Proposal to fund sodium picosulfate oral liquid (Dulcolax SP drops)

Medicines

Consultation Closed

We are seeking feedback on a proposal to fund sodium picosulfate oral liquid (Dulcolax SP drops) for use in paediatric patients with constipation.

What we’re proposing

We are seeking feedback on a proposal to fund sodium picosulfate oral liquid (Dulcolax SP drops) for use in paediatric patients with constipation, from 1 July 2021 through a provisional agreement with Sanofi-Aventis New Zealand Ltd. (Sanofi).

Further details on this proposal, including how to provide feedback, can be found below.

Consultation closes at 5 pm on Tuesday 23 February 2021 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

This proposal would mean that from 1 July 2021, Dulcolax SP Drops would be fully funded for paediatric patients with problematic and refractory constipation subject to certain eligibility criteria.  

We estimate that approximately 3,000 people could benefit in the first year of Dulcolax SP Drops being funded, increasing to approximately 7,000 people per year over time.

Who we think will be interested

  • Paediatric patients and their whānau
  • Paediatricians, general practitioners, gastroenterologists, nurses, pharmacists and other clinicians and health professionals involved in the management of paediatric constipation
  • Hospital and community pharmacies, DHB’s, pharmaceutical suppliers and wholesalers

About sodium picosulfate and paediatric constipation

Constipation has a range of definitions occurring with variable severity, and typically involves infrequent, difficult, painful or incomplete evacuation of hard stools. There are many causes for constipation and it is a common occurrence amongst children. For many people, constipation can be managed by dietary measures or through the use of one of the currently funded laxative(external link) agents. However, for some children these treatments aren’t suitable. When this is the case, rectal preparations or hospitalisation for manual evacuation may be required.

Sodium picosulfate is a non-flavoured, low volume stimulant laxative used for the treatment of constipation. It works by stimulating bowel movement and promoting accumulation of water in the bowel to enable production and passing of stools.

Dulcolax SP Drops(external link) is an oral liquid with 1 ml (15 drops) containing 7.5 mg of sodium picosulfate.

Why we’re proposing this

A funding application(external link) for sodium picosulfate oral liquid was reviewed by the Gastrointestinal Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) in May 2014(external link) and was recommended for funding with a high priority subject to Special Authority criteria.

It was noted that the target population that would receive the greatest benefit would be children with chronic constipation; however, people unable to tolerate large volumes of laxatives may also benefit.   

This recommendation was accepted by PTAC in November 2014.(external link)

PHARMAC has reached a provisional agreement with the supplier, Sanofi, to fund Dulcolax SP Drops (sodium picosulfate oral liquid).

Details about our proposal

Dulcolax SP Drops would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2021 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical

Formulation

Brand

Pack size

Proposed price and subsidy

Sodium picosulfate

Oral liquid 7.5 mg per ml

Dulcolax SP Drops

30 ml OP

$7.40

The following eligibility criteria would apply in Section B of the Pharmaceutical Schedule as follows: 

Special Authority for Subsidy

Initial application only from a paediatrician, or Practitioner on the recommendation of a paediatrician.

Approvals valid for 6 months for applications meeting the following criteria:

Both:

  1. The patient is paediatric with problematic constipation despite an adequate trial of other oral pharmacotherapies including macrogol where macrogol is not contraindicated; and
  2. The patient would otherwise require a per rectal preparation.

Renewal from a paediatrician or Practitioner on the recommendation of a paediatrician.

Approvals valid for 12 months where patient is compliant and is continuing to gain benefit from treatment.

Similar restrictions will apply to Part II of Section H of the Pharmaceutical Schedule.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5 pm Tuesday 23 February 2021.

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.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.