assessing the value of medicines in middle income countries n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Assessing the value of medicines in middle-income countries PowerPoint Presentation
Download Presentation
Assessing the value of medicines in middle-income countries

Loading in 2 Seconds...

play fullscreen
1 / 15

Assessing the value of medicines in middle-income countries - PowerPoint PPT Presentation


  • 113 Views
  • Uploaded on

Assessing the value of medicines in middle-income countries. ZF PHARMA SUMMIT 2012 , Buchares , 24 September 2012. For the sustainability of a reimbursement system , proactive and consistent policies are needed in innovative and generic sub-markets. 6. 1.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Assessing the value of medicines in middle-income countries' - sarah-dejesus


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
assessing the value of medicines in middle income countries

Assessing the value of medicines in middle-income countries

ZF PHARMA SUMMIT 2012, Buchares, 24 September 2012

slide2
Forthesustainability of a reimbursementsystem, proactive and consistentpoliciesareneededininnovativeandgenericsub-markets

6

1

Revise effectiveness based on real-world data and restricttheuse of products with no added therapeutic value

Ensureeasy and quickaccess to newgeneric medicines

RECYCLE

5

2

INNOVATIVE

(patent-protected) MARKETS

COMPETITIVE

(genericised)

MARKETS

Apply value-basedschemes to guarantee the optimal allocation of resources

Ensure sustainablegenericpricedecrease and foster generic substitution

4

3

Admit new value-added therapies (active substances) into the formulary

Eliminate inefficiencies in expenditure by identifying all sustainable cost saving potentials

RECYCLE

Enable the treatment of special, ‘complicated’ or rare conditions

THERAPIES FOR MASS DISEASES

Treat high-incidence diseases along a cost-minimisation approach

NICHE THERAPIES

Source: Dankó, D. – Molnár, M.P. (2012, ed.): Handbook of Pharmaceutical Reimbursement. Medicina (in press)

slide3

Pharmaceutical innovation:

underlying dilemmas in the early 21st century

Innovation content of new active substances introduced between 1975 and 2002

  • Real therapeutic breakthrough has become extremely rare
  • Innovation seems to be biased towards „sellable” therapy areas, while other areas are largely neglected
  • BUT policy backlashes against some forms of innovation
  • More and more new substances cause disappointment in real-life settings

Chemical structure

New

Already known

Therapeutic value

Provides progress in treatment

143

(10%)

295

(18%)

Does not provide progress in treatment

201

(14%)

821

(56%)

  • The business model of the pharma industry is undergoing a slow but thorough transformation

Source: Barral, P.E. [2004]: 28 ans de résultats de la recherchepharmaceutiquedans le monde 1975-2002. IRDES, Paris

slide4

Health technologyassessment:

assessingthevalue of healthtechnologies

Health technology assessment (HTA) covers all methods for

  • the systematic evaluationof thecomparativevalueof pharmaceutical products and otherhealthtechnologies
  • linked to pricing & reimbursement decisions by public and private payers
  • preceding to admissionto the reimbursementformulary and during formulary management.
three main paradigms for health technology assessment hta
Three main paradigms for healthtechnologyassessment (HTA)

QUALITATIVE ASSESSMENT

BALANCED ASSESSMENT

ECONOMIC EVALUATION

2

3

1

  • Based on pharmacoeconomics
  • Strict quantitative methods applied by dedicated HTA agency
  • Attempt to arrive at two economic indicators: ICER, budget impact
  • Cost-effectiveness linked to explicit or implicit threshold
  • Supported by structured review
  • Similaritywith regulatory approaches
  • Mainly qualitative methodologies based on collective decision-making
  • No attempt to arrive at ICER: scoring is often used, classification is a priority
  • Consideration of non-financial aspects & broader societal impact
  • Synergiesbetween economic evaluation and qualitative assessment
  • Mainly collective decision-making, which is retraceable and publicly accessible
  • Cost-effectiveness is one input to a classification /scoring algorithm
  • Wide consideration of non-financial aspects & broader societal impact

TW

F

I

J

CAN

AUS

CH

S

PL

HU

UK

KS

slide6

Cost-effectivenessasthecornerstone of economicevaluation

  • Cost-effectivenessmeansthat
  • thenewdrugdeliverslargerhealthbenefitat a lowercostoratthesamecost(‘dominantcase’: therapies ‘B’ and ‘C’ comparedtotherapy‘A’),
  • thenewdrugcosts more thanthecomparatorbuttheincrementalhealthbenefit is more thantheincrementalcostsincurred(therapy ‘D’ comparedtotherapy ‘A’),
  • thenewdrugdeliverslowerhealthbenefitcomparedtothecomparator, butthelossinhealthbenefit is lowerthanthedecreaseincosts(notpreferred, therapy ‘K’ comparedtotherapy ‘A’).

Health gain (u)

Cost of therapy (c)

e conomic evaluation is it really able to capture value
Economicevaluation – is itreallyabletocapturevalue?

Methodologyoverload

Lack of pragmatism, mismatchwithhigher-leveldecision-makers’ style

Pseudo-objectivity

Costly and requirescapabilitieswhicharenon-existentin MIC

Perverted incentives, pricingeffect

Consultancy business

PUBLIC BACKLASH & SHIFT AWAY FROM ONE-SIDED ECONOMIC EVALUATION

overview of qualitative value assessment criteria used in current international practice
Overview of qualitativevalueassessmentcriteriausedincurrentinternationalpractice

Source: owncompilation, Jasmine Pwu (Taiwan), JeremyLim (Singapore)

Differentsystemsweighelementsdifferently, and no systemcoversallelements. Focusis sometimesmissing. Assessmentcriteriausedindifferentcountriesmaycoversimilarconceptsunderdifferentterminology.

pragmatic framework for a redundancy free balanced system
Pragmaticframeworkfor a redundancy-free, balanced system
  • Unmet need (urgency)

Cost-effectiveness

Therapeutic value added

Therapeutic value added

  • More favourable side effect profile
  • Stronger adherence to treatment

Szöveg

  • Higher effectiveness (degree of response)

Budget impact

Explicit local policy priorities

  • Cost-effectiveness is necessary but not sufficientfordrugreimbursement
  • Therapeutic value added is measured along4 factors
  • Health policy priorities help decide between therapy areas

Source: owncompilation

institutional background in middle income countries
Institutionalbackgroundinmiddle-incomecountries
  • Severalpayers, complex decision-making processes
  • Intuitive, rather than analytical, decision-makers at political levels
  • Budget impact focus, emphasis on financial aspects
  • Questions aroundthepracticalapplicability of economic evaluation
  • CAPABILITY GAP, „institutional cost-effiency”

Rationalfree-riding:

Peeringonselectedinternationalassessment

Simplified local evaluation:

Veryfocused, pragmatic local assessment

Regionalshared service centresforvalueassessment?

overview of other strategic variables in middle income countries
Overview of otherstrategicvariablesinmiddle-incomecountries

A

PARADIGM

Economic evaluation

Qualitative assessment

Balanced assessment

B

RESOURCELEVEL

Heavy model

Light model

Ultra-light model

C

SCOPE

Only pharmaceuticals

Pharmaceuticals, diagnostics and medical devices

All health technologies, incl. public health programmes

PROCESS AND ORGANIZATION

D

Independent Drug Committee and HTA Institute

Separate department within sick fund (Health Insurance House)

Separate department within Ministry of Health

PERSPECTIVE

E

Societal perspective

Patient perspective

Payer perspective with societal considerations

blueprint process for reimbursement decision making in middle income countries

Qualitative drug assessment

Simplified economic evaluation

Blueprintprocessforreimbursementdecision-makinginmiddle-incomecountriesBlueprintprocessforreimbursementdecision-makinginmiddle-incomecountries

Technical inspection of dossier

PAYER

Balancedassessment

HTA INSTITUTE

First consultation with the manufacturer, discussion of cost- or risk-sharing proposal

Drug Committee opinion on cost-effectiveness

DRUG COMMITTEE

  • Second consultation with the manufacturer, renegotiation of cost- or risk-sharing proposal

Drug Committee decision on reimbursability

Publication of decision, notification of the manufacturer and the payer

Signature of cost- or risk-sharing agreement

PAYER

Listing (adoption to the formulary)

slide13

Standardized retraceable decision-making processes with clear milestones and deadlines

Pre-defined decision criteria, publicly accessible, intelligible (plainlanguage) individual opinions and collective decisions

Full disclosure of eventual conflicting interests

Balanced composition and properly designed voting mechanisms of the Drug Committee

Individual financial independency of participating experts (remuneration based on agency / ‚national bank model’)

Importantproceduralrequirementsfor a

balanceddrugassessmentsystem

recommend ed strategic options for romania
Recommendedstrategicoptionsfor Romania

PARADIGM

A

Balanced assessment

As negative case studies show, HTA implementation based on balanced assessment offers a one-time historic opportunity to bypass practical problems with economic evaluation and the resulting disappointment.

B

RESOURCELEVEL

Ultra-light model

As a country with limited financial resources, Romania cannot realistically implement a heavy model, while the light model may have higher cost than benefits. Therefore an ultra-light model may be a rational first step.

C

SCOPE

Only pharmaceuticals

HTA for pharmaceuticals carries considerable advantages over other health technologies as methodologies are widely available, and interests and incentives are easier toidentify.

D

ORGANIZATION

Independent Drug Committee and HTA institute

Independent Drug Committee and HTA institute can best support retraceable, publicly accessible and intelligible decision-making based on collective reason.

PERSPECTIVE

E

Payer perspective with societal considerations

As the goal of HTA is to support reimbursement decisions taken by the payer, the payer’s perspective has to be used, complemented by the analysis of wider societal impact.

some high level conclusions
Somehigh-levelconclusions

There is considerablevariationin HTA systemsallaroundtheworld, withtendenciestowardbalancedassessmentframeworks.

Economicevaluation has challengesinmiddle-incomecountries. FollowingthetrackwhichPoland and Hungary has followedinthepastfewyearsis notnecessarilyhelpful.

Both theframework and theprocessarecrucial.