Italy sets new criteria for drugs’ pricing and reimbursement

In Italy, the price of medicinal products which are reimbursed by the National Health System (NHS) is negotiated between the marketing authorization holder (MAH) and the Italian Medicines Agency (AIFA).

On 24 July 2020, the long-anticipated decree setting new criteria and procedures for the negotiation of the price of medicinal products and related reimbursement status, which was approved by the Ministry of Health and the Ministry of Economy and Finance on 2 August 2019 (New Pricing and Reimbursement Decree), has been published in the Italian Official Journal.

On 16 September 2020, AIFA has published a draft of the guidelines (required by the New Pricing and Reimbursement Decree) for preparation by manufacturers of the price and reimbursement dossier, launching a public consultation which remains open until 30 September 2020. As clarified by AIFA, the provisions contained in the New Pricing and Reimbursement Decree will come into effect only at the end of the public consultation, after issuance by the same AIFA, by the end October 2020, of the final version of the above guidelines.

The New Pricing and Reimbursement Decree replaces the Resolution no. 3/2001 of the Inter-ministerial Committee for Economic Planning (CIPE), which has governed drug pricing for the past 19 years, and includes some important aspects related to transparency.

Pharmaceutical companies seeking reimbursement from the NHS are now requested to provide, in addition to scientific documentation showing the possible added therapeutic value of the medicine, information on marketing, sales and reimbursement in other countries, including negotiated prices. Moreover, information should be provided with regard to public contributions and incentives received on research and development (R&D) programs, as well as clear and up to date information on the patent status of the concerned medicinal product and on the company’s production capacity and ability to manage possible unexpected events that could jeopardize manufacturing and supply. Finally, as part of the final agreement for medicines reimbursed by the NHS, companies will have to provide annual reports regarding sales data, revenues and marketing expenses.

The price negotiated with AIFA will generally remain in effect for 24 months. The deadline for either party to propose amendments to the terms of the agreement prior to its renewal has been extended to 60 days before its expiry. If no changes are made, the contract will automatically be renewed for a further 24 months.

However, price increases may be permitted, in exceptional cases and for low-cost medicines only, in the event of objective difficulties in obtaining raw materials or rising costs that would make it unviable to continue manufacturing a drug. In such cases, the MAH may file with AIFA a request for increase of the price, which – according to the guidelines issued by AIFA's Pricing and Reimbursement Committee on 1 April 2020 – must be based on the following grounds:

• A documented increase of production costs with reference, in particular, to the cost of raw materials;

• A documented increase of production costs due to new regulatory provisions concerning the improvement of the product's quality and safety profile.

Pursuant to the New Pricing and Reimbursement Decree, the pricing review process can be triggered also by AIFA in the event of medium-term changes in the market, such as to predict an excessive increase in the level of use of the drug or to configure a cost-therapy ratio unfavourable compared to existing alternative medicines already included in the National Pharmaceutical Formulary (PFN - Prontuario Farmaceutico Nazionale).

The pricing review procedure may be started by AIFA also in the event that there is new evidence on the efficacy and safety of the drug showing a substantial reduction in the clinical benefits estimated at the time of negotiation, as well as in the event of a clear shortage of the drug on the Italian market.