Australia's new minister for health Peter Dutton has announced the addition of 50 new and amended medicines to the Pharmaceutical Benefits Scheme, including a significant new listing for GlaxoSmithKline (UK)'s BRAF V600-positive targeting melanoma treatment Rafinlar (dabrafenib).
IHS Global Insight perspective | |
Significance | One of the most prominent inclusions is GlaxoSmithKline (GSK; UK)'s BRAF-targeting melanoma treatment Rafinlar (dabrafenib; marketed as Tafinlar in the United States and Europe), which also sees a Medicare Benefits Scheme listing for the accompanying biomarker test. |
Implications | Other prominent listings include Pfizer (US)'s Sutent (sunitinib), for pancreatic cancer, and Amgen (US)'s Prolia (denosumab), approved for reimbursement in men with osteoporosis. |
Outlook | Rafinlar gains a listing after initially being deferred during the March meeting of the Pharmaceutical Benefits Advisory Committee (PBAC) to allow pricing negotiation. Roche (Switzerland) decided not to pursue a listing for its own BRAF-inhibitor melanoma treatment Zelboraf (vemurafenib) following the same meeting, which looks set to benefit GSK. |
Australia's Minister of Health Peter Dutton has announced the addition of 50 new and amended medicines to the Pharmaceutical Benefits Scheme (PBS), treating a range of diseases including cancer, diabetes, and multiple sclerosis.
New and amended PBS listings, 28 October 2013 | |||
Drug | Sponsor | Indication | Comments |
Sutent (sunitinib) | Pfizer | Pancreatic neuroendocrine tumour (pNET) | Recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) during special meeting held in August 2013. |
Aubagio (teriflunomide) | Sanofi (France) | Multiple sclerosis | Recommended by PBAC in July 2013, on a cost-minimisation basis to interferon beta-1a and interferon beta-1b. |
Protos 2 g (strontium ranelate) | Servier (France) | Osteoporosis | PBAC decision to list made in July 2013, not released until Therapeutic Goods Administration marketing approval for the drug granted. |
Xifaxan (rifaximin) | Norgine (Netherlands) | Hepatic encephalopathy | Recommended by PBAC in April 2013. |
Stromectol (ivermectin) | Merck, Sharpe & Dohme (MSD; US) | Round worm infestation | Increased maximum quantity of 8 tablets with 2 repeats for the strongyloidiasis indication. |
Coralan (ivabradine) | Servier | Chronic heart failure | |
Flutiform (fluticasone with eformoterol) | SkyePharma/Mundipharma | Asthma | Recommended by PBAC in July 2013 |
Atozet (ezetimibe with atorvastatin) | MSD | High cholesterol | |
Afinitor (everolimus) | Novartis (Switzerland) | Tuberous sclerosis | PBAC recommended April 2013 |
Tecfidera (dimethyl fumarate) | Biogen Idec (US) | Multiple sclerosis | On a cost-minimisation basis with ABCR therapies |
Prolia (denosumab) | Amgen | Osteoporosis | Approved for use in men with osteoporosis |
Forxiga (dapagliflozin) | Bristol-Myers Squibb (BMS; US) | Type 2 diabetes | Recommended by PBAC in July 2013 |
Tafinlar (dabrafenib) | GSK | BRAF V600 mutation positive advanced (unresectable stage III) or metastatic (stage IV) melanoma | Recommended by PBAC in March 2013 |
Invokana (canagliflozin) | Janssen (subsidiary of Johnson & Johnson, US) | Type 2 diabetes | Listed on cost-minimisation basis with sitagliptin. Recommended by PBAC in July 2013 |
Nesina (alogliptin) | Takeda (Japan) | Type 2 diabetes | Recommended by PBAC in July 2013 |
Symbicort Rapihaler (budesonide with eformoterol) | AstraZeneca | Chronic obstructive pulmonary disease and asthma | Recommended by PBAC in July 2013 |
Botox (botulinum toxin type A) | Allergan (US) | Chronic migraine | Recommended by PBAC in July 2013 |
Source: PBS | |||
Outlook and implications
The new and amended listings have yet to be formally published to the PBS website, which can be expected imminently.
In Minister Dutton's first substantial set of PBS additions since election victory in September, the inclusion of GSK's Rafinlar – marketed as Tafinlar in Europe and the United States – is of particular interest. The PBAC issued a deferral of decision against Rafinlar in March this year, commenting that this was "in order for the Department to consider an appropriate arrangement for data collection related to BRAF testing, and to enable price negotiations between the Department and the sponsor". At the same meeting it also deferred Roche's own BRAF-targeting melanoma treatment Zelboraf (vemurafenib) for the same reasons, although it also noted that it did not view Zelboraf as cost-effective versus comparator (see Australia: 29 April 2013: Australia's PBAC releases March outcomes). Roche reacted angrily to the course of negotiations at that time, deciding against pursuing a listing for Zelboraf (see Germany - Australia - Switzerland: 6 May 2013: Australian government continues Yervoy price negotiations, Roche gives up on Zelboraf PBS listing). GSK is now benefiting from Roche's decision, and joins Bristol-Myers Squibb (US)'s melanoma treatment Yervoy (ipilimumab), listed in July this year, on the PBS.
Raflinar targets the specific BRAF V600 mutation, estimated to be prevalent in about half of all melanoma cases. The genetic test needed to determine eligibility for the drug is also reimbursed under the Medicare Benefits Scheme, with around 800 Australians set to benefit from reimbursed testing and treatment as a consequence. GSK estimated that the drug would cost the PBS AUD30 million to AUD60 million by the fifth year of use. The decision will be particularly welcomed in Australia, which has the world's highest incidence of skin cancer, with one in 17 Australians at risk of developing the disease during their lifetime (source: DoHA).
The listing for Sutent, meanwhile, is expected to benefit only 50 patients, and was viewed by the PBAC as providing a treatment alternative for a disease with unmet needs at little financial impact on the PBS. The drug was already reimbursed in Australia for gastrointestinal tumours and renal cell carcinoma. Prolia's approval for use in men with osteoporosis will benefit around 5,700 patients.
Related articles
- Australia: 1 July 2013: Australian government approves delayed PBS listings for Yervoy, Zytiga, and Xarelto