Proposal to fund denosumab for osteoporosis

Medicines

Consultation Closed

PHARMAC is proposing to fund denosumab (Prolia) injections from 1 June 2018 for the treatment of severe, established osteoporosis subject to certain clinical criteria being met.

Consultation closes at 5 pm on Wednesday, 4 April 2018 and feedback can be emailed to Alexander Rodgers at alexander.rodgers@pharmac.govt.nz.

What would the effect be?

Certain patients with severe, established osteoporosis who have received inadequate benefit from oral treatments and for whom zoledronic acid is contraindicated due to renal impairment would be eligible for funded treatment with denosumab.

This treatment is an injection given twice a year. Many patients would be able to self-administer, however, some patients may have the injection administered by their general practitioner or a nurse.

We estimate there would be around 5000 patients over five years who may be eligible for treatment with denosumab under this proposal.

Who we think will be interested

  • Health practitioners involved in the treatment of osteoporosis
  • Patients with osteoporosis, or people at risk of developing it
  • Organisations with an interest in osteoporosis treatments
  • Hospital and community pharmacists, DHBs, suppliers and wholesalers.

About denosumab

Denosumab is a fully human IgG2 monoclonal antibody. It is registered with Medsafe for the treatment of osteoporosis.(external link)

The presentation of denosumab that is proposed for funding is a 60 mg prefilled syringe. One syringe is administered every six months for as long as it is considered to have benefit.

Why we’re proposing this

PHARMAC received an application in 2012 to fund denosumab (Prolia) from the supplier, Amgen.

The application was reviewed on a number of occasions by both the Pharmacology and Therapeutics Advisory Committee (PTAC) and its Endocrinology Subcommittee. The final recommendation of PTAC was to fund denosumab for the treatment of osteoporosis in postmenopausal women who have received inadequate benefit from oral treatments and for whom zoledronic acid is contraindicated due to renal impairment, with a medium priority subject to certain criteria. The full history of the proposal can be found at our Application Tracker(external link).

Details about our proposal

  • Denosumab (Prolia) would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 June 2018 at the following price and subsidy (ex-manufacturer, excluding GST):
Presentation Pack size Proposed price and subsidy
Inj 60 mg prefilled syringe 1 $326.00
  • A confidential rebate would apply to Prolia that would reduce its net price to the Funder.
  • Prolia would be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria: