Market access

MMIT Reality Check on Chronic Obstructive Pulmonary Disease

A review of market access for treatments of adults with chronic obstructive pulmonary disease (COPD) shows that under the pharmacy benefit, about 13% of the lives under commercial formularies are covered with utilization management restrictions. Around 29% of the lives under Medicare formularies are not covered for at least one of the drugs.

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MMIT Reality Check on Heterozygous Familial Hypercholesterolemia

A review of market access for treatments of adults with heterozygous familial hypercholesterolemia (HeFH) shows that under the pharmacy benefit, about 65% of the lives under commercial formularies are covered with utilization management restrictions. Around 45% of the lives under Medicare formularies are not covered for at least one of the drugs.

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After Aduhelm, Congress May Revamp Accelerated Approvals

The FDA’s accelerated approval of Alzheimer’s drug Aduhelm (aducanumab) last year was extremely controversial, prompting harsh criticism and calls for reform of the accelerated approval process itself. Congress has taken up the issue and is considering one bill from each major party that would revamp the process in the hope of addressing concerns that the pathway has allowed flawed drugs to stay on the market without being revisited.

Medical research and health care policy experts have raised a number of critiques of the current accelerated approval framework. Two critiques stand out: The first concerns the quality of data used in measuring the effectiveness of accelerated approval drugs. After a drug is granted accelerated approval, the FDA mandates that the drug be evaluated using confirmatory clinical trials. Experts have criticized the quality of data collected for accelerated approval drugs; in particular, the measurements used to gain approval for Aduhelm were heavily criticized by clinicians.

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MMIT Reality Check on Immune Globulin (PID)

A review of market access for treatments of primary humoral immunodeficiency (PID) disease shows that under the pharmacy benefit, about 49% of the lives under commercial formularies are covered with utilization management restrictions. Around 25% of the lives under Medicare formularies are not covered for at least one of the drugs.

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MMIT Reality Check on Non-Small Cell Lung Cancer EGFR-Mutated

A review of market access for non-small cell lung cancer epidermal growth factor receptor (EGFR)-mutated treatments shows that under the pharmacy benefit, about 55% of the lives under commercial formularies are covered with utilization management restrictions. Around 29% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Nonprofit Will Sell $30 Insulin Direct to Patients Starting in 2024

CivicaRx, the nonprofit drug manufacturer owned by a consortium of health systems and health plans, aims to release a line of three insulins — glargine (Lantus), lispro (Humalog) and aspart (Novolog) — as soon as 2024. Those insulins will be available in vials or prefilled pens and will be priced at “no more than $30 per vial and no more than $55 for a box of five pen cartridges” for all consumers, regardless of whether they have insurance; the products will soon be submitted for review for interchangeable biosimilar approval by the FDA.

The CivicaRx initiative could do something that existing proposals to cap the price of insulin would not: It may actually lower the list price of insulin products. Ge Bai, Ph.D., tells AIS Health, a division of MMIT, that she expects the insulins will set the standard price in their category when they become available. (Bai, a professor at Johns Hopkins University’s schools of business and public health, has authored several publications with Dan Liljenquist, an executive at the Intermountain Healthcare hospital system and the chair of CivicaRx’s board.)

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MMIT Reality Check on Crohn’s Disease

A review of market access for Crohn’s disease treatments shows that under the pharmacy benefit, about 53% of the lives under commercial formularies are covered with utilization management restrictions. Around 48% of the lives under Medicare formularies are not covered for at least one of the drugs.

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MMIT Reality Check on HIV

A review of market access for HIV treatments shows that under the pharmacy benefit, about 11% of the lives under commercial formularies are covered with utilization management restrictions. Around 14% of the lives under Medicare formularies are not covered for at least one of the drugs.

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MMIT Reality Check on Type 2 Diabetes (GLP-1 and Combo)

A review of market access for type 2 diabetes (GLP-1 and combo) treatments shows that under the pharmacy benefit, about 47% of the lives under commercial formularies are covered with utilization management restrictions. Around 12% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Big 3 Implement Conflicting Formulary Exclusions on Biosimilars

The Big Three PBMs — Cigna Corp.’s Express Scripts, UnitedHealth Group’s OptumRx, and CVS Health Corp.’s Caremark — once again added new drugs to their formulary exclusion lists for the 2022 plan year, but the rate of new exclusions slowed. Industry insiders tell AIS Health, a division of MMIT, that the slowing amount of exclusions indicates the PBMs find high value in opaque, complex contracting agreements with providers, even though certain preferences in areas like insulins, specialty drugs and biosimilars defy the logic of list prices.

According to an analysis of plan documents by Adam Fein, Ph.D., CEO of the Drug Channels Institute, Caremark now excludes 433 products from its formularies, Express Scripts excludes 485 and OptumRx excludes 492. Each amount sets a record number of exclusions for each company.

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