Doctors have accused medicines authority INFARMED of holding back on potentially game-changing remedies for hundreds of patients (see update below).
The controversy blew up over the weekend, during which INFARMED countered that doctors were free to make ‘special requests’ to see new meds released under certain circumstances.
But leading oncologist Luís Costa says the argument is specious: the bottom line, he stressed, is that if given in time (ie the moment they’re needed not once INFARMED has mulled over any hypothetical request), these state-of-the-art remedies ‘could be decisive’.
If given only once INFARMED has made a special decision, patient survival is put further at risk.
As Costa explained, we’re talking here about treatments that have “already been positively evaluated by the European Medicines Agency”.
“It’s not possible that these days treatments can be approved and used in many European countries, particularly the most modern countries, and that here in Portugal the only possibility for patients to receive them is if they go private”, Costa told SIC.
The treatments at issue are those for breast cancer, lung cancer, prostate cancer and melanoma.
Says Expresso, they cost the SNS health services between 2,000-5,000 euros per month per patient.
For now, INFARMED’s rule is that they can only be administered once the patient is suffering “immediate risk to life” – that is, at the stage when the cancers have metastasized.
Luís Costa’s point – backed by specialist colleagues within the famously centre right PSD-supporting Doctors Association (readers have to be aware that we are in the run-up to legislative elections) – is that patients should not need to reach this point before receiving game-changing medication.
“Timing” is everything, Costa insisted. The earlier innovative treatments are administered, the better for patients’ chances of survival.
UPDATE: The following text has been received from INFARMED since writing this story:
INFARMED and the National Health Service (SNS) have provided patients in Portugal with access to the best treatments and health care as soon as they are available, and the availability of new medicines in recent years is demonstrative of this. In fact, more than 40 new cancer drugs have been funded since 2016, and this year alone 15 new drugs have been approved for funding. These assessments are essential to ensure access for all citizens to both innovative therapies and other care they need in the context of the SNS.
As is well known, the SNS has also provided access through exceptional use permits, either in the pre-marketing authorization (AIM) phase or after the marketing authorization (MAA), with more than 4000 AUEs (Authorization for Execution Use) approved for cancer patients in the last 3 years. It should be noted that these AUEs are a part of the therapeutic response that has been guaranteed to all Portuguese, and is demonstrative of the excellent response in the field of cancer by the SNS. Over 4000 AUEs have been approved for cancer patients in the last 3 years.
It is worth mentioning that it is an area in constant evolution, where there are more and more drugs available and more options and therefore we have to make a careful evaluation according to all available data. This therapeutic innovation comes at different stages, namely adjunctive therapy, used to prevent relapses.
In conclusion, the assessment of AUE applications thus depends on criteria that are only technical and clinical, based on the analysis of medical experts from various SNS institutions (namely IPO Porto, IPO Lisbon and CHULN). These are technical decisions made by medical experts who have analyzed these exceptional requests, which, it is recalled, are a part of the therapeutic response and have been guaranteed to all Portuguese. At this stage the financing issues do not weigh
