Lapatinib: where the agencies disagree

This page collects every recorded health technology assessment decision for one molecule across the agencies in our archive, and compares them. The comparison is the point: each agency publishes its own verdict, none publishes how that verdict sits against the others.

What the record shows

PBAC (Australia) and PHARMAC (New Zealand) recommended or restricted lapatinib, while SMC (Scotland) did not recommend it.

Assessment has run over 6.8 years, from 23 Oct 2008 at TLV (Sweden) to 2015 at PBAC (Australia).

TLV (Sweden) changed its position: not recommended on 23 Oct 2008, restricted by 4 Feb 2015, after a resubmission.

No assessment is on file from HAS (France), CIPM (Spain) and G-BA (Germany), each among the eight highest-volume agencies here.

Not every gap is a refusal: for lapatinib, 2 submissions were never made — an outcome set by the company rather than the assessor.

Nothing has been added since 2015; on this evidence the file is dormant.

Against its own class, lapatinib is an outlier: 50% of its decisive outcomes were positive, where molecules sharing ATC class L01E average 75%.

5 distinct indication wordings are recorded for lapatinib by the agencies that label one in English (AWMSG, PBAC and SMC).

1 of these 10 records carries a year of decision but no day, so any interval quoted here is approximate to within a year.

TLV (Sweden) was first to assess lapatinib, on 23 Oct 2008; PBAC (Australia) did not open a file until 2015 — a wide spread of 6.8 years between the earliest and latest system to look at it.

Restriction is doing real work here: 2 of 8 decisive outcomes narrowed lapatinib to a subgroup rather than accepting or refusing it outright, at AWMSG (Wales) and TLV (Sweden).

3 of the 5 agencies here assessed lapatinib more than once, SMC (Scotland) most often at 4 entries — repeat review is the norm for this molecule rather than the exception.

Coverage is narrow: only 5 of the 18 agencies here have assessed lapatinib.

The full ledger for lapatinib reads 4 not recommended, 2 restricted, 2 recommended and 2 non-submission.

Decisions on file

AgencyDateIndication as recorded OutcomeSource
PBAC (Australia)2015Metastatic (Stage IV) HER2 positive breast cancerThe PBAC recommended a change to the listing of lapatinib for metastatic (Stage IV) HER2 p…source
TLV (Sweden)4 Feb 2015Tyverb ingår i högkostnadsskyddet med begränsningrestricted subsidysource
AWMSG (Wales)6 Dec 2013Treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with trastuzumab for pat…not endorsed (non-submission)source
SMC (Scotland)11 Nov 2013Treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with trastuzumab for patients with hormone receptor-negative metasta…not recommendedsource
PHARMAC (New Zealand)15 Apr 2011Breast cancer - first line metastatic HER2 positive breast cancerPTAC advice: Cost Neutral · decision reachedsource

5 further decisions for lapatinib, across 3 agencies, are not shown here. They link to 5 further source documents.

Related molecules

Coverage: 10 decisions for lapatinib from 5 agencies, 2008 to 2015. Data to 7 Sep 2026. ATC class L01E — Antineoplastics. How this page is produced. Compiled by Altima Partners; queries: sales@altimapartners.co.uk.

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