Proposals for funding in the immunosuppressant, oncology, vasodilator and smoking cessation therapeutic areas
We are seeking feedback on proposals for funding in the immunosuppressant, oncology, vasodilator and smoking cessation therapeutic areas.
What we’re proposing
We are seeking feedback on proposals for funding in the immunosuppressant, oncology, vasodilator and smoking cessation therapeutic areas.
In summary, the proposals would result in the following changes:
From 1 September 2019:
- Adalimumab (Humira) access would be widened to include treatment of severe or chronic ocular inflammation.
- Dexrazoxane would be funded in DHB hospitals for cardioprotection in children and young adults treated with anthracycline chemotherapy.
- Sildenafil access would be widened to include people who have erectile dysfunction as a result of spinal cord injury.
From 1 January 2020:
Further details on these proposals, including how to provide feedback and background information, can be found on the below.
Consultation closes at 5 pm on Friday, 26 July 2019 and feedback can be emailed to consult@pharmac.govt.nz.
To provide feedback
Send us an email: consult@pharmac.govt.nz by 26 July 2019.
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.
Feedback we receive is subject to the Official Information Act 1982 (OIA). Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.
We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.
Adalimumab (Humira) for ocular inflammation
What would the effect be?
Funded access to adalimumab would be widened to include treatment of severe or chronic ocular inflammation (uveitis), as an alternative first-line biologic treatment to infliximab. This change would apply to both the community and hospital listings in the Pharmaceutical Schedule.
Adalimumab would be funded for people who have tried steroids and/or other immunosuppressants, or who are either intolerant to, or have had inadequate benefit from, infliximab. Funding criteria would be similar to infliximab.
For some people, this treatment would result in improvements in vision. People who use adalimumab would be able to self-administer and would not need to go to hospital for an infliximab infusion.
We estimate that approximately 15-30 people each year would be eligible for treatment under the proposed criteria for funding. We note that some people have been funded in the past via Named Patient Pharmaceutical Assessment (NPPA) applications.
Preventing disease progression would likely result in reduced healthcare costs. There may be a reduction in infusion costs for DHBs if people move from infliximab to adalimumab.
Who we think will be interested
- People with chronic ocular inflammation and their whānau
- Ophthalmologists
- Community and hospital pharmacies
About adalimumab and ocular inflammation (uveitis)
Adalimumab is a recombinant human tumour necrosis factor (TNF) inhibitor that reduces chronic inflammation and immune response activation. It is administered by subcutaneous injection. Adalimumab is currently funded to treat a number of autoimmune inflammatory conditions, which include both approved and unapproved (off-label) indications.
Ocular inflammation is a general term for inflammation of the eye or surrounding tissue. Chronic and severe cases usually occur in the uvea. This condition is commonly referred to as uveitis. Non-infectious uveitis is associated with inflammatory cytokines, including TNF, which are thought to cause damage to the photoreceptor cells of the retina.
Uveitis can occur at any age, however, is most likely to affect people of working age. Non-infectious uveitis can affect one or both eyes and goes through phases of active inflammation or flare when people are aware of eye discomfort, pain, redness, or blurred and decreased vision. At other times there may be no symptoms. Vision loss is usually temporary, lasting weeks or months. For some people, vision loss can be long term due to cataract formation.
Why we're proposing this
Adalimumab is a recombinant human tumour necrosis factor (TNF) inhibitor that reduces chronic inflammation and immune
A funding application for adalimumab for the treatment of ocular inflammation was reviewed by the Pharmacology and Therapeutics Advisory Committee (PTAC) in August 2017. PTAC recommended widening access to adalimumab, with a low priority, to people with severe and chronic ocular inflammation as an alternative first-line biologic treatment to infliximab, or for people who are intolerant to infliximab or who have received inadequate benefit from infliximab.
Details about our proposal
Access to adalimumab (Humira) would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML) from 1 September 2019 to include chronic ocular inflammation as follows (new criteria only shown below):
Special Authority for Subsidy
Initial application — (severe ocular inflammation) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:
Either
- Both:
1.1 The patient has had an initial Special Authority approval for infliximab for severe ocular inflammation; and
1.2 Either:
1.2.1 The patient has experienced intolerable side effects from infliximab; or
1.2.2 The patient has received insufficient benefit from infliximab to meet the renewal criteria for infliximab for severe ocular inflammation; or
- Both:
2.1 Patient has severe, vision-threatening ocular inflammation requiring rapid control; and
2.2 Any of the following:
2.2.1 Treatment with high-dose steroids (intravenous methylprednisolone) followed by high dose oral steroids has proven ineffective at controlling symptoms; or
2.2.2 Patient developed new inflammatory symptoms while receiving high dose steroids; or
2.2.3 Patient is aged under 8 years and treatment with high dose oral steroids and other immunosuppressants has proven ineffective at controlling symptoms.
Renewal — (severe ocular inflammation) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:
Any of the following:
- The patient has had a good clinical response following 3 initial doses; or
- Following each 12-month treatment period, the patient has had a sustained reduction in inflammation (Standardisation of Uveitis Nomenclature (SUN) criteria < ½+ anterior chamber or vitreous cells, absence of active vitreous or retinal lesions, or resolution of uveitic cystoid macular oedema); or
- Following each 12-month treatment period, the patient has a sustained steroid sparing effect, allowing reduction in prednisone to < 10mg daily, or steroid drops less than twice daily if under 18 years old.
- Adalimumab to be administered at doses no greater than 40 mg every 14 days.
Note: A trial withdrawal should be considered after every 24 months of stability, unless the patient is deemed to have extremely high risk of irreversible vision loss if adalimumab is withdrawn.
Initial application — (chronic ocular inflammation) from any relevant practitioner. Approvals valid for 4 months for applications meeting the following criteria:
Either
- Both:
1.1 The patient has had an initial Special Authority approval for infliximab for chronic ocular inflammation; and
1.2 Either:
1.2.1 The patient has experienced intolerable side effects from infliximab; or
1.2.2 The patient has received insufficient benefit from infliximab to meet the renewal criteria for infliximab for chronic ocular inflammation; or
- Both:
2.1 Patient has severe uveitis uncontrolled with treatment of steroids and other immunosuppressants with a severe risk of vision loss; and
2.2 Any of the following:
2.2.1 Patient is 18 years or older and treatment with at least two other immunomodulatory agents has proven ineffective; or
2.2.2 Patient is under 18 years and treatment with methotrexate has proven ineffective or is not tolerated at a therapeutic dose; or
2.2.3 Patient is under 8 years and treatment with steroids or methotrexate has proven ineffective or is not tolerated at a therapeutic dose; or disease requires control to prevent irreversible vision loss prior to achieving a therapeutic dose of methotrexate.
Renewal — (chronic ocular inflammation) from any relevant practitioner. Approvals valid for 12 months for applications meeting the following criteria:
Any of the following:
- The patient has had a good clinical response following 12 weeks’ initial treatment; or
- Following each 12-month treatment period, the patient has had a sustained reduction in inflammation (Standardisation of Uveitis Nomenclature (SUN) criteria < ½+ anterior chamber or vitreous cells, absence of active vitreous or retinal lesions, or resolution of uveitic cystoid macular oedema); or
- Following each 12-month treatment period, the patient has a sustained steroid sparing effect, allowing reduction in prednisone to < 10mg daily, or steroid drops less than twice daily if under 18 years old.
- Adalimumab to be administered at doses no greater than 40 mg every 14 days.
Note: A trial withdrawal should be considered after every 24 months of stability, unless the patient is deemed to have extremely high risk of irreversible vision loss if adalimumab is withdrawn.
The same changes to the restrictions for adalimumab (Humira) would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML). Similar changes would also be made to the infliximab criteria to include prior use of adalimumab.
Dexrazoxane for cardioprotection in children and young adults treated with anthracycline chemotherapy
What would the effect be?
Dexrazoxane would be listed in Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML) for use as a supportive care treatment for the prevention of cardiotoxicity in children and young adults receiving some cancer treatments and who meet certain clinical criteria.
There is currently no Medsafe-approved brand of dexrazoxane in New Zealand so this listing would be as an unapproved medicine (Section 29 product).
Who we think will be interested
- People undergoing anthracycline treatment and their whānau
- Clinicians, including medical oncologists and haematologists
About dexrazoxane
Dexrazoxane is an iron chelator used to prevent and reduce the incidence and severity of heart problems associated with higher cumulative doses of anthracycline chemotherapy (such as doxorubicin, daunorubicin, idarubicin and epirubicin). High doses of anthracycline chemotherapy are essential to the clinical effectiveness of cancer treatment protocols for several childhood malignancies, and there is a correlation with a higher rate of cardiac risk in these populations.
Dexrazoxane is administered by infusion immediately prior to administration of anthracycline chemotherapy.
Why we're proposing this
The funding of dexrazoxane for cardioprotection has been considered by both PTAC and the Cancer Treatments Subcommittee (CaTSoP) of PTAC on a number of occasions, most recently by PTAC in February 2018.
In February 2018, PTAC recommended that dexrazoxane be funded with low priority for cardioprotection in conjunction with anthracycline chemotherapy in children and young adults who meet certain clinical criteria. PTAC noted updated evidence for the benefit and safety of dexrazoxane, and that anthracycline-induced cardiotoxicity remained a significant clinical issue with long-term consequences for paediatric oncology.
People receiving treatment for osteosarcoma, Ewing’s sarcoma, rhabdomyosarcoma, acute myeloid leukaemia (AML) and nephroblastoma are the most likely to require dexrazoxane treatment due to cumulative high dose anthracycline treatment.
Details about our proposal
Dexrazoxane would be listed in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML), from 1 September 2019, as follows:
|
Chemical |
Formulation |
Brand |
Pack size |
Proposed price |
|---|---|---|---|---|
|
Dexrazoxane |
Inj 500mg |
(any brand) |
(any pack size) |
(any price) |
Dexrazoxane would be listed for use as a cardioprotective agent to be used in conjunction with anthracycline chemotherapy in children and young adults.
It would be subject to the following funding restriction criteria:
Restricted
Initiation
Medical oncologist, paediatric oncologist, haematologist, paediatric haematologist
All of the following:
- Patient is to receive treatment with high dose anthracycline given with curative intent; and
- Based on current treatment plan, patient’s cumulative lifetime dose of anthracycline will exceed 250mg/m2 doxorubicin equivalent or greater; and
- Dexrazoxane to be administered only whilst on anthracycline treatment; and
- Either:
4.1. Treatment to be used as a cardioprotectant for a child or young adult; or
4.2. Treatment to be used as a cardioprotectant for secondary malignancy.
Dexrazoxane would be listed as an unapproved medicine (Section 29).
Sildenafil for erectile dysfunction due to spinal cord injury
What would the effect be?
Funded access to sildenafil would be widened to include people with erectile dysfunction as a result of spinal cord injury. This change would apply to both the community and hospital listings in the Pharmaceutical Schedule. Funding restriction criteria would apply.
Who we think will be interested
- People with erectile dysfunction due to spinal cord injury
- Healthcare practitioners working with spinal cord injury patients
- General practitioners
- Community and hospital pharmacists
- Pharmaceutical suppliers
About sildenafil
Sildenafil is a phosphodiesterase V (PDE5) inhibitor that selectively blocks the PDE5 enzyme, resulting in increased blood flow through smooth muscle. It is currently funded for pulmonary arterial hypertension and Raynaud’s Phenomenon. Through its vasodilatory effects, sildenafil can be used to treat erectile dysfunction, which occurs in 75% of people with spinal cord injury.
Why we're proposing this
A funding application for PDE5 inhibitors to treat erectile dysfunction in people with a spinal cord injury was reviewed by PTAC in May 2014. PTAC recommended that access to PDE5 inhibitors and/or intracavernosal alprostadil should be widened to include this group in the hospital setting, with a medium priority.
This proposal is to widen access to sildenafil in both the community and hospital, as some spinal cord injury patients with erectile dysfunction may require ongoing treatment in the community. This proposal is only for sildenafil because it is the only PDE5 inhibitor currently funded.
Details about our proposal
Access to all strengths of sildenafil tablets would be widened in Section B and Part II of Section H of the Pharmaceutical Schedule, from 1 September 2019, to include the following funding restriction criteria (new criteria only shown below):
Special Authority for Subsidy
Initial application – (erectile dysfunction due to spinal cord injury) from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:
- Patient has a documented history of traumatic or non-traumatic spinal cord injury; and
- Patient has erectile dysfunction secondary to spinal cord injury requiring pharmacological treatment.
Renewal from any relevant practitioner. Approvals valid for 2 years where the treatment remains appropriate and the patient is benefitting from the treatment.
The same restrictions would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).
Varenicline for smoking cessation – reducing re-treatment period to 6 months
What would the effect be?
From 1 January 2020, the funding criteria for varenicline would be changed to allow eligible people to receive a funded 12-week course once every 6 months. Currently people can only access a funded 12-week course once every 12 months.
Reducing the re-treatment timeframe to 6 months would provide people with a second opportunity in a year to quit smoking using varenicline.
This change would widen access to both the community and hospital listings in the Pharmaceutical Schedule. The other funding restriction criteria that people need to meet would remain the same.
Who we think will be interested
- People who want to quit smoking
- General Practitioners
- Pharmacists working in the community or hospital
- Smoking cessation providers
- DHB clinicians
About varenicline
Varenicline tartrate binds to acetylcholine receptors, alleviating the symptoms of nicotine craving and withdrawal. It also blocks the rewarding and reinforcing effects of smoking by preventing nicotine binding to those same receptors.
Varenicline has been funded since November 2010 as a second or third-line treatment for smoking cessation. Funding is currently limited to a single 12-week course within a 12-month period.
Why we're proposing this
A funding application for varenicline tartrate was reviewed by PTAC in February 2016, and it was recommended that funded access to varenicline for smoking cessation be widened to reduce the re-treatment interval from 12 to 6 months (which would permit a funded 12-week course every 6 months rather than every 12 months) with a low priority.
Details about our proposal
This proposal is to widen access to varenicline in both the community and hospital by changing the funding restriction to allow one 12-week course to be funded every 6 months. This change would take effect from 1 January 2020.
It would involve amending the Special Authority criteria in Section B of the Pharmaceutical Schedule as follows (amendments shown in strikethrough and bold):
Special Authority for Subsidy
Initial application from any relevant practitioner. Approvals valid for 5 months for applications meeting the following criteria:
All of the following:
- Short-term therapy as an aid to achieving abstinence in a patient who has indicated that they are ready to cease smoking; and
- The patient is part of, or is about to enrol in, a comprehensive support and counselling smoking cessation programme, which includes prescriber or nurse monitoring; and
- Either:
3.1 The patient has tried but failed to quit smoking after at least two separate trials of nicotine replacement therapy, at least one of which included the patient receiving comprehensive advice on the optimal use of nicotine replacement therapy; or
3.2 The patient has tried but failed to quit smoking using bupropion or nortriptyline; and
- The patient has not used varenicline in the last
126 months; and - Varenicline is not to be used in combination with other pharmacological smoking cessation treatments and the patient has agreed to this; and
- The patient is not pregnant; and
- The patient will not be prescribed more than 12 weeks’ funded varenicline (see note).
Renewal from any relevant practitioner. Approvals valid for 5 months for applications meeting the following criteria:
All of the following:
- Short-term therapy as an aid to achieving abstinence in a patient who has indicated that they are ready to cease smoking; and
- The patient is part of, or is about to enrol in, a comprehensive support and counselling smoking cessation programme, which includes prescriber or nurse monitoring; and
- The patient has not used varenicline in the last
126 months; and - Varenicline is not to be used in combination with other pharmacological smoking cessation treatments and the patient has agreed to this; and
- The patient is not pregnant; and
- The patient will not be prescribed more than 12 weeks’ funded varenicline (see note).
The patient must not have had an approval in the past 12 6 months.
Note: a maximum of 12 weeks’ varenicline will be subsidised on each Special Authority approval. This includes the 4-week ‘starter’ pack.
The same restriction changes would apply in Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML).