Doctors ask Health to exercise the option to purchase Sotrovimab to expand its use and avoid future shortages
Although the variant omicron is causing a constant increase in hospitalized patients, the Spanish Medicines Agency (AEMPS) approved at the end of December some indications for the use of the only drug of monoclonal antibody effective against the new variant so restrictive that very few patients can benefit from the drug marketed under the name of Xevudy and whose active ingredient is sotrovimab.
The European Medicines Agency (EMA) authorized its marketing on December 16 for the treatment of people over 12 years of age who do not yet require oxygen or are seriously ill but have risk factor’s elevated against covid. That is to say, patients with diseases such as obesity, heart failure, haematological, immunosuppressed or oncological. The authorization is based on data from a phase III trial showing that intravenous treatment with sotrovimab causes a 79% reduction in hospitalizations.
But nevertheless, the AEMPS limited on December 28 the administration of monoclonal antibodies in Spain to adults in “serious or critical” condition, with “negative serology” – that is, they do not have antibodies either because they have not been vaccinated or because the immunization has no effect on them – and who have “high risk” conditions such as having been recipients of transplant, have primary immunodeficiencies or cystic fibrosis. The AEMPS based its decision on the “limited availability” of this drug and demanded that health professionals request authorization for its administration on a patient-by-patient basis.
The joint acquisition
In other words, the EMA authorization is intended to prevent severe forms of covid in a large sector of the population, while the indications of the Spanish Medicines Agency restrict its use to a handful of patients, with the aim of danger that it is being applied in a profile of seriously ill patients for those who sotrovimab not specifically tested.
The spokesperson for the PP Health Commission, Ana Pastor, asked Carolina Darias, in mid-December, “why” this drug has been authorized by the EMA and “it has not yet been authorized for marketing” on a large scale, to which the Minister of Health replied that the Government “is in European purchasing procedures centralized with the autonomous communities“, without giving more details of when this process will end.
The danger of being late
But in the hospitals it is not understood delay, at the same time that there is the fear that given the high demand for this medicine both in the EU and in other countries -the US purchased 750,000 doses at the end of November and has announced the acquisition of 600,000 more-, Spain is late and if you have to queue up, further delaying its widespread use. The EU has given countries free rein to acquire 220,000 treatments and some countries have already made their requests.
Pedro Sánchez announced with great fanfare on January 10 the acquisition this month of 344,000 pills antivirals from the pharmacist Pfizer, but the specialists claim to have all the medicines available, because each one is indicated for a situation and a type of patient. “We need different therapeutic options for the vulnerable population that does not respond well to vaccines, and monoclonal treatments are one of the most effective drugs,” he says. Pablo Guisado, specialist in internal medicine at the Quirónsalud University Hospital in Madrid. “It is not exclusive to have the Pfizer drug and the monoclonal,” he adds, while pointing out that he hopes “that in the next few days” Spain will exercise its purchase option and there will be a “larger stock“.
The cost: 2,240 euros
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And it is that in the current situation it is restricting the use even to some transplant patients, as he regrets Luis Perez de Llano, head of the Pulmonology service of the Hospital Lucus Agusti from Lugo; At the same time, a specialist from a private center, who prefers to hide her identity, asserts that the AEMPS also rejects the requests of some patients who would not hesitate to pay for the medication out of pocket, which costs €2,240.
Cost may be one of the reasons for which Spain does not acquire the necessary doses. “It may be that they do not want to spend the money or that they do not see it as an effective cost,” says Pérez de Llano. However, hospitalization is more expensive than those 2,240 euros of treatment. And “if Spain negotiated the cost with the laboratory, it would drop quite a bit,” the doctor from the private hospital points out.
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