Decisions to list and amend restrictions on various pharmaceuticals

Medicines

Decision

PHARMAC is pleased to announce decisions to list, delist and amend the restrictions for various pharmaceuticals in Section B or Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List; HML), from 1 August 2015 (unless otherwise noted). All of these were the subject of a consultation letter dated 20 May 2015.

The proposals were approved essentially as consulted on, with the exception of the following:

  • An amendment was made to the proposed restriction changes for aripiprazole for severe irritability associated with autism spectrum disorder, such that the renewal criteria do not include a requirement for the patient to be aged under 18 years.
  • No decision has been made on the proposal to widen access to somatropin for people with Prader-Willi syndrome. Some significant clinical issues were raised in consultation responses, and we require additional time to consider them and seek further clinical advice before a decision can be made on the proposal.

Accordingly, we intend to seek advice from the Endocrinology Subcommittee of our main clinical advisory committee, the Pharmacology and Therapeutics Advisory Committee (PTAC), at its next meeting in early 2016. The Subcommittee will be provided with a copy of all consultation responses and supporting publications. If you have additional information that you would like the Subcommittee to consider you are welcome to submit it to us. The deadline for receiving submissions is 4 December 2015. Submissions can be sent to Bronwyn Hale at Bronwyn.Hale@pharmac.govt.nz.

A summary of the decisions is provided below; for further details please refer to the consultation letter. All changes will occur on 1 August 2015 unless otherwise noted.

The Special Authority criteria applying to aripiprazole 10 mg, 15 mg, 20 mg and 30 mg tablets (Abilify) will be widened to include the following new indication in Section B of the Pharmaceutical Schedule, and the HML restrictions will be widened in the same way:

Initial application – (Autism spectrum disorder*) only from a psychiatrist or paediatrician.

Approvals valid for 12 months for applications meeting the following criteria:

All of the following:

  1. The patient has been diagnosed with an autism spectrum disorder* and has symptoms of severe irritability; and
  2. An effective dose of risperidone has been trialed and has been discontinued because of unacceptable side effects or inadequate response; and
  3. The patient is aged less than 18 years.

Renewal application – (Autism spectrum disorder*) only from a psychiatrist or paediatrician or medical practitioner on the recommendation of a psychiatrist or paediatrician.

Approvals valid for 2 years for applications where the treatment remains appropriate and the patient is benefiting from treatment.

Note: Indications marked with * are Unapproved Indications

The Special Authority criteria applying to benzbromarone 100 mg tablets (Benzbromaron AL 100) will be amended as follows in Section B of the Pharmaceutical Schedule (additions in bold, deletions in strikethrough), and the HML restrictions will be amended in the same way:

Initial application from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

All of the following: Both:

1. Patient has been diagnosed with gout; and

2 Any of the following:

2.1   The patient has a serum urate level greater than 0.36 mmol/l despite treatment with allopurinol at doses of at least 600 mg/day and appropriate doses ofaddition of probenecid at doses of up to 2 g per day or maximum tolerated dose; or
2.2   The patient has experienced intolerable side effects from allopurinol such that treatment discontinuation is required and serum urate remains greater than 0.36 mmol/l despite appropriate doses ofuse of probenecid at doses of up to 2 g per day or maximum tolerated dose; or
2.3   Both:

2.3.1     The patient has renal impairment such that probenecid is contraindicated or likely to be ineffective and serum urate remains greater than 0.36 mmol/l despite optimal treatment with allopurinol (see Notes); and
2.3.2     The patient has a rate of creatinine clearance greater than or equal to 20 ml/min; or

2.4   All of the following:

2.4.1     The patient is taking azathioprine and requires urate-lowering therapy; and
2.4.2     Allopurinol is contraindicated; and
2.4.3     Appropriate doses of probenecid are ineffective or probenecid cannot be used due to reduced renal function; and

3. The patient is receiving monthly liver function tests.

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

Both:

1. The treatment remains appropriate and the patient is benefitting from the treatment; and

2. There is no evidence of liver toxicity and patient is continuing to receive regular (at least every three months) liver function tests.

Notes: Benzbromarone has been associated with potentially fatal hepatotoxicity.

In chronic renal insufficiency, particularly when the glomerular filtration rate is 30 ml/minute or less, probenecid may not be effective. Optimal treatment with allopurinol in patients with renal impairment is defined as treatment to the creatinine clearance-adjusted dose of allopurinol then, if serum urate remains greater than 0.36 mmol/l, a gradual increase of the dose of allopurinol to 600 mg or the maximum tolerated dose.

The New Zealand Rheumatology Association has developed information for prescribers which can be accessed from its website www.rheumatology.org.nz(external link) 

The Special Authority criteria applying to febuxostat 80 mg and 120 mg tablets (Adenuric) will be amended as follows in Section B of the Pharmaceutical Schedule (additions in bold, deletions in strikethrough), and the HML restrictions will be amended in the same way:

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid for 6 months for applications meeting the following criteria:

Both:

1   Patient has been diagnosed with gout; and

2   Any of the following:

2.1   The patient has a serum urate level greater than 0.36 mmol/l despite treatment with allopurinol at doses of at least 600 mg/day and appropriate doses of addition of probenecid at doses of up to 2 g per day or maximum tolerated dose; or
2.2   The patient has experienced intolerable side effects from allopurinol such that treatment discontinuation is required and serum urate remains greater than 0.36 mmol/l despite appropriate doses ofuse of probenecid at doses of up to 2 g per day or maximum tolerated dose; or
2.3   Both:

3.1    The patient has renal impairment such that probenecid is contraindicated or likely to be ineffective and serum urate remains greater than 0.36 mmol/l despite optimal treatment with allopurinol (see Notes); and
3.2   The patient has a rate of creatinine clearance greater than or equal to 30 ml/min.

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

Notes: In chronic renal insufficiency, particularly when the glomerular filtration rate is 30 ml/minute or less, probenecid may not be effective. The efficacy and safety of febuxostat have not been fully evaluated in patients with severe renal impairment (creatinine clearance less than 30 ml/minute). No dosage adjustment of febuxostat is necessary in patients with mild or moderate renal impairment. Optimal treatment with allopurinol in patients with renal impairment is defined as treatment to the creatinine clearance-adjusted dose of allopurinol then, if serum urate remains greater than 0.36 mmol/l, a gradual increase of the dose of allopurinol to 600 mg or the maximum tolerated dose.

The listing of diphtheria toxoid 2IU with tetanus toxoid 20 IU, pertussis toxoid 8 mcg, pertussis filamentous haemagluttinin 8 mcg and pertactin 2.5 mcg in 0.5 ml syringe (Boostrix) on the National Immunisation Schedule (Section I of the Pharmaceutical Schedule) will be amended as follows (deletions in strikethrough), and the HML restrictions will be amended in the same way:

Funded for any of the following criteria:

  1. A single vaccine for pregnant woman between gestational weeks 28 and 38 during epidemics; or
  2. A course of up to four vaccines is funded for children from age 7 up to the age of 18 years inclusive to complete full primary immunisation; or
  3. An additional four doses (as appropriate) are funded for (re-)immunisation for patients post haematopoietic stem cell transplantation or chemotherapy; pre or post splenectomy; pre- or post solid organ transplant, renal dialysis and other severely immunosuppressive regimens.

Notes: Tdap is not registered for patients aged less than 10 years. Please refer to the Immunisation Handbook for appropriate schedule for catch up programmes. 

The Special Authority criteria applying to tacrolimus 0.5 mg, 1 mg and 5 mg capsules (Tacrolimus Sandoz) will be widened to include the following new indication in Section B of the Pharmaceutical Schedule, and the HML criteria will be amended in the same way:

Initial application – (steroid-resistant nephrotic syndrome*) only from a relevant specialist. Approvals valid without further renewal unless notified for applications meeting the following criteria:

Either:

1. The patient is a child with steroid-resistant nephrotic syndrome* (SRNS) where ciclosporin has been trialled in combination with prednisone and discontinued because of unacceptable side effects or inadequate clinical response; or

2. All of the following:

2.1   The patient is an adult with SRNS; and
2.2   Ciclosporin has been trialled in combination with prednisone and discontinued because of unacceptable side effects or inadequate clinical response; and
2.3   Cyclophosphamide or mycophenolate have been trialled and discontinued because of unacceptable side effects or inadequate clinical response, or these treatments are contraindicated.

Note: Indications marked with * are Unapproved Indications

Nicotine oral spray 1 mg per dose (example brand name Nicorette QuickMist Mouth Spray) will be listed under the Treatments for Substance Dependence (Nervous System) subheading of Part II of Section H of the Pharmaceutical Schedule (the HML) subject to the following restrictions:

Restricted

Any of the following:

  1. For perioperative use in patients who have a ‘nil by mouth’ instruction; or
  2. For use within mental health inpatient units; or
  3. For acute use in agitated patients who are unable to leave the hospital facilities.

The Special Authority restrictions and HML restrictions for valaciclovir 500 mg tablet will be removed from 1 March 2016.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received were considered in their entirety in making a decision on the proposed changes. Most responses were supportive and the following common issues were raised:

Theme Comment

Responders supported the proposal for aripiprazole for severe irritability associated with autism spectrum disorder and considered it was reasonable to restrict initiation of treatment to patients under the age of 18 years. However, responders considered it would not be clinically reasonable to cease aripiprazole treatment in responding patients when they turn 18 years, which would have been required under the proposed renewal criteria as consulted on.

After considering this feedback and receiving further comment from the Mental Health Subcommittee of PTAC, we did not include the proposed requirement for patients to be less than 18 years of age in the renewal criteria.

Responders considered that there is a need for a 5 mg aripiprazole tablet for people who require a dose lower than 10 mg (the 10 mg tablet is not scored).

This issue was also highlighted by PHARMAC’s Pharmacology and Therapeutics Advisory Committee. PHARMAC staff are currently discussing this possibility with the supplier of aripiprazole, Otsuka Australia.

Responders had various queries about delivery (e.g. by pharmacy) and uptake of the diphtheria, tetanus and pertussis vaccine.

While these queries were not directly related to the proposal, PHARMAC is aware of the issues raised and is working closely with the Ministry of Health and DHBs to consider this topic.

Responders raised a concern about the risk for increased expenditure from the use of nicotine oral spray versus cheaper alternatives.

We note that, as there is no national contract for the supply of nicotine oral spray, PHARMAC does not have any control over the price. We also note that there is a range of alternative less expensive nicotine replacement therapy formulations listed on the HML which can be used (instead of nicotine oral spray) where clinically appropriate.

Responders queried aspects of the proposal for valaciclovir in light of the relatively high cost of the currently funded brand (Valtrex – which costs $102.72 per pack of 30 tablets).

From 1 January 2016, the Vaclovir brand of valaciclovir (supplied by Mylan) will be listed at a price of $6.42 per pack of 30 tablets and the subsidy for Valtrex will be decreasing to match that of Vaclovir on 1 March 2016.

For further information, please see the June 2015 tender notification.

More information

If you have any questions about these decisions, 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.

To repeat, in relation to the funding of somatropin for people with Prader-Willi syndrome, if you have additional information that you would like the Endocrinology Subcommittee of PTAC to consider, please send it to us by 4 December 2015 (to Bronwyn Hale).