👉 Alofisel was the first ATMP with a broad rebate contract coverage and a generally agreed option to negotiate P4P-contracts.

Alofisel (active substance: darvadstrocel) is a somatic cell therapy product and was approved for treatment of complex perianal fistulas in patients with luminal Crohn’s disease in March 2018. The efficacy of Alofisel was assessed in the ADMIRE-CD study. ADMIRE-CD was a placebo-controlled RCT in a 1:1 design and 205 patients received a local injection of either Alofisel or placebo.

🏆German HTA rating: 

The German HTA rating in November 2018 came to the conclusion, that an additional benefit exists because of statistically significant advantages in morbidity outcomes in favor of Alofisel but could not be quantified because the scientific data basis does not allow for quantification. The reasons lay, among others, in the chosen threshold for complete closure of the fistula (not validated), the limitations of the clinical remission assessment (examination was not standardized) and the imputation of missing values (insufficient information on method).

💵 Launch price: € 60,000 € for one package containing 4 vials of 30 million cells each. Alofisel is injected intralesionally in a single application. The efficacy or safety of repeated administration of Alofisel has not been established. Reimbursement price: € 50,000. Rebate: 17 %.

📘 Special features of reimbursement:

Alofisel is reimbursed in Germany.

The price of Alofisel was not officially listed at time of launch. Alofisel is exempt from pharmacy distribution obligation. The product was therefore not subject to German drug price regulation. The price was only listed after reimbursement price negotiation was completed.

The reimbursement price contract of Alofisel allows the option to negotiate individual P4P-contracts with the health insurance companies.

From Dezember 2021 on, Alofisel had a rebate contract coverage of over 65 %.

💡The German HTA on Alofisel yields insights on the assessment principles of the German HTA body and on reimbursement.

🔎 Insights on HTA: To allow for quantification of an additional benefit the submitted evidence needs to be of high validity. E. g. the response thresholds for endpoints need to be validated, endpoints need to be collected using standardized measures, and imputation of missing value needs a detailed methodological description.

🔎 Insights on reimbursement: Individual P4P-contracts for Alofisel can be negotiated with the health insurance companies. Since 3,5 years after launch Alofisel has a rebate contract coverage of over 65 %.