Medicines Regulation and Subsidy in Australia – The PBS

Question 1

Regulatory and Reimbursement: Medicines can’t get onto the PBS without what?

Answer 1

Without being registered with TGA

Question 2

Regulatory and Reimbursement: Initially, what does the TGA do?

Answer 2

Initially, TGA will give marketing approval

Efficacy, safety, quality

Question 3

Regulatory and Reimbursement: After a drug has been listed by TGA what happens?

Answer 3

The manufacturer can then put in an application to the PBAC, depending upon results – will advise whether a medicine should be listed on PBS

Compare effectiveness, safety and costs

Minister for Health and Aging must approve listing

Question 4

Australia’s National Medicines Policy: What is the TGA involved in?

Answer 4

Quality, Safety and Efficacy

Question 5

Australia’s National Medicines Policy: What is the PBS involved in?

Answer 5

Equity of Access

Question 6

Who pays for any medicine that we get under the PBS?

Answer 6

Commonwealth Government

Includes medicines supplied from Private Hospitals and dispensed at Community Pharmacies

Also includes medicines supplied at discharge from public hospitals

Highly Specialised Drug Program (S100)

Question 7

What does the State and Territory Governments pay for?

Answer 7

Responsible for funding of drugs that are used within public hospitals

Question 8

What does the Minister for Health do?

Answer 8

Ultimately responsible for deciding whether a medicine should be subsidised under PBS. Sits as head of Department of Health

Question 9

What does the Pharmaceutical Benefits Advisory Committee (PBAC) do?

Answer 9

Advises on what medicines/vaccines should be PBS listed

Question 10

What does the Economics Sub Committee (ESC)?

Answer 10

Assess clinical and economic evaluations of medicines submitted to the PBAS for listing, and advises PBAC on the technical aspects

Question 11

What does the Drug Utilisation Sub Committee (DUSC) do?

Answer 11

Assesses estimates on projected usage and financial cost for medicines and collects and analyses data on actual use

Question 12

What does Pricing Section do?

Answer 12

Negotiates price with the medicine’s Sponsor

Question 13

Who is in charge of Decisions?

Answer 13

Minister for Health, PBAC, ESC, DUSC and Pricing Section

Question 14

What is the Role of Medicare Benefits Schedule (MBS)?

Answer 14

Medical, pathology, diagnostic, imaging services

Medical Services Advisory Committee (MSAC) - advise on listing on the MBS like the PBAC, but the Minister for Health and Aging has final approval

If a medicine requires a diagnostic test in order to be used, this should be funded under the MBS

Question 15

What 3 Factors are used in the Assessment of Medicines for Subsidy?

Answer 15

Comparative Cost-Effectiveness (‘value for money’)

Financial Implications for PBS/Health Budget

Comparative Health Gain

Question 16

What are Orphan Drugs?

Answer 16

Drugs for medical conditions that have limited financial incentive for development

Rare/orphan diseases e.g. cystic fibrosis

Diseases uncommon in first world countries (e.g. malaria)

Question 17

What is the aim of Constraints on Prescribers?

Answer 17

Constraints are used to target drugs to those indications, patient groups or clinical settings which achieve the optimum clinical and cost effectiveness

Question 18

Constraints on Prescribers: What is Leakage?

Answer 18

The use of drugs outside the restrictions

Question 19

Constraints on Prescribers - What are the Different Types of Restrictions on Medicines?

Answer 19

Unrestricted benefits:

Restricted benefits

Authority required benefits

Question 20

Constraints on Prescribers - Types of Restrictions on Medicines: What are Unrestricted Benefits?

Answer 20

Can use in anyone for any indication

Question 21

Constraints on Prescribers - Types of Restrictions on Medicines: What are the types of Authority Required Benefits?

Answer 21

Authority required - Call to DHS or DVA and Require pre-approval to provide

Authority required (streamlined) - Have a streamlined code for a specific indication

Question 22

What are Authority Only Items?

Answer 22

Have initiating and continuing criteria

For initial prescriptions: May require the provision of evidence to document that the patient fulfils the criteria

Continuing criteria: May require some evidence of response for continuation of supply

Question 23

Section 100 Programs: Programs funded under this provision include

Answer 23

Highly Specialised Drugs Program

Efficient Funding of Chemotherapy

The Botulinum Toxin Program

The Human Growth Hormone Program

The IVF/GIFT Program

The Opiate Dependence Treatment Program

Question 24

What are some Challenges of the PBS?

Answer 24

Growing consumer demands and expectations: Early access to new medicines

Rising prices of and expenditure on health care services, drug development, medicines

Increasing pressure on budgets (governments, institutions and individuals)

Use of pharmacogenomics to target therapy

Uncertain long-term safety, effectiveness, cost-effectiveness of medicines

Question 25

If a drug is covered by the PBS, how much do you pay?

Answer 25

Individuals provide a co-payment (maximum of $40.30 per script dispensed) towards the cost of a drug on the PBS

Seniors, concession card holders: lower co-payment = $6.50

Question 26

PBS payment: What if Individuals use a large number of drugs?

Answer 26

After spending a certain amount on medications each year the co-payment is significantly reduced = safety net

E.g. after $1550, co-payment reduced to $6.50 for medications bought in the remainder of year. For concessions, once patient reaches $390, medicines are free

Question 27

The originator is likely to continue to be preferred due to?

Answer 27

Being well known

Perception that it is superior/higher quality to generic versions of the drug

Question 28

What is a Brand Price Premium?

Answer 28

The company producing the originator product often continues to charge a small amount more than the generic versions (brand price premium)

Government will not pay more for the originator product since there’s no evidence of superior effect compared to placebo

Consumer will need to pay the additional cost themselves