Patient Input Template for CADTH CDR and pcodr Programs
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1 Patient Input Template for CADTH CDR and pcodr Programs Name of the Drug and Indication Name of the Patient Group Author of the Submission Name of the Primary Contact for This Submission Herceptin-Perjeta (trastuzumab-pertuzumab) Combo Pack for 8 cycles for the treatment of HER-positive early breast cancer patients at high risk of recurrence. High risk of recurrence is defined as either node-positive or hormone receptor-negative disease. Rethink Breast Cancer Adam Waiser MJ DeCoteau MJ@rethinkbreastcancer.com Telephone Number (6) About Your Patient Group If you have not yet registered with CADTH, describe the purpose of your organization. Include a link to your website. Rethink Breast Canada s mission is to empower young people worldwide who are concerned about and affected by breast cancer through education, support and advocacy. Since, we have been building community for young women dealing with breast cancer and providing support and resources to help them live the best quality of life. Because up to % of all breast cancers become metastatic, Rethink Breast Cancer has always worked closely with young MBC patients women who, sadly, leave our community far soon. We represent the voice of young women dealing with breast cancer and strive to ensure their needs and values are heard and considered in all aspects of breast cancer treatment and care at all stages of their breast cancer experience. Information Gathering CADTH is interested in hearing from a wide range of patients and caregivers in this patient input submission. Describe how you gathered the perspectives: for example, by interviews, focus groups, or survey; personal experience; or a combination of these. Where possible, include when the data were gathered; if data were gathered in Canada or elsewhere; demographics of the respondents; and how many patients, caregivers, and individuals with experience with the drug in review contributed insights. We will use this background to better understand the context of the perspectives shared.
2 Rethink Breast Cancer collected the information for this submission from online surveys and one-to-one interviews with patients. Online patient surveys were conducted between March, 8 and April, 8. The survey asked questions about the impact of breast cancer on the lives of patients, the effect of current treatments and their willingness to accept greater side effects for improved health outcomes. The survey also included questions directed to patients with Herceptin-Perjeta experience. Potential respondents were identified through messages to Rethink Breast Cancer s mailing list as well as Rethink s Young Women s Network, Facebook group and partner organizations. Messages were also posted on Facebook and Twitter as well as the Breastcancer.org and Cancer Survivors Network online discussion boards. A total of women completed the patient survey. Of these respondents, 9 were from Canada (representing Alberta, British Columbia, Manitoba, Ontario, Prince Edward Island, Quebec & Saskatchewan), were from the United States, one was from Australia and one chose not to answer. 9 of the respondents have been diagnosed with HER+ early breast cancer and reported that it was either node-positive or hormone receptor-negative. respondents have experience with Herceptin-Perjeta. The online patient survey asked respondents if they would be willing to participate in an interview to elaborate on their experience. Five women were interviewed by a member of the Rethink Breast Cancer staff. One-to-one interviews were conducted by telephone or . Phone interviews were recorded for reference and to ensure the correct transcription of patient comments.. Disease Experience CADTH involves clinical experts in every review to explain disease progression and treatment goals. Here we are interested in understanding the illness from a patient s perspective. Describe how the disease impacts patients and caregivers day-to-day life and quality of life. Are there any aspects of the illness that are more important to control than others? Two respondents was diagnosed in 8, eight were diagnosed in 7, seven were diagnosed in 6, eleven were diagnosed in - and three were diagnosed earlier. When Rethink Breast Cancer asked patients to rate how the symptoms associated with breast cancer has affected their lives on a scale of (no impact) to (significant impact), respondents indicated that the greatest impact was on their ability to exercise and their ability to work. However, none of the scores averaged more than., likely due to the early nature of their breast cancer. Impact of breast cancer symptoms on the lives of patients - no impact Ability to work 6 Ability to travel 6.67% Ability to exercise 6.67% Ability to perform household chores - significant impact 6.67% % 6.67% 6.67% 6.67% Average.7.7..
3 Ability to care for children 6.67%.7 Ability to fulfill family obligations 6.67% 7.7 Ability to spend time with family and friends %.8. Experiences With Currently Available Treatments CADTH examines the clinical benefit and cost-effectiveness of new drugs compared with currently available treatments. We can use this information to evaluate how well the drug under review might address gaps if current therapies fall short for patients and caregivers. Describe how well patients and caregivers are managing their illnesses with currently available treatments (please specify treatments). Consider benefits seen, and side effects experienced and their management. Also consider any difficulties accessing treatment (cost, travel to clinic, time off work) and receiving treatment (swallowing pills, infusion lines). respondents provided information about the treatments they had undergone since their diagnosis. Almost all respondents had experience taking Herceptin and many also received Perjeta prior to their experience with the combo pack. Treatments Received n Treatments Received n Trastuzumab 9 Goserelin Pertuzumab 7 Letrozole Docetaxel Denosumab Tamoxifen Carboplatin FEC Doxorubicin Cyclophosphamide Neratinib Radiotherapy Paclitaxel Ado-trastuzumab emtansine Anastrazole AC-T Diarrhea was the most commonly reported side effect for these treatments (67%, n=7), followed by joint pain (6%), nausea (6%), decreased neutrophil count and muscle pain (8% each). When asked about financial challenges, the most common response was lost income due to work (6%, n=9), followed by drug costs and parking costs (%). % of respondents reported that they required financial assistance due to the costs associated with the cancer and its treatment.
4 . Improved Outcomes CADTH is interested in patients views on what outcomes we should consider when evaluating new therapies. What improvements would patients and caregivers like to see in a new treatment that is not achieved in currently available treatments? How might daily life and quality of life for patients, caregivers, and families be different if the new treatment provided those desired improvements? What trade-offs do patients, families, and caregivers consider when choosing therapy? Rethink Breast Cancer asked patients to evaluate the importance of different outcomes for their breast cancer treatment on a scale of (not important) to (very important). Respondents heavily prioritized health outcomes with every patient giving the highest score to preventing recurrence and 9% of patients doing the same with controlling disease. Importance of outcome - not important Controlling disease Reducing symptoms 6.67% Maintaining quality of life Managing side effects Preventing recurrence very important 6.67% 6.67% % % Average Respondents were asked if they would be willing to tolerate new side effects from new drugs that can control disease progression or prevent recurrence. On a scale of (will not tolerate side effects) to (will tolerate significant side effects), respondents gave an average score of 7.8 (n=8) with only four respondents giving a score less than a. These results would support the conclusion that patient values prioritize health outcomes. Rating Responses Rating Responses.7% 6 7.% %.7% % 9.7%.7% 8.7% 8 Some of the patient comments include: I would tolerate any side effects if it improved my chances of disease-free survival. I m HER+ and I need do everything to keep this cancer at bay. I am willing to do anything to be here for my children. They are still quite young and I want to be here to witness their life milestones.
5 I want to do everything that I can to keep the cancer form coming back. Patients were also asked to comment about whether they would be willing to accept drugs with more severe side effects for some medical benefit in initial treatment or whether they would prefer to begin with milder treatments before trying more severe options. While % of respondents (n=7) preferred to begin with milder treatments and another % were uncertain, over 7% of respondents said that they were willing to accept harsher side effects in initial treatment protocol for drugs with some medical benefits. This is supported by patient comments: I would begin with the one most likely to reduce disease. I would be willing to [accept] drugs with severe side effects if [they] improved my chances of survival. Hit it hard and fast. I figure I only have one shot at it, so I will throw everything at it and I have dedicated this time, even if the side effects are worse. Once it comes back at stage four, I don t get that chance again. While patients expressed concerns about quality of life, patient values strongly prioritize controlling disease and preventing recurrence. Patients are also willing to tolerate harsher side effects for some survival benefit in an early stage treatment protocol and overall. 6. Experience With Drug Under Review CADTH will carefully review the relevant scientific literature and clinical studies. We would like to hear from patients about their individual experiences with the new drug. This can help reviewers better understand how the drug under review meets the needs and preferences of patients, caregivers, and families. How did patients have access to the drug under review (for example, clinical trials, private insurance)? Compared to any previous therapies patients have used, what were the benefits experienced? What were the disadvantages? How did the benefits and disadvantages impact the lives of patients, caregivers, and families? Consider side effects and if they were tolerated or how they were managed. Was the drug easier to use than previous therapies? If so, how? Are there subgroups of patients within this disease state for whom this drug is particularly helpful? In what ways? respondents reported that they had been treated with Herceptin-Perjeta. of these respondents received other treatments prior to Herceptin-Perjeta. All of these patients were diagnosed with HER+ early breast cancer and were either node-positive or hormone receptor-negative. were treated for -6 months, were treated for 6- months and was treated for more than one year. Patients were asked to rate changes to their quality of life on Herceptin-Perjeta compared to other therapies they had received on a scale of (much worse) to (much better). The average scores for drug side effects, maintaining quality of life and controlling disease were all rated
6 higher than.. These patients overwhelmingly believe that Herceptin-Perjeta had a beneficial effect on their health and quality of life. Change to quality of life on Herceptin-Perjeta Metastatic cancer symptoms much worse.% Drug side effects Maintaining quality of life Controlling disease much better 7.%.% 7.%.% 8.7% % 6.67% %.8% 76.9% Average Patients also discussed the psychological value of knowing that they were using every possible tool to treat their cancer: To have that extra drug or that feeling of protection would just sort of, I don t know, boost your confidence in the whole process. I think knowing that there was something out there, no matter what the side effects were, that could potentially help keep the cancer away and not being able to access it, or at least give it a go, I think would be really tough for me to take. It was important for my peace of mind. Patients overwhelmingly consider the side effects associated with Herceptin-Perjeta to be tolerable. When asked how much they could tolerate the side effects associated with Herceptin- Perjeta on a scale of (completely tolerable) to (completely intolerable), the average score was.7 and only one respondent rated the tolerability higher than a five. Rating Responses Rating Responses % Some of the comments about Herceptin-Perjeta s side effects include: Herceptin and Perjeta were very tolerable as a treatment. I have no nausea, just fatigue. My hair is growing back on both. I can eat I have no GI issues. The only complaint I have is fatigue. I felt flu-ish after the infusion for a couple of hours so I just made sure I rested after and then I'd feel better. I can go about my business and lead a pretty normal life. Several patients from northern rural areas commented about their difficulty accessing Herceptin- Perjeta. As the combo pack was only available through clinical trials or private clinics, they were forced to travel significant distances to access the treatment.
7 7. Companion Diagnostic Test If the drug in review has a companion diagnostic, please comment. Companion diagnostics are laboratory tests that provide information essential for the safe and effective use of particular therapeutic drugs. They work by detecting specific biomarkers that predict more favourable responses to certain drugs. In practice, companion diagnostics can identify patients who are likely to benefit or experience harms from particular therapies, or monitor clinical responses to optimally guide treatment adjustments. What are patient and caregiver experiences with the biomarker testing (companion diagnostic) associated with regarding the drug under review? Consider: Access to testing: for example, proximity to testing facility, availability of appointment. Testing: for example, how was the test done? Did testing delay the treatment from beginning? Were there any adverse effects associated with testing? Cost of testing: Who paid for testing? If the cost was out of pocket, what was the impact of having to pay? Were there travel costs involved? How patients and caregivers feel about testing: for example, understanding why the test happened, coping with anxiety while waiting for the test result, uncertainty about making a decision given the test result. 8. Biosimilar If the drug in review is a biosimilar (also known as a subsequent entry biologic), please outline any expectations or concerns held by patients, caregivers, and families about the biosimilar. If the biosimilar was less expensive than the brand name drug, what would the impact be for patients, caregivers, and families? 9. Anything Else? Is there anything else specifically related to this drug review that CADTH reviewers or the expert committee should know? Rethink Breast Cancer also posted an online caregiver survey. However, there were only two respondents. One of the respondents from the United States ended her interview with this comment: I hope it helps the women up north.
8 Appendix: Patient Group Conflict of Interest Declaration To maintain the objectivity and credibility of the CADTH CDR and pcodr programs, all participants in the drug review processes must disclose any real, potential, or perceived conflicts of interest. This Patient Group Conflict of Interest Declaration is required for participation. Declarations made do not negate or preclude the use of the patient group input. CADTH may contact your group with further questions, as needed.. Did you receive help from outside your patient group to complete this submission? If yes, please detail the help and who provided it. We asked Roche to provide us with information about the general characteristics of the drug and its benefits. We also contracted Adam Waiser to help us with writing this submission.. Did you receive help from outside your patient group to collect or analyze data used in this submission? If yes, please detail the help and who provided it. We contracted Adam Waiser to help us develop the survey we used to collect the data used in this submission. All interviews were conducted by Rethink Breast Cancer staff. Adam Waiser helped us analyze the findings of our survey and interviews.. List any companies or organizations that have provided your group with financial payment over the past two years AND who may have direct or indirect interest in the drug under review. Company $ to, Check Appropriate Dollar Range $, to, $, to, Roche 7 X Roche 6 X In Excess of $, I hereby certify that I have the authority to disclose all relevant information with respect to any matter involving this patient group with a company, organization, or entity that may place this patient group in a real, potential, or perceived conflict of interest situation. Name: MJ DeCoteau Position: Executive Director Patient Group: Rethink Breast Cancer Date: April, 8
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