The Italian Medicines Agency has issued two new positive reimbursement decisions on new innovative medicines and two on new presentations of existing ones in recent weeks.
IHS Global Insight Perspective | |
Significance | In the past weeks, the Italian Medicines Agency (AIFA) has issued two positive decisions on the reimbursement of new innovative medicines, as well as two positive decisions on the reimbursement of new presentations of medicines already on the reimbursement list. |
Implications | The decisions indicate the ongoing reliability of Italy as a market for innovative pharma, although the country's public debt continues to cause worries. |
Outlook | Italy's AIFA is set to continue to back the early and nationwide reimbursement of innovative medicines approved for reimbursement, with the agency's new director making several pro-innovative statements since his inauguration; Italy's high public debts, however, may yet present an obstacle to the realisation of these noble aims in due course. |
The Italian Medicines Agency (AIFA) has issued a number of new reimbursement approvals, which have appeared in the past few days on the internet service of the Official Gazette of the ItalianRepublic. Among these, there are two new reimbursement decisions for innovative medicines, and two decisions approving the reimbursement of new presentations of already-reimbursed medicines.
Jevtana Gains Reimbursement
AIFA has approved the reimbursement of French pharma Sanofi's medicine Jevtana (cabazitaxel) for the first time since it was approved at the centralised level in the EU in mid-March 2011, in combination with prednisone or prednisolone, for the treatment of metastatic hormone-refractory prostate cancer that has previously been treated with a docetaxel-containing treatment regimen. The drug is classified for reimbursement in Italy under category "H", indicating drugs that are only reimbursed within hospitals or equivalent structures. A discount is required on the cost of Jevtana to public healthcare facilities in Italy, although at this stage, no details of this are available. The reimbursement contract is valid for 12 months, and there is an expenditure ceiling imposed on the drug's use within the Italian national health service (SSN) of EUR15 million (USD20.07 million).
Brilique Approved for Reimbursement
Secondly, UK pharma AstraZeneca's Brilique (ticagrelor) has been approved by AIFA for reimbursement, following its centralised approval in the EU in December 2010. Brilique is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome, and is classified for reimbursement in Italy under class "A" of the reimbursement system, referring to medicines available with full reimbursement from pharmacies. It is subject to a 24-month reimbursement contract between AIFA and the producer, and an expenditure ceiling—measured in ex-factory prices—of EUR62.5 million for the duration of the contract.
New Presentations of Pegasys and Ovitrelle Reimbursed
Swiss pharma Roche's drug Pegasys (peginterferon alpha-2a) has been approved for reimbursement in a number of new prefilled pen packages, on the basis of the centralised decision taken by the European Commission at the end of June. Thus, Pegasys is now reimbursed in six new presentation forms, all featuring prefilled pens. The medical indication for which the drug is indicated remains the same: hepatitis B e-antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, increased alanine transaminase and histologically verified liver inflammation and/or fibrosis, as well chronic hepatitis C in adult patients who are positive for serum HCV-RNA, including patients with compensated cirrhosis and/or co-infected with clinically stable HIV.
The medicine is classified under the Italian reimbursement system under class "A", and so is available via pharmacies. The reimbursement contract is valid for two years, and there is a discount in place on the ex-factory price, agreed by AIFA and Roche, although no details of this are provided.
Similarly, AIFA has given its approval to the reimbursement of a new set of pen injectors for German firm Merck KGaA's fertility treatment Ovitrelle (choriogonadotropin alpha), approved at the central level in Europe in late June (see Germany: 5 July 2011: Merck KGaA Receives EU Approval for New Family of Pens). The reimbursement contract between AIFA and Merck KGaA in connection with this decision is also 24 months, and reimbursement is subject to a discount, which is part of the terms of the agreement, although the details of this are not revealed. Reimbursement of Ovitrelle is also subject to AIFA's Note 74, which places certain restrictions on the reimbursement of fertility treatments. The full details of Note 74 can be accessed, in Italian, here.
Outlook and Implications
Having had Jevtana rejected for reimbursement in the United Kingdom, it will certainly be a boost to Sanofi that Italy's reimbursement system remains reassuringly open to new therapies, although it can be observed that recent risk-sharing or payment-by-result schemes in the country are increasingly less favourable to producers.
Brilique has been approved fairly late on in Italy, considering the fact that in the UK, Ireland and Germany, positive decisions have already been made on its reimbursement. A fairly generous expenditure ceiling is in place for the drug, although without information on the type of discount in place, it is hard to tell how good the deal is for AstraZeneca.
In the case of Roche and Merck KGaA, the reimbursement approvals for their new presentations of existing products come quite quickly after approval at the central European level, which is a positive development for them. Indeed, AIFA's new director, Luca Pani, 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.
The economic difficulties being experienced in Italy today and the 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. That said, the government’s pro-innovative stance sends a positive signal to the big pharma and will be a boost to growth in value-based drug sales and health spending.