A Payer View On Pricing and Reimbursement in Italy
Understanding more about what payers want means pharma is better positioned to create value adding propositions. With this in mind eyeforpharma talks with Giuseppe Rosano, Expert Member of AIFA & EMA, about some of the challenges and opportunities that manufacturers are facing in Italy.
Within the European Union the policy for pharmaceuticals focuses on linking a high level of public health with innovation, ultimately aiming to ensure that Europeans continue to benefit from new medicines. This suggests that market access conditions for manufacturers within individual Member States should be relatively smooth.
Rosano explains that whilst the European Medicines Agency (EMA) has extensive legislative powers to determine the regulatory pathway for authorizing the marketing of new products in accordance with strict criteria on safety, quality and efficacy, it actually has “no influence on the commercial pathway of drugs, nor on the prices and conditions under which products are purchased by national health care providers”. He points out that this means the manner in which each of the Member States define access and prices of medicines are still crucial in determining the overall marketing policy.
“There are differences in how regional and central government decisions are made in terms of access and reimbursement and this, says Rosano, can present some challenges for manufacturers”
In Italy the centralized process of pricing and reimbursement of new drugs is “transparent and very effective” observes Rosano. He says that the Italian health care system is mostly public and, therefore the price of drugs is determined under strict Health Technology Assessment (HTA) processes. Due to strong political pressures in the past this market has seen a general move to regionalizing the provision of health care. “This has led a distortion of the market that had penalized the manufacturers since in some cases they have to repeat a process similar to the National centralized procedure resulting in a waste of time and effort.”
There are differences in how regional and central government decisions are made in terms of access and reimbursement and this, says Rosano, can present some challenges for manufacturers. Decisions made at the central government level are based upon clear HTA assessment criteria. So if a product has a positive profile there is no obstacle for its reimbursement.
“Different forms of reimbursement can be foreseen according to the demonstrated effectiveness of the molecule and its health economic impact”. These range from full unrestricted reimbursement to payment by result. He explains that for political reasons there are few regions that replicate the centralized procedure meaning the access to reimbursement is limited. “This, for example, consequently limits the number of clinical centers that may prescribe innovative drugs or restricts the population that may be prescribed with newer drugs.”
“It is essential to provide data on the population that may benefit with the new treatment, the price difference with existing treatments and the possible savings for the health care system”
Payers in Italy are keen to interface with pharmaceutical manufacturers and the Italian Drug Agency is very transparent in its interactions with pharma. Rosano says that Institutionalmeetings are regularly scheduled with the General Manager of the AIFA. “For specific questions it is possible to ask for meetings with one or more of the members of the commissions. The meetings take place at the Italian drug agency and full collaboration is given.” In Italy when a drug has gone through a centralized European Union procedure there is no need for an extensive clinical dossier to be produced. Instead, outlines Rosano, it is essential to provide data on the population that may benefit with the new treatment, the price difference with existing treatments and the possible savings for the health care system – such as additional treatments, hospitalizations, etc. “If a drug is for a completely new therapeutic area, then the estimated population to be treated, the economic burden of the disease and the economic gain offered by the new treatment need to be provided.”
An example of this is the ways in which AIFA would consider a value proposition for a new oncology product and how the different economic, patient factors and clinical considerations are weighed up. “The oncology products are extremely overpriced. Very few products are disease modifying and for these products reasonably high prices are justified”, observes Rosano.
He points out that the majority of oncology products are approved on progression free survival without any hint into the possible benefit. “For these products the only reasonable reimbursement scheme is the payment by result keeping in mind that the cost of the diagnostic procedures should be on the pharmaceutical industry and not on the health care system”. For this reason the clinical considerations are assessed very highly and thus survival is more important than progression free, and quality is more important than quantity of life. “The assessment of patient related outcomes however should only be applied to palliative care.”
For manufacturers promoting their products in Italy Rosanobelieves it is important for them tounderstand that since the Italian National Health System provides full health care and pharmaceutical coverage for all Italian citizens and visitors, any costs for new pharmaceuticals should be balanced by savings on other expenses of the health care system. “Therefore, a drug that is more expensive but reduces the need for a specific expensive monitoring may become more convenient for the health care system than a new drug that is not too expensive but is an add on to an existing therapy”.
We look forward to hearing more from Rosano about his thoughts on changing payer perspectives and how manufacturers can best engage with payers at the eyeforpharma Payers’ Forum Europe on 21stand 22ndOctober 2013 in Berlin.
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