ZIN Rejects Kaftrio Plus Kalydeco, Urges 75% Price Reduction and Renegotiation of All Vertex Drugs

AMSTERDAM, Netherlands – The Zorginstituut (ZIN) has advised the Minister of Medical Care to exclude Vertex’s triple-combination therapy Kaftrio (elexacaftor/tezacaftor/ivacaftor) plus Kalydeco (ivacaftor) from the Medicines Reimbursement System (GVS) unless the company meets a handful of conditions, including reducing the price of the drug by 75%.

While ZIN is confident in the effect of Kaftrio and Kalydeco, especially when it comes to improving lung function and reducing respiratory complaints, the agency is uncertain of the long-term benefits of the drug and feels its cost-effectiveness is “very unfavorable” and its price a “heavy burden.” According to ZIN, Kaftrio costs €194,040 per patient per year, and additional costs in the third year are expected to be €156.4 million, threatening to displace other care, warned ZIN.

Besides a price reduction, ZIN requested that the Netherlands enter into joint price negotiations with other European countries, conclude an agreement outlining appropriate use of Kaftrio and Kalydeco, and ensure long-term data collection to evaluate the safety and efficacy of Vertex’s drugs.

In general, however, ZIN is urging the Minister to renegotiate a price agreement for all Vertex’s CFTR modulators, including Kaftrio, Kalydeco, Orkambi (lumacaftor/ivacaftor) and Symkevi (tezacaftor/ivacaftor)—as noted by ZIN, “Each new drug turns out to be more expensive than the previous one.”