The Australian government has left the Pharmaceutical Benefits Scheme (PBS) untouched in its latest round of budget cuts, and instead a number of drugs have been granted new or extended listings. The government has also agreed to increase the price of nine PBS-listed drugs.
IHS Global Insight perspective | |
Significance | Regeneron (United States)'s and Boehringer Ingelheim (Germany)'s Eylea (aflibercept) saw its listing on the PBS extended; having previously been available only to treatment-naïve patients, sufferers of wet age-related macular degeneration (AMD) may now switch from Lucentis (ranibizumab) or Visudyne (verteporfin) to Eylea. |
Implications | A number of other drugs are either added to the PBS or given extended listings, covering therapeutic areas including cancer, deep-vein thrombosis, high blood pressure, and high cholesterol. In addition, nine other drugs will see price increases take effect from 1 December. |
Outlook | The extended listing for Eylea means the drug becomes the first choice for wet AMD. Meanwhile, the new and extended listings reflect that the Australian government has refrained from targeting the PBS for savings cuts in its latest mini-budget. |
Australia's Pharmaceutical Benefits Scheme (PBS) has announced a number of new or extended drug listings, and raised the prices of nine listed drugs, after the reimbursement scheme was left unscathed during the government's latest attempts to find budget savings.
New and extended listings
The most high-profile of the new or extended drugs is the extension to the listing of Regeneron (United States)'s and Boehringer Ingelheim (Germany)'s wet age-related macular degeneration (AMD) treatment Eylea (aflibercept). Having previously been restricted to treatment-naïve patients, patients already being treated with the PBS's other listed wet AMD treatments – Lucentis (ranibizumab; Novartis, Switzerland) or Visudyne (verteporfin; Valeant Pharmaceuticals, Canada) – may now switch to Regeneron. The decision was taken on the recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC), which first recommended Eylea for the restricted listing in March, and then recommended extended the listing in August. The drug costs USD1,850 per dose in the US, versus USD2,000 for Lucentis, but will now be available to patients in Australia for AUD5.80 (USD5.96). Minister of Health Tanya Plibersek welcomed the decision, stating on her website that, as well as being priced under the level of Lucentis, Eyelea "has a simple but real benefit for patients. Instead of receiving eye injections every month, all patients will now have the option of using a medicine that only requires an injection every two months".
Plibersek also hailed an extended listing for Myfortic (mycophenolate sodium; Novartis), an immunosuppressant drug used to prevent organ rejection after transplants, but which also has benefit for treating kidney inflammation caused by lupus, a problem particularly affecting the Aboriginal and Torres Strait Islander population in Australia.
Other drugs given extended or new listings are listed below, and the relevant PBS website page can be found here.
- Emend (aprepitant; Merck & Co, US) – for nausea and vomiting associated with chemotherapy for cancer.
- Atenolol-AFT (atenolol; AFT Pharmaceuticals, Australia) – for high blood pressure.
- Vytorin (ezetimibe with simvastatin; Merck & Co and Schering Plough, US) – for high cholesterol.
- Naloxone Min-I-Jet (naloxone hydrochloride; CSL Pharma, Australia) – for the emergency treatment of opioid overdose.
- VitA-POS (paraffin compound eye ointment; Croma-Pharma GmbH, Austria) – for severe dry eye syndrome.
- Xarelto (rivaroxaban; Bayer AG, Germany) – for deep-vein thrombosis (blood clots).
- Hylo-Fresh/Hylo-Forte (sodium hyaluronate; AFT Pharmaceuticals) – for the treatment of severe dry eye syndrome.
- Temodal (temozolomide; Johnson & Johnson, US) – for the treatment of certain types of malignant brain cancer.
Price changes
A number of unspecified price increases and decreases were also agreed by the PBS, set to take effect from 1 December. The increases will affect nine drugs, including hepatitis B treatment Zeffix/3TC (lamivudine; GlaxoSmithKline, United Kingdom), and two treatments for infertility in women will see decreased prices, Cetrotide (cetrorelix) and Orgalutran (ganirelix). See here for a full list.
Outlook and implications
The decision to allow patients already undergoing wet AMD treatment to switch to Eylea is of particular note; the drug's benefit to the patient in terms of requiring one injection every two months, as well as being less costly than Lucentis, means it would now appear to be the PBS's first choice in the AMD sphere, although decisions will still be made by physicians with reference to particular patient requirements. Lucentis and Visudyne remain restricted to treatment-naïve patients only, and Novartis in particular will be worried by the decision in favour of another competitor to Lucentis, following Genentech (US)/Roche (Switzerland)'s Avastin (bevacizumab)'s rise as an off-label alternative. The news for Eylea has been increasingly positive of late, with soaring sales set to continue; Regeneron recorded returns of USD124 million from the drug in the first quarter of 2012, and is reported to have captured 13% of the US AMD market within nine months of launch. The drug was recently recommended for approval in Europe, approved in Japan, and has seen its indications extended in the US (see United States - Europe: 24 September 2012: Eylea Gains Positive Recommendation for Wet AMD in Europe, Extended Indications for CRVO in US).
The Australian government states that 110,000 patients are set to benefit in total from the new and extended PBS listings, and the listings and price increases indicate that the PBS has escaped inclusion within the AUD16.4 billion in spending cuts announced in the Australian government's mini-budget yesterday (23 October). Although this will be the cause of relief for the pharma industry and patients, in truth the damage has already been done in recent months. Savings were achieved by the government's decision to put off a moratorium on government delays to listings on the PBS, while a number of price cuts are set to take effect from 1 December this year, the latest in a long line of cost-saving measures dating back to 2006 (see Australia: 1 October 2012: Australian government delays decision on PBS listings until 2014 and Australia: 27 July 2012: Australian Government to Cut Price of Atorvastatin by 25%, Rosuvastatin by 21%). Such measures have certainly achieved stable growth in PBS spending, which grew by 1.6% to AUD9.8 billion in 2010–11, and there will now be calls from industry groups for the government to consider alternatives to price reductions in order to achieve health spend savings (source: PharmacyNews.com.au). The government has achieved a fall in total health spending during fiscal year 2012/13 to AUD61.008 billion, from AUD61.168 billion in 2011/12 (source: Department of Health and Ageing).
Related articles
- Australia: 1 October 2012: Australian government delays decision on PBS listings until 2014
- Japan: 10 September 2012: Japan's PAFSC Makes Seven Recommendations
- United States: 30 April 2012: Regeneron Reaches Profitability on Eylea Sales
- Australia: 21 December 2011: Price of Generics in Australia to Be Slashed by Up to 80%
- Australia: 18 November 2011: Drug Makers and Pharmacies Cite Low Growth to Delay Further Savings Measures
- Australia: 10 March 2011: Subsidies for New Medicines to Depend on Offset Budget, Australian Health Minister Shocks Pharma Chiefs