Policy

H.R. 3, The Lower Drug Costs Now Act, passed 2 committees in the House of Representatives Thursday, with a bipartisan amendment intended to boost uptake of biosimilars tucked inside.

A trio of employer groups has formed a new partnership to advocate for policies that address the problem of high—and growing—drug costs.

Representatives Paul Tonko, D-New York, and Rob Gibbs, R-Ohio, have introduced H.R. 4629, the Star Ratings for Biosimilars Act, in the House. The bipartisan bill would require HHS to evaluate Medicare Advantage (MA) plans based on whether biosimilars are available to enrollees.

No matter which piece of a Congressional Budget Office (CBO) report or a similar one from CMS actuary that observers seize on, both documents indicate that HR 3, the Lower Drug Costs Now Act of 2019, would save federal spending and improve health, at least in the short term, and also have a dramatic impact on the prescription drug industry.

The MAGIC Act would amend the Affordable Care Act to allow chemically synthesized insulins to be approved under abbreviated new drug applications.

The bill prohibits these agreements between brand name and generic drug manufacturers by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company. The bill would make violating these provisions punishable by civil penalty.

Major drug companies poured hundreds of millions of dollars into nonprofit patient advocacy groups last year, as a fight over federal legislation to curb rising pharmaceutical prices is underway, Bloomberg Government reports.

A new KPMG report, commissioned by generic and biosimilar trade group Medicines for Europe, identifies some of the features of drug procurement in hospitals in different countries in Europe, explains how they impact biosimilar uptake, and gives recommendations to help biosimilars play a role in the strong—and growing—need to reduce spending in health systems.

A trio of health policy experts, writing in The New England Journal of Medicine, recently analyzed 3 proposals to redesign Medicare Part D in an effort to curb the effect of rising drug prices on beneficiaries.

The Institute for Clinical and Economic Review (ICER) has issued its first annual report on unsupported price increases for US drugs. The report found that 3 brand-name biologics that have FDA-approved biosimilars—adalimumab, rituximab, and pegfilgrastim—have had significant price increases that were not supported by new clinical evidence.

The state’s Department of Health and Human Services this week sent letters to firms that did not provide required information about production costs, marketing and advertising costs, patient assistance programs, wholesale acquisition costs, and historical increases, among other information.

The Labour party, the United Kingdom’s official opposition party, revealed during a conference that it plans to reduce the cost of drugs by setting up a government-owned generic drug manufacturer that would supply medicine to the National Health Service and by employing compulsory licensing to use drug makers’ intellectual property to develop generics.

This week, the White House has been signaling that it sees progress on the problem of high drug prices, a subject of such concern to the administration that it released the “American Patients First” blueprint for reducing drug prices in 2018. However, some groups are calling for redoubled efforts on encouraging biosimilars as a way to generate savings and relieve the burden of high drug costs on the healthcare system and on patients.

President Donald Trump has signed an executive order on improving Medicare.

The Center for Biosimilars® recaps the top stories for the week of September 30, 2019.

The case over whether drugmakers can be compelled to disclose pharmaceutical prices in direct-to-consumer (DTC) television advertisements continues in the US Court of Appeals for the District of Columbia, with HHS appealing and AARP and the AARP Foundation filing an amicus brief this week in Merck & Co. Inc. et al v US Department of Health and Human Services et al.

A newly introduced item of legislation proposes to eliminate co-payments for patients when they receive a biosimilar rather than an originator biologic in Medicare Part B.

Step therapy, which requires that patients try the payer’s preferred treatment before the one a physician recommends, jeopardizes the health of patients with cancer by delaying treatment and creating unnecessary barriers, according to a recent position statement from the Community Oncology Alliance (COA).

While policy makers have hailed drug price transparency laws as steps toward bringing down the high cost of drugs for US patients, questions remain as to how effective these laws are at achieving their aims. Now, in a research letter published in JAMA Network Open, researchers say that these laws are largely ineffective at revealing true transaction prices for drugs.

With the US Congress back from its summer recess, September marked a busy time on Capitol Hill for policy proposals that touch on drug pricing, biosimilars, and patient access to high-cost therapies.

The bill would amend the Employee Retirement Income Security Act to require group health plans to provide an exception process for step therapy so that patients can access treatment without delays.

A report out this week from the House Ways and Means Committee details the extent to which Americans pay more for drugs than other countries—nearly 4 times as much, in fact.

Two biosimilar bills, both with bipartisan sponsors, were unveiled last week and aim to boost uptake in the United States, one through increased Medicare payment and the other via additional education.

The Center for Biosimilars® recaps the top stories for the week of September 16, 2019.

On the same day that House Speaker Nancy Pelosi, D-California, unveiled her plan to lower drug prices by giving the United States the ability for Medicare to negotiate certain drug prices and seek rebates from drug makers if their prices soar above inflation, a new AARP report shows that retail prices in 2017 were 2.1% above the general inflation rate and marked 12 straight years of price increases.

While acknowledging the role that the Orphan Drug Act had in incentivizing drug companies to develop treatments for small populations suffering from rare diseases, America’s Health Insurance Plans (AHIP) says pharmaceutical companies are using orphan drug status to create blockbuster drugs that are then used to treat other common medical conditions.

The Biosimilars Council, a part of the Association for Accessible Medicines, has issued a second component of its recent white paper on barriers to biosimilars in the United States; the newly published segment highlights postmarket barriers to biosimilar adoption and says that they have taken a significant toll on the US healthcare system in terms of lost savings.

The United States Court of Appeals for the Third Circuit has sided with Johnson & Johnson (J&J) and its Janssen division, requiring a dispute between the Remicade maker and Rochester Drug Cooperative to be sent to arbitration.

While it is well understood that timely access to treatment is key for the management of rheumatic diseases, respondents to The American College of Rheumatology (ACR) 2019 Rheumatic Disease Patient Survey reported difficulty accessing and paying for their therapies in the past year.

Kaiser Health News, in its latest update to its campaign contributions tracking tool, reports that Senator Chris Coons, D-Delaware, received the most contributions from the pharmaceutical industry during the first half of 2019, at $103,000. Coons, together with Senator Thom Tillis, R-North Carolina, who himself received $102,000 this cycle, released a draft of a patent reform bill in May, and concerns among drug makers about the eventual passage of that bill have run high.