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Table 3 Examples of patient access schemes involving price caps in operation in Europe and US

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

Country Examples
Italy Bevacizumab for the management of approved cancers cannot exceed €25,941 per year
Sweden Stockholm County Council initially signed an agreement in April 2008 lasting until end December 2009 whereby if patients with advanced cancer exceeded an accumulated dose of 10,000 mg of bevacizumab, the additional costs would be fully covered by the Company
The scheme has now been extended into 2010
Other regions in Sweden have also been offered similar schemes
UK - England, Wales Schemes include the Ranibizumab Reimbursement Scheme. Under the scheme, the first 14 injections in the eye for the management of wet age-related macular degeneration (AMD) are paid for by the national health service with patients demonstrating an 'adequate response' to therapy to continue with treatment. The drug costs of any subsequent ranibizumab injections will be reimbursed by the company (Novartis) either as free drug or as a credit note
Other schemes include Lenalidomibe for patients with multiple myeloma who have received prior therapy. This scheme was approved to enhance the cost effectiveness of lenalidomibe. Under this scheme, the manufacturer pays the cost of the drug if more than 26 cycles are needed for any patient (approximately 2000 patients in the UK) - equating to any patient needing more than 2 years of therapy
Ustekinumab for moderate to severe psoriasis is another example. Under this scheme two 45 mg vials (90 mg) are provided for people who weigh more than 100 kg at the same cost as a single vial in the form of free drug
UK - Scotland Schemes incude'Ranibizumab Reimbursement Scheme - as above
In addition Ustekinumab - as above. SMC estimates that this patient access scheme will minimise the additional budget impact so long as prescribing is in line with the manufacturer's proposed positioning
US Programmes were introduced by Genentech in the US in 2006 to cap the total cost of bevacizumab at $55,000 per year for patients below an income of $75,000 per year. Costs are a particular issue especially for patients with breast cancer, as well as earlier stages of lung and colon cancer, with the scheme resulting in a 50% reduction or more in costs for one year of treatment. The company believed this would help address public concern over the rising prices for cancer drugs
ImClone Systems and Bristol-Myers Squibb announced in 2006 that lower-income patients who reached a price cap of approximately US$10,000 monthly for cetuximab could receive additional supplies at no extra cost, or at a large discount. This administered through an independent charitable programme
Amgen in 2006 introduced the Oncology Assistance (AOA) programme to provide financial assistance for patients prescribed panitumumab for the treatment of metastatic colorectal cancer when co-payments reached 5% of patient's adjusted gross income. This administered via a Foundation
Pfizer recently launched the MAINTAIN scheme running from 1 July 2009 to 31 December 2009. Under the scheme, Pfizer will help patients who have recently made redundant to continue obtaining their medicines
There are also a number of assistance programmes for patients with HIV both for antiviral drugs to treat the disease as well as side-effects of therapy. Eligible patients include those with low income not covered by existing programmes including Medicare Part D
In addition, Managed Care Organisations have also instigated maximum dose policies with manufacturers to reduce their exposure, e.g. United Healthcare