As a result of the Inflation Reduction Act (IRA), which was signed into law in 2022, patients with Medicare Part D prescription drug plans can now “benefit from lower prescription drug costs and a redesigned prescription drug program.”

Yet, according to Mark Miller of the New York Times, awareness of these changes made to Medicare are surprisingly low, as revealed in a recent survey conducted by the Kaiser Family Foundation (KFF).

Hopefully, information in this week’s blog will help raise awareness about the benefits of IRA to Medicare enrollees, both now and in the future.

According to the Centers for Medicare and Medicaid Services (CMS),“the Inflation Reduction Act provides meaningful financial relief for millions of people with Medicare by improving access to affordable treatments and strengthening the Medicare Program both now and in the long run.” 

“The new drug law makes improvements to Medicare that will expand benefits, lower drug costs, keep prescription drug premiums stable, and improve the strength of the Medicare program,” says CMS.

Benefits of the program include:

• Beginning January 1, 2024, patients with high prescription drug costs will no longer be required to pay out-of-pocket costs once they reach a certain level of spending known as the catastrophic phase of Medicare Part D. The Kaiser Family Foundation estimates that enrollees who take only brand-name drugs in 2024 will have a cap of about $3,250 for calendar year 2024.
• Expansion of the low-income subsidy program (LIS or “Extra Help”) under Medicare Part D to 150 percent of the federal poverty level starting in 2024
• A yearly cap ($2,000 in 2025) on out-of-pocket prescription drug costs in Medicare
• Access to recommended adult vaccines without cost-sharing
• Insulin available at $35/month per covered prescription

Other provisions for Medicare in the IRA, as stated by CMS:

Medicare Drug Price Negotiation
“Medicare will be able to negotiate directly with drug manufacturers to lower the price of some of the costliest single-source brand-name Medicare Part B and Part D drugs.”
 
Inflation Rebates in Medicare
“The new law requires drug companies that raise their drug prices faster than the rate of inflation to pay Medicare a rebate.”  

Changes to Medicare Part B
Changes in the Medicare Part B program will aim to increase access to biosimilars for those enrolled in the program, as well as impose a $35/month cost-sharing cap on insulin used in durable medical equipment pumps.
 
For more information and guidance on the Inflation Reduction Act and Medicare, visit CMS.gov. 

What is the Extra Help Program?

According to CMS, the Extra Help Program “helps some people pay their Medicare drug coverage (Part D) costs, like premiums, deductibles, coinsurance, and other costs.” 

Beginning January 2024, the Inflation Reduction Act expands the program to cover more drug costs for people with limited resources.

In 2024, this program will help lower costs for those who qualify by:

• $0 for their Medicare drug plan premium
• $0 for their plan deductible
• Reducing the amount for both generic and brand-name drugs

Additionally, Miller points out two important changes that will be implemented in 2025: “A beneficiary’s total out-of-pocket spending will be capped at $2,000 and people will be able to spread their out-of-pocket costs throughout the year by setting up a monthly payment plan with their Part D insurance companies.”

More information on the Medicare Prescription Payment Plan can be found on the CMS Fact Sheet. 

Currently, there are about 300,000 low-income individuals enrolled in the Extra Help program who will be eligible for expanded benefits, including no deductible, no premiums, and fixed, lowered copayments for certain medications.

About 3 million are qualified but have not yet enrolled in the Extra Help program. There are also some who have been automatically enrolled in the program and are already receiving assistance to help pay for Medicare costs. However, this does not apply to everyone. 

To know if you qualify for Medicare’s Extra Help program and to find out how to apply for the program, please refer to this CMS drop-in article. 

The International Myeloma Foundation is always ready to help. If you need more information or have any questions about Medicare’s redesigned prescription drug program, you may reach out to the IMF InfoLine Team by calling 1(800)452-CURE(2873) (Phone lines are open Monday-Thursday, 9 a.m. to 4 p.m. PST) or by emailing [email protected].

The DREAMM-7 Trial: Positive Outcomes

This week, GSK announced the results of an interim analysis of the DREAMM-7 phase III clinical trial—“a multicenter, open-label, randomized trial evaluating the efficacy and safety of belantamab mafodotin in combination with bortezomib and dexamethasone (BorDex) compared to a combination of daratumumab and BorDex in patients with relapsed/refractory multiple myeloma who were previously treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy,” states GSK’s press release.

According to GSK, the DREAMM-7 phase III trial is a head-to-head comparison between Blenrep (belantamab mafodotin, an anti-BCMA drug conjugate) combined with Velcade (bortezomib) plus dexamethasone (BorDex) versus daratumumab (an anti CD38 monoclonal antibody) plus BorDex in second line and later treatment of relapsed or refractory myeloma. 

Data from these findings were presented at the American Society of Clinical Oncology (ASCO) Plenary Series on February 6, 2024.

Key observations from the interim analysis were:

• With a median follow up of 28.2 months, the median PFS (progression-free survival or remission) was 36.6 months with the belantamab + BorDex combination versus 13.4 months with the daratumumab + BorDex combination an almost three-fold longer PFS with a 59% reduction in the risk of disease progression or death (P value <  0.00001 : obviously highly significant difference). The benefit occurred for all different subgroups of patients including those with high risk cytogenetic and those patients refractory to lenalidomide. No new safety concerns were noted.
• There was also an improved achievement of deeper responses (CR; sCR, and MRD negativity) with the belantamab + BorDex combination.
• There was a strong and clinically meaningful trend towards improved duration of response (DOR) as well as overall survival (OS) with the belantamab + BorDex combination.

This is an especially meaningful level of benefit versus the dara + BorDex combination, which is considered to be a current standard of care (SOC) therapy.

As noted by DREAMM-7 Trial Principal Investigator María-Victoria Mateos, MD, PhD (Head of Myeloma and Clinical Trials Unit, Haematology Department and Professor of Medicine at the University of Salamanca, Spain): “These results from DREAMM-7 show how belantamab mafodotin in combination with BorDex represents a significant improvement over the daratumumab-based regimen in a second-line multiple myeloma treatment setting. Anti-BCMA therapies are helping to improve outcomes for patients with multiple myeloma, and having an off-the-shelf option, like belantamab mafodotin, that can be administered in a community oncology treatment center where the majority of patients are treated has the potential to transform the way we treat myeloma at or after first relapse.”

The results of the DREAMM-7 phase III trial will be presented to health authorities worldwide. There is optimism that this important new option can become broadly available as a community oncology treatment.

The Bottom Line


2024 has started right with this week’s dose of good news for the myeloma community. There is a lot of optimism, both on the healthcare and research fronts. Hopefully, more will be coming in the next few months.

Meanwhile, let’s all stay positive.