Spotlight on Market Access

Since the FDA’s approval of the first biosimilar — Zarxio (filgrastim-sndz) from Sandoz, a division of Novartis Pharmaceuticals Corp. — on March 6, 2015, the agency has approved almost 40 more agents via the 351(k) pathway established under the Biologics Price Competition and Innovation Act (BPCIA), itself part of the Affordable Care Act (ACA). Although not all of those agents have launched yet, and almost all of the ones that have are all professionally administered, industry experts say they expect to see more competition in the space, depending on interchangeability status, provider uptake and the impact of the Inflation Reduction Act.

CVS Health Corp.’s Aetna is the third-largest health insurer in the U.S., serving more than 22 million lives across all market sectors. Nationally, Aetna ranks No. 3 in administrative services only (ASO) non-risk contracting, No. 4 in the group risk commercial market and No. 3 in Medicare Advantage (MA), an area of significant investment for the insurer in recent years. For the 2023 plan year, Aetna will expand its MA offerings to 141 new counties across its 46-state market, compared to 83 counties in 2022. And as the COVID-19 pandemic rattled the employer group markets, Aetna in 2022 returned to the Affordable Care Act (ACA) exchanges after pulling out in 2018. While it enrolls just under 60,000 exchange lives as of October 2022, its footprint will expand to four additional states in 2023.

Highmark Health recently implemented a medical policy stating the insurer will cover digital prescription therapeutics (DPTs) under certain circumstances. The decision is “incredibly significant for our industry,” Akili Interactive Labs chief executive and co-founder Eddie Martucci, Ph.D., writes in an email to AIS, a division of MMIT.

Highmark’s policy pertains to Akili’s EndeavorRx treatment for children with attention-deficit/hyperactivity disorder as well as the eight other FDA-approved DPTs, which are software-based therapies to treat medical and behavioral conditions. DPTs treat conditions such as substance use disorder, opioid use disorder, irritable bowel syndrome and chronic lower back pain.

Total inflation-adjusted spending on prescription drugs grew from $520 billion in 2016 to $603 billion in 2021, before accounting for rebates, according to a report published by HHS’s Assistant Secretary for Planning and Evaluation (ASPE). Retail drug expenditures represented about 70% of prescription drug spending in 2021. For retail prescription drugs, there was a 13% increase in drug spending over the five years studied, yet only a 5.7% increase in the number of prescriptions.

Meanwhile, more and more Americans received their drugs from mail order pharmacies, clinics and home health care organizations between 2016 and 2021.

Amid a global pandemic and inflation challenges, CEOs surveyed for a recent report expressed confidence in the three-year outlook for their companies and the economy. While many respondents from the life sciences sector said they expect a recession will occur within the next year, almost the same amount said their growth prospects are strong, according to the KPMG 2022 CEO Outlook. Those CEOs also expressed a growing interest in environmental, social, and governance (ESG); and diversity, equity and inclusion (DEI) initiatives.

For the eighth edition of the report, KPMG spoke with 1,325 CEOs from 11 markets around the globe and 11 key industry sectors, including life sciences, between July 12 and Aug. 24. The company shared the responses from the life sciences CEOs on their three-year outlook with AIS Health, a division of MMIT.

The FDA recently approved the first novel long-acting granulocyte colony-stimulating factor (G-CSF) in more than 20 years. Payers say they are likely to manage the new agent similar to existing ones, but oncologists have indicated that they are willing to prescribe it in place of other neutropenia agents, according to Zitter Insights.

On Sept. 9, the FDA approved Spectrum Pharmaceuticals, Inc.’s Rolvedon (eflapegrastim-xnst) to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. The company developed the drug with South Korea’s Hanmi Pharmaceutical Co. The recommended dose is 13.2 mg administered subcutaneously once per chemotherapy cycle. The company says it expects the product to be available in fourth-quarter 2022. It has not revealed the agent’s price yet.

Mark Cuban Cost Plus Pharmacy, the online pharmacy and generic manufacturing startup backed by the eponymous billionaire investor, recently struck its first deals with a health plan, Pennsylvania’s Capital Blue Cross, and a PBM, Rightway Healthcare Inc. The direct contracting deal represents a major step for the startup, which has done most of its business so far as a direct-to-consumer retailer — and one drug pricing expert tells AIS Health, a division of MMIT, that the deals help Cost Plus moves toward its ambitious, disruptive goals.

Only 9% of Medicare beneficiaries who sign up for a stand-alone Prescription Drug Plan (PDP) in 2023 will be in contracts rated 4 stars or higher, compared to 42% in the 2022 plan year, CMS recently estimated based on current enrollment figures. The average star rating for stand-alone PDP plans declined to 3.25 in 2023 from 3.70 in 2022, with only two PDP contracts receiving a 5-star rating. The change in distribution is largely due to adjustments in measure scores, and “the unusual circumstance of nearly all contracts qualifying for the regulatory adjustment for extreme and uncontrollable circumstances” driven by the pandemic, which led to higher than normal 2022 Star Ratings distributions, CMS explained in a fact sheet accompanying the release of the 2023 Star Ratings.

While the pharmaceutical industry has accepted the importance of digital, implementing it in patient solutions remains a challenge. Manufacturers should prioritize patients’ needs and understand how they can evolve over the course of their treatment journey to offer them accessible and useful solutions, according to industry experts at a recent webinar sponsored by Reuters Events.

One trend within the digital space is tied to the change within the health care landscape and its digital support methods. Most would agree that this is a positive development. But according to Paul Fu, M.D., chief medical information officer at City of Hope, a cancer research and treatment organization, as well as a research center for diabetes and life-threatening diseases, “I think that one of the challenges of being a health care system is that the technology is moving faster than our ability to handle that rate of change. We see that with our patients.”

SelectHealth is the wholly owned health insurance unit of Intermountain Healthcare, a Salt Lake City-based health system of 33 hospitals and more than 3,800 physicians. SelectHealth is the largest insurer in Utah and also has a presence in Idaho and Nevada. The majority of SelectHealth’s members are enrolled in commercial risk-based products, with the insurer holding a robust Affordable Care Act exchange presence in Utah, where it dominates the individual market. SelectHealth also holds a Medicaid contract in Utah and has expanded its Medicare Advantage presence in recent years.