Market access

A review of market access for schizophrenia treatments shows that under the pharmacy benefit, about 27% of the lives under commercial formularies are covered with utilization management restrictions. Around 10% of the lives under Medicare formularies are not covered for at least one of the drugs.

This summer, Opill (norgestrel) became the first over-the-counter (OTC) daily contraceptive pill approved by the FDA, and it’s slated to hit the U.S. market in early 2024. However, Opill’s OTC designation — which on the surface would seem to increase access to birth control — may have the opposite effect for patients seeking reimbursement from their health plans, experts said during a recent KFF web event.

“Having over-the-counter contraceptives is definitely a positive step,” said Christine Gilroy, M.D., chief medical officer of The Cigna Group’s PBM, Express Scripts. “I am concerned, though, that while it removes the barrier of needing to pay for a physician visit and get a prescription from the physician…in order to be processed against a pharmacy benefit, it does need to be entered into a system that essentially turns it into a prescription.”

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.

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.

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.

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.

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.”

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.

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:

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.