Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Osteoporosis 

Treatment: Formulary Exception for Evenity

The insurer denied coverage for Formulary Exception for Evenity

The denial is upheld 

This case involves a Request for a Formulary Exception for Evenity for the treatment of osteoporosis in an adult patient. Rheumatology notes indicated the patient presented for evaluation and treatment of osteoporosis as well as joint pain. The examination noted temporomandibular joint (TMJ) tenderness bilaterally with swelling as well as tenderness in the hands. It was noted that the Dual-Energy X-ray Absorptiometry (DEXA) scan showed a T-score of -3 revealing osteoporosis. The patient has not undergone any treatment and had a history of severe gastritis and reflux. The provider did not feel bisphosphonates would be appropriate given the risk of reflux esophagitis. The treatment plan was to switch from Prolia to Evenity. It was noted the patient cannot self-inject due to anxiety of daily needles. 

The determination letter reported the request for Evenity was denied as the preferred product was Tymlos which had not been tried. 

An undated letter from the provider reported the patient was under care for osteoporosis with bone density initially revealing a T-score (bone density) of -4.2 of the lumbar spine. The patient had severe gastritis and reflux and was put on Prolia but a repeat bone density scan noted a T-score of -4.4. The patient was recommended for usage of a bone formation agent since T-score was not less than -3.0 and alternatives such as Tymlos or Forteo were not an option due to anxiety and fear of needles with self-injection.

The formulary drug (Tymlos) is not likely to cause the patient an adverse reaction.

The patient has not tried the formulary drug (Tymlos).

The non formulary drug (Evenity) would not be more effective than the formulary drug (Tymlos). As summarized in UpToDate, "For postmenopausal women with severe osteoporosis, some UpToDate experts prefer initial treatment with an anabolic agent, whereas other UpToDate experts prefer initial treatment with bisphosphonates because of the cost of anabolic therapy, subcutaneous route of administration, and long-term safety concerns. When a decision has been made to treat with an anabolic agent, we suggest teriparatide or abaloparatide (Tymlos). Romosozumab (Evenity) is an alternative." They also note that while "Romosozumab induces a greater Bone Mineral Density (BMD) response than either abaloparatide or teriparatide, but treatment is indicated for only one year because clinical experience is limited, and the long-term side effects are uncertain."

In this case, the patient was recommended for Evenity for osteoporosis. The patient has been utilizing Prolia but given worsening T-scores was recommended to switch to Evenity. The provider noted that the patient could not use the formulary drug (Tymlos) due to fear of self-injection. Evenity is also an injection but is administered by a healthcare professional. While Tymlos is self-injected both medications are injections and therefore needle phobia would not be a sufficient contraindication to go outside of formulary alternatives. As such, the Request for Formulary Exception for Evenity is denied and the prior determination is upheld. 

The formulary drugs are not expected to cause adverse effects. 

The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.

The formulary drug is not expected to be ineffective. 

The not formulary drug is not expected to be more effective that the formulary alternatives.

The carrier's denial of Request for Formulary Exception for Evenity is upheld.