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Therapeutic positioning reports in Spain: More doubts and questions

21 January 2015 Tania Rodrigues

Since completing my research poster on the new model of therapeutic positioning reports (IPTs), for ISPOR last November, more doubts and questions have arisen. The main aim of this collaborative IPT model is to assist with pharmaceutical pricing and reimbursement (P&R) decisions. Published on the Spanish Agency for Medicines and Health Products (AEMPS) website, an IPT usually contains a comparative effectiveness and safety evaluation, as well as criteria of use and for follow-up for one or more medicines.

A key objective of an IPT is to determine the patient population most likely to benefit from a drug. The Inter-Ministerial Pricing Commission (CIPM), responsible for setting the maximum factory price, can also ask for an IPT following a funding request of a new indication for an already funded drug. However, as unveiled during the debate entitled "Evaluation of the innovation in oncology" in January 2015 and reported by the news source Gaceta Medica, the economic crisis has delayed the approval of new medicines as well as second indications. According to that debate, there are instances when second orphan indications are more blocked in terms of financing than some first indications.

At the centre of a recent storm was the much-awaited November 2014 publication of IPTs for hepatitis C virus (HCV) drugs Janssen's Olysio and Gilead's Sovaldi. Olysio was reportedly the first medicine with a P&R decision made before its IPT was concluded. In August 2014, after months of negotiation, Olysio received funding approval despite the Ministry of Health (MoH) and the AEMPS methodology proposal stating clearly that IPTs will be sent to the Directorate General of Pharmacy and Basic Services (DGCBF) prior to a P&R decision. (The DGCBF decides on public reimbursement.)

In November of 2014, Sovaldi started to be financed , however, it is subject to the budget and willingness of the 17 Spanish autonomous communities (CCAAs). Set against this backdrop is an IPT implying considerable restrictions despite the recognised added therapeutic value of Sovaldi in relation to current treatment standards. It also includes outdated data compared to the new clinical evidence with regards to the antiviral combinations. These are the reasons why the prominent Spanish Association of the Study of the Liver refused to participate in the creation of the IPT itself and the filing of an administrative appeal by the Socialist Party of Madrid (PSM) in the National High Court (Audiencia Nacional, in Spanish). The appeal lodged in January 2015 is against the MoH for the approval of the actual IPT.

Unlike those published before, the IPTs for Olysio and Sovaldi were generated after the European Commission's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion. Most of the previous IPTs were created at the request of the CIPM and/or the DGCBF. Furthermore, the vast majority of IPTs are not reportedly adhering to the initially proposed timeline of 90 days of publication from the assignment of AEMPS experts. More specifically, the Therapeutic Positioning Coordination Group, responsible for the initial IPT elaboration, intended to make an IPT available to the CIPM within 97 days.

Under the new proposed model, an IPT is theoretically supposed to take on board comments from stakeholders including patient associations, scientific societies and the manufacturers. The initial IPT is made available to them during 10 days. However, critics claim that these stakeholders' opinions have not carried much weight until now as none of the published IPTs had their original text altered.

Although some stakeholders believe IPTs avoid redundant evaluations, others view them as an additional step in the P&R process delaying market entry even further. In practice, hospital evaluations of new medicines are still deemed important because the latest IPT model is still regarded as lacking. This is most probably because IPTs are missing a crucial economic evaluation that would help guide CCAA payers that ultimately pay the drug bill through the healthcare budget transferred from central government. For IPTs to be regarded as truly meaningful there is need for an urgent clarification of their use and of the procedure used to create them, including more realistic timelines.

Tania Rodrigues is a senior life sciences research analyst for IHS
Posted 19 January 2015

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