ST. PAUL, Minn., Oct. 26, 2015 /PRNewswire/ -- As costly, six-figure drugs continue to gain approval by Food and Drug Administration (FDA), the need for analysis and understanding of utilization patterns increases. The FDA approved palbociclib (Ibrance®), an oral kinase inhibitor, in February for the treatment of metastatic breast cancer. A new study by pharmacy benefits manager Prime Therapeutics LLC (Prime) on the utilization and cost of Ibrance has earned gold status for quality research and will be presented at the Academy of Managed Care Pharmacy (AMCP) Nexus event in Orlando, Oct. 26-29.
The FDA approved and granted breakthrough therapy designation for Ibrance to treat postmenopausal women with estrogen positive and human growth factor receptor 2 negative advanced breast cancer. Results of a Phase 2 trial finding that palbociclib used in combination with the anti-hormone drug letrozole doubled progression-free survival compared to letrozole alone determined the breakthrough designation. The FDA approval is only for palbociclib to be taken in combination with letrozole.
A serious side effect of Ibrance is neutropenia, low white blood cell count, which increases infection risk. In the Phase 2 trial, 36 percent of patients underwent a dose reduction and 6 percent discontinued therapy permanently due to neutropenia.
With a wholesale acquisition price of $128,037 per year, previous Prime analysis forecasted palbociclib to have significant uptake and impact at 5.2 per 100,000 commercial members and cost $0.51 per member per month (PMPM) 12 months post launch. This cost could potentially rank palbociclib in the top 10 cancer drugs by total cost.1
This research included a combination of claims and member analyses for over 18 million members from February – June 2015 (17.5 million commercially-insured and 1.1 million covered under Medicare). Also measured in the study were letrozole utilization, Ibrance dose reduction and drug waste associated with dose reduction.
Prime's researchers found:
- In fewer than six months post-launch, palbociclib resulted in more than $9 million in expenditures to commercial and Medicare pharmacy benefits, including five-times higher utilization and cost within Medicare, accounting for approximately 5 percent of the analyzed population but 23 percent of the cost.
- One in six members who start palbociclib was no longer using the drug at a two month follow-up.
- One in 10 members had no evidence of letrozole use despite the labeling requiring simultaneous use.
- One in six members had a dose reduction and in one-third of those instances, drug waste occurred.
- In September 2015 palbociclib cost was:
- $0.27 PMPM for commercial, and
- $1.47 PMPM for Medicare
Focused attention should be applied to the following concerns identified in this research:
- Likely due to the high rate of side effects, discontinuation and dose reductions cause significant waste and emphasize the need for specialized care management. Palbociclib is not consistently being properly used with letrozole, and this should be included in prior authorization criteria and care management.
- A split fill program would have a projected annual savings of $164,220 in the 23 members with overlapping claims of different capsule strengths.
To help address these concerns, members using Prime Specialty Pharmacy receive specialized care management services including education upon starting a new therapy, adherence and side effect management, and assessment of Ibrance/letrozole combination therapy.
"As the FDA is approving cancer drugs more quickly and with limited safety data, it is essential for insurers to do surveillance studies – like this with Ibrance – so we can ensure our members are safely and effectively getting the medicine they need to feel better and live well," said Pat Gleason, PharmD, director of health outcomes at Prime. "With the Ibrance safety concerns and a $476 per capsule cost, it is vital that we work with our health plan clients to assess and implement effective programs that address appropriate use and prevent unnecessary waste and costs."
To view the poster that will be presented at the AMCP event, visit primetherapeutics.com.
About Prime Therapeutics
Prime Therapeutics LLC (Prime) helps people get the medicine they need to feel better and live well. Prime manages pharmacy benefits for health plans, employers, and government programs including Medicare and Medicaid. The company processes claims and delivers medicine to members, offering clinical services for people with complex medical conditions. Headquartered in St. Paul, Minn., Prime serves more than 26 million people. It is collectively owned by 13 Blue Cross and Blue Shield Plans, subsidiaries or affiliates of those plans. Prime has been recognized as one of the fastest-growing private companies in the nation.
For more information, visit www.primetherapeutics.com or follow @Prime_PBM on Twitter.
1 Bowen, KL, Gleason PP. ISPOR 19th Annual International Meeting Research Abstracts. Value in Health 2014;17:3. All brand names are the property of their respective owners.
SOURCE Prime Therapeutics LLC