Radar on Specialty Pharmacy

Implemented through the CMS Center for Medicare & Medicaid Innovation (CMMI), the most-favored-nation (MFN) model (85 Fed. Reg. 76180, Nov. 27, 2020) “will test whether more closely aligning payment for Medicare Part B drugs and biologicals…with international prices and removing incentives to use higher- cost drugs can control unsustainable growth in Medicare Part B spending without adversely affecting quality of care for beneficiaries.”

The mandatory model will be tested nationwide for seven years, running from Jan. 1, 2021, to Dec. 30, 2027. It is taking a phased-in approach, with reimbursement at 75% average sales price plus 25% MFN price the first year, 50% ASP plus 50% MFN in 2022, 25% ASP plus 75% MFN in 2023, with the remaining four years at 100% MFN.

✦ CMS is delaying the start of the Radiation Oncology Model from Jan. 1, 2021, to July 1, 2021. The move comes after CMS announced the launch date on Sept. 18, and multiple entities, including the American Society for Radiation Oncology and the Community Oncology Alliance, called for the start of the mandatory model to be pushed back in light of the COVID-19 pandemic. The agency said it intended to pursue rulemaking to implement the change. CMS proposed the program in July 2019 (84 Fed. Reg. 34478, July 18, 2019), and it initially proposed a start date in 2020 with an end date of Dec. 31, 2024. Participants will include physician group practices, hospital outpatient departments and freestanding radiation therapy centers for radiotherapy in selected Core Based Statistical Areas. The model will test whether changing from fee-for-service payments to prospective site-neutral, episode-based payments would save Medicare money and provide better care for beneficiaries. Episodes will cover 17 types of cancer and span 90 days. Visit https://bit.ly/2TDKoV9.

✦ Availability and use of biosimilars are increasing, and the products are on track to reduce drug costs by $100 billion over the next five years, according to a study by the IQVIA Institute for Human Data Science. The report, titled Biosimilars in the United States 2020-2024 and released Oct. 6, found that the oncology biosimilars — which have reference drugs of bevacizumab, trastuzumab and rituximab — are expected to reach almost 60% market share by the end of their second year on the market. By June 2020 — one year after launch — biosimilar bevacizumab had picked up 42% of volume share. Download the report at www.iqviainstitute.org.

While a variety of strategies are available to manage specialty drugs in the pharmacy benefit, that’s not traditionally been the case with drugs that fall under the medical benefit. Prime Therapeutics LLC is adding to its offerings for medical benefit management with MedSelect, its newly launched national medical drug management list.

Prime has populated MedSelect with therapies based on their clinical efficacy and/or superiority and cost- effectiveness. It combines utilization management and site-of-care strategies to produce savings and appropriate drug use. The company says it expects the list will help Blues plans achieve a 4% to 7% reduction in medical drug costs.

As the specialty pharmacy industry continues to grow, more entities within the health care system are boosting their capabilities in this area, and various health systems are implementing some form of a specialty pharmacy. These entities have some issues and challenges that may differ from those of traditional specialty pharmacies. In order to make sure their voices are heard, a group of seven health systems plus a specialty pharmacy integrator have joined together to form a new alliance known as the Health System Owned Specialty Pharmacy Alliance (HOSP).

In an Aug. 18 blog on his Drug Channels website, Adam Fein, Ph.D., CEO of Drug Channels Institute, a subsidiary of Pembroke Consulting, Inc., shared information from the American Society of Hospital Pharmacists’ survey of 487 pharmacy practices located in hospitals. That survey found that 26% of respondent hospitals in 2019 owned a specialty pharmacy, up from 20% in 2018 and less than 9% in 2015.

With the FDA’s approval last month of Onureg (azacitidine), people with acute myeloid leukemia (AML) now have an oral version of a longtime injectable treatment within that class. Zitter Insights found that more than half of oncologists polled are likely to prescribe the drug as a maintenance treatment for the condition.

On Sept. 1, the FDA approved Bristol-Myers Squibb Co. unit Celgene Corp.’s Onureg, a tablet, for the continued treatment of adults with AML who achieved first complete remission or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy (RSP 9/20, p. 8).