Allison Inserro

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 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 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.

A recent preliminary study examined whether adults treated with anti–tumor necrosis factor agents (anti-TNFs) had reduced the risk of Alzheimer disease, and found that patients with rheumatoid arthritis (RA) and psoriasis who were treated with anti-TNFs had a lower risk of developing the incurable neurocognitive disorder.

There are some health policy experts who believe that price transparency will work to bring down healthcare spending. In a recent article in JAMA, Gilbert Benavidez, MPH, and Austin Frakt, PhD, say that the notion has rarely worked, but they suggest there are 2 ways that it might.

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.

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).

The FDA has approved another indication for reference rituximab (Rituxan), this time for children with rare vasculitis diseases.

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.

A pair of studies appearing in The New England Journal of Medicine report on 2 separate studies of biologics in patients with moderate-to-severe ulcerative colitis: One study confirms top-line results seen earlier this year in a head-to-head study of vedolizumab and adalimumab, and the other reports on the results of a single intravenous infusion of ustekinumab followed by subcutaneous maintenance injections.

A small investor who currently holds 20 shares of Allergan has filed a proposed securities class action lawsuit seeking to stop its purchase by AbbVie, according to reports.

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.

Premier, Inc. recently released updated inflation estimates for contracted and non-contracted pharmaceutical pricing for fiscal year 2020 and said most of the overall pharmaceutical inflation comes from new drugs (2.8%), including cellular and gene therapies.

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.

A recent study says step therapy in rheumatoid (RA) or psoriatic arthritis (PsA) can hurt treatment outcomes.

While chances of her leaked plan to force lower drug prices in the United States getting through the Republican-controlled Senate are extremely small, House Speaker Nancy Pelosi, D-California, put biosimilars, including insulins, into the national conversation this week.

National and state patient, physician, and healthcare professional organizations—370 in all—are asking Congress to pass a bipartisan bill aimed at curtailing prior authorization requirements in Medicare Advantage, saying that they needlessly delay or deny access to medically necessary care.

A new report released Monday by UnitedHealth Group finds that administering specialty drugs—which are typically injected or infused—in homes or in independent physician offices instead of hospitals could save as much as $4 billion each year.

This week, British Columbia began the process of transitioning patients with inflammatory bowel disease (IBD) to biosimilars.

More than 20 groups, representing patients, employers, and others, are asking HHS to end cost-sharing for Medicare Part B patients when a provider administers a biosimilar rather than a reference biologic.

The pharmaceutical industry hit bottom in public opinion, ranking last in Gallup’s list of 25 industries, according to a new annual poll.

Health Canada recently updated its fact sheet on biosimilars, including new or clarified information about key topics including interchangeability and switching.

Results of a phase 3 trial of IBI303, a proposed adalimumab biosimilar referencing Humira, showed that it is therapeutically equivalent in terms of efficacy, safety, and immunogenicity to the originator product, according to a study published in the first issue of The Lancet Rheumatology.

Treating macular edema associated with central retinal vein occlusion (CRVO) with aflibercept was noninferior to ranibizumab treatment at 100 weeks, while the results for bevacizumab versus ranibizumab were inconclusive.

This week saw a pair of developments for patients with neuromyelitis optica spectrum disorder (NMOSD), a rare, severe, relapsing, neuroinflammatory autoimmune disease that can be fatal.

Women are more likely than men not to take their diabetes medication as prescribed in an effort to control prescription drug costs, as are adults under age 65, according to a report published this month by the Centers for Disease Control and Prevention (CDC).

Early dose reductions in the adjuvant chemotherapy combination of 5-fluorouracil, epirubicin, cyclophosphamide, and docetaxel negatively impacted survival rates for patients with intermediate- or high-risk breast cancer.

“These results will fully usher the treatment of chronic lymphocytic leukemia [CLL] into a new era,” said Tait Shanafelt, MD, professor of medicine at Stanford. “It seems likely that, in the future, these patients will be able to forego chemotherapy altogether.”