Cancer patients undergoing treatment within Spain's National Health Service (SNS) are not being given new drugs, many of which have been approved and available for the last year, and in some cases up to two years, due to the failure of the government and pharmaceutical companies to reach agreement on prices. "We are all looking for a sustainable solution, and prices must be reduced as much as possible," says Agustín Rivero, the head of the SNS's Supply of Basic Services.
But cancer specialists and patients' associations say that even after the price of a new drug treatment has been agreed and the medication approved for use, some regional governments and hospitals are subsequently applying their own criteria, which often create further delays for many patients; in some cases they stand accused of simply refusing to administer them on the basis of cost.
"Two years ago, the waiting time from the point that the European Commission approved a drug to the health service agreeing financing was around six months, and the delay rarely went beyond nine months; at the moment, the waiting time is a minimum of 12 months, and often as long as 18 months," says Juan Jesús Cruz, the president of the Spanish Medical Oncology Society (SEOM). Last week, at a meeting in Madrid of Geicam, the Spanish Breast Cancer Research Group, specialists reiterated their concern about delays in providing cancer patients with new medicines, pointing out that Spain's health service, which along with Austria was once an EU leader in making new anti-cancer treatment available to patients, is now at the bottom of the table, alongside Portugal and Greece. In the last three years, health spending in Spain has fallen by 10.6 percent, a cut of 6.7 billion euros.
There are many interests at stake: new anti-tumor medicines are increasingly costly, and in many cases the evidence suggests that the benefits they produce are limited. Since the crisis kicked in, Spain's health system has been increasingly subjected to cost-cutting, and budgets are getting tighter. At the same time, the pharmaceutical industry wants to see a return on its research and development costs, while the central government wants to pay less for drugs. Meanwhile, oncologists want to give their patients the best drugs available on the market, while patients demand access to treatment as quickly as possible in the hope of stopping the spread of the disease or to prolong their life, even if only for a few months.
“They wouldn't give me the drug because of the cost”
M. González, a retired 77-year-old from a small town in the province of Ávila, northwest of Madrid, who spoke to EL PAÍS on condition of anonymity, has been living with prostate cancer for the last four years.
The illness seems to be hereditary: his father and a brother were also diagnosed with it. His doctors have been treating him with drugs and radiotherapy. "He has always felt that he was being looked after properly," says his son Jesús. Until a month ago. The disease began to spread quickly, and in response his specialist recommended a new treatment: abiraterone acetate. The drug was duly prescribed, and González took it to the pharmacy of the La Paz hospital in Madrid, where he was being treated. "They told me they weren't going to give it to me because it was too expensive," he says. "More than 40 years of paying into the Social Security system and when you need something, they won't give it to you."
A course of treatment using abiraterone acetate, sold under the brand name Zytiga, costs between 50,000 and 80,000 euros. It is a relatively new drug, which was initially approved for a specific problem: patients with advanced cancer who had already undergone chemotherapy.
Since then, the European Medical Agency has approved the drug for the treatment of prostate cancer where other treatments such as depriving androgens have failed, and where chemotherapy will no longer have any impact: exactly the case with González and hundreds of other patients throughout Spain.
Last November, the Spanish Health and Medication Products Agency, Aemps, announced in its bulletin that Zytiga could now be used for the treatment of prostate cancer. But the Health Ministry has yet to set a price for the drug. It is negotiating with Janssen, the company that makes it, says a spokeswoman. This is the reason that the La Paz hospital, and many others throughout Spain, says that it cannot issue the drug for patients who have not yet undergone chemotherapy. However, some hospitals, such as Puerto Real in Cádiz, have carried out studies to establish which patients it could use the drug for, while the government and the pharmaceutical company negotiate prices.
"Approval of prices is another way for the government to delay the entry of new pharmaceuticals. It is common for waiting times of several months, often more than a year, after which hospitals will sometimes decide that they are not going to provide the drug," says an oncologist, adding that patients may find themselves being treated in a more cost-conscious hospital.
González says that after La Paz denied him the drug he had been prescribed he was "very worried, very nervous." His son filed complaints with the Madrid Health Department, which has yet to reply to him, as well as to the Health Ministry, which told him it could not "interfere" with the regional government's decision, suggesting he take up the matter with the Ombudsman's Office. Last week González and his son met with a hospital representative, who said his case was not urgent, providing him with an alternative medicine until a price is set. "I am calmer," he said afterward. "The doctors have behaved well."
Among the drugs approved by the European Commission but still not available in Spain are Everolimus, marketed as Afinitor by Spanish pharmaceutical company Novartis, which is used to treat breast cancer. The European Commission approved its use in July 2012, but it is still not on the list of drugs subsidized by the SNS for the treatment of breast cancer, although it is available for renal cancers. Eribulin, marketed as Halaven by Esai, was approved by the European Commission in March 2011 for the treatment of breast tumors that had already been subjected to two previous treatments.
Vemurafenib, marketed by Roche as Zelboraf, was approved in February 2012 for the treatment of melanomas, while Ipilimumab, sold as Yervoy by BMS, for the treatment of advanced melanoma, was approved in July 2011, but not made available to Spanish cancer patients until October 2012.
The cost of a course of treatment to the SNS of these drugs is around 57,000 euros per patient.
The Health Ministry blames the delays in making these drugs available to patients on new authorization procedures called therapeutic positioning studies, and only reached agreement with the regional governments a few weeks ago. The ministry says that the new procedure will speed up the process of making new drugs available. Rivero says that the funding for Eribulin and Everolimus will soon be available, and adds that if the drug turns out to be effective and improves patients' conditions, as well as not containing compounds already available, "it will not take longer than three months to be approved."
In any event, as Cruz notes, there are ways around the waiting time if drugs are necessary: "They can be obtained through extraordinary procedures such as on the grounds of compassionate treatment," he says, although the paperwork is complicated.
The Foundation for Excellence and Quality in Oncology, which brings together 27 heads of service within the SNS, recently warned about continued delays in making new drug treatments available to patients based on the region where they live: "Everything that has been achieved so far in terms of survival rates and quality of life could suffer an important setback."
The Spanish Cancer Patients' Group, Gepac, has also spoken out about the issue, accusing the government of dragging its feet in order to reduce costs. "The longer the delay in making a drug available within the public health system, the less the government has to spend on administering these pharmaceuticals: it is a question of saving money," says Gepac's president, Begoña Barragán.
Cancer treatment has been undergoing a paradigm shift since the 1990s. New therapies are increasingly focused on directly attacking the specific molecular mechanisms involved in the development of the tumor. This new approach is very expensive and tends to produce partial results at best, because not all patients share the same altered cell mechanisms.
That said, there have been major advances in cancer treatment over the last two decades, says SEOM: "We should not forget that of the more than 20,000 breast cancer cases in Spain each year, a one-percent improvement in treatment means that 200 women with cancer will not go into remission."
But the crisis is not only affecting the way that the Health Ministry authorizes new medicines. Regional governments in turn are reassessing the ministry's criteria; there is then a third barrier put up by hospitals themselves in the form of their own therapeutic guidelines, which often establish yet another set of criteria regarding the application of anti-cancer medicines.
"In this way, it is the payer [the regional governments and the hospitals] that establish selection criteria regarding the administration of pharmaceuticals, an approach that makes for an inefficient system that in turn generates deficiencies regarding access to treatment between different regional governments and hospitals," says Cristina Avendaño, the vice president of the Spanish Society for Clinical Pharmacology. "It is also unacceptable that the ministry sets the price and conditions of use but that in the end it is the regional governments that pay," adds Albert Jovell, head of the Spanish Forum of Patients, which is calling for regional governments to be given a greater say in deciding health policy.
The process of therapeutic positioning includes taking into account the opinion of specialists from evaluation panels set up by regional governments to set common criteria for the use of pharmaceuticals once they have been approved. "The idea is to avoid the need for medications to be constantly reevaluated," says Agustín Rivero. This would mean that all patients would have access to the same drugs, regardless of which region they live in, or which hospital they are being treated at.
"It's not going to be easy, and we hope that all parties will stick to the agreement," adds Rivero. "But we're going to try."