In Italy, recent positive reimbursement decisions for important drugs indicate that the country is set to remain a market for innovation, although the continuing national debt crisis may present a stumbling block, a leading analyst warns.
The reimbursement decisions announced by the national drugs agency, AIFA, concern two new products - Sanofi's prostate cancer drug Jevtana (cabazitaxel) and AstraZeneca's acute coronary syndrome (ACS) treatment Brilique (ticagrelor) - and new presentations of two drugs which are already reimbursed - Roche's Pegasys (peginterferon alpha 2a) for hepatitis C and Merck KGaA's fertility treatment Ovitrelle (choriogonadotropin alpha).
AIFA has approved reimbursement for Jevtana used in combination with prednisone or prednisolone for the treatment of metastatic hormone-refractory prostate cancer that has previously been treated with a regimen containing docetaxel. Jevtana's reimbursement classification is "H," indicating use by hospitals or similar institutions only, and the manufacturer is required to supply it at a discount to the national health service, the SSN. A cost ceiling of 15 million euros has been set on Jevtana's use within the SSN during its reimbursement contract, which is set for 12 months.
Brilique’s reimbursement covers its use in the prevention of atherothrombotic events in adult ACS patients, and it is listed for full reimbursement - classification "A." Its reimbursement contract runs for 24 months and includes an undisclosed discount, and the SSN expenditure ceiling for its use is 62.5 million euros.
Six new presentations of Pegasys in prefilled pen packages have been approved for reimbursement, under classification "A" and with a 24-month contract. An undisclosed discount has been agreed between the manufacturer and the agency.
Ovitrelle is also now reimbursed in a new pen injector presentation, with a 24-month contract and requirement for a discount which, again, has not been made public.
Following the UK's National Institute for Health and Clinical Excellence (NICE)'s recent draft guidance not recommending the use of Jevtana on the NHS, "it will certainly be a boost to Sanofi that Italy's reimbursement system remains reassuringly open to new therapies," comments Brendan Melck, European analyst at IHS Global Insight. However, he also points out that recent risk-sharing or payment-by-result schemes in Italy are increasingly less favourable to producers.
Mr Melck also decribes the expenditure ceiling set by AIFA for Brilique as "fairly generous," although he adds that, "without information on the type of discount in place, it is hard to tell how good the deal is for AstraZeneca."
Reimbursement approvals for the new presentations of Pegasys and Ovitrelle have come quite quickly after they were approved at European Union (EU) level, he adds, and points out AIFA's new director Luca Pari has re-emphasised the position of his predecessor, Guido Rasi (now head of the European Medicines Agency), concerning "the importance of the consistent, nationwide reimbursement of innovative medicines, which can be blocked to some extent by the regions' own cost-containment agendas."
However, Mr Melck also warns that Italy's economic difficulties and high levels of public debt, "to which the SSN is an important contributor, should be a counterweight to any sense of relief that Italy continues to be a reliable market for innovative pharma."