What a year it’s been for relapsed refractory multiple myeloma (RRMM)!!  The year has already ushered in an FDA approval of a second CAR-T therapy, Carvykti™ (ciltacabtagene autoleucel, cilta-cel), in February!  Last year we saw the approval of the first RRMM CAR-T therapy, Abecma® (idecabtagene vicleucel, ide-cel). Both are approved as a single dose after at least 4 lines of therapy, with many patients enrolled in each pivotal trial having received a median of 6 or more lines of therapy.

The FDA approval and NCCN 2A recommendation for both drugs is for patients who failed prior treatment with an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. In the ide-cel trial, 92% of patients had received prior autologous stem cell transplant while in the cita-cel trial, 90% of patients had received prior autologous stem cell transplant and, of note, 8% had received a prior allogeneic stem cell transplant. Unfortunately, RRMM has no known cure for heavily pre-treated patients. That being said,  B-cell maturation agent-directed CAR-T cell therapies reported high response rates (ide-cel:  72% ORR [28% sCR; 25% VGPR]; cilta-cel: 97.9% ORR [78.4% sCR; 16.5% VGPR]) which were durable (median DOR: ide-cel 11 months; cilta-cel 21.8 months).

MM is largely a disease of the elderly with a median age of diagnosis being 69 years. In 2018, an estimated 149,956 Americans were living with MM.  The rate of new multiple myeloma cases is trending up, with an estimated 34,920 new cases diagnosed in 2021 (1.8% of all new cancer cases) and a projected 2,410 deaths.  Even though relative 5-year survival has increased over time, it has been 55.6% from 2011-2017.

Concerns around the monetary cost of CAR-T therapy continue.  Even though CAR-T therapy demonstrates high response rates and carry the hope of a sustained, durable response, how long will response last? What treatment(s) will follow?

CAR-T therapy is a single dose, with a significant high monetary cost. The medication wholesale acquisition price for ide-cel and cilta-cel is $419,500 and $465,000 respectively. In addition, the time to product availability and rate of manufacturer product failure remains a concern (ide-cel median availability of 33 days with a 1.5% failure rate; cilta-cel median availability of 32 days with an 18% failure rate). Another hurdle is the shortage of the lentiviral vectors used to deliver ide-cel. However, the manufacturer is working to increase production.  For cilta-cel, the manufacturer plans to make vectors in-house in order to meet longer-term demand.

A forecasted cost impact model is demonstrated below. With more than 8 CAR-T drugs in the pipeline for multiple myeloma, more for hematologic cancers, and the possible expansion from hematologic to solid tumor treatment, more contemplation is sure to follow.

References:

1. Martin T, Usman SZ, Berdeja JG, et al. Updated Results from CARTITUDE-1: Phase 1b/2Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Patients With Relapsed/Refractory Multiple Myeloma. ASH update 12 December 2021. https://ash.confex.com/ash/2021/webprogram/Paper146060.html. Accessed April 12, 2022.
2. Berdeja JB, Madduri D, Usmani SZ, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021;398(10297):314-324 doi: 10.1016/S0140-6736(21)00933-8.
3. Carvykti [package insert]. Horsham, PA; Janssen; March 2022
4. Abecma [package insert]. Summit, NJ; Celgene; March 2021.
5. Munshi NC, Anderson LD Jr, Shah N, et al. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med 2021;384:705-16. DOI: 10.1056 /NEJMoa2024850.
6. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Myeloma. Available at: https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed April 12, 2022.
7. Kanas, G, Clark O, Keeven, K et al. Population-level Projections for Multiple Myeloma Patients by Line of Therapy in the USA. Poster No. 653 | Presented at the 62nd American Society of Hematology Annual Meeting and Exposition (Virtual Format) | December 5–8, 2020. https://d201nm4szfwn7c.cloudfront.net/5f95dbd7-245e-4e65-9f36-1a99e28e5bba/5b3ee4c1-c770-4504-9d91-08c64ae7bcc6/5b3ee4c1-c770-4504-9d91-08c64ae7bcc6_viewable_rendition__v.pdf?medcommid=REF–ALL-003261. Accessed 4-12-22.
8. Liu A. Johnson & Johnson, Legend’s CAR-T Carvykti enters myeloma ring with FDA nod. Fierce Pharma. Johnson & Johnson, Legend’s CAR-T Carvykti enters myeloma ring with FDA nod | Fierce Pharma. Accessed April 14, 2022
9. Osterweil N. Novel CAR T Therapy for Solid Tumors: ‘Exciting Advance’. 2022. https://www.medscape.com/viewarticle/972297. Accessed 4-19-22.

Have you heard that the world of cervical cancer therapy is evolving? There are two players who recently stepped onto the field of oncology for the treatment of recurrent, metastatic, or persistent disease. In 2021, FDA approval moved Keytruda® (pembrolizumab) from second-line to first-line therapy in PD-1 positive patients. Tivdak™ (tisotumab vedotin-tftv) also obtained FDA approval as second-line and subsequent therapy in the same space.

Why is the approval of two therapies in the same year significant? Since the 2014 approval of bevacizumab, no new first-line therapy for cervical cancer has hit the oncology market, and prior to bevacizumab, the last new approval in the category was the combination therapy with topotecan and cisplatin in 2006. So Keytruda and Tivdak are possible game-changers for patients!

From 1975-2010, new diagnoses of cervical cancer have decreased by more than 50% due to screening. With the introduction of the HPV vaccine in 2006, there was hope that HPV infection prevention would lead to decreased cervical cancer cases. In 2020, a Swedish study published in the New England Journal of Medicine found that the quadrivalent HPV vaccination was associated with a significant reduction in the risk of invasive cervical cancer. In 2018, there were 293,394 women living with cervical cancer in the U.S. As cervical cancer cases decline, according to SEER data, there were an estimated 14,480 new cases and 4,290 deaths reported in 2021. The total annual medical cost of cervical cancer care is estimated to be $1.6 billion. Due to its move from second to first-line, Keytruda will likely demonstrate a net neutral effect on the budget. A forecasted cost impact model for Tivdak is demonstrated below:

The Role of Precision Medicine in Oncology Care

The approach to cancer treatment has been transformed dramatically over the last decade. The use of medications to treat cancer is shifting from a “one size fits all” approach to more personalized therapies. The individual patient’s specific tumor characteristics may now drive the selection of the best treatment option. Identification of these tumor characteristics is often accomplished through genomic testing. Because clinical data regarding genomic testing is being published at an unprecedented pace, both providers and payers may struggle to keep up and need access to a shared, unbiased decision-support technology to ensure patients are receiving optimal treatment options.

How can you accurately approve tests and treatments while at the same time streamlining the prior authorization processes?  Here are four ways:

1. Follow evidence-based standards – there are many different lab companies who offer genomic testing as well as variations in the testing products offered by many labs. Clinical decision support for genomic testing assures that that each molecular test ordered meets clinical, evidence-supported standards and also ensures the use of cost-efficient testing. When physicians utilize this clinical decision support to order genomic testing, it streamlines and optimizes prior authorization and reimbursement arrangements with health plans
2. Enable transparency – provide a real-time window into the precision medicine decision-making process. Currently, it is difficult to ensure that all patients who could benefit genomic testing are receiving appropriate testing. When health plans have access to real-time genomic testing results, quality initiatives can be designed to track appropriate care interventions.
3. Take a patient-centered approach – ensure patients get the most appropriate tests from preferred labs at the right time in their treatment journey. Patients are understandably anxious awaiting test results and a system that streamlines workflow for practices and expedites the delivery of test results ensures appropriate, quality care for patients when time matters most.
4. Promote collaboration – ensuring scalable, appropriate use of precision medicine for cancer means working collaboratively with oncologists and molecular testing labs. Cancer care is often fragmented and solutions are needed that align all stakeholders while keeping the patient at the center of the solution. Providing clinical decision support for genomic testing as well as corresponding drug selection allows for all parties to work quickly and efficiently in order to maximize coordinated, quality cancer care.

To learn more about Magellan Rx Management’s approach to precision medicine in collaboration with Trapelo Health, click here.

Magellan understands that the market looks at pharmacy trends as a gauge to measure pharmacy benefits manager (PBM) success. However, you really can’t compare one trend number to another as every PBM uses different methodologies, different data sets and different calculations to arrive at their trend number, and often adjustments are made to these calculations year-over-year. This is something Magellan likes to call little ‘t’ trend.

Do you know what most of these trend numbers are missing? One of the largest cost drivers today – prescriptions drugs dispensed through the medical benefit – when you combine pharmacy benefit with medical benefit spend, you get what we like to call big ‘T’ Trend. In fact, you need to combine both to see that there is as much, if not more specialty spend going through the medical benefit today that is going unmanaged.

As specialty costs continue to soar the need to leverage effective management and thought-leading expertise is essential.  As pioneers in this complex specialty environment, we have dedicated ourselves to solving the challenges and creating solutions that resolve what’s truly driving big ‘T’ Trend.

Watch our video to learn more.

A major trend in the pharmacy space continues to be increasing specialty drug spend, which is expected to continue with the introduction of new specialty agents for oncology, autoimmune disorders and rare diseases. In this year’s Medical Pharmacy Trend Report Employer Group Supplement, we found that 88 percent of employers reported a medical benefit spend of less than $10 million, and a year-over-year drug trend between 1-20 percent. For the few employer groups with spend above $10 million, it was due to a higher number of lives, and may be assumed that the employee mix for these groups may have included those with more costly health expenditures.

The Employer Group Supplement assists employer groups and third-party administrators in determining specialty drug trends and strategies to solve complex challenges impacting the medical benefit drug landscape. Our goal is to expand the information shared with employer groups to create a more dynamic picture of specialty drug management and help employers make more effective healthcare decisions. Building an effective medical benefit drug management strategy requires an in-depth knowledge of and expertise in this complex area, but it’s essential to help employers rein in costs and improve the quality of care for members. It is our hope that the survey data presented in this report helps employer groups begin to think about and investigate escalating medical pharmacy costs.

Download the full report or listen to our webinar to learn more.

Learn more about ways to keep specialty spend, an important — and quickly growing — area of pharmacy spend, from Matt Ward, Magellan Rx Management’s general manager of the employer segment. Ward’s op-ed on the subject was recently published in WorldatWork’s magazine. WorldatWork is a nonprofit human resources association and compensation authority for professionals and organizations focused on compensation, benefits and total rewards.

Read more here: Six Ways to Keep Specialty Spend Under Control 

Uncertainty is the name of the game for many industries today, including healthcare. With rapidly emerging technologies, regulations and changing consumer demands, companies must manage differently in order to keep up. Jeff Dyer, innovation visionary and co-author of the highly acclaimed, The Innovator’s DNA and its follow-on publication, The Innovator’s DNA: Mastering the Five Skills of Disruptive Innovators highlighted the threat to many companies today – predicting that 50 percent of the S&P 500 will be replaced over the next 10 years.

Human-Centered Innovation

As consumer experiences across nearly every industry become more personalized, on-demand and targeted, he encouraged pushing our thinking beyond meeting functional needs by looking at social and emotional ones as well. By doing so, companies are able to identify unmet needs that can be catalysts for more useful solutions that ultimately win in the market.

The GE Adventure Series Scanner, an MRI scanner designed for children to make scanning a less frightening experience, was a prime example shared of human-centered innovation. While advanced in functional features, what was discovered through observing young patients getting a scan was that the former machine was intimidating – the designer learning that as many as 80 percent of pediatric patients had to be sedated in order to sit still long enough for the scan.  Witnessing this, a new approach was taken, ultimately applying human-centered design methods to redesign the experience as a series of “adventures” for children, delighting and no longer scaring its young users.

The Big Picture in Quality Care

While human-centered innovation can be applied product by product and interaction by interaction, we heard another thought-provoking point from the day’s presentations – that it’s really hard to detect poor quality care through one interaction. The path to a poor outcome most likely includes bouncing from doctor to doctor and breakdowns in coordination and communication between interactions. Often, the big picture reveals the flaws.

The reality today is that many people still get prescriptions from multiple, independent physicians, and many hospital admissions come with undiagnosed behavioral health concerns. The healthcare system has an immense opportunity to come together around the whole patient and to better identify needs at a population level to deliver on value-based care that leads to healthier outcomes.

Physician Collaboration

Our physician panel sparked further ideas in how to collaborate with PCP’s, nurses and other care workers to better meet patients’ needs. Often at the front lines of the patient experience, creativity in finding unidentified needs was discussed as pivotal to creating an effective healthcare experience. While concepts of self-directed, consumer-focused healthcare and increasing consumer participation in healthcare decisions have become popular, the role of physicians is also being transformed. Their responsibility is increasingly to supplement and put into perspective available information, manage expectations, and instill confidence. The discussion thus encouraged leveraging physicians as “natural, trained problems solvers”, bringing them into the ideation for a better patient experience, and empowering them with action-oriented data and decision support along the way.

We thank all of our leaders, clients and partners for joining us in a memorable and energizing event. We look forward to our next gathering in January 2017.

The room at the inaugural Magellan Open Vision Exchange (MOVE) this past March was a sight to see. Filled with a buzz of energy and openness to think differently, Magellan executives, clients and partners gathered in shared pursuit of a better, more efficient healthcare experience of tomorrow. Collectively, the leaders in the room had impact over the healthcare experience for a significant portion of America. Yet, the focus of the conversation was clearly in how to pivot care to be more accessible and effective, one person at a time.

Help One, Help Many

The event kicked off with stories from Mick Ebeling, CEO of Not Impossible Labs, whose commitment to changing the lives of a few individuals has sparked a few of the most impactful innovations in healthcare. From his entrée into healthcare innovation with the eyewriter, helping a graffiti artist paralyzed by ALS to create art again using his eyes, to Project Daniel, a 3D prosthetic printing process that started with the goal of creating an arm for a Sudanese boy, he challenged the group to “recognize an absurdity” and then to “just commit to figuring it out.”

Neither an engineer nor a healthcare expert, his “open source” method for creating healthcare inventions turned heads. He demonstrated a commitment to designing a solution through the eyes of the individual suffering, which made all the difference in his ability to impact lives. He reminded us that he did not have all of the answers -far from it. But asserted that a key point to breaking the mold was to think of challenges as “not impossible.” He reminded us that it would be very difficult to name something that is possible today that wasn’t at one point thought of as impossible.

Healthcare as an Experience

Our client presentations continued to emphasize applications of human-centered innovation in healthcare, sharing approaches grounded in first understanding the behaviors that drive and influence healthcare experience. Key takeways included:

• Remembering that the most common reasons for a hospital stay are the more common ailments of mankind, from childbirth to respiratory and circulatory conditions, musculoskeletal conditions and mood disorders. While emphasis is often placed on advancement in rarer, more specialized conditions, a significant portion of patients can be impacted by anticipating the needs for more routine healthcare experiences.
• Listening to what’s working, and what’s not, disease state by disease state. From crowdsourcing feedback from patients to understand what helped them get better, to creating focused innovation platforms within organizations to spawn creative solutions unencumbered by traditional perceived barriers, we learned of many approaches to closing gaps in the system.
• Speaking to people successfully living with their conditions provides tremendous perspective for recovery and chronic condition management programs. When the formula isn’t as simple as issue identification + treatment = healthy, concepts like peer support become an opportunity to support living well with a physical, mental or emotional challenge by empowering the patient to learn to thrive through peer experience.
• Re-positioning healthcare leaders as “chief experimenters.” It was underscored that healthcare leaders today can’t simply focus on making decisions, they must design and enable experiments to truly push the healthcare experience forward.

Stay tuned for Part 2 of our event recap.

Looking for more information about MOVE, our gathering of healthcare innovators and thought leaders? View media and request an invitation to our January 2017 event. For questions, contact mediarelations@magellanhealth.com.