Proposal to amend or remove funding restrictions from various pharmaceuticals

Medicines

Consultation Closed

PHARMAC is seeking feedback on a proposal to remove or amend the funding restrictions for a number of pharmaceuticals from 1 October 2014.

The proposed changes are summarised below. Details of the proposed changes and background information follow.

The Special Authority and/or hospital medicines list (HML) restrictions for the following products would be removed from 1 October 2014 (unless another date is specified below):

  • Bee and wasp venom allergy treatments
  • Bicalutamide
  • Imiquimod (from 1 February 2015)
  • Mycophenolate mofetil
  • Nicorandil
  • Perhexiline maleate

The funding rules for the following products would be amended to widen funded access from 1 October 2014:

  • Acitretin: some of the prescriber-related criteria would be amended or removed from the Special Authority.
  • Adalimumab, etanercept and tocilizumab: access would be widened to include adult-onset Still’s disease.
  • Benzydamine hydrochloride: full subsidy would be available via prescription endorsement in the community for patients with oral mucositis resulting from cancer treatment.
  • Deferiprone: access would be widened to include acquired red cell aplasia.
  • Gabapentin (Arrow-Gabapentin and Nupentin brands only): access would be widened to include uraemic pruritus and the requirement to trial a tricyclic antidepressant prior to gabapentin would be removed.
  • Insulin pump and insulin pump consumables: access would be widened to include cystic fibrosis-related diabetes;
  • Isotretinoin: some of the prescriber-related criteria would be amended or removed from the Special Authority, and the requirement for a trial of other available treatments prior to accessing isotretinoin would be removed.
  • Midodrine: the requirement for a trial of fludrocortisone and other non-pharmacological treatments prior to accessing midodrine would be removed.

Feedback sought

PHARMAC welcomes feedback on this proposal. Please specify in your response which product(s) your feedback relates to. To provide feedback, please submit it in writing by 5 pm on Friday, 8 August 2014 to:

Geraldine MacGibbon
Senior Therapeutic Group Manager
PHARMAC

Email: july25consult@pharmac.govt.nz  

Fax: 04 460 4995  

Post: PO Box 10 254, Wellington 6143

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) and we will consider any request to have information withheld in accordance with our obligations under the 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. 

Details of the proposal

The proposal is to remove or amend the funding access restrictions applying to various pharmaceuticals in Section B of the Pharmaceutical Schedule and in the Hospital Medicines List (HML; Part II of Section H of the Pharmaceutical Schedule). Existing restrictions for these pharmaceuticals can be found on PHARMAC’s website at the links below – for practical reasons these have not been reproduced in this consultation document.

https://schedule.pharmac.govt.nz/(external link)

Pharmaceutical Schedule (Section H).

Unless another date is specified below, all proposed changes would occur on 1 October 2014.

In relation to the removal of Special Authorities and hospital restrictions

  • The Special Authority and hospital restrictions would be removed from the listings of the following products in Section B and Part II of Section H of the Pharmaceutical Schedule. There would be no change to the price, subsidy, presentation, or listed brand of these pharmaceuticals as a result of this proposal.
Chemical (Therapeutic Group Subheading) Presentation Brand
Bee and wasp venom allergy treatment (Antiallergy Preparations) Treatment Kits (bee venom, paper wasp venom and yellow jacket venom) and Maintenance Kit (bee venom) Albay
Bicalutamide (Endocrine Therapy) Tab 50 mg Bicalaccord
Imiquimod (Wart Preparations) (change from 1 February 2015) Crm 5%, 250 mg sachet AldaraApo-Imiquimod Cream 5% (to be listed 1 December 2014)
Mycophenolate mofetil (Immunosuppressants) Cap 250 mg, tab 500 mg, powder for oral liq 1 g per 5 mlInj 500 mg vial (HML only) Cellcept
Nicorandil (Vasodilators) Tab 10 mg and 20 mg Ikorel
Perhexiline maleate (Calcium Channel Blockers) Tab 100 mg Pexsig

In relation to acitretin

  • The Special Authority for acitretin cap 10 mg and 25 mg (Neotigason and Novatretin) 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:

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:

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:

  • 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:

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:

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:

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.

Further Information

The proposed changes for each pharmaceutical are generally in line with recommendations from PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) or one of the PTAC Subcommittees (subsequently ratified by PTAC). The table below contains links to the most recent relevant PTAC or Subcommittee meeting minutes. Further information for some of the proposed changes can be found in PHARMAC’s Application Tracker at https://connect.pharmac.govt.nz/apptracker/s/(external link); specific links are provided below where relevant. Please contact Geraldine MacGibbon if further information is required (contact details on page 1 of this document).

Pharmaceutical Link to PTAC minutes and Application Tracker (where relevant)
Acitretin, bicalutamide, bee and wasp venom allergy treatments, imiquimod, isotretinoin, midodrine, nicorandil and perhexiline

PTAC minutes - May 2014 [PDF, 286 KB]

Gabapentin

PTAC minutes - May 2014 [PDF, 286 KB]

www.pharmac.govt.nz/ApplicationTracker?ProposalId=1202

Mycophenolate mofetil

PTAC minutes - May 2014 [PDF, 286 KB]

www.pharmac.govt.nz/ApplicationTracker?SearchTerm=mycophenolate+mofetil

Adalimumab, etanercept, tocilizumab

PTAC minutes - May 2013 [PDF, 224 KB]

www.pharmac.govt.nz/ApplicationTracker?ProposalId=800

Benzydamine

Cancer Treatments Subcommittee of PTAC - 22 March 2013 [PDF, 76 KB]

www.pharmac.govt.nz/ApplicationTracker?ProposalId=788

Deferiprone

Cancer Treatments Subcommittee of PTAC - November 2010 [PDF, 145 KB] 

www.pharmac.govt.nz/ApplicationTracker?ProposalId=435

Insulin pumps and consumables

Diabetes Subcommittee of PTAC - December 2013 [PDF, 30 KB]

www.pharmac.govt.nz/ApplicationTracker?ProposalId=807