According to the statement released by the American Society of Transplantation (AST):
“The Food and Drug Administration (FDA) and the American Society of Hospital Pharmacists (ASHP) recently published data on shortages of tacrolimus, an anti-rejection medicine used to prevent rejection after organ transplantation. At the time this information was published, these shortages apply to some generic versions of tacrolimus, and dates for resolution of the shortages range from July 2019 to April 2020. Generic formulations have been evaluated by the FDA and are equivalent to brand-name (innovator) medicines. If this shortage affects your patients, we recommend discussing alternative options within your teams to devise a management strategy.
In the first major transformation in kidney care in almost 50 years, the Trump Administration announced the Advancing the American Kidney Health initiative on July 10, 2019. The comprehensive kidney health strategy will bring sweeping changes to care for people with kidney diseases, including more choices for dialysis modalities, greater access to transplantation, and concerted support for development of innovative therapies, including artificial kidneys.
CMS is proposing to give Medicare Part D and Medicare Advantage plans the option to limit coverage of drugs in six categories — known as the “protected classes” — in a bid to lower pharmaceutical costs. The agency posted a proposed rule in the Federal Register on Nov. 30, available for public comment through Jan. 25, that would give health plans the ability to exclude protected class drugs from medication prescription lists in certain instances. The changes are estimated to save the government about $1.9 billion over 10 years and save Medicare enrollees $692 million in cost sharing.
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule yesterday, November 26, 2018, that includes changes to Medicare Advantage and Part D. Medicare says its proposal will give Part D drug plans more power to negotiate with pharmaceutical companies, but some patient and provider groups say that it will reduce access and shift costs onto beneficiaries.
CMS said in its proposed rule that it would start allowing Part D plans to exclude a drug from the "protected" classes on their formularies if the increase in the drug's price is greater than inflation or if CMS determines that the drug is not a significant innovation over the original product. Current policy requires Medicare Part D plans to cover drugs in the following six categories: