IHS Global Insight Perspective | |
Significance | The head of the Italian antitrust authority, Antonio Catricalà, has issued a report arguing against the proposals contained in a draft bill before the senate health committee, which would mean biosimilars could be considered not to be therapeutically equivalent to their reference biologic drugs for the purposes of tenders run by public health centres. Meanwhile, five innovative drugs have recently obtained positive reimbursement decisions. |
Implications | The stance of the Italian authorities on biosimilars is turning into a saga resembling the scandals and controversies that have abounded over the years in connection with small-molecule generics. |
Outlook | Although considerations of cost containment should be sufficient to guarantee biosimilars will not be discriminated against legislatively, there is no guarantee of this in today's Italy, where there are strong and entrenched views on both sides. Meanwhile, the new reimbursement decisions taken recently are consistent with Italy's status as a liberal country in reimbursement terms; however, with many of the country's regional health authorities in severe financial difficulties, questions will be raised over continued affordability. |
The head of the Italian anti-trust authority, Antonio Catricalà, has issued a report in response to the draft bill currently before the health committee of the Italian senate that seeks to challenge the concept of the therapeutic equivalence of biosimilar drugs with their biotech originators, reports Italian newspaper Il Sole 24 Ore. In the report, Catricalà defends the concept of therapeutic equivalence and calls for equal treatment of originators and biosimilars in tenders run by public health facilities. Meanwhile, five innovative medicines have recently benefited from positive reimbursement decisions by the Italian medicines agency (Agenzia Italiana del Farmaco: AIFA), with these made official through their publication in the Official Gazette of the Italian Republic.
Antitrust Head Defends Biosimilars
In a report, Catricalà has challenged the draft bill prepared by three senators from the governing People of Freedom (Il Popolo della Libertà: PdL) party that proposes the possibility of excluding by law the therapeutic equivalence between biosimilar medicines and their biotech originators, and also medicines of the same class, in the case of tenders run by health facilities so that they could not compete in the same tender. This bill (number 1875) is currently before the health committee of the senate.
According to Catricalà, the bill would unreasonably restrict competition between biosimilar and originator biotech drugs, thereby preventing health facilities from making considerable savings through the purchase of cheaper biosimilar medicines. He emphasises that the antitrust authority is acutely aware of the guidance on biosimilar medicines from both the European Medicines Agency (EMA) and AIFA, and the lack of bioequivalence between them and originators. However, he stresses that there is no substantive reason to conclude that the biosimilar would necessarily be therapeutically inferior to the originator, adding that in some cases, biosimilars are of superior quality.
Potential Savings from Biosimilars
Catricalà concludes that there should not be separate tenders for biosimilars and originator biotech drugs in Italian public healthcare facilities, focusing mainly on the positive effect the increased use of biosimilars in Italy would have on the finances of the Italian National Health Service (Servizio Sanita Nazionale: SSN).
Five Innovative Medicines Gain Positive Reimbursement Decisions
Meanwhile, five innovative medicines have recently had positive reimbursement decisions officially registered in the Official Gazette of the Italian Republic, with these decisions due to come into law several weeks after their publication. United States firm Bristol-Myers Squibb's (BMS's) oncology drug Sprycel (dasatinib) has been approved for reimbursement in newly diagnosed Philadelphia-chromosome positive chronic myeloid leukaemia (Ph+ CML); blastic or accelerated-phase CML in patients resistant or intolerant to previous therapy, including Glivec (imatinib mesylate; Novartis, Switzerland); acute lymphoblastic leukaemia; and Ph+ lymphoid blast-crisis CML. Another BMS medicine, Orencia (abatacept), has been approved for new indications: in combination with methotrexate for the treatment of moderate-to-severe active rheumatoid arthritis in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs, including methotrexate, or a tumour necrosis factor-alpha inhibitor; and for children aged six and over, in combination with methotrexate, for the treatment of moderate-to-severe polyarticular juvenile idiopathic arthritis. Novartis's high-blood-pressure drug Rasilez HCT (aliskiren + hydrochlorothiazide) has been approved for reimbursement, and consequently, a new determination has also been issued reducing the price of the original Rasilez product, albeit only slightly: for example, the 150-mg form has been reduced to an ex-factory price of EUR19.56 (USD27.6), from EUR22.83. US firm Abbott's HIV/AIDS drug Kaletra (lopinavir + ritonavir) has received a positive reimbursement decision, which presumably relates to the once-daily dosing treatment that was approved by the European Commission in December 2009. Finally, Spanish firm Grifols' intravenous liquid immunoglobulin product Flebogamma DIF has been approved for reimbursement in a number of indications. All of the medicines mentioned are categorised for reimbursement under class "H"—medicines that are available in hospitals and similar structures—apart from Rasilez HCT, which is categorised under class "A", that of outpatient prescription medicines.
Innovative Medicines Gaining Positive Reimbursement Decisions in Italy, February–March 2011 | |||||
Name of Medicine | Producer | Disease Area | Reimbursement Category | Length of Contract | Other Provisions |
Sprycel | BMS | Chronic myeloid leukaemia | H | 24 months | Added to AIFA's oncology drug monitoring system |
Orencia | BMS | Rheumatoid arthritis | H | 24 months | Prescription only from rheumatologist or internal-medicine specialist |
Rasilez HCT | Novartis | High blood pressure | A | 12 months | Cost cap of EUR8 million for first year (monotherapy and in combinations) |
Kaletra | Abbott | HIV/AIDS | H | 24 months | - |
Flebogamma DIF | Grifols | Many, including primary immune deficiency disorder, severe combined immunodeficiency disease | H | 24 months | Only for use in hospitals or similar facilities |
Source: Official Gazette of the Italian Republic | |||||
Outlook and Implications
The dispute over the therapeutic equivalence of biosimilars in Italy has been simmering for well over a year now, and it has been more than a year since the draft bill proposing that biosimilars should not be considered therapeutically equivalent with their reference biotech drugs was first submitted to the Italian senate (see Italy: 25 January 2010: Assogenerici Criticises Confusing Bill on Biosimilars in Italy). Essentially, the senators who have prepared this draft bill are opposing the guidance of both the EMA and AIFA with their proposals. This situation is symptomatic of the obstacles faced by generics and biosimilars producers in Italy, who meet unusually strong opposition from groups ostensibly supporting innovation through their stance against "copycat" drugs. The dilemma in the country should be solved quickly when the shaky state of the economy is considered, as well as the considerable savings that can be made from increasing the use of biosimilars. However, in Italy today, this is not a foregone conclusion.
Meanwhile, the new positive reimbursement decisions published in the Official Gazette confirm that there is no particular change in Italy's status as a liberal reimbursement market; in the case of the new decision for Sprycel, this comes only a couple of months after the Commission's approval, which is a very quick turnaround in Italian terms. Contrastingly, Rasilez HCT was approved for marketing in the EU in January 2009, and so its approval in Italy comes more than two years later. On a less positive note, considering the huge deficits of many Italian regional health authorities, these new reimbursement decisions represent an additional burden on their already overburdened finances.