Medicines for the treatment of melanoma

Page last updated: 26 October 2018

Drug utilisation sub-committee (DUSC)

May 2018

Abstract

Purpose

To review the utilisation of molecularly targeted drugs and immunotherapies listed on the PBS for the treatment of unresectable stage III or metastatic (stage IV) melanoma.

Date of listings and key listing amendments on the Pharmaceutical Benefits Scheme (PBS)

Drug name	Listing date	Details
Ipilimumab	1 August 2013	First listing for ipilimumab as monotherapy.
Dabrafenib	1 December 2013	First listing for dabrafenib in patients who are BRAF V600 mutation positive. For use in previously untreated patients and those developing intolerance to another BRAF inhibitor.
Trametinib	1 August 2015	First listing for trametinib for use in combination with dabrafenib for patients who are BRAF V600 mutation positive.
Pembrolizumab	1 September 2015	First listing for pembrolizumab for use as a sole PBS-subsidised therapy.
Dabrafenib and trametinib	1 April 2016	The restriction levels of dabrafenib and trametinib were changed from Authority Required (telephone) to STREAMLINED Authority.
Nivolumab	1 May 2016	First listing of nivolumab for use as a sole PBS-subsidised therapy.
Ipilimumab	1 December 2016	The clinical criteria were amended from “The treatment must be as monotherapy” to read “The treatment must be the sole PBS-subsidised therapy for this condition”.
Vemurafenib	1 April 2017	First listing of vemurafenib in patients who are BRAF V600 mutation positive. For use as monotherapy or in combination with cobimetinib.
Cobimetinib	1 April 2017	First listing of cobimetinib for use in combination with vemurafenib.
Pembrolizumab	1 July 2017	Listing of an additional strength, 100 mg concentrated injection, under the same conditions as the 50 mg listing.

Data Source

Data to assess the utilisation of medicines listed on the Pharmaceutical Benefits Scheme (PBS) was obtained from the Department of Human Services (DHS) PBS prescription claims database. Data on the utilisation of Medicare Benefits Schedule (MBS) services for mutation testing of the BRAF gene were extracted from the DHS Medicare Item Statistics Report.

Key Findings

• There was substantial growth in the overall utilisation of medicines to treat Stage III unresectable and Stage IV metastatic melanoma since the listing of pembrolizumab from 1 September 2015. In 2017, a total of 3,792 patients received a supply of a PBS subsidised medicine.
• For patients initiating therapy between 1 January and 30 June in 2016, the time on PBS therapy with pembrolizumab and BRAF targeted medicines was similar to the progression-free survival times observed in clinical trials. The duration of treatment with ipilimumab, for both induction and re-induction, was less than anticipated.
• Pembrolizumab was the most commonly dispensed medicine in patients first initiating on PBS therapy in 2016 or 2017. A relatively small proportion (less than 10 percent) of patients was supplied further episodes of therapy with a different drug regimen. Ipilimumab was the most commonly supplied drug regimen to patients who were refractory to their first episode of therapy.

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