Health policy articles within Nature Reviews Clinical Oncology

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  • Review Article |

    Lung cancer is the commonest cancer globally. Reflecting patterns of smoking and other risk factor exposures, both the incidence of and mortality from lung cancer are highest in economically developed countries. Nonetheless, developing and less economically developed countries are likely to have the biggest increases in lung cancer in the coming years. In this Review, the authors describe the global epidemiology of lung cancer, and how changes in exposures, socioeconomic status, public health interventions and better treatment strategies are influencing both the incidence of and mortality from lung cancer.

    • Amanda Leiter
    • , Rajwanth R. Veluswamy
    •  & Juan P. Wisnivesky

  • Comment |

    Crossover in a randomized trial can skew the interpretation of the efficacy of a cancer drug. In this Comment, I use examples from clinical trials presented at the 2023 ASCO annual meeting to highlight why ‘allowing’ crossover in randomized trials testing cancer drugs is problematic, and propose that crossovers should either be mandated or prohibited depending on the context.

    • Bishal Gyawali

  • Comment |

    Between 2016 and 2022, 83 previously approved oncology drugs were covered and reimbursed in China through a value-based pricing negotiation programme, which resulted in substantial price cuts but did not improve the correlation between drug cost and clinical benefit. Herein, we call for an improved, transparent value-based pricing model to better account for high-value innovation in oncology drugs.

    • Jing Yuan
    • , Minghui Li
    •  & Z. Kevin Lu

  • Comment |

    Timely and comprehensive updating of treatment guidelines remains a challenge and necessity in medical oncology. Herein we discuss our assessment of how trial results with four off-patent drugs have been considered for integration into major guidelines in the absence of a commercial sponsor, in which we found reasons for concern.

    • Gauthier Bouche
    •  & Lydie Meheus

  • News & Views |

    Surgical quality remains a priority for patients with cancer, payers and policymakers. Whether the risk-standardized mortality rate (RSMR) is a better metric than surgical volume to inform the regionalization of cancer surgery remains controversial. In particular, RSMR has been criticized on both theoretical and methodological grounds. Novel alternative means that incorporate surgical volume, as well as evidence-based process measures, are needed.

    • Karl Y. Bilimoria
    •  & Timothy M. Pawlik

  • Comment |

    Legislators in the USA have been discussing reforms to reduce the high cost of brand-name drugs, which are much higher in the USA than in other industrialized countries. One solution is to actively negotiate prices based on drugs’ clinical benefits. We discuss two important complexities from such an approach: drugs that have been approved for multiple indications and as part of a combination regimen.

    • Kerstin N. Vokinger
    •  & Aaron S. Kesselheim

  • Comment |

    Data from several trials support the efficacy of first-line tyrosine-kinase inhibitors combined with immune-checkpoint inhibitors (ICIs) in metastatic renal cell carcinoma. However, whether combining these drugs is preferable to using them sequentially remains unclear. Here, we assess the implications for patients and payers of limited access to second-line ICIs in the control arms of trials.

    • Garth W. Strohbehn
    •  & Daniel A. Goldstein

  • Comment |

    Zanubrutinib was recently granted expedited approval by the USA and Chinese drug regulatory authorities for the treatment of mantle cell lymphoma, thus becoming the first investigational new drug discovered in China to achieve simultaneous development in both countries. Here, we provide an overview of the regulatory processes and considerations of the two health authorities and discuss the pathways of concurrent review and approval.

    • Guanqiao Li
    • , Xiaozhen Liu
    •  & Xiaoyuan Chen

  • Perspective |

    Monitoring both cancer incidence and death rates is important for guiding health policy and the direction of future research. In this Perspective, the authors describe changes in cancer incidence and death rates in the USA, highlighting the effects of specific policies and research developments, and providing insight into unmet needs that should be addressed by future health policies.

    • Farhad Islami
    • , Rebecca L. Siegel
    •  & Ahmedin Jemal

  • Comment |

    The FDA has demonstrated a willingness to expedite access to new cancer medicines by using real-world evidence to support regulatory drug approval. In this article, we explore three recent examples of such approvals and the lessons that can be learned from this collective experience.

    • Michael J. Raphael
    • , Bishal Gyawali
    •  & Christopher M. Booth

  • Comment |

    In 2019, the FDA Oncology Center of Excellence (OCE) approved 11 new drugs and biologic agents, 30 supplemental drug and biologic applications, and four biosimilar applications in oncology. These included two landmark approvals involving collaboration among international regulators as part of OCE Project Orbis, as well as the approval of three novel antibody–drug conjugates.

    • Harpreet Singh
    • , Gideon Blumenthal
    •  & Richard Pazdur

  • Editorial |

    Dramatic reductions in drug costs in 2020 are unlikely, although early signs suggest that the issue of unsustainable drug pricing is beginning to attract the attentions of policymakers.

  • Comment |

    Shortages of drugs, including chemotherapeutics, are increasingly common in the USA, and compromise patient care, delay clinical trials and are associated with substantial financial costs. The recent shortage of vincristine, a chemotherapeutic used for most children with cancer and countless adult patients, presents a particularly vexing challenge. Drug shortages can cause patients unnecessary anxiety and challenge clinicians to ration lifesaving medications for which no alternative agent exists. We provide an overview of this problem and discuss potential solutions.

    • Erin R. Fox
    •  & Yoram Unguru

  • Editorial |

    An increasing number of studies suggest that artificial intelligence could revolutionize medicine. In oncology, we are only beginning to fully understand the practical implications.

  • Comment |

    The FDA grants Accelerated Approval when deemed necessary to address an unmet need, with a promise that post-marketing research commitments will be fulfilled and that the approvals will be revisited and eventually changed if clinically meaningful results are reported. Herein, we present a timeline of all Accelerated Approvals granted to immune-checkpoint inhibitors to illustrate three ways in which the FDA has failed to fulfil their part in this social contract.

    • Jennifer Gill
    •  & Vinay Prasad

  • Review Article |

    In the past few years, the use of data from the real world has garnered increasing interest; however, studies using real-world data (RWD) should not be used as substitutes for clinical trials. The authors of this Review explore the quality of RWD, provide a framework for the use of RWD and draw attention to the methodological pitfalls inherent to using RWD.

    • Christopher M. Booth
    • , Safiya Karim
    •  & William J. Mackillop

  • Comment |

    In 2018, the FDA approved 19 new drug and biologic applications, 38 supplemental drug and biologic applications and 4 biosimilar applications in oncology. These advances in anticancer therapy included a landmark approval of the first histology-agnostic, biomarker-defined new molecular entity and approvals based on real-time data review and novel end points, such as minimal residual disease rate and metastasis-free survival.

    • Gideon M. Blumenthal
    •  & Richard Pazdur

  • Perspective |

    Historically, academic surgeons, so-called surgeon scientists, have been at the forefront of cancer research. However, the role of the surgeon scientist is changing, and concerns have been raised about declines in the number of surgeons performing basic science research alongside clinical activity. Herein, the multifactorial drivers of these changes are discussed and strategies to increase surgical engagement in oncology research are described.

    • Robert. P. Jones
    • , Chandrakanth Are
    •  & Graeme J. Poston

  • Comment |

    Multidisciplinary team meetings have several flaws; herein, we propose approaches for cancer centres to transform these limitations into improvements in the quality control of oncological care and into research opportunities.

    • N. Gopalakrishna Iyer
    •  & Melvin L. K. Chua

  • News & Views |

    The ESMO Scale for Clinical Actionability of molecular Targets (ESCAT) will be useful as a common language to harmonize discussions in precision oncology and could also guide policy and reimbursement decisions, but it is far from perfect. Herein, we highlight how ESCAT can be further improved to increase its utility in clinical and policy decisions.

    • Bishal Gyawali
    •  & Aaron S. Kesselheim

  • Perspective |

    With the expansion of the precision medicine paradigm, seamless trial approaches to drug development hold great promise for accelerating the accessibility of novel therapeutic agents but are also accompanied by important trade-offs. The authors describe several opportunities to improve the efficiency of drug development in oncology, as well as new mechanisms to obtain information about anticancer therapies throughout their life cycle.

    • Sharyl J. Nass
    • , Mace L. Rothenberg
    •  & Richard L. Schilsky

  • Comment |

    The value of medical treatments is an issue that has been actively debated in recent years and is not unique to oncology. In this Comment, we discuss why we pursue treatments which might have limited benefit from the point of view of three parties: the patient, the physician, and the pharmaceutical industry.

    • Christopher M. Booth
    •  & Allan S. Detsky

  • Comment |

    Burnout is a substantial issue associated with the medical profession, with oncology being no exception. Increasing focus is being placed on implementing solutions to address physician burnout, and successful interventions have encompassed the following themes: the presence of an organizational mandate, data-driven and grassroots quality improvements, and a focus on systems change.

    • Krithika Murali
    •  & Susana Banerjee

  • News & Views |

    Population-based mammographic screening is widely accepted as an intervention to reduce overall mortality from breast cancer, but at the cost of morbidity due to false positives and substantial overdiagnosis and overtreatment of ultra-low-risk disease, as well as personal and health-economic burdens. Recent data from a modelling study strengthen the rationale for personalized, risk-based screening approaches, now being tested in multiple clinical trials.

    • Laura J. Esserman
    •  & Andrea Z. LaCroix

  • News & Views |

    The approval of blinatumomab based on achievement of undetectable minimal residual disease (MRD) in patients with B cell acute lymphoblastic leukaemia in complete remission is the first of its kind and raises important considerations. This drug might improve outcomes in this setting, although considerable evidence is needed to validate the performance of MRD as a surrogate end point and confirm the hypothesis.

    • Talal Hilal
    •  & Vinay Prasad

  • News & Views |

    Accelerated approval enables investigational drugs to reach the US market on the basis of their demonstrated effects in unvalidated surrogate measures, only reasonably likely to predict clinical response. To fulfil the social compromise, regulators should ensure that confirmatory trials testing clinically meaningful end points are already underway at the time of approval.

    • Bishal Gyawali
    •  & Aaron S. Kesselheim

  • Comment |

    Drug regulators’ acceptance of any statistically significant improvement shown in a single randomized trial and lofty drug prices has created a situation where it is now, hypothetically, profitable for a company to run a clinical trials portfolio of chemically inert compounds. While the current cancer drug pipeline is certainly superior to inert drugs, we must rethink market incentives to encourage transformational drug development.

    • Vinay Prasad
    • , Christopher McCabe
    •  & Sham Mailankody

  • News & Views |

    The affordability of newly approved anticancer agents is a challenge to many national health services and reimbursement systems. Therefore, we have developed an approach based upon the adoption of a novel model of price setting and herein provide examples of how it might be implemented. This model is intended to alter the balance between social and economic entrepreneurship.

    • Carin A. Uyl-de Groot
    •  & Bob Löwenberg

  • News & Views |

    Despite the rising incidence of cancer in low-income and lower-middle-income countries, very few oncologists are present in these regions — or, in some areas, even none. However, limited evidence of the global oncology workload inequity is available in the literature. Herein, we summarize recent findings that shed some light on this problem and discuss potential oncology workforce solutions.

    • Temidayo Fadelu
    •  & Lawrence N. Shulman

  • News & Views |

    Recently published data from a large-cohort study confirm the substantial burden of chronic health conditions among childhood cancer survivors, and describe the multiple chronic conditions faced by these individuals. The findings emphasize the need for specialized care in this unique patient population that, as discussed herein, often goes unmet. More must be done to ease the burden on cancer survivors; new models of care are required to improve their long-term health.

    • Tara O. Henderson
    •  & Kevin C. Oeffinger

  • Comment |

    Women's health is more than reproductive health. Why does this phrase still need to be repeated? This commentary highlights the urgent need to encourage more women to lead, research, and educate to move beyond stereotypes and to ensure we push forward in improving the lives of women everywhere.

    • Ophira Ginsburg

  • Comment |

    Does a patient with advanced incurable disease have a right not to hear the bad news? We think not. Failing to disclose a poor prognosis undermines patient autonomy and increases the likelihood of poor end-of-life care.

    • Devan Stahl
    •  & Tom Tomlinson

  • Comment |

    The 69 National Cancer Institute-designated Cancer Centers are premier academic institutions that place significant value on research integrity and an ethic that rigorous evidence should guide patient care and define expectations. Recent patient-focused advertising has strayed from these values, obscuring valid reasons for seeking care at these centres.

    • David Rubenson
    •  & Daniel S. Kapp

  • News & Views |

    The VOICE study addressed the oncologist–patient dyad by adding a two-sided intervention. The results of this ostensibly positive study are, at best, limited and, at worst, cosmetic because clinically relevant long-term outcomes were unaffected. VOICE is the first attempt at addressing complexity in this genre of studies and, even with its shortcomings, teaches us some important lessons.

    • Nathan Cherny

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