When the PBS listing changes — what has to move, and what doesn't.

The PBS schedule changes on the first of the month, and somewhere in every affiliate a spreadsheet of "pieces that mention the listing" gets opened. A new listing, a restriction widened or narrowed, an authority level changed, a price moved, a delisting — each touches one line on every promotional piece for the product, and each is also a moment the Code treats specially in what a company may say to the public. This is the checklist of what has to move, in the Code's words, and the one thing that does not.

The line that moves

Every promotional piece carries "a statement indicating the public funding or reimbursement status of the product, with or without details of listing, or a direction to where the relevant information is available" § 2.1(e). When the listing changes, that statement is wrong on every piece in market until it is corrected — and the Code's standard for all promotional information is that it is "current, accurate, balanced" § 1, under a Principle that says companies "are responsible for providing current, accurate, balanced, and scientifically valid information" § OP 3.

Two decisions follow from the words with or without.

Short statements age better. The Help Desk's note on the PBS statement (#32) confirms there is no required box format and offers a minimal form: the product is PBS listed, refer to the PBS website for authority information. A piece that carries only that line survives a restriction change; a piece that reprints the restriction text is wrong the day the text changes. And where the restriction is broader than the TGA indication, the Promotional Claims Guidance records the TGA's advice that printing it may risk breaching Therapeutic Goods legislation — the short statement is the safe one for that reason too.

Accuracy is per use, not per product. A product listed for one of two registered indications is "PBS listed" for one and unfunded for the other. A piece promoting the unfunded indication with a bare "PBS listed" line is inaccurate for its use § 2.1(e). It is not off-label — the ceiling for what may be promoted is the PI, not the schedule — but it is a finding.

How long you have

The Code sets no timeframe for correcting material after a change; the Help Desk's note (#50) says so and asks instead for a documented action plan with prioritised pieces and timeframes. Its indicative figures — around three months for prescribing-information corrections, up to a year for a change of company address — are suggestions, not requirements, and a funding change sits nearer the first than the second: the funding line is one of the seven inclusions, and a prescriber acts on it.

The practical answer is an inventory. Which pieces carry the funding line; which of those carry restriction detail; which are in print, in a representative's bag, on a portal, in a journal's forward schedule; which were prepared or revised on what date § 2.1(g). A revised piece carries a new date, and the date is what tells a reader — and a Committee — which schedule it was written to. Keeping that inventory current is what a materials library is for; the Material library holds every piece with its date and its status, which is the list the sweep starts from.

What may be said to the public

A listing change is one of the few occasions on which a company may speak to consumers about a prescription product by name. Product-specific media statements "may be issued when the information is relevant to the Australian public", and the Code names the circumstances: "announcement/s of a new product or new indication registration, new public funding such as a PBS listing, or a change to public funding" § 10.1(b). A change to public funding runs both ways — a delisting is as much a change as a listing.

The permission is narrow. Each statement is issued once per circumstance, though that may be "a single, coordinated release across multiple channels such as consumer media, patient organisations and via companies' digital channels" § 10.1(c). It must contain seven things: the brand name; the Australian Approved Name; the approved indications relevant to the statement; the therapeutic class; "public funding status and restrictions, or a notation if the product is not publicly funded"; a summary of the side-effect profile, precautions, adverse effects, warnings, contraindications and interactions; and a copy of, or link to, the Consumer Medicine Information § 10.1(e). It may add a non-comparative description of the mechanism of action, the price to the patient, and the date of availability § 10.1(f).

And it must not include "promotional statements or claims", comparisons, promotional or comparative quotes from experts or patients, an image of the pack, or — the one that catches delisting announcements — "reference to a Company product access program" § 10.1(g). A company that wants to tell patients about compassionate supply after a delisting cannot do it in the media statement the delisting entitles it to issue; that message travels through a patient organisation § 11 or a patient support program § 13.

A media statement is not promotional material to healthcare professionals, so the § 2.1 inclusions do not apply to it; § 10.1(e) is its own set, and therapeutic class is the item most often missed when a statement is drafted from a detail aid.

What does not move

The PI. A listing change does not change what may be promoted. A widened PBS restriction does not widen the claims; the Guidance is explicit that where reimbursement criteria are broader than the approved indications, only claims consistent with the PI may be made. A narrowed or lost listing does not make promotion of a registered indication off-label — it makes the funding line different. Pre-reimbursement promotion of a TGA-registered indication is within the Code. The schedule moves the funding statement and the media statement; the ceiling stays where the TGA put it. The off-label guide has the reasoning.

The sweep

1. On the day the change is known: list every piece for the product that carries a funding line, with its medium and its date.
2. Decide the new statement — short where the restriction is wider than the PI, accurate for each piece's promoted use.
3. Prioritise by exposure: anything a prescriber acts on first, anything in print with a long tail, anything on a portal that can be changed today.
4. Set and record the timeframes; the Help Desk's three months is a reasonable outer mark for the funding line.
5. Revise, re-date § 2.1(g), re-approve; withdraw what cannot be corrected.
6. If a media statement is warranted, draft it to § 10.1(e) from scratch — not from the detail aid — and check it against § 10.1(g) before it goes.
7. Leave the claims alone unless the PI has also changed. It usually hasn't.