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Abemaciclib (Verzenio): CADTH Reimbursement Review: Therapeutic area: Adjuvant treatment of hormone receptor–positive, human epidermal growth factor receptor 2–negative early breast cancer [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2022 Dec.
Rethink Breast Cancer (Rethink) is a Canadian charity known for making positive change. Rethink educates, empowers and advocates for system changes to improve the experience and outcomes of those with breast cancer, focusing on historically underserved groups: people diagnosed at a younger age, those with metastatic breast cancer and people systemically marginalized due to race, income or other factors. We foster spaces to connect, listen, empower and rethink breast cancer, together. Rethink’s strategic priorities and organizational direction are guided by the unique, unmet needs identified by breast cancer patients and their families.
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For over 20 years, Rethink has been working closely with breast cancer patients in Canada. We learn from and listen to the community to understand their values, priorities and pain points to help drive change and system improvements. Each year, we learn from the patients we serve, survey and collaborate with. We learn from the 40 individuals that we work extremely closely with as key patient advisors; the 100 patients that share their stories on our blog; the 500 patients that participate in our virtual support groups; the 1,600 members of our private peer- support network; the 30,000 people that have joined our Instagram community; and the 150,000 individuals reached each month through the reach of that channel. We listen, learn, engage and have conversations in all these spaces.
Rethink Breast Cancer has several important patient advisory boards and working groups that offer experience-focused insights on issues related to those affected by and concerned about breast cancer, including:
For this submission, we have drawn on our general observations and insights gathered through programming and meetings with breast cancer patients as described above. Rethink also conducted in-depth telephone interviews in March 2022 with two patients who have experience with abemaciclib for HR+, HER2- high risk early breast cancer, and one patient who has been prescribed it by her oncologist but, two months later, was still waiting to start it.
Most people in the Rethink community are diagnosed at a younger age. When young people get breast cancer it may be more aggressive, which can lead to tougher treatments. In addition, those diagnosed in their 20s, 30s and early 40s face age-specific issues such as fertility or family-planning challenges, diagnosis during pregnancy, childcare, impact on relationships, body image, dating and sexuality, feeling isolated from peers who don’t have cancer, career hiatuses, and financial insecurity. The physical and emotional toll that a breast cancer diagnosis and treatment takes on a young person’s life is devastating and traumatic.
When it comes to those in the community who have been told their breast cancer is at a high risk of recurrence, treatment is less about controlling an aspect of the illness and more a deep desire to take on whatever treatment(s) are needed to decrease the chance of recurrence and metastatis. They are facing mortality prematurely and many express a goal to treat aggressively to optimize treatment. Those we interviewed in March for this submission shared:
“I think when anyone gets a cancer diagnosis, you’re always scared of the illness coming back. Especially when I have young kids that I want to be there for, and I have a lot of things I want to do myself. It’s not only my kids, but also my life too. I want to be able to enjoy it. Because I feel that I’m doing anything and everything that’s available out there to have a lower chance of recurrence, it gives me peace of mind. It gives me less anxiety in my life.” —Negar
“I am generally a fan of treatment - the more aggressive the better. In fact, after having chemo done, I advocated to have a total axillary LN dissection, and I also had my ovaries out last year. Again, I don't mind treatment at all, even the side effects that come with it - I'm more concerned about the prospect of mortality.” — Ada
“I want to try anything to prevent recurrence, I want to add it to my exercise routine and healthy diet in my bag of tricks.” — Jessica
Current treatment for HR positive HER2 negative early breast cancer depends on the details of the persons diagnosis and the characteristics revealed on their pathology report. It is usually treated with a combination of surgery, chemotherapy, radiation therapy, and hormonal therapy, which can reduce the risk of early-stage breast cancer coming back. Some patients will opt for an oophorectomy. These treatments are all incredibly difficult with both physical and emotional impacts that require a lot of support and care. Peer support is incredibly helpful as is professional support. Being well prepared for what you are about to endure is essential and oncology nurses and a peer community are extremely helpful in this regard both with short term and long-term side effect management. Difficulty coping with the side-effects of hormone therapy is frequently discussed in our community.
Each individual patient brings their own personal values and goals to their discussions with their oncology team. Communication and trust in their team is essential. In our experience working closely with many young high risk breast cancer patients, we find most are willing to trade toxicity for confidence in knowing they’ve “thrown everything they could” at the cancer. In other words, they will choose to endure additional side-effects and impacts on quality of life from the toxicity of a stronger therapy to ensure they are doing everything they can to treat what they know is an aggressive form of breast cancer. That was a take-away from the patients we interviewed for this submission who are on Verzenio and the one that has been prescribed it and is waiting. We’ve also had patients in the community reaching out to our organization, asking when it will be available in Canada for early breast cancer.
Rethink conducted in depth phone interviews with two patients with high-risk early breast cancer who have experience with abemaciblib (Verzenio). We also interviewed one person whose only experience with Verzenio was that she’d been prescribed it by her oncologist over two months ago and was still waiting to start it as she deals with navigating the challenges of her insurance’s heavy co-pay.
My name is Negar. I’m located in Vancouver, BC. At the end of my pathology report, I was Stage 2B. I was 39 at the time. I had three tumours. I found it myself. We never had any family history. The lump was moving. My family physician was sure that it wasn’t cancer, but she just wanted to make sure and have peace of mind, so she sent me for testing and here I am. I did surgery first and then 8 rounds of chemo, 25 rounds of radiation. I did an oophorectomy. At the beginning I was going to do Zoladex, but I talked with my doctors, after 10 years I’ll be almost 50 so there was no point for me to stay on Zoladex, so I did an oophorectomy in March.
In regards to my treatment path, I wouldn’t say hell, although I had days that looked like hell. I was lucky I caught it early. I had node involvement and normally when there’s a lymph node involvement it spreads quickly after that. It was a lot of ups and downs; I still have a lot of that. Sometimes I think I came to terms with it, but I don’t think I have yet. It was very scary as I have 2 young children. I was working full time. I always say it was my prime time with my kids and my work, but I had to put everything on pause. It’s a scary, scary situation to be in because you see so many people that had the same diagnosis, they got the same care, but they had a recurrence. So, when my doctor talked about Verzenio although the side effects are not something that I look forward to, but again it’s bringing the possibility of recurrence lower, so I take it.
I was really lucky that my oncologist referred me – I think the manufacturer is the one paying for me, I’m not paying out of pocket. Here it’s $13,000 per month and I definitely cannot afford that. I was very concerned about the cost. Maybe if I didn’t have kids, it would be a totally different experience. I had a cousin; she was like my sister. She was 5 years younger than me. She passed away from ovarian cancer in 2019, so we had that scare in our family. Not in a blaming way, but one thing that everyone thought is that she didn’t take the cancer seriously. So, from the minute I was diagnosed, I was quite proactive on finding the best solution. When I was talking with my oncologist, I already had done tons of research on breast cancer, what treatments are available, my second opinion from MD Anderson, etc. So, when the Verzenio got approved by Health Canada, I knew about it, I read about it, I did research. I follow quite a few of women with breast cancer on Instagram and I saw them talking about it and the cost of it. So, the cost was something that I was concerned about. $13,000 a month is a lot of money. Both my husband and I are making good money, but this is still a lot of money per month. We thought, we’re going to try to do this, and even if we have to remortgage our house to get the money from the equity in our house to pay for the treatments, we’re going to do it.
My oncologist was on board for me taking this medication and said there’s ways it can be covered. Thankfully I was approved for it. So, I feel very blessed and lucky that this treatment was available to me for free. I understand some provinces don’t cover oral chemo and it’s scary. Especially with cancer, time is of the essence. You need to be very quick. You cannot wait a year for this to become available because in that year, the cancer might spread and turn metastatic.
I feel so lucky that I have access to it at no cost. But the side effects, I haven’t had severe ones yet. I’m very tired, but I’ll take being tired rather than the cancer coming back. I think when anyone gets a cancer diagnosis, you’re always scared of the illness coming back. Especially when I have young kids that I want to be there for, and I have a lot of things I want to do myself. It’s not only my kids, but also my life too. I want to be able to enjoy it. Because I feel that I’m doing anything and everything that’s available out there to have a lower chance of recurrence, it gives me peace of mind. It gives me less anxiety in my life.
I would absolutely recommend Verzenio to other patients in my position. This is $13,000 per month. But what if the illness relapses? If you compare the amount of emotional distress and money that they’re going to put the family through with loss of life, other chemo, hospice, etc. so many things. When I got diagnosed with breast cancer in Canada, I felt so lucky because finances weren’t something I had to worry about. Of course, we were losing my income, but I didn’t have any extra costs. But this is the extra cost. If the Canada doesn’t fund this, I cannot imagine this stress in having the thought that something was available to me, and I wasn’t able to access this because I didn’t have the financial resources. It’s not fair.
I am 36 years old and was diagnosed with breast cancer when I was 33 years old. I had hormone positive and receptor negative type. I had my double mastectomy first, and my lump was 4.3cm! with 3/4 sentinel lymph nodes positive. I live in Richmond BC. I'm a social worker at a very large long term care home in Richmond. Being sick during the COVID 19 pandemic meant that I wasn't able to be at work during a time when they really needed staff and that was hard. I have a 4-year-old and 6-year-old now.
I didn't mind the treatment because for me, having treatment was taking action. I don't mind treatment at all, even the side effects that come with it - I'm more concerned about the prospect of mortality. My oncologist, who I trust, thought Verzenio would be good for me, so I didn't even hesitate to say yes. As long as it doesn't make my Anastrazole less effective, then I'm game - always.
The Lilley program is paying for my Verzenio. My extended health from work doesn't cover it. The pharmacy that it comes from has been good too. I just don't like that they deliver it
monthly because it's a hassle to coordinate, and I'm always worried that something will happen where I don't get my next delivery. I was expecting to get diarrhea my first week, so I took Imodium but then I ended up with constipation for like a week. Now my body has gotten used to it. I still get the occasional cramping or bloating, but nothing I can't tolerate. I would say though, for people just starting on Verzenio that I think once your body adjusts to it, it gets better. The first couple of weeks can be rough.
I would recommend Verzenio. Patients should never have to worry about getting their medications through bureaucratic processes. Please make life easier for patients than they already are. Provinces should fund this medication and make it easy for those who fit the criteria to get it.
I am currently 41 years old, having just passed the one-year anniversary of my diagnosis in April 2021. I live in Ottawa with my husband and our 7-month-old son. I work at Global Affairs Canada in the Foreign Service, so I was actually diagnosed in Brazil and came home immediately to start treatment. I was also 15 weeks pregnant while diagnosed.
I’m not sure where to begin. Diagnosed with IDC, stage 2B, HR+, PR+, HER-. I started Chemo in April, AC-T dose dense protocol. I finished in August and had a few weeks to recover before my son was induced at 38 weeks which resulted in a c-section. From there I had a lumpectomy, balancing reduction and a SLND a little over a week after the birth of my baby. My margins did not come back clear and there was a significant number of affected lymph nodes. The pathology report was fairly damming. My Ki score was very high. I had surgery again a few weeks after the first, this time a mastectomy and a complete lymph node dissection. I followed with 15 rounds of radiation. I have been, and continue to be, terrified I will not be able to watch my son grow-up. It is my constant worry.
My oncologist told me about the success of the Monarch E studies and the announcement in the US came right around the same time as my pathology report. It gave me hope that my cancer, at very high risk for recurrence, could be kept at bay. I want to try it because I want to try anything to prevent recurrence, I want to add it to my exercise routine and healthy diet in my bag of tricks.
I am still waiting to access Verzenio. My oncologist prescribed it two months ago. I do have private insurance but the additional 20% is still quite steep. My understanding is that the hospital is trying to sort out the payment plans.
It is not an easy treatment and there are many side effects, but it could allow people like me to do everything possible to prevent recurrence. From a purely financial perspective, the medication is expensive, but the cost of treating MBC, or even just a second early-stage cancer, paired with 20 potential years of lost employment/productivity is a heavy burden as well.
Nothing to report on this topic.
We’d like to emphasize that young, high-risk breast cancer patients want more effective tools in their toolbox that will help improve their chances against this challenging disease that’s turned their life-plans upside-down.
As we ponder “anything else,” we think about the MBC community that we know so well—and their loved ones. We think about those we’ve lost. Too, too many at such a young age over the years. Their families will never be the same. We also think about the MBC community that we see currently thriving. The CDK 4/6 inhibitors have been more of a game-changer in our community than we could have ever imagined. That said, moving the needle on MBC outcomes is still not the same as a cure. Verzenio as an option for those with HR+ HER2- breast cancer that is at a high risk of recurrence can give patients a tangible way to help achieve their goal of a cure.
And, finally, as we have been in the thick of #BitterestPill, an advocacy campaign calling for equal funding for Take Home Cancer Treatments in Ontario, we think about the delays, dollars, distress and discrimination that the current program in Ontario entails, which negatively impacts patient outcomes. Many in our community are underinsured and uninsured and our hearts go out to Jessica, who has been waiting two months to start the Verzenio she was prescribed by her oncologist because of the cost of her insurance co-pay. Too many are impacted by a policy that’s needed updating for over a decade!
To maintain the objectivity and credibility of the CADTH reimbursement review process, 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.
No.
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.
No.
List any companies or organizations that have provided your group with financial payment over the past 2 years AND who may have direct or indirect interest in the drug under review.
Financial Disclosures for Rethink Breast Cancer.
The Canadian Breast Cancer Network (CBCN) is a leading, patient-directed, national health charity committed to ensuring the best quality of care for all Canadians affected by breast cancer through the promotion of information, education and advocacy activities. www.cbcn.ca
The Canadian Breast Cancer Network is committed to strict adherence to the Code of Conduct Governing Corporate Funding.
Information for this submission was collected via:
CBCN’s 2017 Lived Experience Breast Cancer Patient Survey: An online survey was distributed in English and French to patients living with breast cancer. No patients surveyed had direct experience with the treatment under review. Survey questions comprised of a combination of scoring options and free form commentary. Patients were contacted through the membership databases of CBCN and other patient organizations.
Patient Respondents Profile: 278 early-stage, breast cancer patients responded to the survey in English and French. In this submission, CBCN specifically utilizes the data provided by 103 Canadian, early- stage, HR-positive, HER2-negative breast cancer patients who responded to our survey.
The respondents mostly (91) identified as female and primarily (89) spoke English as a first-language, with 4 speaking French as a first language, and 2 respondents selecting other as their first language (split between Hungarian and Italian), and 8 respondents undeclared. The majority of respondents were from Ontario (27) and Saskatchewan (21), 9 from British Columbia, 9 from Manitoba, 8 from Nova Scotia, 3 from New Brunswick, 4 from Quebec, 4 from Newfoundland and Labrador, 4 from Alberta and 1 from Prince Edward Island, 1 from Northwest Territories and 1 from Yukon. The remainder did not specify their province of residence.
Most of the respondents (41) were between the ages of 40-49 when diagnosed, 37 respondents were in the 50-59 age range, 14 were 60-69 years, 8 were between 30-39 years, 2 were 70-79, and 1 were between 20-29 years of age.
Most respondents were in a relationship (75), while 15 declared themselves as single, and the rest did not specify their relationship status. Most of the patients (70) had children, with the majority (42) with children 20 years or older, 28 had children between the ages of 13-19, 16 had children between 6-12 years of age 3 had children 2-5 years of age, and none had children below 1 year.
Printed sources: A review was conducted of current studies and grey literature to identify issues and issues and experiences that are commonly shared among many women living with breast cancer.
A diagnosis of early-stage, hormone receptor (HR)-positive breast cancer has a significant impact on the day-to-day life of the patient. The diagnosis of HR-positive breast cancer, as well as the treatments that are used, impact both the emotional and physical well-being of a patient.
HR-positive, HER2-negative breast cancer is the most common form of breast cancer, affecting 70 percent of patients. The majority (90 percent) of these patients are diagnosed in non-metastatic, early stages (stages I-III). The median overall survival among patients with stage IV HR+/HER2− disease ranges from four to five years. Roughly 20 percent of HR-positive patients have high-risk disease and will develop a recurrence, either locally in the breast or elsewhere in the body over the first 10 years of treatment.
Treatment of HR+/HER2− breast cancer has mainly focused on hormone-blocking endocrine therapy. For early-stage, HR-positive, HER2-negative breast cancer, this includes at least 5 years of tamoxifen or aromatase inhibition with anastrozole, exemestane, or letrozole in post-menopausal or ovarian suppressed women. Extended adjuvant therapy is recommended for women at high risk of recurrence. The decision to add adjuvant chemotherapy is informed by a combination of clinical and genomic risk assessment, as well as patient preference. Standard surgical approaches include mastectomy or lumpectomy, typically followed by radiation.
Despite the effectiveness of standard endocrine therapy, as many as 41 percent of women diagnosed with HR-positive, early-stage BC will experience distant (or metastatic) recurrence. Recent studies have revealed that for patients with high-risk HR-positive, HER2-negative breast cancer, the risk of recurrence is even greater, especially during the first few years on adjuvant endocrine therapy. High risk, early breast cancers are also known to show a degree of resistance to hormone therapy, relapsing early, despite treatment with endocrine therapy. It is therefore of critical importance for patients to have targeted therapies available to them to reduce the risk of disease recurrence.
The primary aspect to control for patients with early-stage, high-risk HR-positive breast cancer is reducing the risk of recurrence and disease progression to improve patients’ overall survival. Several factors are known to increase the risk of recurrence in these patients, including lymph node involvement, tumor size, and tumor grade which can indicate aggressiveness of the cancer. Another key factor used in risk-calculation clinically, is the percentage of Ki-67 protein expression, which is associated with cell division. However the Ki-67 index marker is not routinely determined for all HR-positive breast cancer patients currently.
Some of the side effects of HR-positive breast cancer and the therapies used to manage this disease include: Hot flashes, night sweats, and vaginal dryness are common side effects of all hormone therapies. Many patients also experience gastro-intestinal symptoms, as well as nausea, vomiting, and constipation, weakness and fatigue, and an associated risk of blood clots. Many of these symptoms have the ability to impact daily life, primarily: fatigue, pain and nausea. Therefore it is important for patients to have access to therapies that will extend their life expectancy without significantly increasing side effects that will negatively impact their daily lives.
Despite the efficacy of adjuvant endocrine therapy, adherence rates range from 41 percent to 72 percent. Aromatase inhibitor adherence in particular is sub-optimal, ranging from 50 percent to 91 percent over 5 years of therapy and only 40 percent to 60 percent of women complete the recommended course of aromatase inhibitors. Early discontinuation or non-adherence to adjuvant endocrine therapy is associated with increased mortality
Managing early-stage, high-risk, HR-positive, HER2-negative breast cancer is always a challenge-particularly in terms of adherence to endocrine therapy. As these breast cancers have been clinically demonstrated to have a higher risk of recurrence than other tumors, the goal of therapy is to target cancer cells in the body and reduce the risk of disease recurrence. Currently, most patients receive a combination surgery, radiation, endocrine therapy and possibly chemotherapy.
This was reinforced in our 2017 survey, most of the HR-positive, HER2-negative, early- stage breast cancer patients had been or were currently being treated with a combination of surgery, radiation, chemotherapy and hormone therapy.
Respondents in our 2017 Survey indicated that the following key factors influenced their decision-making around treatments:
In our survey of HR-positive, HER2-negative, early-stage breast cancer patients, the majority of respondents (43) were diagnosed with Stage 2 cancer , 36 were diagnosed Stage 1, 14 were diagnosed with Stage 3, 10 did not specify their stage. Most patients had undergone surgery (94), radiation therapy (58) chemotherapy (54) and endocrine therapy (79) as part of their overall breast cancer treatment. Of the patients taking hormone therapy, 12 stated that they discontinued hormone therapy, with 11 citing side effects as the primary reason for non-adherence.
When asked about deciding on treatment options, patients cited the following as most important to them:
“To do everything I could to eradicate the cancer and decrease recurrence rate.” — Patient respondent
“For me it was all about effectiveness.” — Patient respondent
Reducing the risk of recurrence was also ranked highly as a priority for patients with 79 patients stating it was very important to them and 11 stated it was important in their treatment deliberation.
“I just wanted to do everything possible to prevent the cancer from returning”. — Patient respondent
“The main concern was to have the treatment get rid of any remaining cancer cells and to prevent a recurrence.” — Patient respondent
“I wanted to do everything in my power to make sure the cancer did not come back.” — Patient respondent
Maintaining quality of life was also crucial for patients, with 49 patients declaring it very important, 32 stating it was important and 5 stating it was somewhat important.
“Making my body whole again in order to live the life I want to live” — Patient respondent
“What will be the impact on my quality of life on AI’s?” — Patient respondent
Maintaining mobility was also essential for patients, with 40 patients stating it was very important to them and 29 stating it was important.
Maintaining productivity was also a key concern, with 20 patients stating it was very important, 29 patients stating it was important and 31 stating it was a somewhat important factor in their treatment decision-making.
Minimal side effects was cited by 23 patients as very important, 42 patients as important and 19 patients as somewhat important. Eight patients also stated that side effect management was the single most important factor in making decisions about their treatment.
“I think the most important factors for me are that the treatment actually works and that the cancer won't come back. I don't want a lot of side effects either, but I take the good with the bad”. — Patient respondent
“The side effects of the treatment vs their effectiveness at preventing future reoccurrence.
I chose not to have chemo for this reason”. — Patient respondent
“Although I was given a pamphlet about chemo side effects, they were dismissed by my oncologist as rare. I had every side effect in the book and had to postpone treatment three times. Also had to abort taxol. I now have cataracts, heart damage, esophagus damage and terrible chemo brain.” — Patient respondent
Finally, ability to continue childcare duties was ranked by 13 patients as very important, 8 patients as important, and 57 patients as not important. CBCN would like to note that the majority of patients who responded to our survey had children over the age of 20 years, and as such it is understandable that for these respondents, childcare was not a concern during their treatment. However, for patients with younger children, childcare would be a much more critical factor in determining treatment options.
“I am a mother. I need to do everything I can in order to increase my chances of survival.“ — Patient respondent
“I wish I could have more support with my home life. Dealing with cancer and taking care of kids and other domestic work-it’s not easy.” — Patient respondent
The financial burden associated with living with breast cancer extends far beyond any loss of income during a temporary or permanent absence from employment. In addition to the loss of income during illness, breast cancer patients can incur substantial costs associated with treatment and disease management.
Research on the financial impact of breast cancer on patients identified the following:
These findings were consistent with the responses in our current survey of 103 HR- positive, HER2-negative, early stage breast cancer patients:
“Financial security is a big issue. With no income and so far no government assistance my retirement savings have been impacted. Also, I am uncertain of when I will be able to begin searching for a job again or when I will be successful in my search. you don’t need this stress on top of everything else.“ — Patient respondent
Other barriers included access to private insurance coverage and support medications: While 82 of the patients surveyed reported having private insurance coverage, several (10) also reported challenges accessing medications not publicly reimbursed. Many patients (32) stated that they had been prescribed support medications as part of their treatment and 14 patients stated that their support medications were not provincially reimbursed. Instead, respondents stated that they had to use private insurance (18 respondents) or pay out of pocket (7 respondents) to access medications they had been prescribed. Three patients also accessed manufacturer assistance programs to cover the costs of treatments.
“Although I had access to health insurance through work it was not 100% and included a cap on spending.” — Patient Respondent
“I had to get approval for the anti-nausea medications. It was horrible after my first chemo treatment to not have anti-nausea medications”. — Patient Respondent
“My only comment is that I was fortunate to have private coverage I'm not sure what others do that do not.” — Patient Respondent
For HR-positive, HER2-negative, early-stage breast cancer patients, reducing the risk of recurrence is of critical concern. Patients have an expectation that Verzenio will provide a possibility for improving their rate of invasive disease-free survival and reduce their risk of recurrence allowing them to live a better quality of life. This is based on the data from the international Phase 3 MonarchE study, which showed that abemaciclib reduced the risk for invasive recurrence by 25.3% compared with endocrine therapy alone. In addition, the 2-year invasive disease-free survival (DFS) rates were 92.2% with abemaciclib versus 88.7% with endocrine therapy alone. Patients treated with abemaciclib plus endocrine therapy had a 31.3 percent reduction in risk of distant recurrence or death compared to patients treated with endocrine therapy alone. The greatest reduction in sites of metastatic disease with abemaciclib was seen in bone and liver, followed by the brain, lymph nodes, pleura, and central nervous system. Patients are aware that more than 86% of people treated with abemaciclib and endocrine therapy had not experienced a recurrence after 3 years compared with 79% of those treated with endocrine therapy alone.
Patients understand that Verzenio was approved as adjuvant treatment for people with HR-positive, high-risk, early-stage breast cancer in the U.S. in 2021. Given the propensity for patients with this type of breast cancer to face recurrence, and progression to metastatic disease, there is an understanding that these patients have an unmet medical need for treatments, such as abemaciclib, that improve long-term outcomes. The breast cancer patient community has expressed general concern that treatments that have been accepted internationally as standard of care for early-stage breast cancer and having demonstrated value and clinical benefit for patients, may not be publicly accessible in Canada. Patients want to feel confident that they will be receiving treatment and care that is on par with international standards and protocols.
It is also of utmost importance to breast cancer patients that adjuvant access to HR- positive-directed agents, like abemaciclib, should not end up limiting access to these agents in the metastatic setting. Should patients be treated with HR directed therapies in the earlier stage setting, and subsequently progress to a metastatic setting, it is vital that they remain eligible to benefit from these targeted HR directed therapies for their metastatic disease.
The Phase 3 MonarchE trial showed that the Verzenio regimen had a tolerable and manageable safety profile. The most common adverse reactions (≥20%) were diarrhea, infections, neutropenia, fatigue, leukopenia, nausea, anemia, and headache.
In treating the cancer and reducing the risk of recurrence, this treatment can relieve cancer-related symptoms, and improve a patient’s quality of life. When living with no or with minimal cancer-related symptoms, and with minimal side effects from the treatment, patients are able to reduce the impact of cancer on their ability to care for children and dependents, continue with their employment and earn income, spend time with loved ones and participate in their life in a meaningful way by engaging in social activities, travelling, maintaining friendships, and pursuing personal interests.
Given that this treatment is not yet widely accessible in Canada, CBCN was unfortunately unable to connect with, and interview, breast cancer patients with experience on the treatment.
At this time, Ki-67 index marker testing is only available through select clinical testing programs and is not implemented routinely in breast cancer care in Canada.
Accessing testing and treatment is of great importance for hormone-receptor-positive breast cancer patients. It is imperative that all HR-positive, HER2-negative breast cancer patients who could benefit from this therapy are being identified and offered testing to assess their eligibility for adjuvant treatment with Verzenio. It is critical that access to adequate marker testing does not create a barrier for access to effective therapies for cancer patients.
Is there anything else specifically related to this drug review that CADTH reviewers or the expert committee should know?
While CBCN was not able to interview patients with direct experience of the treatment, it is vital to note what the breast cancer patient community feels about the value and benefit of abemaciclib in the early-stage setting.
Of particular note is the fact that Verzenio represents a major advancement in the treatment of early-stage, HR-positive, HER2-negative breast cancer. This is of significant relevance and importance to high-risk patients who face greater risk of recurrence and resistance to hormone therapies alone. Since Verzenio demonstrated an ability to delay cancer recurrence and improve the curation of cancer free survival from 79% at 3 years to 86%, it has the potential to become a new standard of care for this patient population, and should be regarded as filling a gap in our current treatment protocol for high-risk, HR-positive, HER2-negative patients.
To maintain the objectivity and credibility of the CADTH reimbursement review process, 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.
CBCN did connect with the manufacturer, Eli Lilly Canada, to try and connect us with patients with experience on the treatment.
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.
All other research, interviews and outreach to patients was conducted independently by the Canadian Breast Cancer Network, as was the compilation of information and data for the writing of this submission.
The Canadian Breast Cancer Network is committed to adhering to the Code of Conduct Governing Corporate Funding
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.
Financial Disclosure for the Canadian Breast Cancer Network.
OH-CCO’s Drug Advisory Committees provide timely evidence-based clinical and health system guidance on drug-related issues in support of CCO’s mandate, including the Provincial Drug Reimbursement Programs (PDRP) and the Systemic Treatment Program.
Discussed jointly at a DAC meeting.
Standard treatment varies depending on risk of recurrence but includes combinations of surgery, radiotherapy, adjuvant/ neoadjuvant chemotherapy, and endocrine therapy (ET). Adjuvant ET is standard treatment of HR+, HER2- early breast cancer (EBC) and has been associated with a significant reduction in risk of recurrence and death. There is a lack of access to Ki67 testing within Canada.
Abemaciclib is an oral, continuously dosed, CDK4/6 inhibitor approved for HR+, HER2- advanced breast cancer (ABC). Efficacy and safety of abemaciclib in ABC supported evaluation in the adjuvant setting.
Treatment goals would be improved survival and decrease risk of recurrence.
Despite the advances of treatment in HR+, HER2- BC, up to 30% of patients with high-risk clinical and/or pathologic features may experience distant recurrence. Superior treatment options are needed to prevent early recurrence and development of metastases for this group of patients.
How would the drug under review fit into the current treatment paradigm?
Abemaciclib would be used in addition to ET in high-risk patients following surgery and chemotherapy (if applicable).
Which patients would be best suited for treatment with the drug under review? Which patients would be least suitable for treatment with the drug under review?
Patients best suited would be HR+, HER2- early breast cancer (EBC) at high risk of recurrence who are node positive. Patients best suited would align with the inclusion criteria from the clinical trial.
Patients least suitable would be patients listed in the exclusion criteria from the clinical trial.
What outcomes are used to determine whether a patient is responding to treatment in clinical practice? How often should treatment response be assessed?
No extra imaging is needed but patients would need extra monitoring for hematologic toxicity, diarrhea, and extra visits would be required. Patients should be assessed for toxicity.
What factors should be considered when deciding to discontinue treatment with the drug under review?
Disease progression and toxicity.
What settings are appropriate for treatment with [drug under review]? Is a specialist required to diagnose, treat, and monitor patients who might receive [drug under review]?
Experience with treating breast cancer patients, access to laboratory blood work, and expert pharmacy support.
We have significant concerns about the inclusion of patients with high Ki 67. All patients benefit from this drug. Ki 67 was prognostic and not predictive. Additionally, the methodology is challenging for Ki 67 requirement and not standard. Lastly, Ki 67 is not a standard pathology test for breast cancer in Ontario.
We strongly recommend against the inclusion of high Ki 67 as the sole criteria for drug eligibility.
To maintain the objectivity and credibility of the CADTH drug review programs, all participants in the drug review processes must disclose any real, potential, For perceived conflicts of interest. This conflict of interest declaration is required for participation. Declarations made do not negate or preclude the use of the clinician group input. CADTH may contact your group with further questions, as needed. Please see the Procedures for CADTH Drug Reimbursement Reviews (section 6.3) for further details.
Did you receive help from outside your clinician group to complete this submission? If yes, please detail the help and who provided it.
OH-CCO provided secretariat support to the DAC in completing this input.
Did you receive help from outside your clinician group to collect or analyze any information used in this submission? If yes, please detail the help and who provided it.
No
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. Please note that this is required for each clinician who contributed to the input.
Name: Dr. Andrea Eisen
Position: OH-CCO Breast Cancer Drug Advisory Committee Lead
Date: 8/4/2022
Conflict of Interest Declaration for Ontario Health Cancer Care Ontario Breast Cancer Drug Advisory Committee Clinician 1.
Name: Dr. Orit Freedman
Position: OH-CCO Breast Cancer Drug Advisory Committee Member
Date: 8/4/2022
Conflict of Interest Declaration for Ontario Health Cancer Care Ontario Breast Cancer Drug Advisory Committee for Clinician 2.
Name: Dr. Phillip Blanchette
Position: OH-CCO Breast Cancer Drug Advisory Committee Member
Date: 8/4/2022
Conflict of Interest Declaration for Ontario Health Cancer Care Ontario Breast Cancer Drug Advisory Committee Clinician 3.
Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/
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