Decision to fund sodium picosulfate liquid (Dulcolax SP drops)
We're pleased to announce a decision to fund sodium picosulfate oral liquid for the treatment of paediatric constipation.
What we’re doing
We're pleased to announce a decision to fund sodium picosulfate oral liquid for the treatment of paediatric constipation.
From 1 July 2021, Sanofi-Aventis Limited’s brand of sodium picosulfate oral liquid (Dulcolax SP Drops) will be fully funded, subject to certain eligibility criteria.
We estimate that approximately 3,000 children will benefit from this decision in the first year, increasing to approximately 7,000 people per year over time.
What does this mean for people?
Sodium picosulfate (Dulocolax SP Drops)(external link) is a Medsafe approved 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.
The decision means that children with problematic and refractory constipation, for which currently funded laxative agents aren’t suitable,(external link) or have already been tried without good effect, will have funded access to sodium picosulfate subject to certain eligibility criteria.
Any changes to the original proposal?
We received feedback from 23 different individuals, professional societies, and advocacy groups. We would like to thank everybody who took the time to provide us with their feedback.
After carefully considering the consultation feedback we have made some changes to the proposed Special Authority criteria. These changes were made to clarify the patient population intended for funding and to remove any unnecessary barriers to access.
The changes from the original criteria are shown below (additions in bold, deletions in strikethrough).
Special Authority for Subsidy
Initial application only from a paediatrician, or Practitioner on the recommendation of a paediatrician from any relevant practitioner.
Approvals valid for 6 months for applications meeting the following criteria:
Both:
- The patient is paediatric a child with problematic constipation despite an adequate trial of other oral pharmacotherapies including macrogol, where macrogol is not contraindicated where practicable; and
- The patient would otherwise require a per rectal preparation high-volume bowel cleansing preparation or hospital admission.
Renewal from a paediatrician or Practitioner on the recommendation of a paediatrician any relevant practitioner.
Approvals valid for 12 months where patient is compliant where the treatment remains appropriate and the patient is benefitting from treatment.
Who we think will be most interested
- Whānau and caregivers
- General practitioners, paediatricians, gastroenterologists, nurses, pharmacists and other health professionals involved in the management of constipation in children
- Hospital and community pharmacies, DHBs, pharmaceutical suppliers and wholesalers
Detail about this decision
Dulcolax SP Drops will 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 soln 7.5 mg per ml |
Dulcolax SP Drops |
30 ml OP |
$7.40 |
The following eligibility criteria will apply in Section B of the Pharmaceutical Schedule as follows:
Special Authority for Subsidy
Initial application from any relevant practitioner.
Approvals valid for 6 months for applications meeting the following criteria:
Both:
- The patient is a child with problematic constipation despite an adequate trial of other oral pharmacotherapies including macrogol where practicable; and
- The patient would otherwise require a high-volume bowel cleansing preparation or hospital admission.
Renewal from any relevant practitioner.
Approvals valid for 12 months where the treatment remains appropriate and the patient is benefiting from treatment.
Similar restrictions will apply to Part II of Section H of the Pharmaceutical Schedule.
Our response to what you told us
We’re really grateful for the time people took to respond to this consultation. The feedback we received was numerous, thoughtful, and overwhelmingly supportive. A summary of the main themes raised in feedback, our responses to the feedback received, are set out in the table below.
|
Theme |
PHARMAC Response |
|---|---|
|
Strongly supportive of the proposal to fund sodium picosulfate for the treatment and management of constipation in children. |
We are encouraged that the funding of sodium picosulfate is supported by the community. |
|
Request that applications for funding be extended beyond paediatricians to include all relevant practitioners, to avoid placing an unnecessary burden on specialist services and creating inequitable barriers to access. |
Following consideration of the feedback received, we have amended the eligibility criteria (as detailed above) so that access can be made available for patients by any relevant practitioner. |
|
Concerns regarding the requirement that children complete an adequate trial of other pharmacotherapies (unless otherwise contraindicated) on the basis that these are often not suitable for children due to palatability issues. |
Following consideration of the feedback we have reviewed the language around this requirement. We have subsequently amended the language to ensure that patients who cannot tolerate other medicines due to palatability can too access treatment. |
|
Concerns around the criteria specifying the need for rectal therapies, noting that it is not generally appropriate or required outside of the dis-impaction phase. |
Following specialist clinical feedback, we have amended the criteria to enable use, consistent with good clinical practice while limiting funding to patients who will benefit the most from access. |
|
One responder was strongly supportive of the proposal to fund sodium picosulfate but suggested that the eligibility criteria be extended to all adults who could not tolerate high volume laxatives due to palatability issues. |
While we have considered widening access to include adults who cannot tolerate high volume laxatives, we consider this to be a distinct patient population that would require further consideration given the existence of available alternatives for this patient group. |
|
A few responders questioned the need for eligibility criteria more broadly, citing the relatively inexpensive nature of the drug. |
While we acknowledge that an open listing of sodium picosulfate could benefit a number of patients, we consider that the current criteria enable access for those patients with the highest unmet health need, who stand to benefit most from treatment. |
If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.