Italy’s medicines agency, AIFA, has published the list of innovative medicines which the country’s regions and provinces are now required to make available to patients.
The list follows the recent agreement between Italy’s central government and the country’s regions and autonomous provinces which seeks to bring an end to the variations in availability of innovative new drugs across the nation. This access “lottery” has arisen when some regions have chosen, after AIFA has published its reimbursement decisions on certain innovative new products, not to add these medicines to their formularies, frequently on the grounds of the drugs’ high costs.
Under the agreement, the regions and provinces are now required to list all 19 drugs on the list within 30 days of AIFA publishing its reimbursement decisions. They will be able to challenge these decisions, and if any alterations are made to a product’s reimbursement status as a result of such appeals, the changes will be applied nationwide.
Four of the 19 drugs on the list have been classified by AIFA’s advisory committee as “important” innovations - these are Novartis’ Lucentis (ranibizumab) and Pfizer’s Macugen (pegaptanib), both treatments for wet age-related macular degeneration (AMD), and two HIV/AIDS treatments, Merck & Co’s Isentress (raltegravir) and Pfizer’s Celsentri (maraviroc). All four are listed as category H (hospital drugs) in the reimbursement system of Italy’s national health service, the Servizio Sanitario Nazionale (SSN).
Two other drugs on the list are category H products – Astellas Pharma’s antifungal Mycamine (micafungin) and Mitsubishi Tanabe Pharma’s Novastan (argatroban), which is licensed for anticoagulation in adult patients with heparin-induced thrombocytopenia type II who require parenteral antithrombotic therapy.
The other 13 products are listed as category A drugs, ie, fully reimbursed prescription drugs supplied through pharmacies. They include seven treatments for type 2 diabetes – Eli Lilly’s Byetta (exenatide), Novartis’ Galvus (vildagliptin) and Eucreas (vildagliptin and metformin), Merck & Co’s Januvia (sitagliptin) and Janumet (sitagliptin and metformin), Bristol-Myers Squibb/AstraZeneca’s Onglyza (saxagliptin) and Novo Nordisk’s Victoza (liraglutide).
The other six category A drugs on the list are: Pfizer’s Conbriza (bazedoxifene) for postmenopausal osteoporosis; Eli Lilly/Daiichi Sankyo’s antiplatelet agent Efient (prasugrel); Servier’s Procoralan (ivabradine) for angina pectoris; Wyeth’s Relistor (methylnaltrexone bromide) for the treatment of opioid-induced constipation; Santen’s Taflotan (tafluprost) for ocular hypertension; and UCB’s epilepsy treatment Vimpat (lacosamide).
Commenting on the list’s publication, analysts at IHS Global Insight suggest that it could represent a very positive development for companies producing the drugs on the list and an opportunity to increase revenue as access to their medicines expands - not to mention the potential benefits for certain patients who have had difficulty gaining access to these medicines in their regions. However, they also point out that some of these drugs are very expensive – Lucentis and Macugen, for example, are supplied under risk-sharing agreements with AIFA - and warn of the financial implications for the regions, many of whose health authorities are already carrying very large debts, of being required to supply these products, particularly those regions which have large elderly populations.
“As yet, the issue of large regional healthcare and hospital debts has not been raised in connection with this new regional innovative-drug access initiative, and there is a sense that it is only a matter of time before it is raised, considering the high cost of some of these drugs,” the analysts forecast.