JointHealth™ express April 8, 2016
Call for patient input on subsequent entry biologic etanercept for rheumatoid arthritis and ankylosing spondylitis
Do you have rheumatoid arthritis or ankylosing spondylitis or care for someone who does? We need your valuable input.
Health Canada defines subsequent entry biologics (SEBs) as biologic medicines that are similar to, and would enter the market after an approved innovator biologic (such as Enbrel®).
Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and are sensitive to changes in manufacturing practices. SEBs are not identical to their innovator products because their chemical characteristics cannot be precisely duplicated during the manufacturing process. Therefore, SEBs may have unique efficacy, immunogenicity, and safety profiles that are different from their innovator products.
The Common Drug Review (CDR) is currently welcoming patients and their caregivers to provide input to patient organizations on the manufacturer’s submission for SEB etanercept for the treatment of rheumatoid arthritis or ankylosing spondylitis. The innovator biologic, or reference product, is etanercept (Enbrel®).
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). Because patient input is vitally important to government decision-making about medications, we would like to gather your views and share them with the CDR.
These are the questions they are asking:
Please contact us at feedback@jointhealth.org to provide your input or arrange for a phone interview at 604-974-1366.
Call for patient input on subsequent entry biologic etanercept for rheumatoid arthritis and ankylosing spondylitis
Do you have rheumatoid arthritis or ankylosing spondylitis or care for someone who does? We need your valuable input.
Health Canada defines subsequent entry biologics (SEBs) as biologic medicines that are similar to, and would enter the market after an approved innovator biologic (such as Enbrel®).
Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and are sensitive to changes in manufacturing practices. SEBs are not identical to their innovator products because their chemical characteristics cannot be precisely duplicated during the manufacturing process. Therefore, SEBs may have unique efficacy, immunogenicity, and safety profiles that are different from their innovator products.
The Common Drug Review (CDR) is currently welcoming patients and their caregivers to provide input to patient organizations on the manufacturer’s submission for SEB etanercept for the treatment of rheumatoid arthritis or ankylosing spondylitis. The innovator biologic, or reference product, is etanercept (Enbrel®).
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). Because patient input is vitally important to government decision-making about medications, we would like to gather your views and share them with the CDR.
These are the questions they are asking:
- What are the disease-related symptoms and problems that impact the patients' day-to-day life and quality of life? For example, what aspects of their disease are more important to control, how does the disease affect day-to-day life, and are there any activities that the patient is not able to do as a result of the disease?
- How well are patients managing their disease with currently available treatments? Examples of the types of information to be included in the answer are:
- Are patients using or have they ever used the originator (Enbrel®) for the treatment of their disease?
- What therapy are patients using for the treatment of their disease?
- How effective are current treatments in controlling the common aspects of the disease?
- Are there needs, experienced by some or many patients, which are not being met by the current treatments? What are these needs?
- Do current treatments have adverse effects that are more difficult to tolerate than others? What are they?
- Do patients have difficulty accessing current treatments because of costs, such as costs related to travel and drug administration costs?
- When offered, how do the patient assistance or support programs impact on the accessibility and effectiveness of the treatment?
- How does the disease affect caregivers?
- What challenges do family and friends who support a patient to manage the disease face?
- What impact does the treatment have on the caregiver’s daily life, such as emotional/psychological effects, fatigue, stress, and physical challenges?
- What are patients’ expectations for the SEB?
- What are the perceived advantages or disadvantages of the SEB?
- What are the aspects of the patients’ disease that it is hoped will be addressed?
Please contact us at feedback@jointhealth.org to provide your input or arrange for a phone interview at 604-974-1366.
Arthritis Consumer Experts
ACE thanks Arthritis Research Canada (ARC) for its scientific review of ACE and JointHealth™ information and education programs.