The Common Drug Review (CDR) is now welcoming patients and their caregivers to provide input to patient organizations on the manufacturer’s submission for secukinumab (the medication’s generic name) for the treatment of moderate to severe plaque psoriasis. This medication has not yet been approved for use by Health Canada and therefore does not have a brand name. However, the Common Drug Review, in an effort to speed up the review process, is calling for patient input prior to Health Canada’s approval. Secukinumab is a fully human monoclonal antibody that targets IL-17A, a protein central to the development of inflammatory diseases. It is given by an injection. In two phase III clinical trials, it has been shown to be effective and well tolerated for treating plaque psoriasis.
The CDR is part of the Canadian Agency for Drugs and Technologies in Health (CADTH). The CDR conducts objective, rigorous reviews of the clinical and cost effectiveness of drugs, and provides formulary listing recommendations to the publicly funded drug plans in Canada (except Quebec).
To help them make their recommendations, the CDR accepts input from patient groups, like Arthritis Consumer Experts (ACE). We are calling for input from our members, subscribers and their family members who have moderate to severe plaque psoriasis on its own or with their psoriatic arthritis. Caregivers are also invited to provide input.
We would like to gather your views and share them with the CDR.
These are the questions they are asking:
- What are the plaque psoriasis-related symptoms and problems that impact the patients' day-to-day life and quality of life? For example, what aspects of plaque psoriasis are more important to control, how does plaque psoriasis affect day-to-day life, and are there any activities that the patient is not able to do as a result of plaque psoriasis?
- How well are patients managing their plaque psoriasis with currently available treatments? Examples of the types of information to be included in the answer are:
- What therapy are patients using for plaque psoriasis?
- How effective is current therapy in controlling the common aspects of plaque psoriasis?
- Are there adverse effects that are more difficult to tolerate than others?
- Are there hardships in accessing current therapy?
- Are there needs, experienced by some or many patients, which are not being met by current therapy?
- What are these needs?
- What challenges do caregivers face in caring for patients with plaque psoriasis?
- How do treatments impact on the caregivers' daily routine or lifestyle?
- Are there challenges in dealing with adverse effects related to current therapy?
- Based on no experience with secukinumab for the treatment of plaque psoriasis, what are the expectations for the medication?
- Is it expected that the lives of patients will be improved by secukinumab, and how?
- Is there a particular gap or unmet patient need in current therapy that secukinumab will help alleviate?
- Would patients be willing to experience serious adverse effects with secukinumab if they experienced other benefits from the medication?
- How much improvement in the condition would be considered adequate? What other benefits might secukinumab have, for example, fewer hospital visits or less time off work?
- What experiences have patients had to date with secukinumab as part of a clinical trial or through a manufacturer's compassionate supply?
- What positive and negative effects does secukinumab have on the condition?
- Which symptoms does secukinumab manage better than the existing therapy and which ones does it manage less effectively?
- Does secukinumab cause adverse effects?
- Which adverse effects are acceptable and which ones are not?
- Is secukinumab easier to use?
- How is secukinumab expected to change a patient's long-term health and wellbeing?
If you live with moderate to severe plaque psoriasis, either on its own or along with psoriatic arthritis, or care for someone with the disease, please send us your input by Wednesday, December 17, 2014, so that we may make a submission by the December 24 deadline. Your input will be anonymous.
Please contact us at firstname.lastname@example.org to provide your input or arrange for a phone interview at 604-974-1366.