Drug Pricing

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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News Briefs: Lilly Alzheimer’s Drug Fails to Win Accelerated Approval

The FDA declined to grant accelerated approval for Alzheimer’s disease treatment donanemab and requested additional data from its manufacturer, Eli Lilly & Co. said on Jan. 19. The move comes on the heels of the FDA’s decision to bestow accelerated approval on another Alzheimer’s treatment called Leqembi (lecanemab) from Biogen and Eisai — although a National Coverage Determination issued for Biogen’s Aduhelm (aducanumab) significantly limits who can access any drug in that class that receives accelerated approval. In its response letter to Lilly, the FDA cited “the limited number of patients with at least 12 months of drug exposure data provided in the submission” for accelerated approval as its justification for denying the application, and the agency asked Lilly to provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. Lilly said it expects to unveil results from its Phase III confirmatory trial in the second quarter of this year, and that “will form the basis of donanemab's application for traditional approval shortly thereafter.”

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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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Insulin-Pricing Lawsuit Adds to Growing Pressure on PBMs

The state of California filed a lawsuit this month against three major PBMs and three pharmaceutical companies, accusing them of inflating the cost of insulin and violating the state’s Unfair Competition Law.

Other states have had similar legislation pertaining to insulin costs, and the Federal Trade Commission (FTC) announced in June that it was examining the business practices of the six largest PBMs in the U.S., including the use of rebates for insulin medications. Still, David Kaufman, an attorney with Laurus Law Group LLC, tells AIS Health that the case in California could be significant and add to the growing pressure to make the PBM industry more transparent.

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MA, Part D Plans Face New Premium Calculus With Drug Price Negotiation

The coming year is unlikely to see any major new policy developments come out of the split Congress, but health insurers and other stakeholders will have their hands full figuring out the implications of the Inflation Reduction Act’s (IRA) Medicare drug price negotiation policy, according to a Jan. 18 panel of Avalere Health experts.

Last November’s election led to divided control of Congress, with Republicans in control of the House of Representatives and Democrats in control of the Senate. Given that, “the activity this year, over the next two years, is going to look quite a bit different than we saw in Congress from the previous two years,” said Matt Kazan, managing director at Avalere.

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FDA Approves Gilead’s First-in-Class HIV Drug Sunlenca

The FDA recently approved a new HIV drug for a small patient population desperately in need of treatments. And the twice-yearly medication’s annual price came below the level that respondents to a Zitter Insights poll said they would consider a good value.

On Dec. 22, the FDA approved Gilead Sciences, Inc.’s Sunlenca (lenacapavir) for the treatment, in combination with other antiretroviral(s), of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The agency gave the first-in-class capsid inhibitor priority review, fast track and breakthrough therapy designations.

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New Organization Will Focus on Medical Benefit Drugs

A group of Blue Cross and Blue Shield-affiliated companies recently unveiled a new medication contracting organization focused on medical benefit drugs. The new company, known as Synergie Medication Collective, will be successful in improving the affordability of these treatments and patients’ access to them, an industry expert says, but it also will need to show that patients are seeing those savings.

Unveiled Jan. 5, the company says it “is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans.” It will focus not only on infusible treatments for conditions such as cancer but also on multimillion dollar gene therapies. The company says its goal is to “significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders.” It plans to “bring to market several new product offerings” this year, among them “transformative value-based models.”

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Medicare Will Select 10 Drugs for Price Negotiation by Sept. 1

HHS set important deadlines for Medicare drug price negotiation on Jan. 11: Biden administration officials said that the first 10 drugs selected for negotiation will be announced on Sept. 1 of this year, and the maximum fair price for those drugs will be revealed on the same day in 2024. Those prices will go into effect at the start of 2026. HHS also released more information about the process it designed to select drugs and negotiate prices, which will include public comment periods and official consultations with stakeholders including manufacturers, insurers and providers.

HHS has a “plan to voluntarily solicit public comments on key elements of the program,” said CMS Administrator Chiquita Brooks-LaSure during a press conference call. “Input from our partners is essential to effectively and expeditiously implementing the Medicare drug pricing negotiation authority. We are committed to engaging with our partners through our timeline to maximize transparency, predictability and collaboration.”

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New Organization Will Focus on Medical Benefit Drugs

A group of Blue Cross and Blue Shield-affiliated companies recently unveiled a new medication contracting organization focused on medical benefit drugs. The new company, known as Synergie Medication Collective, will be successful in improving the affordability of these treatments and patients’ access to them, an industry expert says, but it also will need to show that patients are seeing those savings.

Unveiled Jan. 5, the company says it “is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans.” It will focus not only on infusible treatments for conditions such as cancer but also on multimillion dollar gene therapies. The company says its goal is to “significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders.” It plans to “bring to market several new product offerings” this year, among them “transformative value-based models.”

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For Alzheimer’s Drug Leqembi, Coverage Hinges on Full FDA Approval

Via the FDA’s accelerated approval pathway, Biogen and Eisai got the green light from federal regulators on Jan. 6 to take their Alzheimer’s drug Leqembi (lecanemab) to market. But sources tell AIS Health, a division of MMIT, that uptake and coverage of the medication will likely be underwhelming until it receives full FDA approval — a designation the manufacturers have already filed to acquire.

Leqembi represents the drugmakers’ second crack at offering a breakthrough Alzheimer’s drug, as they launched Aduhelm (aducanumab) in 2021 after it received its own accelerated approval nod despite considerable controversy over the medication’s safety and efficacy. Both drugs are monoclonal antibodies that aim to slow cognitive decline in Alzheimer’s patients by reducing amyloid plaque buildup on the brain of patients in early stages of the disease.

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