The Italian Medicines Agency (AIFA) has approved for reimbursement five originator medicines in recent weeks
IHS Global Insight perspective | |
Significance | The Italian Medicines Agency (AIFA) has issued five positive reimbursement decisions on originator medicines in recent weeks. |
Implications | The decisions provide patients with access to treatments at inpatient and outpatient levels. |
Outlook | The positive decisions for the manufactures concerned should result in increased sales on the Italian market. |
The Italian Medicines Agency (AIFA) has issued five new reimbursement approvals for originator drugs, which have been published on the country's Official Gazette. (Full text for the 5 February decision is available, in Italian, here; and the 11 February decision is available here.)
Pfizer's Revatio gains reimbursement
AIFA approved for reimbursement Pfizer (US)'s drug Revatio (sildena?l) for the treatment of adult patients with pulmonary arterial hypertension (WHO) functional class II and III, with the aim of improving the ability to do physical exercise. The efficiency has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Furthermore, the drug is also approved for reimbursement for the treatment of pediatric patients aged 1 to 17 years with hypertension pulmonary arterial hypertension. The efficiency in terms of improving the ability to do physical exercise or pulmonary hemodynamic has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease. The drug has been granted classification A status that indicates that the medicine is fully reimbursed subject to prescription. The agency's provision also specified the maximum price approved for the reimbursement, which is fixed at EUR284.71 (USD380.35, ex-manufacturer price) and EUR469.89 (retail price). In addition, AIFA specifies that further to the negotiation, a mandatory discount will be applied when the drug is supplied to public healthcare facilities.
GSK's anti-epileptic drug Trobalt approved
GlaxoSmithKline (GSK, United Kingdom)'s Trobalt (retigabine) has been granted reimbursement as adjunctive treatment of partial onset seizures with or without secondary generalisation in people aged over 18 with epilepsy. The medicine has been granted classification A status, with a maximum price approved for reimbursement of EUR3.84 (ex-manufacturer) and EUR6.34 (retail) for a pack of 21 50mg tablets. However, the same drug has not been approved for reimbursement for an initiation pack of 21 50mg tablets + 42 100mg tablets, receiving classification C status (non-reimbursed medicines subject to prescription). The provision also specifies that further to the negotiation, a mandatory discount will be applied to public healthcare facilities. Furthermore, AIFA introduced an ex-manufacturer expenditure ceiling of EUR7 million in the 24 of validity of the contract.
Leukaemia drug Busilvex reimbursed within hospitals
AIFA has approved the reimbursement of Pierre Fabre (France)'s medicine Busilvex (busulfan), indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in adult patients when the combination is considered the best available option. Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in pediatric patients. The drug is classified for reimbursement in Italy under category H. The maximum price approved in the provision is EUR2,285 (ex-manufacturer) and EUR3,771.16 (retail) for an eight-phial package. The provision specifies that the expenditure ceiling is suppressed according to negotiating terms.
HIV drug Eviplera gets the nod
Gilead Sciences (US)'s Eviplera (emtricitabine + tenofovir disoproxil + rilpivirine) has been granted classification H reimbursement status for the treatment of human immunodeficiency virus type 1 (HIV-1) in adult patients who have not been treated with antiretroviral therapy with a viral load greater than 100,000 copies/mL of HIV-1 RNA. A genotypic resistance testing must be used to regulate it. The provision indicates the price cap approved for a 30-tablet package as EUR728.46 (ex-manufacturer) and EUR1,202.25 (retail). Further to the negotiation, a mandatory discount will be applied to public healthcare facilities.
Sanofi's diabetes treatment approved
AIFA also approved for reimbursement French pharmaceutical group Sanofi's insulin Insuman, granting the drug classification A status. The provision approved three different types: Insuman Comb 30, Rapid, and Basal for the treatment of diabetes mellitus as well as hyperglycaemic coma and ketoacidosis, and to stabilise pre-, intra- and post-operative patients with diabetes. AIFA indicated the maximum price for which the drug is approved is EUR9.88 (ex-manufacturer) and EUR16.31(retail).
Outlook and implications
AIFA's decisions clearly indicate that the Italian policymakers are trying to counterbalance tight budget constraints on the pharmaceutical and healthcare budget with stimulus for innovation.
The reimbursement represents positive news for patients and manufacturers, with the former provided access to a series of innovative treatments, and the latter have the opportunity to boost sales following the receipt of reimbursement on the Italian market. However, they manufacturers have had to accept price caps and in some cases discounts as a prerequisite for receiving reimbursement.
It is particularly positive news for Gilead Sciences' HIV drug Eviplera, which was recently launched in France (see France - United States: 20 September 2012: HIV Combination Drug Eviplera Launched in France). However, the drug will compete with other products available for reimbursement in Italy for the treatment of HIV, example Janssen Pharmaceutica (subsidiary of Johnson & Johnson, US)'s Edurant (rilpivirine).