farmàcia hospitalària. oriol de solà-morales 20110416

Agència d’Informació, Avaluació i Qualitat en Salut (AIAQS)

www.aatrm.net

Oriol Solà-Morales, HTA Director

II Trobada de Farmacèutics d’Hospital de CatalunyaSCFH- Sociietat Catalana de Farmàcia HospitalàriaMont St Benet, 16 d’Abril de 2011

Estratègies de Gestió per fer front a la crisi econòmica:

l’avaluació de fàrmacs

12.117.772.605 €

Interanual Gener 2011

Outline

• Algunes reflexions generals• Algunes propostes

algunes reflexions generals

Spain’s Healthcare System

• 17+2 Health Care Systems

• EU 15+12 Health Care Systems

Total Health Expenditure x capita (PPP)

- €

200 €

400 €

600 €

800 €

1.000 €

1.200 €

1.400 €

1.600 €

1.800 €

2.000 €

1960 1965 1970 1975 1980 1985 1990 1995 2000

Financial ‘crunch’: expenditure in public prescriptions

Financial ‘crunch’: % Change in public prescriptions

Preus de Referència

Partides de despesa

Partides de despesa

Effect of reforms

• Austalia (Pharma benefit adv Board): +14% anual

• Canada (Ontario): +10% anual (15% 2001)

Registry & Financing of drugs

Registry Price Financing

AEMPS Ministry Cabinet DoH / Insurer

FDA: Security & Efficacy

EMA: quality, safety & efficacy

CMS: Reasonable & NecessaryCatSalut: appropriate adjustment of supply to the health needs of citizensNHS UK: comprehensive range of services

CAIAQ: safety, effectiveness & efficiency

The impact of healthcare on health

McKeown, Determinants of health, 1978

Benefits of new treatments

Seruga, Annals Oncology 2010

Survival after Bone Marrow Graft

autologous heterologous

Which is the current paradigm?

Innovation

cost

?

What the industry wants(HTAi Policy Forum, June 2010)

• Regulation only linked to scientific considerations, not economical

• All eligible patients have access, without restrictions

• Early dialogue with HTA/payers to align expectations and reduce development uncertainty

• Reduce the development costs• Accept alternatives forms of evidence

What the industry wants(HTAi Policy Forum, June 2010)

• Regulation only linked to scientific considerations, not economical

• Eliminates equity and distributive justice

• All eligible patients have access, without restrictions• No budget limits considerations

• Early dialogue with HTA/payers to align expectations and reduce development uncertainty

• Will that affect price seemingly?

• Reduce the development costs• Introduces market imperfections

• Accept alternatives forms of evidence• Reduces security? Are there any compensations? Risk Sharing?

algunes propostes

oferta

Cost= Preu x Volum (C=P*Q)

Collaboration with the industry

Horizon Scanning

‘competence’ / renovation

Methodological evaluation / introduction

Rearrangement /‘Quality’ Evaluation

time

use

For who?

Registry Price Reimbursement

AEMPS Cabinet Insurer

Prescription Only

Non prescription / OTC

Pharmacies -----

PromoterInsurer / Manager/ Physician

MSyPS /AEMPS

Hospital Manager

Physician

Hospital

Pharmacies

Spain’s Healthcare System

Risk Sharing

• Qui el vol?• Qui paga?• Com es financia / qui el financia?• Com es distribueix el risc?

• Estm preparats?

demanda

• Formació continuada• Guíes farmacoterapèutiques• Guies de Pràctica Clínica

• Copagament

• Racionar:− Denial− Delusion− Defusion− Deterrance− Delay

• Arquitectura de decisions• Avaluació de Tecnologies

Arquitecura de decisions

Nudge (Thaler i Sundstein)

• Incentivar: conèixer qui utilitza, qui escull, qui paga i qui obté els beneficis d’una intervenció;

• Entendre els mapes mentals: transformar les variables de decisió complexes en variables assimilables pel decisor;

• Accions per defecte: determinar quines són les accions que es realitzaran quan hi hagi falta d’acció–decisió;

• Esperar l’error: determinar què es farà quan l’usuari no segueixi l’opció considerada prioritària perquè reavaluï si la seva decisió és coherent amb l’escenari o ha estat fruit d’un error;

• Estructurar decisions complexes: en cas de decisions en què intervinguin concurrentment múltiples variables, intentar presentar les possibilitats de decisió estructurades per grups categòrics de dificultat creixent.

HTA, Technologies and Choice

Rationalise PrioritiseEmpower

Rationalise PrioritiseEmpower

HTA, Technologies and Choice

1. Effective (efficacious)

2. Secure3. Efficient

Opportunity cost Appropriate

Mix> Equity

HTA, Technologies and Choice

Efficacy >

Security >

RoA >

Cost >

CAIAQ Criteria

Results

NO YES‘PAS’ Population (Q)

Reimbursement (P)

Dimensions to consider

Volume

Age

Life Stile

Demand

Waiting Time

Socioeconomic

Occupational

Dependency

Severity

Use Services

‘Sick pay’

Adequacy

Cost

Variability

Ethical/Legal

Net effect

Solution Time

CAIAQ Approach

Forecast

n. drugs orphan Low High Patients €/patient

Budget Impact 13 12 20.909.270 35.767.550 859 24.335

• Assume 5/10.000 inhab• Spain= 22.500 affected

• Estimated Budget impact: 505M€ (4%)

Creating Value

This suggests that the producer or source of value must understand the relative knowledge of potential users and the context in which the evaluation of novelty and appropriateness will take place

Lepak, Acad Manag Rev 2007

Creating Value

• Value is …..− is subjective and related to individual WTP−WTP > production cost−Related to

novelty appropriateness

−Related to competitive advantage, dynamic capabilities organisational knowledge

• Buyers ….−Must have specialised knowledge−Cannot be separated from their context

Where?

ContextImplementation

FundsKnowledge

PROS CONS

Local

Context specific Adjusted to needs

Participation Implementation

Limited Knowledge Disconnected from innovation

Limited resources (k&l) Atomisation

Low productivity

Regional Context specific

Adjusted to priorities More resources available

Participation Implementation Limited funding

National

More Available Funds Adjusted to policy Broad Knowledge

Experts

Dispersonalised

Not context specific Implementation

Coordination

International Diversity ‘Sector specific productivity’

Disconnected from policy Disconnected from ‘realpolitik’

Conclusions

En el context actual cal

1. revisar les mesures que afecten a la oferta i a la demanda

2. facilitar (estructurar) la presa de decisions3. prendre les decisions