Understanding the Impact of Biosimilars on Employer Health Care Costs
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Rising health care costs will likely continue to impact employers in the foreseeable future. The introduction of biosimilar drugs as an alternative to biologics may bring value to health care by offering cost savings and increasing employee access to necessary medications. While biosimilars can help employers mitigate rising prescription drug costs, employers will need to learn more about them before considering how their health plans can accommodate these newer drugs.
This article explores biosimilar drugs and their impact on employers’ health care costs.
Biosimilar Overview
Unlike generic drugs, biosimilars are not identical to their reference biological products (also called the brand-name counterpart) and aren’t created from synthesized chemicals. A biosimilar drug is a biological product produced from living organisms—humans, animals or microorganisms. Approved by the Food and Drug Administration (FDA), biosimilars are similar to the reference drug (a previously FDA-approved biologic), but have no significant clinical differences. Compared with biologics, biosimilars have the same strength, dosage and potential side effects but provide the same treatment benefits.
The FDA rigorously evaluates biosimilars to validate their efficacy, safety and quality. The FDA has approved over 40 biosimilars; however, not all are commercially available.
Biosimilars are safe and effective treatment options for many illnesses, including chronic skin and bowel diseases (e.g., psoriasis, irritable bowel syndrome, Crohn’s disease and colitis), arthritis, kidney conditions and cancer. They can potentially increase access to lifesaving medications at a lower cost.
Impact on Health Care Costs
As prescription drug costs continue to rise, employees are realizing increased out-of-pocket expenditures for the medications they and their families depend on. Specialty drugs, including biologics, are the fastest-growing part of drug costs.
The Biosimilars Council estimates that 1.2 million people will have access to more affordable biologic medicines by 2025 due to the availability of several leading biosimilars. The exclusivity period for the following drugs either has ended or will expire before 2025, which will open the door for biosimilar approval:
- Humira (adalimumab) for rheumatoid arthritis (RA), Crohn’s disease and ulcerative colitis
- Remicade (infliximab) for RA, Crohn’s disease and ulcerative colitis
- Neulasta (pegfilgrastim) to prevent infection following chemotherapy
- Enbrel (etanercept) for RA
- Avastin (bevacizumab) to treat eye diseases and different types of cancer
- Lucentis (ranibizumab) to treat eye diseases
- Rituxan (rituximab) to treat certain autoimmune diseases and types of cancer
Five of those seven products are among the country’s biggest-selling brand biologics, accounting for more than 30% of total biologic sales in the United States. The research further suggests that women, lower income and elderly individuals stand to benefit most from access to biosimilars. Utilization demographics of those previously-mentioned specific products reveal that 86% of patients are older than 40, 67% are women and 42% are low-income.
Research suggests that large and self-insured employers have the most to save regarding biosimilars. According to The ERISA Industry Committee (ERIC), in 2018, self-insured employers in the United States could have saved $1.4 billion by promoting the use of biosimilars in their employer-sponsored health plans. Furthermore, ERIC research found that patients who took the biosimilar medicine paid, on average, 12% (about $300) and 45% (about $600) less out of pocket than those who took the biologic.
Ford Motor Co. (Ford) is one such organization exploring biosimilar substitution plans and having success. Ford required new and current users of Remicade to convert to Inflectra. Since the transition began in 2019 and an expansion to four other biosimilars, Ford has saved nearly $5 million.
By 2025, the Biosimilars Council reports that biosimilars will save the national health care system up to $183 billion. With many Americans relying on their employers for health coverage, more employers are considering biosimilars as a viable solution to lower health expenditures and pass savings to their employees. Not only can employers potentially reduce specialty drug costs, but also promote better health outcomes for their employees and their families.
Summary
Biologics account for much of specialty drug costs and are typically cited as a leading driver of rising prescription drug costs. As the potential for biosimilars continues to grow, more employers may consider promoting them to help realize cost savings in their health plans and offer less expensive drug alternatives to their employees.
Contact us to learn more about health care cost mitigation trends.
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The Industry Impact of Medicare Drug Price Negotiations
This article is from RISQ Consulting’s Zywave client portal, a resource available to all RISQ Consulting clients. Please contact your Benefits Consultant or Account Executive for more information or for help setting up your own login.
The Biden administration recently unveiled the first 10 prescription drugs subject to Medicare price negotiations. The Medicare Drug Price Negotiation Program—part of the Inflation Reduction Act (IRA)—is the Biden administration’s latest effort to combat rising health care costs. According to a Kaiser Family Foundation survey, more than 60% of the 65 million people on Medicare take prescription medication, and 25% take at least four prescriptions. Medicare drug price negotiation aims to lower out-of-pocket costs for millions of seniors and offer savings for taxpayers.
The first round of Medicare Part D drug negotiations will begin this year, with the new prices becoming effective in 2026. Over the next four years, Medicare plans to negotiate prices for up to 60 Part D and Part B drugs—and up to an additional 20 drugs every year after that. This article outlines the potential impacts of the Medicare Drug Price Negotiation Program on the health care industry.
Overview of Medicare Drug Price Negotiations
Under the IRA, the Medicare Drug Price Negotiation Program allows the federal government to negotiate directly with drug manufacturers to improve access to some of the costliest brand-name drugs. Many Medicare Part D enrollees depend on medications to treat life-threatening conditions, such as diabetes and heart failure, but may not be able to access them due to costs.
The following Medicare Part D drugs will be the first ones subject to these negotiations:
- Eliquis, for preventing and treating blood clots
- Jardiance, for treating diabetes and heart failure
- Xarelto, for preventing and treating blood clots; risk reduction for patients with coronary or peripheral artery disease
- Januvia, for treating diabetes
- Farxiga, for treating diabetes, heart failure and chronic kidney disease
- Entresto, for treating heart failure
- Enbrel, for treating rheumatoid arthritis, psoriasis and psoriatic arthritis
- Imbruvica, for treating blood cancers
- Stelara, for treating psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis
- Fiasp/Novolog, for treating diabetes
These 10 drugs are among the highest costs in total spending in Medicare Part D. In fact, Medicare enrollees taking these drugs paid a collective $3.4 billion in out-of-pocket costs in 2022 to obtain them. However, according to the Centers for Medicare and Medicaid Services’ (CMS) guidelines, if a biosimilar enters the market and finds substantial buyers, the agency will cancel or adjourn negotiations for the corresponding name-brand drug listed for negotiations. For example, two biosimilar versions of Stelara are set to launch in 2025. If they are successful, the CMS will no longer be able to negotiate a lower price for Stelara.
Pharmaceutical companies have until Oct. 2, 2023, to present data on these drugs to the CMS. The CMS will then make initial price offers in February 2024, which will start the negotiation process. Negotiations are scheduled to end in August 2024, with the new prices becoming effective in January 2026. However, several pharmaceutical companies have filed lawsuits to stop the Medicare Drug Price Negotiation Program. Some of these lawsuits argue that the IRA’s price negotiation process violates the U.S. Constitution by allowing the federal government to impose its preferred price unilaterally. According to legal experts, it’s unclear whether these lawsuits will be successful since Medicare is a voluntary program for drug companies. However, these lawsuits could delay the timing of Medicare drug negotiations.
Impact of Medicare Drug Price Negotiations
Medicare has been setting prices for services as well as physician and hospital payments but has not been allowed to be involved in pricing prescription drugs, which Medicare started covering in 2006. Therefore, allowing Medicare to negotiate drug prices could have a significant impact on the health care industry. While the first 10 drugs subject to price negotiations are used by only 9 million Medicare beneficiaries, the CMS plans to negotiate prices for 50 drugs by 2029. These 10 drugs include some of the most expensive for Medicare, costing a combined $50 billion in 2022; however, the impact of Medicare drug price negotiations may be slow at first but grow with time.
Short-term Impacts of Medicare Drug Price Negotiations
The initial impact of the Medicare Drug Price Negotiation Program may have muted financial impacts on manufacturers and the federal government, at least for the first round of negotiations, according to analysts. This is largely due to factors that impact the revenue and profits of the 10 drugs scheduled for negotiation. For example, many of these drugs currently face competition from other branded medications or patent expirations, which will allow generic alternatives to hit the market. Additionally, some of these drugs do not contribute significantly to pharmaceutical companies’ businesses, so any decline in drug sales may have little impact on a company’s overall business and profitability.
Moreover, Medicare Part D plans (prescription drug plans) and pharmacy benefits managers have already negotiated rebates for the first 10 drugs set for negotiation. Further, many of these drugs come with manufacturer discounts, decreasing their prices well below the list price. As a result, the negotiated prices for these first 10 drugs may not be significant or reduce what the federal government currently pays for them.
Long-term Impacts of Medicare Drug Price Negotiations
While the commercial impact of negotiations may be limited for the initial list of drugs, this could change in future rounds of negotiations. In 2028 and beyond, Medicare drug price negotiations will begin to target Medicare Part B drugs, which cover more specialized medications that are administered by health care providers rather than pharmacies. Many of these drugs offer fewer rebates than the ones currently listed for negotiation. Additionally, some of these drugs are biologics, which will likely have a more significant impact on drug companies because they are much more expensive and have a greater impact on the earnings and growth of these companies.
Pharmaceutical companies claim that the drug price negotiations will curb the development of new drugs. As a result, Medicare drug price negotiations may result in pharmaceutical companies altering their drug development strategies over time. However, according to the Congressional Budget Office’s estimates, only a few drugs would not be developed each year because of Medicare drug price negotiations.
Impact on Individuals
Due to the high costs of these prescriptions, many Americans are forced to choose between paying for vital medications or buying food and other necessities. While some individuals may save money on their prescriptions because of price negotiations, the Medicare Drug Price Negotiation Program aims to lower overall Medicare costs. By doing this, the Medicare program and taxpayers could see significant savings. Moreover, starting in 2025, the IRA will deliver further relief to Medicare beneficiaries by limiting their drug spending to $2,000.
However, the impact of drug price negotiations on individuals not receiving Medicare is currently unclear. Some experts believe that by reducing how much drug companies can charge Medicare beneficiaries, they will increase prices for privately insured individuals. Others believe that Medicare drug price negotiations may enable private health plans to negotiate for lower drug prices for the medications they cover. Additionally, Medicare drug price negotiations could incentivize pharmaceutical companies to lower listed gross prices for medications, which could lower out-of-pocket payments for privately insured individuals.
Employer Takeaway
Medicare drug price negotiations allow the federal government to negotiate prices for a limited number of drugs to lower out-of-pocket costs for millions of seniors and offer savings for taxpayers. While the drugs scheduled for negotiation are among the most expensive, it will likely be some time before the impact of these negotiations is seen. Even if the negotiated prices do not result in large savings for the federal government and taxpayers, Medicare beneficiaries may still experience some savings. The ultimate savings will likely depend on how successfully the federal government negotiates prices.
Contact us for more health care resources.
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PBM Drug Pricing Transparency Bill Heads to Senate
This article is from RISQ Consulting’s Zywave client portal, a resource available to all RISQ Consulting clients. Please contact your Benefits Consultant or Account Executive for more information or for help setting up your own login.
The Senate Committee on Commerce, Science and Transportation recently advanced a bill to increase pharmacy benefit manager (PBM) transparency and combat what some legislators called “deceptive practices.” The proposed bill received bipartisan support in the committee, with an 18-to-9 vote, and is supported by many health care and consumer organizations.
The Pharmacy Benefit Manager Transparency Act identifies activities that would be unlawful for PBMs to engage in, including the following:
- Spread pricing, a practice in which PBMs charge health plans and payers more for prescription drugs than they reimburse pharmacies
- Clawing back reimbursement payments from pharmacies
Additionally, PBMs would be required to direct 100% of any rebate to the plan or payer and disclose the cost and reimbursement to the health plan.
PBMs were initially formed to process claims and negotiate lower drug prices with drug makers. Today, they administer prescription drug plans for hundreds of millions of Americans and manage many aspects of the prescription drug process for health insurance companies, self-insured employers, unions and government programs. This includes developing lists of covered medications, negotiating rebates from drug manufacturers and contracting with pharmacies for reimbursement. According to the Pharmaceutical Care Management Association, PBMs play a positive role in creating savings and options and providing expertise for employers regarding prescription drug benefit design and coverage.
What’s Next?
Since PBMs have largely operated out of the view of regulators and consumers, this bill could impact how PBMs operate, potentially increasing prescription drug transparency. There’s currently no timeline for the Senate to consider the bill. Last year, the Senate Committee on Commerce, Science and Transportation passed the same bill, but it was never put to a full vote on the Senate floor.
Employers should continue to monitor the situation closely. [B_Official] will keep you apprised of notable changes.
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More Drugs, Less Money
By Alison Nelson, Account Manager
You may know him from Shark Tank or as the owner of the Mavericks, but you may soon know Mark Cuban as the man disrupting the pharmaceutical industry. It was recently announced that, billionaire Mark Cuban, has launched an online pharmacy boasting significant savings when compared to some traditional pharmacies. What makes this online pharmacy, Cost Plus Drug Company, stand out is their commitment to pricing transparency.
Cost Plus Drug Company is basing their prices on a 15% markup from the manufacturer cost and a $3 labor charge. This results in candid transparency on how much prescriptions costs to make. One of the medications listed on their website, estimates a $6,112.28 savings. The pharmaceutical industry is often associated with price gouging, prompting anticipation to see how other pharmacies respond.
To read more about Cost Plus Drug Company, read this NPR article or visit their website here.
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