The Italian Medicines Agency (AIFA) has published a major report in which it outlines plans to address the challenge of "sustainable innovation", publishing soon afterwards its second concept paper on biosimilars, in which the agency removed the words "treatment-naïve" from its recommendations.
Implications | The paper marks an attempt to seek new pricing and reimbursement models for an era of increasingly high-cost, effective innovative medicines. The biosimilars concept paper generally accords with the previous publication, with the sole major omission. |
Outlook | The change in position within the biosimilars concept paper is likely to prove highly controversial, and could signal a change in mindset by the agency in the face of the growing economic burden it faces from high-cost innovative medicines. |
AIFA seeks to meet challenge of "sustainable innovation"
The Italian Medicines Agency (AIFA) has published a major report outlining its position and response to the challenges of continuing to provide access to innovative medicines. In general, the report – entitled "Sustainable Innovation – Medicines and the Challenges for the Future of the National Health Service" – concludes that the current mechanisms and instruments in place to meet these challenges are inadequate in an age of increasingly high-cost and highly effective medicines. In the context of the Italian National Health Service (SSN) being the organisation almost entirely responsible for ensuring that these medicines are available to citizens, the report considers that in the absence of changes to the mechanisms and instruments used in the pricing and reimbursement (P&R) of drugs, the SSN itself will come under serious financial threat.
In the report, it is implied that AIFA intends to follow developments at a European Union (EU) level, involving what the agency terms "progressive patient-access schemes" – described as a more accurate description of "adaptive licensing", and involving a more flexible approach to providing access to new innovative therapies that allows for marketing authorisation to be extended to larger patient populations as evidence emerges. This is inextricably linked with developments in the collection of data on clinical outcomes.
Inevitably, the issue of the hepatitis C drug Sovaldi (sofosbuvir; Gilead Sciences, US) is raised in the report, with the agency putting forward some strong criticisms of the producer's pricing policy, while defending its own "progressive access" approach to the drug. AIFA states that joint EU-level pricing negotiations are the best response to the complex ethical and technical issues involved with such cases.
At the launch meeting for the report, AIFA head Luca Pani is reported by Quotidiano Sanità as stating that cost-sharing and risk-sharing schemes must be abandoned, with the entire system re-focused into payment by results. While the report details the well-established system of monitoring registers for innovative medicines in Italy, the implication is that these registers in themselves are not sufficient to achieve the aims of sustainable innovation; new developments within this ground-breaking system must be made in order to meet the associated challenges.
The full report, translated into English, can be accessed here.
AIFA makes important change in second biosimilars concept paper
Separately, AIFA published a new concept paper on biosimilars for public consultation on 16 June. This is the second such concept paper issued by the agency, the previous report having been published in 2013. Importantly, although the main elements of the paper are consistent with AIFA's initial report, the agency does not make any specific reference to treatment-naïve patients with regard to which patients should be considered appropriate for treatment with biosimilars, as was the case in the previous concept paper. In the latest research, AIFA has instead concluded only that substitution of originator biologics with biosimilars is a possibility that should be left to the clinical judgement of the doctor involved. AIFA concludes, unsurprisingly, that biosimilars offer a favourable opportunity to develop the competitiveness of the market, and to aid the rationalisation of public spending.
The concept paper, which is out to public consultation until mid-September, can be accessed here (in Italian).
Outlook and implications
Although it is presumably co-incidental that the publication of AIFA's report and its second biosimilars concept paper occurred on successive days, there is certainly a strong common theme running between the papers. In the "Sustainable Innovation" report, AIFA dedicated a long chapter to biosimilars, in which it also emphasised the drugs' importance in terms of helping to rationalise public spending. The small but important change to the agency's stance on biosimilars – declining to propose a particular recommendation for their use in treatment-naïve patients, implying that doctors would be within their rights to change a patient's treatment from an originator biologic to a biosimilar – could, in the medium to longer term, have a significant impact on the penetration of biosimilars in Italy. The agency's position is also bound to prove highly controversial in a country in which the development of the biosimilars market has encountered strong resistance from some policymakers.
AIFA's report is a signal of what should be expected in the Italian market in the coming years. As the country continues to struggle in its attempts to rein in expenditure on medicines in the hospital sector in particular, among the numerous proposals for addressing this problem are those examining the drug P&R innovations that attempt to take into account not only the cost of pharmaceutical treatment itself, but the savings to the SSN that can be made through patients potentially being taken out of the hospital sector through utilisation of pharmaceuticals. Although the report criticises the pricing policies of some companies, AIFA has also attempted to present its vision as sensitive to the needs and aspirations of the pharmaceutical industry. It remains to be seen to what extent this will be reflected in the agency's future regulations.