Press review

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Spanish activist group publishes list of reimbursed drug prices

MADRID, 9 Nov (APM) - The Spanish health ministry has shared the list of prices of reimbursed drugs with a group of associations under the umbrella campaign ‘No es Sano’ (It is not healthy) after its representatives repeatedly complained about the lack of transparency of the ministry’s pricing commission and took the matter to the transparency commission of the Spanish government, daily El Diario reports on Friday.
The ministry sent the list of prices of all reimbursed drugs to the association, which made it public on Thursday, the newspaper reports.
The paper quotes Eva Iráizoz, from No es Sano, as saying: “We are pleased… but we would like the government to take further steps to make the process of drug pricing more transparent. This information should not only be available for us. It should be displayed on the ministry’s website”.
Representatives of No es Sano have also demanded more transparency on pricing talks with pharma.
Gilead’s hepatitis C drugs Epclusa (sofosbuvir+velpatasvir) and Vosevi (sofosbuvir+velpatasvir+voxilaprevir) are highlighted as being some of the most expensive reimbursed drugs in Spain, at around €47,000 per patient.
Cancer medicines, of which the newspaper does not mention any specific ones, are also specified as being very expensive therapies, with an average price of approximately €7,000 (the figures do not include details of treatment duration or annual treatment cost).
Other drugs in the story include Biogen’s Spinraza (nusinersen), sold at €70,000; Shire’s Revestive (teduglutide) and Vertex’s Kalydeco (ivacaftor), with prices ranging from €16,000 to €18,000. (APMHE 60526)

Confusion, misinformation about painkiller ban for British tourists

Misleading reports about the Spanish health ministry banning doctors from prescribing painkiller Nolotil (metamizole) to British tourists have been extensively published in Spanish media since Tuesday.
After Sanofi's Nolotil (metamizole magnesium) was linked to the death of 10 British people, the pharmacovigilance committee of Spanish regulator AEMPS produced a report warning that the drug can only be administered to patients who can return to the physician’s office for follow-ups and recommended caution, particularly in elderly patients. However, most newspapers said AEMPS had forbidden physicians from prescribing the drug to British tourists.
Some newspapers changed their internet headlines during the week to clarify that this was just a recommendation and that it affected all tourists, not just British ones.
On Wednesday, daily El Mundo carried the story saying AEMPS had issued a warning after Nolotil had been linked to cases of agranulocytosis in British patients. This severe reaction was already known, El Mundo noted.
El Mundo quoted a Sunday story in The Times with the headline: “Spanish painkiller Nolotil banned for Britons”.
The research carried out by a translator with expertise in medical texts raised concerns over the drug’s safety 11 months ago. Nolotil is a widely used painkiller, but there have been warnings about its effects in patients from Northern Europe, daily La Razón reported on Thursday.
Dailies ABC, El País, La Vanguardia, El Español, El Periódico, 20 Minutos, Público, a number of regional newspapers, news agencies and main tv channels also carried the story.

Four out of 10 new EMA-approved drugs are orphan

“Good news. Pharma has increased clinical trials on orphan drugs, research on rare diseases, particularly leukaemia, lymphoma, immune and metabolic diseases,” financial Cinco Días reported on Thursday.
There is an increasing number of innovative drugs to treat these disorders. This is possible thanks to specific regulation in the EU and U.S., the financial said.
Four out of 10 new drugs approved in Europe and the U.S. are orphan medicines to treat rare diseases, which affect three million patients in Spain, most of them children, the financial added.
A total of 14 orphan drugs were approved by the European Medicines Agency (EMA) last year. They include treatments for neurotrophic keratitis, neuroblastoma and carcinoid syndrome.
The U.S. Food and Drug Administration (FDA) approved a total of 18 orphan drugs in 2017, including a therapy for Batten disease and a drug to prevent haemorrhagic episodes in patients with a specific type of haemophilia A, Cinco Días noted.
Up until April 2018, a total of 105 orphan drugs have been approved by the EMA. Patient involvement in R&D has also helped these recent advances, the financial added.
In Spain, 10.8% of pharma-supported clinical trials carried out from 2015 to 2017 were devoted to rare diseases, a 7% increase from the period from 2010 to 2014, the newspaper reported.
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