Biosimilar Policy Roundup: May 2019

In May 2019 policy news, bills touching on various aspects of biosimilars progressed through Congress, and HHS finalized 2 proposals affecting drug pricing. One state capped monthly insulin prices, while in Canada, one province will move patients taking reference biologics for rheumatological diseases and diabetes to biosimilars within 6 months.

In the House of Representatives, legislators passed pair of bills to make changes to the FDA’s Purple Book and Orange Book, which provide information on biosimilars and generic drugs, respectively. The Purple Book Continuity Act will require that the Purple Book be updated to include patent information similar in format and in requirements to what appears in the Orange Book, to disclose whether a product was deemed biosimilar or interchangeable, and to disclose whether it was considered for reference product exclusivity.

The Orange Book Transparency Act will require that drug makers update their information with the FDA in a timely fashion. For both books, the FDA would be required to solicit public comments on the kinds of information that should be listed.

The House also passed a long-awaited bill, the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (CREATES Act), as well as 2 other bills dealing with drug prices: the Protecting Consumer Access to Generic Drugs Act of 2019, and the Bringing Low-cost Options and Competition While Keeping Incentives for New Generics (BLOCKING) Act of 2019.

Whether or not the bills, which generally have bipartisan support, progress through the Senate and onto the president’s desk remains to be seen. The bills were packaged with other measures, supported only by Democrats, which target the Trump administration’s actions towards the Affordable Care Act.

On the Senate side, the Committee on Health, Education, Labor, and Pensions released bipartisan draft legislation, the Lower Health Care Costs Act, aimed at lowering the cost of healthcare. The package includes various proposals aimed at reducing the prices of prescription drugs, some of which feature biosimilars’ role in doing so.

Meanwhile, the Biosimilars Forum said that if Congress enacted other changes, the federal government and beneficiaries could save billions of dollars in Medicare Part B. Using a scoring analysis from Avalere Health, the industry group said using shared savings or add-on payments to providers to incentivize use of biosimilars could potentially reduce out-of-pocket costs and federal spending in the range of $1.9 billion to $5.2 billion between 2020 and 2029, and cut beneficiary costs by $2.2 billion to $3.3 billion.

Also during May, CMS issued a final rule that makes changes to Medicare Advantage and Medicare Parts D and B. Under the rule, Part D sponsors will still have to include on their formularies all drugs in the protected classes of antidepressants, antipsychotics, anticonvulsants, immunosuppressants for transplant rejection treatment, antiretrovirals, and antineoplastics. Part D sponsors can impose prior authorization and step therapy requirements, but only for new patients.

CMS did not finalize its intended plan to create exceptions that would have allowed Part D sponsors to exclude a protected class drug on the basis of price hikes, or to exclude a protected class drug if it represents only a new formulation of an existing product.

In addition, HHS set details of a finalized rule requiring list prices to be disclosed in pharmaceutical direct-to-consumer advertising on television. The price transparency effort is aimed at drugs covered by Medicare or Medicaid if the wholesale acquisition cost is $35 or more for a month’s supply. Affected drugs include adalimumab (Humira), with its wholesale acquisition cost (WAC) of $5174 per month, and etanercept (Enbrel), with its WAC of $5174 per month.

In Canada, British Columbia announced that patients currently taking reference biologics for rheumatological diseases and diabetes will be switched to biosimilar products within 6 months. The new policy will affect the approximately 20,400 British Columbians who have diabetes, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis. Patients will have 6 months to work with their healthcare providers to transition to a biosimilar from their current reference product, and after November 25, 2019, public coverage for reference products will not be provided, other than in exceptional cases (such as when physicians deem individual patients medically unable to transition).

In Colorado, the governor signed into law a measure capping the price of insulin at $100 a month for people with commercial insurance coverage. The bill also authorizes the state’s attorney general to investigate the rising price of insulin. The cap takes effect next year, although the investigation can begin immediately.

Given the concern about rising insulin prices, the FDA held a hearing about biosimilar insulins , 10 months before the products transition in March 2020 from the Food Drug and Cosmetic Act to biologics under the Public Health Service Act. The FDA workshop heard from a variety of stakeholders, including Vizient, Inc; Eli Lilly, maker of insulin lispro; Mylan; the JDRF; the American Diabetes Association; and the Association for Accessible Medicines, to name a few.

In patent-related policy news, a Federal Trade Commission (FTC) analysis found that, despite an increase in patent settlements concerning generic drugs, fewer settlements included the kinds of “pay-for-delay” provisions that are likely to be anticompetitive in nature. The document summarizes data on the 232 final patent settlements filed with the FTC and the Department of Justice during the financial year 2016.