Market access

MMIT Reality Check on Multiple Sclerosis (1Q2023)

A review of market access for multiple sclerosis treatments shows that under the pharmacy benefit, about 62% of the lives under commercial formularies are covered with utilization management restrictions. Around 47% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Economy, IRA, Pharma Competition May Impact Industry in 2023

The pharmaceutical industry likely will continue to battle challenges posed by a variety of factors in 2023, including global economic issues, competition and the Inflation Reduction Act (IRA). The biosimilars space in particular is expected to undergo a change as the world’s top selling drug, AbbVie Inc.’s Humira (adalimumab), finally faces competition from a number of companies. But industry experts tell AIS Health, a division of MMIT, that they expect a number of positive developments in the space in 2023.

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New Law Could Make Accelerated Approval Stricter, If FDA Enforces It

The FDA’s accelerated approval pathway will see major changes following December’s passage of the Consolidated Appropriations Act, 2023 (2023 CAA), the latest version of the annual legislation that funds the federal government. Experts say that the changes should force drugmakers to be more diligent about proving the clinical value of their early-stage pharmaceuticals — as long as the FDA uses its enforcement powers.

Stakeholders across the health care system have criticized the FDA’s approach to accelerated approval in recent years. The agency’s critics say that it has taken a lax approach, granting accelerated approval to drugs of dubious clinical value, which ultimately costs the health care system billions. In particular, the FDA’s move to grant accelerated approval to Biogen Inc.’s Alzheimer’s drug Aduhelm (aducanumab) faced criticism from researchers, medical practitioners, health systems and insurers. In addition, a recent congressional report documented ethical lapses by agency employees during the accelerated approval process for Aduhelm, and the HHS Office of Inspector General is currently investigating the agency’s decision.

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MMIT Reality Check on Macular Edema (1Q2023)

A review of market access for macular edema treatments shows that under the pharmacy benefit, about 30% of the lives under commercial formularies are covered with utilization management restrictions. Around 58% of the lives under Medicare formularies are not covered for at least one of the drugs.

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ICER Report Aims to Nudge Payers Toward Fairer Drug Coverage Policies

In a new analysis that assesses whether major formularies provide “fair access” to select prescription drugs, payers achieved high scores in most categories. But industry observers as well as the organization behind the report, the Institute for Clinical and Economic Review (ICER), say that conclusion may not be the most important takeaway.

ICER — which is best known for its assessments of prescription drugs’ cost-effectiveness — says in a press release that “one of the most notable results of this effort is the change in coverage policies made by five payers for 11 drugs following receipt of draft results of the assessment.”

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Amazon Offers Subscription Scripts, Optum Rx to Roll Up Coupons for Members

UnitedHealth Group’s Optum Rx PBM is rolling out a new price shopping tool, while Amazon.com Inc.’s pharmacy division is offering a flat-rate monthly prescription service to Prime members. Experts tell AIS Health, a division of MMIT, that the new offerings are signs that disruptors like Amazon, Mark Cuban Cost Plus Drug Co. and GoodRx Inc. are mounting an effective challenge to traditional generics coverage inside the pharmacy benefit.

Amazon’s new offering, RxPass, will allow members to pay a flat fee of $5 per month to fill any combination of 52 eligible generics, plus free delivery, per a Jan. 24 press release. RxPass will be available in 42 states.

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New Law Could Make Accelerated Approval Stricter, If FDA Enforces It

The FDA’s accelerated approval pathway will see major changes following December’s passage of the Consolidated Appropriations Act, 2023 (2023 CAA), the latest version of the annual legislation that funds the federal government. Experts say that the changes should force drugmakers to be more diligent about proving the clinical value of their early-stage pharmaceuticals — as long as the FDA uses its enforcement powers.

Stakeholders across the health care system have criticized the FDA’s approach to accelerated approval in recent years. The agency’s critics say that it has taken a lax approach, granting accelerated approval to drugs of dubious clinical value, which ultimately costs the health care system billions. In particular, the FDA’s move to grant accelerated approval to Biogen Inc.’s Alzheimer’s drug Aduhelm (aducanumab) faced criticism from researchers, medical practitioners, health systems and insurers. In addition, a recent congressional report documented ethical lapses by agency employees during the accelerated approval process for Aduhelm, and the HHS Office of Inspector General is currently investigating the agency’s decision.

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MMIT Reality Check on Epilepsy (1Q2023)

A review of market access for epilepsy treatments shows that under the pharmacy benefit, about 35% of the lives under commercial formularies are covered with utilization management restrictions. Around 11% of the lives under Medicare formularies are not covered for at least one of the drugs.

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For Now, New Alzheimer’s Treatment Is Subject to Limited Medicare Coverage

Marking the second approval of an Alzheimer’s disease treatment aimed at slowing cognitive decline by reducing amyloid plaque buildup on the brain, the FDA on Jan. 6 granted accelerated approval to Biogen and Eisai, Co., Ltd.’s Leqembi (lecanemab-irmb). For now, the drug remains subject to the restrictive National Coverage Determination that Medicare initially gave its predecessor, Aduhelm (aducanumab-avwa), and similar Alzheimer’s treatments last year, but CMS could consider broader coverage if the drug receives traditional FDA approval.

The drug is indicated for the treatment of Alzheimer’s disease in people with mild cognitive impairment or mild dementia. Patients must have confirmed presence of amyloid beta pathology before starting treatment. The FDA gave the humanized immunoglobulin gamma 1 monoclonal antibody fast track, priority review and breakthrough therapy designations. Japanese pharmaceutical company Eisai developed the drug and will co-market it with its U.S. partner Biogen, which launched Aduhelm in 2021 and had to halve its price from $56,000 a year to $28,000. Eisai estimates the cost of Leqembi will be $26,500 per year, though the actual price could vary by patient.

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MMIT Reality Check on Non-Small Cell Lung Cancer ALK+ or ROS1+ (1Q2023)

A review of market access for non-small cell lung cancer ALK+ or ROS1+ treatments shows that under the pharmacy benefit, about 72% of the lives under commercial formularies are covered with utilization management restrictions. Only 4% of the lives under Medicare formularies have access to at least one of the drugs without utilization management restrictions.

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