Spotlight on Market Access

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.

On Oct. 15, 2021, the FDA granted interchangeability status to Cyltezo for all of its approved uses. Boehringer Ingelheim’s Phase III VOLTAIRE-X clinical trial found no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity and safety over multiple switches between Humira and Cyltezo. Per the Biologics Price Competition and Innovation Act (BPCIA) of 2009, the drug will have one year of exclusivity upon launch during which the FDA cannot grant interchangeable status to another Humira biosimilar.

The FDA recently approved a first-in-class agent for the treatment of chronic myeloid leukemia (CML). Oncologists showed much more interest in the agent than did payers when Zitter Insights surveyed both stakeholder groups.

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.

Eli Lilly & Co. has announced plans to run a head-to-head clinical trial of its Alzheimer’s drug, donanemab, against Aduhelm (aducanumab), the controversial Biogen Inc. Alzheimer’s drug. Meanwhile, Aduhelm has continued to have what one expert calls “the worst drug launch ever,” after state Medicaid leaders told CMS they want no part of paying for the drug.

In its third-quarter results, Biogen reported in a Securities and Exchange Commission filing that Aduhelm revenues totaled $300,000, citing the fact that many clinicians don’t want to prescribe the drug. Meanwhile, Eli Lilly & Co.’s donanemab is under an accelerated approval process. That process will include a Phase III study comparing donanemab directly to Aduhelm, according to Daniel Skovronsky, M.D., Ph.D., a Lilly senior vice president and its chief scientific and medical officer.

Medication abortion — which involves using two drugs, mifepristone and misoprostol — accounts for 54% of all pregnancy terminations before nine weeks of gestation in the U.S., according to a recent Kaiser Family Foundation analysis. The FDA’s Center for Drug Evaluation and Research exercised “enforcement discretion” of the Risk Evaluation and Mitigation Strategy requirement that asks prescribers to dispense mifepristone to patients in-person during the pandemic. This allows providers in 32 states and the District of Columbia that do not have laws that ban medication abortion to dispense mifepristone via telehealth. Currently, 18 states and D.C. allow both advance practice clinicians and medical doctors to dispense abortion pills.

As precision medicine continues to evolve, companion diagnostics (CDxs) are increasingly being used to guide sometimes life-or-death treatment decisions. Their aim is to improve clinical outcomes by using predictive biomarkers to target patients, especially those with cancer, who could respond well to particular therapeutics. But industry experts cite a disconnect at times between FDA approval and payer reimbursement, slowing the potential impact of a burgeoning array of CDxs and prompting pharma companies to take proactive steps to market them.

MMIT’s FormTrak solution allows pharma companies to keep providers updated with real-time, accurate data about coverage for their brands — a critical step in ensuring a therapy gets to patients who need it. Now it’s even easier to communicate new coverage wins to healthcare providers, with FormTrak’s native integration with Veeva CRM.

This summer, Incyte Corp. hit a roadblock in the company’s quest to have its drug retifanlimab become the first FDA-approved treatment of its kind for patients with the most common type of anal cancer.
Retifanlimab is an immune checkpoint inhibitor (also known as immunotherapy) that aims to treat adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) whose disease has progressed after receiving platinum-based chemotherapy or who were intolerant of that type of chemotherapy. Currently, there are no approved treatment options available to patients who meet these criteria, according to Incyte.

Founded in 2012, Oscar Health Inc. calls itself “the first health insurance company built around a full stack technology platform.” Since its founding, Oscar has grown to serve more than 500,000 members in 18 states, largely via the Affordable Care Act (ACA) exchanges and off-exchange individual and family plans. Oscar also offers Medicare Advantage (MA) plans in three states and in 2020 partnered with Cigna Corp. to offer co-branded small group commercial products in California, Connecticut, Georgia, Missouri and Tennessee. CVS Caremark serves as Oscar’s pharmacy benefits manager.

The FDA is requiring revisions about increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots and death to the labels of the Janus kinase (JAK) inhibitors indicated for inflammatory conditions: Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and AbbVie Inc.’s Rinvoq (upadacitinib). The move follows the agency’s review of a large, randomized safety clinical trial of Xeljanz.

In 2020, specialty trend — which consists of utilization and cost trend components — continued to increase, but it did so at a slower pace than that of the past five years. That’s one of the findings of Pharmaceutical Strategies Group (PSG), an EPIC company, in its State of Specialty: Spend and Trend Report, published in August. The report, which is based on PSG’s Artemetrx platform and uses integrated pharmacy and medical claims data, also found that biosimilars finally are beginning to produce real savings.