The Gulf of California harbor porpoise or “vaquita” is the most endangered cetacean in the world. Threatened with extinction by the use of gillnets, the development of a new lightweight trawl could prove to be the most promising tool for the vaquita’s conservation. The complexity of socio-economic factors in the Upper Gulf of California and Colorado River Biosphere Reserve has tied fishing communities and vaquita conservation together in an antagonistic relationship. The application of market incentives provides a unique opportunity for collaboration and mutual gain. This paper explores the use of ecolabels as tools for conservation and envisions the development of a Vaquita-Safe ecolabel. Caveats, next steps, and project development are discussed.

Objective

To evaluate the factors associated with Medicare spending on newly approved anticancer drugs in the US from 2012 through 2021.

Patient and methods

Using a cross-sectional analysis, we searched US FDA new oncology drug approvals (2012-2021). We analyzed clinical attributes and institutional factors influencing the annual cost of new anticancer drugs in the US. Annual treatment cost was calculated based on average spending per beneficiary from the Centers for Medicare and Medicaid Services, with product factors sourced from the FDA's annual New Drug Therapy Approval reports and drug package inserts at the time of approval.

Results

Over a ten-year period, 112 new anticancer drugs were approved, of which 97 met the study's criteria. A significant majority, 93 %, received expedited development designations from the FDA. At the time of approval, 40 % of these drugs had data on progression-free survival, and 19 % had data on overall survival; 29 % were first-in-class. The study found a significant relationship between the year of approval and factors associated with the size of the treatment population. No statistically significant relationship was found between the clinical value of a drug and its price.

Conclusions

Spending on anticancer drugs by Medicare are predominantly determined by reference pricing and the size of the anticipated treatment population, without an association with therapeutic value. The study advocates for reforms in reimbursement mechanisms for drugs lacking comparator arms and greater transparency for patients treated with these drugs.