An oral farnesoid X receptor agonist for the treatment of primary biliary cirrhosis.
Horizon Scanning
It is a challenge for health plans and clinicians to know what emerging technologies are in the preapproval phase and what their clinical, financial, and risk impacts might be. This is where we come in.The Hayes Horizon Scanning Solution identifies innovative and potentially disruptive health technologies that are in various stages of the regulatory approval process. Our Research Analysts continually investigate new technologies that are on the horizon or in the early stages of clinical investigation, as well as the testing of existing technologies that may be seeking approval for new clinical applications. Hayes Horizon Scanning helps you track emerging technologies before you need to make decisions. Accessed through the Hayes Knowledge Center, Hayes Horizon Scanning addresses the following fundamental questions to help our clients forecast emerging technologies:
- Is this emerging technology new or replacing an existing technology?
- Where is this technology in the FDA regulatory process?
- When will this technology be commercially available in the market?
- What is the projected use, cost, and financial impact of this technology?
Rovalpituzumab Tesirine (Rova-T; SC16LD6.5) for SCLC
An intravenous antibody-drug conjugate targeting delta-like protein 3 (DLL3) for third-line treatment of small cell lung cancer.
CyPass Micro-Stent
A supraciliary microstent proposed to reduce intraocular pressure in patients with mild-to-moderate glaucoma undergoing cataract surgery.
Probuphine (Buprenorphine Extended-Release Subcutaneous Implant)
A buprenorphine subdermal implant for maintenance treatment of opioid dependence in patients stabilized on a transmucosal buprenorphine-containing product at doses of 8 milligrams per day or less.
Epclusa (Sofosbuvir and Velpatasvir) for Chronic HCV Infection
Epclusa is the first FDA-approved pangenotypic regimen for the treatment of chronic hepatitis C virus infection. The fixed-dose combination pill contains sofosbuvir 400 mg and velpatasvir 100 mg. Sofosbuvir is sold separately under the brand name Sovaldi. Velpatasvir is a new HCV NS5A inhibitor that is active across all 6 HCV genotypes; it is not sold separately.
Organ Care System (OCS) Heart
Health problem: Heart transplantation
Technology description: An ex vivo heart perfusion system for portable normothermic perfusion of donor hearts for transplantation.
Best available evidence: Single published phase II/III trial.
Regulatory status: Under FDA review.
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Durvalumab for Non-Small Cell Lung Cancer
An investigational checkpoint inhibitor proposed as a third-line treatment for advanced non-small cell lung cancer in patients whose disease expresses programmed death-ligand 1 (PD-L1).
Darzalex (Daratumumab)
A monoclonal antibody to treat multiple myeloma in patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulator, or who are double refractory to these agents.
Venclexta (Venetoclax)
An oral B-cell lymphoma-2 inhibitor initially proposed for single-agent use to treat relapsed or refractory chronic lymphocytic leukemia in patients harboring the 17p deletion.
Zepatier (Elbasvir and Grazoprevir) for Chronic Hepatitis C Infection
A single-pill grazoprevir/elbasvir regimen for chronic HCV genotype 1, 4, or 6 infection.