Market access

In a move derided by some health care stakeholders and applauded by others — including private payers — CMS on April 7 finalized its National Coverage Determination (NCD) for an Alzheimer’s treatment that has been steeped in controversy since it received accelerated approval last June.

The final coverage decision largely affirmed what CMS had proposed in its draft NCD: Medicare will cover Biogen Inc.’s Aduhelm (aducanumab) only for patients enrolled in randomized, controlled clinical trials conducted either through the FDA or the National Institutes of Health. Patients also must have a clinical diagnosis of mild cognitive impairment due to Alzheimer’s disease or mild dementia with a confirmed presence of plaque on the brain.

Large numbers of Medicare beneficiaries who are ineligible for low-income subsidies and have been prescribed high-price prescription drugs for conditions such as cancer don’t initiate their treatment, likely because they can’t afford it, according to new research published in Health Affairs. One of the study’s authors tells AIS Health that severe illness is a possible outcome of noninitiation in the studied clinical areas and adds that proposals under consideration in Congress to cap out-of-pocket spending for Medicare beneficiaries would make a big difference to the affected patients.

According to the paper, “among beneficiaries without subsidies, we observed noninitiation for 30 percent of prescriptions written for anticancer drugs, 22 percent for hepatitis C treatments, and more than 50 percent for disease-modifying therapies for either immune system disorders or hypercholesterolemia.”

A review of market access for treatments of adults with acute myeloid leukemia (AML) shows that under the pharmacy benefit, about 68% of the lives under commercial formularies are covered with utilization management restrictions. Around 7% of the lives under Medicare formularies are not covered for at least one of the drugs.

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.

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.

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.

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.

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.

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.

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.)