Decisions to fund treatments for people with kidney disease, osteoporosis, cancers, hyperparathyroidism, and injuries from burns

Medicines Decision

What we’re doing

We're pleased to announce a decision to: 

Who we think will be most interested

  • People with autosomal dominant polycystic kidney disease, their whānau and carers
  • People with osteoporosis, Paget’s disease, hypercalcaemia, breast cancer and bone metastases requiring treatment with zoledronic acid and their whānau and carers
  • People with hyperparathyroidism and their whānau and carers
  • People with serious burns and their whānau/carers
  • Healthcare professionals
  • Pharmaceutical suppliers
  • Pharmacies and wholesalers 

Tolvaptan for kidney disease

What does this mean for people?

The decision will mean that people with autosomal dominant polycystic kidney disease (ADPKD) who meet the eligibility criteria described below will have funded access to tolvaptan (Jinarc) from 1 December 2022. 

ADPKD is a genetic condition characterised by an increase in the number of fluid-filled cysts in the kidneys. ADKPD causes kidney function to decline over time and may result in a need for treatment with either renal dialysis or a kidney transplant. It is expected that treatment with tolvaptan will slow kidney cyst growth and kidney function decline; treatment may also reduce kidney pain, delay the progression to end stage renal disease, delay the need for dialysis and transplantation and reduce the risk of early death. 

We estimate that approximately 370-400 people will be eligible for treatment with tolvaptan each year.

We are aware that there are often delays in receiving dialysis treatment for Māori with kidney disease, and that Māori with ADPKD are likely to have poorer outcomes than non-Māori with ADPKD. We consider that funding a treatment that delays progression of kidney disease and time to dialysis will therefore be of benefit to Māori and their whānau.

We estimate that approximately 7% of people with ADPKD eligible for treatment with tolvaptan will be Māori. We do not have any data on the proportion of Pacific people who will be eligible. 

Any changes to the original proposal?

This decision was subject to a consultation letter dated 31 August 2022. 

We’re really grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal, with some requests for changes to the proposed funding criteria, and wider access. 

More feedback and our responses about funding tolvaptan for kidney disease

After considering all the feedback received, we have amended the Special Authority criteria approvals period to be 12-monthly and removed the requirement “that the patient is benefitting from treatment”.

Detail about this decision

Tolvaptan (Jinarc) will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 December 2022 at the following price and subsidy (ex-manufacturer, excluding GST): 

Chemical Formulation Brand Pack size Price and subsidy
Tolvaptan Tab 15 mg Jinarc 28 OP $873.50
Tolvaptan Tab 30 mg Jinarc 28 OP $873.50
Tolvaptan Tab 45 mg + 15 mg Jinarc 56 OP $1747.00
Tolvaptan Tab 60 mg + 30 mg Jinarc 56 OP $1747.00
Tolvaptan Tab 90 mg + 30 mg Jinarc 56 OP $1747.00

A confidential rebate will apply to Jinarc that will reduce the net price to Pharmac. Jinarc will have subsidy and delisting protection until 31 December 2025. 

Jinarc will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule subject to the following eligibility criteria:

Special Authority for Subsidy/Hospital Indication Restriction

Initial application – (autosomal dominant polycystic kidney disease) only from a renal physician or relevant practitioner on the recommendation of a renal physician. Approvals valid for 12 months for applications meeting the following criteria: 

All of the following: 

  1. Patient has a confirmed diagnosis of autosomal dominant polycystic kidney disease; and
  2. Patient has an estimated glomerular filtration rate (eGFR) of greater than or equal to 25 mL/min/1.73 m2 at treatment initiation; and
  3. Either:
    1. Patient’s disease is rapidly progressing, with a decline in eGFR of greater than or equal to 5 mL/min/1.73 m2 within one-year; or
    2. Patient’s disease is rapidly progressing, with an average decline in eGFR of greater than or equal to 2.5 mL/min/1.73 m2 per year over a five-year period.

Renewal application – (autosomal dominant polycystic kidney disease) only from a renal physician or relevant practitioner on the recommendation of a renal physician. Approvals valid for 12 months for applications meeting the following criteria: 

Both: 

  1. Patient has not developed end-stage renal disease, defined as an eGFR of less than 15 mL/min/1.73 m2; and
  2. Patient has not undergone a kidney transplant

Zoledronic acid – removing funding restrictions

What does this mean for people?

This decision means that all funding restrictions will be removed from all presentations of zoledronic acid from 1 March 2023. Zoledronic acid will be funded for any relevant use. 

We anticipate that 6,000 additional people will be able to access zoledronic acid over the next 5 years, in particular people with osteoporosis who did not meet the previous eligibility criteria, or people with early breast cancer who could benefit from additional years of treatment. 

Osteoporosis affects Māori and Pacific people at a lower rate than other ethnicities. We estimate that 1% of people who access zoledronic acid will be Māori and 1% will be Pacific. We anticipate that this change will have a significant impact on people who live rurally or who would otherwise have had difficulty accessing the scanning that was required under previous funding restrictions. 

We understand that limited infusion service capacity and the general practice infusion co-payments may be barriers for some people. We are working closely with our health system partners, including Te Whatu Ora – Health New Zealand, to minimise barriers to access. 

Any changes to the original proposal?

This decision was subject to a consultation letter dated 31 August 2022. No changes were made to the original proposal following consultation. 

We’re really grateful for the time people took to respond to this consultation. Many responses were supportive of the proposal; however, respondents did raise concerns about infusion service capacity and the increased demand this proposal would create. We can confirm that funding restrictions will be removed from 1 March 2023 to give the health system time to prepare for more infusions, while ensuring that people who could benefit from zoledronic acid with the removal of restrictions do not have to wait longer.   

More feedback and our responses about removing restrictions on zoledronic acid

Detail about this decision

All presentations of zoledronic acid will continue to be listed on the Pharmaceutical Schedule as they currently are, however, all funding restrictions will be removed from 1 March 2023. 

Cinacalcet for hyperparathyroidism

What does this mean for people?

The decision will mean that people with hyperparathyroidism who meet the eligibility criteria described below will have funded access to cinacalcet (brand name Cinacalcet Devatis) from 1 December 2022.

It is expected that treatment with cinacalcet will reduce serum calcium levels and the risk of cardiovascular events. It may also reduce death from any cause.

We estimate that approximately 725 people will be eligible for treatment in the first year of funding, and this will increase to approximately 945 people per year after five years.

We consider that funding a treatment that may reduce the risk of cardiovascular events and death will be of benefit to Māori, Pacific peoples and their whānau, noting the following points:

  • We understand, from the advice we have received, that Māori are less likely to receive curative treatments for hyperparathyroidism such as parathyroidectomy and kidney transplant, due to higher rates of comorbidities.
  • We also understand that the incidence and prevalence rates of end-stage chronic kidney disease (the underlying cause of most cases of secondary and tertiary hyperparathyroidism) are higher for Pacific peoples than for any other ethnic group.
  • Of the people eligible for treatment we estimate that:
    • approximately 18% of those with primary hyperparathyroidism are Māori and 12% are Pacific people
    • approximately 33% of those with secondary hyperparathyroidism are Māori and 29% are Pacific people
    • approximately 22% of those with tertiary hyperparathyroidism are Māori and 17% are Pacific people. 

Any changes to the original proposal?

This decision was subject to a consultation letter dated 31 August 2022. 

We’re really grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal, with some requests for wider access and funding of additional treatments. 

More feedback and our responses about funding cinacalcet for hyperparathyroidism

No changes have been made to the original proposal 

Detail about this decision

Access to cinacalcet will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 December 2022 as follows (new criteria shown only):

Primary hyperparathyroidism 

Special Authority for Subsidy/Hospital Indication Restriction

Initial application – (primary hyperparathyroidism) from any relevant practitioner. Applications valid without further renewal for applications meeting the following criteria: 

  1. All of the following: 
  2. Patient has primary hyperparathyroidism; and
  3. Either:
    1. Patient has hypercalcaemia of more than 3 mmol/L with or without symptoms; or
    2. Patient has hypercalcaemia of more than 2.85 mmol/L with symptoms; and
  4. Surgery is not feasible or has failed; and
  5. Patient has other comorbidities, severe bone pain, or calciphylaxis.

Secondary or tertiary hyperparathyroidism

Special Authority for Subsidy/Hospital Indication Restriction

Initial application – (secondary or tertiary hyperparathyroidism) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria: 

All of the following: 

  1. Either:
    1. Patient has tertiary hyperparathyroidism and markedly elevated parathyroid hormone (PTH) with hypercalcaemia; or
    2. Patient has symptomatic secondary hyperparathyroidism and elevated PTH; and
  2. Patient is on renal replacement therapy; and
  3. Any of the following:
    1. Residual parathyroid tissue has not been localised despite repeat unsuccessful parathyroid explorations; or
    2. Parathyroid tissue is surgically inaccessible; or
    3. Parathyroid surgery is not feasible. 

Renewal application – (secondary or tertiary hyperparathyroidism) from any relevant specialist. Approvals valid for 12 months for applications meeting the following criteria: 

Either: 

  1. The patient has had a kidney transplant, and following a treatment free interval of at least 12 weeks a clinically acceptable parathyroid hormone (PTH) level to support ongoing cessation of treatment has not been reached; or
  2. The patient has not recieved a kidney transplant and trial of withdrawal of cinacalcet is clinically inappropriate.

Selenium and copper chloride supplementation for people in hospital with major burns

What does this mean for people?

The decision will mean that hospitals can purchase any brand of selenium oral drops and injection; and copper chloride injection and these supplements will be funded for people in hospital with major burns.

It is expected that supplementation with selenium and copper will result in improved wound healing, a decrease in infectious episodes, and is likely to be associated with a reduced risk of infection-related death.

We understand that there are higher reported rates of hospital admission for treatment of burns for Māori, Pacific and socioeconomically deprived populations (Mistry et al. Burns. 2010;36:403-8(external link)). We consider that funding a treatment that may reduce infections and infection-related death will therefore be of benefit to these population groups with burns and their whānau.

We estimate that approximately 195 people will receive supplementation with selenium and copper chloride injection each year.

We understand that these agents have already been used by some burns centres across New Zealand via the hospital assessment Named Patient Pharmaceutical Application (NPPA)-rapid process. Funding selenium oral drops and injection; and, copper chloride injection will mean hospitals no longer need to go through this process, for patients who meet the eligibility criteria. 

Any changes to the original proposal?

This decision was subject to a consultation letter dated 31 August 2022. 

We’re really grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal and included a request for an additional presentation of selenium. 

More feedback and our responses about funding selenium and copper chloride supplementation

After considering all the feedback received, we have made a decision that selenium injection (300 mcg per ml, 1 ml ampoule) will also be funded from 1 December 2022 for those that meet the eligibility criteria described below. 

Detail about this decision

Selenium oral drops and injection; and copper chloride injection will be listed in Part II of Section H of the Pharmaceutical Schedule from 1 December 2022, with an example brand for selenium oral drops and no brand for selenium injection or copper chloride, meaning that hospitals could purchase any brand of these formulations. 

Chemical Formulation Brand
Selenium Oral liq 150 mcg per 3 drops eg Clinicians selenium oral drops
Selenium Inj 300 mcg per ml, 1 ml ampoule -
Copper chloride Inj 0.4mg per ml, 10 ml vial -

Selenium oral drops and injection; and copper chloride injection will be listed subject to the following restrictions in Part II of Section H of the Pharmaceutical Schedule:

Initiation – Moderate to severe burns

Limited to 3 months treatment.
Both:

  1. Patient has been hospitalised with moderate to severe burns; and
  2. Treatment is recommended by a National Burns Unit specialist.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Responses were largely supportive of the proposals. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you are summarised below. 

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. 

Theme

Comment

Tolvaptan for kidney disease

Requests for the Special Authority approval periods to be 12-monthly.

We have amended the Special Authority criteria in line with this feedback

Requests to remove the Special Authority renewal criteria “that the patient is benefitting from treatment”

We have amended the Special Authority criteria in line with this feedback

Request for wider funding access for treatment of syndrome of inappropriate antidiuretic hormone (SIADH) post neurosurgery or rarely for treatment of chronic SIADH

We have not assessed tolvaptan for the treatment of SIADH.

We would be happy to receive and assess a funding application for use of tolvaptan for SIADH. Details on how to submit a funding application are on the Pharmac website.

Alternatively, if appropriate, the Named Patient Pharmaceutical Assessment (NPPA) process is available for individual patients with exceptional clinical circumstances. NPPA is Pharmac’s process for considering funding for medicines for individual patients in exceptional circumstances where the treatment is not listed on the Pharmaceutical Schedule of is not funded for their particular clinical circumstance. More information regarding NPPA and the information we require to consider an application can be found on our website

Request for wider access to enable treatment of disease at earlier stage than proposed, via incorporation of the Mayo Imaging Classification(external link) into the Special Authority criteria.

Evidence to support use in this patient group would need to be reviewed in full. We would welcome a funding application for consideration of use of tolvaptan in earlier stages of disease. Information on how to submit a funding application is on the Pharmac website

Would like the dispensing ‘wastage’ rule to be applied, as some patients receive prescriptions for 30 day supply of medicines and tolvaptan is supplied in 28 day pack sizes

We anticipate the most common presentations of tolvaptan prescribed will be the combination packs. Due to the nature of these packs, containing more than once strength of tablet presented in a calendar type fashion, it would be difficult to split packs.

Pharmac staff consider that many patients have different mixes of 10, 28, 30, or 90 day prescriptions and that it is up to the pharmacist, the patient and their prescriber to work out how to make this work best for the individual.

Zoledronic acid – removing funding restrictions

Infusion services do not have funding and resource capacity to administer more zoledronic acid infusions.

We understand this decision will increase demand for infusions. We have engaged with Te Whatu Ora around this, particularly in relation to infusion capacity in community settings. We appreciate that limitations will take time to address, but we consider, based on the feedback from the Te Whatu Ora Early Actions Programme, that this should not delay funding of the medicine.

We are implementing this change from 1 March 2023 to give infusion services time to plan and prepare. Consultation feedback was supportive of this date, given the benefit zoledronic acid provides to people’s health and the health system.

The proposal would worsen inequities due to the cost barriers of infusions given in general practice and the lack of capacity in publicly funded services.

We are aware that access can be limited for people who cannot access hospital infusions or afford the patient co-payment for infusions in general practice settings. This feedback is important to us under our Factors for Consideration, and we have carefully balanced this against other factors before making a funding decision.

Removal of requirements for DEXA (bone density) scans may, however, increase access to those who live rurally or otherwise have less access to scanning.

We will continue partnering with our health system partners to address these inequities.

Concern that zoledronic acid would be inappropriately used.

We note that funding restrictions (Special Authority criteria) in the Pharmaceutical Schedule are tools to ensure funding is targeted to those with the greatest health need and/or those most likely to benefit from treatment and should not be a replacement for clinical decision-making and evidence-based guidelines. These changes only reflect the decision that there are no longer targeted funding restrictions for access.

Cinacalcet for hyperparathyroidism

Request for wider access for patient groups for whom surgery is feasible

The criteria are based on the clinical advice we have received, that those unable to have surgery are the group most likely to benefit with the highest health need.

More information, including links to the Advisory Committee records, can be found in the Application Tracker record for cinacalcet for primary(external link), secondary(external link) and tertiary hyperparathyroidism(external link).

We intend to seek further advice from the Nephrology Advisory Committee at its next meeting on the benefit of cinacalcet for those waiting for surgery and at risk of complications.

Request to widen access further to for patients who have undergone renal transplantation, as a bridge to parathyroidectomy.

We intend to seek further advice from the Nephrology Advisory Committee at its next meeting on the benefit of cinacalcet for those waiting for surgery and at risk of complications.

Request to fund other additional treatments: lanthanum or sevelamer

 

At its February 2022 meeting, the Pharmacology and Therapeutics Advisory Committee (PTAC) recommended(external link) the funding application for lanthanum be declined. The primary reason for this was the high-quality evidence that showed no benefit of lanthanum carbonate over currently funded calcium carbonate.

However, PTAC has requested further advice from the Nephrology Advisory Committee about this, and we intend to seek this at the next Nephrology Advisory Committee meeting.

We have also assessed funding applications for sevelamer carbonate and sevelamer hydrochloride. PTAC has recommended that both be funded with a low priority but that we seek further advice from the Nephrology Advisory Committee about the target population. We intend to seek this at the next Nephrology Advisory Committee meeting.

More details including links to the full records can be found in the application tracker record for lanthanum(external link), sevelamer carbonate(external link) and sevelamer hydrochloride.(external link)

Selenium and copper chloride supplementation for people in hospital with major burns

Request to also fund selenium injection for those with critical illness as these patients have incomplete absorption of medicines administered enterally

We have amended the proposal to also include funding for selenium injection