Drug Pricing

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.

ICER Draft Report Deems Four COVID Drugs Reasonably Priced

The manufacturers of four treatments aimed at easing the disease burden of mild-to-moderate COVID-19 received good news recently when the Institute for Clinical and Economic Review (ICER) determined in a draft report that their prices are “reasonably aligned with patient benefits.”

Each of the treatments — molnupiravir, Paxlovid and fluvoxamine, which are delivered orally, and the IV-administered sotrovimab — have been shown in clinical trials to greatly reduce the risk of hospitalization or death in comparison to placebo treatments, according to a draft evidence report released Feb. 3 by ICER.

Cardinal Health Predicts Biosimilar Boom in New Report

Pharmaceutical distribution and wholesaling giant Cardinal Health Inc. is optimistic that biosimilars will be broadly adopted and deliver big cost savings to the U.S. health care system in the next several years. The findings of a new white paper from the company run counter to more pessimistic predictions by other industry insiders, but Cardinal executives tell AIS Health, a division of MMIT, that even though some barriers to biosimilars remain, new approvals and regulatory changes have already accelerated adoption.

“I am deeply encouraged by the progress made in the U.S., especially this past year,” Sonia Oskouei, Cardinal Health’s vice president for biosimilars, wrote in the report. “Following the launch of the first biosimilar in 2015, we now have 33 FDA approved biosimilars with 21 available on the market as of January 2022. The U.S. biosimilars story that was initially described as sluggish and delayed has now transformed to one of progress and momentum. This past year, the promise of biosimilars has started to become a reality, as greater competition for some of the costliest biologic treatments on the market is beginning to drive meaningful cost savings.”

News Briefs: New Drug to Break List Price Record

Ramona Sequeira has become the new chair of the Pharmaceutical Research and Manufacturers of America (PhRMA) board of directors. She is the first woman to hold that top leadership position at the industry’s chief lobbying group. Sequeira is the president of Takeda Pharmaceuticals’ U.S. business unit and head of global portfolio commercialization at the Japanese drugmaker, per a Feb. 3 press release.

Mark Cuban’s Cash Pharmacy Launches Amid Strong Competition

Mark Cuban Cost Plus Drug Company (MCCPDC) launched its online, generic-dispensing pharmacy on Jan. 19, becoming the latest entrant into a burgeoning market of prescription drug retailers that operate independent of traditional pharmacy benefits. Health care insiders say that the amount of activity in the emerging segment is encouraging, but they add that no one player is likely to become dominant in the space.

MCCPDC, a discount prescription drug startup launched by venture capitalist and Dallas Mavericks owner Mark Cuban, now operates an online pharmacy that sells directly to consumers and does not accept insurance. MCCPDC CEO Alex Oshmyansky, M.D., Ph.D., told AIS Health, a division of MMIT, in October that the firm is registered as a pharmaceutical wholesaler with the FDA.

News Briefs: CMS Says It Found a Way to Cover Medicare Beneficiaries’ At-Home COVID Tests

CMS on Feb. 3 said it is working on an initiative to enable Medicare coverage of over-the-counter (OTC) COVID tests in early spring. The administration in January issued guidance requiring group and individual health plans to reimburse members for up to eight at-home COVID tests per month without cost sharing. Sen. Debbie Stabenow (D-Mich.) and 18 other senators on Jan. 24 wrote to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure urging them to extend the same access to Medicare enrollees. And in a bipartisan letter issued Jan. 20, House representatives made a similar request. Despite several issues that complicated CMS’s efforts to cover the tests, the agency said it has “identified a pathway that will expand access to free over-the-counter testing for Medicare beneficiaries.”

Mark Cuban’s Cash Pharmacy Launches Amid Strong Competition

Mark Cuban Cost Plus Drug Company (MCCPDC) launched its online, generic-dispensing pharmacy on Jan. 19, becoming the latest entrant into a burgeoning market of prescription drug retailers that operate independent of traditional pharmacy benefits. Health care insiders say that the amount of activity in the emerging segment is encouraging, but they add that no one player is likely to become dominant in the space.

MCCPDC, a discount prescription drug startup launched by venture capitalist and Dallas Mavericks owner Mark Cuban, now operates an online pharmacy that sells directly to consumers and does not accept insurance. MCCPDC CEO Alex Oshmyansky, M.D., Ph.D., told AIS Health, a division of MMIT, in October that the firm is registered as a pharmaceutical wholesaler with the FDA.

What Can Hepatitis B Drugs Tell Us About Generic Pricing Games?

While the average price that pharmacies pay for a common hepatitis B treatment has seen a steep drop as more generics entered the market, the list price for the drug — which helps determine patient cost sharing — has stayed stubbornly high, according to new research published in JAMA. The study’s authors say their findings “highlight the need for policies that improve transparency around generic drug financing and pharmaceutical benefit manager practices,” but one industry expert points out that there are also private-sector solutions to the problem arising.

“In my view, the high out of pocket costs for entecavir and other generics is something that, given Good­Rx and companies like it…patients can do something about themselves directly, bypassing their PBM and pharmacy benefits altogether,” says Elan Rubinstein, Pharm.D., principal of EB Rubinstein Associates. GoodRx, which went public in 2020, offers an app-based drug price comparison tool, aggregates drug coupons and contracts with several PBMs, which allows the firm to offer patients the cheapest price for a drug among its partners’ negotiated network rates.

News Briefs: US Drug Price Growth Offsets Falling Prices Elsewhere

The price of the average brand-name drug has increased by 18.3% annually on average over the last five years, according to research firm GlobalData. Floriane Reinaud, research and analysis director at GlobalData, said in a statement that this price growth is unique to the U.S. “While drug list prices have only been increasing in the US, major markets in the rest of the world are seeing declines. Japan, for example, saw drug prices decline by more than 9% while Germany declined by around 7.5%,” Reinaud said.

The business strength of “speculative grade” pharmaceutical companies varies considerably, mainly due to differences in their produce concentration and drug development pipelines, according to S&P Global Data. S&P analysts Patrick Bell and David A. Kaplan also wrote that “although speculative-grade companies are frequently more aggressive in pricing and life cycle management strategies, legislators and the media primarily focus criticism on well-known investment-grade peers and their more widely prescribed blockbuster drugs. Similarly, we believe pharmacy benefit managers place more attention on controlling spending on blockbuster drugs than those with narrower patient bases such as orphan drugs. Nevertheless, with a higher proportion of revenues generated in the U.S. and higher leverage, we believe drug price reform could hurt speculative-grade pharma companies disproportionately.”

CMS Proposed NCD Will Provide Limited Medicare Coverage of Aduhelm, Other Similar Therapies

To say that the FDA’s approval of Biogen and Eisai, Co., Ltd.’s Alzheimer’s disease treatment Aduhelm (aducanumab-avwa) on June 7, 2021, garnered an immense amount of attention would seem to be an understatement. That said, the drug has somehow gathered even more notice over the past few months due to multiple developments, with CMS most recently issuing a proposed National Coverage Determination (NCD) on Aduhelm and other monoclonal antibodies that target beta amyloid plaque that will allow Medicare coverage for the therapies but only under certain circumstances. While commercial payers often follow CMS’s lead, it remains to be seen whether that decision — plus a dramatic price cut on Aduhelm — will prompt payers that have declined to cover the therapy to change course.

There is a 30-day public comment period on the proposed NCD, which was published Jan. 11. A final decision is expected on April 11.