How are drugs classified on the Pharmaceutical Benefits Scheme?

With Schedule 4 drugs costing between $1,500 and $20,000 per treatment, the pharmaceutical benefits scheme has a strict system for the classification of drugs.

In order to be classified, a drug must meet three criteria: 1) it must have significant potential for use; 2) it has an approved therapeutic use; and 3) there is sufficient evidence to support its benefits.

Drugs on the PBS scheme are considered either to have the potential for drug use or to be approved for drug development, but it’s unclear if that has been the case for some of the drugs on the scheme.

For example, while drugs on a Schedule 4 are not eligible for the PBR, it’s clear from the drugs listed below that some are being marketed on the basis of its potential for medicinal use.

Drug Classification Scheme Classification of drugs Drug name Pharmacological name Drugs classified on PBS Schedule 4Drugs classified on Schedule 4Schedule 4-Generic drug-type (e.g. ritonavir) and/or combination of drugs-types, with the inclusion of one or more of the following characteristics: (a) an approved clinical trial for use in treating an infectious disease; (b) a pharmacological indication for which a registered indication exists; (c) a therapeutic use trial conducted in a randomized, controlled trial format that has demonstrated the safety and efficacy of the drug; and (d) a mechanism for efficacy testing.

Drugs on the PBS scheme are classified according to the following categories:(a) Class 1 drugs are those that have no medical value, are not approved for use, or are likely to cause harm.

Drug classification is determined by an expert panel.

The expert panel includes a drug development company that is the manufacturer of the generic drugs on Schedule 3 drugs, a pharmacy or medical device manufacturer, and a research firm that is a member of the European Medicines Agency (EMA).

The expert group is chaired by a panel of international experts who are appointed by the Minister for Science, Technology and Innovation (MOST), the Minister responsible for Science and Innovation and the Minister of Health (Minister).

This panel also includes representatives from pharmaceutical companies, research institutions, industry and governments.

The expert panel’s decision is made by consensus and is binding on all stakeholders.

The Expert Panel is responsible for ensuring that the decision is based on the best available evidence.

Drug classifications are made on a case-by-case basis.

Some drugs have multiple drug classifications, but the panel considers only the one most appropriate to the drug class.

Drug classifications on the pharmaceutical benefit scheme (PBS) are subject to the same rules and requirements as those for Schedule 4-generic drugs.

For more information on the classification scheme, please see:Drug classification on the Pharmacological Benefits Scheme (PhBSA)Drug classification Scheme-Generic drugs are classed as a generic drug and are eligible for treatment in the PBS program.

The drugs classified as generic on the Pfizer Pharma Pharma PBM, Pfizer PBM2 and Pfizer Rx are not covered by the PBS.

Generic drugs may also be covered by other PBS schemes.

The Pfizer Pharmabox, Pfizers Medici, Pfistil, Pfitzil, and Pfitzum products are covered by PBS-Generic Drugs Scheme, and the Pfizers Ticagunx, Pfitzer, Pfilx, and other Pfizer products are not.

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