LEXINGTON, MASS. -- Agenus Inc. (Nasdaq: AGEN), a leader in immuno‑oncology, announced its investigational combination botensilimab plus balstilimab (BOT/BAL) is now available to eligible patients with refractory microsatellite‑stable (MSS) metastatic colorectal cancer (mCRC) under France’s compassionate access (Accès compassionnel, or AAC) framework. The French National Agency of Medicines and Health Products Safety’s (ANSM) listings for botensilimab and balstilimab are live and detail eligibility (including MSS and no active liver metastases) and dosing. BOT/BAL remains investigational and is not approved for commercial marketing in France or elsewhere.

How AAC reimbursement works

Once the ANSM authorizes AAC, hospital use is covered 100% by Assurance Maladie. Hospitals are reimbursed at the invoiced purchase price (TTC), outside the Diagnosis-related Group (DRG), referred to in France as “en sus du GHS”. During AAC the manufacturer either provides the medicine free of charge or invoices an “indemnity”—a temporary, company‑set price for the product. For AAC, the maximum indemnity must be declared to the French Ministers after the first authorization. Agenus has declared a maximum indemnity for BOT/BAL in line with these rules. Ex‑post rebate mechanisms apply where relevant.

“This is a breakthrough for patients and their physicians. MSS colorectal cancer resists currently approved immunotherapies, and available options to patients after standard regimens are scarce. On behalf of patients, families, and the clinical community, we thank ANSM, Assurance Maladie, and the Ministry for their leadership. We will support French centers without delay to ensure reliable supply of BOT/BAL and high quality real world evidence,” commented Garo Armen, PhD, Chairman & CEO of Agenus.

Why it matters

Peer‑reviewed and congress data show durable activity of BOT/BAL in refractory MSS mCRC, particularly in patients without active liver metastases—a population with limited options. Recent updates describe ~21‑month median OS, ~42% 2‑year survival, and ~20% ORR in expanded cohorts.

International patient access

European Union (EU) and the European Economic Area (EEA) patients may obtain planned care in France under Directive 2011/24/EU, usually with prior authorization for hospital or specialist care and reimbursement is provided by the patient’s home system based on its national tariffs. Outside the EU, countries such as Turkey operate treatment‑abroad programs on a case‑by‑case basis. Patients should consult their National Contact Point or insurer as France’s reimbursement for French residents does not automatically extend to non-residents.