Policy

The Center for Biosimilars® recaps the top stories for the week of November 11, 2019.

Organizations reacted this week to news that CMS is raising Part B premiums with a variety of opinions, as CMS blamed rising drug prices for the increase.

Postmarket drug price changes alone accounted for most of the recent spending growth on biologics, and manufacturers’ rebates had little impact, according to an abstract presented at the American College of Rheumatology’s 2019 meeting, being held in Atlanta, Georgia, this week.

Today in the European Union, we can be proud and celebrate the fact that in 28 EU Member States, biosimilar medicines are in use, and competition in the biological medicines field has consistently brought value for patients and healthcare communities. In general, broader access (more patients treated) is an immediate consequence of biosimilar competition, and earlier access to treatment (where clinically appropriate) has been observed in a number of countries.

The high cost of healthcare is putting a strain on employers who provide health insurance coverage to their employees, and prescription drug prices are now front and center in the push to make coverage more affordable to provide to American workers.

Among all respondents, 53% of beneficiaries reported having had a serious problem paying a medical bill of any kind. Thirty percent of respondents said prescription drugs created the largest burden.

During the International Society for Pharmacoeconomics and Outcomes Research 2019 meeting being held in Copenhagen, Denmark, 3 teams of researchers presented findings that show that, despite the fact that Europe’s biosimilars market is far more mature than that of the United States, the region still sees setbacks from stakeholder perceptions of biosimilars and from policies that do not adequately incentivize biosimilar use.

The Center for Biosimilars® recaps the top stories for the week of October 28, 2019.

A bipartisan bill introduced in the Senate this week aims to address the growing issue of drug shortages.

The American Society of Clinical Oncology (ASCO) today released its third annual National Cancer Opinion Survey, results of which highlight the added stress that the financial burden of treatment places on patients with cancer.

A bipartisan bill to require patent transparency in an effort to bring down the cost of prescription drugs has been introduced in the House of Representatives; the bill is a piece of companion legislation to one introduced in the Senate in March.

Republicans in the House of Representatives this week laid out their alternative to the Affordable Care Act (ACA) in an effort to position themselves against various Democratic healthcare proposals. The document contains many ideas that have been debated previously when Republicans tried to repeal the ACA, and it draws on work from the Heritage Foundation and the Cato Institute.

While some data suggest that overall drug price increases may have moderated recently, prices for specific drugs continue to rise at rates above inflation.

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.