Endobronchial valves for persistent air leakage added to the Spanish Common Package of Benefits

Earlier this year, the Commission of Benefits, Insurance, and Financing came to an agreement in relation to endobronchial valves for persistent air leakage (PAL). The proposal made by the Commission of Benefits, Insurance, and Financing concerning endobronchial valves for PAL, was approved by the Interterritorial Council of the National Health System (CISNS) on June 30, 2021.

On July 22, 2021, the Resolution of the General Directorate of the Common Package of Benefits of the National Health and Pharmacy System was published outlining that:

• The endobronchial valves for PAL should be kept in the Common Package of Benefits of the National Health System under the same conditions as in the monitoring study protocol. The following criteria must be met:
  • PAL caused by alveolar-pleural (peripheral) fistula, lasting more than seven days, and refractory to conventional treatment with pleural drainage;
  • It is possible to locate the air leak;
  • Surgery or other previous treatments have not resolved the leak, or the patient is not a candidate for surgery due to comorbidity or his will, or the endobronchial valve implantation could be considered as a first choice in the treatment of secondary pneumothorax (in exceptional cases, and always after evaluation by a thoracic surgeon);
• The exclusion criteria include:
  • PAL caused by broncho-pleural (central) fistula;
  • PAL due to primary pneumothorax with an indication for surgery;
  • Pregnancy;
  • The patient has any of the following contraindications to undergo bronchoscopy with sedation: recent ischemic heart disease (four weeks), refractory respiratory failure, severe coagulation disorders, treatment with anticoagulants, or antiplatelet agents (excluding 100 mg of acetylsalicylic acid) that cannot be withdrawn.

The Resolution also provides information on minimum requirements the hospitals should meet in order to be eligible to perform this service. It will be possible for the centers that have not participated in the monitoring study to gain experience in the technique in a proctored manner until meeting the requirements established in the monitoring study protocol.

This decision was based on the reports (HTA report and monitoring study) by the Evaluation Unit of the Canary Islands Health Service (SESCS).

The full details in Spanish can be found here. The HTA report and the monitoring study protocol (part 1) by the SESCS can be accessed here and here.

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