Safe, Therapeutic, Safe, Therapeutic, Economical, Pharmaceutical Economical, Pharmaceutical

Selection (STEPSelect)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 drugsSelection criteria for drugs

Rational criteria (efficacy, safety, cost)

Emotional criteria (company, experience)

Hidden criteria (financial)

Unconscious criteria

SOJA method SOJA method

System of Objectified Judgement Analysis

System is not objective!!!

Objectified---transparent drug selection

SOJA methodSOJA method

Panel of experts determines:

- selection criteria

- relative weight

- relative properties of each drug

- score per criterion

- total score

MethodologyMethodology

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%

MethodologyMethodology

Dosage frequency, standard score:

Authors Weight: 60 points

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%

MethodologyMethodology

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

MethodologyMethodology

Safety:

Authors

Drug A 80%

Drug B 90%

Drug C 50%

Drug D 20%

Drug E 80%

Drug F 70%

MethodologyMethodology

Safety:

Authors Weight 120 points

Drug A 80%

Drug B 90%

Drug C 50%

Drug D 20%

Drug E 80%

Drug F 70%

MethodologyMethodology

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: ProcedureSOJA method: Procedure

1. Determination of criteria by experts

2. Medline search/Embase/Cochrane/EMEA/meta-analyses/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 Selection criteria

Efficacy

Effects on clinically relevant endpoints

Safety

Side-effects (tolerability)

Dosage frequency

Drug interactions

Acquisition cost (pharmacoeconomics)

Documentation

Selection criteria (2)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)

ValidationValidation

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

InternetInternet

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 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)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)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)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 projectSTEPSelect 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 methodologySTEPSelect methodology

Step I Clinical evaluation

Step II Risk assessment

Step III Budget impact analysis

Step IV Final product selection

Step 1 Clinical evaluationStep 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 assessmentStep 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 assessmentStep 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 Step III Budgetary impact analysisanalysis

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 Step IV Final procurement selectionselection

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 classesSTEPSelect: 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, outcomeSTEPSelect, 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 STEPSelectKey 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

BENEFITSBENEFITSOptimised 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 Implementation in other countriescountries

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