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Table 2 Examples of patient access schemes in Australia and Europe including free drug or discounts

From: Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers

Country Examples
Australia There are pricing arrangements for Section 100 drugs (restricted supply of specialist drugs to hospitals or other similar facilities) whereby companies typically provide free drugs to lower the cost per unit; alternatively provide an agreed percentage discount to Medicare Australia
Examples include Abacavir - the Pharmaceutical Benefit Scheme would only pay for 2 packs for every 3 supplied, Cirone progesterone gel - Listing was achieved with the help of a 49.5% discount, and Deferasirox - a 20% discount was applied to achieve reimbursement
Serbia Patient access schemes were initiated in 2008 to enhance the value of three cancer drugs, namely bevacizumab, cetuximab and mabCampath
For these medicines to be included (reimbursed) in the positive list covered by mandatory health insurance, specific agreements were established between the Serbian Health Fund and the manufacturers
Under the terms, the manufacturers agreed to rebate of 25% of the reimbursed costs in 2008; this was reduced to 11% in 2009. One cancer treatment was excluded as the manufacturer did not want to enter into the scheme
UK (England, Wales) NICE (National Institute for Health and Clinical Excellence) has recently entered into a number of patient access programmes to enhance the value of new medicines
Examples include cetuximab as first line treatment of metastatic colorectal cancer. Under this scheme, Cetuximab will be rebated as free stock (1 vial per 8 utilised) when used in combination with FOLFOX. Alternative methods will be found if 'free stock' is not suitable. In addition, patient registration is essential to ensure scheme integrity and NICE usage criteria are followed. The Trust pharmacy will carry out a monthly/quarterly audit of usage to make claims from the manufacturer, with free stock delivered directly to the Trust
Other examples include Sunitinib for patients with metastatic renal cell carcinoma. Under this scheme, the first treatment cycle (6-weeks costing an average of GB£3139/patient) is provided free via a patient access programme. Subsequent cycles are funded by the NHS until disease progression. The Department of Health considered the scheme did not constitute an excessive administration burden on the NHS
Sorafenib for metastatic renal cell carcinoma is another example. Under this scheme, the first pack (200 mg × 112 tablets) is provided free by the manufacturer under the agreed patient access programme. This equates to £2980.47 p excluding VAT
UK (Scotland) A Patient Access Scheme Assessment Group (PASAG) has recently been established under NHS National Services Scotland reviewing and advising NHS Scotland on the feasibility of proposed schemes for implementation. PASAG operates separately from the Scottish Medicines Consortium (SMC) in order to maintain the integrity and independence of SMC's assessment process. The first scheme was accepted in November 2009
Schemes accepted by NICE may be implemented in Scotland if the medicine was previously accepted by SMC prior to November 2009 or if the medicine has been assessed via the NICE multiple technology appraisal process and the advice has been accepted by NHS Scotland
Examples include cetuximab where the manufacturer estimated that the budget impact in Scotland for suitable patients would increase from £1.8 mn in year 5 to £2.5 mn if no patient access scheme was in place