Spotlight on Market Access

MMIT Payer Portrait: Bright Health

Founded as a consumer-oriented, technology-focused startup in 2015, Bright Health has quickly made its presence known in the health care industry, despite its newcomer status. The company launched its first product offerings in Colorado's individual market in 2016 and has since expanded to offering individual, Medicare Advantage (MA) and small group plans in 17 states. Bright Health's value-based care model revolves around partnerships with select health and hospital networks, including Tenet Health, Novant Health and HCA Healthcare, emphasizing the importance of the patient-provider relationship. CVS Caremark serves as Bright Health's pharmacy benefits manager.

Nearly 13 Million Americans Skipped Prescription Drugs Due to Costs Before COVID

Almost 12.8 million adults delayed or did not get prescription drugs in 2018-19 due to costs, including about 3.8 million privately insured nonelderly adults and 2.3 million elderly Medicare beneficiaries, according to a study by the Robert Wood Johnson Foundation and Urban Institute based on 2018–19 data from the Medical Expenditure Panel Survey. About 9.5% of adults who were uninsured all year reported unmet prescription drug needs, compared with 4.9% of Medicare beneficiaries and 5.6% of nonelderly Medicaid enrollees. More than one-quarter of adults with Medicare and 5.3% of privately insured people spent more than 1% of their family incomes on out-of-pocket prescription drug costs. In November, the House of Representatives passed the Build Back Better Act, which includes provisions seeking to bring down drug costs, but the bill’s fate in the Senate is in peril.

Innovative New Drugs, Collaborative Efforts, Digital Health Care Deals Were Among 2021 Trends

While the COVID-19 pandemic still drove a lot of the conversation around the pharmaceutical industry over the past year, much of it was focused on the development of vaccines and their rollout starting in late 2020, as well as treatments for the virus. But other innovative agents also came to market in 2021, continuing the industry’s trend of producing pioneering products. AIS Health, a division of MMIT, spoke to industry experts about the impact of COVID-19 on the industry and other 2021 pharma trends.

Biomarker Testing Is Not Keeping Up With Drug Innovations

Despite the tremendous progress made over the past decade in developing targeted oncolytic therapies, testing for specific mutations —or biomarkers — to determine the proper candidates for those treatments lags behind. A few states have passed or are considering legislation requiring insurers to cover biomarker testing, with California becoming the most recent state to pass such a law.

Non-small cell lung cancer (NSCLC) is one area that has undergone the most development. There are now more than two dozen drugs that target nine different changes in NSCLC cells that help them grow. But an article published July 7 in Cancer Therapy Advisor — which summarized a presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting — revealed that less than half of people with metastatic NSCLC received a test for five analyzed biomarkers before starting first-line treatment.

FDA Approves Keytruda for Earlier Stage Melanoma Setting

Since 2011, the FDA has approved 10 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.

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.

Use of New Cancer Drugs Without Documented Clinical Benefit Substantially Increases

A growing share of patients have been prescribed oral targeted cancer drugs without documented overall survival (OS) benefit — from 12.7% in 2011 to 58.8% in 2018, according to a JAMA study, which analyzed dispensing claims for oral cancer drugs first approved by the FDA between Jan. 1, 2011, and Dec. 31, 2018. Cumulative spending on all 44 sample drugs reached $3.5 billion by the end of 2018, and 96.8% of that spending was on drugs approved based on a pivotal randomized clinical trial (RCT). Meanwhile, cumulative spending on drugs without documented OS benefit surpassed that on drugs with a documented benefit by the end of 2018. Among the top 20 drugs by spending amounts in 2018, one drug lacked a pivotal RCT and 13 drugs had no documented OS evidence at the time.

Obesity Management Targets Complex Disease via New Drugs, Better Awareness

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.

HHS Rule Not Only Empowers Patients but Also Benefits Other Industry Stakeholders

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.

MMIT Payer Portrait: Cambia Health Solutions

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.

New FDA Appointee Is Likely to Emphasize Real-World Data

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.