Pharmaceutical Benefits Scheme

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The Pharmaceutical Benefits Scheme (PBS) is a programme of the Australian Government that provides subsidised prescription drugs to residents of Australia. The PBS ensures that Australian residents have affordable and reliable access to a wide range of necessary medicines. The PBS has faced increased scrutiny as its cost has increased. The scheme assumes responsibility for the cost of drugs to patients in the community setting rather than while in hospital which is the responsibility of each state and territory.[1] Together with Medicare the PBS is a key component of health care in Australia.

History[edit]

The PBS was introduced on 1 July 1948[2] by the Labor Chifley Government as part of a wider plan to create a British-style National Health Service. Though the High Court of Australia ruled that most of Chifley's health care plans were unconstitutional, the PBS was ruled to be constitutional. Initially, PBS covered approximately 140 lifesaving and disease-preventing drugs. Medicines on the PBS list were free to the consumer until 1960, when a 50 cent co-payment was introduced.[2] By 2003 the number of drugs included under the scheme had expanded to 601 general products which were marketed as 2,602 different brands.[2] The scheme was appealing to policy makers because it required no major capital works program and could be implemented immediately without lengthy consultation with the medical profession.[3]

Operation of the PBS[edit]

Diagram showing the provision of medication under the PBS

PBS is governed by the National Health Act 1953 and National Health (Pharmaceutical Benefits) Regulations 1960 (Cth). Pharmaceutical benefits under PBS may only be supplied by pharmacists and medical practitioners approved under the Act. Applications to list a drug on the PBS are administered by the Department of Health. Prescription benefits supplied under the PBS are administered by Medicare Australia (formerly the Health Insurance Commission) under the Health Insurance Act 1973 (Cth).

To receive a pharmaceutical benefit under PBS, a consumer must be prescribed a drug listed in the Schedule of Pharmaceutical Benefits. The drug may be listed for general use as an unrestricted benefit, or for a specific indication as a restricted benefit. The subsidy is automatically applied when the drug is dispensed at a pharmacy and the cost to the patient is the patient contribution rather than the full cost of the medication.[4]

The cost of a medication is negotiated between the Government of Australia, through the Department of Health, and the supplier of the drug. The agreed price becomes the basis of the dispensed price of the medication which is negotiated between the Commonwealth Government and the Pharmacy Guild of Australia under the current Community Pharmacy Agreement. The dispensed price includes the wholesaler's markup, pharmacist's markup, and a dispensing fee. Pharmacies purchase PBS-listed drugs from the wholesaler or supplier, and claim the difference between the dispensed price and the patient co-payment contribution from Medicare Australia.

The PBS is separate to its counterpart, the Medical Benefits Schedule, which provides subsidised medical services such as doctors consultations and diagnostic tests.

Patient contribution and safety net[edit]

When purchasing a medication under PBS the maximum price a patient pays is the patient contribution, which in 2013 was A$36.10 for general patients. For PBS drugs up to $36.10, the patient pays the PBS dispensed price plus an additional $1.11 safety net recording fee plus an optional pharmacy charge of $4.11 or less, provided that the total charge does not exceed $36.10. Concessional patients - i.e., low-income earners, welfare recipients, Health Care Card holders, etc. and those covered under the Repatriation Pharmaceutical Benefits Scheme (RPBS) - pay a patient contribution of $5.90 in 2013. Patient contributions are compulsory and cannot be discounted by pharmacies.

Safety net provisions in PBS reduce patient contributions when singles and families exceed in a calendar year the PBS safety net threshold on PBS medications: general patients are entitled to PBS medications at the concession price for the remainder of that calendar year; while concession patients are entitled to PBS medications at no cost for the remainder of the year. The PBS safety net is separate from and in addition to the Medicare safety nets.

Changes in co-payments and the safety net over the years are as follows:[5]

Year Co-payment
(general)
Co-payment
(concession)
Safety net
(general)
Safety net
(concession)
1960 $0.50 n/a
1971 $1.00 n/a
1975 $1.50 n/a
1976 $2.00 n/a
1978 $2.50 n/a
1979 $2.75 n/a
1981 $3.20 n/a
1983 $4.00 $2.00
1985 $5.00 $2.00
1986 $10.00 $2.50 25 scripts 25 scripts
1988 $11.00 $2.50
1990 $15.00 $2.50
1997 $20.00 $3.20
2000 $20.60 $3.50 $631.20 $171.60
2001 $21.90 $3.50 $669.70 $182.00
2002 $22.40 $3.60 $686.40 $187.20
2003 $23.10 $3.70 $708.40 $192.40
2004 $23.70 $3.80 $726.80 $197.60
2005 $28.60 $4.60 $874.90 $239.20
2006 $29.50 $4.70 $960.10 $253.80
2007 $30.70 $4.90 $1059.00 $274.40
2008 $31.30 $5.00 $1141.80 $290.00
2009 $32.90 $5.30 $1264.90 $318.00
2010 $33.30 $5.40 $1281.30 $324.00
2011 $34.20 $5.60 $1317.20 $336.00
2012 $35.40 $5.80 $1,363.30 $348.00
2013 $36.10 $5.90 $1390.60 $354.00
2014 $36.90 $6.00 $1421.20 $360.00

Safety Net 20 day rule[edit]

In an effort to limit the cost of PBS, PBS prescriptions should not be filled earlier than needed. Under the Safety Net 20 day rule, a repeat prescription supplied within 20 days of a previous supply of the same medicine will not count towards the PBS Safety Net threshold. If a consumer has already reached their safety net threshold, they will be charged the normal patient contribution instead of the reduced safety net amount.

Brand Premium and generic medicines[edit]

In an effort to limit the cost of PBS, the Australian Government introduced Brand Premiums on medications where cheaper generic brands were available. The Brand Premium is usually the price difference between the innovator brand and the generic brand. The patient pays the Brand Premium in addition to the normal patient contribution if they declines to purchase the generic brand. The Brand Premium paid does not count toward either safety net threshold and must still be paid even after the threshold is reached.

Pharmacists are allowed to substitute generic brands for prescribed brands if the brands are flagged "a" in the Schedule of Pharmaceutical Benefits, and if consent is obtained from the patient and prescriber. The prescriber's consent is always assumed to be granted unless "brand substitution not permitted" is indicated on the prescription.

Therapeutic Group Premium[edit]

On 1 February 1998,[6] another effort to limit the cost of the PBS involved the introduction of Therapeutic Group Premiums (TGPs) on medications that are priced significantly above the cheapest medication in a defined therapeutic sub-group where the drugs are considered to be of similar safety and efficacy. The TGP is the price difference between the premium brand and the benchmark (base) price for drugs in the class. The patient must pay this TGP in addition to the normal patient co-payment contribution if they have been prescribed such a medication. The TGP paid does not count toward the Safety Net threshold.

However, a prescriber may obtain an exemption from the TGP if:

  • adverse effects occurring with all of the base-priced drugs; or
  • drug interactions occurring with all of the base-priced drugs; or
  • drug interactions expected to occur with all of the base-priced drugs; or
  • transfer to a base-priced drug would cause patient confusion resulting in problems with compliance.

Such an exemption requires an approved PBS Authority prescription from Medicare Australia.

Reciprocal Health Care Agreements[edit]

Although PBS subsidies are available only to Australian residents, certain foreign visitors are also eligible under Reciprocal Health Care Agreements between Australia and the United Kingdom, Ireland, New Zealand, Malta, Italy, Sweden, the Netherlands, Finland, Norway and Slovenia.

Schedule of Pharmaceutical Benefits[edit]

The Pharmaceutical Benefits Advisory Committee (PBAC) makes recommendations to the Minister for Health and Ageing regarding drugs which should be made available as pharmaceutical benefits, which are listed on the Schedule of Pharmaceutical Benefits. The Schedule is published monthly since January 2007, (prior to this it was published three times a year).

In considering a medication for listing on the PBS, the PBAC considers factors including:

  • The conditions for which the drug has been approved for use in Australia by the Therapeutic Goods Administration. The PBAC only recommends the listing of a medicine for use in a condition which is in accordance with the Australian Register of Therapeutic Goods.
  • The conditions in which use has been demonstrated to be effective and safe compared to other therapies.
  • The costs involved. The PBAC is required to ensure that the money that the community spends in subsidising the PBS represents cost-effective expenditure of taxpayers' funds.
  • A range of other factors and health benefits. These factors may include, for example, costs of hospitalisation or other alternative medical treatments that may be required, as well as less tangible factors such as patients' quality of life.

Decisions on PBS listing are generally made on a health economics perspective, using cost-effectiveness analysis. Cost-effectiveness analysis evaluates the cost and health effects of one technology versus the cost and health effects of another technology, which is usually standard of care. A new technology whose incremental health benefit justifies its additional expense is deemed to be cost-effective and thus reimbursed by PBAC. Drugs that provide little health benefit at considerable additional expense, such as the PDE5 inhibitors (e.g. sildenafil) and certain expensive cancer chemotherapy drugs are not listed on the basis of poor cost-effectiveness. The principles that are applied during the evaluation of drugs for PBS listing are described in the PBAC Guidelines.[7]

Unrestricted benefits[edit]

Drugs that have unrestricted benefit listing on the PBS are available for general use without being limited to particular indications. Such items are typically those whose use in clinical practice is widely accepted. Examples include methotrexate, prednisone and amoxycillin.[8]

Restricted benefits[edit]

Certain medications listed on the PBS are available only for specific therapeutic indications or to patients meeting specific criteria where the PBAC has deemed that the cost-benefit analysis is favourable only in those indications/patients. These are noted as "restricted benefits" on the Schedule. Medicare Australia places the onus of policing restricted benefits on the prescribers themselves and the pharmacists dispensing (unless the listing is also 'Authority Required'). For example, the COX-2 inhibitor celecoxib is listed on the PBS as a restricted benefit for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. Prescribers using celecoxib for other indications are expected to indicate "non-PBS" on the prescription, and/or the pharmacist dispensing the celecoxib should charge the patient the full cost.

Authority required benefits[edit]

Some PBS medications are restricted and require prior approval from Medicare Australia. These are noted as "authority required benefits" on the Schedule. Again, the PBAC has deemed that the cost-benefit analysis is favourable only under in specific indications/patients under certain circumstances. Authority may be obtained by telephone to Medicare Australia (known as "phone approval") or in writing from an authorised delegate of the Minister for Health. Prescriptions must be written on Authority Prescription Form, and the approval number must be noted on the prescription. Pharmacists cannot dispense the item as a pharmaceutical benefit unless it has been approved by Medicare Australia (indicated by the presence of the approval number).

In obtaining a phone approval, the doctor simply identifies themselves (using their name and provider number), the patient (using their Medicare number), and when asked by the operator, confirms which of the conditions eligible for an authority the patient is suffering from. Medicare normally assumes the doctor's assertion that the condition exists as sufficient. For a written Authority however, evidence of diagnosis and patient eligibility criteria such a pathology test results are usually required.

Some drugs may have Authority Required (Streamlined) status which does not require an explicit approval from Medicare, instead the doctor can use the Authority code found in the published Schedule for a given drug/indication.

Sustainability of the PBS[edit]

In its first year, the PBS cost the Commonwealth Government £149,000 (or $7,600,000 in 2009). The PBS now costs the Commonwealth approximately $6.5 billion a year to operate, despite consumers contributing around $1.3 billion in patient co-payments.[citation needed] According to a report by the Australian Productivity Commission the PBS is expected to cost 2.6% of Australia's GDP by 2045 up from 0.7% in 2005.[9] Further attempts to restrain the growth in costs of the PBS may be needed, however, attempts to increase consumer prices of drugs have always proved politically unpopular. The comparative cost-effectiveness processes of the PBS nonetheless ensure it provides Australian citizens with more equitable access to medicines than in many other developed nations and for many the issue of sustainability of the PBS as a key component of the egalitarian architecture of Australian society is equivalent to asking whether that nation's education system or defence forces are sustainable.

Former federal Treasurer Peter Costello and the Liberal Party attempted to raise the patient co-payment of PBS medicines by up to 30 per cent in the 2002 Federal Budget, however this measure was blocked in the Senate in which various minor parties held the balance of power. However, in June 2004 the main opposition party, the Australian Labor Party, announced that it would allow the PBS co-payment increases to proceed through the Senate.

The Grattan Institute Report March 2013[edit]

Grattan Institute Health Program released a report titled "Australia’s bad drug deal" by Dr Stephen Duckett, in which he states that Australia’s Pharmaceutical Benefits Scheme pays at least $1.3 billion a year too much for prescription drugs. New Zealand, which has capped its budget and appointed independent experts to make decisions, pays a sixth as much as the PBS for the same drugs. Public hospitals in two Australian states pay much lower prices than the PBS. In one case,the prices are just a sixth of PBS prices. In one extreme example the report states that "The price of one drug, Olanzapine, is 64 times higher on the PBS than in Western Australian public hospitals". This report proposes three ways Australia can regain its lost leadership in pharmaceutical pricing.[10]

Recent changes to the PBS[edit]

In July 2007 changes to the National Health Act 1953 (Cth) divided the PBS formulary into an F1 category (for patented, single brand medicines) and an F2 category (for generic medicines)with reduced reference pricing between them. Academic opinion is divided about the value of these changes and the extent to which they arose from industry lobbying drawing strength from Annex 2C of the AUSFTA.[11][12][13]

2012 price drop[edit]

The biggest cuts on prices of medicines in Australian history occurred from 1 April 2012 under the Gillard Labor government. PBS pricing for low-income consumers remained at $5.80 per script.[14][15][16][17]

See also[edit]


References[edit]

  1. ^ Harris, Anthony; Liliana Bulfone (2004). "Getting value for money: The Australian experience". In Jost, Timothy S. Health Care Coverage Determinations: An International Comparative Study. McGraw-Hill International. p. 27. ISBN 0335225993. Retrieved 24 April 2014. 
  2. ^ a b c Gauld, Robin (2004). Comparative Health Policy in the Asia-Pacific. McGraw-Hill International. pp. 108–109. ISBN 0335225101. Retrieved 24 April 2014. 
  3. ^ Gillespie, James A. (2002). The Price of Health: Australian Governments and Medical Politics 1910-1960. Cambridge University Press. p. 210. ISBN 0521523222. Retrieved 24 April 2014. 
  4. ^ (8 February 2006). Review of Prescription Charges in Western Europe, North America and Australasia. The Scottish Government. Retrieved 24 April 2014.
  5. ^ History of PBS Copayments and Safety Net Thresholds. Department of Health. Retrieved 24 April 2014.
  6. ^ The effect of the introduction of therapeutic group premiums on patient care. Australian Government. Retrieved 17 June 2014
  7. ^ PBAC Guidelines Version 4.4 [1] Retrieved 28 June 2014.
  8. ^ PBS Online [2] Retrieved 28 June 2014.
  9. ^ OECD (2006). OECD Economic Surveys: Australia 2006. OECD Publishing. pp. 63–64. ISBN 9264026355. Retrieved 24 April 2014. 
  10. ^ Stephen Duckett. Australia’s bad drug deal. Grattan Institute. Retrieved 24 April 2014.
  11. ^ Faunce TA and Lofgren H. Drug price reforms: the new F1–F2 bifurcation. Australian Prescriber. 2007;30. pages 138–140. (last accessed 22 June 2009)
  12. ^ Faunce TA. Reference pricing for pharmaceuticals: is the Australia-United States Free Trade Agreement affecting Australia's Pharmaceutical Benefits Scheme? Medical Journal of Australia. 2007 August 20. Volume 187(4). pages 240-242. (last accessed 22 June 2009)
  13. ^ Faunce TA. Policy challenges of nanomedicine for Australia’s PBS. Australian Health Review. May 2009. Vol 33 No 2. pages 258-267. (last accessed 22 June 2009)
  14. ^ Price Disclosure - Information for Consumers: PBS website
  15. ^ Summary of claimed prices and brand premiums for 1 April 2012 Price Disclosure price reductions. Department of Health. Retrieved 24 April 2014.
  16. ^ (1 April 2012) Samantha Maiden. PBS slashes prices of major drugs in major win for families. Daily Telegraph. News Limited. Retrieved 24 April 2014.
  17. ^ (31 March 2012) Samantha Maiden. Huge savings as Federal Government cuts price on prescription drugs. The Advertiser. News Limited. Retrieved 24 April 2014.

External links[edit]