Transcript Rob Janknegt - Erasmus Observatory on Health Law

Safe, Therapeutic,
Economical, Pharmaceutical
Selection (STEPSelect)
Development, introduction and use in Northern
Ireland
Dr. Robert Janknegt, clinical pharmacologist
Orbis Medical Centre Sittard, the Netherlands
Prof. Michael Scott, hospital pharmacist
Antrim Hospital, Northern Ireland
Health Care Rationing, Rotterdam, December 2010
Selection criteria for drugs
Rational criteria (efficacy, safety, cost)
Emotional criteria (company, experience)
Hidden criteria (financial)
Unconscious criteria
SOJA method
System of Objectified Judgement Analysis
System is not objective!!!
Objectified---transparent drug selection
SOJA method
Panel of experts determines:
- selection criteria
- relative weight
- relative properties of each drug
- score per criterion
- total score
Methodology
Dosage frequency, standard score:
Authors
Once daily
100%
1-2 x daily
90%
2 x daily
80%
2-3 x daily
60%
3 x daily
40%
4 x daily
10%
Methodology
Dosage frequency, standard score:
Authors
Once daily
100%
1-2 x daily
90%
2 x daily
80%
2-3 x daily
60%
3 x daily
40%
4 x daily
10%
Weight: 60 points
Methodology
Dosage frequency, standard score:
Authors
Weight: 60 points
Once daily
100%
60
1-2 x daily
90%
54
2 x daily
80%
48
2-3 x daily
60%
36
3 x daily
40%
24
4 x daily
10%
6
Methodology
Safety:
Authors
Drug A
80%
Drug B
90%
Drug C
50%
Drug D
20%
Drug E
80%
Drug F
70%
Methodology
Safety:
Authors
Drug A
80%
Drug B
90%
Drug C
50%
Drug D
20%
Drug E
80%
Drug F
70%
Weight 120 points
Methodology
Safety:
Authors
Weight 120 points
Drug A
80%
96
Drug B
90%
108
Drug C
50%
60
Drug D
20%
24
Drug E
80%
96
Drug F
70%
84
SOJA method: Procedure
1. Determination of criteria by experts
2. Medline search/Embase/Cochrane/EMEA/metaanalyses/reviews
3. Article version 1
4. Article sent to industry/professional organisations for
comments
5. Interactive program
6. Process takes 250 hours or more, so don’t do this at home!
Selection criteria
Efficacy
Effects on clinically relevant endpoints
Safety
Side-effects (tolerability)
Dosage frequency
Drug interactions
Acquisition cost (pharmacoeconomics)
Documentation
Selection criteria (2)
Pharmacokinetic properties
Number of formulations
Number of approved indications
Therapeutic drug monitoring necessary?
Contra-indications, warnings and precautions
Group specific criteria (development of resistance)
Validation
Standardised procedure
Standardised selection criteria
Experts serve as sounding board (correctness and
completeness). Comments by email (cc to all)
Manuscript sent to all companies, including generic (correctness
and completeness)
Comments of professional organisations
Publication in peer reviewed journals
Internet
www.sojaonline.nl / www.informatrix.nl www.stepselect.com
/www.medicines-management.ie
All interactive programs available
Continuous update of programs
Over 50 programs available
Monthly price adjustments
Interactive sessions content
User may assign weight to criteria (S) or criteria and drugs (I)
Results are highly predictable:
High weight: efficacy, end points, safety, dosage frequency
Look at effects of weighting factor variation
“Play the product manager”
The truth, the whole truth and nothing but the truth…….
Feedback from participants may be highly relevant (exclusion
criteria in db studies)
Advantages (physicians)
Based on clinically relevant criteria, not primarily on cost!
Concrete discussions
Saves lots of time (SOJA)
Freedom of prescription maintained (but with limitations)
Advantages (pharmacists)
Rational drug selection
SOJA saves huge amounts of time for formulary committees
National formulary useful, local adjustments can be made very
easily
Central role for the hospital pharmacist
Sound basis for further protocols
Advantages (authorities)
Top-down information (quality)
Bottom-up decision (compliance)
Evidence based formularies
Rational drug selection
Generics perform well when these are available
Very suitable for guideline development
Major savings on time-expenditure
Major cost-savings
STEPSelect project
Part of an eight workstream programme
On-going project in Northern Ireland
Goal: Raise quality and safety and drive health gain and
efficiency(S+Q=H+E)
Integrated medicines management for primary care and hospital
care
Active participation of prescribers and pharmacists
Clnically driven not cost driven
STEPSelect methodology
Step I
Clinical evaluation
Step II
Risk assessment
Step III
Budget impact analysis
Step IV
Final product selection
Step 1 Clinical evaluation
Use of matrix models as a part of Integrated Medicines
Management
Matrix models used for pre-selection of drugs within a class
Criterion of acquisition cost is excluded
Pre-selection on quality aspects only
Drugs with best score on efficacy, endpoints, safety, ease of use
etc proceed to the next step
Northern Irish panel of experts judges existing matrices
Step II Risk assessment
Critical evaluation of packaging and labelling:
English language, packaging, labelling, storage, blister, patient
information leaflets
Added value:
calendar packs, barcoding, etc.
-
Structured judgement of all items
Knock-out criterion if anything is insufficient
Step II Risk assessment
Critical evaluation of packaging and labelling:
English language, packaging, labelling, storage, blister, patient
information leaflets
Added value:
calendar packs, barcoding, etc.
-
Structured judgement of all items
Knock-out criterion if anything is insufficient
Step III Budgetary impact
analysis
Cost of each product determined and related to Defined Daily
Dose (or Prescribed Daily Dose)
Fair comparison of drug-dosages within a class
Procurement for primary care
Tendered prices for hospital care
Use same packaging in primary and hospital care (reduces
medication errors, patient recognises own medication)
Step IV Final procurement
selection
Final selection based on tendered prices. Selection of one-three
providers per drug.
Selection of 1-3 drugs within a class
These drugs are 70-80% of volume of the class
Combined with guidance aiding in optimal use of the drugs
2010: guidance incorporated into an electronic prescription
system, providing almost perfect adherence to guidance
Germany: any procurement/tendering system applicable
STEPSelect: drug classes
Drug classes included in STEPSelect:
Statins
Protonpump inhibitors
SSRIs
ACE inhibitors
Angiotensin II antagonists
Erythropoiesis stimulating agents
Biologicals in rheumatoid arthritis
Wound dressings
STEPSelect, outcome
Good compliance with guidance
Clear shift towards selected drugs
Significant savings: about 14 Euro per capita per year
Expected savings with full implementation: at least 25 Euro per
capita per year
Key aspects of STEPSelect
Evaluation of all clinical evidence
Continuous updates
Interactive matrix model allows nationwide participation of physicians
and pharmacists
Various interactive tools available
Preselection on quality aspects only
Risk management of packaging
Evidence based guidance
Flexibility (not 100% compliance needed)
Integration between primary and hospital care
Significant savings on drug expenditure
Savings partly reinvested to improve patient care
BENEFITS
Optimised patient care
Fully integrated product use in both sectors
Selection of product on safety and therapeutic efficiency as the prime
determinant
Quality at best value for the service
Robust, transparent, defensible system of selection
Web-based guidance – evidence based
Dynamic with regular updates
Compliance with EU legislation
Implementation in other
countries
Translation/adjustment of existing matrices
If necessary add new drugs to matrices
National panel of experts to judge matrices
National panel of pharmacists to look at packaging criteria
National panel of experts to judge dosages used in procurement
phase
All these “steps” can be made quickly