The CSPA Position on Subsequent Entry Biologics
- Patients and their needs come first. Decisions about appropriate treatment are solely to be determined by patients and their physicians.
- Cost should never be the primary driver for decision-making. The doctor and patient should together consider all the information and make decisions based on what is best for the patient.
- SEBs have a role to play in providing additional alternatives for patients, rather than one which ends up limiting choices. Given that the SEBs are not identical to existing approved treatments, their introduction to formularies as additional options is encouraged.
- There should not be a presumption of substitutability or interchangeability by physicians, pharmacists, or public or private insurers.
- In order to protect the safety of our patients, we call on the Canadian government to:
- Require any medication that is not clinically identical to a currently available drug to be subjected to the exact same rigorous safety and efficacy Helath Technology Assessment safety and efficacy processes required of all new therapies in Canada. Specifically:
- Separate submission for each disease indication seeking approval
- Rigorous Canadian clinical trial data required of any new medication
- SEBs should have names that are distinct and different from the reference drugs, so there is no risk for accidental substitution, nor the incorrect perception that they are identical
- Require any medication that is not clinically identical to a currently available drug to be subjected to the exact same rigorous safety and efficacy Helath Technology Assessment safety and efficacy processes required of all new therapies in Canada. Specifically:
- However, should Health Canada approve an SEB for a skin disease based on data referenced from either the original reference molecule or based on results for another non-skin disease indication there is a critical a requirement for rigorous post market safety monitoring.
For a more in-depth discussion of these positions, please refer to
CSPA Comments on CDR procedures and process for reviewing SEBs
Sessions éducatives de l’ACPD
L’ACPD tient des sessions d’éducation annuelles dans diverses villes au Canada qui sont destinées aux patients atteints de psoriasis et à leurs dispensateurs de soins.
La liste des nouveaux événements est affichée plus bas et est mise à jour au fur et à mesure que de nouvelles dates y sont ajoutées.
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Liens d'intérêt
General skin health and educational sites:
- Canadian Arthritis Patient Alliance (CAPA)
- Canadian Cancer Action Network
- Canadian Dermatology Association
- Canadian Institute for Health Information
- Coalition of Skin Diseases
- DermWeb
- DrugCoverage.ca - Your guide to reimbursement for prescription medications in Canada
- Eczema Channel on medbroadcast.com
- Institute of Musculoskeletal Health and Arthritis (IMHA)
- Itching for Answers - A diseases state website for Chronic Idiopathi Urticaria Patients
- Skin Care Guide
- Psoriasis Channel on medbroadcast.com
- SkinCell International Forum for Skin Disorders
- Sketch an Itch - providing Chronic Idiopathic Urticaria Patients a voice to share their experience. You can share your story and it may be picked by an artist and then drawn to be added to the website!
- World Health Advocacy
