Package advice cabozantinib in combination with nivolumab (Cabometyx-Opdivo®)
The National Health Care Institute advises the Minister to include cabozantinib in combination with nivolumab in the health care package, provided the price negotiations with the marketing authorisation holder successfully deliver a net price that does not exceed that of the existing treatment. The National Health Care Institute has concluded that cabozantinib in combination with nivolumab as first line treatment for adult patients with advanced renal cell carcinoma complies with the legal criterion of ‘established medical science and medical practice’. The reason for this advice is that cabozantinib in combination with nivolumab is being placed in the lock procedure for expensive medicinal products.
Registered indication
Reimbursement is requested for cabozantinib in combination with nivolumab (Cabometyx®/Opdivo®) as first line treatment for adult patients with advanced renal cell carcinoma.
Package advice
The National Health Care Institute has concluded that cabozantinib in combination with nivolumab as first line treatment for adult patients with advanced renal cell carcinoma complies with the legal criterion of ‘established medical science and medical practice’. The National Health Care Institute has established that the therapeutic value of this medicinal product is comparable to the value of the already reimbursed medicinal products pembrolizumab in combination with axitinib; in patients with an intermediate or unfavourable prognosis, the therapeutic value is also comparable to the value of nivolumab in combination with ipilimumab. All of these combination treatments have a clinically relevant effect on overall survival, compared to treatment with sunitinib.
The National Health Care Institute advises the Minister to include cabozantinib in combination with nivolumab in the health care package, provided that the net price after successful price negotiations with the marketing authorisation holder is not higher than the net price of pembrolizumab in combination with axitinib or nivolumab in combination with ipilimumab. We would like to point out that the Insured Package Advisory Committee has recommended that the price for a treatment should be reduced when several medicinal products are available for the same indication.