Prime Therapeutics finds members using Botox® to treat migraines didn’t stay on the drug, saw substantially higher total migraine cost of care

EAGAN, Minn. – A real-world study by pharmacy benefit manager (PBM) Prime Therapeutics LLC (Prime), found while most Botox® (onabotulinumToxinA) use is for chronic migraine prevention at an annual cost of more than $6,300, less than half of new Botox users receive the four recommended treatments during the first year of therapy. Findings also show individuals new to Botox did not see reductions in migraine related medical or pharmacy costs after one year of therapy, but instead had a three-fold increase in total migraine related costs. Botox real-world costs and persistency – staying on the drug as prescribed – prove the need to compare use, cost and persistence to competing drugs in the migraine class when making managed care decisions regarding chronic migraine treatment coverage.

Botulinum toxins (BT) are biologic drugs modeled after a neurotoxic protein produced by bacteria and are U.S. Food and Drug Administration (FDA) approved for a variety of conditions including muscle dystonia, gland secretion and migraine prevention. Botox is the only BT (of the four commercially available) indicated for migraine prevention, and has been the only biologic migraine treatment available for the past eight years. In 2018, Botox’s first biologic competitor for chronic migraine prevention – cGRP products – joined the market following FDA approval.

For the study, Prime analyzed pharmacy and medical claims data for 15 million commercially insured members and identified 61,944 BT claims from October 2017 to September 2018. Researchers found that one drug and one indication, Botox for migraine, accounted for 66 percent of all BT claims and 65 percent of all BT expenditures.

Botox for migraine use cost $52.3 million of the $80.3 million total BT drug category cost during the 12-month period. And the vast majority (97 percent) of BT expenditures were processed through the medical benefit. Among Botox for migraine use, there was an average of 194 units paid per treatment. FDA-approved dosing is 155 units per treatment, however, due to vial sizes of 100 units and 200 units, there is an expected waste of 45 units for which providers are allowed to bill. Using the real-world units billed and paid, the average allowed Botox treatment cost was found to be $1,576 including administration costs.

Using the average Botox migraine allowed treatment cost of $1,576 and applying it to the labeled 84-day dosing schedule, Prime researchers determined the estimated annual cost for four treatments is $6,304. Analysis of the annual cost showed 34 percent of the cost was due to drug waste and drug administration. However, less than half (47 percent) of members starting Botox treatment for the first time receive the four annual recommended treatments during their first year of therapy.

Prime researchers concluded there is an opportunity for a value-based pricing approach. Researchers also uncovered opportunities for clinical program development, suggesting more analyses are needed to determine which members benefit most from Botox compared with cGRP products.

“Botox is considered by the Institute for Clinical and Economic Review (ICER) to be priced to value,¹ but real-world data should be considered as ICER analytic methods use data primarily from randomized clinical trials where persistency is high and drug waste is not included,” said Patrick Gleason, PharmD, assistant vice president of health outcomes for Prime. “Our claims data reveal Botox for migraine use was associated with substantial drug waste, increased total migraine cost of care, and low Botox therapy persistency. Better pricing of migraine therapy relative to its value is needed, so we can help ensure members use the most cost effective chronic migraine treatment,” said Gleason.

Prime researchers will present the study at the Academy of Managed Care Pharmacy’s (AMCP) Managed Care & Specialty Pharmacy 31st Annual Meeting, March 25-28 in San Diego, CA.

1. https://icer-review.org/wp-content/uploads/2017/11/ICER_Migraine_Final_Evidence_Report_070318.pdf