OIA response: hydroxychloroquine in the treatment of COVID-19

Request for information relating to COVID-19 treatments.

2 November 2020

Dear [name and contact details redacted]

REQUEST FOR INFORMATION

Thank you for your request, transferred to us from Nelson DHB on 2 October 2020, under the Official Information Act 1982 (OIA) for information relating to COVID-19 treatments. Your questions transferred to us are detailed below with our answers provided in response.

1. Why has there been no change made to the regulations around the availability of these treatments, namely Hydroxychloroquine, that would help save lives and/or reduce the severity of the virus?

Medsafe is the authority responsible for the regulation of therapeutic products in New Zealand. PHARMAC is the government agency that decides which medicines and related products are funded in New Zealand and as such, is unable to comment on the process of regulatory changes to medicines.

As you are aware, effective from 24 March 2020, PHARMAC restricted funded access to hydroxychloroquine (Plaquenil) to make sure it is available for patients who need it for use in treatment of proven (and registered) indications. Hydroxychloroquine is currently funded by endorsement(external link) in Section B (community) of the Pharmaceutical Schedule (“Schedule”) and by restriction(external link) in Section H (hospital) of the Schedule.

There has not been any specific conclusive evidence to confirm the efficacy or safety of hydroxychloroquine in the treatment of COVID-19. We refer you to the Medsafe website where a letter from the supplier of Plaquenil (Sanofi) is made publicly available which informs healthcare professionals about the off-label use of Plaquenil in the context of COVID-19: https://medsafe.govt.nz/safety/DHCPLetters/PlaquenilMay2020.pdf(external link).

We also refer you to a recent study[1] which has concluded “among patients hospitalized with COVID-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care.”

2. How much funding has been directed (overseas or within New Zealand) from our New Zealand government towards the increased manufacture and availability of these proven drugs for Covid-19 treatment and towards the education of New Zealand Healthcare professionals around usage of these treatments?

On 21 July 2020, Minister Chris Hipkins announced additional funding(external link) to assist with the increase in COVID-19 related costs. The additional funding granted to PHARMAC can be used to secure funding for medicines that are proven to be effective for treating COVID-19.

In general, PHARMAC has a process for funding a new medicine or widening access to a medicine that is already funded. At every stage in the process, we use the Factors for Consideration to guide our thinking. Furthermore, to help us with our decision making, our expert clinical advisors provide us with recommendations about the evidence about the treatments, including for COVID-19. PHARMAC has not received any funding applications for medicines to be used for the treatment of COVID-19.

PHARMAC is involved in the All of Government COVID-19 Vaccines Strategy taskforce and its working group as well as with the Ministry of Health’s COVID-19 immunisation implementation programme planning.  We maintain a keen watch on evidence development regarding new therapeutic treatments for COVID-19, including vaccines, and will seek advice from our clinical experts in order to support decision-making about whether new vaccines or medicines need to be secured for New Zealand or access funding changes need to be made to existing medicines.

Please be advised that PHARMAC has not funded any education or training activities for New Zealand health care professionals as this is outside the portfolio responsibilities for PHARMAC.

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

 

[1]Horby. (2020, October 8). Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19. The New England Journal of Medicine. doi:10.1056/NEJMoa2022926