A new therapeutic solution for patients with COPD (chronic obstructive pulmonary disease) or severe emphysema has been reimbursed by social security since last May. But it has undesirable side effects.
- A valve, newly reimbursed by social security, improves the living conditions of patients with severe COPD.
- However, according to one study, it causes pneumothorax in 25% of cases.
It’s the end of the marathon for the American company Pulmonx. More than a year after the validation of its Zephyr valve to fight against severe forms of COPD (bchronic obstructive pulmonary disease) by the High Authority for Health (HAS), the group announced the reimbursement by social security last May of its valve costing more than €2,300. For the manufacturer it is “of a decisive turning point“, an assertion qualified by the HAS which considers that “endobronchial valves meet a need partially covered by endobronchial coils“while considering its therapeutic interest.
This disease is not curable. There are different therapies to limit the undesirable – and sometimes disabling – effects of this long-term condition such as shortness of breath. According to the HAS, the main treatments in 2019 were bronchodilators, mechanical respiratory assistance and sometimes surgery for the most severe cases. The manufacturer’s valve Pulmonx allows “regulate airflow to improve lung function in patients with hyperinflation associated with severe emphysema and/or reduce air leakage“explains the HAS.
“This treatment represents an important advance for interventional pulmonology, assures Plumonx, quoting Dr Nicolas Guibert, lecturer and hospital practitioner in the service of the Toulouse University Hospital. Before the Zephyr valves, patients presenting with an advanced stage of the disease, severely debilitated, had as their only alternative surgical procedures but for which they often did not have access in view of the invasiveness and comorbidity of the surgery. The French medical community has an unprecedented opportunity to access this option to help patients breathe easier and resume their daily activities..”
1 in 4 patients had a pneumothorax
As formidable as its opinion on this valve is, the HAS has decided to authorize it only for patients with severe forms. The reason ? Non-anecdotal side effects. A randomized study “Liberate” measured the impact of Zephyr up to 2 years after its implantation on 190 patients. This valve improves the forced expiratory volume per second of almost half of the patients, so it is much more effective than the optimal standard treatment which only improves it for 17% of them.
However, even if the manufacturer assures that it is a “minimally invasive” solution, the side effects are significant. Thus, according to this study examined by the HAS, more than 1 in 4 patients equipped with the valve had a pneumothorax within 45 days after the operation, compared to none for the control group. In addition, the valve seems to promote the exacerbation of the disease since in the medium (45 days) and long term (1 year), a greater proportion of people who have been fitted with the Zephyr valve have seen their condition deteriorate compared to to those on optimal standard therapy.
Despite these undesirable side effects, the HAS has concluded that it is therapeutically beneficial for the most severe forms. “The results of this study [Liberate, NDLR] show that the effectiveness of the ZEPHYR valves is maintained at 1 year in terms of evolution of forced expiratory volume per second, quality of life and physical exercise on the 6min walk testwrites in its report the HAS. These benefits must be weighed against the occurrence of approximately 6 times more serious respiratory adverse events (mainly pneumothorax) in patients implanted with Zephyr valves compared to patients with optimal medical treatment alone.”
The HAS recalls that COPD is the leading cause of severe chronic respiratory failure in France. Between 5 and 10% of the population over 45 would be affected by this pathology, ie between 1.5 and 3 million adults. However, as INSERM reminds us, thehe chronic obstructive pulmonary disease is a chronic inflammatory disease of the bronchial tubes, most often associated with other diseases. It is characterized by progressive narrowing and permanent obstruction of the airways and lungs, causing difficulty in breathing. This disease has four stages, of which forms III and IV are the most severe and concern between 150,000 and 450,000 patients according to the HAS. This disease is part of the list of long-term illnesses (ALD).
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