During the last panel at the Alliance for Patient Access 4th Annual National Policy and Advocacy Summit on Biologics and Biosimilars, panelists discussed some of the administration’s proposals, such as moving Medicare Part B drugs to Part D, a proposal to end protected drug classes in Medicare, and the International Price Index.
What would the ramifications be in terms of price and access for patients if some of the administration’s price proposals took effect?
During the last panel of the day at the Alliance for Patient Access 4th Annual National Policy and Advocacy Summit on Biologics and Biosimilars, panelists discussed some of the administration’s proposals, such as moving Medicare Part B drugs to Part D, a proposal to end protected drug classes in Medicare, and the International Price Index (IPI).
HHS has proposed shifting Medicare Part B drug costs to Medicare Part D in an effort to reduce pharmaceutical spending and out-of-pocket (OOP) costs. Some fear that while the plan may reduce total drug spending, it could increase OOP costs for some beneficiaries.
Kevin Kirby, a partner with The Moran Company said the idea has not yet “died on the vine.”
Physicians are concerned that moving expensive therapies that used to be paid for Part B to Part D prescription drug plans would make them less accessible to patients because of the cost.
“A lot of our patients can’t afford Part D,” said Madelaine Feldman, MD, representing the Coalition of State Rheumatology Organizations, referring to drugs that patients may receive in doctors’ offices, such as injectable biologics.
Feldman said she fears that patient access would be harmed and that the introduction of “middlemen” (ie, pharmacy benefit managers) would negate any savings or hinder patient access.
In Medicare Part D, CMS wants to give the plans more flexibility for which drugs must be included in the protected drug classes. Those classes are antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretrovirals, and antineoplastics.
Currently, all drugs in those classes must be included on Part D formularies; CMS has said that creates an incentive to keep prices high.
Gavin Clingham, with the Alliance for Patient Access, said an insurer would be allowed to go down to 1 drug in each class and expand utilization management tools. He questioned the amount that would be saved, saying that most drugs that are prescribed are already generics.
“Is the disruption [to patients] worth the savings that may come?” he asked.
Feldman said those drugs are protected for a reason. “We’re going to have problems with some of the sickest, most vulnerable patients,” she said.
Another administration proposal, to use an IPI based on drug prices in other countries to determine reimbursement for Part B therapies, was discussed. The IPI model was announced by the Trump administration in October.
Clingham said the proposal, if it applies to 50% of practices in the United States, should not be considered a “demonstration” project as originally envisioned under the Center for Medicare & Medicaid Innovation (CMMI) and said it would have a “disruptive” effect on pricing.
Do reimbursement rates impact physician prescribing behavior? Or whether or not patients have the same access to medication? There is some debate on both those points; Feldman said that the inability to “buy and bill” would hurt practices and that about 30% of patients stop treatment if they can no longer get treatment in their doctor’s office.
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.
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.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Perceptions of Biosimilar Switching Among Veterans With IBD
December 2nd 2024Veterans with inflammatory bowel disease (IBD) prioritize shared decision-making, transparency, and individualized care in biosimilar switching, favoring delayed switching for severe cases and greater patient control.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.