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Our Take: As FDA approves first interchangeable insulin biosimilar, insurers take steps to restrict use of biosimilars

Aug 02, 2021

On Wednesday, the FDA announced its approval of the first interchangeable biosimilar insulin product, Viatris and Biocon Biologics’ Semglee (insulin glargine-yfgn). Semglee is indicated for adult and pediatric patients with type 1 and type 2 diabetes.

The agency noted that Semglee “is both biosimilar to, and interchangeable with,” Lantus, a long-acting insulin analog developed and marketed by Sanofi.

Although the FDA approved Semglee in June 2020 under the generic 505(b)(2) New Drug Application pathway (as it did Eli Lilly and Boehringer Ingelheim’s Basaglar [insulin glargine] follow-on product in 2015 and Sanofi’s Admelog [insulin lispro] follow-on product in 2017), Semglee did not have “interchangeable” status at that time.

That meant physicians had to specifically prescribe Semglee or approve it as a substitute for Lantus.

In March 2020, the FDA implemented the 351(k) regulatory pathway, which allows insulins and certain other biologic drugs that traditionally have been approved as drugs to instead be approved as interchangeable biosimilars. Pharmacies can substitute an approved interchangeable biosimilar product for the reference product, also called the originator, without having to contact the prescriber — as long as state law permits.

Mylan (which merged with Pfizer’s Upjohn division to form Viatris last December) and Biocon Biologics launched Semglee in the U.S. under the original FDA approval last August and filed a separate application for approval of Semglee as an interchangeable biosimilar. The application for interchangeable status requires additional information.

Viatris and Biocon Biologics said in a press release that the current product would be transitioned to the 351(k) interchangeable product over the next few months, and the interchangeable product would be introduced before the end of the year. The companies are eligible for a 12-month period of exclusivity, during which the FDA cannot approve another biosimilar interchangeable to Lantus.

Modern Healthcare reported that a month’s supply of Semglee injector pens costs $150 to $190, without insurance, whereas an equivalent supply of Lantus pens costs $340 to $520.

The new interchangeable designation could help to alleviate concerns about substituting biosimilars for their reference product. Because biologics are grown from living organisms, they can mimic the reference product but they can’t always precisely duplicate it the same way a generic drug can duplicate a brand-name product.

As a result, there can be some variation in efficacy between a biosimilar and its reference product. That variation can sometimes affect how well a biosimilar will work for a specific patient.

The FDA said its approval of Semglee as an interchangeable biosimilar was based on evidence that showed it was highly similar to Lantus and there are no clinically meaningful differences between the two products in terms of safety, purity, and potency. Further, the evidence showed that Semglee can be expected to produce the same clinical results as Lantus in any given patient and that the risks in terms of safety or diminished efficacy of switching between Semglee and Lantus are not greater than the risk of using Lantus without such switching.

That last part is important: The risks of switching between the biosimilar and the reference product are not higher than the risk of using the reference product and not switching.

It could have implications for payers as they determine their coverage policies for biologic therapies and their biosimilars.

Modern Healthcare published an article last week about policies that UnitedHealthcare, Cigna, and Aetna have implemented this year that either  basically force their members to switch to biosimilars or restrict the dosage of a biologic therapy members can receive. Cigna even launched a new program in June that encourages members to switch from Remicade (infliximab) to biosimilars Avsola or Inflectra by offering them a one-time $500 debit card.

Earlier this year, the American Gastroenterological Association (AGA) published an article titled “Fighting back against payer coverage policies.” The article describes the organization’s interactions with UnitedHealthcare regarding the insurer’s decision to include Avsola and Inflectra on its preferred list and move Remicade and a third biosimilar, Renflexis, to its nonpreferred list.

AGA said it was able to “reconcile the policy and knowledge gaps” with UnitedHealthcare through coordinated efforts with the insurer and other medical associations.

And the American Academy of Ophthalmology just issued a news release on Thursday about insurers “pushing” biosimilars to Avastin that could damage vision — even though the manufacturers of the biosimilars are advising against such use because there is no clinical evidence to support it.

Our Take: It’s not unexpected that insurers are trying to get their members to use biosimilars. After all, the more they can trim costs, the better it is for their shareholders.

Years ago, payers played a key role in convincing the public that switching from brand-name drugs to generics was a good idea. They kept reiterating the message that generics are safe, they’re as effective as the brand-name product, and they save money.

Eventually, formularies grew from having two tiers to having four or more.

The problem with trying to repeat that process with biosimilars is the greater variation between the reference product and its biosimilars and among related biosimilars. Plus, insurers don’t typically specify which generic drug members should use instead of the brand-name drug, but they are choosing specific biosimilars.

Modern Healthcare pointed out another factor that needs to be considered: When infusion centers have to stock multiple versions of similar treatments, it can cause logistical problems in terms of storage — and the centers can lose their ability to negotiate pricing based on volume.

Ideally, physicians should be the ones to decide which treatments are clinically appropriate for their patients, and it’s encouraging to see that at least in some cases insurers are willing to show some flexibility in modifying their coverage policies.

We can see these policies adding to the administrative burden for many physicians, though, especially if they have to request exceptions in order for their patients to continue receiving a therapy that’s been working well. We can also see a lot of frustration for patients, along with the potential for decreased adherence and poorer outcomes.

Seems like more evidence of a broken health care system in which patients end up paying the price — one way or another. Maybe the FDA’s approval of Semglee as an interchangeable biosimilar is a small step in the right direction.

What else you need to know
Amgen will acquire Teneobio in a deal worth up to $2.5 billion. Privately held Teneobio has developed bispecific and multispecific antibody technologies that could accelerate the discovery of new drugs for “a wide range of important diseases across Amgen’s core therapeutic areas,” Amgen said in a press release. One candidate in Teneobio’s pipeline is an early-stage bispecific T cell-engager in development for the treatment of metastatic castrate-resistant prostate cancer. Amgen has agreed to pay $900 million in cash up front and up to $1.6 billion in contingent milestone payments. The transaction is expected to close by the end of the year if customary closing conditions are met. Last year, Gilead’s Kite Pharma entered into a license and collaboration agreement with Teneobio for potential CAR T therapies. In June, AbbVie bought TeneoOne, a spinoff of the Newark, Calif.-based company. Three other affiliates — TeneoTwo, TeneoFour, and TeneoTen — will be spun off to the company’s existing equity holders before the deal with Amgen closes.

Humana and Anthem are partnering with SS&C Technologies on a joint venture called DomaniRx, which SS&C described as “a next-generation claim adjudication and PBM platform” in its announcement. Danny Delmastro, general manager of DomaniRx, said the cloud-based platform will use insights drawn from “hundreds of millions of claims transactions” to provide participating members with flexible tools, advanced analytics, and customizable programs while increasing transparency, accessibility, and service quality. A filing with the Securities and Exchange Commission shows an initial cash contribution of $138.3 million, with SS&C holding an 80.2% interest and Humana and Anthem holding minority stakes. SS&C said Humana is DomaniRx’s first customer.

Amwell signed definitive agreements to acquire two digital companies — SilverCloud Health and Converse Health — to enhance its virtual care platform. Boston-based SilverCloud Health is a digital mental health platform with headquarters in London and Dublin. Converse Health, based in Portland, Ore., provides automated virtual health care by using an AI chatbot to engage patients in text-based conversations. Amwell said in a press release that it would pay a total of approximately $320 million in stock and cash for the two companies and expects the transactions, which are subject to the usual closing conditions, to be completed in the third quarter.

Humana is suing Regeneron Pharmaceuticals for allegedly inflating the price of Eylea (aflibercept), a drug used to treat wet age-related macular degeneration (AMD), and then providing “illegal kickbacks disguised as donations” to the Chronic Disease Foundation to cover patients’ cost-sharing obligations for Eylea but not for alternatives such as Avastin (bevacizumab), a significantly less expensive drug marketed by Genentech. (Editor’s note: Avastin is not approved for wet AMD but is commonly used off label to treat the disease.) In doing so, Humana claims, Regeneron influenced patients enrolled in Medicare plans to choose Eylea, leaving contracted payers to cover the rest of the cost of the drug. Humana is reportedly seeking upward of $2.7 billion in compensatory and punitive damages. The Department of Justice filed a similar complaint against Regeneron a year ago. A spokeswoman for Regeneron said both lawsuits are without merit.

UPMC’s board of directors chose Leslie Davis to succeed Jeffrey Romoff as president and CEO, effective Aug. 1, the health system announced Wednesday. Romoff, who has been with UPMC for 48 years and has led the organization since 1992, will stay on as president emeritus until Oct. 1 to assist with the transition. Davis has been with UPMC for 17 years, serving most recently as president of the organization’s health services division.

What we’re reading
The Growing Problem of Out-of-Pocket Costs and Affordability in Employer-Sponsored Insurance. JAMA, 7.9.21
Health Equity And Value-Based Payment Systems: Moving Beyond Social Risk Adjustment. Health Affairs, 7.28.21
Audio Interview: Looking Back and Looking Forward. NEJM, 7.29.21

What else we’re reading
Predictably Irrational: The Hidden Forces That Shape Our Decisions, by Dan Ariely.

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