OBJECTIVES : Infantile hemangiomas are the most common benign vascular tumors in childhood and their propranolol treatment, although not indicated on the label, is widely used in SUS as tablets. The aim of the study was to make a critical evaluation of the dossier submitted by the industry for incorporation into the SUS of the drug propranolol hydrochloride, oral solution.

METHODS : Critical dossier evaluation and evidence search in MEDLINE (Pubmed), Cochrane Library, and Latin American and Caribbean Health Sciences Literature (LILACS) search platforms.

RESULTS : Of the 1067 publications identified, five were selected, only two of these publications were submitted by the plaintiff. Studies have shown that propranolol hydrochloride is effective and safe compared to placebo. Neither of the retrieved studies compared the two pharmaceutical forms (tablet and oral solution), or compared propranolol hydrochloride with other medicinal products. Also, no studies evaluating treatment adherence or quality of life were found. The proposed price for incorporation was $ 84.24 for oral solution form (3.75 mg / mL - 120 mL), while the price for tablet form (40 mg - 20 to 40 units) ranged from $ 0.70. - 1.49. The economic assessment resulted in an incremental cost-utility of $ 186.85 / QALY, but the model has significant limitations. The budget impact considered was 40 million accumulated over five years, ranging from $ 3.13 million in 2019 to 12 million in 2023.

CONCLUSIONS : The critical evaluation of the available evidence and the significant price difference between the pharmaceutical forms supported Conitec's recommendation, which decided not to incorporate propranolol hydrochloride (oral solution 3.75 mg / mL) in SUS for treatment of patients with Proliferative HI. Despite the favorable clinical evidence for the use of technology, the price proposed for incorporation into SUS of the drug does not justify the possible added benefits to use in a new pharmaceutical form.