Could STIVARGA Court Ruling Change the Meaning of Class Cnn Reimbursement in Italy?

Over the past two years, the Cnn classification has become a tried and true method of achieving temporary, sub-nationally reimbursed access in Italy. In these cases, hospitals and patients shoulder the burden of financing in the interim, which requires them to negotiate the price of the therapy directly with manufacturers. All of this is temporary, as once AIFA negotiations are complete, national pricing and reimbursement recommendations are determined, which either results in “H” classification (reimbursed hospital product) or “A” classification (reimbursed because it is an essential product for the health system). In some cases products classified as Cnn can be re-classified to Class C, as was the case for IMNOVID (pomalidomide), in September 2014. It is worth noting that a product that receives Cnn designation is most likely to be reclassified as Class H.

Another important law that provides access of new therapies to patients is Law 648/96. It allows patients to gain access to a post-Phase II product that also is either authorised in another country, continuing to undergo further clinical study, or already authorised under another indication. Under this law, the clinician must initiate the request and the use of the product in question must be in an area of high unmet need. The requirements for the CTS (Consultiva Tecnico Scientifica) application are extensive, but once the product is listed, it is fully financed.

A recent court ruling on STIVARGA, EMA approved for mCRC and mGIST, is causing a stir that could go as far as to undermine how Class Cnn funding is interpreted in Italy. STIVARGA was first granted access under Law 648/90 before it was reclassified as Class Cnn on July 24th, 2014. STIVARGA costs EUR 9,680 per month and is taken until disease progression. Recently, one patient that could not afford to pay for this treatment sued the regional payer (ASL di Latina), and the court ultimately ruled with on the side of the patient and ordered the regional authority to pay for the medication (Final sentence handed down on the 26th of August 2015). While the legal proceedings were ongoing, the patient was receiving STIVARGA from their hospital, the prestigious Policlinico Gemelli di Roma. Hospital products that are Class Cnn are paid for from the hospital budget, but if the drug is not a hospital product (as is the case of STIVARGA) the drug is typically paid for by the patient. In this unique case, the hospital picked up the cost of treatment to ensure the patient would receive the needed medication, while at the same time expecting the cost to eventually be picked up by the regional payer. This is indeed what eventually happened.

This decision creates uncertainty in the meaning of Class Cnn by creating a precedent of a regional payer being required to pay for a product under this classification. In this sense, the product is being treated more like a Class A product. This could radically affect the pricing and access dynamics in Italy. Should Class Cnn drugs be funded at the regional level (even if only for those unable to pay), this classification would become even more attractive as an early access pathway. Should this lead to greater scrutiny over the designation of Class Cnn, a strategy that has grown increasingly popular for manufacturers of high-cost drug launches, an uncertain future may loom.

To learn more about alternative access schemes, please also see our thought piece on alternative access schemes.