Decision for funding in the immunosuppressant, oncology, vasodilator and smoking cessation therapeutic areas

Medicines

Decision

We're pleased to announce the approval of a decision relating to medicines in the immunosuppressant, oncology, vasodilator and smoking cessation areas.

Any changes to the original proposal?

No changes were made to this proposal as a result of consultation feedback.

This decision was subject to a consultation letter dated 11 July 2019.

Who we think will be most interested

  • People with chronic ocular inflammation and their whānau
  • Ophthalmologists
  • Community and hospital pharmacies
  • DHBs

Details about this decision

The following changes will occur from 1 September 2019: 

Access to adalimumab (Humira) will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule (the Hospitals Medicine List; HML) to include severe or 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

1.   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

2.   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:

Both

1.    Any of the following:

1.1  The patient has had a good clinical response following 3 initial doses; or
1.2  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
1.3  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; and

2.   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

1.   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

2.   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:

Both

1.    Any of the following:

1.1 The patient has had a good clinical response following 12 weeks’ initial treatment; or
1.2 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
1.3 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; and

2.   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) will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML). Similar changes will also be made to the infliximab criteria to include prior use of adalimumab.

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. Responses were supportive of the proposal.

A summary of the main theme raised in feedback and our response to the feedback received is set out below.  

Theme

PHARMAC Comment

Supportive of widening access to this treatment and considered increased access would meet known clinical needs.

Noted.

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 66 00 50.

Dexrazoxane for cardioprotection in children and young adults treated with anthracycline chemotherapy

Any changes to the original proposal?

No changes were made to this proposal as a result of consultation feedback.

This decision was subject to a consultation letter dated 11 July 2019.

Who we think will be most interested

  • People undergoing anthracycline treatment and their whānau
  • Clinicians, including medical oncologists, paediatric oncologists, haematologists and paediatric haematologists
  • Hospital pharmacists
  • DHBs

Details about this decision

The following changes will occur from 1 September 2019:

Dexrazoxane will be listed in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML), as follows:

Chemical

Formulation

Brand

Pack size

Proposed price

Dexrazoxane

Inj 500mg

eg Cardioxane

N/A

N/A

Dexrazoxane will be listed for use as a cardioprotective agent to be used in conjunction with anthracycline chemotherapy in children and young adults.

Dexrazoxane will be listed as an unapproved medicine (Section 29) and be subject to the following funding restriction criteria:

Restricted
Initiation

Medical oncologist, paediatric oncologist, haematologist, paediatric haematologist

All of the following:

  1. Patient is to receive treatment with high dose anthracycline given with curative intent; and
  2. Based on current treatment plan, patient’s cumulative lifetime dose of anthracycline will exceed 250mg/m2 doxorubicin equivalent or greater; and
  3. Dexrazoxane to be administered only whilst on anthracycline treatment; and
  4. 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.

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal.

A summary of the main themes raised in feedback and our response to the feedback received is set out below.  

Theme

PHARMAC Comment

Supportive of listing this treatment.

Noted.

Supportive but requested consideration be given for an additional indication to be added in the HML to allow dexrazoxane for the treatment of anthracycline extravasation in both adults and paediatric patients.

Noted. PHARMAC has not received a funding application for anthracycline extravasation in adults and children. We would welcome a funding application for this patient group.

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 66 00 50.

Sildenafil for erectile dysfunction due to spinal cord injury

Any changes to the original proposal?

No changes were made to this proposal as a result of consultation feedback.

This decision was subject to a consultation letter dated 11 July 2019.

Who we think will be most interested

  • People with erectile dysfunction due to spinal cord injury
  • Healthcare practitioners working with spinal cord injury patients
  • Spinal cord injury units
  • General practitioners and other primary care prescribers
  • Community and hospital pharmacies
  • Pharmaceutical suppliers

Details about this decision

The following changes will occur from 1 September 2019:

Access to all strengths of sildenafil tablets will be widened in Section B and Part II of Section H of the Pharmaceutical Schedule 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:

  1. Patient has a documented history of traumatic or non-traumatic spinal cord injury; and
  2. 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.

Similar restrictions for sildenafil will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal.

A summary of the main themes raised in feedback and our response to the feedback received is set out below.  

Theme

PHARMAC Comment

Supportive of widening access to this treatment.

Noted.

Supportive but noted erectile dysfunction is a common symptom of several diseases so would like access further widened to include erectile dysfunction due to other causes (e.g. diabetes).

Noted. The funding application was specifically for spinal cord injury patients with erectile dysfunction. PHARMAC has not, to date, received a funding application for PDE-5 inhibitors for a broader group of people with erectile dysfunction. PHARMAC would welcome a funding application for a wider patient group and would consider this option for funding via its usual application assessment process.

Not supportive as considers that ACC currently funds sildenafil for spinal cord injury patients. Also noted that there are multiple causes of erectile dysfunction. Considers there is significant unmet need for other patients with erectile dysfunction and expressed concern that this proposal would result in inequitable access for this indication.

 

Noted. PTAC and PHARMAC are aware that ACC funds treatments for erectile dysfunction attributed to spinal cord injury for some patients in the community setting. PHARMAC has been advised by ACC that funding for erectile dysfunction is not available to patients in the hospital setting.

PHARMAC has not, to date, received a funding application for PDE-5 inhibitors for a broader group of people with erectile dysfunction. PHARMAC would welcome a funding application for a wider patient group and would consider this option for funding via its usual application assessment process.

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 66 00 50.

Varenicline for smoking cessation – reducing re-treatment period to 6 months

Any changes to the original proposal?

Access to varenicline tartrate will be widened from 1 October 2019. This date is earlier than that proposed in the consultation document. This earlier access will give more people the opportunity to stop smoking sooner using varenicline.

As a result of consultation feedback, changes have also been made to the funding criteria to make it clearer that the 6-month time period in which a patient can receive a funded 12-week course of varenicline tartrate starts from the date the Special Authority is approved.

This decision was subject to a consultation letter dated 11 July 2019.

Who we think will be interested

  • People who want to quit smoking
  • General Practitioners and other primary care prescribers
  • Community and hospital pharmacies
  • Smoking cessation service providers
  • DHB clinicians

Details about this decision

The following changes will occur from 1 October 2019. 

Access to varenicline will be widened in both the community and hospital by changing the funding restriction to allow one 12-week course to be funded every 6 months, as follows (changes 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:

  1. Short-term therapy as an aid to achieving abstinence in a patient who has indicated that they are ready to cease smoking; and
  2. 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
  3. 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

  1. The patient has not used funded varenicline in the last 12 months The patient has not had a Special Authority for varenicline approved in the last 6 months; and

  2. Varenicline is not to be used in combination with other pharmacological smoking cessation treatments and the patient has agreed to this; and
  3. The patient is not pregnant; and
  4. 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:

  1. Short-term therapy as an aid to achieving abstinence in a patient who has indicated that they are ready to cease smoking; and
  2. 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
  3. The patient has not used funded varenicline in the last 12 months It has been 6 months since the patient’s previous Special Authority for varenicline was approved; and

  4. Varenicline is not to be used in combination with other pharmacological smoking cessation treatments and the patient has agreed to this; and
  5. The patient is not pregnant; and
  6. 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 will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML).

We will also add a note of clarification to the varenicline listing in Section B of the Pharmaceutical Schedule, as follows:

The 6-month time period in which a patient can receive a funded 12-week course of varenicline tartrate starts from the date the Special Authority is approved.

Our response to what you told us

We’re grateful for the time people took to respond to this consultation. Responses were supportive of the proposal.

A summary of the main themes raised in feedback and our response to the feedback received is set out below.  

Theme

PHARMAC Comment

Supportive of widening access to this treatment.

Noted.

Supportive but requested clarity about when the 6-month period would apply from.

Noted. The 6-month time period would commence from the date that the Special Authority is approved. In applying for a Special Authority, the prescriber is taking responsibility for confirming that the patient meets the funding criteria and is eligible to receive funded varenicline. When the prescription is presented for dispensing, the pharmacy should only have to ensure the Special Authority is current.

PHARMAC has added a note to the varenicline listing in Section B of the Schedule to clarify that the 6-month time period in which a patient can receive a funded 12-week course of varenicline tartrate starts from the date the Special Authority is approved. We have also amended the wording in the Special Authority to provide supporting clarification on the new note.

Some patients delay getting their varenicline prescription dispensed and in the interim the Special Authority expires.

Noted. Special Authority approvals for varenicline remain valid for 5 months. There is a mechanism by which prescribers can seek a waiver to extend Special Authority approvals in instances where a patient has either not had their prescription dispensed or not completed the 12-week course of varenicline.

PHARMAC makes the decisions on waiver requests.

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 66 00 50.