National Guidance in Spain Attracts Regional Opposition in HCV

With 19 therapeutic positioning reports (IPT: informe de posicionamiento terapéutico) now published, the focus and intention of the new Spanish health technology assessment paradigm can be reviewed. And in some quarters, the guidance has attracted substantial opposition. Dr Steven Bradshaw and Dr David Carr of Market Access Solutions discuss these issues.

Introduced to evaluate the therapeutic value of therapies and outline the patient populations that would receive most clinical benefit, the IPTs also act as a consensus document with the aim of aligning drug utilisation across the autonomous regions in Spain. Since the regions actively participate in the process (two regions at a time, on a rolling basis), the national-level guidance has the opportunity to trickle down and harmonise care throughout Spain.

"Orphan drugs can garner high prices, so the IPTs aim to ensure that they are used in the correct patient populations."

Of the total 19 reports completed, over one third apply to orphan drugs. With a high therapeutic need and low patient volume, orphan drugs can garner high prices, so the IPTs aim to ensure that they are used in the correct patient populations. And, it is not a huge surprise that oncology products make up more than half the total number of reports, with both Bristol-Myers Squibb's Yervoy® and Roche's Zelboraf® being assessed in melanoma.

Hepatitis C, a therapeutic area of intense global payer scrutiny, sees four reports, including an assessment of Sovaldi®. And it is this report of Gilead's drug that has seen particular controversy. Clinicians and patient groups are unhappy with the recommendations for using Sovaldi® only in later-stage patients when benefit can be realised for patients at an earlier stage of the disease.

"Drug manufacturers will still need to consider the regions as fundamental to their market access strategies."

Given disagreements like that in Hepatitis C, and the concurrent provision of regional access programs, it seems that the harmonisation process is far from achieved. Therefore, when planning launches in Spain, drug manufacturers will still need to consider the regions as fundamental to their market access strategies, while also ensuring that they provide robust data for the IPT.

Figure: Distribution of IPTs by disease area and orphan status

Dr Steven Bradshaw is the European Director of Market Access Solutions (MKTXS)
Dr David Carr, PhD is a Market Access Analyst at MKTXS
www.mktxs.com

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