What is ‘Bayesian Hierarchical Modelling’ and how can it be used to evaluate oncology treatments studied in basket trials?

Should payers cover a new oncology treatment targeting specific biomarkers across multiple tumor types? One the one hand, one could require a separate trial for each tumor type. While this would be convincing evidence, it also is very expensive to conduct clinical trials for every tumor type, particularly if treatment efficacy is homogenous across tumor…

Single Arm Trials for FDA Drug Approvals in Oncology

These are becoming increasingly common. Agrawal et al. (2022) use data between 2002-2021, and found that FDA approved: …176 new malignant hematology and oncology indications based on single-arm trials, including 116 accelerated approvals (AAs) and 60 traditional approvals. Overall, 87 approvals (49%) were for new molecular entities or original biologics and 89 (51%) were supplemental…

Part B drug reimbursement

In the past Medicare has reimbursed physicians that administer Part B drugs–typically injectable medications administered in a physician’s office–at 6% of the drug’s cost.  The 6% aims to cover the cost of purchasing and storing the drug as well as administering it.  Because physician reimbursement is proportional to the cost of the drug, physicians have…

Precision acquires ACT Oncology

My employer, the Precision Medicine Group, recently made a new acquisition.  Details are in this press release and the excerpt below. Precision for Medicine, part of the Precision Medicine Group, announced today that it has executed a binding agreement to acquire ACT Oncology, the leading contract research organization (CRO) specializing exclusively in the field of oncology. ACT…

Benefits of mammogram oversold?

That is what one new study finds. The Boston Globe reports that: Doctors may have oversold the benefits of mammography and underplayed its risks, which has left many women unable to make an informed decision about whether or not to have regular breast cancer screenings beginning at age 40. That troubling finding is based on…

Access to Oncology Care

Oftentimes, health services research measure access as the distance between a patient and the nearest provider of a given type (e.g., hospital, physician).  This issue of access is particularly relevant for individuals with cancer, since cancer care typically requires supervisions from specialist oncologists.  In most cases, health services researchers assume that individuals located far from…