driving innovation procurement forward international perspective: what can we learn from change...
TRANSCRIPT
Driving innovation procurement forward
International Perspective: What can we
learn from change leadership in Spain
Antoni Gilabert-PerramonDirector o Pharmacy and Medicines
Leveraging change leadership: Driving innovation procurement forward
Council for innovation procurement in heath care
The Conference Board of Canada
Toronto, 11th April 2017
I + S = MU = CU + MO + SR
@AntoniGilabert 2014
Formula for market access to medicines
Health Care organization in Spain
• National Health Service (71’5% of total health care
expenditure)
• Decentralized System: Health Care Managed by 17
Autonomous Communities (Catalonia: 16% population)
– Responsible for regulation development; health care planning; and
resource management, purchasing, delivery, and funding
“Limited” Role of the Central Ministry of Health
– Medicines marketing authorization
– Pricing decisions on financed drugs
• Insurance model
– Public insurance (public funding and public management or private
management)
– Private insurance (private funding ; no coverage of drugs, except
hospital in some insurance policies). It represents 28’5% of total
health care expenditure.
Some figures: NHS Catalonia (Spain)
National Health Service Spain Catalonia
Population covered 46,4 M 7,5 M
Health care expediture / inhab. 1.233 € 1.241 €
Primary Care Centers 10.081 369
Hospitals 325 71
Pharmacies 21.832 3.187
Access to medicines in the Spanish NHS
Licencing
MINISTRY
OF HEALTH
CATALAN
HEALTH
SERVICE
Pricing and
reimbursementManagement
and funding
SPANISH
MEDICINES
AGENCY
Central
Government
Regional
Government
DemandSupply
HEALTH
CENTERS
NETWORK
Providing
health care
The Catalan Health and Social Care Consortium (CSC) is a public association reference in the sector and represents and defends the interests of around 100 associate members (health centres, social services providers and local town councils) and 43,000 professionals, providing them with protection and support to carry out their work in social services and health care. All CSC associates are public or private non-profit bodies.
Innovating in management and
financing access to new drugs
Why not?
1) To have a strategic vision
2) To develop and adopt metodology
1) Strategic Vision
The challenge: a new vision
Expenditure Investment
Health outcomes
1) Improve health outcomes ; 2) Stay into the budget
Health Plan
Strategic plan of
pharmaceutical services
Strategy 5.3: Paying medicines
according with clinical outcomes
Strategies 1.4 and 1.5:
Co-responsibility stakeholders and sharing
with pharmaceutical industry
2) Methodology
Access, innovation and sustainability
Managing uncertainty
Collaborative model
Who is it intended for?
What are the most pertinent alternatives?
What are the criteria for use?
What is the prescription variability?
What are the follow-up indicators?
What are the ultimate results for success?
How can equity of acces be guaranteed?
Real world evidence:
- How effective is it?
- How safe is it?
How many people does it affect?
How variable are the outcomes?
How are the recommendations adhered to?What is the proposed cost of treatment?
What should the fair cost of treatment be?
What is the value for money in terms of healh?
How is the budget impacted?
How should the risk be shared?
Evaluation
MonitoringCo-responsability and sharing risks
Patient registries and outcomes monitoring
Criteria for eligibility, follow-up and outcomes
How to minimize the uncertainty to
guarantee access to innovation
1
2
Financing
3
Clarity
Methodology
Meticulousness
Transparency
Collaborative
Predictibility
Access program to innovation
I + S = MU = CU + MO + SR
I = Innovation
S = Sustainability
MU = Managing uncertainty
CU = Criteria for using
MO = Monitoring outcomes
SR = Sharing risks
@AntoniGilabert 2014
Formula for access to innovation
Access program to innovation
Finançament: COPIF
EVALUATION
MONITORING
Coresponsability and sharing risks
Registries and monitoring outcomes
Criteria for using, follow-up and outcomes. 2
3
1
FINANCING
Access program to innovation
Stage 1: Evaluation
Criteria for using (CU)
Drug Harmonization: Committees
Orphan
Drugs
2008
Hospital
Drugs
2010
Primary Care
Drugs
2012
Advisory CommitteeAgency for health and
quality assessment
Advisory CommitteeHospital experts
Advisory CommitteeAgency for health and
quality assessment
Executive CommitteeCatSalut and external
experts
Executive CommitteeCatSalut and external
experts
Executive CommitteeCatSalut and external
experts
1. Clinical criteria for indication, follow up and outcomes2. Individual authorizations and renewal for some HCT. 3. Patients Register (HCT and Hospital drugs): indicators and objectives4. Provision and funding conditions
http://www20.gencat.cat/portal/site/salut/menuitem.6c4bc79d438cb6ec3bfd8a10b0c0e1a0/?vgnextoid=13a648432c80b310V
gnVCM1000008d0c1e0aRCRD&vgnextchannel=13a648432c80b310VgnVCM1000008d0c1e0aRCRD&vgnextfmt=default
Drug Harmonization: Reports
(CatSalut website)
Access program to innovation
Stage 2: Monitoring
Monitoring outcomes (MU)
From evaluation to the decisión making process
RECOMMENDATIONS
PATIENTS AND TREATMENTS
REGISTY (RPT)
EVALUATON
(Harmonization
Program)
Criteria for using, follow
up and outcomes
Clinical variables
HOSPITALS: Doctor
Pharmacy
Multidisciplinar
Expertos clínicos
Evaluation
Decision
making
Desicion
making
Transparentes
Participativos
Improve management and knoledge of
pharmalologic treatments
• To know the indication used in real practice
• To monitoring the adherence to the recommendations
• To evaluate and authorizate treatments
• Feedback to doctors and managers
Quality indicators of process
Heath outcomes indicators
Aim of the Patients and Treatments
Registry (RPT)
Pathology
Oncohematology
HIV
Arthritis
Orphan drugs
Starting variables
ECOG
Previous treatments
QT asociada
Viral load
CD4
DAS
Previous treatments
Specific data for eachpathology / treatment
Follow-up variables
RECIST/EMBT
CEA levels
Treatment response
Viral loadl
CD4
DAS
Treatment respons
Discontinue variables
Progresion
Non-response
Viral failure
Non-acceptable toxicity
Non-followup
Death
RECORDING VARIABLES
OUTCOMESDECISION MAKING
MEASURE
1
2
34
Patients and Treatments Registry (RPT)
Multiple Esclerosis, Hepatitis C,
Growth hormone…
>120.000 registered treatments
436 pharmacologic indications
142 drugs (chemical entities)
8 therapeutic areas (oncology,HIV, Artritis, HC...)
64 hospitals
Access program to innovation
Stage 3:Financing
Sharing risks (SR)
Payment by product
Price – volum agreements
Payment according to criteria of use and follow up
Ceiling expenditure / patients (caps)
Pharmacological fixed rate pricing
Pathology fixed rate pricing
Payment by results (Risk Sharing Schemes)
Variable rate pricing according to outcomes
Payment by a health care solution
Payment systems ongoing
Access program. Stage 3: Financing
• New approach endorsed by CatSalut.
• Several experiences ongoing:
- Gefitinib in lung cancer
- Erlotinib in lung cancer
- Afatinib in lung cancer
- Cetuximab in metastatic colorectal cancer
- Bevacizumab in metastatic colorectal cancer
- Panitimumab in metastatic colorectal cancer
- Cetuximab in metastatic colorectal cancer
- Aflibercept in metastatic colorecal cancer
- Certolizumab in rheumatoid arthritis
- …/…
• Guideline to identify possible drug
suitable for this approach
“Guidance for RSS and payment by results”
Risk sharing based on health outcomes
Access program. Stage 3: Financing
108 patients
Drugs
ResultsSecond follow-upFirst follow-ùp
ODEfficacy
evaluation
Week 8
+ RESPONSEEfficacy
evaluation
Week 16SD
- RESPONSE
RESPONSDER
7 (10,1%) 8 (11,5%)
P EXITUS
16 (23,1%)
+ RESPONSE
CR PR
1 (1,4%) 37 (53,6%)
- RESPONSE
7 (10,1%) 1 (1,4%)5 (7,2%)
P EXITUS
Refund 100 %
18 % patients
Refund 100 %
7 % patients
Funding 100%
22% patients
Funding 100%
53 % patients
15
7 (10,1%) 1 (1,4%)5 (7,2%)
+ RESPONSE
CRSD PR
Exemple RSA/PRS: Oncology drug
RSS based on health outcomes
They are:
• An innovative option to promote access to new drugs
• A clear commitment to results and to ensure that new
treatments are an investment, not an expense.
Alternative to traditional drug payment
Allow delineate the uncertainties of economic and health impact of
pharmaceutical innovation
It allows more flexible access to innovation by sharing risks
Create incentives for cost effective use of medicines
Aling industrial and health system incentives: results
Develop information systems oriented to record results in a valid and
reliable way
The ARC on results are difficult to apply and require a clear strategic
positioning, maturity and confidence in the relationship
There must be clear outcome preferably short term
It requires a new organizational culture with high value of
positive externalities
RSS based on outcomes
What have we learned?
