Clostridium botulinum type A toxin (Botox) in DHB hospitals

Medicines

Consultation Closed

PHARMAC seeks feedback on a proposal to amend the contractual terms of listing for clostridium botulinum type A toxin (Botox(external link)) inj 100 u vial, following a provisional agreement with Allergan New Zealand Limited (Allergan).

Consultation closes at 4 pm on Wednesday, 21 December 2016 and can be emailed to Geraldine MacGibbon at consult@pharmac.govt.nz.

What we’re proposing

  • The net price for Botox inj 100 u vial would reduce from 1 April 2017 via a confidential rebate applied to all sales to DHB hospitals.
    • Botox and Dysport have different potencies, meaning doses are different and prices are not directly comparable unit for unit.
    • At a dose equivalency of 3:1 Botox would be the most cost effective treatment option for DHBs, compared to Dysport.1  2
  • Botox would have protection from purchase price reduction, delisting and application of indication restrictions until 31 March 2020.
  • There would be no changes to the listing of the other brand of clostridium botulinum type A toxin (Dysport) currently listed in the Hospital Medicines List for use in DHB hospitals.

1  Wohlfarth et al. (J Neurol. 2008;255:1932–9)

2  Gollomp (Pract. Neurol. 2011;9:27-33)

What would the effect be?

DHBs would spend less on Botox after receiving rebates. The rebate for Botox would be included in PHARMAC’s regular advice to each DHB regarding rebate payments.

There would be no change to the listed treatment options for patients receiving clostridium botulinum type A toxin if this proposal is approved.

Who we think will be interested in this proposal

This proposal will be of interest to hospital clinicians, for example, neurologists, paediatricians, urologists, hospital pharmacists and nurses working in relevant specialties, Operations managers and DHB pharmacy and finance staff.

About Clostridium botulinum type A toxin

Clostridium botulinum type A toxin is a potent natural toxin that blocks normal synaptic release of acetylcholine from the neuromuscular junction. This blockade causes non-permanent muscle relaxation, which is useful in treating disorders characterised by excessive muscle tone.

The therapeutic uses for clostridium botulinum type A toxin are broad and continue to grow. Common uses include movement disorders such as blepharospasm and limb dystonias.

Why we’re proposing this

The use of clostridium botulinum type A toxin in DHB hospitals has increased steadily in recent years. It is now one of the top four expenditure items in DHB hospitals at almost $4 million per year.

Steps we took

PHARMAC asked the Pharmacology and Therapeutics Advisory Committee (PTAC) for clinical advice on future funding options for clostridium botulinum type A toxin in DHB hospitals in November 2015. [PDF, 1.4 MB] PTAC advised us that the products available in New Zealand were similar in terms of efficacy and safety and considered that it would be clinically reasonable to fund just one brand.

In March 2016 PHARMAC issued a request for information (RFI) about the use of clostridium botulinum type A toxin in DHB hospitals, to help PHARMAC to determine the best approach for achieving savings for DHB hospitals in this market.

PHARMAC considered all responses and identified a number of potential options that could achieve savings for DHB hospitals in this market. These included a competitive process, direct contracting or restricting access on an indication-specific basis, noting that differences in the registered indications of the two listed brands presents some challenges. At this time we have determined that this proposal to directly contract with Allergan to reduce the net price of Botox to DHB hospitals would provide a good mix of savings and market certainty while maintaining unrestricted access to multiple brands of clostridium botulinum type A toxin.

Listed treatment options and effect of this proposal

PHARMAC lists the following presentations of clostridium botulinum type A toxin in Part II of Section H (the Hospital Medicines List; HML) of the Pharmaceutical Schedule, without restriction. There are currently no rebates associated with these listings. 

Chemical Presentation Brand Pack size Price per pack
(ex-man, ex-GST)
Clostridium botulinum
type A toxin
Inj 100 u vial Botox 1 $467.50
Inj 300 u vial Dysport 2 $388.50
Inj 500 u vial Dysport 2 $1,295.00

If the proposal goes ahead:

  • Botox inj 100 u vial would remain listed in Part II of Section H of the Pharmaceutical Schedule from 1 April 2017 at the same price (ex-manufacturer, excluding GST).
  • A confidential rebate would apply to Botox that would reduce its net price to DHB hospitals from 1 April 2017.
  • Botox would be protected from price reductions, delisting and the addition of specific indication restrictions until 31 March 2020.
  • Dysport would remain listed in Part II of Section H of Schedule at the same price (ex-manufacturer, excluding GST).

To provide your feedback to this proposal

Send us an email or write to us by 4 pm on Wednesday, 21 December 2016 to:

Geraldine MacGibbon
Senior Therapeutic Group Manager
PHARMAC 

Email: consult@pharmac.govt.nz  

Fax:     04 460 4995
Post:   PO Box 10 254, Wellington 6143

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, where 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.