 Pulse on Policy
By Michelle Leeds On Thursday, the US House of Representatives passed H.R. 3, the Lower Drug Costs Now Act, a sweeping bill designed to lower drug prices. There is almost no chance the Senate will bring it up for a vote, but the bill represents an aggressive position on drug prices that Democrats will use as a key campaign message in the 2020 election. The bill, championed by Speaker Nancy Pelosi, aims to reduce drug prices through several policies opposed by the pharmaceutical industry, including: - Medicare negotiation: the bill would enable the federal government to directly negotiate the prices of the most costly 250 drugs covered by Medicare every year. It would also allow private insurers to buy drugs at the price negotiated for Medicare. Drug manufacturers that refuse to negotiate prices with Medicare would be penalized with fines of 65-95% of a drug's gross sales.
- International reference pricing: the bill would cap payments for drugs in the U.S. at 120% of the average prices paid in Germany, Japan, Canada, France, the UK and Australia.
- Inflation caps: the bill would prohibit price increases for drugs covered by Medicare Parts B and D beyond the rate of inflation, requiring companies to either roll back price increases taken since 2016 or rebate the difference to the U.S. Treasury.
According to the Congressional Budget Office, the bill is estimated to save approximately $450 billion over 10 years. The CBO also acknowledges the flip side of these savings, which would be a decline in pharma industry revenue that could lead to eight fewer drugs coming to market in the next 10 years and 30 fewer drugs in the following decade. The Senate is working on a less aggressive drug pricing bill, but the fate of that bill is uncertain. What this means for life sciences companies: Although H.R. 3 has little chance of becoming law this year, it is almost certain to be a key talking point for Democrats on the campaign trail next year. Expect this topic to stay hot in media coverage of the elections, and potentially beyond, if Congress returns to the issue for legislative action in 2021. Life sciences companies should be prepared to respond to media inquiries about how this bill and similar policies may impact their currently marketed medicines and pipeline.  CAR-T Cost Offsets
By Rose Shelley CAR-T therapies were a hot hot hot topic at the 61st American Society of Hematology (ASH) annual meeting last weekend. It’s no secret that some hospitals have been struggling to pay for treating patients with CAR-Ts, because of insufficient reimbursement relative to the care required to administer them. In fact, a study in Journal of Clinical Oncology published in November found hospitals may be losing upwards of $300,000 for each CAR-T administered, which in some cases is nearly the entire list price of the therapy! This has led to questions about the price and uptake of CAR-Ts -- and whether they can yield the value investors hoped. But to the skeptics, a real world evidence study presented at ASH argued that CAR-Ts may be more cost effective than people assumed. The study evaluated Medicare patients with non-Hodgkin's lymphoma who received CAR-T therapy and compared healthcare utilization, costs, and outcomes pre- and post-CAR T therapy. It found treating these patients with CAR-Ts may reduce overall healthcare costs by 27%. Treatment with CAR-Ts was associated with fewer hospitalizations, emergency department visits -- and lower total healthcare costs. And, in exciting news, the patients analyzed seemed to show better survival rates despite being older and sicker. Our Take Will this study unleash better reimbursement and uptake for CAR-Ts tomorrow? Probably not. However, as developers, manufacturers and providers learn how to optimize CAR-T delivery and dosing – this study shows a promising view of how the outcomes and costs solidly justify these therapies’ value. And, increasing data showing good value may support more patients receiving CAR-Ts in earlier lines of therapy – versus coverage being relegated to only more advanced cases.  Who wrote this? The managing editor of TWTW is Randi Kahn, who is excited to breakout her light up “ugly” Chanukkah sweater for a party this weekend. ‘Tis the Season! Syneos Health Communications' Reputation & Risk Management Practice is a team of healthcare communications consultants, policy-shapers and crisis response specialists. We provide unique solutions to the evolving communications challenges in today’s healthcare industry, using evidence-based approaches to help our clients successfully navigate the most sensitive of situations.
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