Proposal to decline inactive applications
What we’re proposing
To provide clarity about which medicines we’re actively considering for funding, we’re proposing to decline 56 funding applications.
All of these applications are inactive which means Pharmac is not currently progressing them.
We understand that a proposal to decline an application may not be what people were hoping for and that is disappointing to hear a medicine is being proposed to be declined. We want your feedback to help us understand whether the funding applications in this consultation should be declined.
Consultation closes at 5 pm on Friday 29 November 2024 and feedback can be emailed to applicationfeedback@pharmac.govt.nz
Why we’re proposing this
Pharmac’s role is to secure the best health outcomes possible for New Zealanders through medicines and related products within the available funding. Because we work within a fixed budget, this requires us to make difficult choices about what can be funded. Medicines funded by Pharmac are listed on the Pharmaceutical Schedule(external link).
We are committed to making our decision-making process clearer and easier for people to understand. We want to ensure people can easily see what is happening with funding applications, including what stage applications are at, and why we make our decisions.
We know people want to see us reach decisions on funding applications so they have certainty about whether a medicine is, or is not, being considered, even if our decision is to decline funding.
Because of this, we’re considering declining a number of inactive applications. These applications may be inactive for a number of reasons, including:
- our expert clinical advisors have recommended that the funding application be declined
- other medicines for the same condition are now funded making the funding application no longer relevant
- our expert clinical advisors have recommended that the medicine would provide no additional benefits over other treatments we already fund, or it may be harmful
- no company is willing to supply the medicine in New Zealand
- we have been waiting for further information on the application from the applicant for at least one year.
Details about our proposal
We have identified 56 inactive funding applications that we are proposing to decline. We will not make a decision on these until we have considered all of the information made available to us.
At the bottom of this document we have noted all 56 applications and the reason we are proposing to decline them. They are grouped by therapeutic group.
- Alimentary tract and metabolism
- Cardiovascular
- Dermatologicals
- Genito-urinary system
- Hormone preparations - systemic excluding contraceptive hormones
- Infections - agents for systemic use
- Musculoskeletal
- Nervous system
- Oncology agents and immunosuppressants
- Respiratory system and allergies
- Sensory
- Special foods
- Vaccines
We are interested to hear from you whether this reason is appropriate or if we should reconsider declining the application. It is important to note that Pharmac has not yet made a decision about these funding applications. We want to consider all relevant information before any final decisions are made.
Declining the application would mean the medicine would not be funded for the use requested at this time. This would not prevent Pharmac from reconsidering funding for the medicines in the future if information became available that addresses the reason for the decline. For example, if new evidence, or other relevant information, became available which addresses the reasons for the decline decision.
We will consider all of the feedback we receive before we make any decisions on these funding applications. The final decisions would be made in line with Pharmac’s Factors for Consideration, and by the Pharmac Board or its delegate. We expect to make these decisions over the next few months.
If we decided to decline a funding application, we can still consider funding the medicine for individuals with exceptional circumstances through the wider Exceptional Circumstances Framework.
More information about how medicines are funded is available on the Pharmac website.
Share your feedback with us
If you have information to share about any of the applications in the table at the end of this proposal, or a reason we should not progress declining the application please let us know.
Send us an email with this information to applicationfeedback@pharmac.govt.nz by 5pm on Friday 29th November 2024.
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
When you give feedback on a consultation, your feedback becomes official information that Pharmac holds. Pharmac has legal responsibilities for how we manage this official information, under laws such as the Official Information Act and Privacy Act.
Pharmac may receive a request from people for official information, which could include your feedback. Legally, Pharmac must consider whether your feedback should be released.
We will consider your views when assessing whether the feedback has to be released.
If your feedback is proposed for release, then Pharmac will contact you, unless there is a legal reason that we can't.
Note that Pharmac collects and holds your information in line with our Privacy Statement. Tell us if there is anything about your feedback that you would prefer wasn’t released.
Glossary of words and terms
To help you understand the words and terms in the table at the bottom of this page, outlining the applications we are proposing to decline, we have explained what some of these mean below.
|
Term |
What does it mean? |
|---|---|
|
Application |
A funding application is a request to fund a specific medicine, or related product, for a specific condition or under specific clinical circumstances. It is usually received from a supplier, clinician, consumer or generated by Pharmac staff. |
|
Inactive application |
Following consideration of expert clinical advice, we are not working on progressing the medicines for funding for the use requested. |
|
The Factors for Consideration are the framework we use when making funding decisions. The Factors are not weighted or applied rigidly, and not every factor is relevant for every funding decision Pharmac makes. This is because the situation for one assessment may require quite different considerations compared with another. Funding decisions are made relative to other options. The context within which decisions are made is constantly changing. |
|
|
Medsafe |
Medsafe(external link) is the Government body responsible for the regulation of medicines and medical devices in New Zealand, ensuring they have acceptable quality, efficacy and safety. |
|
The Pharmacology and Therapeutics Advisory Committee (PTAC)
|
Pharmac’s statutory clinical advisory committee, the Pharmacology and Therapeutics Advisory Committee, PTAC, is made up of senior health practitioners from a range of specialities. It considers evidence for funding applications and takes into account all of the Factors for Consideration before making objective clinical recommendations to Pharmac. |
|
Specialist Advisory Committees (previously known as Subcommittees) |
Pharmac’s specialist advisory committees provide Pharmac with objective specialist knowledge and expertise within specific clinical areas, such as diabetes, cancer, and mental health. They meet as needed to discuss funding applications and issues within their clinical areas. The specialist advisory committees have a different, but complementary, role to that of PTAC. Their expertise and perspectives can differ from those of PTAC. |
|
Recommended for decline |
A recommendation to Pharmac from PTAC or a Specialist Advisory Committee to decline the funding application. A recommendation is not a decision by Pharmac. |
|
Cost neutral recommendation |
A recommendation to Pharmac from PTAC or a Specialist Advisory Committee to only fund a medicine if it costs the same or less than another comparable medicine or combination of medicines (ie one that is already funded which provides the same or similar health benefits). |
|
Proposing to decline |
A proposal from Pharmac to decline funding for a medicine. This is publicly consulted on before a final decision is made. |
|
Decline decision |
A decision by Pharmac (the Board or its delegate), using the Factors for Consideration, to decline funding for a medicine. Pharmac decides which medicines will be funded, comparing all the options, to ensure we are getting the best possible health outcomes for New Zealanders from a fixed budget set by the Minister of Health. |
Applications we’re proposing to decline
In the tables below you can find information on each of the applications that we are proposing to decline and the reasons why. For ease of navigation, the applications have been categorised by therapeutic area.
All of the applications are available to view on the Application Tracker(external link) on the Pharmac website.
Alimentary Tract and Metabolism
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Budesonide, oral viscous nebules - Eosinophilic oesophagitis unresponsive to fluticasone in children |
There is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe approval. |
Please also be aware that a separate funding application for budesonide orodispersible tablets - eosinophilic oesophagitis, 2nd line after fluticasone(external link) would remain active and would be unaffected should this application be declined. |
|
|
Budesonide, oral viscous nebules - Eosinophilic oesophagitis unresponsive to fluticasone in adults |
There is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe approval. |
Please also be aware that a separate funding application for budesonide orodispersible tablets - eosinophilic oesophagitis, 2nd line after fluticasone(external link) would remain active and would be unaffected should this application be declined. |
|
|
Continuous Glucose Monitoring System - Freestyle Libre Flash - Type 1 diabetes |
Since this application was received, we have funded several, clinically appropriate, alternative options. The Freestyle Libre 2, the Dexcom ONE+, the Dexcom G6, the Dexcom G7 and the Freestyle Libre 3 plus are the funded continuous glucose monitors until at least 30 September 2028. |
||
|
Continuous Glucose Monitoring System - Medtronic Guardian 3 and Guardian Connect continuous glucose monitoring system (Guardian) - Type 1 diabetes |
Since this application was received, we have funded several, clinically appropriate, alternative options. The Freestyle Libre 2, the Dexcom ONE+, the Dexcom G6, the Dexcom G7 and the Freestyle Libre 3 plus are the funded continuous glucose monitors until at least 30 September 2028. |
||
|
Insulin Pump (DANA-i) - Diabetes, DANA insulin pumps |
Since this application was received, we have funded two clinically appropriate alternative options. The Tandem t:slim X2 with Basal-IQ or Control-IQ (insulin pump, algorithm, and consumables) and the mylife YpsoPump with CamAPS FX (insulin pump, algorithm, and consumables) will be the only funded insulin pumps, algorithms and consumables until at least 30 September 2028. |
||
|
Insulin Pump infusion set (steel cannula) (DANA Easy Release I 29G) - Diabetes, DANA insulin pumps |
Since this application was received, we have funded two clinically appropriate alternative options. The Tandem t:slim X2 with Basal-IQ or Control-IQ (insulin pump, algorithm, and consumables) and the mylife YpsoPump with CamAPS FX (insulin pump, algorithm, and consumables) will be the only funded insulin pumps, algorithms and consumables until at least 30 September 2028. |
||
|
Insulin Pump infusion set (teflon cannula) (DANA Inset ii) - Diabetes, DANA insulin pumps |
Since this application was received, we have funded two clinically appropriate alternative options. The Tandem t:slim X2 with Basal-IQ or Control-IQ (insulin pump, algorithm, and consumables) and the mylife YpsoPump with CamAPS FX (insulin pump, algorithm, and consumables) will be the only funded insulin pumps, algorithms and consumables until at least 30 September 2028. |
||
|
Insulin Pump reservoir (DANA 3cc Syringe) - Diabetes, DANA insulin pumps |
Since this application was received, we have funded two clinically appropriate alternative options. The Tandem t:slim X2 with Basal-IQ or Control-IQ (insulin pump, algorithm, and consumables) and the mylife YpsoPump with CamAPS FX (insulin pump, algorithm, and consumables) will be the only funded insulin pumps, algorithms and consumables until at least 30 September 2028. |
||
|
Insujet - Insulin administration |
We have been waiting for further information from the supplier on this application since 2015. |
Application Tracker information for Insujet - Insulin administration.(external link) This application was discussed by the Diabetes Subcommittee on PTAC at its meeting in April 2015 [PDF, 94 KB]. The Subcommittee deferred making a recommendation on the application as members required further evidence comparing Insujet to psychotherapy for managing people with needle phobia, to make a recommendation. |
|
|
Octreotide LAR - polycystic liver disease, symptomatic relief |
PTAC recommended that this application be declined at its meeting in May 2023 [PDF, 1.2 MB]. |
Cardiovascular
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Alirocumab - Heterozygous familial hypercholesterolaemia (HeFH), prevention of CV events |
This medicine has been discontinued by the supplier. |
||
|
Alirocumab - hypercholesterolaemia in people with diabetes and acute coronary syndrome (ACS) |
This medicine has been discontinued by the supplier. |
Dermatologicals
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Cavilon barrier cream - Skin integrity |
We are not aware of any supplier who is interested in contracting to supply this medicine to the community in New Zealand. |
Application Tracker information for Cavilon barrier cream - Skin integrity.(external link) Since we received this application, Cavilon barrier cream has been listed on Part III of Section H of the Pharmaceutical Schedule and is funded for use in Health NZ | Te Whatu Ora hospitals without restriction. This funding would remain unaffected should this application be declined. |
|
|
Dimethyl ether and propane - Warts |
The Dermatology Subcommittee of PTAC recommended that the application be declined at its meeting in December 2013(external link). |
Application Tracker information for Dimethyl ether and propane - Warts(external link) |
|
|
Ixekizumab - Inflammatory conditions |
There is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe approval. |
Application Tracker information for Ixekizumab - Inflammatory conditions(external link) |
|
|
Secura Extra Protective Cream - Pressure injury prevention, incontinence |
The Dermatology Subcommittee of PTAC recommended that the application be declined at its meeting in December 2013(external link). |
||
|
Udderly Smooth - Palmar-plantar erythrodysesthesia |
The Dermatology Subcommittee of PTAC recommended that the application be declined at its meeting in December 2013(external link). |
Genito-Urinary System
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Clindamycin vaginal cream - Bacterial vaginosis and desquamative inflammatory vaginitis |
There is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe approval. |
We are aware that an unfunded extemporaneously compounded clindamycin 2% vaginal cream may be being used within New Zealand. We would welcome further information on this compounded product. |
|
|
Mirabegron - Open listing |
There is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe approval. |
Application Tracker information for Mirabegron - Open listing.(external link) |
|
|
Mirabegron - Overactive bladder, 2nd line |
We understand there is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe approval. |
Application Tracker information for Mirabegron - Overactive bladder, 2nd line.(external link) |
|
|
Rituximab - For use in the treatment of people with Class IV(a) lupus nephritis as part of the induction phase of therapy (expanded SA indication) |
The Nephrology Advisory Committee recommended that this application be declined at its meeting in March 2023 [PDF, 205 KB]. |
||
|
Sevelamer hydrochloride - Hyperphosphataemia in people with chronic kidney disease on dialysis |
The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined at its meetings in February 2013 [PDF, 191 KB] and November 2013 [PDF, 206 KB]. The Nephrology Subcommittee of PTAC recommended that this application be declined at its meeting in December 2014 [PDF, 86 KB]. |
Hormone Preparations - Systemic Excluding Contraceptive Hormones
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Cyproterone Acetate 10mg tablets - Testosterone Suppression |
There is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe approval. |
Note cyproterone acetate 50 mg and 100 mg tablets are currently funded without restriction. This funding would remain unaffected should this application be declined. |
Infections - Agents for Systemic Use
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Fosfomycin - Extended spectrum beta lactamase infections |
Pharmac |
This application has been superseded. Since this application was received, an alternative application for the same medicine, fosfomycin for urinary tract infection, has been funded. |
|
|
Fosfomycin IV - Salvage therapy for infections caused by carbapenem resistant Enterobacteriaceae (CREs) in adults |
At its meeting in May 2019, the Anti-infective Subcommittee of PTAC [PDF, 386 KB] recommended that fosfomycin for salvage therapy for infections caused by CRE be deferred, due to insufficient evidence. We have not received this further information. Should further clinical trial data supporting the use of fosfomycin in this indication become available in future we would be happy to reconsider it. |
||
|
Posaconazole - Prophylaxis of fungal infection in patients with acute lymphoblastic leukaemia |
This application has been superseded. Since this application was received, an alternative application for the same medicine, posaconazole for prophylaxis of invasive fungal infections in people with high risk malignancies lung and liver transplant recipients(external link), has been funded which allows people with this condition to access to this medicine. |
||
|
Posaconazole - Prophylaxis of fungal infection in patients with aplastic anaemia |
This application has been superseded. Since this application was received, an alternative application for the same medicine, posaconazole for prophylaxis of invasive fungal infections in people with high risk malignancies, lung and liver transplant recipients(external link), has been funded, which allows people with this condition to access this medicine. |
||
|
Vancomycin - infected arthroplasty |
This application is for a 5g vial of vancomycin for addition to bone cement. There is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe approval. |
Application Tracker information for Vancomycin - infected arthroplasty(external link) |
Musculoskeletal
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Baclofen oral liquid - Muscle relaxant |
Since this application was received a clinically suitable alternative treatment has become available. |
Application Tracker information for Baclofen oral liquid - Muscle relaxant(external link) Baclofen oral liquid is funded when extemporaneously compounded in accordance with the New Zealand Standardised Oral Formulation Batch Sheet [PDF](external link). |
|
|
Clodronate - Osteoradionecrosis |
This application was previously proposed for decline in 2019. In response to consultation to decline the proposal Pharmac received further clinical evidence that had not previously been considered. As a result of this Pharmac decided not to decline the application at that stage and to seek further clinical advice. PTAC reviewed correspondence from the supplier and considered that no additional evidence had been supplied since their last review and therefore considered that the previous recommendation to decline remained appropriate November 2022 [PDF, 702 KB] |
Application Tracker information for Clodronate - Osteoradionecrosis(external link) |
|
|
Collagenase clostridium histolyticum - Dupuytren's contracture |
There is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe approval. We understand that collagenase clostridium histolyticum has been discontinued by Actelion Pharmaceuticals in New Zealand since June 2019(external link). |
Nervous System
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Aprepitant - Nausea and vomiting associated with moderately emetogenic chemotherapy |
In April 2023 [PDF, 1.1 MB]The Cancer Treatments Advisory Committee (CTAC) recommended the access criteria for aprepitant remain unchanged. This treatment is already funded for a wider indication. |
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|
Aprepitant - Nausea and vomiting, carboplatin-based chemotherapy, widen access |
This application has been superseded by changes in clinical guidance that mean that this group of people are already able to access aprepitant treatment according to the current Special Authority criteria [PDF](external link). |
||
|
Buprenorphine sublingual tablets - Acute pain |
There is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe approval. |
Application Tracker information for Buprenorphine sublingual tablets - Acute pain(external link) |
|
|
Morphine sulphate (5 mg / 5 mL pre-filled syringes) - Acute Pain |
In August 2022 [PDF, 361 KB] the Analgesic Advisory Committee considered there was no unmet need in acute pain that was not sufficiently met with the current funded products. |
||
|
Naltrexone hydrochloride - Removal of Special Authority |
In July 2013 The Mental Health Subcommittee recommended that this application be declined [PDF, 121 KB]. Following this recommendation, this application was proposed for decline in June 2021. In response we received consultation feedback that indicated we needed to consider the prescriber type for naltrexone. As a result Pharmac decided not to decline the application and to seek further clinical advice on the prescriber type for naltrexone. We are now progressing an alternative application for consideration, naltrexone hydrochloride - amend Special Authority criteria to include primary healthcare providers(external link). |
Oncology Agents and Immunosuppressants
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Atezolizumab – Advanced non-small cell lung cancer first-line (NSCLC 1L) combination therapy with platinum chemotherapy |
Since this application was received, we have funded a clinically appropriate alternative treatment for this condition. Pembrolizumab is the funded checkpoint inhibitor for the treatment of people with advanced NSCLC as first-line treatment until at least 31 March 2026. |
||
|
Atezolizumab – Non-small cell lung cancer, locally advanced or metastatic, high (>50%) PD-L1 expression, 1st line monotherapy |
Since this application was received, we have funded a clinically appropriate alternative treatment for this condition. Pembrolizumab is the funded checkpoint inhibitor for the treatment of people with advanced NSCLC as first-line treatment until at least 31 March 2026. |
||
|
Certolizumab pegol - Rheumatoid arthritis |
The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined (February 2012) [PDF, 169 KB] Additional advice was requested from PTAC in November 2022, which considered that the Rheumatology Advisory Committee should review the PTAC record. [PDF, 702 KB] The Rheumatology Advisory Committee was supportive of closing the application. |
Application Tracker information for Certolizumab pegol - Rheumatoid arthritis(external link) |
|
|
Eribulin - Locally advanced or metastatic breast cancer (following progression on chemotherapy) |
The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended this application be declined at its meetings in November 2022 [PDF, 702 KB] and May 2023 [PDF, 1.2 MB]. The Cancer Treatments Advisory Committee recommended that this application be declined at its meeting in July 2023 [PDF, 529 KB]. The reasons for the decline were the uncertainty of the health benefit based on clinical trial evidence and insufficient evidence to suggest benefit adding to existing treatments. |
||
|
Gemtuzumab ozogamicin - Acute myeloid leukaemia, favourable and intermediate-risk (AML-19 trial) |
This application has been superseded. Since this application was received, an alternative application for the same medicine(external link), gemtuzumab ozogamicin, has been funded, which allows people with this condition to access to this medicine. |
||
|
Ibrutinib - Waldenstroms Macroglobulinaemia, relapsed within 5 years of treatment, under 55 years |
The Cancer Treatments Advisory Committee considered this application at its meeting in November 2021 [PDF, 698 KB]. It considered that this group of patients should be assessed as part of a wider application for ibrutinib for Waldenstrom macroglobulinaemia, relapsed/refractory disease(external link) which is now progressing for consideration. |
Please note that the application for ibrutinib for Waldenstrom macroglobulinaemia, relapsed/refractory disease would be unaffected and remain progressing for consideration of funding should this application for ibrutinib for Waldenstrom macroglobulinaemia, relapsed within 5 years of treatment, aged under 55 years be progressed to a decline. |
|
|
Ibrutinib - Chronic lymphocytic leukaemia (CLL), previously untreated patients (17p deletion) and relapsed/refractory patients for whom ibrutinib is a more appropriate option (alternate) |
This application has been superseded. An alternative funding application for a bruton tyrosine kinase inhibitor (BTKi) - first-line for chronic lymphocytic leukaemia (CLL) without TP53 mutation(external link) is now being considered for funding. |
A separate funding application for a bruton tyrosine kinase inhibitor (BTKi) - first-line for chronic lymphocytic leukaemia (CLL) without TP53 mutation(external link) would remain active and would be unaffected should this application be declined. |
|
|
Nivolumab – Non-small cell lung cancer, locally advanced or metastatic, 2nd line |
Since this application was received, we have funded a clinically appropriate alternative treatment for this condition. Atezolizumab is the funded checkpoint inhibitor for the treatment of people with advanced NSCLC as second-line treatment until at least 31 March 2026. |
||
|
Nivolumab (with ipilimumab and platinum-based chemotherapy) – Advanced non-small cell lung cancer, 1st line combination therapy, irrespective of PDL-1 status |
Since this application was received, we have funded a clinically appropriate alternative treatment for this condition. Pembrolizumab is the funded checkpoint inhibitor for the treatment of people with advanced NSCLC as first-line treatment until at least 31 March 2026. |
||
|
Pembrolizumab – Non small cell lung cancer, locally advanced or metastatic, PD-L1 positive, 2nd line |
Since this application was received, we have funded a clinically appropriate alternative treatment for this condition. Atezolizumab is the funded checkpoint inhibitor for the treatment of people with advanced NSCLC as second-line treatment until at least 31 March 2026. |
||
|
Tislelizumab (with platinum-based chemotherapy) - Advanced non-small cell lung cancer, 1st line combination therapy, irrespective of PDL-1 status |
Since this application was received, we have funded a clinically appropriate alternative treatment for this condition. Pembrolizumab is the funded checkpoint inhibitor for the treatment of people with advanced NSCLC as first-line treatment until at least 31 March 2026. |
||
|
Tislelizumab - Advanced non-small cell lung cancer, 2nd line monotherapy irrespective of PDL-1 status |
Since this application was received, we have funded a clinically appropriate alternative treatment for this condition. Atezolizumab is the funded checkpoint inhibitor for the treatment of people with advanced NSCLC as second-line treatment until at least 31 March 2026. |
Respiratory System and Allergies
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Fluticasone with salmeterol, high dose - Asthma and chronic obstructive pulmonary disease |
The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended this application be declined at its meetings in November 2007 [PDF, 181 KB], November 2010 [PDF, 287 KB], and August 2011 [PDF, 217 KB]. The Respiratory Subcommittee of PTAC recommended that this application be declined at its meeting in May 2013 [PDF, 89 KB]. This application was then proposed by Pharmac for decline in 2019. Consultation feedback was received noting that it is not currently possible to reach the threshold for the omalizumab Special Authority without prescribing two inhalers and the decision was made to not decline the application at that time, pending further clinical advice. The Respiratory Subcommittee of PTAC then reconsidered the application along with the consultation feedback at is meeting in October 2020 [PDF, 661 KB] and made no change to its previous recommendation. The Subcommittee noted that no further evidence has been provided regarding FP/Sal (high dose), and considered that a daily dose of 1600 mcg budesonide would also satisfy the Special Authority requirement for omalizumab. |
||
|
Fluticasone with Vilanterol, 200/25, high dose, severe asthma - Asthma |
The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended that this application be declined at its meetings in November 2014 [PDF, 653 KB] and May 2021 [PDF, 747 KB]. The Respiratory Subcommittee of PTAC recommended that this application be declined at its meeting in September 2015 [PDF, 209 KB]. The reasons for the decline recommendations were the increased risk of pneumonia associated with this medicine, and no evidence showing a meaningful benefit over currently funded treatments. PTAC considered correspondence from the supplier in November 2022 [PDF, 702 KB] but considered that this provided no new evidence regarding the health benefit of this treatment. |
Sensory
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Moxifloxacin ophthalmic (0.5% USP) - Prophylaxis of post-operative endophthalmitis (POE) following intra-ocular surgery. |
There is currently no Medsafe approved product available in New Zealand. We are not aware of any supplier willing to pursue Medsafe approval. |
Special Foods
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
Elemental Formula - Alfare - Cow's milk protein allergy, food intolerance and hypersensitivity |
This pharmaceutical has been discontinued by its supplier, Nestle. |
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|
Pre-thickened fluids, pudding-thick (extremely thick) - Dysphagia (hospital) |
The Special Foods Subcommittee of PTAC recommended this application be declined at its meeting in December 2013 [PDF, 125 KB]. The Subcommittee considered there was no clinical need for an extremely thick fluid in DHB (now Health NZ) hospitals. PTAC discussed these minutes and ratified the Subcommittee’s recommendations at its meeting in May 2014 [PDF, 286 KB]. |
Vaccines
|
Pharmaceutical and indication |
Applicant |
Why we are proposing this application be declined |
Additional information |
|---|---|---|---|
|
15-valent pneumococcal conjugate vaccine (PCV15) - Prevention of invasive pneumococcal disease |
Since this application was received, we have funded a clinically appropriate alternative treatment for this condition. Pneumococcal (PCV13) conjugate vaccine(external link) (Prevenar 13) is the only conjugate vaccine funded to vaccinate against pneumococcal disease until at least 30 June 2027. |
||
|
Inactivated quadrivalent influenza vaccine, split virion (high dose) - for people aged 60 years and over who meet the criteria |
Since this application was received, we have funded a clinically appropriate alternative treatment for this condition. Influvac Tetra(external link), is the only vaccine funded to vaccinate against influenza until at least 31 December 2025. |
||
|
Quadrivalent Influenza virus haemagglutinin, surface antigen, inactivated, prepared in cell cultures - Prevention of influenza caused by Influenza Virus Types A and B |
Since this application was received, we have funded a clinically appropriate alternative treatment for this condition. Influvac Tetra(external link), is the only vaccine funded to vaccinate against influenza until at least 31 December 2025. |
To provide feedback
Send us an email: applicationfeedback@pharmac.govt.nz by 5pm on Friday 29th November 2024.
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
When you give feedback on a consultation, your feedback becomes official information that Pharmac holds. Pharmac has legal responsibilities for how we manage this official information, under laws such as the Official Information Act and Privacy Act.
Pharmac may receive a request from people for official information, which could include your feedback. Legally, Pharmac must consider whether your feedback should be released.
We will consider your views when assessing whether the feedback has to be released.
If your feedback is proposed for release, then Pharmac will contact you, unless there is a legal reason that we can't.
Note that Pharmac collects and holds your information in line with our Privacy Statement. Tell us if there is anything about your feedback that you would prefer wasn’t released.