Policy

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.

The Institute for Clinical and Economic Review (ICER) said this week it will review the comparative clinical effectiveness and value of therapies for ulcerative colitis, including the reference infliximab product from Johnson & Johnson and biosimilar infliximab from Pfizer.

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.

Patient organizations for those with inflammatory bowel disease (IBD) are upset with the government of British Columbia for a plan to shift patients to biosimilars over the next 6 months.

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.

Amitabh Chandra, PhD, Ethel Zimmerman Wiener professor of public policy and director of health policy research at the Harvard Kennedy School of Government, says that while price regulation is not impossible, “It’s very, very hard to do. Given that it’s hard to do, do we need to do it?”

England’s National Health Service (NHS) says that it has saved £110 million (US $134 million) by implementing its policy to use the best-value adalimumab after the brand-name Humira lost European patent protection in October 2018.

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).

In July, the Trump administration withdrew its proposal to block rebates and discounts given by drug makers to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations. Withdrawal of the rule was a discouraging development for many physicians who hoped that the proposal could give relief to their patients at the pharmacy counter. This week on the podcast, we’re speaking to one such physician, Madelaine Feldman, MD.

Representative Elijah Cummings, D-Maryland, and Senator Bernie Sanders, I-Vermont, have sent letters to executives of 3 generic drug makers in which they ask for drug pricing information as part of a probe into the rising cost of generics.

Concerns about overseas inspections continue in the wake of an HHS plan to create 2 potential pathways to allow the importation of some drugs that were intended for foreign markets.

The Canadian government has announced amendments to its regulations concerning patented drugs that it says will make medicines more affordable. According to Health Canada, these changes will save Canadians $13.2 billion (US $9.97 billion) over the next decade.

The August issue of JAMA Oncology features a Viewpoint that puts forth a free-market solution to lower high drug costs by changing dosing regimens without hurting efficacy using the approach of interventional pharmacoeconomics (IVPE).

The International Generic and Biosimilars Medicines Association (IGBA), which represents generic and biosimilar medicines associations worldwide, recently released its report on how trade agreements can foster generic and biosimilar medicines and improve patient access to care.

A study published this month proposes that biosimilars be assessed in a quantitative benefit-risk analysis to assess whether what the authors call “uncertainty in the clinical performance of biosimilars” can be countered by lower pricing.

Not everyone shares the view that authorized generics are a boon, and concerns are rising that the marketplace may soon see the advent of authorized biologics.

Will biosimilars improve public health? Policy makers should look to that question as they sort through possible solutions, the authors say.