Press review


Spanish cystic fibrosis patients demand access to Vertex’s Orkambi

Country : Spain

Keywords :
MADRID, 14 Sep (APM) - On Saturday, daily El Mundo carried a lengthy story about the need for access to Vertex’s Orkambi for cystic fibrosis patients, presenting the case of a little girl who has been successfully treated with the drug.
The newspaper carried the headline: “Cystic fibrosis patients say they do not understand why a price has been put on our lives”.
The eight year-old used to be hospitalised practically every week due to infections or other complications of the disease. However, since starting treatment with Orkambi (lumacaftor+ivacaftor), she has reached the normal height for her age, she does not need to be fed via catheter and she can walk normally.
According to the newspaper, this is probably the first child and one of the very few patients “lucky enough” to have had access to the drug. Only 22 patients are currently on Orkambi in Spain.
Orkambi is approved in Europe and Spanish regulator AEMPS issued a positive opinion on it in July 2016, but it is not yet available in Spain.
Blanca Ruiz, president of the Spanish Federation of Cystic Fibrosis, told El Mundo: “The ministry of health and the manufacturer have not been able to agree on its price”. A two-year wait is too long for this group of patients, Ruiz argued.
Orkambi is recommended in people with two copies of the F508D mutation, which are particularly severe cases. Even though there is no patient registry in Spain, an estimated 28% of patients would be appropriate candidates to receive the drug, the newspaper noted.
Whereas Germany and Italy have approved Orkambi for reimbursement, Spanish healthcare authorities are still assessing the drug’s efficiency in real life settings due to its extremely high price and its potential impact on the country’s drug expenditure, ministry sources told El Mundo.

Cancer burden on the rise

The number of cancer patients has increased 28% over the past six years, with the disease killing 9.6 million people globally each year, dailies ABC, El País and a number of regional newspapers reported on Thursday.
All the stories used data provided by the International Agency for Research on Cancer (IARC) in its latest report.
One in five men and one in six women worldwide develop cancer during their lifetime, and one in eight men and one in 11 women die from the disease, El País reported.
Several factors, including population growth and ageing, are mentioned as having a substantial impact in this trend. Regarding differences between developed and developing countries, El País quoted Rafael Marcos-Gragera, an epidemiologist from the Catalonian Oncology Institute, as saying: “Life expectancy is higher in developed countries, where cancer incidence is also higher. In developing countries, mortality is linked to infectious diseases such as HIV and malaria.”

Diclofenac increases cardiovascular risk

 A new study published in the British Medical Journal shows that diclofenac increases cardiovascular risk compared to non-use, paracetamol use, and use of other traditional non-steroidal anti-inflammatory drugs, daily La Razón reported on Wednesday.
The link between non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular risk has been known about for some time. However, the new data question the safety of what is one of the most used in this family of drugs, La Razón reported.
The newspaper quoted Federico Díaz, head of the research division of the Spanish Rheumatology Society, as saying: “The truth is that, among all NSAIDs diclofenac is the one with the worst safety profile regarding cardiovascular health. Naproxen, on the other hand, would be the best when it comes to cardiovascular safety”.

Spanish researchers develop experimental drug to halt metastasis

Spanish researchers at Barcelona’s CIBER-BBN Research Institute, Barcelona University and the Spanish Council for Scientific Research (CSIC) have developed an experimental drug which has successfully stopped metastasis in animal models of colon cancer, daily ABC reported on Saturday.
If this drug were to prove useful in humans, it would be the first therapy to be used to prevent metastasis from developing in cancer patients, the newspaper noted.



Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to our last stories

Request a trial to assess coverage that includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.


an initial 10 day temporary access of APM Health Europe.