Spotlight on Market Access

Payers Likely Will Manage Two New NSCLC Therapies to Label

Following May 2020’s seven FDA approvals in non-small cell lung cancer, May 2021 brought only a pair of new NSCLC agents. However, these two drugs are significant because they were the first to gain FDA approvals for their specific indications. According to Zitter Insights research, the drugs should have good uptake among payers.

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Focus on Drug Prices Continues Amid Uncertainty Over Potential Changes

High prescription drug prices continue to be of concern at the federal level. Signaling the administration’s strongest action so far on drug pricing, President Joe Biden on July 9 unveiled his Executive Order on Promoting Competition in the American Economy. And earlier this month, HHS issued a proposed rule seeking to rescind the Most Favored Nation (MFN) drug price model, saying it instead was exploring value-based care options for the Medicare Part B program. However, it remains to be seen whether any significant changes are going to occur any time soon, say industry experts.

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FDA Approves First Interchangeable Biosimilar; Impact Remains Uncertain

More than 10 years after the passage of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as part of the Affordable Care Act, the FDA finally has approved the first interchangeable biosimilar. But while many in the industry are hailing the move, at least one expert wonders whether interchangeables will hamstring use of biosimilars that do not have that designation.

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Rezurock Is Approved in Graft vs. Host With More Transplant Agents in Pipeline

When patients receive an organ or tissue transplant, a critical part of their treatment involves therapies that are used to ensure neither their bodies nor the transplanted material rejects the new arrangement. While many first-line treatments given to this patient population are low-cost generics, experts say there is a robust pipeline of treatments in development, including a just-approved treatment for chronic graft vs. host disease (GVHD).

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Biogen Alzheimer’s Approval Prompts Backlash, Could Bring Investigation

Aduhelm (aducanumab), the Biogen Inc. Alzheimer’s drug recently approved by the FDA, seems less and less likely to be dispensed to patients, as prominent providers, practitioner groups and experts have all publicly argued against doing so. Several health insurers have said they will not pay for the drug unless patients pass strict prior authorization standards — and the FDA approval itself could be in jeopardy as the agency’s acting commissioner has called for the HHS Office of Inspector General (OIG) to investigate the process that led to the approval.

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Current Market Access to Graft vs. Host Disease Medications

The FDA on July 16 approved Kadmon Holdings, Inc.’s Rezurock for the treatment of chronic graft vs. host disease (GVHD) in patients 12 and older. The nod marks Kadmon’s first FDA-approved drug and makes Rezurock the first ROCK2 inhibitor in the GVHD market. While acute GVHD is typically managed using low-cost generic immunosuppressants and steroids (see story, p. 1), the chronic form of the disease is more difficult to treat, with the class including TNF inhibitors (Amgen Inc.’s Enbrel), JAK inhibitors (Incyte Corp.’s Jakafi), BTK inhibitors (Johnson & Johnson and AbbVie’s Imbruvica) and monoclonal antibodies (Roche and Biogen’s Rituxan, Amgen’s Ribani). Among the most advantaged therapies are Enbrel, Jakafi and Imbruvica, which hold covered or better status for 69%, 70% and 71% of all insured lives, respectively. The graphics below show how GVHD drugs are currently covered among commercial health plans, health exchanges and Medicare and Medicaid programs, plus their utilization management restrictions.

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Access Exclusive Payer Research on Biosimilars

Payers expect an increase in their utilization of biosimilars compared with reference products, according to MMIT’s new Biosimilars Special Report. It found that of nine indications, payers are most likely to anticipate an increase in biosimilars for rheumatoid arthritis and breast cancer.

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MMIT Payer Portrait: Health Care Service Corp.

Health Care Service Corporation (HCSC) is the parent company of five large, member owned Blues insurers: Blue Cross and Blue Shield of Illinois, Montana, New Mexico, Oklahoma and Texas. The five subsidiaries enroll more than 16 million lives nationwide across the spectrum of health insurance products, though much of their membership is concentrated in Illinois and Texas. Originally founded in 1936 in Chicago as a prepaid insurance plan for hospital care, HCSC now enrolls more than half of all insured lives in Illinois.

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Experts: Post-COVID Oncology Strategies Call for Regional Focus, Tactical Shift

Oncology service utilization has jumped in 2021 relative to 2020, but it’s still significantly depressed from its 2019 pre-pandemic levels. That means life sciences companies need to shift tactics — looking at screening and diagnosis regionally and at socioeconomic factors that contribute to incidence — in order to partner with providers and help patients, experts say.

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U.S. Health Care System Is Recovering From Pandemic, but Concerns Remain

More than 15 months after the U.S. declared that a public health emergency exists due to COVID-19, the health care sector is showing signs of rebounding. That’s according to the IQVIA Institute for Human Data Science report titled The Use of Medicines in the U.S.: Spending and Usage Trends and Outlook to 2025. But it’s certainly a mixed bag of news, and various services still could use some more improvement, observed industry experts at a recent webinar.

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