Vitrakvi & tumor agnostic treatments: current pricing discussion and outlook

Tumor agnostic treatments are a very new development in the exciting field of personalized medicine. These drugs can be applied to tumors of any type (a pan tumor approach) targeting specific genomic anomalies or molecular differences to healthy tissue. This means that any patient presenting certain biomarkers can be treated by such drugs, which in these patients have fewer side effects & high efficacy. Approvals currently exist for 3 drugs, Keytruda (BMS), Vitrakvi (Bayer) and Rozlytrek (Roche).  In this article, I will specifically focus on Bayer’s Vitrakvi, as it might become a precedent for similar treatments in clinical development with regards to approval and reimbursement decisions.

Negative perception of pricing watchdogs in Germany and the United Kingdom

The IQWIG, an independent authority commissioned by the German federal joint committee (G-BA), evaluates the benefit of new drugs and gives recommendations on pricing within Germany. IQWIG says that although being an innovative treatment, the lack of data, i.e. control arms in the Vitrakvi trials is an issue. It was noted that no clinical data has been shown comparing Vitrakvi with other drugs, thus IQWIG cannot be sure that Vitrakvi provides added benefit as compared to older existing medications. Bayer said that the genetic profile that Vitrakvi was targeting was too rare to allow for a control group [1], thus control arms were not incorporated into the study. In this case, the IQWIG recommended to put Vitrakvi in a price bucket with existing drugs, which are of course much cheaper than the high-priced Vitrakvi. Bayer is now awaiting the final G-BA decision, which is expected for the beginning of April and follows in most cases the IQWIG recommendation.

The National Institute for Health and Care Excellence (NICE) in the United Kingdom also did an evaluation of Vitrakvi, which showed no or a very uncertain cost-effectiveness. This is again because this innovative treatment has not been compared to other drugs. However, NICE and Bayer are still open for discussions, so the last word is not yet spoken.

Outlook on tumor agnostic treatments approvals, pricing and development

For tumor agnostic treatments of this kind with a need for genetic screening, watchdogs for pricing and reimbursement will probably require more and more reliable comparable data in order to properly assess the therapies added benefit. The future will show if this is possible and how companies can provide such data. In the meantime, the NHS is preparing for similar “next generation therapies” and notably is in discussions with Roche around their drug Rozlytrek. In view of Roche yet awaiting Rozlytrek’s EMA approval and its lower price tag as compared to Vitrakvi (USA), I believe that movements on the price range could help to settle Vitrakvi in the EU.

Speaking about the future, there are several more tumor agnostic treatments in the pipeline of companies such as Eli Lilly, Blueprint Medicines Corporation, or Debiopharm Group. These drugs currently are in phase 1 or 2 and it will be exciting to see kind of patient data is collected in their trials in order to convince pricing/reimbursement authorities. Let’s see how the pharma industry will be impacted on their development portfolio by such kind of negative pricing decisions. Alcimed will keep you posted!

About the author

Volker, Great Explorer Oncology in the Alcimed Healthcare team in Germany

[1] https://www.reuters.com/article/us-bayer-vitrakvi-germany/german-drug-assessment-body-not-convinced-by-bayers-cancer-drug-vitrakvi-idUSKBN1ZF211