Spotlight on Market Access

Despite significant medical advances in the U.S. on numerous fronts, obesity management seems stalled by many clinicians’ reliance on a regimen of “diet and exercise” alone to treat as well as prevent. Obesity medicine specialists cite the increasing availability of safe and effective anti-obesity medications on the market — with dozens more in the pipeline — to allow for a multipronged treatment approach, but they point out that physicians seldom prescribe such drugs, and insurers often balk at paying for them.

This is partly because individuals with obesity, an increasingly prevalent, serious and costly disease, continue to confront the societal bias that “lifestyle choices” are to blame, experts say. It is also because obesity is a complex disease to treat, not merely a matter of gauging body mass index (BMI), they explain, and unless treated effectively, it may become the pathway to a wide array of chronic conditions including heart disease, stroke, type 2 diabetes, asthma and some types of cancer, as well as disability and premature death.

As the use of real-world data in the health care system grows, a recent HHS rule giving patients electronic access to their data stands to have a huge impact on this area. And the trend doesn’t show any signs of slowing, with companies such as Amazon.com Inc., Apple Inc., Google and Microsoft Corp. exploring opportunities in the health care industry though the use of patients’ medical data. Various stakeholders within the health care industry stand to benefit from this access in a variety of ways.

The Office of the National Coordinator for Health Information Technology (ONC) last year issued a final rule — The 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program — in order to implement some electronic health information (EHI) and interoperability provisions of the 21st Century Cures Act.

With its roots in the health insurance industry stemming back to 1917, Cambia Health Solutions is a nonprofit health insurance company and member of the Blue Cross Blue Shield Association, offering Blues products in Idaho, Oregon, Utah and Washington. Known as The Regence Group until 2013, Cambia operates four regional managed care organizations under its Regence BlueCross BlueShield branding. Outside of its Blues brands, Cambia also operates BridgeSpan Health Company, which focuses on Affordable Care Act exchange products, and Asuris Northwest Health, a community-based insurer offering commercial and Medicare Advantage plans in Washington state.

President Joe Biden recently nominated former FDA Commissioner Robert Califf, M.D., to run the agency once more, ending nearly a year of temporary leadership under Acting Commissioner Janet Woodcock, M.D. One insider says that Califf might look to reform and improve the accelerated approval pathway following the controversial Aduhelm (aducanumab) approval earlier this year.

Califf previously led the FDA during the Obama administration, running the agency for roughly the last two years of Obama’s term. Califf advocates for using “real-world evidence” in addition to clinical trial data in medical approvals. Aduhelm, an Alzheimer’s drug, was approved without such data, though studies of the drug relying on real-world evidence — which takes into account electronic medical record and insurance claims data — are underway. During Califf’s initial tenure, Sarepta Therapeutics’ eteplirsen, a muscular dystrophy drug, also earned accelerated approval despite a large outcry from medical researchers.

The average annual premium for employer-sponsored health insurance increased 4% to $7,739 for single coverage and $22,221 for family coverage, respectively, this year, according to the Kaiser Family Foundation 2021 Employer Health Benefits Survey. In recent years, high-deductible plans with a savings option have been gaining popularity. About 22% of firms offered an HDHP/SO and 28% of covered workers were enrolled in such a plan in 2021, representing slight declines compared with previous years. Meanwhile, the COVID-19 pandemic has increased the use of telemedicine, as 95% of firms with 50 or more workers offered telemedicine coverage in their largest health plan, up from 85% last year. In addition, about 65% of firms with 50 or more workers made changes to enhance their telemedicine benefits after the beginning of the pandemic.

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.

The FDA approval of the first biosimilar for ocular use is poised to bring savings to a costly class, particularly in Medicare. However, ophthalmologists’ and retinologists’ lack of experience with biosimilars is a potential roadblock to these drugs’ uptake. Payers should focus on provider education and outreach ahead of these drugs’ launches in order to ease concerns about their use, say industry experts.