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| | Weekly View August 12, 2022 |
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From the desk of Priya Ranade |
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Earlier this week, the Senate passed a historic bill allowing Medicare to negotiate prices for some small molecule drugs (7 years after FDA approval) and biologics (11 years after FDA approval). The number of drugs subject to Medicare negotiation will gradually increase from 10 Part D drugs in 2026 to 20 Part D and B drugs in 2029. This bill will also enforce rebates on manufacturers that raise prices faster than the rate of inflation. Finally, Medicare beneficiaries can look forward to a $2,000 out-of-pocket spending cap on Medicare Part D, starting in 2025. The House is expected to pass the legislation today, and President Biden has promised to sign it into law if it reaches his desk.
While the Inflation Reduction Act is a consequential change to prescription Drug Pricing in the U.S., there’s still work to be done -- particularly when it comes to launch prices. ICER strives to complete our reports around the time of FDA approval because this is when an independent assessment of value is most helpful in informing the critical decisions that stakeholders across the US health system need to make around pricing, coverage, and prescribing... all to ensure fair pricing and fair access to prescription drugs for all Americans.
Let’s see what else happened this week. |
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ICER Deems Potential ALS Drug Fairly Priced At No Less Than $9,100 Inside Health Policy
ICER Releases Report Comparing Cost-Effectiveness of ALS Agents Oral Edaravone and AMX0035 Neurology Live
AMX0035, Radicava ORS Costs Could Cloud Therapies’ Benefits: ICER ALS News Today |
Last week we released an Evidence Report assessing the comparative clinical effectiveness and value of AMX0035 (Amylyx Pharmaceuticals, Inc.) and oral edaravone (Mitsubishi Tanabe Pharma Development America, Inc.) for the treatment of amyotrophic lateral sclerosis (ALS). This Evidence Report is also the pre-read for our August 19th public meeting. Register here. |
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Zynteglo May Herald “New Dawn” of Many Seven-Figure Gene Therapies Managed Healthcare Executive
News Briefs: ICER Says Evidence for Beti-Cel Demonstrates Net Health Benefit AIS Health |
We recently released our Final Evidence Report on the gene therapy beti-cel for beta thalassemia. At our June 2022 public meeting, the independent appraisal committee unanimously determined that evidence was adequate to demonstrate that beti-cel provided a net health benefit compared to standard clinical management. Given the high costs of standard care, our cost-effectiveness modeling found that beti-cel meets commonly accepted value thresholds at an anticipated price of $2.1 million — if that price is subject to an 80% payback for treatment failure. |
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MUST READS Senate Passes Democrats’ Climate, Healthcare and Tax Bill The Wall Street Journal
Senate Passes Climate, Health and Tax Bill, With All Republicans Opposed The New York Times
Understanding The Democrats’ Drug Pricing Package Health Affairs |
Rachel Sachs, an associate professor of Law at Washington University in St. Louis, created an explainer of the drug pricing policies in the Inflation Reduction Act:
"The Biden Administration is now on the verge of accomplishing this long-sought policy goal. Even as the scope of the negotiation provisions remain limited, from a precedential perspective, this is a significant change in drug pricing policy.
The expected passage of the IRA by the House this week would be just the beginning, rather than the end, of developments over Medicare drug price negotiation. The pharmaceutical industry has suggested that they are likely to sue to challenge the law. The industry is also likely to attempt to influence the rulemaking process and to sue to challenge CMS’ implementing regulations." |
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Senate’s Medicare drug pricing may ripple into private market Roll Call |
The Senate bill wouldn’t directly impact the 211 million people with private insurance, but some experts say its provisions about pricing for drugs under Medicare could cause drugmakers to try to recoup some lost revenue in the private market. Health insurers and employers are among those worried that lower prices in Medicare will lead drug companies to turn to the private market to offset losses, a theory known as cost-shifting. The concern is particularly high for insulin and other drugs that would trigger a penalty if prices rise faster than inflation. |
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The GOP blocked an insulin price cap: What it means for diabetics The Washington Post
Schumer: Senate will vote again on $35 insulin cap after GOP blocked it The Hill |
Republican senators voted to strip language from the Inflation Reduction Act that would have capped the price of insulin at $35 per month for many patients. A proposal that limits the monthly cost of insulin to $35 for Medicare patients was left untouched. But using a parliamentary rule, GOP lawmakers were able to jettison the part of the proposal that would apply to privately insured patients.
Senate Majority Leader Charles Schumer (D-N.Y.) said Monday night that he is going to bring a $35 cap on patients’ insulin costs back up for a vote this fall. |
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With drug pricing almost done, Congress looks to wrap up FDA user fee legislation Endpoints News |
The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim. |
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