Yesterday, 9 physician groups sent a joint letter to HHS Secretary Alex Azar in which they voiced concerns about the President’s 2019 Budget and the Council of Economic Advisers’ drug plan.
Yesterday, 9 physician groups sent a joint letter to HHS Secretary Alex Azar in which they voiced concerns about the President’s 2019 Budget and the Council of Economic Advisers’ drug plan.
The groups say that the proposal to increase Medicare Part D formulary flexibility to limit or reduce coverage for patients could create problems for patients taking high cost drugs like biologics and biosimilars. This proposal would change the Part D plan formulary standards to require a minimum of 1 drug per category or class rather than the current 2. “We believe Part D benefits should not limit patients’ access to the medical therapy judged by the treating physician to be the most efficacious choice,” say the groups.
In addition, consolidating Part D drug coverage under the Medicare Part D program could also lead to access problems and force patients to use higher-cost sites of care. Given the different formulary structure and cost sharing between Part B and Part D, the groups worry that out-of-pocket costs for patients would increase, particularly for patients taking biologics prescribed by rheumatology, oncology, and neurology providers.
The groups also oppose a restructuring of Medicare Part B physician reimbursement for in-office treatment that would pay physicians 3% above the average sales price (ASP) of a drug rather than the current ASP plus 6%, and the letter urges HHS to repeal the sequester cuts to Part B drug reimbursements: “Many small and rural practices lack the ability to negotiate bulk discounts in their drug purchases and have already been forced to stop administering biologic therapies to Medicare patients,” the letter states.
Finally, the groups call for further clarification on introducing physician reimbursement that is not tied to drug prices, as physicians have no control over the cost of drugs or ancillary services, nor do they control the severity of the illnesses that these drugs treat. “Our physicians should not be penalized for rampant inflation in these sectors,” they said.
The physician groups made it clear that they support proposals that would:
The letter was signed by the American Academy of Dermatology Association, American Academy of Neurology, American Academy of Ophthalmology, American Academy of Physical Medicine and Rehabilitation, American College of Gastroenterology, American College of Rheumatology, American Gastroenterological Association, American Urological Association, and the Infectious Diseases Society of America.
Improving Biosimilar Access Through Global Regulatory Convergence
January 15th 2025Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
The Top 5 Most-Read Policy Articles of 2024
December 28th 2024The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar interchangeability and CMS drug price negotiations under the Inflation Reduction Act, alongside challenges posed by pharmacy benefit manager rebate practices and the need for more active stakeholder engagement.
How Vertical Integration Drives Innovation and Access in Biosimilars
December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.