Policy

The Canadian Agency for Drugs and Technologies in Health, the Canadian entity responsible for health technology assessments (HTAs), has released a new report that explores international policies related to biosimilars and the factors that facilitate their use.

Allergan’s dry-eye drug, Restasis, has been the subject of complex legal wrangling involving the transfer of patents that could next extend to the Supreme Court of the United States. Now, in a separate twist in the story of generic competition for the cyclosporine ophthalmic emulsion, generic developer Teva has sued the FDA in the United States district court for the District of Columbia over Teva’s status as the first filer of a generic version of the drug.

In an effort to combat competition from biosimilar adalimumab products in Europe as patents covering the reference product expired last month, AbbVie, developer of Humira, is reportedly prepared to offer a substantial discount. However, many European nations have policies that require a mandatory reduction of the reference product’s list price after biosimilar entry.

In an interview with The Center for Biosimilars®, Imron Aly, JD, partner at Schiff Hardin LLP, explained that this long-running case to invoke sovereign immunity from inter partes review (IPR) carries important lessons for innovator product sponsors and generic and biosimilar developers as they consider IPR proceedings and the patent landscape as a whole.

US voters will head to the polls next week in the midterm elections, and in the run-up to the election, the Kaiser Family Foundation has revealed that pharmaceutical companies have donated nearly $79 million to members of Congress over the past 6 election cycles.

With the launch of some of the most highly anticipated products thus far in the biosimilar experience, and with the release of key new data on multiple biosimilar products, October 2018 was a memorable month for biosimilar stakeholders.

The Salt Lake Tribune is reporting that public employees in the state of Utah could be paid by their insurance plan to fill prescriptions for high-cost drugs in Mexico instead of in their local pharmacies.

Yesterday, the Trump administration released a new plan aimed at reducing Medicare’s costs for prescription drugs. Under the plan, CMS would be able to set its prices for some drugs, including biologics, based on the prices paid in other nations. Since the announcement, several stakeholders have spoken out about the proposed change.

On Thursday, the Trump administration unveiled a new plan that it hopes will reduce Medicare’s costs for prescription drugs. Under the plan, announced by President Donald Trump in a speech made at HHS, CMS could set its prices for some drugs—including high-cost biologics—based on the prices paid in other nations.

This month, Maryland’s Attorney General Brian Frosh petitioned the Supreme Court to uphold the “first-in-the-nation” law against drug price-gouging.

Among European nations, Denmark has had some of the greatest success with leveraging biosimilars to reduce cost burdens on its healthcare system, and during the fifth DIA Biosimilars Conference, held October 22 to 23, 2018, in London, United Kingdom, stakeholders heard directly from Dorthe Bartels, MSc, on how Denmark has achieved its strong biosimilar uptake.

While it is indeed the case that the current administration has made drug pricing and biosimilars a priority, and while the Biosimilar Action Plan was hailed as a major step forward for biosimilars in the United States, “It’s not the only plan that’s going to exist,” said the FDA's Leah Christl, PhD.

New research from Avalere suggests that moving Part B drugs into Part D could result in higher out-of-pocket costs for beneficiaries with rheumatoid arthritis (RA) unless policy changes are made to reduce Part D cost sharing.

This week, the insurer rolled out some of the changes it will be implementing in its Medicare Advantage (MA) plans as of January 1, 2019.

Ireland’s Medicines Management Program (MMP), a body that promotes cost-effective drug prescribing, has opened a consultation related to its roadmap for prescribing best-value biologics in the Irish healthcare setting. Under the roadmap, the MMP will review the use of currently reimbursed anti–tumor necrosis factor (TNF) therapies, which represent the highest-expenditure category for Ireland’s reimbursement plan.

“When we change the rules, the market players will reorganize their businesses to fit the new world. And it will be a very different world for American drug pricing," said HHS Secretary Alex Azar.

October 16 marks European patent expiry for AbbVie’s blockbuster anti–tumor necrosis factor drug, adalimumab (Humira), and multiple competitors stand ready to launch their biosimilar products on, or shortly after, that date.

As US healthcare increasingly moves toward value-based payment approaches, biosimilars, which reduce costs while maintaining treatment quality, can be an important driver of value. However, according to a white paper, a new framework for assessing the value of biosimilars is warranted.

The Association of European Cancer Leagues, a nonprofit, pan-European organization of national and regional cancer societies, has issued a new white paper that calls for greater biosimilar use as a means to reduce costs and increase patient access to cancer treatment.

Earlier this month, the United States, Mexico, and Canada entered into the United States–Mexico–Canada Agreement, or USMCA, an updated version of the North American Free Trade Agreement. Since the details of the agreement were released, the pharmaceutical intellectual property portions of the deal have come under scrutiny.

Using electronic health records (EHRs) to create a learning healthcare system, say the authors, can enable researchers to generate new knowledge that will accrue benefits to future generations of patients.

The United States House of Representatives has passed the Patient Right to Know Drug Prices Act. The bill will now be sent to the President for his consideration, as the Senate already passed the bill earlier last month with an overwhelming majority of 92 to 2.

Merck’s infliximab biosimilar, sold as Renflexis and approved by the FDA in April of last year, was determined to be the lowest priced infliximab option available to the US Department of Veterans Affairs (VA), and was awarded a national contract. Subsequently, it has become the sole infliximab product available on the VA's National Formulary.

The United Kingdom has opened a consultation on provisions that it hopes will ensure the supply of medicines in the event that no agreement can be made between the United Kingdom and the European Union before the Brexit deadline.

The Association for Accessible Medicines (AAM) and the Biosimilars Council (a division of AAM) have submitted comments to the FDA in reference to its Biosimilar Action Plan.

The poll found that 82% of Republicans, 92% of Democrats, and 91% of Independents polled supported legislation to limit nonmedical switching.

In the United States, biosimilar launches have been met with disappointment over what many view as too-shallow discounts to reference products’ list prices. However, as Aurelio Arias, a consultant at IQVIA, explained during the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, the substantial savings that the European market has realized with biosimilars are not necessarily reflected in list prices, either.

According to an unofficial estimate by the Congressional Budget Office, the Biosimilars Competition Act of 2018 will save about $100 million from 2019 to 2028.

In recent years, payers in Europe have been increasing their scrutiny of new therapies as increasingly high-cost drugs come to the market. And while the United States does not have the same cost constraints as the single-payer health systems, it too faces heightened pressures to lower costs in order to afford innovative therapies.

Fraser Cummings, MBChB, DPhil, led one of the first clinical teams to switch patients receiving the reference infliximab (Remicade) to CT-P13 (Remsima) in UK clinical practice. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Cummings explained his experience with this switch in his gastroenterology clinic, and looked ahead to the arrival of adalimumab biosimilars in the National Health Service (NHS).