The introduction of economic evaluation in the Therapeutic Positioning Reports (IPT) of drugs has been a revolution not without controversy. An example of this has been the last of these reports, focused on the indication of therapy CART Tecartus for certain cases of adult patients with mantle cell lymphoma (MCL), which has generated notable discrepancies both between the specialists as in the collective patients. The reasons for this are mainly two: lukewarmness when it comes to showing the clinical benefit of treatment and alleged shortcomings in assessing the economic impact of it.
The IPT referred to the treatment of kiting, belonging to Gilead Science, was published by the Spanish Agency for Medicines and Health Products (Aemps) Last Tuesday January 18. In it, an estimation of the economic impact of €32.5 million for the attention of 93 patients per year, and reflects that the European Medicines Agency (EMA) requests to update the data of all patients in the pivotal Zuma-2 study at 24 months.
The report, the second made through the REvalMed Coordination Group, has two main points of discrepancy between professionals and patients. The first and most important of these has to do with the way in which the medical necessity and clinical benefit of a highly anticipated treatment are reflected by the lack of current alternatives.
William Rodriguez Garcia, hematologist at Virgen del Rocío Hospital in Seville, explains to Medical Writing that the effectiveness of the drug has been shown to be “enormous” and a “hope” for patients, who in certain cases have no other alternative, because until now the disease is incurable. “Not having this drug in Spain is a significant decline for the lives of these people.
Tecartus is currently approved by the European Medicines Agency (EMA) for adult patients with mantle cell lymphoma at 3L or later after receiving an iBTK. In this sense, the pivotal trial Zuma-2, in which its clinical benefit, determine a rate of overall survival (OS) of 76.6 percent at 12 months and from 66.5 to 24, thus multiplying between two and 12 times the current median between 2.3 and 8.4 months.
The specialist states that this medicine supposes “A hope” because it works with a different mechanism of action and that, in this pathology, if chemotherapy fails “there is very little to hold on to”. Therefore, there is a “clear medical need”, because we are talking about giving new opportunities for people that do not have no effective remedy Today.
This CART in Europe enjoys a conditional marketing authorization, so that in some countries like France and Germany it is already available, so that patients in these countries have a more therapeutic option for patients with this disease.
IPT: economic evaluation
The second of the points of discrepancy is the form of assess the economic impact who will have this treatment. The IPT reflects an estimated price for this drug, since it is not yet funded by the National Health System (SNS), so that it can show alleged deficiencies when setting a actual cost.
On the other hand, the report compares in terms of costs the CART Tecartus with the public CART. This, for patients and clinicians, is not “adequate” due to the difference in criteria of both. The public CART is only approved in Spain through a hospital waiver on a different indication, specifically for acute lymphoblastic leukemia.
And the waiver has been granted based on evidence in nine patients with a follow-up of 100 days, lower requirements than those required of the commercial CART. “The production capacity of an academic CART is not comparable to a commercial one”, points out Rodríguez García.
Likewise, he does not see it as appropriate for the IPT to make a comparison in terms of costs with the conventional chemotherapy schemes used off-label.
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