Anti-angiogenic Drugs in the Treatment for Age-related Macular Degeneration: Issues Associated with Their Use in Québec – Notice

The notice titled Anti-Angiogenic Drugs in the Treatment of Age-Related Macular Degeneration: Issues Associated with their Use in Québec, produced at the request of the Minister of Health and Social Services, aims to shed light on the issues raised by the use of two anti-angiogenic or anti-VEGF agents, ranibizumab (Lucentis^TM) and bevacizumab (Avastin^TM), in the treatment of age-related macular degeneration (AMD). It is aimed at all decision makers involved, including patients, physicians, pharmacists and administrators. This notice is not part of the evaluation process for registration on the lists of medications covered by the public plan.

Lucentis^TM has been approved by Health Canada for the treatment of AMD and other ophthalmic diseases, whereas Avastin^TM has been approved for the treatment of colorectal cancer, but not for AMD. In Québec as in other provinces and countries, Avastin^TM is still used as an off-label treatment because of its recognized clinical benefits and lower cost. To address this complex situation, INESSS worked with a committee of experts and network representatives to perform a detailed analysis of the many issues stemming from this situation from the point of view of the key stakeholders.

With regard to efficacy, evidence shows that Avastin^TM is not inferior to Lucentis^TM. However, Avastin^TM’s safety profile remains to be confirmed, especially in the long term. Avastin^TM’s safety issue concerns the fact that its commercial presentation is not adapted to intravitreal injections and its administration requires manipulations that are not mentioned in the product description. The patient must therefore be provided with the relevant information on the specific risks associated with the use of this medication before consenting to treatment. 

INESSS also highlights the impacts on the technical and logistical organization of care and services, and the value of providing mechanisms to ensure the quality of services.

In addition to the problems of affordability for treated people, the high cost of Lucentis^TM leads to major budgetary consequences for institutions and for public and private insurance plans. The steep difference in cost between the two drugs is a source of concern for public and private health care providers and third-party payers all over the world: treatment with Avastin^TM can be 30 times less expensive than treatment with Lucentis^TM. Furthermore, access to Lucentis^TM is not uniform: it is available in medical clinics, but not in every hospital centre. Avastin^TM is offered in some hospitals and medical clinics; it is sometimes the only possible option.

In conclusion, with the analysis presented in this advisory opinion, INESSS, in collaboration with the expert committee on the use of anti-VEGF agents for the treatment of AMD in Québec, hoped to shed as much light as possible on all the issues raised by their use. It is now up to all the parties concerned to make the necessary decisions regarding the use of either of these drugs that will be the most appropriate for health and well-being on both an individual and a collective level.