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Italy drafts tough new reimbursement rules including pricing information from other markets, proof of added value

MILAN, 2 Aug (APM) - Italy has drafted legislation to introduce tough new reimbursement conditions.
The proposals, announced on Thursday, including a requirement that companies disclose pricing and reimbursement information from other countries and obtain proof of the added value a new product has over available treatments.
The health ministry said in a statement that the legislation was drawn up in conjunction with the finance ministry. It said regional governments have already given their assent to the document which provides the conditions for the reimbursement of drugs in Band A and Band C but not Band H (hospitals).
The legislation abrogates a 2001 measure which has determined reimbursement procedures until now.
"The so-called ‘Prices Decree’ changes the procedures for the negotiation of the price of drugs by AIFA. Its adoption will respond to the need to introduce updated and adequate criteria for the development of drug policy in compliance with the required transparency," the ministry said.
It noted there will be new emphasis put on the added therapeutic value that a medicine must have in relation to the main treatments with which it is compared. The ministry also highlighted the need for companies to provide reassurances about production capacity, the ability to manage unforeseen events and the capability to guarantee an adequate supply of the drug.
The decree makes explicit reference to the resolution adopted at the 72nd World Health Assembly of the World Health Organization (WHO) on drugs and vaccines pricing transparency (APMHE 63144).
"In the regulatory framework in which the decree is inserted, the reference to Resolution WHA 72/2019 on the transparency of the prices of drugs, vaccines and other health products, proposed by Italy and approved during the (72nd Assembly) is significant," the ministry said.
The resolution is also the basis of a proposal by the Valletta joint procurement group, which includes Italy, for the EU to introduce a legal framework for drugs pricing transparency (APMHE 63859).
The new rules introduced by the decree will require companies to be more transparent about conditions in other markets although it is not clear if actual drug prices will have to be revealed.
Among the information that will be needed to support applications for reimbursement, the decree specifies that companies must give "self-certified information about the medicine being negotiated concerning its marketing, consumption and reimbursement in other countries, and in this case the pricing and reimbursement conditions, including any additional negotiated agreements".
The expected annual market share for a drug in the following 36 months in the relevant segment of the market will also need to be shown. Forecasts about expected spending on the product by the national health services are another requirement.
Companies will have to provide a financial benefit for drugs which do not provide added value. "If the medicine does not guarantee any additional therapeutic advantage over the available products, the company will have to provide further elements in terms of financial advantages for the national health service if a negotiated agreement is to be reached," the health ministry explained.
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