The U.S. Centers for Medicare & Medicaid Services is finally making a long-expected, and requested, adjustment to Medicare Part B premiums, which were raised nearly 15% for 2022 in the wake of Biogen Inc.’s initial $56,000 annual price tag for its Alzheimer’s drug, Aduhelm (aducanumab).
Access to advanced therapies proved to be a major talking point at a conference in London, following the U.S. approval of Bluebird Bio Inc.’s Zynteglo (betibeglogene autotemcel) cell-based gene therapy for beta thalassemia and its $2.8 million price tag. Regulators in Europe backed Zynteglo in 2019 but Bluebird opted to withdraw the therapy in 2021 after deciding that the complex thicket of pricing bodies in Europe was too difficult to negotiate.
German regulators have unveiled their initial report covering the prescription and deployment of reimbursable health apps. The survey was carried out by Hamburg-based health insurance fund Techniker Krankenkasse (TK) in conjunction with Bielefeld University in North Rhine-Westphalia and health care economics analysis research bureau Vandage GmbH, also based in Bielefeld.
Payers are known to have a significant burden in crafting coverage and reimbursement policies for in vitro diagnostics, but Gillian Hooker, chief scientific officer at Concert Genetics Inc., of Nashville, Tenn., told an audience at the Next Generation DX Summit that the dilemma may be more expensive than commonly appreciated. Hooker said administrative costs may add as much as $125 per administered test, an artifact of a fragmented value chain that seems to enjoy few, if any prospects of improvement in the near term.
The link between the use of antipsychotic medications and the risk of sudden cardiac arrest may not have yet earned universal recognition among cardiologists, but the U.K. National Institute of Health and Care Excellence (NICE) has seen enough to believe the hypothesis has some merit. The agency recently proposed that the Kardiamobile 6L device by Alivecor Inc., of Mountain View, Calif., be covered for patients taking antipsychotic medications, a policy which if adopted would reflect what NICE sees as an unmet need for a population at grave risk.
The U.K. National Institute for Health and Care Excellence (NICE) issued a pair of health technology assessments related to regurgitation of the tricuspid valve, one each for valve leaflet repair and for valve annuloplasty.
The U.K. NHS is implementing the use of Oxford, U.K.-based Genincode plc’s predictive genetic test for patients suffering with hypercholesterolemia and familial hypercholesterolemia (FH). The Academic Health Science Network for the North East and North Cumbria (AHSN NENC) is adopting the Lipid Incode test in Darlington following a successful pilot study which demonstrated the test can detect and diagnose people with high cholesterol, a known risk factor for the development of cardiovascular disease (CVD). It is the first commercial polygenic test for CVD to be implemented by the NHS.
Turkey needs to provide a level playing field for foreign and domestic drug producers. That’s the recommendation of three World Trade Organization (WTO) arbitrators in a dispute resolution between Turkey and the EU.
The U.S. CMS released the draft Medicare hospital outpatient rule for calendar year 2023, a document that is replete with information on pass-through payment data for drugs and devices. However, the agency said that the Supreme Court’s ruling regarding rates for drugs covered under the 340B drug pricing program came too late in the annual cycle to be fully accounted for in the outpatient rule for 2023, and thus any such permanent adjustments will have to wait until the outpatient rule for 2024.
If anti-aging drugs are to become widely available and adopted, especially in the U.S., they have some serious hurdles to overcome. And those hurdles aren’t all in the lab or clinic. With classes of anti-aging drugs already in the pipeline, “the biggest hurdle is FDA approval. Then reimbursement,” said George Kuchel, a professor and director of the UConn Center on Aging at the University of Connecticut. Read the final installment of BioWorld’s multipart series on extending the human lifespan.
