Preview: RADAR on Drug Benefits

Will Two New PBM Startups Deliver Savings, Transparency?

October 28, 2021

Two new PBMs entered the game in recent weeks: EmsanaRx, a not-for-profit venture owned by the Purchaser Business Group on Health (PBGH), and CostPlus PBM, a startup funded by venture capitalist and Dallas Mavericks owner Mark Cuban as part of his larger foray into the pharmaceutical business. Like other recent PBM startups, both ventures claim they will be more transparent and client-focused than the Big Three PBMs (Cigna Corp.’s Express Scripts, CVS Health Corp.’s Caremark and UnitedHealth Group’s OptumRx) — but health care insiders say those promises are hard to keep.

Both PBMs will begin serving clients in 2023. EmsanaRx will start by serving a small number of PBGH members that year. It will eventually be open to any purchasing entity but will not pursue business on a large scale. On the other hand, CostPlus PBM has aggressive growth targets: Its CEO, Alex Oshmyansky, M.D., Ph.D., tells AIS Health, a division of MMIT, that the company will “absolutely” seek to grow to Big Three size.

Two new PBMs entered the game in recent weeks: EmsanaRx, a not-for-profit venture owned by the Purchaser Business Group on Health (PBGH), and CostPlus PBM, a startup funded by venture capitalist and Dallas Mavericks owner Mark Cuban as part of his larger foray into the pharmaceutical business. Like other recent PBM startups, both ventures claim they will be more transparent and client-focused than the Big Three PBMs (Cigna Corp.’s Express Scripts, CVS Health Corp.’s Caremark and UnitedHealth Group’s OptumRx) — but health care insiders say those promises are hard to keep.

CostPlus PBM will begin serving clients in plan year 2023, while EmsanaRx will serve some clients starting in plan year 2022. EmsanaRx hopes to win the business of several PBGH members starting in 2023. CostPlus PBM has aggressive growth targets: Its CEO, Alex Oshmyansky, M.D., Ph.D., tells AIS Health, a division of MMIT, that the company will “absolutely” seek to grow to Big Three size.

“We’re nothing if not ambitious,” Oshmyansky says. “My goal is somewhere around 100,000 lives in 2023, and hopefully growing from there.”

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Savings From Interchangeable Biosimilars May Be Muted

Infographic: Current Market Access to Lantus, Basaglar

October 28, 2021

The month of October brought two important developments for interchangeable biosimilars, which industry observers have long hoped will help increase uptake of lower-cost versions of complex biologic drugs.

On Oct. 15, the FDA approved Cyltezo, the first interchangeable biosimilar version of blockbuster autoimmune condition treatment Humira. And on Oct. 20, Cigna Corp.-owned Express Scripts revealed that it will now prefer Semglee — the first FDA-approved interchangeable biosimilar on the U.S. market — over the branded long-acting insulin Lantus on the PBM’s largest formulary.

The month of October brought two important developments for interchangeable biosimilars, which industry observers have long hoped will help increase uptake of lower-cost versions of complex biologic drugs.

On Oct. 15, the FDA approved Cyltezo, the first interchangeable biosimilar version of blockbuster autoimmune condition treatment Humira. And on Oct. 20, Cigna Corp.-owned Express Scripts revealed that it will now prefer Semglee — the first FDA-approved interchangeable biosimilar on the U.S. market — over the branded long-acting insulin Lantus on the PBM’s largest formulary.

Experts tell AIS Health that while both moves are a promising sign for the still-developing U.S. biosimilar market, there are entrenched barriers that may prevent Cyltezo and Semglee from making a big impact on overall costs.

“It’s encouraging that we have the possibility of interchangeable drugs. We have two [biosimilars] that have been deemed interchangeable; that will definitely help with the uptake of biosimilars [and] move people more toward realizing the savings from it,” says Renee Rayburg, R.Ph., vice president of specialty clinical consulting at Pharmaceutical Strategies Group, an EPIC company. “But at the same time, there’s other market dynamics, and you can’t forget that the reference products are still available, and they have a play in this game.”

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Eli Lilly Pounces on Flailing Aduhelm With Competing Drug

October 28, 2021

Eli Lilly & Co. has announced plans to run a head-to-head clinical trial of its Alzheimer’s drug, donanemab, against Aduhelm (aducanumab), the controversial Biogen Inc. Alzheimer’s drug. Meanwhile, Aduhelm has continued to have what one expert calls “the worst drug launch ever,” after state Medicaid leaders told CMS they want no part of paying for the drug.

In its third-quarter results, Biogen reported in a Securities and Exchange Commission filing that Aduhelm revenues totaled $300,000, citing the fact that many clinicians don’t want to prescribe the drug. Meanwhile, Eli Lilly & Co.’s donanemab is under an accelerated approval process. That process will include a Phase III study comparing donanemab directly to Aduhelm, according to Daniel Skovronsky, M.D., Ph.D., a Lilly senior vice president and its chief scientific and medical officer.

Eli Lilly & Co. has announced plans to run a head-to-head clinical trial of its Alzheimer’s drug, donanemab, against Aduhelm (aducanumab), the controversial Biogen Inc. Alzheimer’s drug. Meanwhile, Aduhelm has continued to have what one expert calls “the worst drug launch ever,” after state Medicaid leaders told CMS they want no part of paying for the drug.

In its third-quarter results, Biogen reported in a Securities and Exchange Commission filing that Aduhelm revenues totaled $300,000, citing the fact that many clinicians don’t want to prescribe the drug. Meanwhile, Eli Lilly & Co.’s donanemab is under an accelerated approval process. That process will include a Phase III study comparing donanemab directly to Aduhelm, according to Daniel Skovronsky, M.D., Ph.D., a Lilly senior vice president and its chief scientific and medical officer.

The firm will “conduct a head-to-head Phase III study comparing donanemab to aducanumab to assess superiority of brain amyloid plaque clearance in early symptomatic Alzheimer’s disease.…This study, TRAILBLAZER-ALZ 4, is expected to begin enrollment this year and we expect to share primary endpoint data in the second half of 2022,” Skovronsky said during Lilly’s third-quarter 2021 earnings conference call, according to a transcript prepared by the Motley Fool.

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Medication Abortion Regulations, at a Glance

October 28, 2021

Medication abortion — which involves using two drugs, mifepristone and misoprostol — accounts for 54% of all pregnancy terminations before nine weeks of gestation in the U.S., according to a recent Kaiser Family Foundation analysis. The FDA’s Center for Drug Evaluation and Research exercised “enforcement discretion” of the Risk Evaluation and Mitigation Strategy requirement that asks prescribers to dispense mifepristone to patients in-person during the pandemic. This allows providers in 32 states and the District of Columbia that do not have laws that ban medication abortion to dispense mifepristone via telehealth. Currently, 18 states and D.C. allow both advance practice clinicians and medical doctors to dispense abortion pills.

Medication abortion — which involves using two drugs, mifepristone and misoprostol — accounts for 54% of all pregnancy terminations before nine weeks of gestation in the U.S., according to a recent Kaiser Family Foundation analysis. The FDA’s Center for Drug Evaluation and Research exercised “enforcement discretion” of the Risk Evaluation and Mitigation Strategy requirement that asks prescribers to dispense mifepristone to patients in-person during the pandemic. This allows providers in 32 states and the District of Columbia that do not have laws that ban medication abortion to dispense mifepristone via telehealth. Currently, 18 states and D.C. allow both advance practice clinicians and medical doctors to dispense abortion pills.

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News Briefs

October 28, 2021

During Centene Corp.’s Oct. 26 conference call to discuss third-quarter 2021 financial results, executives said the insurer will issue a request for proposals (RFP) in 2022 for PBM services. The move — which comes as Centene has been settling a spate of lawsuits filed by states over its PBM practices — is “going to be a huge opportunity for an external PBM,” Chief Financial Officer Drew Asher said during the company’s call with analysts. In addition to using its own internal PBM, Envolve Pharmacy Solutions, and a cloud-based platform that it has invested in, RxAdvance, Centene has a contract with CVS Health Corp.’s Caremark that expires at the end of 2023. The goal of putting out an RFP is to stay “sharp relative to our external partners” and to glean the “greatest economic benefit where we are leveraging an external partner” for a core capability, said Sarah London, vice chairman of Centene’s board of directors.

During Centene Corp.’s Oct. 26 conference call to discuss third-quarter 2021 financial results, executives said the insurer will issue a request for proposals (RFP) in 2022 for PBM services. The move — which comes as Centene has been settling a spate of lawsuits filed by states over its PBM practices — is “going to be a huge opportunity for an external PBM,” Chief Financial Officer Drew Asher said during the company’s call with analysts. In addition to using its own internal PBM, Envolve Pharmacy Solutions, and a cloud-based platform that it has invested in, RxAdvance, Centene has a contract with CVS Health Corp.’s Caremark that expires at the end of 2023. The goal of putting out an RFP is to stay “sharp relative to our external partners” and to glean the “greatest economic benefit where we are leveraging an external partner” for a core capability, said Sarah London, vice chairman of Centene’s board of directors.

A new AHIP analysis, which examined financial filings from the 10 largest pharmaceutical companies by revenue in 2020, found that seven spent more on selling and marketing expenses than research and development (R&D). The insurer trade group especially highlighted AbbVie, Bayer and Johnson & Johnson as spending amounts on sales and marketing that dwarfed their spending on R&D. “Big Pharma’s practices clearly show that their growth strategy is based on selling a greater volume of drugs to patients — not on creating groundbreaking new therapies and delivering more value to patients,” AHIP concluded. “We do not have to choose between innovation and the affordability of prescription drugs.”

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