Largely negative views from Germany's IQWiG on AstraZeneca's Caprelsa in thyroid cancer

In a new benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of Anglo-Swedish drug major AstraZeneca’s (LSE: AZN) Caprelsa (vandetanib) for the treatment of adult patients with a particular form of aggressive thyroid cancer, under the Act on the Reform of the Market for Medicinal Products (AMNOG). Caprelsa is the first approved treatment for advanced medullary thyroid cancer in Europe (The Pharma Letter February 21, 2012).

There is a hint that pain occurs later or gets worse later in some patients, the ones aged under 65 years. But because of the overall poor data on side effects, no conclusion could be drawn about harm, said the IQWiG. Therefore it was not possible to balance positive and negative effects. Overall, an added benefit of vandetanib is therefore not proven.

Vandetanib underwent a first early benefit assessment procedure in 2012, when it received a negative opinion (TPL July 5, 2012). In this procedure, AstraZeneca did not present any data for the patients for whom the drug is approved. The added benefit was regarded as not proven because the contents of the dossier were incomplete. The pharmaceutical company could apply for a reassessment of vandetanib within a transition period and submit a new dossier to the Federal Joint Committee (G-BA).