JointHealth™ express September 21, 2013
Call for patient input on treatment for rheumatoid arthritis
Do you have rheumatoid arthritis or care for someone who does? We need your valuable input.
The Common Drug Review (CDR) is currently welcoming patients and their caregivers to provide input on the manufacturer’s submission for the intravenous (IV) form of golimumab (Simponi®) for the treatment of rheumatoid arthritis. Earlier this year, the U.S. Food and Drug Administration (FDA) approved golimumab, intravenous (IV) formulation in combination with methotrexate, for the treatment of moderately to severely active rheumatoid arthritis in adult patients. Golimumab is previously approved for subcutaneous injection in patients with moderate to severe rheumatoid arthritis.
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 would like to gather your views and share them with the CDR.
These are the questions they are asking:
Please contact us at info@jointhealth.org to provide your input or arrange for a phone interview at 604-974-1366.
Call for patient input on treatment for rheumatoid arthritis
Do you have rheumatoid arthritis or care for someone who does? We need your valuable input.
The Common Drug Review (CDR) is currently welcoming patients and their caregivers to provide input on the manufacturer’s submission for the intravenous (IV) form of golimumab (Simponi®) for the treatment of rheumatoid arthritis. Earlier this year, the U.S. Food and Drug Administration (FDA) approved golimumab, intravenous (IV) formulation in combination with methotrexate, for the treatment of moderately to severely active rheumatoid arthritis in adult patients. Golimumab is previously approved for subcutaneous injection in patients with moderate to severe rheumatoid arthritis.
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 would like to gather your views and share them with the CDR.
These are the questions they are asking:
- What are the rheumatoid arthritis related symptoms and problems that impact the patients' day-to-day life and quality of life? For example: what aspects of rheumatoid arthritis are more important to control, how does rheumatoid arthritis affect day-to-day life, and are there any activities that the patient is not able to do as a result of rheumatoid arthritis?
- How well are patients managing their rheumatoid arthritis with currently available treatments? Examples of the types of information to be included in the answer are:
- What therapy are patients using for rheumatoid arthritis?
- How effective is current therapy in controlling the common aspects of rheumatoid arthritis?
- 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 rheumatoid arthritis?
- 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 the IV form of golimumab, what are the expectations for the medication?
- Is it expected that the lives of patients will be improved by the IV form of golimumab, and how?
- Is there a particular gap or unmet patient need in current therapy that the IV form of golimumab will help alleviate?
- Would patients be willing to experience serious adverse effects with the IV form of golimumab if they experienced other benefits from the medication?
- How much improvement in the condition would be considered adequate? What other benefits might the IV form of golimumab have, for example, fewer hospital visits or less time off work?
- What experiences have patients had to date with the IV form of golimumab as part of a clinical trial or through a manufacturer's compassionate supply?
- What positive and negative effects does the IV form of golimumab have on the condition?
- Which symptoms does the IV form of golimumab manage better than the existing therapy and which ones does it manage less effectively?
- Does the IV form of golimumab cause adverse effects?
- Which adverse effects are acceptable and which ones are not?
- Is the IV form of golimumab easier to use?
- How is the IV form of golimumab expected to change a patient's long-term health and well-being?
Please contact us at info@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.