Access to Targeted Lung Cancer Drug is Cost-Prohibitive
Article Summary
- The immunotherapy drug durvalumab is part of the standard of care for many patients with lung cancer, but access globally is limited.
- A new study led by Sylvester researchers examines the drug’s cost-effectiveness in four countries.
- The analysis shows that access to durvalumab treatment is constrained by costs but that drug-pricing strategies can help.
Access to new, targeted drugs is often limited by the ability of national health care systems and insurance companies to pay.
Many countries use cost-effectiveness analyses to decide whether to cover new medicines. Such research balances the costs of treatment with positive effects on health.
A new study examines the cost-effectiveness of durvalumab, a targeted immunotherapy for lung cancer that is known to extend lifespan. The findings show that the drug exceeds official cost-effectiveness thresholds for all four analyzed countries: the United States, Brazil, Singapore and Spain.
The findings could help guide drug pricing strategies to reduce financial burdens and increase the number of patients who are treated.
“Cost-effectiveness analyses can help establish a value-based price for discussions with payers,” including insurance companies and national health care systems, said senior author Gilberto Lopes, M.D., chief of the Division of Medical Oncology and associate director for Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine.
Cost-effectiveness analyses can also inform biopharma companies about barriers to access and result in changes in the pricing structure of targeted drugs in different countries.
That is one of the aims of the Access to Oncology Medicines (ATOM) Coalition, a global initiative chaired by Dr. Lopes to improve access to oncology treatments in low-income countries.
Medications Effective but Unavailable
Since its approval for lung cancer in 2018, durvalumab has become part of the standard of care for the disease. The drug is used as a maintenance therapy, generally for a year, after primary chemotherapy for unresectable (inoperable), locally advanced, non-small cell lung cancer (NSCLC).
The drug extends lifespan by an average of 18.4 months compared to a placebo, according to an analysis of five years of data from a pivotal clinical trial.
Despite its effectiveness, access to durvalumab is limited in some settings. In Brazil, for instance, the drug was approved in 2020 but remains unreimbursed in the public health system.
Calculating Cost-Effectiveness
In the new study published in the Journal of the American Medical Association Open Access, researchers developed a model to assess the cost of treatment and health benefits of durvalumab in lung cancer patients over a 10-year period.
To calculate treatment costs, the researchers collected a wide range of data, including drug pricing in different countries, cost of administration, adverse events and follow-up care. In the U.S., the cost of treatment with durvalumab was $114,394.
To quantify health benefits, the researchers used a measurement commonly used in economic evaluations called quality-adjusted life years (QALY). QALY data combines lifespan gains with information on quality of life.
The researchers then generated a single metric called an incremental cost-effectiveness ratio. The researchers found that the cost-effectiveness ratio in the U.S. for durvalumab was $228,788 per QALY.
Though Medicaid and Medicare typically pay for the drug, this cost-effectiveness ratio exceeds the agencies’ threshold target of $150,000. The cost-effectiveness ratios also exceed health system thresholds in the three other countries.
Overall, the study authors concluded that durvalumab treatment for lung cancer remains globally “cost-prohibitive.”
The researchers went on to show how reduced industry pricing can improve cost-effectiveness. This analysis used discounted prices in Singapore that are available through an industry pricing program. The program brought the cost-effectiveness ratio down from $153,461 per QALY to $45,164 — below the official threshold in Singapore.
Increasing Access to Cancer Therapies
“The overall goal of these types of studies is to shed a very academic, and hopefully neutral, light on all these numbers,” said study first author Samuel Kareff, M.D., Sylvester’s chief hematology and oncology clinical fellow. Dr. Kareff will also present the data May 30 as an invited speaker at the OncLive National Fellows Program.
The study’s strengths include accounting for multiple lines of therapy and using biomarker-guided treatments in its model. (Durvalumab targets a molecule called PD-L1, which is typically screened for prior to treatment.)
Limitations of the study include its narrow global coverage and the lack of analyses in poorer countries where access is more restrictive, said Dr. Kareff.
Dr. Kareff notes that drug companies face the challenge of recouping the massive costs of drug development while assuring patients are served. Cost-effectiveness analyses can help, he said.
In May, Bristol Myers Squibb released its 10-year strategy to improve access to treatments for patients in low- and middle-income countries. The strategy includes collaboration with the ATOM Coalition to increase access to another targeted immunotherapy, nivolumab.
“As the pace of innovation increases and more targeted therapies become available, we unfortunately expect treatment costs to increase as well,” said Dr. Kareff.
Tags: Dr. Gilberto Lopes, Dr. Samuel Kareff, Health Equity, Sylvester Comprehensive Cancer Center