Proposal to fund fosfomycin in the community for urinary tract infections and zonisamide for some types of epilepsy
What we’re proposing
We would like to hear your view on the potential funding of two medicines:
- fosfomycin in the community for the treatment of uncomplicated urinary tract infections (UTIs). Fosfomycin is already funded for use in Health New Zealand | Te Whatu Ora hospitals.
- zonisamide for the treatment of some forms of epilepsy, Developmental and Epileptic Encephalopathies (DEE) and focal epilepsy that has not responded to previous treatment.
These medicines would be funded with Special Authority criteria. These are detailed below fosfomycin criteria, zonisamide criteria.
We are proposing to fund these medicines through Pharmac’s Annual Tender process. As the Tender process is still in progress, the brand names, listing dates and pricing are still to be determined.
The Government provided additional funding to Pharmac in June 2024 to fund new medicines and widen access to medicines that are already funded. The funding boost covers medicines for both cancer and non-cancer health conditions. This proposal is one of many that we’re working on to put our budget increase into action.
Media release: Funding boost means more medicines for more New Zealanders
Feedback to this consultation will help us decide how we progress this proposal. Consultation closes at 4.00 pm, Thursday 1 August 2024 and feedback can be emailed to consult@pharmac.govt.nz.
What would the effect be?
Fosfomycin
The proposal would allow New Zealanders to access fosfomycin in the community:
- Access to fosfomycin would be widened to include people with uncomplicated urinary tract infections in the community. It is already funded for use in Health New Zealand hospitals.
We expect that approximately 2,600 additional people in New Zealand would use fosfomycin in the first year of funding. After 5 years, approximately 3,700 people would benefit.
There would be health sector savings from funding fosfomycin in the community, as it would reduce the need for people to be treated for UTIs in the hospital setting. The Anti-Infective Advisory Committee told us that around 80% of cases would be successfully treated in the community.
Anti-Infective Advisory Committee May 2019 meeting record [PDF, 386 KB]
Zonisamide
The proposal would provide another treatment option for people with some types of epilepsy:
- Developmental and epileptic encephalopathies (DEEs). DEEs are a group of severe childhood epilepsy syndromes that do not respond well to treatment and have a severe impact on a child’s development. These syndromes are life-long.
- Refractory focal epilepsies. Focal epilepsies are generally caused by a structural brain abnormality. Most adult-onset epilepsies are focal. Focal epilepsies are also common in childhood. The term ‘refractory focal epilepsy’ means focal epilepsies that have not responded to at least three epilepsy treatments.
We expect that approximately 300 people in New Zealand would use zonisamide in the first year of funding. After 5 years, approximately 1,200 people would benefit.
Who we think will be interested
- People who experience these conditions, their whānau, friends and caregivers.
- Healthcare professionals who are involved in the treatment of these conditions.
- Other organisations who deliver services and support for people with these conditions.
- Health NZ Ora | Te Whatu Ora hospitals.
- Pharmacies and wholesalers.
- Pharmaceutical suppliers.
Fosfomycin powder for urinary tract infections
About urinary tract infections
Urinary Tract Infections (UTIs) are a common type of bacterial infection that affects the bladder. UTIs can infect the bladder / lower urinary tract (called cystitis) and the kidneys / upper urinary tract (called pyelonephritis).
Risk factors for the development of UTIs include sexual intercourse, use of spermicides, and previous UTIs. People who are pregnant are also more likely to be diagnosed with UTIs and are more likely to develop pyelonephritis than people who are not pregnant.
Symptoms of a lower uncomplicated UTI can include dysuria, urinary frequency, urgency, haematuria, and suprapubic pain. Acute uncomplicated UTIs are generally mild and can be resolved rapidly with appropriate antibiotic treatment. If left untreated, complications can include recurrent infections, kidney damage, and sepsis.
About fosfomycin powder
Fosfomycin is a broad-spectrum antibiotic. It works against both gram-positive and gram-negative bacteria. Fosfomycin stops the creation of cell walls in bacteria. Fosfomycin also reduces bacteria sticking to the bladder wall. It is excreted through the kidneys and so reaches high concentrations in urine.
The recommended dosage for adults for uncomplicated UTIs is one 3 g sachet of fosfomycin. Fosfomycin is not recommended for children under the age of 12 years, people with renal (kidney) impairment or people undergoing dialysis.
Why we’re proposing this
The Anti-Infectives Subcommittee recommended widened access to fosfomycin at its May 2019 and September 2020 meetings.
Anti-Infective Advisory Committee May 2019 meeting record [PDF, 386 KB]
Anti-Infective Advisory Committee September 2020 meeting record [PDF, 132 KB]
Fosfomycin with current eligibility and widened eligibility criteria were included in the 2023/24 Invitation to Tender.
Details about our proposal
As part of the 2023/24 Annual Invitation to Tender, we sought bids from suppliers for a range of medicines including fosfomycin.
The pricing and timeframes for listing fosfomycin would be notified as part of a Tender decision. Any products listed through the Tender would have Principal Supply Status until 30 June 2027. There would be an alternative brand allowance of 5%. This means Pharmac could fund an alternative brand for up to 5% of people, if clinically necessary.
We would like to hear from people who have had a urinary tract infection, their whānau and the health sector about the proposed eligibility criteria for fosfomycin.
Initial application – from any relevant practitioner. Approvals valid for 1 month for applications meeting the following criteria:
Both:
- Patient has an acute, symptomatic, bacteriologically-proven uncomplicated urinary tract infection (UTI); and
- Either:
- The bacteria, based on the microbiology report, are resistant to all of trimethoprim, nitrofurantoin, amoxicillin, cefalexin, amoxicillin with clavulanic acid, and norfloxacin; or
- The patient has a contraindication or documented intolerance to all of trimethoprim, nitrofurantoin, amoxicillin, cefalexin, amoxicillin with clavulanic acid, and norfloxacin.
Renewal – from any relevant practitioner. Approvals valid for 1 month for applications meeting the following criteria:
Both:
- Patient has another acute, symptomatic, bacteriologically-proven uncomplicated urinary tract infection (UTI); and
- Either:
- The bacteria, based on the microbiology report, are resistant to all of trimethoprim, nitrofurantoin, amoxicillin, cefalexin, amoxicillin with clavulanic acid, and norfloxacin; or
- The patient has a contraindication or documented intolerance to all of trimethoprim, nitrofurantoin, amoxicillin, cefalexin, amoxicillin with clavulanic acid, and norfloxacin.
There would be no changes to the eligibility criteria for fosfomycin in Part II of Section H of the Pharmaceutical Schedule.
Zonisamide for epilepsy
About epilepsy
Epilepsy is a group of neurological disorders characterised by epileptic seizures. Seizures usually involve involuntary motor activity and may also involve altered levels of consciousness. Epilepsy can be categorised into a number of subtypes. There are two subtypes included in this proposal.
Developmental and epileptic encephalopathies
Developmental and epileptic encephalopathies (DEEs) are severe childhood epilepsy syndromes. They are associated with seizures that do not respond to treatment and have a greater negative impact on a child’s development than we would expect from the underlying condition. The term ‘DEE’ includes syndromes such as Lennox-Gastaut Syndrome, Dravet Syndrome, infantile Epileptic Spasms Syndrome, Early Infantile Epileptic Encephalopathy, Epilepsy with myoclonic-atonic seizures, and others.
DEE is a relatively new term. It was until recently referred to as ‘severe childhood epilepsy syndromes’, including in clinical advice to Pharmac (PTAC in 2020, the Neurological Advisory Committee in 2021). Some adults may previously have been diagnosed with ‘severe, multidrug resistant childhood epilepsy’. This would now be considered a DEE.
PTAC September 2020 meeting record [PDF, 355 KB]
Neurological Advisory Committee October 2021 meeting record [PDF, 270 KB]
Refractory focal epilepsy
Focal epilepsies are generally caused by a structural brain abnormality. Most adult-onset epilepsies are focal. Focal epilepsies are also common in childhood. The term ‘refractory focal epilepsy’ means focal epilepsies that have not responded to at least three epilepsy treatments. Focal epilepsy seizures are sometimes called partial seizures.
About zonisamide
Zonisamide is used as monotherapy (sole treatment) in the management of focal seizures in adults. It is also used as adjunctive (additional) therapy in the treatment of focal seizures in adults. Focal seizures may affect only part of the brain or widen to affect the whole brain. Zonisamide can be used to treat both types of seizures.
Zonisamide is supplied as a capsule. It is taken every day to prevent seizures.
Why we’re proposing this
At its September 2020 meeting, PTAC recommended funding zonisamide for DEEs and as an adjunctive (additional) therapy for refractory focal seizures with a high priority. PTAC also recommended funding zonisamide as monotherapy for refractory focal seizures with a low priority.
PTAC September 2020 meeting record [PDF, 355 KB]
A small number of individuals access funded zonisamide via our Named Patient Pharmaceutical Assessment (NPPA) pathway. This proposal would fund zonisamide for a wider group of people and reduce access barriers for people currently accessing treatment via NPPA.
Zonisamide was included in the 2023/24 Invitation to Tender. This process allows suppliers to bid for pricing and supply for a range of medicines.
Details about our proposal
As part of the 2023/24 Annual Invitation to Tender, we sought bids from suppliers for a range of medicines including zonisamide.
The pricing and timeframes for listing zonisamide would be notified as part of a Tender decision. Any products listed through the Tender would have Principal Supply Status until 30 June 2027. There would be an alternative brand allowance of 5%. This means Pharmac could fund an alternative brand for up to 5% of people, if clinically necessary.
We would like to hear from people with epilepsy, their whānau and the health sector about the proposed eligibility criteria for zonisamide. In particular, we would like to hear if the proposed eligibility criteria clearly describe the groups we are trying to target.
Zonisamide capsules would be listed in Section B of the Pharmaceutical Schedule with the following Special Authority Criteria:
Zonisamide
Initial application - (developmental and epileptic encephalopathy (DEE)) from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:
Both:
- Either:
- Individual has a developmental and epileptic encephalopathy (drug-resistant epilepsies defined as DEEs by the International League Against Epilepsy); or
- The individual has previously been diagnosed with ‘severe, multidrug resistant childhood epilepsy’; and
- Seizures are not adequately controlled by, or the individual has experienced intolerable side effects from, treatment with all of the following: lamotrigine, levetiracetam, sodium valproate, topiramate and clobazam, unless they are contraindicated.
Special Authority for Subsidy
Zonisamide
Initial application - (focal epilepsy) from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:
Both:
- The individual has focal epilepsy; and
- Seizures are not adequately controlled by, or the individual has experienced intolerable side effects from, treatment with at least three of the following: levetiracetam, lamotrigine, carbamazepine and sodium valproate unless they are contraindicated.
Zonisamide capsules would be listed in Part II of Section H of the Pharmaceutical Schedule with similar eligibility criteria.
To provide feedback
Send us an email: consult@pharmac.govt.nz by 4.00pm, Thursday 1 August 2024.
All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to deciding on this proposal.
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