In recent years, the Spanish drug agency, AEMPS, and the “Interministerial Commission on Prices of Medicines and Health Products” have undergone a major reform. The HTA process already starts at positive CHMP opinion, and a first decision, the draft “therapeutic positioning report” or IPT, (Informe de Posicionamiento Terapéutico), can be released as early as 3 months after a drug is approved by EMA.

Cost-effectiveness, budget impact, social value and innovation have all found a place in the new process.  However the key question is “which place”? It remains unclear whether all new criteria are mandatory, and which specific role each of them plays in the HTA process.  This paper addresses the confusion that remains in market access and pricing in Spain.

The non-transparency of requirements is a true challenge for companies that need to submit HTA dossiers to Spanish authorities. As everything may count, new submission dossiers tend to be designed with a mindset of "the more, the better".  Such dossiers have increased the workload for Spanish pharma affiliates considerably. A lot of effort goes into getting the process going very early on in the pre-approval process. What comes next is complex and difficult to manage.

The price and reimbursement process (taking 6 to 9 months and running in parallel with the further discussions on the IPT) involves both manufacturers, external reviewers and regions.

The involvement of regions is probably what makes the Spanish process so complex. Spanish health care has gone through an extreme decentralization, more so than any other decentralized European markets such as Italy.  Spain has heavily invested in regional HTA resources, to such extent that regions may be better equipped than AEMPS to carry out full assessments for some drugs. Therefore regions sometimes take over.  Obviously, this can lead to a disconnect between national and regional stakeholders, causing major delays in ultimate decision making.  For outsiders, including Spanish pharma affiliates, it may be difficult to understand where decisions got stuck and where progress was made.

Initially very few TPRs were issued but this has been gradually growing and AEMPS also publishes the reports^[2]. So far, there have been very few clearly positive or negative recommendations and most decisions were taken relatively slowly.  Relatively few TPRs included an economic evaluations even though these are considered critical by regional bodies.  In September 2017, the government announced plans to improve the TPR model, but so far the specific mechanisms remain unclear.

The complexity and non-transparency of the market access and pricing process make Spain the biggest unknown of the main European markets for global pharmaceutical companies.  

Being a major European market, Spain is commonly considered a key country in primary market access and pricing research. Unfortunately, the intrinsic complexity and the many echelons of stakeholders make it a true challenge to adequately research this market and draw the right conclusions. Designing a good research strategy in Spain requires an in-depth understanding of the dynamics, a good network of stakeholders and smart sample design of interviewees.  Not only do samples need to be larger than in centralized countries but also, getting hold of the appropriate stakeholders is a great challenge.  All these points can discourage global departments from retaining Spain in strategic market access and pricing research.

Sometimes global market access departments tend to exclude Spain from strategic HTA research based on the belief that Spanish decisions are ultimately guided by decisions in other European member states.  There is no foundation for this.  On the contrary, AEMPS may be the first HTA body in Europe to issue an assessment. Therefore, we often defend Spain to be retained as a key country in European HTA research.

Another reason to retain Spain in strategic pricing and HTA research is the high level of sophistication of discounting and confidential rebate mechanisms both at national, regional and hospital level.  Spanish regions make Spain a very patchy market in terms of discounting and tenders. Therefore, we often regard Spain as a good commercial test market for strategic pricing studies.  Other markets, especially  CEE markets may take Spain as a benchmark for their price and discounting negotiations.

To conclude, the lack of transparency and complexity of the market should not be a reason for global departments to neglect Spain in strategic market access and pricing.  The best strategy is the one that can stand the test of the most difficult market in EU5: Spain.