Roflumilast (Daxas®) for maintenance treatment of severe chronic obstructive lung disease (COPD)

Zorginstituut Nederland has carried out an assessment of whether roflumilast (Daxas®) is interchangeable with a drug currently included in the Medicine Reimbursement System (GVS).

Registration

Roflumilast is registered as an addition to treatment with bronchodilators for the maintenance treatment of severe chronic obstructive lung disease (COPD) associated with chronic bronchitis in adults whose COPD flares up frequently. Roflumilast is available as 500 microgram film-coated tablets. The maintenance dose is one 500 microgram tablet once a day.
The Zorginstituut assessed roflumilast (Daxas®) in 2010 and advised that the product should not be included in the basic package for the registered indication.

Assessment of interchangeability

In 2010 the (former) College voor zorgverzekeringen (Health Care Insurance Board (CVZ) established – based on the GVS criteria for interchangeability – that the GVS includes no product that is interchangeable with roflumilast (CFH-report 10/21). Since 2010 no new products have been included in the GVS with a similar field of indication and the same administration route as roflumilast.

Based on the above, roflumilast (Daxas®) cannot be placed on List 1A. What must be examined is whether roflumilast is eligible for placing on List 1B of the Health Insurance Decree.

Advice on inclusion in the GVS

Roflumilast is not interchangeable with any other product included in the GVS. Based on the above-mentioned considerations, we advised the Minister of VWS to include roflumilast on List 1B and List 2 of the Health Insurance Decree. Inclusion on List 1B will involve additional costs.

Conditions

Only for an insured person aged 18 years and older:

  • who has severe chronic obstructive lung disease (FEV1 <50% of predicted) associated with chronic bronchitis, and,
  • as an addition to maintenance treatment (a corticosteroid, a long-acting β2-sympathicomimetic and a long-acting parasympathicolytic agent) for an insured person who, despite this optimum (maximum dosage of) triple inhalation therapy, still suffers frequent flare-ups (≥ 2 moderate to severe flare-ups or ≥ 1 hospital admission in the year prior to starting treatment).

The original text of this excerpt from advice of Zorginstituut Nederland was in Dutch.