Proposal to change the sole subsidised brand of lidocaine [lignocaine] hydrochloride gel 2%, urethral syringe

Medicines

Consultation Closed

PHARMAC is seeking your feedback on a proposal to make changes to the funded brand of lidocaine [lignocaine] hydrochloride gel 2%, urethral syringe.

What we’re proposing

PHARMAC is seeking your feedback on a proposal to make changes to the funded brand of lidocaine [lignocaine] hydrochloride gel 2%, urethral syringe.

We propose the following changes:

  • The funded brand of lidocaine [lignocaine] hydrochloride gel 2%, urethral syringe would change from Cathejell to Instillagel Lido.
  • Instillagel Lido would be listed 1 January 2020 and become the sole subsidised brand in the community and hospital settings 1 April 2020, following a 3 month transition period.
  • Cathejell would be delisted from the Pharmaceutical Schedule 1 April 2020.

Consultation closes at 4 pm on Thursday, 28 November 2019 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

From 1 January 2020, Instillagel Lido would be listed on the Pharmaceutical Schedule. Instillagel Lido would be the sole subsidised brand of lidocaine [lignocaine] hydrochloride gel 2%, urethral syringe in both community and hospital settings from 1 April 2020 until 30 June 2022. A 1% Discretionary Variance would continue to apply to this product in DHB hospitals. Cathejell would be delisted from the Pharmaceutical Schedule 1 April 2020.

The same supplier, InterPharma, would continue to be the contracted supplier as per the terms of the 2018/19 Invitation to Tender.

This change would result in a change in syringe size from 10 ml to 11 ml and a change in pack size from 25 to 10 syringes. The price per syringe would remain the same.

Who we think will be interested

  • Patients and their carers
  • DHB staff, including nurses, pharmacists and doctors

Why we’re proposing this

PHARMAC has previously entered into a sole supply agreement with InterPharma to supply lidocaine [lignocaine] hydrochloride gel 2%, urethral syringes to New Zealand until 30 June 2022. The supplier has indicated that it is no longer able to supply the Cathejell brand to the New Zealand market due to changing international supply arrangements.

To ensure ongoing supply of this product for patients in New Zealand the supplier has proposed Instillagel Lido as an alternative brand to supply for their contracted sole supply period, and to meet its contractual obligations.

Background

The Cathejell brand of lidocaine urethral syringes was listed on the Pharmaceutical Schedule in 2017/2018 (Community/Hospital) as a result of a significant supply issue with the then funded brand. In April 2019, InterPharma was awarded sole supply in the community and hospital settings for lidocaine [lignocaine] hydrochloride gel 2%, urethral syringe from 1 November 2019. Since this decision, PHARMAC has received mixed responses from DHBs regarding the suitability of the Cathejell brand; with questions regarding its safety and efficacy raised.

Medsafe is the government authority responsible for assessing and monitoring the safety of medicines in New Zealand. Medsafe has been monitoring the reported issues and to date has not taken any further action, noting that in some reported instances it is not clear whether the issue relates to user preference, inadequate information or training in use of the product, or with the product itself. We note that the Instillagel Lido delivery device differs substantially to that of Cathejell. Both Instillagel Lido and Cathejell brands of lidocaine urethral syringes are approved by Medsafe.

Medsafe's monitoring communication(external link)

PHARMAC has already engaged in limited consultation for this proposal and would like to receive further feedback. This consultation is intended to gather feedback on the suitability of the proposed brand, Instillagel Lido. There is no option to return to the previously subsidised brand of lidocaine urethral syringe. However, a 1% Discretionary Variance will continue to apply in DHB hospitals.

About Instillagel Lido

Instillagel Lido is a lidocaine [lignocaine] hydrochloride gel 2%, 11 ml urethral syringe. Instillagel Lido is presented in a non-leur slip, non-parenteral syringe with sterile peel packaging. The syringe tip means that the risk of connecting the syringe to a needle or infusion line is minimised. Unlike the currently listed product (Cathejell), Instillagel Lido is not presented as an accordion syringe.

Instillagel Lido has been approved by Medsafe, which means that it is considered to meet acceptable standards of safety, quality and efficacy.(external link)

Instillagel Lido is marketed around the world including in Australia, Europe, the USA and Canada.

Single use applicator tips would be available separately for $1.00 per 10; however, the supplier has indicated that these applicator tips are not always required for use. PHARMAC has investigated the potential for applicators to be packaged with the urethral syringe, however the supplier has confirmed that this is not possible. The supplier has indicated that international practice is to use these syringes without the applicator and therefore there is no combined presentation.

The supplier would provide in-service training for Instillagel Lido to ensure that relevant DHB staff are comfortable using the brand.

See below images of the applicator (left), syringe with the applicator (middle) and without the applicator (right).

Details about our proposal

The sole subsidised brand of lidocaine [lignocaine] hydrochloride gel 2%, urethral syringe would change from Cathejell to Instillagel Lido. The following will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 January 2020 as follows:

Chemical Formulation Brand Pack size Proposed price and subsidy
Lidocaine [lignocaine] hydrochloride Gel 2%, 11 ml urethral syringe Instillagel
Lido
10 $42.00

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4pm, 28 November 2019.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal. 

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request. 

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.