Proposal to amend or remove funding restrictions from various pharmaceuticals

Initial application from any relevant practitioner. Approvals valid for 1 year for applications meeting the following criteria:

All of the following:

1. Applicant is a vocationally registered dermatologist, vocationally registered general practitioner, or nurse practitioner working in a relevant scope of practice; and
2. Applicant has an up to date knowledge of the treatment options for psoriasis and of disorders of keratinisation and is aware of the safety issues around acitretin and is competent to prescribe acitretin; and
3. Either:
   1. Patient is female and has been counselled and understands the risk of teratogenicity if acitretin is used during pregnancy and the applicant has ensured that the possibility of pregnancy has been excluded prior to the commencement of the treatment and that the patient is informed that she must not become pregnant during treatment and for a period of two years after the completion of the treatment; or
   2. Patient is male.
4. Renewal from any relevant practitioner. Approvals valid for 1 year for applications meeting the following criteria:
   1. All of the following:
   2.  1     Applicant is a vocationally registered dermatologist, vocationally registered general practitioner, or nurse practitioner working in a relevant scope of practice; and
   3.  2     Applicant has an up to date knowledge of the treatment options for psoriasis and of disorders of keratinisation and is aware of the safety issues around acitretin and is competent to prescribe acitretin; and
5. Either:
   1. Patient is female and has been counselled and understands the risk of teratogenicity if acitretin is used during pregnancy and the applicant has ensured that the possibility of pregnancy has been excluded prior to the commencement of the treatment and that the patient is informed that she must not become pregnant during treatment and for a period of two years after the completion of the treatment; or
   2. Patient is male.

In relation to adalimumab, etanercept, and tocilizumab

• The following new indication would be added to the Special Authorities for adalimumab inj 20 mg per 0.4 ml prefilled syringe and inj 40 mg per 0.8 ml prefilled pen and syringe (Humira and HumiraPen) and etanercept inj 25 mg and inj 50 mg autoinjector and prefilled syringe (Enbrel) in Section B of the Pharmaceutical Schedule:

Initial application - (adult-onset Still’s disease) only from a rheumatologist. Approvals valid for 4 months for applications meeting the following criteria:

Either:

1. Both:
   1. Either:
      1. The patient has had an initial Special Authority approval for etanercept or adalimumab (as applicable) for adult-onset Still’s disease (AOSD); or
      2. The patient has been started on tocilizumab for AOSD in a DHB hospital in accordance with the HML rules; and
   2. Either:
      1. The patient has experienced intolerable side effects from etanercept, adalimumab or tocilizumab (as applicable); or
      2. The patient has received insufficient benefit from at least a three-month trial of etanercept, adalimumab or tocilizumab (as applicable) such that they do not meet the renewal criteria for AOSD; o
2. All of the following:
   1. Patient diagnosed with AOSD according to the Yamaguchi criteria (J Rheumatol 1992;19:424-430); and
   2. Patient has tried and not responded to at least 6 months of glucocorticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs) and methotrexate; and
   3. Patient has persistent symptoms of disabling poorly controlled and active disease.

Renewal - (adult-onset Still’s disease) only from a rheumatologist or Practitioner on the recommendation of a rheumatologist. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1. Either:
   1. Applicant is a rheumatologist; or
   2. Applicant is a Practitioner and confirms that a rheumatologist has provided a letter, email or fax recommending that the patient continues with etanercept or adalimumab (as applicable) treatment; and
2. The patient has a sustained improvement in inflammatory markers and functional status.

• The restrictions for adalimumab, etanercept, and tocilizumab inj 20 mg per ml, 4 ml, 10 ml and 20 ml vial (Actemra) in Part II of Section H of the Pharmaceutical Schedule would be amended in the same way.

In relation to benzydamine hydrochloride

• Benzydamine hydrochloride solution 0.15% (Difflam), which is not currently fully subsidised, would be fully subsidised in Section B of the Pharmaceutical Schedule by prescription endorsement as follows:

Additional subsidy by endorsement for a patient who has oral mucositis as a result of treatment for cancer, and the prescription is endorsed accordingly.

In relation to deferiprone

• The Special Authority for deferiprone tab 500 mg and oral liq 100 mg per 1 ml (Ferriprox) in Section B of the Pharmaceutical Schedule would be amended as follows (deletions in strikethrough, additions in bold):

Initial application only from a relevant specialist haematologist. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Either:

1. The patient has been diagnosed with chronic transfusional iron overload due to congenital inherited anaemia; or
2. The patient has been diagnosed with chronic transfusional iron overload due to acquired red cell aplasia.

Note: for the purposes of this Special Authority, a relevant specialist is defined as a haematologist.

• The restrictions for deferiprone in Part II of Section H of the Pharmaceutical Schedule would be amended in the same way.

In relation to gabapentin

• The neuropathic pain criteria in the Special Authority for gabapentin cap 100 mg, 300 mg and 400 mg (Arrow-Gabapentin and Nupentin brands only) in Section B of the Pharmaceutical Schedule would be amended as follows (deletions in strikethrough, additions in bold):

Initial application - (Neuropathic pain and Chronic Kidney Disease-associated pruritus) from any relevant practitioner. Approvals valid for 3 months for applications meeting the following criteria:

Either:

1. The patient has tried and failed, or has been unable to tolerate, treatment with a tricyclic antidepressant.
2. The patient has been diagnosed with neuropathic pain; or
3. Both:
   1. The patient has Chronic Kidney Disease Stage 5-associated pruritus* where no other cause for pruritus can be identified (e.g. scabies, allergy); and
   2. The patient has persistent pruritus not relieved with a trial of emollient/moisturising creams alone.

Renewal - (Neuropathic pain and Chronic Kidney Disease-associated pruritus) from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

Either:

1. The patient has demonstrated a marked improvement in their control of pain or itch (prescriber determined); or
2. The patient has previously demonstrated clinical responsiveness to gabapentin and has now developed neuropathic pain in a new site.

Notes: Indications marked with * are Unapproved Indications (see Interpretations and Definitions). Dosage adjustment of gabapentin is recommended for patients with renal impairment.

• The restrictions for gabapentin (including tab 600 mg) in Part II of Section H of the Pharmaceutical Schedule would be amended in the same way.

In relation to insulin pump and insulin pump consumables

• The first criterion in the “Initial criteria for Subsidy” for insulin pump and insulin pump consumables for hypoglycaemia and for HbA1c in Section B of the Pharmaceutical Schedule would be amended to include cystic fibrosis-related insulin dependence as follows (additions in bold):

1     Patient has type 1 diabetes or has undergone a pancreatectomy or has cystic fibrosis-related insulin dependence;

In relation to isotretinoin

• The Special Authority for isotretinoin cap 10 mg and 25 mg (Oratane) in Section B of the Pharmaceutical Schedule would be amended as follows (additions in bold, deletions in strikethrough) and re-numbered accordingly:

Initial application from any relevant practitioner. Approvals valid for 1 year for applications meeting the following criteria:

All of the following:

1. Patient has had an adequate trial on other available treatments and has received an inadequate response from these treatments or these are contraindicated; and
2. Applicant is a vocationally registered dermatologist, vocationally registered general practitioner, or nurse practitioner working in a relevant scope of practice; and
3. Applicant has an up to date knowledge of the treatment options for acne and is aware of the safety issues around isotretinoin and is competent to prescribe isotretinoin; and
4. Either:
   1. Patient is female and has been counselled and understands the risk of teratogenicity if isotretinoin is used during pregnancy and the applicant has ensured that the possibility of pregnancy has been excluded prior to the commencement of the treatment and that the patient is informed that she must not become pregnant during treatment and for a period of one month after the completion of the treatment; or
   2. Patient is male.

Note: Applicants are recommended to either have used or be familiar with using a decision support tool accredited by their professional body.

Renewal from any relevant practitioner. Approvals valid for 1 year for applications meeting the following criteria:

All of the following:

1.  Patient has had an adequate trial on other available treatments and has received an inadequate response from these treatments or these are contraindicated; and
2. Applicant is a vocationally registered dermatologist, vocationally registered general practitioner, or nurse practitioner working in a relevant scope of practice; and
3. Applicant has an up to date knowledge of the treatment options for acne and is aware of the safety issues around isotretinoin and is competent to prescribe isotretinoin; and
4.  Either:
   1. Patient is female and has been counselled and understands the risk of teratogenicity if isotretinoin is used during pregnancy and the applicant has ensured that the possibility of pregnancy has been excluded prior to the commencement of the treatment and that the patient is informed that she must not become pregnant during treatment and for a period of one month after the completion of the treatment; or
   2. Patient is male.

Note: Applicants are recommended to either have used or be familiar with using a decision support tool accredited by their professional body.

In relation to midodrine

• The initial Special Authority criteria for midodrine tab 2.5 mg and 5 mg (Gutron) in Section B of the Pharmaceutical Schedule would be amended as follows (deletions in strikethrough):

Initial application from any relevant practitioner. Approvals valid for 2 years for applications meeting the following criteria:

All of the following:

1. Patient has disabling orthostatic hypotension not due to drugs;  and
2. Patient has tried fludrocortisone (unless contra-indicated) with unsatisfactory results;  and
3. Patient has tried non pharmacological treatments such as support hose, increased salt intake, exercise, and elevation of head and trunk at night.

Note: Treatment should be started with small doses and titrated upwards as necessary. Hypertension should be avoided, and the usual target is a standing systolic blood pressure of 90 mm Hg.

Renewal from any relevant practitioner. Approvals valid for 2 years where the treatment remains appropriate and the patient is benefiting from treatment.