Specialty Pharmacy

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.

Payer Groups Applaud CMS Coverage Decision on Aduhelm

CMS on Jan. 11 issued its long-awaited proposed National Coverage Determination (NCD) for Aduhelm (aducanumab), the Alzheimer’s drug that has been the subject of controversy since the FDA approved it last June. In what officials acknowledged was an unusual decision, CMS said Medicare will cover Aduhelm — and any other FDA-approved monoclonal antibodies that target amyloid plaques — only for people who are enrolled in qualifying clinical trials.

Health insurer trade groups praised the decision, which comes after Aduhelm manufacturer Biogen cut the price of the drug approximately in half in a bid to encourage both provider uptake and payer coverage.

Two More Accelerated Approval Indications Are Being Pulled

Within the span of one week, Secura Bio, Inc. has revealed that it will withdraw one oncology drug from the U.S. market, as well as an indication for another oncolytic. The FDA had given both accelerated approval. The moves come amid growing scrutiny of that approval pathway, and they mark the ninth and 10th oncology indications and/or drugs taken off the U.S. market since December 2020.

Secura Bio said on Nov. 30 that it will withdraw the new drug application for Farydak (panobinostat). The FDA granted the capsule accelerated approval on Feb. 23, 2015, for the drug in combination with Takeda Pharmaceuticals U.S.A., Inc.’s Velcade (bortezomib) and dexamethasone for the treatment of people with multiple myeloma who have received at least two regimens, including Velcade and an immunomodulatory agent. That indication is the only one the drug has in the U.S. The company said it will continue to market the drug in other areas in which it is approved.

Aduhelm Price Cut May Not Sway Private Payers’ View of Drug

Since the FDA greenlit the Alzheimer’s drug Aduhelm (aducanumab) in July under the accelerated approval program, concerns over the drug’s hefty price tag and overall effectiveness have been mounting. Now, the drug’s manufacturer, Biogen Inc., has cut the price approximately in half. One expert tells AIS Health that the move may cause private insurers to view the drug slightly more favorably, but they’re still likely to impose coverage restrictions on it. And a health plan trade group signaled that it isn’t impressed by the price cut.

After all, the furor surrounding Aduhelm is not all about price. “The clinical evidence that the FDA relied upon when approving the drug had various limitations, and the findings of the two clinical studies were conflicting,” James Chambers, Ph.D., MPharm., an associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, tells AIS Health via email.

OptumRx Flags 5 Drugs to Watch At Close of ‘Evolutionary’ Year

In a move that demonstrates just how quickly things can change in the prescription drug world, one of the five drugs featured in OptumRx’s latest quarterly Drug Pipeline Insights Report was rejected by the FDA not long after the report went live in late November. But an expert from the UnitedHealth Group-owned PBM says the other four drugs highlighted in the report remain worth watching — including one that just got the FDA’s blessing.

The rejected drug in question is plinabulin, which was being developed to prevent chemotherapy-induced neutropenia (CIN) — a condition in which patients have an abnormally low amount of a certain type of white blood cell. The FDA sent a response letter to plinabulin’s manufacturer, BeyondSpring Pharmaceuticals, on Dec. 1, stating that the results of a single registrational trial conducted by the company was not sufficiently robust to demonstrate the drug’s benefit and that a second, well-controlled trial “would be required to satisfy the substantial evidence requirement to support the CIN indication,” according to the drugmaker.

Scemblix Is First-in-Class STAMP Inhibitor for CML

The FDA recently approved a first-in-class agent for the treatment of chronic myeloid leukemia (CML). The drug’s novel mechanism of action may offer an improvement over other therapies within the class, industry experts say.

On Oct. 29, the FDA approved Novartis Pharmaceuticals Corp.’s Scemblix (asciminib) for the treatment of CML in two indications: (1) adults with Philadelphia chromosome-positive CML in chronic phase previously treated with at least two tyrosine kinase inhibitors (TKIs), which was given accelerated approval, and (2) adults with PH+ CML-CP with the T315I mutation, which was granted full approval. It is the first FDA approval of a CML therapy that is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor.

Two More Accelerated Approval Indications Are Being Pulled

Within the span of one week, Secura Bio, Inc. has revealed that it will withdraw one oncology drug from the U.S. market, as well as an indication for another oncolytic. The FDA had given both accelerated approval. The moves come amid growing scrutiny of that approval pathway, and they mark the ninth and 10th oncology indications and/or drugs taken off the U.S. market since December 2020.