ADVI Instant: IRA Implementation: CMS Patient-Focused Listening Session on Imbruvica

On November 6, 2023, CMS held a Medicare Drug Price Negotiation Patient-Focused Listening Session for the selected drug Imbruvica. Ten participants were selected to speak, including patients, patient advocates, and researchers. Participants were limited to three minutes, during which time they were asked to address:

• Patients’ day-to-day experiences living with the condition(s) treated by the selected drug, including how the experience may differ for different patient populations as well as patient caregivers and families.
• How the selected drug impacts patients, including both benefits and side effects, as compared to the therapeutic alternative(s), and which outcomes matter most to patients with the condition(s) treated by the selected drug.
• Patient experiences of access, adherence, and affordability of the selected drug as compared to therapeutic alternative(s).
• Any other information about the selected drug, the condition(s) it is used to treat, and other treatments used for that condition(s) that the speaker believes is important.

Background

Imbruvica is a kinase inhibitor manufactured by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc. It is indicated for the treatment of adult patients with:

• Mantle cell lymphoma (MCL) who have received at least one prior therapy,
• Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL),
• CLL/SLL with 17p deletion,
• Waldenstrӧm’s macroglobulinemia (WM),
• Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy, and
• Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

Imbruvica was selected for Medicare drug price negotiation for the Initial Price Applicability Year 2026 based on their total Part D gross covered prescription drug costs from June 2022 – May 2023 of $2.7 billion; a total of 20,000 Medicare Part D enrollees used Imbruvica during this time.

Key Takeaways from Imbruvica Patient-Focused Listening Session

• Participants expressed concerns about a lower negotiated price resulting in Part D plans limiting coverage to non-negotiated products through utilization management, negatively affecting patient outcomes.
• Several participants commented on the impact of innovation. Participants asked CMS to monitor any shifts in innovation patterns. One participant expressed that she believed innovation would not be impacted.
• Participants asked if and how the negotiated price will be passed on to consumers.

Additional Participant[1] Points

• Disease Burden
  • 18,000 people are newly diagnosed each year with CLL. CLL presents itself differently in each patient. In 2021, my swollen lymph node turned out to be CLL. – Ron Katz, Patient/Patient Advocate, Development Director, CLL Society
  • The targeted diseases are not curable but can go into remission – Elizabeth Helms, Patient Advocate, Director, Chronic Care Policy Alliance
  • 1,500 people are diagnosed with WM each year in the U.S. I was diagnosed with WM in 2006. I started to develop peripheral neuropathy. It was motor neuropathy and I ended up using a walker. I have some residual sensory neuropathy. – Joel, Patient
  • I was diagnosed in 2000 and given a 10-year survival time. We think of cancer as once you have a treatment you are cured, but that is not the case for CLL. It causes a tremendous amount of stress for patients. – Ann, Patient

• Imbruvica Benefit
  • Access to an oral blood medicine is life-changing for patients. A significant number of patients can remain on this for years without disease progression. However, a significant number of patients have to reduce their dosage or stop the drug because of side effects. – Robin Brumble, Patient Advocate, Director of Scientific Affairs & Research, CLL Society
  • Imbruvica is very effective although some people have side effects. – Joel, Patient
  • I have been taking Imbruvica successfully now for eight years and have not suffered any side effects. – Lynn, Patient
  • In 2004 I began a clinical trial at Ohio State University. My only option was chemotherapy which left me in remission but with a breathing issue. In 2009, I started coming out of remission and went back into “watch and wait.” I needed treatment in 2011 but was fearful of chemotherapy, but I was chosen to participate in the NIH’s Imbruvica clinical trial. I stayed on Imbruvica until May 2023, when I was advised to stop treatment. I had been in remission just by taking the pills. Imbruvica saved my life – I am no longer in fear of CLL and losing my life. I have familial CLL, and I have two children, but I am not as concerned now if they get this disease. – Ann, Patient
• Unique Patient Considerations & The Need for Options
  • I field thousands of questions from patients about their disease and medications and I consistently observed that patients are concerned about access to the best treatment possible. – Robin Brumble, Patient Advocate, Director of Scientific Affairs & Research, CLL Society
  • You cannot switch from a BTK therapy if it has been successful. There are no therapeutic alternatives. – Carly Boos, Patient Advocate, Executive Director, CLL Society
  • Millions of patients need access to a specific drug that is most effective for their cancer. Treatments are not interchangeable. – Lisa Lacasse, President, ACS-CAN
  • I want to ensure that medication does not impact access to treatments. Our lives depend on being able to receive the right medication for each case. – Ron Katz, Patient/Patient Advocate, Development Director, CLL Society
  • A variety of medications are necessary to determine the best treatment for the individual. – Elizabeth Helms, Patient Advocate, Founder and Director, Chronic Care Policy Alliance
  • I was treated for WM first with a chemotherapy cocktail and a monoclonal antibody…Looking ahead, I will probably need treatment in the future. I am looking ahead to using a BTK inhibitor rather than having another round of chemo. – Joel, Patient
• Cost Concerns
  • Chemotherapy was covered 100% by Part B (Medicare and Medigap), but oral therapies are quite expensive…the problem is that you have to take it for the rest of your life, and it is quite expensive. – Joel, Patient
  • It has afforded me a very good quality of life at the cost of $17,000 a month. It is not affordable. I depend on grants and state assistance to pay for my medication. I worry every year if I will be eligible. I worry about my life without my medication, and I am certain my disease would progress, and I would succumb. – Lynn, Patient
  • I try to help a lot of new patients on a Facebook CLL group. One of their biggest concerns is the cost of drugs to treat CLL. – Ann, Patient
  • In August 2022, the FDA asked AbbVie to undergo three small studies in pediatric populations, which came with a six-month extension of patent exclusivities. The cost is expected to be massive. The government should not use a pediatric extension for small studies at a large cost to society. – James Love, Researcher, Director, Knowledge Ecology International
• PBM & Plan Concerns
  • We ask for treatment decisions to not be driven by formularies or step protocols but rather by shared decision-making between providers and patients. CMS needs to hold plans accountable if they do not do the right thing for patients. – Robin Brumble, Patient Advocate, Director of Scientific Affairs & Research, CLL Society
  • We are asking CMS to understand how plans will respond to their decisions. If plans limit options, patients on proton pump inhibitors will, in effect, be denied treatment. Patients cannot do step therapy. Simply monitoring plans will put patients at risk. – Carly Boos, Patient Advocate, Executive Director, CLL Society
  • Insurers are already incentivized to steer patients towards lower-cost medicines. Negotiating lower prices could create a greater incentive to direct patients toward lower-priced drugs. We want to make sure CMS is looking at these potential changes. – Lisa Lacasse, Patient Advocate, President, ACS-CAN
  • Any chance that plans would require a switch to a new therapy is an absurd risk. – Ron Katz, Patient/Patient Advocate, Development Director, CLL Society
• Considerations and Concerns Regarding Negotiation
  • We urge CMS to consider the downstream impact of new therapies and existing treatments. Post-approval research is crucial – it took two and a half years to get an indication for Imbruvica as a first-line therapy for CLL. Will CMS initiate price renegotiation if Imbruvica has a new indication? – Carly Boos, Patient Advocate, Executive Director, CLL Society
  • There is potential for real savings for millions of beneficiaries if the program is administered in a way that ensures savings reach patients. Medicare beneficiaries will only directly benefit if they pay less than they were previously paying. Innovation is critical to reduce the burden of cancer. We urge CMS to work with the FDA to monitor shifts in innovation patterns and to continue to reach out to patients to understand if real savings were achieved. – Lisa Lacasse, Patient Advocate, President, ACS-CAN
  • Research offers new opportunities for shorter treatment durations, but it is costly and is less likely to occur when the drug would be selected for drug negotiation. – Ron Katz, Patient/Patient Advocate, Development Director, CLL Society
  • We need development to continue. We want new treatments that work better, longer, and with fewer side effects. – Elizabeth Helms, Patient Advocate, Founder and Director, Chronic Care Policy Alliance
  • I am concerned about the impact of Imbruvica’s negotiation on other BTK inhibitors. A-fib is a side effect of Imbruvica, and a lot of doctors are recommending [other drugs]. – Joel, Patient
  • It is my hope that future negotiations will make these medications affordable to more seniors. Negotiated pricing will not affect, hinder, or impede research or new drug innovation in any way, as the majority of research is funded by the American taxpayer. – Lynn, Patient
  • Patients will benefit from the new out-of-pocket maximum. The Medicare program will save [Medicare] money, and we may find that premiums will be lower, but drug costs may not be lower. – Ron Katz, Patient/Patient Advocate, Development Director, CLL Society

[1] Note: Participants were asked to not share their last names for confidentiality purposes; some patient advocates identified full names, titles, and organizations.

ADVI will continue monitoring developments and the next steps. This is a delayed release. ADVI Instant content is distributed in real-time for retainer clients. Get in touch to learn more about how we can support your commercialization, market access, and policy needs.

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Brenna Raines, MHA
Vice President