What is the best course of action for a patient with severe osteoporosis and high risk of fracture, who has been denied Evenity (romosozumab) and is dissatisfied with Prolia (denosumab), given their history of cancer with radiation treatments and low bone density T scores?

From the Guidelines

For a patient with severe osteoporosis, high fracture risk, cancer history with radiation treatments, and dissatisfaction with Prolia after being denied Evenity, I strongly recommend considering teriparatide (Forteo) or abaloparatide (Tymlos) as anabolic therapy options, as they stimulate bone formation and have been shown to reduce fracture risk in patients with very low bone density, as seen in this patient with T scores ranging from -3.9 to -4.5 1.

Given the patient's history of cancer with radiation treatments and low bone density, it is crucial to prioritize treatments that not only prevent further bone loss but also promote bone formation. The patient's denial of Evenity and dissatisfaction with Prolia, which is less potent, necessitate exploring alternative therapies that can more effectively address their high fracture risk.

The recommended regimen involves daily subcutaneous injections of teriparatide 20mcg or abaloparatide 80mcg for up to 24 months. After completing this course, transitioning to an antiresorptive agent like zoledronic acid (Reclast, 5mg IV yearly) would help maintain bone gains. This approach is supported by guidelines that suggest the use of anabolic agents for patients with very severe osteoporosis 1.

Key considerations in the management of this patient include:

• Ensuring adequate calcium intake (1000-1200mg daily) and vitamin D supplementation (1000-2000 IU daily) to support bone health.
• Encouraging regular weight-bearing exercise to further reduce fracture risk.
• Consulting with the patient's oncologist before starting anabolic therapy, especially if their cancer history includes breast or prostate cancer.
• Regular monitoring with bone density scans every 1-2 years and bone turnover markers to assess treatment effectiveness, as recommended by recent guidelines 1.

This comprehensive approach prioritizes both the immediate reduction of fracture risk and the long-term maintenance of bone health, aligning with the most recent and highest quality evidence available 1.

From the FDA Drug Label

EVENITY is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. The patient's severe osteoporosis with high risk of fracture, history of cancer with radiation treatments, and low bone density T scores (-3.9 to -4.5) meet the criteria for Evenity treatment.

• Key points to include in the appeal letter:
  • Patient's high risk of fracture due to severe osteoporosis
  • History of cancer with radiation treatments
  • Low bone density T scores (-3.9 to -4.5)
  • Patient's dissatisfaction with alternative treatment options, such as Prolia
  • Evenity's indication for postmenopausal women at high risk for fracture 2 The appeal letter should emphasize the patient's high risk of fracture and the need for a more effective treatment option, such as Evenity. Given the patient's history and current condition, Evenity may be a suitable treatment option. However, it is essential to carefully evaluate the patient's overall health and medical history before making a treatment decision. In this case, the patient's lack of cardiac issues is a positive factor, as Evenity may increase the risk of myocardial infarction, stroke, and cardiovascular death 2.

From the Research

Appeal Letter for Evenity Denial

To appeal the denial of Evenity (romosozumab) for a patient with severe osteoporosis and high risk of fracture, the following points can be emphasized:

• The patient's history of cancer with radiation treatments and low bone density T scores (-3.9 to -4.5) indicate a high risk of fracture, as noted in studies on osteoporosis management 3.
• The patient's dissatisfaction with Prolia (denosumab) due to its perceived lack of efficacy is understandable, given the availability of more potent treatments like Evenity, which has been shown to increase bone mineral density and reduce fracture risk more effectively than alendronate 4, 5.
• The use of fracture risk assessment tools, such as FRAX, can help identify patients at high risk of fracture and inform treatment decisions, as discussed in a review of fracture risk assessment in osteoporosis 6.
• Evenity's unique mechanism of action, which involves inhibiting sclerostin to increase bone formation and decrease bone resorption, makes it a valuable treatment option for patients with severe osteoporosis and high fracture risk, as highlighted in a study on romosozumab as a novel bone anabolic treatment option for osteoporosis 5.

Key Points to Include in the Appeal Letter

• The patient's medical history, including their history of cancer and radiation treatments
• Their current bone density T scores and fracture risk assessment results
• The patient's dissatisfaction with alternative treatments, such as Prolia
• The potential benefits of Evenity in reducing fracture risk and improving bone mineral density
• Relevant clinical trial data and study results supporting the use of Evenity in patients with severe osteoporosis and high fracture risk, as discussed in studies on osteoporosis treatment 7, 4, 5

Supporting Evidence

• Studies have shown that Evenity can reduce the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis, with a significant increase in bone mineral density and a decrease in bone resorption markers 4, 5.
• The use of fracture risk assessment tools, such as FRAX, can help identify patients at high risk of fracture and inform treatment decisions, as discussed in a review of fracture risk assessment in osteoporosis 6.
• Osteoporosis treatment guidelines recommend considering the individual patient's needs and overall health when selecting a treatment, as noted in a study on the prevention, screening, and management of osteoporosis 7.