Radar on Specialty Pharmacy

With its third FDA approval in less than two-and-a-half years, Alnylam Pharmaceuticals, Inc. is bringing another orphan drug for a rare condition to the U.S. market. And similar to the first two, Oxlumo (lumasiran) comes with a costly price tag. To help provide payers with some predictability around costs, the company is extending a new value-based agreement, as well as offering another VBA that the company introduced with its previous approval.

On Nov. 23, the FDA approved Alnylam’s Oxlumo for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. The agency says it is the first treatment approved for the rare genetic disorder, in which the body overproduces oxalate. This, in turn, results in the deposition of calcium oxalate in the kidneys and urinary tract, which can lead to kidney stones, nephrocalcinosis, kidney failure and organ damage throughout the body.

The FDA has approved only a few drugs to treat triple-negative breast cancer (TNBC), and last month saw Merck & Co., Inc’s Keytruda (pembrolizumab) gain accelerated approval for the condition. Commercial payers have indicated a willingness to cover it at parity with Roche Group member Genentech USA, Inc.’s Tecentriq (atezolizumab), as well as preferring Keytruda over Tecentriq, but providers are a bit more uncertain about how they will prescribe the newly approved therapy. The condition, though, remains largely unmanaged by payers, a source tells AIS Health.

Some breast cancers test positive for estrogen receptors, progesterone receptors or overexpression of human epidermal growth factor receptor 2 (HER2), but people with TNBC do not have these proteins, which limits their treatment options, according to the American Cancer Society. It also is a fairly aggressive cancer and recurs more often than other breast cancers.

As the Supreme Court decides on the fate of the Affordable Care Act (ACA), much of the focus understandably has been on the millions of people who would lose health insurance coverage and protections for pre-existing conditions if the law is overturned. Another not-so-often-discussed ramification of such a ruling is that the biosimilars market could be completely upended. While industry experts tell AIS Health that such an outcome probably will not occur, they still recommend that stakeholders prepare for this possibility.

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created the 351(k) biosimilar pathway. After more than one attempt to get a stand-alone bill to pass, lawmakers made it part of the ACA, and it became law on March 23, 2010 (RSP 4/10, p. 1).

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.