Budget law in the Senate: the news for pharmaceuticals

La manovra interviene sulla partita del payback e annuncia un monitoraggio sull’impatto dei farmaci innovativi finanziati dai due fondi ad hoc. Inizia l’iter parlamentare. La Commissione Bilancio riferirà in Aula il 21 novembre

Of Aboutpharma Online editorial staff – 31 ottobre 2017 – Aboutpharma

A roadmap for the "payback issue" and monitoring to evaluate the impact of innovative medicines. These are the main measures for the pharmaceutical sector contained in the text of the 2018 Budget Law, which today arrived at Palazzo Madama. With the communications in the Chamber on the content of the bill by the president of the Senate, Pietro Grasso, the budget session is officially inaugurated.

The payback

Article 41 of the 2018 Budget Law is dedicated to "health measures". The first three paragraphs intervene on the payback, or rather on the shelf of the overrun of the pharmaceutical expenditure ceilings charged to the companies.

Paragraph 1 requires the Italian Medicines Agency (Aifa) to adopt in the first months of 2018 (within 30 days of the entry into force of the law) the decisions on the payback relating to the overruns of territorial and hospital expenditure in the year 2016. companies will be given 30 days to pay the amounts due. “This – reads the illustrative report of the Budget law - in order to allow the regions to collect, as required by current legislation, the sums due to them paid by pharmaceutical companies by way of payback".

The second paragraph closes the payback game for the years 2013-2015, the subject of a long dispute. The budget law provides that AIFA concludes - within 120 days of the entry into force of the provision - the transactions with companies relating to disputes still pending as at 31 December 2017. Provided that the companies are "up to date" with the payback relating to 2016, according to the methods set out in the first paragraph.

Aifa has the task (paragraph 3) of adopting a summary determination of the amounts to be paid by each company for the years 2013-2014-2015 and, therefore, of the sums due to the individual Regions. Numbers that will be the subject of a decree from the Ministry of Economy and Finance (MEF).

Innovative medicines

Paragraph 4 of article 41 is dedicated to innovative medicines. The text provides that the Ministry of Health, in collaboration with the MEF, will launch an experimental monitoring for the three-year period 2018-2020 on the "effects of the use of innovative and innovative oncological drugs on the cost of the overall therapeutic-assistance path". The monitoring activity will be headed by the Standing Committee for verifying the provision of the essential levels of assistance (Lea). Attention will be focused on one or more therapeutic areas and the assessments will be based on real world evidence data and on information obtained from the Registers of innovative and innovative oncological drugs subjected to AIFA monitoring. The objective - reads the explanatory report - is to document "the economic-welfare effects of the introduction of innovative drugs, in order to calculate the related health care costs saved for each item of health care activity". For example, the reduction in the frequency of hospitalizations, less complex hospitalizations, the possibility of delaying or overcoming the hypothesis of liver transplantation in patients with HCV, the increase in survival in cancer patients.

The outcome of the monitoring - states paragraph 5 - will be "functional to a better allocation of resources planned for the National Health Service" and, above all, "to the sizing of funds for innovative drugs and innovative oncological drugs" envisaged by the Budget law 2016.

Purchases of goods and services

Among the measures of interest for health, paragraph 7 provides - in order "to encourage the efficiency and transparency of the public administration procurement system" - the use of the electronic format for any document relating to orders and purchases of goods and services. For NHS entities, the transmission of documents must take place through the management system made available by the State General Accounting Office.

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