Policy

An American Medical Association survey of 1000 physicians regarding the impact of prior authorization (PA) found that most providers reported a significant or negative impact on patient care, and more than a quarter reported a serious adverse event.

Recent research attempted to assess consumer response to the disclosure of drugs' list prices in direct-to-consumer advertising.

A recent study examining Medicare Part D reimbursement policies for off-label uses, using dermatology as a focus, found that health coverage decisions have significant shortcomings that could hamper patient access to evidence-based treatments.

The Center for Biosimilars® recaps the top news for the week of February 4, 2019.

Express Scripts said this week that it expects US drug spending to rise about 2% over the next 3 years, lower than projected inflation rates. However, a lack of competition will affect 2 of the costliest categories of pharmaceuticals—inflammatory conditions and diabetes—between 2019 and 2021.

Addressing the rising cost of drugs in the United States has become a problem that many entities and stakeholders are hoping to solve. From the federal government down to the state level, everyone seems to be taking the problem into their own hands.

This week, Senator Patrick Leahy, D-Vermont, reintroduced The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act.

HHS Secretary Alex Azar offered a view of hope and optimism for the future of the American healthcare market in his remarks delivered as the closing keynote address at the Association for Accessible Medicine’s Access! 2019 meeting.

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.