrade, Oct 13, 2006 – At the proposal of the Ministry of Health and the Ministry of Trade, Tourism and Services, the Serbian government adopted a Decree amending the Decree on criteria for setting prices of medicines,



under which imported medicines will go down in price by 5.3%, while the price of domestically produced medicines will decrease 2% on average.

One of the main criteria was comparison with the prices of medicines in Slovenia, Croatia and Italy, according to a statement by the Ministry of Health.The price correction applies to 33.8% of domestic medicines and 89.8% of the imported ones.The price reduction will influence the reduction of expenses of the Serbian Health Insurance Administration by approximately 108 million dinars in the forth quarter of the year, the statement adds.

* Serbian Government official website news

Sept. 5, 2009 (Belgrade) – (Beta) Government of Serbia has reduced prices of medicines in Serbia on average by 4.5 - 5 percent, it was announced on Saturday by the Minister of Health Tomica Milosavljevic.

“Upon the analysis of referential pricing in Italy Croatia and Slovenia as



Upon the analysis of referential pricing in Italy, Croatia and Slovenia, as well as taking under the consideration the current currency exchange of dinar versus euro”, decision has been made in regards to lowering the costs of drugs, stated Milosavljevic to (news) agency Beta.

Milosavljevic stated that this reduction will help with the reduction of inflation “by a bit more than half percent”, as well that it will create savings to the National Health Insurance Office.

* Serbian Government official website news


Pricing- lack of stimulation for innovation;- high prices of generics.

Reimbursement- lack of transparency and Evidence Based Medicine use;- insufficient understanding of Health Technology

Con’sCon’s

insufficient understanding of Health Technology.Assessment

- no clear guidelines within reimbursement process.

Evidence Based Medicine and Health Technology Assessment are acknowledged as very important future factors.

Pro’sPro’s

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October 07, 2009 -European Health forum awarded Director of National Insurance Office Svetlana Vukajlovic a special award for the achieved results in the reform of medicines financing.

“With the financing reform, it has been achieved that the List of Medicines that are provided by/charged to the national insurance

Serbian Health Insurance Office (RZZO)Serbian Health Insurance Office (RZZO)

Medicines that are provided by/charged to the national insurance office according to the number and type of medicine does not trail behind other European countries, whose citizens give more funds for health insurance than the citizens in Serbia.”

“With measures of forming lower price medicines, prices of original medicines and their generic parallels are identical, which makes Serbian Healthcare system unique in Europe.”

* RZZO official website news

National compulsory health insuranceNational compulsory health insurance

Managed by insured personsManaged by insured persons

Bismarck Model Bismarck Model –– solidarity systemsolidarity system

2,500 employees in all municipalities 2,500 employees in all municipalities throughout Serbiathroughout Serbia



throughout Serbia.throughout Serbia.

Contracting with healthcare Contracting with healthcare institutions institutions (Line(Line--item budget)item budget)

37,000 hospital beds37,000 hospital beds

104,000 employees in health care 104,000 employees in health care system (20% doctors, 28% nonsystem (20% doctors, 28% non--medical staff and 52% medical staff)medical staff and 52% medical staff)~ 1.5% of overall population~ 1.5% of overall population

Source: RZZO: “Health Economics in the Serbian Health Care System” ISPOR Serbia 2009 Conference

Revenue in 2008Revenue in 2008

70% 70% -- contributions paid contributions paid by employeesby employees 7%



by employeesby employees

23% 23% -- Social Security Social Security Contributions and National Contributions and National Employment ServiceEmployment Service

7% 7% -- Other revenueOther revenue

70%

23%


Expenditure in 2008Expenditure in 200846% 46% -- salaries of 104,000 salaries of 104,000 healthcare employeeshealthcare employees

38% 38% -- healthcare costshealthcare costsenergents, drugs, consumable energents, drugs, consumable and implantation material, aids..and implantation material, aids..

46%

11%3% 1%1%


11% 11% -- prescription drugsprescription drugs

3% 3% -- sicksick--leave and travel costs leave and travel costs reimbursementsreimbursements

1% 1% -- HIF costsHIF costs

1% 1% -- interest rate and loans interest rate and loans paymentpayment

38%


FinancingFinancing7.7 million of inhabitants7.7 million of inhabitants

3.5 million 3.5 million –– pays health insurance contributions for pays health insurance contributions for themselves and family members, covering 6.5 themselves and family members, covering 6.5 million inhabitantsmillion inhabitants


1.2 million of persons without personal income 1.2 million of persons without personal income ––unemployed, refugees and dislocated persons and unemployed, refugees and dislocated persons and other social categories.other social categories.


Learning ProcessLearning ProcessLearning ProcessLearning Process

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It is important to look at others’ experiences!It is important to look at others’ experiences!

Source: Blue Ocean Strategy® 2009


Recession destroying middle classRecession destroying middle class

About 4.3 million businesses with 19 or fewer employees closed during the fourth quarter of 2007 through the fourth quarter of 2008, according to the Bureau of Labour Statistics (United States)to the Bureau of Labour Statistics (United States).

Wall Street Journal, October 6th, 2009 -http://online.wsj.com/article/SB125478399429765967.html?mod=dist_smartbrief

Regulating Drug / Medical Device prices:Regulating Drug / Medical Device prices:Theoretically, Monopoly Power Control Theoretically, Monopoly Power Control through Price Regulation, traditionally through Price Regulation, traditionally throughthrough

•• 1. 1. Rate of Return (RoR) RegulationRate of Return (RoR) Regulation


•• 2. 2. Price SettingPrice Setting

•• 3. Value3. Value--based pricingbased pricing

•• 4. Controlling use (price4. Controlling use (price--volume volume tradeoffs)tradeoffs)

•• 5. International price referencing5. International price referencing


Current practiceCurrent practice

DenmarkDenmark SwitzerlandSwitzerland SwedenSweden FinlandFinland

Under preparation or Under preparation or rising in influencerising in influence

FranceFrance GreeceGreece PolandPoland

3. Value3. Value--based pricing in EU, 2008: use of clinical based pricing in EU, 2008: use of clinical and/or economic evidence to assess extent of and/or economic evidence to assess extent of

(clinical) benefits and value of innovation(clinical) benefits and value of innovation

The NetherlandsThe Netherlands England & Wales [NICE]England & Wales [NICE] PortugalPortugal NorwayNorway Baltic states (Estonia, Baltic states (Estonia,

Latvia, Lithuania)Latvia, Lithuania) ItalyItaly

PolandPoland SpainSpain HungaryHungary SloveniaSlovenia Czech RepublicCzech Republic SlovakiaSlovakia


VariationsVariations

External referencingExternal referencing•• Define a “basket of countries” to take as referenceDefine a “basket of countries” to take as reference•• Apply particular methodologyApply particular methodology

1. Average Pricing1. Average Pricing

5. International Reference Pricing5. International Reference Pricing

2. Average Pricing with Wealth Adjustments2. Average Pricing with Wealth Adjustments 3. International Price Comparisons3. International Price Comparisons

The above are distinct from The above are distinct from clusteringclustering (Internal reference (Internal reference pricing), which chiefly relate to pricing), which chiefly relate to reimbursementreimbursement

Different types of ClusteringDifferent types of Clustering Foreign prices in terms of PPPs*Foreign prices in terms of PPPs*

* PPP - purchasing power parity

Learning ProcessLearning ProcessPricing criteria for originator products in Pricing criteria for originator products in selected OECD countriesselected OECD countries

Feature UK GER FRA ITA SPA DEN POL NET

Medical value✓

✓ ✓

Comparator prices✓ ✓

Cross country comparisons

✓ ✓ ✓ ✓ ✓

Sales volumes✓

Pricing process is usually kept separate from Pricing process is usually kept separate from reimbursement processreimbursement process

Multiple criteria often apply to set pricesMultiple criteria often apply to set prices Administrative simplicity of price setting may be Administrative simplicity of price setting may be

outweighed by pricing policy in other parts of the outweighed by pricing policy in other parts of the marketmarket

EvidenceEvidence--based pricing over the mediumbased pricing over the medium--term term

Conditions of use✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

Price freedom✓ ✓ ✓ ✓

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Brand prices per unit in EU countries, Brand prices per unit in EU countries, DDDDDD--adjusted, inadjusted, in €€, 2007, 2007

INN name Norway Belgium Germany Sweden Denmark UK Nether Lands Spain Portugal Italy Greece France Ireland Austria

Atorvastatin 0.78 0.86 1.37 1.04 0.72 1.01 0.95 0.96 0.91 0.63 0.55 0.91 0.89 0.97 Pravastatin 1.25 1.08 1.63 1.00 0.98 1.67 1.04 1.58 1.11 0.91 0.66 1.07 1.55 0.92 Simvastatin 1.43 1.28 1.06 N/a 0.81 1.25 1.12 1.19 0.82 0.74 0.62 0.80 1.13 0.96 Captopril 0.48 0.62 0.28 0.21 0.46 0.58 0.54 0.26 0.56 0.30 0.38 0.61 0.50 0.77 Enalapril 0.25 0.29 0.20 N/a 0.22 0.59 0.30 0.19 0.28 0.28 0.19 0.46 0.41 0.24 Quinapril N/a 0.76 0.45 0.49 0.37 0.38 0.88 0.19 0.36 0.37 0.27 0.53 0.75 0.43 Ramipril 0.32 0.51 0.48 0.31 0.17 0.60 0.69 0.21 0.28 0.24 0.18 0.40 0.35 0.36pLosartan 0.83 0.93 0.80 0.85 0.63 0.97 0.87 0.63 0.77 0.69 0.58 0.92 0.77 0.47 Valsartan 0.82 0.59 0.80 0.82 0.60 0.88 0.86 0.45 0.72 0.62 0.39 0.87 0.75 0.77 Clozapine 0.20 0.27 0.25 0.18 0.19 0.92 0.28 0.13 0.28 0.29 0.11 0.30 N/a 0.10 Olanzapine 4.80 5.60 5.78 5.37 3.81 5.48 5.19 3.57 3.90 3.60 3.30 4.83 6.07 5.28 Risperidone 3.98 4.23 5.54 4.08 2.68 5.21 5.47 2.87 3.22 2.93 2.25 3.65 5.03 5.23 Lansoprazole 1.37 2.01 1.84 1.15 0.85 1.33 1.93 1.07 0.90 1.53 1.05 1.68 1.66 1.57 Omeprazole 1.89 2.24 1.77 1.83 N/a 1.60 2.09 0.43 1.66 1.50 0.84 1.86 1.77 1.57 Pantoprazole 1.33 2.01 2.32 1.16 0.83 1.33 1.88 1.27 1.34 1.28 1.10 1.65 1.40 1.57 Citalopram 1.02 1.08 1.12 0.66 0.75 0.90 1.18 0.73 N/a 0.75 0.68 0.90 0.97 0.97 Fluoxetine 0.97 1.04 1.16 0.85 0.78 1.51 1.38 0.53 0.69 0.56 0.65 0.93 0.90 0.61 Paroxetine N/a 1.31 1.16 0.90 0.91 0.93 1.11 0.80 0.86 0.77 0.69 0.90 0.90 0.56 Sertraline 1.08 1.22 1.11 1.12 0.82 0.85 1.31 0.72 0.76 0.87 0.55 0.84 1.36 0.88

International International price price

differentialdifferential


Purchasing Power Parity (PPP) of Gross Domestic Product for the countries of the world as of 2003. The economy of the United States is used as a reference, so that country is set at 100.

In insurance-based systems, price is the outturn of the negotiated process between monopolist (pharma industry) and monopsonist* (purchaser/payer) [bilateral monopoly].


of

Dru

g /

Me

d.

De

vic

e

Monopolist: profit maximisation

Monopsonist: social welfare maximisation

* Kerr, Prue; Harcourt, Geoff (2002), Joan Robinson: Critical Assessments of Leading Economists, Taylor & Francis, pp. 2–3, ISBN 0415217431

A monopsonist Insurance Fund maximizes profits with # of Drug / Medical Device treatments (L), that equates demand, given by the MRP curve, to marginal cost MCat point A. The Drug / Medical Device cost is then determined on the supply curve,

at point M, and is equal to w. By contrast, a competitive insurance market would reach equilibrium at point C,

where supply S equals demand. This would lead to # of Drug / Med. Device Choices “L” and Cost of Drug / Med. Device “w”.

Availability (number) of Drug / Med. Device treatment coverage

Co

st

o

What does social welfare maximisation entail in the case of pharmaceuticals?

Ensuring monopoly rent is not excessive;


The new technology diffuses in an optimal way;

Maintaining adequate return to the pharmaceutical sector to ensure continuation of innovative activity, employment levels

Health Technology AssessmentHealth Technology AssessmentHealth Technology Assessment Health Technology Assessment (HTA)(HTA)


Health Technology and Decision makingHealth Technology and Decision making

“To be useful to decision makers, HTA must be tailored “To be useful to decision makers, HTA must be tailored to the decision nodes of the healthto the decision nodes of the health--care system andcare system andto the decision nodes of the healthto the decision nodes of the health care system and care system and the needs and interests of decision makers at each the needs and interests of decision makers at each of these nodes.”of these nodes.”

The OECD Health Project. Health technology and Decision Making. Paris, France: OECD. 2005.

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Role of HTARole of HTA

●● Facilitate planning for the introduction and diffusion of new Facilitate planning for the introduction and diffusion of new technologiestechnologies

●● Provide a basis for informed decisions about the purchase and Provide a basis for informed decisions about the purchase and use of health technologies by:use of health technologies by:

P idi li bl d ti l i f tiP idi li bl d ti l i f ti Providing reliable and timely informationProviding reliable and timely information

Making complex research accessibleMaking complex research accessible

Synthesizing relevant literatureSynthesizing relevant literature

●● Encourage the appropriate use of health technologiesEncourage the appropriate use of health technologies

* Don Husereau, CADTH 2009


●● Differences health system, different approachesDifferences health system, different approaches

●● HTA can to inform practice, hospital, health region or HTA can to inform practice, hospital, health region or health ministry policy health ministry policy –– often implies often implies policy/reimbursementpolicy/reimbursement

Canadian experience Canadian experience -- Who conducts HTA? Who conducts HTA?

●● Different settings (government, quasiDifferent settings (government, quasi--government, government, academic, hospitalacademic, hospital--based)based)

●● Different technologies (drugs, devices, procedures, Different technologies (drugs, devices, procedures, systems)systems)

●● There are approximately 30 nonThere are approximately 30 non--profit organizations profit organizations in Canada in Canada

●● INAHTA lists 46 nonINAHTA lists 46 non--profit organizations from 26 profit organizations from 26 countriescountries



Canadian Experience Canadian Experience –– CADTH (Canadian Agency for CADTH (Canadian Agency for Drugs and Technologies in Health) Drugs and Technologies in Health) –– formerly CCOHTAformerly CCOHTA

●● Founded in 1989, by the Canadian federal, provincial, and Founded in 1989, by the Canadian federal, provincial, and territorial (F/P/T) Deputy Ministers of Health territorial (F/P/T) Deputy Ministers of Health --

““We need a more coordinated approach across the country to We need a more coordinated approach across the country to ensure that all Canadians are benefiting from the advances ensure that all Canadians are benefiting from the advances b i d i h lth t h lb i d i h lth t h l ” (” (P i B tt Mi i t fP i B tt Mi i t f


being made in health technologybeing made in health technology ” (” (Perrin Beatty, Minister of Perrin Beatty, Minister of National Health and Welfare, 1989National Health and Welfare, 1989)”)”

●● Private, notPrivate, not--forfor--profit organizationprofit organization

●● Funded by Health Canada, the provinces and territoriesFunded by Health Canada, the provinces and territories

●● Head office in OttawaHead office in Ottawa

●● Second office in EdmontonSecond office in Edmonton

●● Liaison presence in provincesLiaison presence in provinces


CADTH StructureCADTH Structure

F/P/T Conference ofDeputy Ministers of

Health

JurisdictionalNon Jurisdictional F/P/T Conference ofDeputy Ministers of

HealthPolicy Forum

Th E hCADTH Board

CADTH

Advisory Committee on

Pharmaceuticals (ACP)

COMPUS Advisory Committee (CAC)

Devices and Systems Advisory Committee (DSAC)

Canadian Expert Drug Advisory

Committee (CEDAC)

COMPUS Expert Review

Committee (CERC)

The Exchange



The Exchange: Collaboration on Producing HTA & Policy AdviceThe Exchange: Collaboration on Producing HTA & Policy Advice

●● A network of HTA producers including CADTH, provincial HTA A network of HTA producers including CADTH, provincial HTA producers, Health Canada and HTA researchersproducers, Health Canada and HTA researchers

●● Mandate includes:Mandate includes:

coordinate the gathering of evidence and policy advice for high coordinate the gathering of evidence and policy advice for high


priority technologies to support the Policy Forumpriority technologies to support the Policy Forum

coordinate the standardization of methods for providing coordinate the standardization of methods for providing evidence and policy advice evidence and policy advice

Reduce duplicationReduce duplication

link with stakeholders in the innovation sectorlink with stakeholders in the innovation sector

identify emerging technologies, and those for which Field identify emerging technologies, and those for which Field Evaluation studies may be appropriateEvaluation studies may be appropriate


CADTH’s HTA ProgramCADTH’s HTA Program

CADTH’s HTA program:CADTH’s HTA program:•• Performs inPerforms in--house HTA and externally commissions HTA house HTA and externally commissions HTA

studiesstudies•• provides recommendations and adviceprovides recommendations and advice•• used by jurisdictions to support decisionsused by jurisdictions to support decisionsused by jurisdictions to support decisionsused by jurisdictions to support decisions•• government is not given any preview of reports government is not given any preview of reports

Scope includes:Scope includes:•• drugs, vaccines, blood productsdrugs, vaccines, blood products•• devices and equipmentdevices and equipment•• medical and surgical proceduresmedical and surgical procedures•• health care systemshealth care systems


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HTA to Health Technology Policy Development ProcessHTA to Health Technology Policy Development Process

35% 26% 19% 23%


Schwarzer R. Siebert U. Methods, procedures, and contextual characteristics of health technology assessment and health policy decision making: Comparison of health technology assessment agencies in Germany, United Kingdom, France, and Sweden. International Journal of Technology Assessment in Health Care, 25:3 (2009), 305–314.

40%

29%

17%38%

Lessons LearnedLessons Learned THENTHEN

HTA academic endeavour HTA academic endeavour ––not well linked to decision not well linked to decision makersmakers

Quantitative Quantitative –– evidence evidence only only

Limited resources Limited resources –– limited limited

NOWNOW

Better linked to decision Better linked to decision makersmakers

More support by policy and More support by policy and decision makers are addresseddecision makers are addressed

Evidence based but with Evidence based but with qualitative aspects qualitative aspects


Limited resources Limited resources limited limited impactimpact

Relied on passive uptake by Relied on passive uptake by usersusers

Uptake of findings poorUptake of findings poor

Decision makers saw role Decision makers saw role for HTA in decision makingfor HTA in decision making

Gap existed between the Gap existed between the information needs of policy information needs of policy makers and what HTA makers and what HTA reports providedreports provided

qualitative aspects qualitative aspects incorporated; e.g. societal incorporated; e.g. societal values, impactvalues, impact

Recommendations and adviceRecommendations and advice

Expanded active dissemination Expanded active dissemination and knowledge transferand knowledge transfer

Effective knowledge exchange Effective knowledge exchange activitiesactivities

Policy maker Policy maker –– HTA gap bridgeHTA gap bridge

♦ ♦

ConclusionConclusion

●● HTA an integral part of HTA an integral part of Healthcare System Healthcare System ManagementManagement

●● Recommendations needed per “right” HTA analysis Recommendations needed per “right” HTA analysis type for the drug / medical device profile.type for the drug / medical device profile.

●● Specialised programs for different decision needsSpecialised programs for different decision needs●● Specialised programs for different decision needsSpecialised programs for different decision needs

●● Direct links to stakeholders and policy makers are Direct links to stakeholders and policy makers are crucialcrucial

●● Challenging to balance timeliness, data, Challenging to balance timeliness, data, dissemination, stakeholder support, resources dissemination, stakeholder support, resources

●● Health economics capacity building is essential to Health economics capacity building is essential to effective healthcare system managementeffective healthcare system management

THANK YOU!THANK YOU!

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