Specialty Drugs

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.

0 Comments

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.

0 Comments

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.

0 Comments

CMS Proposes to Restrict Medicare Coverage of Aduhelm to Patients in Clinical Trials

In a highly anticipated but not-so-surprising move, CMS on Jan. 11 released a proposed National Coverage Determination (NCD) that would restrict Medicare coverage of Biogen and Eisai, Co., Ltd.’s Aduhelm (aducanumab-avwa) and any other FDA-approved monoclonal antibodies that target beta amyloid plaque for the treatment of Alzheimer’s disease. Industry experts say the coverage proposal — coupled with a recent price cut on Aduhelm — is unlikely to alter commercial payers’ hesitancy toward covering the drug, while one actuary says the decision supports Medicare Advantage plans’ expectations that coverage would be limited.

According to the proposed NCD, which is now open to a 30-day comment period, Medicare would cover the therapies under Coverage with Evidence Development (CED), requiring that patients be enrolled in approved randomized controlled trials that are conducted in a hospital-based outpatient setting. Participants must have a “clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia; and evidence of amyloid pathology consistent with AD.” The NCD also would allow coverage of one beta amyloid positron emission tomography (PET) scan per patient as part of the protocol.

0 Comments

Medicare Plans to Cover Aduhelm but With Certain Restrictions

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.

0 Comments

Notable 2021 Approvals Included Oncolytics, Interchangeables

Between the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER), the agency approved 60 new products in 2021, including biologics, cell and gene therapies, vaccines and blood products. As the COVID-19 pandemic continued for the second year, much of the pharma industry’s focus, understandably, was on vaccines and therapeutics for the coronavirus. As with prior years, oncology dominated the specialty drug space, but the FDA also approved novel treatments in other areas as manufacturers continued to pursue innovative new products. Moreover, the U.S. saw the first two interchangeable biosimilars gain approval. AIS Health, a division of MMIT, spoke with various industry experts about what they considered the most notable FDA approvals in 2021.

0 Comments

Many Melanoma Therapies Exist, but Treatment Remains Challenging

Since 2011, the FDA has approved multiple therapies for advanced or late-stage melanoma. Recently, the agency granted an additional approval to one of those drugs for the earlier stage melanoma setting, filling an unmet need, industry experts note. However, the condition is complex to treat and may be challenging for health plans to manage.

On Dec. 3, the FDA approved Merck & Co., Inc.’s programmed death receptor-1 (PD-1) inhibitor Keytruda (pembrolizumab) for the adjuvant treatment of people at least 12 years old with stage IIB or IIC melanoma following complete resection. The agency also expanded the indication for the agent’s use as an adjuvant treatment of stage III melanoma following complete resection to include pediatric patients at least 12 years old.

0 Comments

Specialty Pharmacy, Home Infusion Spaces Saw Myriad 2021 Changes

While the COVID-19 pandemic continued to impact the specialty pharmacy and home infusion spaces for the second straight year, other events also played a role. AIS Health spoke to some industry experts about 2021’s impact.

AIS Health: Looking back over the past year, what do you think were the most noteworthy occurrences within the specialty pharmacy industry, and why?

Dea Belazi, Pharm.D., M.P.H., president and CEO of AscellaHealth: Some of the noteworthy trends in SP have included the continued rise of the cost of specialty agents within health care expenditures, the continued emergence of ultra-high-cost specialty agents for rare and orphan diseases and the continued vertical integration of specialty pharmacies into health care organizations.

0 Comments

New FDA Approvals: FDA Approves Additional Indication for FoundationOne CDx | Jan. 13, 2022

Dec. 8: The FDA gave another approval to Foundation Medicine, Inc.’s FoundationOne CDx as a companion diagnostic for current and future BRAF inhibitors used to treat melanoma, including monotherapies targeting BRAF V600E and BRAF/MEK inhibitor combination therapies targeting BRAF V600E or V600K mutations. The agency first approved the test on Nov. 30, 2017.

Dec. 9: The FDA granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to help identify people with non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 20-insertion mutations who may be candidates for treatment with Rybrevant (amivantamab-vmjw) from Janssen Biotech, Inc., a Johnson & Johnson company. The agency initially approved the test on June 22, 2017.

0 Comments

News Briefs: CMS Rescinds Most Favored Nation Model | Jan. 13, 2022

CMS issued a final rule on Dec. 29 that rescinded the Most Favored Nation model. The mandatory model would have priced Medicare Part B drugs on the U.S. market based on their prices in certain countries. An interim final rule that was published in November 2020 had been blocked from being implemented on Jan. 1, 2021.

CMS published a proposed rule on Jan. 12 that would rein in direct and indirect remuneration (DIR) fees, which pharmacies have long complained about. The proposal would save consumers about $21.3 billion but cost the federal government $40.0 billion from 2023 through 2032.

0 Comments