Market access

MMIT Reality Check on Acute Migraine (3Q2023)

A review of market access for acute migraine treatments shows that under the pharmacy benefit, about 47% of the lives under commercial formularies are covered with utilization management restrictions. Around 41% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Now That Humira Biosimilars Have Launched, What Are Lessons Learned for Stelara Biosimilars?

Following the launch of almost 10 biosimilars of AbbVie Inc.’s Humira (adalimumab) this year, 2025 will be another big year for the U.S. biosimilar market, when no less than three versions of Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson are set to become available. Having the experience of assessing multiple competitors with varying attributes could help payers as they prepare for the launches, say industry experts.

Stelara is a human interleukin-12 (IL-12) and -23 (IL-23) antagonist indicated for the treatment of adults with moderately to severely active Crohn’s disease, adults with moderately to severely active ulcerative colitis, people at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 years old with active psoriatic arthritis.

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MMIT Reality Check on Breast Cancer HR+/HER2- (3Q2023)

A review of market access for treatments of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) shows that under the pharmacy benefit, about 48% of the lives under commercial formularies are covered with utilization management restrictions. Around 38% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Now That Humira Biosimilars Have Launched, What Are Lessons Learned for Stelara Biosimilars?

Following the launch of almost 10 biosimilars of AbbVie Inc.’s Humira (adalimumab) this year, 2025 will be another big year for the U.S. biosimilar market, when no less than three versions of Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson are set to become available. Having the experience of assessing multiple competitors with varying attributes could help payers as they prepare for the launches, say industry experts.

Stelara is a human interleukin-12 (IL-12) and -23 (IL-23) antagonist indicated for the treatment of adults with moderately to severely active Crohn’s disease, adults with moderately to severely active ulcerative colitis, people at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 years old with active psoriatic arthritis.

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Payers Are Reluctant to Offer Commercial Coverage for Alzheimer’s Drug Leqembi

When the FDA in July granted full approval to the Alzheimer’s drug Leqembi (lecanemab), CMS followed with a swift announcement that Medicare will cover it — although just for people with a specific diagnosis who have a physician willing to participate in a qualifying clinical registry. However, payers so far seem reluctant to cover the drug for their commercially insured populations, which represent a smaller but still important portion of the addressable market for Leqembi.

Two Pennsylvania-based insurers — Highmark Inc. and Independence Blue Cross — are taking heat for deciding not to cover the drug for their commercial members. A Philadelphia-area neurology practice recently sent them a critical open letter that claims the insurers are wrong to deem Leqembi “experimental.”

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MMIT Reality Check on Non-Small Cell Lung Cancer Systemic Therapy (3Q2023)

A review of market access for non-small cell lung cancer systemic therapy treatments shows that under the pharmacy benefit, about 38% of the lives under commercial formularies are covered with utilization management restrictions. Around 67% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Uncertainties Still Loom Over IRA Negotiations

The guessing game surrounding the identities of the first 10 drugs to be selected for Medicare price negotiations under the Inflation Reduction Act (IRA) finally ended on Aug. 29 when CMS published the list of agents. While many on the list were expected, there were still a few surprises, and other uncertainties around the process remain, industry experts say.

The first 10 Medicare Part D drugs selected by CMS to be negotiated — listed in order of their total Part D gross covered prescription drug cost from June 1, 2022, through May 31, 2023 — are:

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Majority of Drugs Selected for Price Negotiation Are on ‘Preferred’ Tiers in Medicare

Major blood thinners are among the first 10 prescription drugs for which the Biden administration will seek lower Medicare prices as part of the Inflation Reduction Act (IRA). The negotiated prices will be announced on Sept. 1, 2024, and go into effect in 2026.

Medicare beneficiaries who filled prescriptions for the 10 selected drugs paid a total of $3.4 billion in out-of-pocket costs for those therapies in 2022. The Medicare program paid more than $50 billion for the drugs between June 2022 and May 2023, CMS reported. Bristol Myers Squibb’s blood thinner Eliquis (apixaban) alone accounted for more than $16 billion.

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MMIT Reality Check on Ulcerative Colitis (3Q2023)

A review of market access for ulcerative colitis treatments shows that under the pharmacy benefit, about 54% of the lives under commercial formularies are covered with utilization management restrictions. Around 32% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Majority of Drugs Selected for Price Negotiation Are on ‘Preferred’ Tiers in Medicare

Major blood thinners are among the first 10 prescription drugs for which the Biden administration will seek lower Medicare prices as part of the Inflation Reduction Act (IRA). The negotiated prices will be announced on Sept. 1, 2024, and go into effect in 2026.

Medicare beneficiaries who filled prescriptions for the 10 selected drugs paid a total of $3.4 billion in out-of-pocket costs for those therapies in 2022. The Medicare program paid more than $50 billion for the drugs between June 2022 and May 2023, CMS reported. Bristol Myers Squibb’s blood thinner Eliquis (apixaban) alone accounted for more than $16 billion.

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