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DGI-018 Budget Impact Analysis on New 3-Year Imatinib Adjuvant Treatment For Patients with Operable GIST at High Risk of Recurrence
  1. V Manescotto1,
  2. S Osella1,
  3. E Cagliero2,
  4. A Leggeri3,
  5. L Cattel4,
  6. A Comandone5
  1. 1University of Turin, School of specialisation in hospital pharmacy, Turin, Italy
  2. 2ASL CN1, Territorial Pharmacy, Cuneo, Italy
  3. 3Director San Giovanni Bosco Hospital, Hospital Pharmacy, Turin, Italy
  4. 4University of Turin, Director School of specialisation in hospital pharmacy, Turin, Italy
  5. 5Gradenigo Hospital, Director UOA Oncology, Turin, Italy

Abstract

Background The results of Phase III of the (SSG)XVIII/AIO clinical study on imatinib (IM) in adjuvant treatment of GIST show that, after five years of follow up, 3 years of treatment lead to 66% of patients free of recurrence compared to 48% who received IM for only one year, with a 18% relative risk reduction. This result will determine the new standard of 3 years of adjuvant IM treatment in GIST patients at high risk of recurrence.

Purpose To analyse the budget impact on Piedmont Region, over 3 years, after the approval by the Italian National Regulatory Agency of 3 years’ adjuvant treatment in high-risk GIST.

Materials and Methods The analysis was performed considering the estimated incidence of 60 new cases of GIST in Piedmont: 28 patients are at very low/low risk of relapse and don’t need IM; 8 patients are at intermediate risk of recurrence and should receive IM only for 1 year; 12 patients are at very high/high risk and are treated with adjuvant IM for 3 years; 12 patients are metastatic at diagnosis and require lifelong treatment (5–13 years). The price of IM considered in this study was fixed (6–2011) in the regional competition in Piedmont (at 16.7305€/100 mg capsule).

Results The annual expenditure for 12 very high/high risk patients is 293,118.6€ which adds up to a total of 879,355.08€ in 3 years. Given the stability of GIST incidence (5 cases/1,000,000 people) and 30% drop off from treatment for intolerance as reported in the SSG/AIO study, the result of our study was: in the first year 12 patients were treated at a total cost of 293,118.36€. The second year for 20 patients (8 from the first year + 12 new) the expenditure was 488,530.6€ (+66.66%). The third year there were 27 patients (7 from the first year, 8 from the second year, 12 new) and a total amount of 659,516.31€ (+35% compared to the second year). The total expenditure on very high/high risk patients at the end of 3 years of observational study was 1,441,165.27€ and the overall incremental cost was +125%.

Conclusions The cost of health interventions in rare tumours should be carefully planned with a specific cancer and pharmacological registry. The availability of comprehensive databases or regional registries of these treatments would allow a more accurate analysis that takes into account both the cost of medicines and ambulatory treatment and follow-up cost. Even though data on current costs are alarming it is important to consider that in 2014 IM will lose the Novartis patent and costs will drop about 30–40%.

No conflict of interest.

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