Policy

Two senators from either side of the aisle introduced a bill this week that is aimed squarely at the patent strategies that are used to block biosimilars from coming to market.

The Medicare Payment Advisory Commission (MedPAC) begins its 2-day March meeting Thursday, and the first item on the agenda is a discussion about reference pricing and binding arbitration for Part B drugs in order to improve price competition and value.

A few weeks after the United States Supreme Court rebuffed Maryland in its attempt to regulate drug prices, legislative committees are meeting Wednesday on a drug price transparency bill, as well as a bill to create a commission to review prices and set ceilings on insurers, pharmacies and hospitals.

News that FDA Commissioner Scott Gottlieb, MD, will step down from his position in 1 month’s time took stakeholders by surprise on Tuesday and raises questions about how the agency will approach biosimilars when it comes under new leadership. While Gottlieb’s departure has garnered the most attention, it is not the only recent FDA shake-up that could have an impact on the agency’s approach to biosimilars; Leah Christl, PhD, previously the director of the Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs, left the FDA in February 2019.

The industry group for pharmacy benefit managers (PBMs) launched a public relations blitz in the wake of scrutiny regarding their role in prescription drug prices.

The Center for Biosimilars® recaps the top news for the week of February 25, 2019.

A California legislator wants to make the state the first to bar “pay-for-delay” tactics used by drug companies to prevent competition, targeting both generics and biosimilars, in a move that would create the first piece of state law about this issue.

February 2019 was a busy month for biosimilars on the policy front, with pharmaceutical executives called to testify before law makers and industry attempting to navigate a raft of proposed Trump administration policies aimed at reducing the cost of drugs.

This week, US Magistrate Judge Richard Lloret directed Boehringer Ingelheim to disclose its launch plans for its biosimilar adalimumab, Cyltezo, as part of a long-running patent dispute with AbbVie, maker of the reference adalimumab, Humira.

In today’s second full committee hearing on drug pricing held before the US Senate Committee on Finance, executives representing 7 drug makers provided testimony on the high prices of their products.

As part of its investigation into drug pricing, the Senate Finance Committee is launching a bipartisan probe into insulin prices, while a Democratic congressman from Vermont announced a bill to allow the importation of insulin from Canada and other countries.

A recent issue brief, published by the Commonwealth Fund, described Germany’s approach as an alternative to the current US model that imposes high cost-sharing on patients.

The Center for Biosimilars® recaps the top news for the week of February 18, 2019.

More payers began to significantly adjust their reimbursement strategies for biosimilars last year, according to pharmacy benefit manager (PBM) Magellan Rx Management.

Despite the fact that the investigation confirmed many of the allegations against Janssen, the bureau concluded that, "at this time, there is insufficient evidence" that Janssen's conduct prevented competition.

A United States District Judge in New Jersey has allowed a proposed class-action lawsuit against 3 major insulin makers to proceed.

After the Association for Accessible Medicines’ (AAM’s) Access! 2019 annual meeting came to a close last week, The Center for Biosimilars® spoke with Christine Simmon, senior vice president of policy and strategic alliances, AAM, and executive director, AAM’s Biosimilars Council, to get her take on some of the outcomes of the meeting.

The United Kingdom’s National Institute for Health and Care Excellence (NICE) today released a final appraisal of pertuzumab (Perjeta) together with intravenous trastuzumab and chemotherapy for the treatment of HER2-positive early breast cancer, and recommended pertuzumab for use in patients if they have lymph node–positive disease and if drug maker Roche adheres to its promised discount for the drug.

The Center for Biosimilars® recaps the top news for the week of February 11, 2019.

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.