Policy

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.

“We wish biosimilar competition would efficiently lower biologics prices to the socially optimal level of marginal economic cost,” wrote Bach and coauthors. “But, in this case, the ideological preference for competition needs to be put aside for a more effective, efficient, and economically justified approach of regulating biologics as natural monopolies.”

A study published this week in PLoS Medicine suggests that brand-to-brand competition is not likely to reduce drugs’ list prices.

The chairman and the ranking member of the Judiciary Subcommittee on Courts, Intellectual Property and the Internet in the House of Representatives, proposed a bipartisan bill to amend the patent dance in the Biologics Price Competition and Innovation Act (BPCIA) by capping the number of some types of patents that may be claimed by the maker of the reference product.

The first pathway for importation outlined in the plan would rely on a notice of proposed rulemaking to authorize importation of drugs from Canada. The second pathway would allow manufacturers to import versions of FDA-approved drugs that are sold in other countries.

Earlier this month, a federal appeals court heard arguments in Texas v Azar. If the judge sides with the Republican point of view that the entire Affordable Care Act (ACA) is unconstitutional and invalidates the landmark law, the Biologics Price Competition and Innovation Act (BPCIA), the pathway for biosimilars included in the ACA, would have to start over from scratch. That shouldn’t be a problem, according to 2 conservative healthcare and pharmaceutical observers interviewed by The Center for Biosimilars®.

Genentech had asked the court for a temporary restraining order and a preliminary injunction against Amgen in a Biologics Price Competition and Innovation Act (BPCIA) litigation related to patents covering Herceptin. The United States District Court for the District of Delaware denied Genentech’s motion, and the court has now made public a redacted version of the memorandum opinion in the matter.

The Senate Finance Committee has released its long-awaited chairman’s mark of the Prescription Drug Pricing Reduction Act of 2019. The bill, aimed at lowering the cost of drugs for American patients, contains a number of provisions that impact biosimilars.

This month, the president and chief executive officer of Green Shield Canada, the fourth-largest private payer in Canada, hailed British Columbia’s strategy as “forward-thinking” and “essential to maximizing opportunities in healthcare.”

Senator Ted Cruz, R-Texas, has reintroduced a bill he thinks will speed US approval of drugs, biologics, or devices approved in other countries.

When the Senate Committee on Health, Education, Labor, and Pensions released bipartisan legislation aimed at lowering the cost of healthcare in the United States in May, biosimilar stakeholders had some cause for optimism. However, one provision of the bill that has garnered significantly less attention from the broader healthcare community has raised concerns among many biologics stakeholders.

According to the Congressional Budget Office (CBO), enacting the bill would increase direct spending by about $18.7 billion and increase direct revenues by $26.2 billion, resulting in a net decrease in the deficit of $7.6 billion by 2029.

Medicare Part D enrollees may actually pay more for some generic drugs than they would for their brand-name counterparts because of the Part D benefit, according to findings of a new study appearing in Health Affairs.

More than 100 House Democrats this week wrote to US Trade Representative Robert E. Lighthizer to ask him to drop language from the United States-Mexico-Canada Agreement (USMCA) trade agreement that would give 10 years of marketing exclusivity for biologic drugs.