Biosimilar Policy Roundup: August 2018

August 2018 saw a variety of developments in the policy landscape for biosimilars, both in the United States and worldwide.

In the United States, CMS announced a new policy that will allow Medicare Advantage (MA) plans to use step therapy for newly diagnosed patients. Step therapy—widely used in the private sector but previously prohibited for Part B drugs and services under a 2012 CMS policy—requires patients to start their treatment with less expensive drugs. Only after failing to respond adequately to those options do patients become eligible for more expensive treatments. According to CMS, this policy could entail a newly diagnosed patient starting with a biosimilar rather than a higher-cost reference product, thereby saving costs. (However, in contrast with CMS’ suggestion that biosimilars could be used as a first step, among commercial plans, experience thus far has shown that biosimilars are not typically used first.)

Leaders in rheumatology and oncology voiced serious concerns about the policy, with David Daikh, MD, PhD, president of the American College of Rheumatology, saying that the policy undermines the clinical judgment of providers, and Jeff Vacirca, MD, FACP, president of the Community Oncology Alliance calling the policy a “nightmare” for patients.

Read more about step therapy.

In the legal realm, patents on biologics continued to be a hot-button issue in August. The Initiative for Medicines, Access, and Knowledge (I-MAK), a public interest team of attorneys and scientists who seek to ensure that patents do not obstruct patient access to affordable medicines, issued a report detailing the number of patents that drug makers have tried to secure for drugs in the United States. The “worst patent offender,” said I-MAK, was AbbVie, which attempted to gain 247 patents for its adalimumab (Humira) and also raised prices on the drug by 144% since 2012.

Ever-rising prices, also a challenge for patients who rely on insulin, were the target of a 2017 California drug price transparency law, and 1 insulin maker is now saying that it will not comply with the statute that requires drug makers to disclose and defend increases to prices.

Eli Lilly has said that it is “not able” to provide required information related to price hikes on its products until after a legal challenge of the bill, filed by industry trade and lobbying group Pharmaceutical Research and Manufacturers of America, has concluded. State Senator Ed Hernandez, OD, a Democrat who represents the district of West Covina, has called Eli Lilly’s position an “egregious defiance” of the law.

In other legal developments, the district court for the Eastern District of Pennsylvania has denied Johnson & Johnson’s (J&J) motion to dismiss an antitrust civil action brought by Pfizer over infliximab. The suit, filed in September 2017, alleged that J&J engaged in exclusionary contracts, bundled rebates, and multi-product bundling practices related to its originator infliximab, Remicade, that have effectively denied patients access to biosimilar therapies, including Pfizer’s Inflectra, and have undermined price competition in the biologics marketplace.

Also this month, Pfizer submitted a citizen petition to the FDA, asking the agency to issue guidance clarifying how drug sponsors may communicate about biosimilars. “Just as there is a need for policies that support innovation, there is also a need for policies that ensure that patients and physicians have truthful and non-misleading information that encourages appropriate uptake of biosimilars so that biosimilars can reach their full potential for patients,” read the petition.

In the European context, England’s National Health Service (NHS) revealed this month that using biosimilars helped it to exceed its target for cost savings in the past fiscal year, and that it could save the equivalent of $131 million more in the current fiscal year by using biosimilars for trastuzumab and adalimumab.

Despite the potential for biosimilar trastuzumab to make a significant impact on the NHS’ bottom line, however, the United Kingdom’s National Institute for Health and Care Excellence has deemed pertuzumab (Perjeta) not cost effective for the adjuvant treatment of patients whose breast cancer has a high risk of recurrence, even when pertuzumab is used with cost-saving biosimilar trastuzumab rather than the higher-cost reference. NICE’s decision highlights the fact that, despite the ability of biosimilars to expand access to other high-cost drugs, the cost of biologics remains a serious issue for health systems.

In efforts to rein in the cost of biologics, the UK government is considering changing its national policies in order to bring biosimilars under its existing statutory price controls as of 2019. The controls require brand-name drug makers to pay the government 7.8% of their sales of products to the NHS, and also establish criteria for the maximum price a company can charge the NHS. The new approach would address all biologic medicine—including biosimilars—within the price controls, but biosimilar makers have said that the policy would be harmful to the industry and would make launching biosimilars financially impossible.

In other European policy developments, Michael Barry, MB, FRCPI, PhD, clinical director of the Irish health technology assessment body, the National Centre for Pharmacoeconomics, is calling for all new patients to start biologic treatment with biosimilars, and for hospitals in particular to focus on using cost-saving biosimilars.

“You’ve got to put in the structures to enable this to happen at a hospital level,” Barry said. “We have spent the last 5 years concentrating on community expenditure because that is where most of it takes place, but we need to get to grips with hospital prescribing,” he said.

On the global level, the World Health Organization (WHO) has released a new report on reimbursement policies in which it called on nations to support the uptake of generics and biosimilars. The WHO says that educational policies—including local initiatives among physicians in hospitals or in the outpatient setting—will be of key importance to greater biosimilar uptake, because acceptance and trust in biosimilars among healthcare providers is a driver of adoption.