IHS Global Insight Perspective | |
Significance | Italian Medicines Agency AIFA has published its first list of drugs that are subject to the recent agreement between Italy's regions and autonomous provinces and the central government concerning equal access across regions to innovative drugs approved for reimbursement by AIFA; prominent among the drugs on the list are Type 2 diabetes, wet AMD, and HIV/AIDS treatments. |
Implications | Regions that do not have these drugs on their regional formularies will now presumably be required to add them, although the regions concerned will have the opportunity to appeal. |
Outlook | This could represent a very positive development for the 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 had previously had trouble gaining access to these medicines in their regions. However, 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 Italian Medicines Agency (AIFA) has published its first list of drugs covered by the recent agreement between the Italian regions and autonomous provinces and the central government concerning access to innovative medicines approved by the agency (see Italy: 19 November 2010: Breakthrough Agreement Reached with Italian Regions on Access to Innovative Drugs Approved by AIFA). This agreement, made within the framework of the Permanent Conference for Relations between the State, Regions, and Autonomous Provinces, has come into existence in order to reduce the regional disparities in access to innovative medicines, which is the result of regions adopting their own formularies and opting not to add certain medicines to these, reportedly often due to cost-containment reasons.
Type 2 Diabetes, HIV/AIDS, and Wet AMD Drugs to the Fore
The list contains medicines categorised under the reimbursement system of the Italian national health service as hospital drugs—or category "H"—as well as those coming under category "A", which comprises fully reimbursed prescription drugs, available from pharmacies. It also differentiates between those drugs deemed to represent an "important" innovation by AIFA's scientific and technical committee, and those deemed by the committee to have innovative potential. A total of 4 out of the 19 medicines on the list are classified as "important" innovations: of these four, two are treatments for wet age-related macular degeneration (AMD)—Lucentis (ranibizumab; Novartis, Switzerland), and Macugen (pegaptanib; Pfizer, U.S.). The other two are HIV/AIDS treatments Isentress (raltegravir; Merck & Co., U.S.) and Celsentri/Selzentry (maraviroc; Pfizer, U.S.).
There is a strong emphasis on "next-generation" Type 2 diabetes drugs, with all of the marketed dipeptidyl peptidase-4 inhibitors, including Merck & Co's Januvia (sitagliptin), and incretin mimetics, including U.S. firm Eli Lilly's Byetta (exenatide), included on the list.
Medicines Included on AIFA List of "Important" and "Potential" Innovation for Regional Reimbursement | |||
Name | Producer | Indication / Drug Type | Reimbursement Category |
Lucentis (ranibizumab) | Roche (Switzerland) | Wet AMD | H |
Macugen (pegaptanib) | Pfizer | H | |
Isentress (raltegravir) | Merck & Co. | HIV/AIDS | H |
Celsentri/Selzentry (maraviroc) | Pfizer | H | |
Januvia (sitagliptin) | Merck & Co. | Type 2 Diabetes | A |
Janumet (sitagliptin + metformin) | |||
Galvus (vildagliptin) | Novartis (Switzerland) | ||
Eucreas (vildagliptin + metformin) | |||
Onglyza (saxagliptin) | Bristol-Myers Squibb/AstraZeneca (U.S./U.K.) | ||
Byetta (exenatide) | Eli Lilly | ||
Victoza (liraglutide) | Novo Nordisk (Denmark) | ||
Efient (prasugrel) | Eli Lilly/Daiichi Sankyo (U.S./Japan) | Platelet inhibitor | A |
Procoralan (ivabradine) | Servier (France) | Angina pectoris | A |
Conbriza (bazedoxifene) | Pfizer | Postmenopausal osteoporosis | A |
Mycamine (micafungin) | Astellas Pharma (Japan) | Candidiasis and related complications | H |
Taflotan (tafluprost) | Santen (Japan) | Ocular hypertension | A |
Vimpat (lacosamide) | UCB (Belgium) | Epilepsy | A |
Novastan (argatroban) | Mitsubishi Tanabe Pharma (Japan) | Selective antithrombic agent | H |
Relistor (methylnaltrexone bromide) | Wyeth (U.S.) | Opioid-induced constipation | A |
Source - AIFA | |||
Outlook and Implications
According to the agreement signed by the regions on 18 November, these drugs will now have to be included on the regional hospital formularies of those regions in which such formularies are in force, within 30 days of the reimbursement decision by AIFA; however, the regions will be free to dispute any reimbursement decisions by AIFA, in which case, any changes that are made subsequent to a disputed decision will be applied to the whole of Italy. Thus, from first view, it would seem that for the producers of these drugs, it is a very positive development, as well as for patients in regions that may have opted not to reimburse some of these drugs due to cost-containment concerns. There is, however, a sense that even though it is far more desirable for there to be access to drugs with high (or potential) innovative value across regions, with no discrepancies, the question of the huge debts of Italian regional healthcare authorities and hospitals—in which hospital-supply drugs have a major share—does not seem to have been addressed in connection with this new regional innovative-drug access initiative. Indeed, looking at the case of Lucentis and Macugen—very high-cost drugs, which are subject to risk-sharing agreements with AIFA—it is difficult to imagine how the obligation to reimburse these drugs will not put pressure on the budgets of some regions, particularly those with large populations of elderly people.
The addition of the full list of "next-generation"' Type 2 diabetes drugs follows soon after the addition to the Italian reimbursement list of the two most recently approved examples of these to appear on the market, Victoza and Onglyza (see Italy: 29 July 2010: Two Innovative Type 2 Diabetes Drugs Approved for Reimbursement in Italy). A recent report suggested that Italy was lagging behind in terms of access to innovative diabetes treatments; there is a possibility that with the inclusion of these drugs on the list, this phenomenon will be reversed. Indeed, it is a significant boost for these Type 2 diabetes drugs to be included on the list, considering the doubts and concerns that have persisted concerning them on the part of drug agencies and health technology assessment (HTA) agencies in recent years (see Europe: 3 June 2010: Next-Generation Type 2 Diabetes Drugs—the Role of HTA Agencies).