11 April 2019 - The information in the public domain reveals PHARMAC's opacity and tardiness in its consideration of pabociclib (Ibrance) and trastuzumab emtansine (Kadcyla).

What is known

Medsafe registration

Ibrance - registered by Medsafe on 29 June 2017 for treatment of hormone receptor-positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or in combination with fulvestrant in women who have received prior endocrine therapy.

Kadcyla - registered by Medsafe on 26 September 2013 for use as a single agent for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.

PHARMAC submission

Ibrance - submission was received in February 2018. No further details regarding the submission are available.

Kadcyla - submission was received in August 2017.

Consideration by PHARMAC

Ibrance - considered by CaTSoP in September 2018; recommended for funding with medium priority.

Kadcyla - considered by PTAC in November 2017; recommended for funding with low priority. Considered by CaTSOP in September 2018; recommended for funding with medium priority.

What is unknown 

Whether the submissions for Ibrance and Kadcyla both need to considered (recommended by PTAC) before their listing in the NZ Pharmaceutical Schedule.

When Ibrance and Kadcyla will be considered by PTAC. PHARMAC is yet to announce which applications will be considered by the PTAC at its next scheduled meeting in May.

Key questions PHARMAC needs to address/answer

Why was the submission for Ibrance was first considered by CaTSoP rather than PTAC (as was the case for Kadcyla)?

Why it has taken more than a year for Ibrance to be considered by PTAC and why it has taken more than a year for the PTAC to reconsider the application for Kadcyla?

Last week, PHARMAC CEO Sarah Fitt claimed that the funding of these products "comes back to the evidence".  Insofar as Ibrance and Kadcyla have been (or soon will be) funded in Australia, England, Canada, Germany and France what are the evidence deficiencies to prevent these medicines being funded in NZ? Have the funding agencies in these countries got it wrong?

Ms Fitt also claimed that "when PHARMAC does see benefits, it can move quickly to fund a drug."  Ms Fitt needs to provide several examples to support this statement; the widely held view and the available evidence indicates the very opposite.