19 April 2021: OIA response | Information about funding for Cladribine 

19 April 2021: OIA response | Information about funding for Cladribine 

Dear [name and contact details withheld] 

REQUEST FOR INFORMATION 

Thank you for your request dated 30 March 2021 under the Official Information Act 1982 (OIA) for information relating to the funding decision for cladribine for the treatment of Multiple Sclerosis. You requested: 

Would you please advise how in reaching your decision you accounted for and valued the following requirements of your Factors for Consideration.

  1. Cost savings: how did you value the cost savings to the person with MS and their families of the obvious benefit of taking a short course of pills against alternative treatments.
  2. Cost savings: How did you cost or value the savings to the “wider health system” of a short course of pills rather than the cost of providing alternative treatments.
  3. Suitability: How did you value or cost “impact or ease of use” against alternative treatments.
  4. Suitability: How did you measure the efficacy and use of fingolimod against cladribine to require cost-neutrality. 

Funding cladribine

PHARMAC has not declined the funding application for cladribine, it remains an option for investment for PHARMAC, however it is not currently a working priority for PHARMAC. This follows the advice we received from the Pharmacology and Therapeutics Advisory Committee (PTAC) in November 2019. 

In July 2018, the Neurological Subcommittee of PTAC recommended the funding application for cladribine be declined. Following this, the supplier submitted additional information and in November 2019, PTAC recommended that cladribine should be funded only if it is cost-neutral to fingolimod.

The record of the PTAC recommendation and discussion about cladribine can be found within the funding application tracker for cladribine(external link). Additionally, a record of the full November 2019 PTAC meeting can be found on our website: www.pharmac.govt.nz(external link) > About > How we get expert advice > Pharmacology and Therapeutics Advisory Committee (PTAC) > Records of PTAC meetings. 

The funding application for cladribine has been compared and ranked against all other available options for investment and the funding application for cladribine remains open. Details and progress of the funding application for cladribine can be found via the PHARMAC Application Tracker: https://connect.pharmac.govt.nz/apptracker/s/(external link)

Cost of cladribine compared to fingolimod

The PTAC recommendation of ‘cost-neutral’ means that the Committee considered no investment for cladribine should be made over what is already being spent on fingolimod.

With this recommendation, our budget impact analysis and cost-neutrality analysis for cladribine has only assessed the impact of cladribine to the pharmaceutical budget. At this time, we have not analysed cost savings to people with multiple sclerosis, their whānau or the wider health system.

The results of our analysis showed that the proposal received for cladribine was not cost-neutral to fingolimod, so we have not progressed funding of cladribine at this time. However, we are open to considering an updated commercial proposal from the supplier at any time. 

Please note: fingolimod pricing is confidential. Because of this, we cannot disclose a price range to anyone in which cladribine would be considered cost-neutral. 

Suitability of cladribine

In the July 2018 Neurological Subcommittee meeting, the Subcommittee considered that there would be reduced administration and monitoring burden with cladribine, however that it is likely that additional monitoring would be required in years 3 and 4 once cladribine administration had concluded. The Subcommittee considered that if cladribine was listed, approximately 25% of patients receiving fingolimod and dimethyl fumarate may switch due to the convenience associated with administration; however, most patients who would receive cladribine would be treatment-naïve. 

Efficacy of cladribine compared with fingolimod

In the November 2019 PTAC meeting, the Committee noted that there were no head-to-head trials comparing cladribine to a relevant comparator at the time. PTAC considered that cladribine is likely to have similar efficacy to fingolimod, based on indirect analysis. Additionally, the Committee noted the supplier had provided PHARMAC with data from its Australian market access programme in which 23% of those who received cladribine were treatment-naïve. 

We trust that this information answers your queries. We are making our information more freely available, so we will now publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this.

Yours sincerely

Rachel Read
Manager, Policy and Government Services