The Centers for Medicare & Medicaid Services on Wednesday outlined a series of proposed policy changes for next year that would change the way non-opioid drugs and certain radiopharmaceutical diagnostics are paid for.
The final rule will be issued in early November, according to a CMS press release, and the rule would go into effect next year.
Incentivizing non-opioid drugs
CMS’ guidance follows the NOPAIN Act, which was signed into law in 2022, to incentivize the use of non-opioid pain products. The proposal would provide separate payment for non-opioid pain drugs and devices beginning next year, with the goal of making it easier to access non-opioid options over cheaper opioids.
That’s key as a new non-opioid drug could receive FDA approval in the coming months to a year.
Vertex reported in January that its non-opioid pain drug succeeded in pivotal clinical trials, and the company began a rolling FDA submission in April. If the treatment, now known as suzetrigine, is approved by the FDA, it would become the first novel non-opioid drug to reach the market in more than two decades, according to Vertex.
“When it comes to treating pain in this country, we are asking our healthcare providers to do more with less,” Chris Fox, executive director of the advocacy group Voices for Non-Opioid Choices, said in a press statement. “This guidance makes clear our nation’s intent to incentivize the use of non-addictive forms of pain management where practicable.”
Lantheus’ shares spike
Diagnostic radiopharmaceuticals with a per-day cost more than $630 would be paid for separately under CMS’ newly-proposed rule, rather than being bundled with nuclear medicine tests.
The news sent Lantheus’ shares $LNTH up 37% Wednesday. The company markets prostate cancer imaging agent Pylarify, which generated $259 million in sales in the first quarter of the year.
“This update should address challenges for patients in accessing these prescribed nuclear medicine tests with higher-cost radiopharmaceuticals,” CMS wrote in its press release describing the rule.
“The proposed rule suggests that CMS should support separate favorable reimbursement of specialized diagnostic radiopharmaceuticals such as Pylarify” after this year, according to Leerink Partners analyst Roanna Ruiz.
In addition, CMS proposed a change in payment incentives for the widely-used imaging agent technetium-99m to boost the domestic market.
CMS’ current policy provides an additional $10 payment for technetium-99m produced without using highly-enriched uranium, which has historically been used at reactors outside the US.
While next year is the final year of that policy, CMS is proposing a new policy that would provide a $10 add-on payment for the imaging agent derived from a source material called molybdenum-99 if it is produced domestically. Molybdenum-99 production has been subsidized by foreign governments, disincentivizing domestic investments, according to CMS.