NPS MedicineWise experience

with HTA evidence dissemination

…and implementation

Belo Horizonte

November 2014

NPS MedicineWise , Melbourne N

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Outline

Australian healthcare system

Role of NPS MedicineWise

NPS approach

The range of strategies used

Example of activities

Successes and challenges

Terms and synonyms

medicine

= drug

= pharmaceutical

= medication

rational use of medicines (RUM)

= quality use of medicines (QUM)

= better use of medicines (_UM)

Health technology assessment (HTA) evidence

- knowledge translation

- dissemination

- implementation

Population: 23.5 million Multicultural Ageing population: 13% >65 years Life expectancy: 78-83 years

Australians

Health priorities in Australia

Arthritis and

musculoskeletal conditions

Asthma

Cancer control

Cardiovascular health

Dementia

Diabetes mellitus

Injury prevention and

control

Mental health

Obesity

Australian health system

Universal health care scheme

Public-private partnership

Pharmaceuticals, pathology and radiology, medical

practitioners, and hospital care

Funding is from both Federal and State Governments

Private health insurance also available for hospital and

allied health care

Health expenditure as % of GDP

0

2

4

6

8

10

12

14

16

18

20

UnitedStates

Euro area World Brazil Australia Argentina LatinAmerica &Caribbean

Sub-SaharanAfrica

Europe &Central Asia

Middle East& North

Africa

East Asia &Pacific

South Asia

Who pays?

Pharmaceutical expenditure as

a percentage of total health expenditure

Source: WHO Global Health Expenditure Database; OECD Health Database, 2012

MEDICINES IN AUSTRALIA

National Medicines Policy

Quality, safety and efficacy of medicines

- Therapeutic Goods Administration

Equitable access

- Pharmaceutical Benefits Scheme

Responsible and viable industry

- Pharmaceutical industry

Quality use of medicines

- NPS MedicineWise

National Medicines Policy

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Equitable access:

Pharmaceutical

Benefits Scheme

Prof Lloyd Sansom, Former Chair of Pharmaceutical Benefits Advisory Committee

Pharmaceutical Benefits Scheme (PBS)

Timely access to medicines,

at a cost individuals and the community can afford

Began

1947

1960s

Co-payments

Safety net

1980s

1990s

Formal economic analyses

Pharmaceutical Benefits Scheme (PBS)

>750 drug substances

~1970 forms and strengths

- ~4500 products

>197 million prescriptions/2013

- 1.2% > 2012

AUD 9 billion/year (= BRL 19.7b)

- 2.1% < 2012

Patient co-payment

- Concession AUD 6.00 (= BRL 13)

- General AUD 36.90 (= BRL 81)

Assessment of medicines for

reimbursement

Pharmaceutical Benefits Advisory Committee (PBAC)

Statutory committee established under the National

Health Act

Health minister cannot list a medicine under the scheme

without a positive recommendation from the PBAC

Assessment of medicines for

reimbursement

Sponsor (usually industry) makes requests for listing,

including type of listing (e.g. generally available,

restricted or prior authorisation)

In assessing medicines for listing, the PBAC is required

by legislation to consider:

- Comparative efficacy

- Comparative safety

- Cost-effectiveness (mandatory since 1993)

Cost-minimisation assessment or cost-effectiveness

assessment, includes whole of health costs

- Budget impact

Listings types

Unrestricted

- available to everyone

Restricted

- available only for specific indications

Require prior authorisation

- tiered approach to prior authorisation

streamlined approval

telephone approval

written approval

Process for listing on the

Pharmaceutical Benefits Scheme

registration

economic analysis

utilisation estimates

PBS listing criteria

price

Overall PBS costs

0

1

2

3

4

5

6

7

8

9

10

Government PBS expenditure ($ billions)

Patient

contributions

~$1.6 billion

Medicine utilisation changes

(government reimbursed only)

0

10

20

30

40

50

60

70

80

19

92

19

93

19

94

19

95

19

96

19

97

19

98

19

99

20

00

20

01

20

02

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

20

11

Co

un

ts (

mill

ion

s)

Alimentary Tract andMetabolism

Anti-Neoplastic andImmunomodulating Agents

Cardiovascular System

General Anti-Infectives forSystemic Use

Nervous System

Respiratory System

Medicine expenditure changes

(government reimbursed only)

0

0,5

1

1,5

2

2,5

19

92

19

93

19

94

19

95

19

96

19

97

19

98

19

99

20

00

20

01

20

02

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

20

11

20

12

20

13

Co

st (

bill

ion

s $

AU

D)

Alimentary Tract andMetabolism

Anti-Neoplastic andImmunomodulating Agents

Cardiovascular System

General Anti-Infectives forSystemic Use

Nervous System

Sensory Organs

Policy measures to ensure PBS

sustainability

Pharmacoeconomic analysis

- pay what the drug is worth with respect to health outcomes

Monopsony buying power

- counter monopoly power of pharmaceutical companies during patent

protection

Reference pricing

- subsidise only the lowest price product in a generic group and in some

therapeutic classes

Risk sharing arrangements

- such as price-volume and rebate agreements

Increased patient co-payments and safety net limits

Generic substitution for interchangeable medicines

Policy measures to ensure PBS

sustainability

Creation of 2 separate formularies on the PBS.

- Formulary One (F1): drugs where there is only one brand

- Formulary Two (F2): drugs where there are 2 or more brands

Mandatory 12.5% price reduction

- in the price paid for all interchangeable drugs in a therapeutic class

when the first generic brand in that class appears.

Price disclosure system for all F2 drugs

- Required to provide information about the prices at which drug sold.

- A ‘weighted average disclosed price’ (WADP) is calculated that reflects

the price at which the drug is being supplied in the market.

- If WADP >10% below PBS price, then PBS price is reduced to WADP.

QUM programs (NPS MedicineWise)

National Medicines Policy

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Why do we need activities

to improve medicine use?

Medication safety

- Avoidable adverse drug events are common

Clinical benefit

- Prescribing is often suboptimal

Value for money

- Sustainability of PBS

Why do we need activities

to improve medicine use?

Decision making is difficult

- risks of harm versus benefits of therapy

- negotiating complexity, uncertainty and ambiguity

The medicines situation keeps changing

- new evidence

- changing drug availability

Abundance of information

- poor quality and/or biased information

Patients are demanding access to trusted information

Health professionals need support

Proliferation of expensive new drugs

Category Number %

Major advance 7 0.2%

Real advantage 78 2%

Some advantage 227 7%

Nothing new 2789 69%

Not acceptable 106 3%

Judgement reserved 128 4%

A French review of 3335 new drugs from 1981-2005 (La Revue Prescrire)

PHARMA-doctor interaction correlates with:

Preferences for new products that have no benefit over existing ones

Decreased prescribing of generic drugs

A rise in both and irrational and incautious prescribing

Rising prescription expenditures

Suboptimal prescribing

Prescribing not consistent with best practice

Under use of medicines

- beta blockers for heart failure

- adequate dosage of ACE inhibitors in heart failure

- metformin for diabetes

Over use of medicines

- antibiotics for upper respiratory tract infections

- benzodiazepines for sleep disorders

- antihypertensives and lipid lowering drugs in place of lifestyle

modification

Using second line before first line therapy

- aspirin versus clopidogrel

- broad spectrum versus narrow spectrum antibiotics

The role of formularies & treatment

guidelines Common diseases & complaints

Treatments of choice

Use to identify & solve problems

Improved availability & use

Harvey K, Dartnell J, Hemming M. Improving antibiotic use: 25 years of antibiotic guidelines and related initiatives. Commun Dis Intell 2003; 27 Suppl: S9–S11

Australian Medicines Handbook

Therapeutic Guidelines series

HTA, evidence and medicine policy

Evidence question Who Outcome

•Safety? •Efficacy? •Product quality?

Therapeutic Goods Administration

•Registration and marketing

•Comparative efficacy? •Comparative safety? •Cost effectiveness? •Budget impact?

Pharmaceutical Benefits Advisory Committee

•Availability on Pharmaceutical Benefits Scheme

•Best practice in real world?

Therapeutic Guidelines •Standard treatment guidelines

•What is practice in real world?

NPS MedicineWise •Program design •Program evaluation •Policy change

HTA evidence to practice pipeline

Paul Glasziou. Bond University. Australia

National Medicines Policy

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Who is NPS MedicineWise?

Established as the National Prescribing

Service Limited in 1998

Largely funded by the Australian

Government

Independent, not-for-profit organisation

Membership based

Work in partnership

- consumers

- health professionals

- government

- industry

Dr Lynn Weekes

Chief Executive Officer,

NPS, since 1998

OUR PURPOSE

To achieve better health and economic outcomes

Enable people to make better decisions about medicines and other medical choices

health professionals consumers

QUALITY USE OF MEDICINES

Selecting treatment options wisely - including non

medicine options

Choosing suitable medicines, if a medicine is deemed

necessary

Using medicines safely and effectively (including

prescription, non-prescription and complementary

medicines)

..AND QUALITY USE OF MEDICAL TESTS

How do we work?

Who are our audiences?

Health professionals

- general practitioners

- medical specialists

- pharmacists

- nurses (primary health care)

- students

Consumers

- communities

- mass audience

Government

Industry Dr Janette Randall, Chair of

NPS Board and general

practitioner

Promotion

PBS

Registration

Social marketing

STG

Drug information

Reframing

decision making

When decisions are made

Immediate impact

Between decision making

Intermittent impact

Teaching how to make decisions

Enduring impact

Building the evidence base

? Impact

Decision support tools

Guideline support

Medicine information

Academic detailing

Peer group discussion

Audit and feedback

Continuing education

Undergraduate

education

Research

NPS interventions and activities

Drug and therapeutic information

resources

http://www.nps.org.au/health_professionals/publications

NPS RADAR

New drugs on PBS

Timely

- coincides with PBS updates

Independent

- evidence-based, review process

Reach

- >60,000 health professionals including

almost all GPs

website

Email subscription

Print

Prescribing software

Review process

Expert advisory group members

- information needs, key points for consumer information, place in

therapy, practice points

External clinical expert

- clinical management of condition, use in practice

- conflicts of interest considered

Department of Health

- details of PBS listing

Sponsor

- interpretation of clinical and economic evidence, launch dates,

issues that may arise after publication

NPS MedicineWise approach to

implementation

consumer

identify problem

clinical issues

barriers + enablers

evidence based

messages

mix of inter-

ventions

across disciplines + sectors

evaluate

Understand barriers to change

Awareness, knowledge

Beliefs, attitudes

Skills

Systems, practicalities

Motivation, readiness for change

External environment

Analysis of needs and barriers (formative research)

• Literature reviews

• Surveys

• Key informant interviews

• Data analysis / audits

• Phone line questions

• Environmental and market analyses

• Previous evaluation results

• Advisory groups

Consider possible interventions

Educational materials

Educational meetings

Clinical audit & feedback

Reminder systems

Educational visiting

Patient mediated strategies

Map interventions to barriers

• Required change

• Evidence for interventions

• Active v/s passive engagement

• Multi-faceted approach

• What will work (or not work) in general practice

Opinion leaders

Consumers: gateways and influences

Family & friends

General practitioner

Specialist

Pharmacist Internet

Media

Non-medical prescriber

Family & friends

General practitioner

Specialist

Pharmacist Internet

Media

Non-medical prescriber

Web

Social media

Radio

SMS

Telephone support

Smart phone apps

Media releases

TV

Delivering our programs

Products and services created and packaged for target

audience and target problem

Multiple-channel strategy

Fit-for-purpose delivery

General practice programs

Face-to-face educational visits

- academic detailing

- GPs and practice staff

Data review and feedback

- Self audits

- Comparison with national data,

practice data, MedicineInsight network

Peer group discussions

- based on case studies

Voluntary participation

- Quality Practice and professional development incentives

Recent therapeutic programs

Lipid management and cardiovascular risk

Vitamin D testing

Osteoporosis

Antipsychotics

Heart failure

Generic medicines

Antibiotics in respiratory infections

Depression

Headache

Diabetes

Oral anticoagulants

Health checks

Medicines in older people

Diabetes programs

Diabetes has been an Australian national health priority.

Several new oral antidiabetic drugs and insulins have

become available in recent years.

There are established guidelines1 in Australia for the

management of type 2 diabetes.

Metformin is an established cost-effective oral

antidiabetic drug and recommended as first-line therapy.

Management has not been optimal.

1. RACGP and Diabetes Australia. Diabetes management in General Practice. 2009/10. Diabetes Australia

Diabetes program schedule

NPS MedicineWise implemented national programs to

improve management of type 2 diabetes in primary care:

1. 2001–03

2. 2005–06

3. 2007–08

4. 2012-13

Key messages

Key messages focused on encouraging lifestyle

interventions, management of risk factors, and first-line

use of metformin, for example:

- Early and continuing lifestyle interventions decrease disease

progression.

- Use metformin as initial drug therapy and ensure is part of

ongoing therapy.

- Consider early use of insulin if oral therapy is unsatisfactory.

- Manage cardiovascular risk factors.

- Consider glitazones only if combination therapy fails and review

use in heart failure and ischaemic heart disease.

Interventions

For each program, NPS deployed a range of activities to

deliver key program messages:

- Academic detailing: NPS facilitators based in local areas

conducted face-to-face visits with practitioners and small group

case study discussions.

- Clinical audits with feedback were available to help clinicians

reflect on their practice.

- Information resources on the management of diabetes were

distributed to support good decisions by health professionals and

consumers.

- Self management tools for diabetes were distributed to support

consumers

Academic detailing (educational outreach)

Educational

facilitators across

Australia

Face-to-face, one-

to-one visits with

GPs

Trained

facilitators, usually

pharmacists

Targeted and

general messages

Good evidence

that is effective at

changing practice

Clinical self audits

Completed by general

practitioners.

Self-audits of records (paper

or electronic).

Assesses practice in

comparison with evidence-

based guidelines (using

indicators of quality

prescribing).

Feedback is given on their

practice in comparison with

their peers.

Drug and therapeutic information resources

NPS News

- program key messages

Prescribing Practice

Review

- prescribing feedback

NPS RADAR

- New drug updates

Australian Prescriber

- reviews and updates

http://www.nps.org.au/health_professionals/publications

GP participation

Year Educational visit

Small group

GP clinical audit

Case study

Interactive workshop

Total unique GPs

2001-03 4211 1535 1626 1673 - 6,704

2005-06 3922 2699 1769 1603 131 6,965

2008-08 5963 4921 2073 1467 353 8,756

2012-13 6233 4689 640 935 11,362

0

2.000

4.000

6.000

8.000

10.000

12.000

14.000

0

2

4

6

8

10

12

14

16

18

DD

D/

100

0 p

op

ula

tio

n p

er

day

Actual

Estimated with NPS Intervention

Estimated without NPS intervention

Cumulative count participating GPs

Cu

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lati

ve

GP

co

un

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Impact on prescribing

Metformin DDD/1000/population per day (concessional scripts only)

7% increase in metformin prescriptions (2009-11)

Impact on prescribing

Glitazones: rate of prescribing per 1000 GP consultations

↓13% in 2008 & ↓ 16% in 2009

Cost consequence analysis: modelling logic

All diabetes patients in Australia (AIHW)

Patients managed by participating GPs (NPS data)

Patients managed by GPs with improved prescribing (NPS DU analysis)

Patients reached HbA1c target (clinical audit)

Patients with less complications (international)

Process to determine the patient population and health and economic

outcomes

e-Audit: 1378 GPs completed; 27,679 patients

19% patients (n = 5030) achieved chosen target HbA1c (%)

NPS program: 9496 unique GPs; Type 2 patients

treated by NPS GPs = 290,897

19% patients “better controlled”,

i.e., achieved 1% HbA1c reduction

(n = 56,285)

10yr incidence rates and associated risk reduction with 1% reduction in HbA1c (from the literature)

Consequences: type & number of

sequelae avoided over 10yr follow-up period

Costs of delivering NPS 2008 program

DU Study: Metformin 7% PBS Rxs increase

DU Study: Insulin add-on 7% PBS Rxs increase

Diabetes sequelae: Eg., myocardial infarction, retinopathy, etc.

CONSEQUENCES COSTS

Number of sequelae avoided x unit cost =

Total cost per sequela avoided

Cost consequence summary

20% of the diabetic patient population managed by the GPs who

participated in the program would benefit from improved glucose

control

5,745 avoided cases of complications over a ten-year period

- Lower extremity amputations (477 cases)

- Cataract extraction (950 cases)

- Major cardiovascular events (2,602 cases)

- Retinopathy or nephropathy (1,529 cases)

Direct hospital costs potentially avoided totalling AU$36.5 million (in

addition to the AU$46.4 million of cost-saving to the PBS)

Extending evaluation of NPS program beyond prescribing change

MedicineInsight: real world data

First Australian large scale general practice

longitudinal data platform for policy and

practice improvement

De-identified patient data collected from

general practices across Australia

Links information on patient diagnosis to the

medicines prescribed, the health services

provided and clinical and patient

characteristics

Practice profile data (target 500 practices,

2500 GPs)

Clinical encounter data (target 2.0-2.5 million

patients)

MedicineInsight data flow

MedicineInsight

Live laboratory with real world data

Greater insights into how medicines are used in practice

- when, what dose, and for what type of patient medicines are

being used

- the effects of a medicine(s) on an individual

- how new medicines are adopted once released

- alignment with recommended best practice

- adverse events

- monitor effects of policy changes

Improve policy and PBS decision making

Better program design and evaluation

Improve clinical practice

Why invest in national programs to improve HTA

evidence dissemination and implementation?

Adds value to registration (TGA) and

subsidisation (PBS) processes.

Valued by health professionals

Demonstrated changes in

attitudes and practice

Savings on medicines and

medical tests for Australian

Government >AUS$660 million.

Contributes to better health and

economic outcomes.

QUESTIONS?

www.nps.org.au

Dementia program

Around 200,000 Australians have dementia with the

most common being Alzheimer’s disease (50% to 70%

of cases).

Cholinesterase inhibitors and memantine commonly

cause adverse effects and benefits are small.

Difficult to objectively assess the efficacy.

Pressure from carers to prescribe and continue therapy.

Program goal to improve decision making regarding use

of non-pharmacological and pharmacological

management.

Key messages

Use non-pharmacological strategies at all stages.

Benefits of cholinesterase inhibitors and memantine, if any, are likely

to be small and adverse effects are common.

Monitor and objectively assess the effectiveness of cholinesterase

inhibitors and memantine if they are to be used.

Trial a withdrawal of antipsychotics if there are no clear beneficial

effects.

Plan to review medications regularly as well as opportunistically.

Counsel patients and their carers on the limited benefits of drug

therapy.

Prescription expenditure: cholinesterase inhibitors & memantine

Model of actual data over time with the NPS intervention

Model of data over time with the NPS intervention effect removed (predicted)

PBS cost-savings achieved by

reducing volume or expenditure on

prescriptions following the NPS

intervention

National Prescribing Curriculum

Web-based interactive

modules

WHO Guide to Good

Prescribing

Case-based topics

Diagnosis provided –

focus on prescribing

Medical, pharmacy,

nurse practitioner and

dentistry students

Development of the National Prescribing

Curriculum

Case based topics informed by survey of final year Australian medical students during 1999*

Process of development, writing and review governed by a committee of clinical pharmacologists

Biennial review of content – review evidence and update resources

Concordance with national guidelines and formulary

links to Therapeutic Guidelines, Australian Medicines Handbook, Australian Prescriber

Local champions from ten medical schools involved as authors and reviewers

* Rolfe, I., et al., Identifying medical school learning needs: a survey of Australian

interns. Education for Health, 2001. 3: p. 395 - 404.

Examples of topics

• Chronic obstructive

pulmonary disease

• Peptic ulcer disease

• Hypertension

• The confused patient

• Seizures

• Acute chest pain

• Acute otitis media (child)

• Heart failure

• Anticoagulation

• Postoperative pain and

vomiting

• Polypharmacy

• Intern orientation

Introduction

+ Learning

Objectives Case Study +

Context

Defining the

patient problem

Review

Therapeutic

Goals-voting

Specify

therapeutic

objective

Therapeutic

Goals

Feedback

Specify

therapeutic

objective

Non Drug

Treatment +

Feedback-Q&A

Choose a

treatment Drug

Treatment

Choose

treatment +

P-drugs

Verify

Suitability

Verify

suitability

Start

treatment

Write

Prescription

Prescription

Feedback

Start

treatment

Monitor

Treatment

Monitor

treatment

Provide

Information +

Feedback-Q&A

Monitor

treatment

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