Spotlight on Market Access

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.

Now that Medicare can negotiate the price of prescription drugs it purchases, the Biden administration needs to figure out how it will hash out deals with drugmakers. Experts tell AIS Health, a division of MMIT, that implementation of the long-sought negotiation program will come with plenty of challenges and pitfalls.

The administration will have to issue new regulations, hire hundreds of staff, determine which drug prices will be negotiated first and design the criteria that will select drugs for negotiation in the future.

More than 50,000 Medicare Part D beneficiaries experienced an opioid overdose in 2021, while almost a quarter of Part D enrollees (12.1 million) received at least one prescription opioid through Medicare, according to a recent report from the HHS Office of Inspector General.

The proportion of beneficiaries receiving opioids has been declining, from 33% in 2016 to 23% in 2021. Alabama saw the highest proportion of opioid recipients (36%), while New York and Hawaii ranked the lowest (15%).

Genetic testing is becoming a greater part of health care, as providers can take advantage of it to help inform patients’ diagnosis and treatment. Multiple tests are now available, and many health plans are covering their costs if certain criteria are met. But that’s a tall order with more than 77,000 genetic tests available and new tests constantly coming to market.

Many payers have prior authorization for genetic tests: An AHIP industry survey conducted between September and December 2019 found that genetic testing was the third most common treatment for prior authorization behind specialty drugs and high-tech imaging.

As FDA approval of biosimilars continues and agents are expanding into new indications, more payers are using these drugs and seeing cost savings through that utilization, according to Zitter Insights.

When the FDA approved Fresenius Kabi’s Stimufend (pegfilgrastim-fpgk) on Sept. 1, it was the sixth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) that the agency had approved. It also was the 38th biosimilar approved since the first one, Novartis Pharmaceutical Corp. division Sandoz’s Zarxio (filgrastim-sndz), was approved March 6, 2015, referencing Amgen’s Neupogen (filgrastim).