Specialty Drugs

2022 Outlook: Notable FDA Approvals, Payer Strategies Are Specialty Trends

The specialty pharmacy industry will continue its growth in 2022, experts tell AIS Health, a division of MMIT. Multiple agents for rare diseases are poised for FDA approval, and the market may see additional cell and gene therapies. In addition, payers will carry on their efforts to keep prices for specialty medications affordable, among other trends.

AIS Health: What are some specialty pharmacy issues to keep an eye on in 2022, and why?

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FDA Approves Novartis Drug That Will Go Up Against PCSK9s

More than a year after pandemic travel restrictions pushed back the FDA’s approval decision on Novartis Pharmaceuticals Corp.’s inclisiran, the agency finally approved it. The new first-in-class therapy targets so-called bad cholesterol and is set to compete with two other biologics that target the same protein.

On Dec. 22, the FDA approved Leqvio as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-c).

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Biosimilar Approvals Are Expected to Undergo Upward Trend in 2022

The FDA approved only four biosimilars in 2021, down from its high of the 10 it approved in 2019, but slightly more than the three such therapies approved in 2020. The agency also granted interchangeability to the first two biosimilars. This year may up the excitement level, industry experts tell AIS, a division of MMIT, with numerous products expected to be approved, while other noteworthy therapies will lose patent protection and potentially face biosimilar competition.

Dea Belazi, Pharm.D., M.P.H., president and CEO of AscellaHealth: The United States has been slow to approve and adopt biosimilars. Since the initial biosimilar approval in 2015, the FDA has approved 33 biosimilars, but only 18 are currently available on the U.S. market with a projected market value of $13 billion in 2021. Even with this slow uptake in the United States, there is increased utilization and a growing pipeline of products that will drive use and savings. In 2021, many blockbuster drugs were approved in the biosimilar space, along with the two interchangeable biosimilar products, [Boehringer Ingelheim Pharmaceuticals, Inc.’s] Cyltezo and [Viatris Inc. and Biocon Ltd. subsidiary Biocon Biologics Ltd.’s] Semglee.

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With New Data, Oncopeptides Rescinds Pepaxto Withdrawal

Three months after Oncopeptides AB said it was voluntarily withdrawing Pepaxto (melphalan flufenamide) from the U.S. market, the company is now taking back that withdrawal and has begun working with the FDA to review new data on the multiple myeloma therapy.

On Jan. 21, the company said that it had contacted the FDA to rescind its Oct. 22 letter requesting voluntary withdrawal of the agent’s New Drug Application (NDA). According to a company press release, “further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials have led the Company to reconsider its previous voluntary withdrawal request. Oncopeptides has discontinued the marketing of Pepaxto in the US and does not intend to market Pepaxto in the US at this time. The company has initiated a dialogue with the FDA to review the new data.”

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Drug Pricing Remains Hot Topic, but Legislation Addressing It Has Stalled

While drug prices continue to be an issue of concern to many Americans, whether it can get any legislative traction issue remains unclear. So what might happen on the issue in 2022?

Dea Belazi, Pharm.D., M.P.H., president and CEO of AscellaHealth: Pharmaceutical drug pricing continues to be a contentious policy issue. Recent data has branded drug list prices growing annually by more than 9% over the last decade, which is much higher than gross domestic product (GDP) growth. However, a RAND study found that prices for unbranded generic drugs...are slightly lower in the United States than in most other nations. Additionally, patients’ out-of-pocket costs for specialty drugs have increased faster than GDP growth over the same period — 2.8% vs. 2.3%. Furthermore, the current White House administration and Congress have declared that reining in Medicare prescription drug costs to help older adults and people with disabilities is a top priority. This will put drug pricing in the crosshairs of elected officials, advocacy groups and patients.…

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New FDA Approvals: FDA Grants Additional Indication to Rinvoq

Jan. 14: The FDA expanded the label of AbbVie Inc.’s Rinvoq (upadacitinib) to include the treatment of moderate-to-severe atopic dermatitis in people at least 12 years old whose disease did not respond to previous treatment and is not well controlled with other pills or injections or when those treatments are not recommended. The agency initially approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. Dosing of the tablet for people weighing at least 40 kg who are at least 12 years old and less than 65 is 15 mg once daily and can be increased to 30 mg once daily. For people at least 65, the recommended dose is 15 mg once daily. Website Drugs.com lists the price of 30 15 mg tablets as more than $5,500.

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News Briefs: Gilead Withdraws Two Zydelig Indications

Gilead Sciences, Inc. said on Jan. 14 that it is voluntarily withdrawing two indications for Zydelig (idelalisib): for the treatment of relapsed follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic leukemia (SLL), both of which had accelerated approval. “As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” said the company in a press release. Along with the FL and SLL approvals on July 23, 2014, the FDA granted traditional approval to the drug for the treatment of relapsed chronic lymphocytic leukemia. Zydelig will remain on the U.S. market for this indication.

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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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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.

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FDA Approves Cholesterol-Lowering Drug That Will Go Up Against PCSK9s

More than a year after pandemic travel restrictions pushed back the FDA’s approval decision on Novartis Pharmaceuticals Corp.’s inclisiran, the agency finally approved it. The new first-in-class therapy targets so-called bad cholesterol and is set to compete with two other biologics that target the same protein.

On Dec. 22, the FDA approved Leqvio as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia who require additional lowering of low-density lipoprotein cholesterol.

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