MADRID, Sept 22 (APM) - Spain's ministry of health has failed to make a decision on the reimbursement of new EU authorised orphan drugs or refused to pay for them because of their high price, with a total of 23 medicines affected by disparities between approval and reimbursement, financial El Economista reported on Monday.
Unfinished pricing talks prevent some of these drugs being available in Spain, where the Association of Orphan and Ultra-orphan Drug Manufacturers (AELMHU) has made the situation public.
For 11 of them, the ministry has denied public funding due to high price, so those companies which want to make them available in Spain’s public healthcare premises will have to reduce their prices, the financial said.
According to the association, only 49 of the 94 orphan drugs which had been given the European Commission's green light from 2002 to 2011 were approved for reimbursement in Spain. The situation has been particularly difficult over the past four years, with an increase in discrepancies between approvals and reimbursement.
From 2012 to 2016, the European Commission approved 58 new orphan drugs, but only 18 (31%) were approved for reimbursement in Spain, El Economista reported.
The financial quoted sources from the association as saying: “Access to orphan drugs in Spain is not easy now. In spite of EU approval, long pricing talks in Spain prevent patients affected by rare diseases from getting these drugs”.(APMHE 54606
Manufacturers admit that these medicines are expensive, but only if considered at the individual level. When looked at from a general perspective, since rare diseases affect quite few people, the impact of reimbursing these therapies on the healthcare budget is rather small. According to their estimates, there are 4,300 patients in need of orphan drugs in Spain, the financial added.
Chinese biotech growth driver for big pharma
Chinese firms are best known for producing cheap generics, but a new generation of domestic pharmaceutical firms, like Zai, run by former Pfizer executive Samantha Du, are focused on biological medicines and signing agreements with big western companies, financial Cinco Días reported on Wednesday.
Big western pharma is helping Chinese companies carry out expensive clinical trials and obtaining rights to sell drugs developed in China in western markets. Examples of this kind of agreement are the one signed by Celgene and BeiGene and the one signed by Eli Lilly and Johnson & Johnson with other Chinese companies, the financial reported. (APMHE 53816
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In terms of the future, this could help Chinese manufacturers enter the U.S. market, where the chances of success for a new drug to comply with all regulatory requirements, from the first clinical trial to an eventual approval, are below 10%, Cinco Días added.
Private funds essential for research in blood cancers
Early phase trials are crucial to improving therapies for blood cancers such as leukaemia, lymphoma and multiple myeloma, daily La Razón reported on Saturday.
Until recently, being diagnosed with blood cancer was “practically a death sentence”. Today, these diseases are not impossible to fight. The cause of the change is research, but public funds provided to this kind of projects are not enough, the daily said.
An example of this is the HUNET-CRIS unit ay 12 de Octubre Hospital in Madrid, which exists thanks to private funds provided by the CRIS Cancer Foundation.
Trials involving genetically engineered T-cells are carried out in this unit, among other therapies. Researcher Joaquín Martínez said only 1% of lymphoma patients access this kind of research because “not all centres are authorised to carry them out and patients can be called in as often as 15 to 20 times in one month, so not all can commit”, he told La Razón.
Guide to the post-Brexit pharma market
The consequences of Brexit on the pharmaceutical market have been drafted by the European Commission in a new document, medical journal Redacción Médica reported on Thursday.
Specifically, the document warns that, from March 30, 2019, the authorisation of new medicines must be carried out by the EU, and it will be extended to Norway, Iceland and Liechtenstein, but not the UK.
According to this guide, all UK filings will need to be presented and carried out again before European authorities if a drug is to be sold across Europe, the journal noted.
Almirall launches Skinlarence in psoriasis
Barcelona-based Almirall has launched Skinlarence (dimethylfumarate) in first-line and maintenance therapy of moderate to severe plaque psoriasis, medical journal Diario Médico reported on Saturday. Gaceta Médica carried the story on Monday.
The first market where it will be available is the UK, followed by Germany, Denmark, Sweden and Norway, Gaceta Médica reported.
Risk of taking five drugs a day
One out of three people over 65 in Spain takes five drugs a day or more, and at least one of those is prescribed by mistake, daily ABC reported on Wednesday.
A daily intake of five drugs or more is associated with a higher risk of adverse reactions (88% over the general population). Miguel Ángel Hernández, from the Spanish Society of Family and Community Medicine (SEMFYC), told ABC medication prescribed to the elderly should be revised regularly.