Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Rheumatoid arthritis. 
Treatment: Orencia SQ (subcutaneous) 125 mg (milligrams). 
The insurer denied coverage for Orencia SQ 125 mg. 
The denial is overturned. 

The patient has a history of rheumatoid arthritis. She has tried and failed or been intolerant to Humira and Remicade. She has been receiving Orencia for two years and has been doing well on this treatment. The patient's treating provider is requesting continuation of therapy with Orencia, which is under review. 

The formulary drug(s) are not likely to cause the patient an adverse reaction. While Enbrel would, it is unknown whether an adverse reaction would occur with the remaining drugs. 

The requested drug (Orencia) could be more effective than the formulary drug(s). 

Rheumatoid arthritis is a disease with high mortality and morbidity. It is recommended to continue the same treatment if that treatment is working, as it is not guaranteed that patient will respond to the alternatives. The patient has been doing well on Orencia for two years and there is no reason to switch biologicals. 

"Receipt of non-medical switching requests were common among specialist physicians. Non-medical switching may lead to negative effects on patient care and require increased healthcare utilization" (Costa, O. S., et al. 2020). 

"Non-medical switching of medication, whereby a patient's treatment regimen is changed for reasons other than efficacy, side effects, or adherence, is often related to drug formulary changes aimed at reducing drug costs. In the era of health care reform, while cost-cutting measures are important, there is considerable evidence that non-medical switching, particularly when applied to medication used to treat chronic conditions such as diabetes, may impact patient outcomes, medication-taking behavior, and use of health care services. Ultimately, overall costs may be increased, as savings by insurers are cancelled out by higher costs to the health care system as a whole, such as extra administration, treatment failure from new medicines, and increased adverse events" (Dolinar, R., et al. 2019). 

"Often respondents felt non-medical switching increased medication side-effects, errors, and treatment abandonment, as well as patients' out-of-pocket medication costs. Moreover, physician reported non-medical switching increased the frequency of non-office, office and prescriber-pharmacy contact, and to a lesser extent, increased laboratory testing, additional medication utilization and emergency department or hospital visits. Few responding physicians felt non-medical switching was associated with a positive impact on treatment effectiveness, medication adherence or patient or physician confidence in overall quality-of-care" (Coleman, C., et al. 2020). 

"Physicians are in an ideal position to describe the impact of medication non-medical switching (switching commonly due to formulary changes by insurer for reasons unrelated to patient health) on their practice dynamics and patient care..." (Salam, T. et al. 2020)

The formulary drug is not expected to be ineffective. 

The non formulary drug is expected to be more effective than the formulary alternatives. 

The carrier's denial of a request for a Formulary Exception for Orencia SQ 125 mg (milligrams) is overturned.