Why Certain Cancer Drugs Aren’t Available to French Patients: Understanding the Role of National Medicines Safety Agency and High Authority for Health

2023-06-05 16:19:19

The High Authority for Health (HAS) decides on the reimbursement of a drug (credit: getty images)

Despite sometimes spectacular results, certain drugs such as cancer drugs are not available to French patients outside clinical trials.

A lung cancer drug caused a stir when it was presented at the World Cancer Congress in Chicago (USA) this weekend. And for good reason, osimertinib, a tablet marketed under the name Tagrisso and developed by the pharmaceutical group AstraZeneca, has reduced cancer recurrences by half in patients suffering from a form of lung cancer.

More specifically, this form of cancer concerns a mutation on the EGF (Epithelial Growth Factor) receptor and affects between 10% and 25% of patients with lung cancer. The results of this 5-year clinical trial were expected, even though osimertinib is already authorized in dozens of countries. A majority of patients already benefit from this targeted therapy in France, notes franceinfo. This is not the case with all drugs, despite their sometimes very promising results.

In France, it is the National Medicines Safety Agency (ANSM) which authorizes or not the marketing of a medicine. The High Authority for Health (HAS) then decides whether its clinical interest deserves reimbursement by the Health Insurance, in particular in relation to the treatments already available. If the medicine scores between 1 and 4, it has a chance of being reimbursed. With the rating of 5 (ASMR 5), the worst, it will not be or at the expense of hospitals. “This amounts to condemning the drug, health establishments cannot assume such an expense”, notes The world who cites the example of cell therapy Carvykti (Janssen), intended for the treatment of multiple myeloma, a rare cancer of the bone marrow.

Several cancer drugs

Since January, repeated unfavorable opinions from the HAS have annoyed many oncologists. “Not registering them for reimbursement means preventing all patients from accessing them. The loss of chance is immense”, regrets for example Pascal Pujol, president of the French society of predictive medicine, in the columns of the Parisian. “For a doctor, there is nothing worse than knowing that the right drug exists but that he will not be able to give it”, adds Professor Frédérique Penault-Llorca, director of the Jean-Perrin anticancer center in Clermont- Ferrand also interrogated. Doctors are all the more angry that these drugs have been validated at European level.

Were thus withdrawn le Keytruda (pembrolizumab) in the treatment of rare advanced or recurrent endometrial cancer or cancer of the stomach, small intestine or bile ducts. The same applies to and Retsevmo (selpercatinib), a reimbursement candidate for the treatment of advanced lung cancer with a positive REarranged during Transfection (RET) fusion. The therapy, however, shows excellent response rates, according to one study. And Brukinsa (zanubrutinib) also received an adverse opinion for reimbursement for the treatment of patients with Waldenstrom’s macroglobulinemia, a rare blood cancer. This therapy authorized in November 2021 by the European Union is reimbursed in several other countries.

The HAS justifies its choices by “insufficient” data to demonstrate a benefit or safety for the patient in the therapies in question, while saying that it is ready to review its decisions in the event of new data. Not enough to calm doctors and patients. “There is no reason that for the same cancer, some have the right weapons, and others do not”, protests to the Parisian Suzanne, 43, diagnosed with lung cancer who benefited du Rozlytrek (entrectinib) in a clinical trial.

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