How NAFLD screening can be cost-effective in people with type 2 diabetes.
Non-alcoholic fatty liver disease, NAFLD, originates from fat accumulation in the liver. If inflammation is present, it can lead to scarring of the tissue, cirrhosis, and liver cancer. It is known as a component of metabolic syndrome. There are currently no medical therapies that have been approved. Lifestyle changes such as improving one’s diet and adding or increasing an exercise regimen could help patients better manage their disease. There are currently no recommendations for NAFLD screenings for individuals with type 2 diabetes by the American Association for the Study of Liver Diseases (AASLD).
The trial design was a Markov model. This particular model compared having treatment and screening versus no treatment or screening of NASH in hypothetical patients with NAFLD and type 2 diabetes. The study consisted of patients 55 years old with type 2 diabetes. Multiple combinations of screening methods were used. The plans include ultrasound imaging, liver biopsy, and alanine aminotransferase or aspartate aminotransferase. The test checked for inflammation and fibrosis. Individuals who received an ultrasound scan with a positive test result for NAFLD received more screenings. After screenings were performed, individuals diagnosed with non-alcoholic steatohepatitis (NASH) with Stage 2 were further enrolled in an intervention program with a year-long duration. Life tables from the Center for Disease Control and Prevention give mortality rates for patients’ ages yearly. The primary outcome was the cost-effectiveness ratio. Patients would fall into one of the twelve health states; the transition time was one year between each health state. The threshold placed to determine cost-effectiveness was $50,000 per quality-adjusted life years. The secondary outcome was the incremental cost per additional year of life added.
VCTE was used to find lower stage fibrosis. If lower stage fibrosis was present, then treatment could be administered early on. Sensitivity analyses were performed. It allowed all models to be sampled randomly, which led to a comprehensive review of the possible incremental cost-effectiveness ratio. 100% of patients with stage 1 fibrosis who lost 10% of their body weight experienced 1 point of fibrosis regression, as did 77% of patients with stages 2-3 fibrosis. Patients that have NASH were given intensive lifestyle interventions after the first year they were diagnosed. After the six screening approaches were followed, patients would then enter the intensive lifestyle interventions. The patients were required to attend 2 hours of 1-to-1 meetings every 8 weeks during the first 6 months, followed by 2-hour group sessions every 8 weeks for six more months.
The intervention cost for intensive lifestyle intervention was approximately $2,864.60 for one year. The elastography cost was $39.65; liver biopsy $922.40; AST test and AST ranged from $6.54 to $5.18. NAFL or NASH with no fibrosis cost $431 per year. Patients with VCTE screening could fall into one out of four categories regarding results: false positive, false negative, true positive, and real negative. The patients who fall under the false-negative test result would still have their NASH detected. Next, they would be transitioned to a true-positive section with a probability of 21%. There was a 3% discount applied to the cost and supplies. The disutility value that was documented for intensive lifestyle intervention was 0.01.
The study limitations included vibration controlled transient elastography availability, intensive lifestyle intervention with body weight changes, and accuracy based on the assumptions gathered from references, data, and treatment effects. All causes of mortalities were taken into consideration. The results showed that screening at a younger age boosts cost-effectiveness. The high occurrence and cost of a liver biopsy would lead to the fact that it would not be considered cost-effective. Disease management should still be utilized while screening for NAFLD.
- NAFLD screening is considered cost-effective in people with type 2.
- Screening at younger ages boosts cost effectiveness.
- There are no current recommendations for NAFLD screenings for individuals with type 2 diabetes.
Shadrielle Robbins, PharmD Candidate, South College School of Pharmacy