In divvying up U.S. spending on orphan vs. nonorphan indications for drugs approved for both, a new study could fuel future debates and inform policy on orphan drug incentives. The study, led by a team of University of Michigan and Boston University researchers, found that 21% of the total dollars spent in 2018 in the U.S. on the 15 top-selling partial orphan drugs went to the treatment of rare diseases, while more than 70% went to the treatment of common diseases.
In its first decision on excessive drug pricing, the European Commission (EC) accepted a commitment Feb. 10 from Aspen Pharmacare Holdings Ltd. to immediately drop the price of six essential cancer drugs in Europe by an average of 73% and to continue to supply the drugs for at least the next five years.
Among the low-hanging fruit for pruning back U.S. drug prices is the development of generics referencing complex drugs, a category that includes drug-device combination products and nonbiologic drugs with a complex molecular base, route of administration or formulation, such as abuse-deterrent opioids.
The Medicare Part D rebate rule finalized by the Trump administration last November could be in limbo for a while. As it did with other so-called midnight rules issued in the waning days of the Trump presidency, the U.S. Department of Health and Human Services, under the Biden administration, is postponing the implementation of the rule, which was intended to simplify the U.S. drug pricing system by eliminating the rebates drug makers pay to pharmacy benefit managers for formulary placement or requiring plans to pass the discounts directly to patients.
COVID-19 undoubtedly will be the top U.S. health care priority for the 117th Congress and the incoming Biden administration, but that doesn’t mean prescription drug prices are no longer an issue. A raft of new-year price increases, many for already costly drugs, is ensuring drug pricing remains high on the congressional agenda.
A New Year tradition in the U.S. is the inevitable price increase for a multitude of brand drugs. 2021 isn’t breaking with that tradition, despite American families being ravaged economically by nearly a year of the COVID-19 pandemic.
When U.S. President Donald Trump and Health and Human Services (HHS) Secretary Alex Azar announced last week the Jan. 1 launch of a Medicare Part B most-favored nation (MFN) drug pricing model and a final rule to end Medicare’s safe harbor for the rebates that create a black box around the pricing of Part D drugs, they called the reforms “historic.”
If a new federal rule withstands politics and potential court challenges, U.S. health care prices may finally be freed from their historic black box. The Centers for Medicare & Medicaid Services, along with the Departments of Labor and the Treasury, issued the Transparency in Coverage final rule Oct. 29 requiring most private health plans to disclose pricing and cost-sharing information so Americans will know in advance how much they will have to pay for prescription drugs, medical devices and other health care products and services.
The U.S. pathway for legally importing certain prescription drugs from Canada to take advantage of lower prices is closer to opening for business with the FDA issuing a final rule and guidance on making it happen.
Ignoring industry’s threat of a lawsuit, U.S. President Donald Trump is moving forward with his plan for “most-favored nation” pricing of certain prescription drugs. The president, on Sept. 13, signed the executive order he threatened in July if industry didn’t come up with a better offer by Aug. 24. Industry did make a counter offer last month, but apparently it wasn’t enough.
