ITALIAN MONITORING REGISTRY OF BEVACIZUMAB IN THE TREATMENT OF METASTATIC COLON RECTAL CARCINOMA

Author(s)

Siviero PD, Montilla S, De Nigro L, Foggi P, Tomino C, Rasi GItalian Medicines Agency (AIFA), Rome, Italy

OBJECTIVES: The treatment of bevacizumab in patients with metastatic colorectal carcinoma, in combination with fluoropyrimidine-based chemotherapy, is purchased by the NHS according to an agreement issued between AIFA and the manufacturer. The agreement includes the enrollement of patient in a monitoring registry and a cost-sharing scheme, based on 50% discounts of initial therapy cycles for all eligible patients and the refund of cost of doses exceeding the total dosage of 11.000 mg for each year of treatment (capping-dosage). This study is aimed at the economic evaluation of the financial agreement on the basis of evidences collected by the Registry. METHODS: Data were collected for patients enrolled in 2009, lock-on database at November 30, 2010. Data on baseline characteristics were analysed for eligible patients, whereas duration treatment, dosage and financial outcome were collected for patients whose therapy was completed. RESULTS: The Registry enrolled 4602 patients. Baseline patient age included 52.8% patients aged < 65 years, 24.4% of patients with an ECOG performance status ≥1. At database lock, 2667 (57.9%) patients had completed the treatment, 66.3% for progression disease, 2.8% patients had died, 13.3% for clinical decision and 4.7% for the medicine toxicity, 13.3% for non-related medicine causes. The dosage of 5-mg/kg every two-weeks was the most used, both in first (84.5%) and in second-line (81.9%). Median-duration therapy was 160-day (9 cycles). Data on safety were consistent with available evidences. The cost-sharing-agreement financial outcome produced was a median discount of 12.2% of therapy costs reimbursed by NHS: cost-sharing accounting for 12.1% and capping-dosage for 0.1%.  CONCLUSIONS: The implementation of the cost-sharing scheme supported early patient access to the treatment, introducing bevacizumab in Italy at global-reference-price, with an effective overall discount produced essentially by the cost-sharing tool, linked to dosage and number of total doses required. The Registry also facilitated the collection of utilization evidences from real clinical world, improving the appropriate use and increasing efficiency.

Conference/Value in Health Info

2011-05, ISPOR 2011, Baltimore, MD, USA

Value in Health, Vol. 14, No. 3 (May 2011)

Code

PCN99

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes

Disease

Oncology

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