How to manage a patient with severe osteoporosis, history of vertebral fractures, and poor response to Alendronate (bisphosphonate), with a T score of -3.9 at the hip and -4.5 at the lumbar spine, who has been denied coverage for Evenity (romosozumab) by insurance?

From the Guidelines

For a patient with severe osteoporosis, vertebral fractures, and poor response to alendronate who has been denied Evenity coverage, I strongly recommend switching to an anabolic agent such as teriparatide (Forteo) or abaloparatide (Tymlos) at standard doses (teriparatide 20 mcg subcutaneously daily or abaloparatide 80 mcg subcutaneously daily) for up to 24 months, as supported by the most recent guidelines 1.

These medications stimulate bone formation rather than just preventing bone loss like bisphosphonates, which is crucial for patients with severe osteoporosis and a history of fractures. The patient's T-scores of -3.9 at the hip and -4.5 at the lumbar spine, along with a history of 2 vertebral fractures, indicate a very high risk of fracture, necessitating aggressive intervention beyond continued bisphosphonate therapy.

If these anabolic agents are also denied, consider denosumab (Prolia) 60 mg subcutaneously every 6 months, which works through a different mechanism than bisphosphonates by inhibiting RANK ligand. For insurance approval, submit documentation of the patient's severe disease (T-scores, fracture history), treatment failure with alendronate, and file a formal appeal with supporting clinical evidence, as suggested by recent studies 1.

While awaiting approval, ensure the patient receives adequate calcium (1000-1200 mg daily) and vitamin D (1000-2000 IU daily), and address modifiable risk factors like smoking cessation and fall prevention. Consider a formal endocrinology or osteoporosis specialist referral to help navigate treatment options and insurance challenges. The severity of this patient's condition indicates high fracture risk requiring immediate and effective intervention.

Key points to consider in managing this patient include:

• The use of anabolic agents for severe osteoporosis with a high risk of fracture 1
• The importance of addressing modifiable risk factors and ensuring adequate calcium and vitamin D intake
• The potential need for specialist referral to navigate complex treatment and insurance issues
• The critical role of recent clinical guidelines in informing treatment decisions for patients with severe osteoporosis and a history of fractures.

From the FDA Drug Label

EVENITY significantly reduced the incidence of new vertebral fracture at 24 months EVENITY significantly increased BMD at the lumbar spine, total hip, and femoral neck compared with alendronate at month 12. The patient has a history of 2 vertebral fractures, T scores -3.9 hip with lowest Lumbar T score -4.5, and has taken Alendronate with poor results. Evenity (romosozumab) has been shown to significantly reduce the incidence of new vertebral fractures and increase BMD at the lumbar spine, total hip, and femoral neck compared to alendronate. Given the patient's severe osteoporosis and poor response to Alendronate, Evenity may be a suitable treatment option. An appeal letter should highlight the patient's severe osteoporosis, history of vertebral fractures, and poor response to Alendronate, as well as the potential benefits of Evenity in reducing the risk of future fractures and increasing BMD 2. Key points to include in the appeal letter are:

• Patient's history of 2 vertebral fractures and severe osteoporosis (T scores -3.9 hip and -4.5 lumbar spine)
• Poor response to Alendronate
• Potential benefits of Evenity in reducing the risk of future fractures and increasing BMD
• Clinical significance of Evenity's ability to increase BMD and reduce fracture risk compared to alendronate 2

From the Research

Patient Profile

• The patient has a history of 2 vertebral fractures and severe osteoporosis, with T scores of -3.9 at the hip and -4.5 at the lumbar spine.
• The patient has taken Alendronate with poor results and has been denied coverage for Evenity (romosozumab) by insurance.
• The patient has no cardiac history, which is an important consideration when evaluating the risk-benefit profile of romosozumab treatment 3, 4.

Rationale for Appeal

• Romosozumab has been shown to significantly reduce the risk of vertebral and clinical fractures in postmenopausal women with osteoporosis, particularly in those with a high risk of fracture 3, 4.
• The patient's history of vertebral fractures and severe osteoporosis, despite prior treatment with Alendronate, suggests a high risk of future fractures and a potential benefit from romosozumab treatment 3, 5.
• The patient's lack of cardiac history reduces the risk of cardiovascular adverse events associated with romosozumab treatment, making it a more suitable option for this patient 3, 4.

Key Points for Appeal Letter

• The patient's severe osteoporosis and history of vertebral fractures, despite prior treatment with Alendronate, demonstrate a high risk of future fractures and a need for alternative treatment options.
• Romosozumab has been shown to be effective in reducing the risk of vertebral and clinical fractures in postmenopausal women with osteoporosis, particularly in those with a high risk of fracture.
• The patient's lack of cardiac history reduces the risk of cardiovascular adverse events associated with romosozumab treatment, making it a more suitable option for this patient.
• The use of T-scores as a therapeutic target for patients with osteoporosis, as demonstrated in the ARCH trial, supports the potential benefit of romosozumab treatment in improving bone mineral density and reducing fracture risk 6.