Press review

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Rapid access biggest challenge in rare diseases - Shire Spain head

MADRID, 21 Sept (APM) - Stefanie Granado, Shire’s head of Spain and Portugal, told financial Cinco Días in a Thursday interview about the biggest challenges in rare diseases - prompt access to new treatments and more reference centres with disease specialists.
According to Granado, rapid access to new therapies for rare diseases is a challenge, but advances are being made, with an increased interest in innovation and research in the field.
“There are 42 ongoing clinical trials [for orphan drugs] in Spain”, she told Cinco Días. She also said physicians’ knowledge about rare diseases is increasingly good.
Granado said Germany and Scotland are an inspiration in this regard, with immediate access to new therapies for patients with rare diseases in both countries.
According to her, cooperation between pharmaceutical companies and healthcare authorities is key to improving access to innovative therapies. She praised the advantages of outcome-based deals to accelerate availability of orphan drugs and reduce the cost of treating complications that use of these therapies can prevent. As an example, she cited Shire’s Replagal (agalsidase alfa), which can prevent kidney disease in patients with Fabry disease.
In Spain, Shire’s goal is to act as a strategic partner for both the health ministry and autonomous regions. “We have signed risk-sharing agreements with a number of regions and a total of 100 hospitals (not named for confidentiality reasons) in more than 20 treatments,” Granado told the financial.
Asked by Cinco Días about possible moves to reduce the price of orphan drugs, Granados argued that there are few patients for any one of these diseases (only 50 in some cases, compared to millions with diabetes), yet requirements are the same in terms of research and filing procedures by the EMA, the Spanish ministry of health, autonomous regions and then hospitals. This explains why the cost of developing orphan drugs is so much higher.
She mentioned launches including the firm's recombinant human factor VIII Adynovi (recently launched) and upcoming products such as Veyvondi (vonicog alfa, recombinant von Willebrand factor), the recombinant porcine factor VIII Obizur (susoctocog alfa), Takhzyro (lanadelumab) and Elvanse Adult (lysdexamfetamine).
The most widely used of Shire’s drugs in Spain are Replagal, Elaprase (idursulfase), Advate and Adynovi, Granado told Cinco Días.

Manufacturing in China damages trust in generics

Following the withdrawal of valsartan-containing medicines due to carcinogenic impurities, an increasing number of physicians are reluctant to prescribe generic drugs due to lack of trust in cheap manufacturing processes in Asia, financial Cinco Días reports on Friday. (APMHE 59685)
Currently, most generics companies use drugs manufactured by a group of companies located in China, South Korea and India due to lower costs. Miguel Camafort, head of vascular risk at the Spanish Society of Internal Medicine (SEMI), told Cinco Días: “Alarm bells go off when healthcare authorities carry out safety controls and disparities arise between what companies say a drug is and what it really is”.
During production, changes take place and different excipients are included, among other things. Clinical trials are always carried out using originator drugs, whereas manufacturers of generic medicines only have to prove bioequivalence, Camafort said.
“As a matter of fact, some experts are starting to ponder the need for carrying out clinical trials on generic versions,” Cinco Días reports.
The story quotes Óscar López Moreno, from Madrid pharmaceutical association COFM, as saying that in July, 6,000 drugs were withdrawn from community pharmacies. The case of valsartan, used as an example, affected over 100 generic drugs marketed by 20 different companies. The problem was not the active principle, but an impurity which had its origin in Chinese manufacturing premises.
In a linked information box with the headline “The dark side of the pharmacy”, the newspaper says almost 90% of healthcare alerts issued by Spanish regulator AEMPS affect drugs (others are related to supplements). Of these, 60% are related to drugs sold at community pharmacies, while the remaining 30% affect hospital medicines.

Ending copayments would cost government €395 million

The end of drug copayments for pensioners, as planned by the Spanish ministry of health, would cost the government €395 million a year, according to an estimate by pharmacists' association FEFE, daily El País reported on Thursday.
Together with regions’ drug expenditure, which was €10.3 billion over the past 12 months, this would translate into a 3.8% increase in the country’s drug bill, which would be added to the 3.1% increase already registered in that period, the newspaper noted.
Newly appointed minister María Luisa Carcedo has this issue on her agenda, as planned by her predecessor, Carmen Montón, El País added. (APMHE 59059).

Oncologists defend José Baselga

This week, a number of newspapers carried articles defending José Baselga, who recently resigned from from a top New York cancer centre over failure to disclose payments from pharma, as a top researcher and clinician whose career should not be destroyed or overlooked. (APMHE 59734)
On Friday, El País carries a letter signed by Josep Tabernero, president of the European Society of Medical Oncology, praising his work and saying that even though he made a mistake (and resigned for it), the fight against cancer needs experts like Baselga.
Dailies ABC, La Razón, El Mundo, El Diario and EFE agency carried similar articles by other prominent oncologists during the week.
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