Infarmed says authorization for cancer drugs based on medical evaluation – The Economic Journal


The College of Oncology of the Order of Doctors believes that Infarmed's assessments have denied access to drugs with “proven effect on decreasing or relapsing” cancer or increasing the likelihood of survival, according to Expresso.

Speaking to Lusa, Infarmed President Rui Ivo indicated that these are cases of drugs that are still under evaluation and for which doctors can request access through an exceptional use authorization, and these authorizations are decided. based on the advice of medical experts, many of them oncologists from National Health Service (NHS) hospitals, including from the Oncology Institutes.

These exceptional use permits allow doctors to apply for access to a drug while it is still undergoing drug-economic evaluation to be reimbursed and provided by the NHS.

According to Rui Ivo, the assessment of authorizations for exceptional use is made by medical experts, based on technical and clinical criteria, with funding issues aside.

The president of Infarmed also considers that Portugal is an example of “access to the best available treatments”, particularly in the cancer area.

In terms of approval of new cancer drugs, between 2016 and 2018, 40 new substances were approved and 15 new ones have been approved this year alone, according to official data from the Medicines Authority.

Also Nuno Miranda, oncologist and expert of the Commission for Health Technology Assessment, emphasizes that when evaluating the authorizations for exceptional use of a drug, the price of the drug is not taken into account (which remains for the evaluation of the drug-economic analysis). which decides whether it will be assigned to the NHS to all who need it).

In the case reported by the College of Oncology in the newspaper Expresso, Nuno Miranda points out that it is an adjunctive therapy for cancer patients who have already had surgery or treatment.

“The eventual benefit is marginal (…). It does not make a dramatic difference to patients' lives, ”the oncologist told Lusa.

Nuno Miranda recalls that the exceptional use authorization figure serves to give access to medicines that are still undergoing evaluation and in cases of imminent life-threatening or when there is a real risk of disease progression.

“In the case of adjunctive therapy, not making a dramatic difference in the lives of our patients, what makes sense is to wait for the drug evaluation to see if it makes sense to change medications. Efficacy, toxicity and price need to be evaluated, ”he said.

The oncologist also points out that these patients are already undergoing treatment, underwent surgery, "the most important treatment they should have," and adjunctive therapy is a possible alternative to the medication that was already determined and planned.

Infarmed also points out that in the case of medicinal products in the context of exceptional authorization there is “a considerable level of uncertainty, as the comparative safety and efficacy results are not known for the other treatments in national clinical practice”.

According to Expresso newspaper, at the center of the discussion are about five drugs, which cost the NHS between two thousand and five thousand euros per patient per month, with indication to be used between six months to one year.

Infarmed's official figures for cancer drugs show that this year more than 1,100 applications for exceptional use have been made, 859 of which have been approved.

Exceptional authorization application values ​​have grown over the years, with more and more new drugs entering the market. Compared to 2015, this year the number of orders has tripled.



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