The Challenge of Balancing Access to and Paying for New, High-Cost Cancer Therapies
Many significant and interesting topics highlighted at ASCO 2016 are discussed in this publication, covering clinical, safety, and economic issues related to cancer therapies. The challenge for health plans and other insurers is to balance the need to provide reasonable and appropriate patient access to new therapies and the ability to pay for them, because many new cancer treatments are designed for orphan diseases and are launched into the market at extremely high costs.
It is expected that spending on specialty drugs will reach 50% of the total drug spending by 2018 in the United States, which means that half of the pharmacy budget will be consumed by ≤5% of the total US population. This, however, is an unsustainable business model, and therefore, the ongoing pressure to improve patient access to treatment while containing costs is not a viable solution.
The Impact of Out-of-Pocket Costs
In her discussion, Dawn L. Hershman, MD, MS, raises important concerns related to out-of-pocket costs for oral cancer therapies and the impact on patient adherence. Clearly, high copayment or coinsurance may prompt patients to stop taking their medications or to ration their doses to minimize their out-of-pocket expenses. However, it is important to assess the exact reasons for a patient’s nonadherence to therapy and, when appropriate, to identify other issues that could be ameliorated to improve adherence, such as medication side effects, the fear of long-term or serious side effects, and a patient’s potential denial of the need for treatment. If patients are only concerned with cost, many copay assistance programs and foundations are available that may defray the cost for patients facing financial constraints.
Sharon H. Giordano, MD, MPH, points out that different regimens may have comparable efficacy and yet have very different out-of-pocket costs for the patient based on their insurance. However, health plans have traditionally limited the use of various restrictions in oncology, because of the lack of comparative data to support a preferred treatment regimen for a particular cancer type. Physicians need to work with patients and plans to provide treatment options that balance efficacy and cost for the patient.
Alternative Payment Models
In her Presidential Address, Julie M. Vose, MD, MBA, discussed the needs for patient-centered care, alternative payment models, and the “tsunami” of patients who will be presenting with cancer over the next decade. And health plans are anticipating a “tsunami” of new drugs to treat these patients in the adjuvant and nonadjuvant settings, requiring a greater degree of utilization management and coordination with providers and other caregivers to maximize the appropriate use of the new drugs and to promote reasonable access to them. Alternative payment models are of particular interest to health plans as a way to improve the care coordination of patients with cancer and to reduce the costs associated with the adverse events seen with many of these newer therapies.
Promising Biosimilars and Targeted Therapies
The promise of biosimilars is an area of high interest to insurers with their potential to reduce costs for select cancers and provide increased access to therapies for patients who may be affected by high out-of-pocket expenses. Hope S. Rugo, MD, discussed the positive efficacy and safety of the trastuzumab biosimilar in the treatment of patients with HER2-positive breast cancer. In addition, a lack of demonstrated immunogenicity in the drug provides hope that this and other biosimilars could be incorporated into clinical pathways and guidelines for patients with breast cancer. As Dr Rugo noted, the price for this biosimilar will be an important consideration toward the adoption of this drug by oncologists.
Targeted therapies designed for specific cancers continue to show promise in the oncology market, and health plans support the effort to better identify patients who would be likely to respond to a particular drug. MyPathway is a very interesting approach to treatment that targets the cancer cells at the molecular level rather than at the tumor site. John D. Hainsworth, MD, presented very interesting early-phase clinical results that may provide insight into other treatment approaches in patients with cancer that is refractory to traditional or preferred regimens.
Health plans struggle with the concept of paying for treatments that are not effective, because the patient’s genetic makeup did not align with the clinical mechanism of action of the drug. If pharmacogenomics and molecular targeting can be combined to predict improved outcomes, we will have the opportunity to achieve better disease responses and to avoid costly medical expenses for adverse events and other complications associated with a particular drug regimen.
Advances in the Treatment of Cancer
Some of the exciting highlights presented at ASCO 2016 related to specific drug therapies included (1) the use of daratumumab in the setting of relapsed or refractory multiple myeloma; (2) a novel vaccine for acute myeloid leukemia (AML); and (3) use of alectinib as first-line therapy for non–small-cell lung cancer (NSCLC) with ALK mutation.
Antonio Palumbo, MD, discussed the emergence of daratumumab as a potential new standard of care in the treatment of relapsed or refractory multiple myeloma, based on the results of the phase 3 CASTOR trial. This novel option continues the significant improvements in clinical efficacy seen in the treatment of patients with multiple myeloma, along with several other agents approved over the past 5 years, with 4 of the new drugs approved late last year. The challenge for health plans and for patients will be to manage the cost of multidrug regimens in multiple myeloma to ensure appropriate patient access and improved outcomes.
Peter George Maslak, MD, provided information on vaccination with galinpepimut-S to promote an immunologic response in patients with AML. The use of the vaccine in patients whose disease is in remission to maintain that status offers a novel approach in AML. The promise of vaccines in cancer continues to promote additional research, and more data are needed to support this important effort.
Hiroshi Nokihara, MD, PhD, presented data on the use of alectinib as a potential first-line therapy for patients with NSCLC associated with the ALK mutation. Such a head-to-head study is welcomed by insurers as a way to clearly differentiate treatment options that could support future pathway development and coverage decisions. The study demonstrated improved efficacy and safety in the alectinib group versus the crizotinib group in the first-line setting.
These last 3 presentations highlight a few of the important advances in the treatment of cancer and the promise of future improved outcomes for patients. Health plans will need to develop methods to incorporate new treatment options into coverage policies, while managing costs and ensuring appropriate patient access. Head-to-head trials, comparative effective research, and novel cancer treatment pathways can provide important evidence to support coverage and access decisions for novel cancer regimens.