Policy

Some stakeholders have welcomed the proposed rule to bar drug makers from giving pharmacy benefit managers rebates, while others raised serious concerns.

“Today’s healthcare system is unsustainable. [US] national health spending is expected to grow at 5.5% each year,” said Carol Lynch, president of Sandoz US and head of North America, setting the stage for a session at the Association for Accessible Medicine’s Access! 2019 meeting. “If all approved biosimilars had been marketed in a timely manner, Americans could have saved $4.5 billion.”

The assumption that Medicare Part B payment rates lead providers to create higher drug utilization for costlier treatments in order to benefit from larger add-on payments is not correct, a recent white paper said. The paper from Xcenda, a part of AmerisourceBergen, also found similar results when looking at physician-administered drugs in the hospital outpatient setting.

A recent white paper recaps the many barriers to biosimilar adoption in the United States and proposes a few ways that plans could change their reimbursement policies to help boost uptake.

A raft of biosimilars possibly coming to market is not expected to relieve the burden of healthcare costs in 2019, but it is possible that the combination of products in the queue, as well as reimbursement changes, could be the beginning of change, according to a drug pricing forecast out this week from Vizient.

On Thursday, HHS proposed a rule intended to reduce patients’ out-of-pocket costs for prescription drugs by blocking rebates and discounts given to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations and encouraging discounts given directly to patients.

The Center for Biosimilars® recaps the top news for the week of January 28, 2019.

By 2023, the segment of the biologics market in the United States that faces competition from biosimilars will have grown 3 times larger than in 2019, resulting in nearly 10% cumulative savings, says IQVIA.

The House Committee on Oversight and Reform held its first hearing into drug prices this week and received testimony that pointed to increased biosimilar competition as a part of the solution to the problem.

A specific focus of the European Commission and European Parliament is to investigate the effect potential mergers and acquisitions (M&As) will have on the state of the market.

On the last day of the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, the head of the FDA practice at Avalere discussed her point of view that enabling a global reference product for biosimilars would provide global access for patients.

At a panel discussion at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, representatives of employer groups discussed the role that businesses have in driving the discussion about raising awareness and adoption of biosimilars. Employer groups can help overcome barriers, such as patient fears and misinformation, and create confidence about using biosimilars, speakers said.

The current administration in Washington, DC, is one of the most active when it comes to policy and regulation that affects biosimilars, said a presenter who recapped recent changes for the attendees at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.

Last week, CMS unveiled new, voluntary changes for Medicare Part D. The new 5-year model, which CMS calls Part D Payment Modernization, will test the feasibility of shifting more risk to Medicare Advantage and Part D plans.

The European Union has announced that The Committee of the Permanent Representatives of the Governments of the Member States to the European Union (Coreper) agreed this week on the European Council’s draft regulation that grants an exception to Supplementary Protection Certificates (SPCs).

Closed-door sessions began last month on possible patent law reform in 2019 in the United States.

The Center for Biosimilars® recaps the top news for the week of January 14, 2019.

The Institute for Clinical and Economic Review (ICER), an independent, nonprofit organization that seeks to improve healthcare value by providing comprehensive clinical and cost-effectiveness analyses of treatments, tests, and procedures, has announced that it is undertaking a new annual analysis—an Unsupported Price Increase report—that will review significant prescription drug prices increases and determine whether those increases are supported by new clinical evidence.

A new paper, published this week in Current Medical Research and Opinion, seeks to clarify the US definition of interchangeability and differentiate it from the separate concepts of automatic substitution and physician-mediated switching.

After the UK Parliament voted to reject Prime Minister Theresa May’s proposed Brexit deal with just weeks to go before the United Kingdom’s planned withdrawal from the European Union, the pharmaceutical industry has warned that a no-deal Brexit poses “tangible and immediate threats” to patient safety and public health.

When the shutdown ends, said Scott Lassman, JD, partner at Goodwin, “It’s not going to be like flipping a switch…this is going to have longer-term consequences.”

Senators Amy Klobuchar (D-Minnesota) and Chuck Grassley (R-Iowa) recently reintroduced bipartisan legislation aimed at bringing down prescription drug costs.

The House Committee on Oversight and Reform has launched a wide-ranging investigation into prescription drug pricing in the United States.

Last week, Senator Bernie Sanders, I-Vermont, and Representative Elijah Cummings, D-Maryland, introduced legislation comprising 3 bills to curb the cost of prescription drugs.

In May 2018, as part of the Trump administration’s blueprint to reduce drug costs for American patients, HHS proposed shifting coverage of some Medicare Part B drugs to Medicare Part D. However, a new study, published today in JAMA Internal Medicine, finds that shifting reimbursement of these drugs could increase out-of-pocket spending for some Medicare beneficiaries.

The Center for Biosimilars® recaps the top news for the week of January 7, 2019.

Following promises of halts to increases in drug prices in 2018, pharmaceutical makers began January by raising the prices of more than 250 drugs. Now, HHS Secretary Alex Azar is calling on companies to bring their list prices back down.

During the 37th annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California, FDA Commissioner Scott Gottlieb, MD, delivered a keynote address encompassing his goals for the direction of the FDA in the coming year.

While 63% of respondents who had switched to a biosimilar said that they had been consulted in some form prior to the transition, 37% said that they had not been consulted (despite the fact that National Health Service guidelines require the patient to be consulted about such a switch).

The fact that cost growth is driven largely by older products and not by new blockbuster therapies “is particularly important,” write the authors, “because in the current value-based landscape, increasing drug costs attributable to new products can sometimes be justified on the basis of improved outcomes. However, rising costs due to inflation do not reflect improved value for patients.”