Takeda discusses the importance of patient-focused market access
With World Cancer Day on 4 February, Takeda Oncology’s Liviu Niculescu and Stephen J. Noga talk to Pharmafile.com on the issue of patient-focused value in the industry: “We cannot apply a one-size-fits-all approach to determining value.”
One of the hardest parts of a physician’s job is telling a patient that he or she has cancer. Everyone responds in a different way – stoicism, incredulity, grief or anger – but once the patients and their family absorb this life-altering news, some of the questions we receive are surprisingly consistent. Often, recently diagnosed patients ask, “How will I afford treatment?”
While the topic of the financial impact of cancer makes many of us uncomfortable, it is, unfortunately, reality. A cancer diagnosis comes with a high price tag, which can include inpatient stays, physician bills, prescriptions, transportation to and from treatment centers and time off from work. Patients who have insurance worry about what that insurance will cover, and often they – or their loved ones – spend time on the phone with their provider in an attempt to understand why one treatment might be covered while another is not. For most patients, the cumulative impact of all of these factors creates a lot of worry and struggle at a time when they need to be focused on treating their cancer.
We made the change from clinical practice to the pharmaceutical industry in part because it provided the opportunity to bring our perspectives as treating oncologists to the development of medicines and to get those medicines to the patients who need them and are counting on them. Access to therapy for patients in need must be the first and foremost concern for those of us who develop and deliver treatments. With this tenet in mind, Takeda Oncology has adopted, as one of its overarching principles of placing the patient at the center of everything we do, an approach to clinical development and market access again centering on the patient. To us, that means doing all that we can to ensure our patients have access to the best possible treatment for them.
Through a variety of patient-focused approaches, Takeda Oncology has been able to make significant strides toward improving market access across the many regions where we operate, and always with the patient in mind.
Defining value in a way that works for patients
The increasing prominence of pharmacy benefit managers and the emergence of a growing number of value frameworks in the U.S., together with the ongoing role of cost-regulating agencies in Europe, have sharpened public focus on the drug pricing debate globally. We agree that there are a variety of good reasons to spur dialogue about the price of potentially life-saving medicines. That said, we continue to encounter the risk of defining value too narrowly, and as a consequence, limiting the available options for patients.
Although some use the words “cost” and “value” interchangeably, the distinction between the two terms is crucial when it comes to access to medicines. Currently, value is often defined within a purely economic framework by payers, Health Technology Assessment bodies and independent reviewers. From our perspective, that doesn’t begin to encompass the whole of the patient experience and the less tangible components of value, which may be the very aspects that patients consider most important – the ability to continue working during treatment, the ability to spend more time with family and the ability to avoid frequent trips to the clinic.
As an example, patients with multiple myeloma, an incurable form of blood cancer characterized by its relapsing nature, require a variety of treatment strategies to continue battling the disease. Patients face an array of challenges, including the impact of missing work, the stress of having a major illness, the cost of traveling to and from treatment centers (sometimes at great distance) and the devastation of finding out that a therapy has stopped working.
The treatment landscape in multiple myeloma has evolved substantially in recent years, with five new medicines receiving approval from the U.S. Food and Drug Administration in a span of less than one year. Several of these novel therapies have come under fire from critics who are myopically focused on price. They argue that legacy treatments have already proven effective in increasing progression-free survival in patients with multiple myeloma, but fail to acknowledge that despite these incredible advances, this disease remains incurable, and patients will relapse from their previous treatments. Without new options and continued research advancements, patients will succumb to the disease.
In the instance of multiple myeloma, the necessity of looking at value through a patient-focused lens becomes apparent. Existing drugs may be effective, but many of the newer therapies have reduced side effects, which is so important for patients who are now living longer lives with their disease. In addition, what about patients who do not respond to the more “standard” medicines? What about those whose disease progresses after a period of remission? We cannot apply a one-size-fits-all approach to determining which treatments have value, because patients are individuals. They defy the bounds of statistical models designed to predict which medicines should be covered under publicly and privately funded pharmaceutical benefits programs.
A definition of value that puts patients at the center must not only include quantitative measures like the availability of the full range of options, especially for complex, heterogeneous and incurable cancers like multiple myeloma, but also account for the qualitative, even subjective, outcomes that patients care about – quality of life and milestones achieved. At Takeda Oncology, we demonstrate our commitment to this belief by continually working to improve upon current treatments – including our own – so that patients can access effective and valuable therapies. Our Patient Leadership Council, comprised of both cancer patients and caregivers, advises us throughout process so that we know our efforts are rooted in a deep understanding of patients’ needs and the outcomes that matter most to them. The company will continue to support the development of value frameworks that take into account the need for options and incorporate the patient perspective and experience.
Prioritizing adaptability for worldwide access
For a global company like Takeda, it is critical to employ a flexible market access approach that can be adapted to the nuances of each region. As we adjust our strategy to align with local conditions, however, we see one overarching principle as unchanging: doing right for the patient comes first.
Implementing this principle starts with early-stage research, continues through clinical trial design and execution and factors into our conversations with regulatory authorities worldwide. Healthcare budgets are limited, and we believe that these budgets should be spent on effective medicines that help patients through demonstrated efficacy and tolerability.
Once a treatment receives health authority approval, Takeda Oncology addresses patient access on a country-by-country basis, in accordance with local regulations. Our organization is structured to ensure we have experts on the ground in all major markets, coordinating closely with payer systems to secure funding or reimbursement for our medicines.
In the U.S., Takeda Oncology offers programs to support patients with private insurance who may struggle to pay, as well as those who may have no insurance. We also recognize that cancer is a complicated illness in which patients have more than just financial needs. To that end, we invite patients to engage with our clinical educators to receive ongoing personal, emotional and educational support at no cost. Access to medicines encompasses more than just being able to afford treatment. It also involves facilitating patients’ understanding of their disease, the therapy they’re receiving and the resources and support available to them.
From an emerging markets perspective, Takeda recently launched a new access to medicines strategy that aims to address unmet needs in areas with evolving healthcare systems such as Latin America, South East Asia and Africa. The initiative focuses on tackling barriers that limit access to medicines and cancer care and doing so in a sustainable way. For instance, the organization plans to establish public-private partnerships with governments, nonprofits, healthcare professionals, patient associations and communities to build local cancer management capacity. Our access to medicines strategy goes beyond supplying the medicines Takeda makes – it’s a major, ongoing commitment to improving healthcare in these regions.
Despite these efforts, we still encounter roadblocks to funding for novel medicines in certain countries, in which case we apply innovative approaches to address affordability at a patient level, consistently dedicating substantial resources to maximizing access to our medicines.
Pricing medicines fairly
Even with a patient-focused definition of value and a commitment to market access, pharmaceutical companies can fall short on one of the fundamental aspects of access: pricing. The price of a medicine matters – to payers, to governments, to healthcare providers and, most importantly, to patients and their families.
Developing new therapies requires a substantial investment, ranging from time spent by researchers, investigators and employees to the outlay of capital for active pharmaceutical ingredient. To set a fair price for a new medication, companies like Takeda Oncology must carefully balance the importance of ensuring affordability and accounting for the innovation a product delivers.
We will continue to work closely with governments and payers to achieve appropriate prices for our medicines for each country and region. In the U.S., we introduced a novel treatment for multiple myeloma at a cost that aligns with that of the previous standard of care, a decision that upended the long-standing practice to significantly raise the price of a newly-introduced medicine, reflecting our organization’s values and recognition of the need to be a responsible partner.
Takeda Oncology has restricted U.S. price increases on specialty products to less than five percent over the last ten years, while other industry players drove up costs by double- and triple-digit percentages. As an industry, we have a responsibility to those we serve to limit price increases to a manageable level, in line with market conditions.
Patient engagement and perspective are – and always have been – an integral part of how we make decisions and conduct business at Takeda Oncology. We can only make progress toward our aspiration to cure cancer by ensuring people facing a cancer diagnosis receive the medicines they need – for as long as they need them. With a constant eye on how everything we do impacts patients, we focus on enabling value, adapting our approach for global markets and pricing medicines fairly to enable the broadest access possible.
Liviu Niculescu, Vice President, Global and US Oncology Medical Affairs
Stephen J. Noga, Senior Medical Director, Global Medical Affairs
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