Policy

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.”

In October 2018, HHS Secretary Alex Azar proposed requiring drug companies to include the list price of a drug paid for by Medicare or Medicaid in direct-to-consumer (DTC) television advertising. Since the rule was announced, it has drawn feedback from stakeholders across the spectrum. The proposal, for which a comment period recently closed, received more than 140 comments on the Federal Register from payers, providers, patient advocacy groups, and others, varying in support of the proposal to raising concerns.

The Center for Biosimilars® recaps the top news for the week of December 31, 2018.

After several pharmaceutical companies agreed to halt drug price increases in 2018 after receiving pressure from the Trump administration, the industry has kicked off 2019 with price increases on more than 250 prescription drugs.

The American College of Rheumatology (ACR) is apprehensive that “without substantial changes, the demonstration program could disrupt patient access to care, worsen the rheumatology workforce shortage, and exacerbate geographic disparities in access to medical care.”

As Congress prepares to begin its new term, newly elected lawmakers will convene to tackle issues such as the high cost of drugs. As they prepare to address these policy challenges, a new analysis shows that several key congressional leaders have received major contributions from the pharmaceutical industry.

There were a variety of developments in the biosimilars space in 2018, and our expert contributors responded to those changes with in-depth insights that reflected the complexity of the biosimilars landscape.

Gillian Woollett, MA, DPhil, senior vice president of Avalere, discusses policy and biosimilars in the United States.

Drugs that treat rare diseases are granted various incentives under the Orphan Drug Act of 1983 if they meet criteria related to the size of the rare disease population (under 200,000 people) that can be effectively treated by the drug in question. The Government Accountability Office (GAO) recently issued a report that finds serious deficiencies with the ways in which the Orphan Drug Act is administered by the FDA.

The Center for Biosimilars® recaps the top news for the week of December 17, 2018.