Michael Malecki, Ph.D.’s Post

Non-lawyers, tell the truth: did you know what #Chevron Deference was before this morning? As a proud nerd with an interest in Market Access marketing and Regulatory Policy, I wanted to share some thoughts on the Supreme Court's ruling in Loper Bright Enterprises v. Raimondo and its implications for our industry (Market Access professionals, in particular). 1️⃣ Overruling Chevron Deference The Court's decision in Loper Bright means that agencies such as FDA have less latitude in how they interpret laws and that courts now have a greater role in interpretation and will rely less on FDA. That's wonky, I know. 2️⃣ Implications for FDA Regulations for Value Marketing FDA’s historical reliance on its ability to interpret the law, such as FDAMA Section 114, will now face more rigorous judicial scrutiny. Courts will independently assess whether the FDA’s guidelines align with the best reading of the statute, potentially leading to broader allowances for the dissemination of Health Care Economic Information (HCEI). 3️⃣ Opportunities for Biopharma This decision opens the door for the biopharma industry to challenge restrictive FDA interpretations. With courts applying their independent judgment, we can expect a more favorable environment for the dissemination of truthful and non-misleading HCEI in the long run. 4️⃣ Uncertainty for Marketers Because it will take time for our industry to decide to challenge and then ultimately challenge FDA in court, we can expect large, risk-averse manufacturers to stick with status quo and self-restrict for the time being. While the Amarin case opened the figurative door to increased reliance on the First Amendment in allowing promotional speech, big pharma companies have been reluctant to lean on this precedent to advance their own latitude to promote. Access colleagues: What are your thoughts on Loper Bright? #MarketAccess #RegulatoryPolicy #PharmaceuticalMarketing #LoperBright #FDA #HCEI #PharmaIndustry #HealthcareEconomics #FDAMA114

Pretty big news in the #GLP1 and #obesity care space today, with #CMS now saying they will cover agents (with CV outcomes data and approval) to reduce the risk of major cardiovascular adverse events (#MACE) in patients with established #cardiovascular disease. The big surprise (to me, at least) is that CMS made this change by regulation instead of waiting for a change in law. While this decision is within CMS's statutorily defined abilities, that they took the step is encouraging. Particularly because the government will negotiate prices by active ingredient (e.g., Ozempic and Wegovy), the immediate-term opportunity to open access to Medicare-covered patients incentivizes CV outcomes trials for any agent that might get both a weight management label along with any other indication that would be covered. Since this change impacts Part D plans, an open question is how these plans will verify the drug is used for MACE reduction versus "just" weight reduction. In this area, it will be instructive to follow all three of the policy, process, and PA form. https://lnkd.in/gZV_keKn

This morning's bluebird news should give us all pause...why? bluebird is one of the relatively more established #genetherapy developers, having spent many years and much capital to bring important innovation to market. My impression (for what it's worth!) is that the folks at bluebird are really smart and dedicated, too. If that team cannot find a commercial model to support an independently profitable model, one begins to question the modality a bit. Caveat: bridge financing of this sort isn't necessarily a death sentence, and it is entirely possible that they are just working through the uptake curve. In this case, a larger commercial partner may be beneficial, right? https://lnkd.in/dMfGJ3vZ

Congrats to the team at Madrigal Pharmaceuticals for approval of #Rezdiffra (#resmetirom) for #NASH (aka #MASH). This first approval for a MASH therapy is an important step in serving patients. As a large-population disease with an uncomfortable diagnosis journey, the market development required to activate prescribers, motivate patients, and overcome payers will be fascinating. https://lnkd.in/dMQZ8ui7

FDA's approval of #Rybrevant for first-line treatment of non-small cell lung cancer (#NSCLC) with #EGFR exon 20 insertion mutations (and the accompanying transition from accelerated to full approval as monotherapy) is great news for patients. #Exon20 insertion mutations in the EGFR gene correlate with worse prognosis and seem more common in patients with no history of smoking. Additionally, patients carrying one of these mutations have tumors that are often not sensitive to tyrosine kinase inhibitors (TKIs), so an efficacious first-line treatment option for these people is really important. Recall that Rybrevant was one of the drugs recently pulled from Germany due to policies that have made that market increasingly hostile to innovation. (Neil Grubert has helpful analysis on this point, e.g., bit.ly/3L20hR1). As folks think through what U.S. reimbursement policy might look like, this contrast is illustrative! https://lnkd.in/gHkMywQY

Interesting approach from Regneron on how to serve patients with #obesity after initial therapy with a GLP/GIP. It seems that their hypothesis is that patients need to shift to a different mechanism of action in order to retain muscle while keeping weight off. Time will tell how a new MoA compares with longer-lasting GLP/GIP modulation, the former approach taking on the risk of a less clinically understood pathway. Irrespectively of the eventual clinical success of this particular approach, kudos to them for recognizing that fully serving this population will take multiple approaches and lines of therapy, affording positive ROI for several programs. There is a lot of market development to be done here! https://lnkd.in/gGBCf7DK

#Obesity, #MASH, and #BCMA categories all have fascinating competitive dynamics currently or in the near future. What lessons can we learn from markets today?   A broader perspective on the history of #GLP1 agonists is useful in reminding us that: 1. Efficacy matters - Established brands can be displaced with meaningful investment in clinical efficacy. (Humira-Enbrel is also an example of this history!) 2. Patient preference drives consumerized markets - Improved dosing regimens, less time in inpatient settings, etc. make differences. 3. There is room for improvement in tolerability - #Wegovy / #Ozempic and #Zepbound / #Mounjaro are not the last word in #obesity treatment.   Check out the link for a refresher, and please let me know what you think! https://lnkd.in/g4GDBrEY

Recent articles have brought to light the unintended consequences of IRA "negotiation" policy on biosimilar development and overall cost savings. As someone who has worked in biosimilars, I can attest that these regulatory and reimbursement shifts bring about a sense of uncertainty. Businesses thrive on certainty, while uncertainty stifles investment. For those interested in learning more, check out this insightful article on the impact of IRA policy on biosimilar competition and cost savings. #biosimilars #healthcarepolicy #IRAnegotiation

Following on Apex Market Access's deep dive into TPPs, a few questions arose that warranted a double-click. I'm excited to share the latest from Apex Market Access on these more nuanced facets of a #tpp. This latest post, "Expanding the TPP: Advanced Considerations for Market Access Success," is a helpful resource for those of us strategizing in the biopharma industry. It's a deep dive into the strategic, business, and operational intricacies that can define the trajectory of a product's journey in the market. Check it out here: https://lnkd.in/g7ncZxNB #BiopharmaStrategy #MarketAccess #PharmaceuticalInnovation