- Amgen on Monday launched its osteoporosis treatment Evenity into a competitive market, setting a price at $21,900 a year as it takes on Eli Lilly's Forteo and Radius Health's Tymlos, both established anabolic agents.
- Evenity is "34 to 74% lower than currently available anabolic agents over their full course of therapy," Amgen said, although the Food and Drug Administration has limited its use to one year. Curbs on use of Forteo and Tymlos are less restrictive.
- New branded osteoporosis drugs have shown modest benefit over generic agents like zoledronic acid, causing pharmacy benefit managers to tightly control access. Forteo is due to lose patent protection later this year, potentially increasing the pressure on Evenity.
Amgen and UCB struggled to get Evenity (rombosozumab) to market thanks to a late-emerging cardiovascular safety signal. In Phase 3, the sclerostin-blocking antibody was found to have led to an elevated risk of cardiovascular serious adverse events when compared to alendronate, a generic bisphosphonate.
The FDA approved it last week only on condition that its use be limited to postmenoposal women at high risk of fractures, similar to Lilly's Forteo (teriparatide) and Radius' Tymlos (abaloparatide). The agency defined "high risk" as those with a history of fracture, multiple risk factors or intolerance to other treatments.
To reduce the risk of cardiovascular complications, the regulator also instructed physicians to not prescribe Evenity to patients who have had a myocardial infarction or stroke in the last year and limited its use to 12 months. FDA puts a limit of two years on the use of Forteo, and Tymlos is limited if patients have first taken Forteo.
By setting the price at $21,900 for the one year it can be used, Amgen is recognizing that it cannot expect to compete if Evenity costs substantially more than the other two bone-building drugs. Tymlos' list price is $22,000 and Forteo comes in around $45,000, although after rebates insurers get a lower price. At the Federal Supply Schedule price, Tymlos comes in at $11,800 a year and Forteo $26,000.
Although the number of women with postmenoposal osteoporosis is large, many are managed with generic bisphosphonates, which slow bone loss. Evenity, Forteo and Tymlos aid in bone formation, but their price has given payers pause.
The Institute for Clinical and Economic Review, a nonprofit cost watchdog, has calculated that Forteo costs $942,000 per quality adjusted life year gained over the bisphosphonate zoledronic acid and Tymlos $334,000, prompting many PBMs to put it on their restricted "specialty drugs" tiers for restricted use.
In spite of the restrictions, Lilly reported sales of $1.6 billion for Forteo and Radius $99 million for Tymlos in 2018.
Forteo, however, is expected to lose patent protection in the U.S. in August, which could subject it to generic competition, increasing the challenge for Amgen and UCB in marketing Evenity.