Americas Healthcare: Pharmaceuticals: Illustrative Impact Analysis and Company Commentary on CMS Proposed Rule

Research evidence excerpt

Americas Healthcare: Pharmaceuticals: Illustrative Impact Analysis and Company Commentary on CMS Proposed Rule

Equity Research

15 June 2026 | 8:46PM EDT

Americas Healthcare: Pharmaceuticals: Illustrative Impact Analysis and

Company Commentary on CMS Proposed Rule

We have been receiving inbounds regarding the CMS proposed rule on the Medicare Asad Haider, CFA

+1(212)902-0691 | asad.haider@gs.com

Drug Price Negotiation Program, which would, in addition to formally codifying Goldman Sachs & Co. LLC

policies previously implemented under the IRA, look to consider formulations with Nick Jennings

two or more active moieties/ingredients or vaccine antigen components as one for +1(415)249-7412nick.jennings@gs.com|

purposes of negotiation eligibility. Combinations with hyaluronidase are specifically Goldman Sachs & Co. LLC

Jeff Sucalled out, suggesting potential implications for MRK’s Keytruda Qlex, BMY’s Opdivo +1(212)357-9930 | jeff.su@gs.com

Qvantig, and JNJ’s Darzalex Faspro — contributing to slight underperformance (MRK Goldman Sachs & Co. LLC

-2.8%, JNJ -2.2%, BMY -1.6% vs DRG -1.3%, XLV -0.6%). We note this issue was

raised last year, as the CMS draft guidance for the IPAY 2028 class included a

paragraph around fixed combinations — however this clause was removed in the

final guidance. Within, we refresh our illustrative impact analysis for including these

SC drugs in the 2029 IRA price negotiations, which implies a theoretical minimal

low-single digit EBIT impact for these companies in 2029/2030.

Company responses to the proposal are largely consistent with prior commentary.

JNJ notes that their position on Darzalex has not changed — consistent with what

the company has shared previously, they do not expect IRA price setting for Darzalex

Faspro before 2034.