Similar to our discussion in the FY 2022 IPPS/LTCH PPS proposed rule (86 FR 25340), and the FY 2023 IPPS/LTCH PPS proposed rule (87 FR 28290), we note that while TERLIVAZ may address an unmet need because it is the first treatment indicated specifically for the treatment of HRS, the applicant's assertion that TERLIVAZ does not involve the treatment of the same/similar type of disease and the same/similar patient population when compared to an existing technology, on the basis that there is a subset of patients for whom current treatments are ineffective and for whom TERLIVAZ will offer a new treatment option, does not necessarily speak to the treatment of a new patient population for HRS
Collagen Production GHK-Cu is widely recognized for helping stimulate collagen synthesis
GHK-Cu works at a cellular level in several key ways: Collagen & elastin stimulation: It activates genes responsible for rebuilding structural proteins in the skin, helping to smooth fine lines, tighten, and restore elasticity
Treatment Protocols DSIP therapy at Strong Health follows a structured clinical approach: Sleep assessment: Thorough evaluation of sleep patterns, sleep hygiene practices, medical history, and current medications Baseline metrics: Sleep questionnaires, and when indicated, referral for sleep studies to rule out sleep apnea or other primary sleep disorders Protocol design: Physician determines DSIP dosing, timing, and whether combination with other peptides is appropriate Administration: DSIP is typically administered via subcutaneous injection in the evening, 12 hours before desired sleep onset Monitoring: Regular follow-ups to assess sleep quality improvements, adjust dosing, and track any side effects Sleep hygiene integration: Peptide therapy is combined with evidence-based sleep hygiene recommendations for optimal results Safety and Side Effects DSIP has a generally favorable safety profile based on available clinical data
