16 September 2022 -  On Wednesday, PHARMAC announced a "medicines bundle to provide more treatment options for New Zealanders."

In the consultation, PHARMAC stated that it is seeking feedback on proposals to fund two Janssen medicines:

• Paliperidone palmitate (Invega Trinza) for patients with schizophrenia
• Ibrutinib (Imbruvica) for patients with relapsed/refractory chronic lymphocytic leukaemia following treatment with venetoclax.

If approved, funding for both paliperidone and ibrutinib would commence 1 December 2022.

Let's break this proposal down.

First of all, a proposal to list two (a pair) of medicines from the same supplier can hardly be called a 'bundle deal.' Surely a 'bundle deal' must involve at least three medicines. The famous Novartis bundle deal involved eight medicines.

The PTAC recommended the listing of pliperidone palmitate in February 2017. If approved and implemented as outlined above, it will have taken PHARMAC nearly six year to execute this recommendation.

For ibrutinib, there is no record in the public domain to indicate that ibrutinib has been recommended by the PTAC for patients with chronic lymphocytic leukaemia. Our records show that it was last considered by the PTAC for patients with chronic lymphocytic leukaemia back in November 2015 and was rejected.

The PTAC rejected the proposed listing of ibrutinib for the treatment of patients with chronic lymphocytic leukaemia that has relapsed within 24 months of prior therapy. The minutes from the PTAC meeting for this agenda item are very brief (4 pages for 5 recommendations) and make no mention of what constitutes prior therapy.  Insofar as the PTAC outcome predates the availability of venetoclax it cannot be after the use of venetoclax (if prior therapy needs to be specified).

The proposal for ibrutinib is for use after treatment with venetoclax. The use of venetoclax is also restricted. Patients must have received at least one prior therapy for chronic lymphocytic leukaemia and have relapsed within 36 months of previous treatment. Patients also need to have an ECOG performance status of 0-2.

The use of ibrutinib after the use (failure) of venetoclax is unusual to say the least. Not withstanding the fact that some HTA agencies have grappled with the funding of ibrutinib for patients with chronic lymphocytic leukaemia, none have recommended its use after venetoclax.