Italy launches new medicinal assessment reforms to focus on added therapeutic value
By Dimitra Sotou, Senior Consultant
The Italian Government has recently introduced new pricing and reimbursement rules with the central aim of making therapeutic value of prime importance in the assessment of new medicinal products conducted by AIFA.
News sources confirm that the reforms were drafted last year; however, due to political instability they would not come into effect and could therefore not be published in the Official Gazette.
The decree was finally published in the official Gazette a couple of weeks ago. It revokes policies introduced in February 2001 which have governed the Italian pricing and reimbursement of medicines until now.
The Italian government has been a vocal advocate of the need for greater transparency in medicinal pricing and other aspects of the pharmaceutical market. While the newest decree does not explicitly state that its intention is to reduce medicinal prices, the proposed reforms suggest that cost containment is likely to be a key objective.
The new reforms will apply primarily to medicines in Class A (i.e. medicines reimbursed by the SSN) but will also affect medicines in Class C (i.e. medicines that are generally not reimbursed) and Class C-nn (i.e. medicines for which reimbursement has not yet been negotiated) and are used by the SNS for public health reasons.
Summary of key changes
As one of the changes under the new reforms, AIFA can now initiate negotiations in certain situations, including when reimbursement of a medicine is expected to have a significant impact on the pharmaceutical budget. Until now, reimbursement negotiations had to be started by a company making an application to AIFA. If no application was made, the drug was automatically classified as ‘’Class C’’ for non-reimbursed products.
All companies starting reimbursement negotiations must support their application with scientific documentation showing the possible added therapeutic value of the medicine, relative to treatments that are currently available.
The assessment process will consider therapeutic alternatives used in national clinical practice to identify the main treatments with which the new product can be compared. To allow a comparative assessment of the costs of alternative treatments, the dosing schedules and duration of treatments must also be specified by the company.
Now, this naturally raises some questions – What exactly will the criteria be for selecting appropriate comparators and how will AIFA use the information on dosing schedules/duration of treatment?
Companies also need to include in their application, information about the use and reimbursement of the medicine in other countries, including any agreed conditions on the price and reimbursement. However, it is yet to be specified, exactly which countries will manufacturers be required to provide this information for and whether AIFA will require net pricing data – and will these practices be replicated by other EU agencies as well?
Companies will also have to produce forecasts of the annual market share a product is expected to take in the specific segment of the market in which it will be sold in Italy.
The reforms specify that a failure to demonstrate additional therapeutic value compared to products already available will mean that the company will have to provide “additional elements of interest in economic terms” to the national health service. In case there are no appropriate comparator therapies available, the manufacturer will have to present economic assessments to support its proposed price, including data on costs incurred in R&D and production.
From what we currently know, an economic evaluation will be needed only for drugs that do not have suitable comparators, but this is yet to be confirmed.
The new P&R negotiation process
Another section of the new legislation details the role of the two assessment sub-committees that are part of AIFA. The scientific committee, CTS, will assess the clinical value of new drugs and decide whether they have added therapeutic value compared to the medicines indicated as comparators.
This assessment will consider, where available and deemed appropriate, decisions made at a European level and may involve talks between AIFA departments and the pharmaceutical company. Now, it is yet to be specified as to what extend AIFA will make use of joint HTA conducted at the EU-level.
The agency’s pricing and reimbursement committee, CPR, will then take into account the assessments made by the CTS when negotiating a price. It will pay particular attention to:
- The added value
- The positioning of the therapy; as well as
- its costs compared to the medicinal therapies already available
In the event that a drug is judged to not offer any additional therapeutic value over comparators selected by the CTS, it will be excluded from reimbursement unless, the manufacturer offers a price that is equal to or lower than that of the comparators.
Considering the increased focus on the added value, it will be interesting to observe exactly how the additional therapeutic benefit will be translated into a price premium compared to markets such as Germany/France where there are explicit levels of additional therapeutic benefit, including a minimum level.
CPR will also consider the prices applied to different bodies inside the health service and the number of treatments expected, taking into consideration any conditions limiting reimbursement which have been defined by the CTS.
Pricing and reimbursement terms will also consider projected sales volumes, the availability of the product to the SSN, discounts to SSN institutions and public investment in R&D – will that data be used to reduced prices? This is yet to be observed. After launch, manufacturers will be required to notify AIFA annually of sales and revenue data, marketing costs and patent status in Italy.
Moreover, the pricing decree allows for AIFA and manufacturers to pursue innovative contracting models, such as price-volume agreements, expenditure ceilings and payback arrangements; which models are, in fact, already well established in Italy, as AIFA has been a pioneer in promoting innovation and has been encouraging manufacturers to engage in ‘out of the norm’ negotiations.
Will finance-based agreements outperform outcomes-based agreements in Italy under the new reforms? This is yet to be determined, as well as their immediate impact on patient access.
It is also mentioned that price increases may be permitted, in exceptional cases and for low-cost medicines, in the event of objective difficulties in obtaining raw materials or rising costs that would make it unviable to continue manufacturing a drug. AIFA may also adopt measures to rationalise and streamline the pricing negotiation procedure for generics and biosimilars.
In terms of timelines, the time permitted for negotiating P&R will now increase from the current allowance of 90 days to 180 days; however, that implies increasing market access delays which is already an issue in the Italian market. The exact impact of this will become clear in the coming years.
Overall, it appears that the Italian government is increasingly putting pressure on the industry to bring more transparency onto the P&R negotiation table – it will be interesting to witness in actual practice, how much transparency and willingness to negotiate AIFA will bring along.
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AIFA= The Italian Medicines Agency; CPR= The Pricing & Reimbursement Committee, AIFA; CTS= The Scientific Committee, AIFA; EU=European Union; P&R= Pricing & Reimbursement; R&D= Research & Development; SSN= Servizio Sanitario Nazionale; Italian National Health Service
Gazzetta Ufficiale della Republica Italiana, Ministero Della Salute, Decteto 2 agosto 2019; Criteri e modalita’ con cui l’Agenzia italiana del farmaco determina, mediante negoziazione, i prezzi dei farmaci rimborsati dal Servizio sanitario nazionale. (20A03810) (GU Serie Generale n.185 del 24-07-2020) [Link: https://www.gazzettaufficiale.it/eli/id/2020/07/24/20A03810/sg; accessed on 31 July 2020]