Amar Kelkar MD MPH

A communitarian approach to cell therapy and gene therapy access in low-income and middle-income countries In low-income and middle-income countries (LMICs), access to both existing and emerging therapies can be limited. Novel cell and gene therapies (CGT)—such as chimeric antigen receptor T-cell therapies...

8/8 Ultimately, no external entity can dictate the value of CGTs for a community.

Reimagining "Good" in Global Health means empowering communities to navigate these ethical tensions themselves.

Read the full analysis here: www.thelancet.com/journals/lan...

7/8 This isn't just theory. We also discuss logistical pathways:
🏭 Decentralized manufacturing (hub-and-spoke models).
📜 Regional regulatory frameworks (e.g., West African Health Organization).
💊 Managing survivorship and long-term side effects locally.

6/8 The Process > The Outcome 🗳️

We propose using community boards (e.g., representing regions in Ghana) to:
🔥Deliberate.
🔥Assess disease burden.
🔥Weigh opportunity costs.
🔥Vote on prioritization.

Legitimacy comes from collective deliberation, not external mandates.

5/8 The Trade-offs ⚖️

Prioritizing CGTs for a few could divert resources from:
❌ Maternal/Child health
❌ Malaria/HIV/TB treatments
❌ Clean water/sanitation

An exclusive focus on the "individual patient" can obscure these broader social obligations.

4/8 Why does this matter for CGTs?

In LMICs, funding a CAR-T program is a zero-sum game. The Communitarian framework forces a hard conversation:
Does prioritizing high-cost CGTs align with the community's best interests right now?

3/8 We propose a different path: Communitarian Ethics. 🤝

This approach asserts that an individual’s well-being is entwined with the well-being of the community. Instead of rigid rules, it promotes a flexible, context-driven approach where the community defines what is "good."

2/8 In high-income countries, we usually rely on standard ethical frameworks like:
💡Deontology: The duty to care for the individual patient.
💡Utilitarianism: The greatest good for the greatest number.

But in resource-constrained settings, these can feel externally imposed ...

A communitarian approach to cell therapy and gene therapy access in low-income and middle-income countries In low-income and middle-income countries (LMICs), access to both existing and emerging therapies can be limited. Novel cell and gene therapies (CGT)—such as chimeric antigen receptor T-cell therapies...

1/8 Cell and gene therapies (CGT) offer cures, but they are incredibly resource-intensive 🌍

As we consider how to expand access to these therapies to low- and middle-income countries (LMICs), how do we do so ethically and sustainably? 🧵👇 @thelancethaem.bsky.social www.thelancet.com/journals/lan...

Health care decisions belong with patients and their physicians, not in politics. Grateful for the AMA & @ameracadpeds.bsky.social strong statement affirming evidence-based, gender-affirming care and rejecting harmful misinformation.
www.aap.org/en/news-room...

There’s a lot of pushback in Congress and the agencies against health technology assessment tools (like cost-utility analysis) that would facilitate value-based negotiations. The IRA functionally disallowed QALY analyses so we have some work to do educating Congress on this and reversing that …

bsky.app/profile/jama...

bsky.app/profile/jama...

Our article was one of a few recent @jama.com articles on "Most Favored Nation" drug pricing and Medicare drug price negotiation by @dusetzinas.bsky.social @thomasmd.bsky.social @benro.me and others that help explain the current state of the US drug pricing landscape.
bsky.app/profile/jama...

The urgency is real—but the “Most Favored Nation” drug pricing policy is unlikely to deliver lasting reform. In @jama.com, @eddiecliff.bsky.social and I propose accelerating and strengthening Medicare drug price negotiation to align prices with value.
🔗 jamanetwork.com/journals/jam...

Reducing Drug Prices—The Most Favored Nation Policy vs Price Negotiation This Viewpoint discusses the most favored nation policy vs price negotiation for reducing drug prices.

New in @jama.com: The 2025 “Most Favored Nation” (MFN) drug pricing policy rightly captures the necessary urgency in lowering US drug costs—but is likely to face fierce opposition.
We propose accelerating & improving on Medicare drug price negotiation.
jamanetwork.com/journals/jam...

Absolutely-it is horrible that the pricing system has been gamed to maintain such high prices, especially for off patent drugs like lenalidomide!

10/ The MFN policy reflects urgency—but not durability or long-term strategy. With the right reforms, Medicare negotiation can do better: lower prices faster, fairer, and without derailing innovation.

@eddiecliff.bsky.social

📰 Full Viewpoint at @jama.com:
jamanetwork.com/journals/jam...

9/ These changes would:
• Lower prices sooner
• Improve equity and access
• Support innovation responsibly
• Strengthen Medicare and help private insurers who benchmark to Medicare rates

a netflix ad with a girl and the words of course i have a plan on the bottom ALT: a netflix ad with a girl and the words of course i have a plan on the bottom

8/ Our proposal:
✔️ Let Medicare start negotiation 1 year after approval (like Germany)
✔️ Use independent cost-effectiveness assessments
✔️ Delink provider reimbursement from drug prices to align incentives

7/ But the IRA has a critical delay: negotiation only begins 9 years after launch (13 for biologics). During that gap, taxpayers and patients foot the bill for high prices at peak sales volume.

6/ We already have a better tool: Medicare drug price negotiation, passed in the 2022 Inflation Reduction Act. First-year results (which go into effect in 2026)?
📉 >50% reductions in negotiated drug prices
💸 ~$100B in projected savings over 10 years

5/ What’s worse, MFN could become self-defeating. If other countries raise their list prices in response, US prices would go up too, undermining the very goal of the policy.

4/ The 2025 order threatens to revoke FDA approvals or sue companies that resist. It also gives HHS just 30 days to set prices without specifying how. That’s a recipe for legal gridlock, not real reform.

3/ But MFN’s approach is deeply flawed:
❌ Legal and constitutional vulnerabilities
❌ Opaque global pricing benchmarks (obscured by secretive rebates)
❌ Risk to rare disease innovation
❌ Possible retaliation or unsafe drug imports
❌ Could unintentionally raise US prices

patrick star and squidward from spongebob squarepants are standing next to each other and asking why does cost so much ALT: patrick star and squidward from spongebob squarepants are standing next to each other and asking why does cost so much

2/ The US pays 2–3x more for prescription drugs than peer nations. MFN aims to fix this by capping Medicare prices to the lowest paid abroad. For example: $17,000/month ➝ $900/month for a cancer drug like lenalidomide.

Reducing Drug Prices—The Most Favored Nation Policy vs Price Negotiation This Viewpoint discusses the most favored nation policy vs price negotiation for reducing drug prices.

New in @jama.com: The 2025 “Most Favored Nation” (MFN) drug pricing policy rightly captures the necessary urgency in lowering US drug costs—but is likely to face fierce opposition.
We propose accelerating & improving on Medicare drug price negotiation.
jamanetwork.com/journals/jam...

Even if you personally won't lose health insurance with this law, it will result in MANY hospital and clinic closures that will affect the quality of healthcare (including available doctors) that you receive.

The House of Representatives is voting into the night on a massive House Resolution (HR) 1 that will result in 16 million losing healthcare coverage (~11 million on Medicaid, and ~5 million from ACA marketplaces). Call your Congressperson's office tonight and tell them to vote NO!

The American Medical Association President Dr. Bobby Mukkamala. @ama-assn.org

💥Medicaid patients will lose access to care if the OBBBA is adopted.💥

We are facing a serious threat to democracy, law, and liberty. The abuse of prosecutorial power to intimidate, investigate, and detain political opponents is upon us. It is a constitutional crisis. I will keep speaking out until public outrage overflows. I just hope it’s not too little, too late.