Ron Lanton 4/8/24 Ron Lanton 4/8/24

CMS Makes An Impactful Change Regarding Biosimilars

Within its final calendar year 2025 Medicare Advantage and Part D final rule seen here, the Centers for Medicare and Medicaid Servces (CMS) is allowing Part D sponsors the ability to make midyear substitutions of biosimilars for their reference products on their formularies.

Specifically:

All biosimilars may be substituted as formulary maintenance changes: Part D sponsors may treat formulary substitutions of all biosimilars for their reference products as “maintenance changes” that would not require explicit prior approval by CMS. This option has previously been available only for interchangeable biological products. Part D sponsors previously had to obtain explicit approval prior to substituting biosimilars other than interchangeable biological products, and these substitutions applied only to enrollees who began therapy after the effective date of the change — delaying enrollees’ access to cheaper options. Treating all biosimilar substitutions as maintenance changes means that midyear formulary substitutions of biosimilars for their reference products would apply to all enrollees (including those already taking the reference product prior to the effective date of the change) following a 30-day advance notice to affected enrollees.
New interchangeable biological products may be immediately substituted: We are finalizing additional flexibility for interchangeable biological products not on the market at the time that Part D sponsors submit their initial formulary for CMS approval. Part D sponsors meeting certain requirements have the additional option to immediately substitute a new interchangeable biological product for a reference product and provide notice of the change to affected enrollees after making such change.

Biosimilar policy continues to evolve. It’s important to be in the know to plan accordingly.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology.

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Ron Lanton 4/27/23 Ron Lanton 4/27/23

Lanton Law Speaks at Summit & Reverse Expo

We were pleased to be invited to Orlando, Florida to speak with IDN with our presentation titled “Price, Innovation & Policy: What’s on the Horizon for the Industry.

Ron Lanton 3/3/23 Ron Lanton 3/3/23

Congressional Bill Advocating for Biosimilars and Generics Introduced

U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) have introduced the Affordable Prescriptions for Patients Act. The bill seen here seeks to lower drug prices by preventing bad actors’ anti-competitive use of patents to block generic and biosimilar competition from coming to market. The bill addresses two important issues such as product hopping and the patent dance.

Product hopping: As far as product hopping, “the bill puts an end to this practice. It prohibits branded drug manufacturers from engaging in anticompetitive product hopping and facilitates entry to the market for generics and biosimilars, driving down drug costs.”

Patent dance: “This bill places a reasonable limit on the number of patents a manufacturer can contest, preventing a “patent thicket.” This will help deter branded manufacturers of biologics from gaming the system to increase the number of patents they assert, while preserving the incentives provided by the patent system to encourage the core innovation that produces new biologic treatments in the first place.”

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and life science spaces. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Ron Lanton 6/1/22 Ron Lanton 6/1/22

How to Choose a Lobbyist

Since the early 2000s, there has been a steady increase in the amount of government activity that has directly affected healthcare stakeholders. Prior to this time-period, companies could afford to focus only on differentiating their products from their competitors. Now companies are finding that during their strategic planning meetings, they must account for how state and federal government activity may impact their bottom line. In addition to having a Government Affairs staff, these same companies are starting to realize the importance of having established a relationship with a lobbyist. The question is how do you find the right lobbyist for your organization?

First you want to make sure the lobbyist has experience. To be a good lobbyist there is no magic number of how many years you have worked within the political system. However; many lobbyists have worked an average of six months in the legislature as an aide to a legislator or on the other side of the spectrum, many legislators have left the legislature to work as a lobbyist. These individuals have an insider’s perspective into how the legislature works such as when a bill filing deadline date is and whether or not a bill can be introduced due to if a state is in an emergency session where the rules for introducing legislation is different from regular session.

Second the lobbyist should have a minimum number of contacts in the legislature. Whether it is in Congress or on the state level, the lobbyist should be able to have a go to legislator that can get a bill introduced quickly. However; the most successful lobbyist will not be limited to one party. Having contacts on both sides of the aisle will allow the lobbyist the opportunity to bring any bill at any time regardless of what political party has the majority.

Third the best lobbyist should be strategic. He or she should be able to know when a good time to introduce legislation is. The lobbyist should know what legislator to target as the bill sponsor. This is important because the bill sponsor will be the champion for your particular bill from start to finish. The lobbyist will need to educate the bill sponsor on the nuances of the bill so that the sponsor will be educated enough to be able to respond to technical questions during a hearing or when the sponsor is in caucus meetings; explaining to their respective party about why your bill should be voted on. The lobbyists should be able to pick and choose what committee will be best for your bill to go into, who to use as strategic allies for your legislation and be intuitive enough on when to negotiate and when not to.

Next it is important for your lobbyist to know the industry and to have foresight. You need to be comfortable knowing that your lobbyist understands your industry because if not, how can you be sure that your lobbyist is communicating the correct outcome for you? The lobbyist should be skilled enough to draft a bill that solves your problem without having to continuously ask you how something works. Additionally, while many lobbyists only focus on the legislature, the best lobbyists will think long-term to determine if a regulatory body will be involved once your bill passes. If so a lobbyist should be able to guide you through the regulatory process without leaving you to fend for yourself after a bill has passed.

Finally, as with any other professional, you need to be aware of the reputation your lobbyist has. Do they take the time to make sure their clients understand everything that is happening? Does the lobbyist prepare the client and relevant legislators ahead of time for crucial hearings? Does the lobbyist make everything easy to understand? Does the lobbyist dress appropriately for meetings and do they have the needed respect from the legislature? Does the lobbyist closely follow the bill from start to finish or are they overloaded with too many clients? These are important issues to talk with your prospective lobbyist about before entering into a contractual relationship.

While there are other nuances to the lobbying relationship, these should be enough for you to think about as your organization considers whether to engage a lobbyist. Lobbyist should no longer be considered a luxury item. The best lobbyist are quickly becoming essential parts of today’s corporate environment for the value they bring to their clients in either advancing their interests through legislation, or being available to respond to legislative targeting that has been on the rise. You know you have picked the right lobbyist when you can breathe a sigh of relief knowing that they have your back.

Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. We help stakeholders understand what’s at issue so that we can help our valued clients achieve their priorities. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Ron Lanton 3/28/22 Ron Lanton 3/28/22

What to Know about CURES 2.0

In November 2021, U.S. Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) today introduced their bipartisan Cures 2.0 legislation. The bill which is aimed at helping patients of innovative companies within healthcare and life sciences can be viewed here.

According to Congressman Upton’s press release the bill:

Creates an entirely new agency aimed at ending some of the world’s most difficult diseases – such as cancer, diabetes, ALS, Alzheimer’s and more. The so-called Advanced Research Projects Agency for Health, or ARPA-H, would be housed within the National Institutes of Health and tasked with finding new cures and treatments to a slate of illnesses that affect tens of millions of Americans across the country.
Transform how Medicare covers innovative new treatments and technologies to make those new discoveries available to patients sooner.

Increase access to telehealth services for Medicare and Medicaid patients, including those covered under the Children’s Health Insurance Program, known as CHIP, to ensure more Americans are getting the help they need, when they need it.

Provide training and educational programs for at-home caregivers – including family members with no prior health care experience to help them better care for loved ones when they are home.

Require more diversity in clinical trials to ensure any new drugs and treatments approved for use in the U.S. are both safe and effective for a greater – and more representative – portion of the population.

Provide patients more information about the illness they face and the treatment options available to them to make them a more integral part of the decision-making process.

We have featured this bill in a previous November 23, 2021 blog post. We believe that this is a great opportunity if you are a manufacturer, telehealth provider or clinical trial stakeholder. CURES 2.0 is something that we have been forceasting since 2020 as a way to make our system better.

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our life sciences practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Ron Lanton 2/2/22 Ron Lanton 2/2/22

Cancer Moonshot Initiative Returns

In 2017 we wrote an article that previewed the Cancer Moonshot Initiative (CMI). It was a widespread belief that with Joe Biden becoming President that the CMI would return in some capacity. Today, the White House issued a Fact Sheet that has reginited this policy effort.

According to the White House’s announcement on the reignited CMI, here is what the Initiative is going to focus on:

Re-establish White House Leadership, with a White House Cancer Moonshot coordinator in the Executive Office of the President, to demonstrate the President and First Lady’s personal commitment to making progress and to leverage the whole-of-government approach and national response that the challenge of cancer demands.
Form a Cancer Cabinet, which will be convened by the White House, bringing together departments and agencies across government to address cancer on multiple fronts. These include the Department of Health and Human Services (HHS), Department of Veterans Affairs (VA), Department of Defense (DOD), Department of Energy (DOE), Department of Agriculture (USDA), Environmental Protection Agency (EPA), National Institutes of Health (NIH), National Cancer Institute (NCI), Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), Office of Science and Technology Policy (OSTP), Domestic Policy Council (DPC), Gender Policy Council (GPC), Office of the First Lady (OFL), Office of the Vice President (OVP), Office of Management and Budget (OMB), Office of Legislative Affairs (OLA), Office of Public Engagement (OPE), along with additional members, as needed, to help establish and make progress on Cancer Moonshot goals.
Issue a Call to Action on Cancer Screening and Early Detection:
Build on a White House Cancer Roundtable Conversation Series hosted over the last six months, with experts, including people living with cancer, caregivers, and survivors.

As the industry starts to refocus on initiatives prior to COVID-19, we fully expect issues like precision based medicine, gene therapy, biologics and other cutting edge policy solutions to return front and center as we continue our transition towards a world of value based payment models for improved patient outcomes. This means that many private market initiatives will be implemented in state and federal policies.

Ron Lanton 1/5/22 Ron Lanton 1/5/22

CMS Ends Most Favored Nation Drug Price Model Proposal

According to the Centers for Medicare and Medicaid Services (CMS), the agency has published a final rule in the Federal Register on December 27, 2021, that rescinds the November 27, 2020, MFN Model interim final rule with comment period. The final rule rescinding the Most Favored Nation Model interim final rule with comment period can be found here.

Proposed Rule Background:

CMS included the following background to the issue in its announcement:

“In the August 10, 2021 Federal Register (86 FR 43620), we published a proposed rule (86 FR 43618, hereafter, referred to as “the August 2021 proposed rule”) that would rescind the Most Favored Nation (MFN) Model interim final rule with comment period (85 FR 76180) that appeared in the November 27, 2020 Federal Register (hereafter, referred to as “the November 2020 MFN Model interim final rule”). The November 2020 MFN Model interim final rule established a 7-year nationwide, mandatory MFN Model to test an alternative way for Medicare to pay for certain Medicare Part B single source drugs and biologicals (including biosimilar biologicals), under section 1115A of the Social Security Act (the Act), with the model performance period beginning on January 1, 2021. The MFN Model was not implemented on January 1, 2021 as contemplated following four lawsuits and a nationwide preliminary injunction. On December 28, 2020, the U.S. District Court for the Northern District of California issued a nationwide preliminary injunction in California Life Sciences Ass'n v. CMS, No. 3:20-cv-08603, which preliminarily enjoined HHS from implementing the MFN Model and the November 2020 interim final rule. For additional information on the MFN Model and the related lawsuits, see the August 2021 proposed rule, the November 2020 MFN Model interim final rule, and the MFN Model website.[1]”

Why does this matter?

Drug price continues to be an issue and it is essential for stakeholders to monitor how reimbursement will be for your operations.

How Lanton Law Can Help

Ron Lanton 10/20/21 Ron Lanton 10/20/21

FDA Approves First Interchangeable Biosimilar for Humira

According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases.”

According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for), its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. Once on the market, approved biosimilar and interchangeable biosimilar products can play a role in facilitating access to treatments for many serious health conditions.”

Furthermore, “The FDA granted approval of Cyltezo to Boehringer Ingelheim on October 15, 2021. To date, the FDA has approved 31 biosimilar products, including two interchangeable products, for a variety of health conditions.”

The FDA’s announcement can be viewed here.

This is an exciting announcement by the FDA, as competitors to the originator now have a viable path forward to make market inroads.

Ron Lanton 8/10/21 Ron Lanton 8/10/21

FDA Approves First Interchangeable Biosimilar

The U.S. Food and Drug Administration (FDA) has “approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.

Biological products include medications for treating many serious illnesses and chronic health conditions, including diabetes. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). This means you can expect the same safety and effectiveness from the biosimilar as you would the reference product.

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology.

Ron Lanton 6/7/21 Ron Lanton 6/7/21

Bipartisan Congressional Legislation Introduced Seeking Shared Savings Demo Project to Increase Biological/Biosimilar Medicare Access

U.S. Senators Cornyn (R-TX) and Bennet (D-CO) have introduced the Increasing Access to Biosimilars Act also known as S. 1427. The bill seeks to establish a demonstration project to increase access to biosimilar biological products under the Medicare program.

According to Senator Cornyn’s press release “this legislation would direct HHS to establish a shared savings demonstration project to increase access to biosimilars in the Medicare program. This would encourage physicians to prescribe less-expensive biosimilars increasing patient access to more affordable, life-saving drugs and lowering patient out-of-pocket costs.

Under the demonstration, Medicare would provide an additional payment to providers for using lower-cost biosimilar products that reflects the savings created in contrast to administering the higher-cost reference biological product. Additionally, Medicare can use a portion of those savings to reduce the beneficiary’s coinsurance payment.”

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Ron Lanton 4/20/21 Ron Lanton 4/20/21

Two Biosimilar Bills Head to President Biden for Signature

Two Biosimilar Bills Head to President BIden for Signature

S. 164 titled the “Advancing Education on Biosimilars Act of 2021” sponsored by Senator Hassan (D-NH) has passed both the House and Senate and is on its way to the President. This bill requires the Food and Drug Administration (FDA) to advance education and awareness among health care providers about biological products as appropriate, including by developing or improving continuing education programs that address the prescribing of biological products and biosimilars. The FDA may also maintain and operate a website to provide educational materials about biological products.

Additionally, the Ensuring Innovation Act has passed both the House and Senate and is on its way to President for his signature. According to Senator Cassidy’s press release, the bill “would close loopholes to prevent awarding market exclusivity to products that do not represent true innovation and unduly delay cheaper generics from entering the market.”

Ron Lanton 3/15/21 Ron Lanton 3/15/21

Biosimilar Legislation Passes Senate

S. 164 titled the Advancing Education on Biosimilars Act of 2021 sponsored by Senator Hassan (D-NH) has passed the Senate on March 3, 2021. The proposed bill seeks to educate health care providers and the public on biosimilar biological products.

Specifically, the bill states that the Secretary may maintain and operate an internet website to provide educational materials for health care providers, patients, and caregivers, regarding the meaning of the terms, and the standards for review and licensing of, biological products, including biosimilar biological products and interchangeable biosimilar biological products.

Ron Lanton 1/28/21 Ron Lanton 1/28/21

Lanton Strategies: D.C. Based Lobbying Firm with No State Boundaries

COVID-19 has changed the way that we interact in a variety of ways. One of them being the way that businesses large and small interact with the government. Gone are the days where we can meet people in person without having to worry about travel restrictions and COVID-19 protocol. What remains is that businesses still need to get their voices heard. This is where Lanton Strategies has a strategic advantage.

For years our firm has made connections nationwide that have allowed us to tap our business and industry rolodex in order to get client goals realized. Our unique holistic approach enables us to lobby legislators and regulators, no matter the state. In essence we are that “digital lobbyist firm” that you need.

If you are looking for federal or state solutions and you’re unsure how to get something done, contact Lanton Strategies; a division of Lanton Law

Ron Lanton 12/6/20 Ron Lanton 12/6/20

Biosimilars Advocacy Group Outlines Congressional Wish List for 2021

The Association for Accessible Medicines sent letters to all members of Congress, which expressed what measures they would like them to take regarding access to biosimilars.

Key legislation that they focused on was,

1. Increasing Access to Biosimilars Act, incentivizes doctors to prescribe biosimilars through a Medicare demonstration project.

2. BIOSIM Act, allows for an increase in biosimilar payments in Medicare for five years for biosimilars whose average sales price or wholesale price acquisitions cost is less than that of the reference product.

They also advised Congress on policies regarding brands suggesting that Congress provide a more certain date as to when generics and biosimilars enter the market and updating Medicare Part D.

AAM stated that updating Part D should include these three key policies,

1. Increasing the share that plans pay towards the catastrophic phase.

2. Establishing an out-of-pocket cap.

3. Ensure that rebates and discounts do not disadvantage biosimilars and other lower-priced drugs.

With a new Administration transitioning in, 2021 looks to be a major policy shaping year for healthcare and life sciences on the legislative and regulatory fronts.

Ron Lanton 9/27/20 Ron Lanton 9/27/20

Where Do Biden & Trump Stand On The Issues?

With election season underway many are wondering where the two Presidential candidates stand on the issues of importance to voters.

Reuters did a great summary found here that explains the major differences from the economy, trade, healthcare, etc.

With election season underway many are wondering where the two Presidential candidates stand on the issues of importance to voters.

Reuters did a great summary found here that explains the major differences from the economy, trade, healthcare, etc.

The winner of this election will certainly have policies affecting your interests. Whether you are in technology, healthcare/lifesciences or finance, it is important to know what your organization’s priorities are and to have a plan for either candidate should they win.

Lanton Strategies; a division of Lanton Law is a is a full service federal and state lobbying and government affairs firm that has a menu of services to help you achieve your goals.

Ron Lanton 6/2/20 Ron Lanton 6/2/20

New Lanton Law Specialty Drug Blogcast with Ken Kaitin of Tufts University

We are excited to interview Kenneth Kaitin; Professor and Director for the Tufts Center for the Study of Drug Development at Tufts University School of Medicine in Boston, Massachusetts.

Our conversation touches on a wide variety of specialty drug issues such as oncology, orphan drugs, value based care, innovative payment models and Boston’s pharmaceutical R&D expansion.

Click here for the interview.

Ron Lanton 5/14/20 Ron Lanton 5/14/20

Will Immunity Passports Lead to Future Genetic Discrimination?

There is no need to rehash the harsh societal effects that COVID-19 has had not only on our psychological and financial wellbeing, but also on the vulnerable population’s immune system. Those having to deal with underlying health conditions such as diabetes, obesity, hypertension have been especially at risk, including some young and healthy individuals. As we race to understand the rationale behind why such an erratic disease impacts some but not others, the question that frequently comes up is whether a person’s genes has something to do with becoming infected?

While it seems like we have been discussing gene therapy for some time, understanding how to harness the potential of the human genome is still in the “early innings.” According to the National Human Genome Research it was found that there are about 20,500 genes in human DNA. This information had taken 13 years to find and was completed in 2003. There are so many things to learn about our genes in order to be precise enough to fully realize how we can get to the ultimate improvement in patient outcomes. Unfortunately, it seems as though time is not on our side when needing to understand how our genes play a key role in fighting this terrible disease. It seems like the best thing to mitigate our circumstances until we get a vaccine is how to contain it. From social distancing to contact tracing, one idea that has been gaining steam on re-opening the economy is the possibility of immunity passports.

So what are immunity passports? The World Health Organization (WHO) states “Some governments have suggested that the detection of antibodies to the SARS-CoV-2, the virus that causes COVID-19, could serve as the basis for an ‘immunity passport’ or ‘risk-free certificate’ that would enable individuals to travel or to return to work assuming that they are protected against re-infection. There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection.”

Currently there is so much fear and mistrust regarding information on COVID-19 that in order for this to work in my opinion, we would have to have certainty in antibody testing, as well as a 100% understanding about how long immunity actually lasts. Aside from a vaccine, this would certainly move economies forward as a way to slowly start to recoup the financial losses we have witnessed worldwide. But could well intentioned things like immunity passports lead to something unintended such as genetic discrimination?

According to the National Institutes of Health (NIH), genetic discrimination occurs when people are treated differently by their employer or insurance company because they have a genetic mutation that causes or increases the risk of an inherited disorder or they have a familial history of a specific health condition. Surprisingly, this issue could determine whether someone gets hired or fired and could mean the difference between receiving comprehensive coverage.

GINA does provide a solution to genetic discrimination. The Genetic Information Nondiscrimination Act (GINA) provides for protection against this type of discrimination. Title I of GINA prohibits genetic discrimination in health insurance, and Title II prohibits genetic discrimination in employment.

Under the first part of the act, it is illegal for health insurance providers to use or require genetic information to determine whether a person is eligible for coverage. The second part prohibits employers from using a person’s genetic information in making decisions about hiring, promotion, and various other terms of employment.

However, GINA and similar laws do not protect individuals from genetic discrimination under every circumstance, such as an instance in which an employer has fewer than 15 employees. The act also does not apply to those serving in the military or those insured under the Veterans Health Administration or Indian Health Service. Furthermore, the act does not protect against genetic discrimination in other forms of insurance, including life, disability, and long-term care, according to the NIH.

While GINA’s development was designed for genetic discrimination, I believe that we have not yet seen how this law could potentially evolve from its original intent, especially in this circumstance. Constantly looking through both a policy and legal lens, I see potential problems with an immunity passport. While I understand how this is designed to get the economy back on track, how will individuals be judged regarding obtaining an immunity passport. Is this something you will be required to have by an employer? Are there privacy issues that will evolve from having to declare whether you have an immunity passport? Will employees be looked at differently if they have a passport versus those that don’t? Will an employee’s cost of insurance increase because they happened to get COVID-19?

COVID-19 has changed our lives in ways that we cannot yet imagine. As we start transitioning back towards living with this complex disease until there is a cure, our minds are currently undergoing small yet lasting changes that will unconsciously shape the way we make decisions going forward. It is very foreseeable that society will try and mitigate risks to businesses, meaning that it is not unforeseeable that companies may try and understand any genetic risks that may exist to employees. Whether this is the new normal, a threat to privacy or something else remains to be seen.

*Disclaimer: The information provided in this blog post is an opinion and is for informational purposes only and not for the purpose of providing legal advice. Access to this information does not create an attorney client relationship between Lanton Law and the viewer. You should contact your attorney to obtain advice with respect to any particular issue or problem.

Ron Lanton 3/8/20 Ron Lanton 3/8/20

Election May Determine Pace of Biosimilar Legislation

We have a new article out with the Center for Biosimilars titled “Election May Determine Pace of Biosimilar Legislation.”

We have a new article out with the Center for Biosimilars titled “Election May Determine Pace of Biosimilar Legislation.” The article can be viewed here.

If you are having difficulty accessing the article, we have provided it below:

By the end of 2019, 26 biosimilar products had been launched in the United States. As 2020 gets underway, there are several pending legislative proposals designed to encourage more commercialization of these cost-saving drugs.

House Legislation

HR 3: Elijah E. Cummings Lower Drug Costs Now Act
Many parts of this legislation could indirectly affect biosimilars. Two proposals of note would directly change drug costs for biosimilars if the law is passed.

The first proposal would require the HHS secretary to add a new set of measures to the 5-star rating system under Medicare in order to encourage increased access to biosimilar biological products. Specifically, the proposed legislation calls for determining whether a biosimilar is on formulary and whether and how utilization management tools are applied with respect to a biosimilar. The bill also calls for determination of the percentage of enrollees prescribed the biosimilar product when the reference biologic is also available.

The second proposal would temporarily increase the amount Medicare Part B pays for biosimilars for 5 years. This means that Medicare would pay the average sales price (ASP) plus 8% rather than plus 6%. The product would have to meet certain pricing criteria in order to qualify.

Both proposals may increase the utilization of biosimilars. The star rating system currently used does not make a distinction for biosimilars and allows payers to use the same policies for biosimilars and brands as they do for generics and brands. This can mean that a specialty pharmacy that dispenses under Part B does not get the same credit as a pharmacy that dispenses for Part D. Establishing new guidelines for the star rating system can help specialty pharmacy use more biosimilars and get credit toward its ratings with the payer.

An ASP increase of 2 percentage points could help cover additional costs for specialty pharmacy for educating consumers about biosimilar utilization.

This bill has passed the full House and has yet to be taken up by the Senate.

HR 4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act
This bill would eliminate a patient’s copay for a biosimilar under Medicare Part B. The bill would drive down medical costs by increasing access to lower-cost biosimilar drugs and give Americans more treatment options. This bill has been referred to the Subcommittee on Health in the House.

HR 2375: Preserve Access to Affordable Generics and Biosimilars Act
This would prohibit prescription drug companies from compensating other prescription drug companies to delay the market entry of a generic drug, biosimilar biological product, or interchangeable biological product. This would basically make “pay for delay” in patent settlements illegal. This legislation has cleared the Judiciary Committee and is pending in the House.

Senate Legislation

S 1416: Affordable Prescriptions for Patients Act of 2019
Originally, this legislation was aimed at allowing the Federal Trade Commission antitrust enforcement powers to sue manufacturers who use patent thickets to block generic and biosimilar products from launching. Since its introduction, the bill’s main sponsor, Sen John Cornyn, R-Texas, has stated that he is redesigning the bill to shift the enforcement power to the FDA instead of the FTC. As currently modified, the bill addresses anticompetitive practices involving manipulation of the availability of reference drugs. There is other patent thicket legislation proposed, which would be stricter than S 1416, but it is unknown when this would come to a vote in the Senate.

With the election season well underway, it remains to be seen whether any of these bills will advance before the year’s end.

Ron Lanton 3/2/20 Ron Lanton 3/2/20

Pending Antitrust Actions Could Change Biosimilar Dynamics

I have a new article that was published in the Centers for Biosimilars titled Pending Antitrust Actions Could Change Biosimilar Dynamics. If you have trouble accessing the link above we have provided the article text below:

There are 3 major antitrust actions on the biosimilar scene still pending. These have a long way to go before any court resolution, unless the parties involved settle before then. One is a class-action lawsuit attacking the use of patent thickets and pay-for-delay tactics. The other is a claim alleging anticompetitive contract practices to retain market share for an originator product. Related to the latter, an investigation by the Federal Trade Commission (FTC) remains in progress.

Humira (adalimumab) antitrust litigation (1:19-cv-01873)
United Food and Commercial Workers Local 1500 filed a class-action lawsuit against AbbVie, the holder of patents for its blockbuster drug Humira, claiming a monopoly had been created by AbbVie via its use of patent thickets and pay-for-delay tactics to block less-expensive biosimilars of adalimumab and raise prices for indirect purchasers. One of the main allegations is that AbbVie amassed more than 100 patents to prevent biosimilar versions of Humira from reaching market before 2023. Another main argument is that AbbVie colluded with biosimilar makers by using financial inducements to delay the launching of competitors in the United States while allowing them in Europe. AbbVie denies using these tactics to create a monopoly and contends that the lawsuit threatens to “upend the well-settled balancebetween the patent and antitrust laws.” This case is ongoing.

Pfizer versus Johnson & Johnson (J&J; 2:17-cv-04180)
Pfizer, the maker of the biosimilar Inflectra (infliximab), has sued J&J for alleged anticompetitive sales practices in regard to the infliximab reference product (Remicade). J&J is accused of using exclusionary contracts to keep the biosimilar out of the market. These contracts allegedly “led to the near total foreclosure of Inflectra and other infliximab biosimilars.” Bundling Remicade with other drugs in these contracts for hospitals and infusion centers was also done in order to retain market control, Pfizer alleges. Rebate penalties for payers and providers are also alleged. This case is in the discovery phase and will be well into 2020.

Walgreens/Kroger versus Johnson & Johnson (2-18-cv-02357)
Walgreens and Kroger sued J&J in 2018 for antitrust regarding its contracts with wholesale distributers purchasing Remicade which inflated its price. The case was dismissed for lack of standing or insufficient connection to and harm from the action challenged. Walgreens and Kroger appealed to the Third Circuit stating that the lower court was wrong in dismissing the case because of anti-assignment provisions between the wholesaler and the plaintiffs. The Third Circuit overturned the lower court ruling stating that the case could go forward in spite of the clause because the claim arises out of federal anti-trust law and not the contract itself. This case will now go back to the lower courts and start over from scratch. More cases like this could arise as distribution contract anti-assignment clauses are common and may have prevented many from suing in the past.

FTC Civil Investigation

The FTC issued a Civil Investigative Demand (CID) to J&J regarding its contracting practices for Remicade, meaning it is investigating J&J’s contracting practices with respect to the reference product. Although the CID was issued in June 2019, J&J has yet to comment on the investigation. Because the inquiry is in its early phase, it remains unclear whether the FTC will lodge an antitrust suit against J&J. They would need to determine if bundling deals and the rebate practices involved constitute antitrust practices.

All of this litigation may take years to resolve. If the court judgements do not come down in favor of the product originators, the cases could significantly change how biologics are priced, by either eliminating rebates or forcing payers to place both biosimilar and originator products on formularies

Ron Lanton 2/17/20 Ron Lanton 2/17/20

Legislation to Play Significant Role in Drug Pricing Across Specialty Pharmacy

Jennifer Nessel of Pharmacy Times has featured Lanton Law in an article titled “Legislation to Play Significant Role in Drug Pricing Across Specialty Pharmacy.”

Jennifer Nessel of Pharmacy Times has featured Lanton Law in an article titled “Legislation to Play Significant Role in Drug Pricing Across Specialty Pharmacy.” The article can be read here. In case you have difficulty reading the article, we have featured it below. This article appeared in Pharmacy Times on 2/17/20.

As utilization and drug spending continue to rise, health care providers are looking to resolve key questions that address drug pricing and biosimilar implementation in specialty pharmacy.

Hospital and health systems saw nearly 20% growth in the specialty drug market in 2018, according to Becker’s Hospital Review.2 The diversity of specialty pharmacies has resulted in variability across all operational areas, including tracking adherence, educating patients, dispensing medications, and ensuring drug safety.3

However, although the specialty industry has had a positive impact on health systems’ quality and continuity of care initiatives, the administration of specialty drugs is challenging and highly complex given the number of new therapies and payer requirements.

According to Ron Lanton, III, Esq, principal of Lanton Law and biologics committee chair of the New York State Bar Association, policymakers on the federal level understand that the issue of drug pricing needs to be resolved but they are having a hard time coming to an agreement on how this reform should be done.

The Drug Price Conundrum
Due to the fact that the legislative session has recently begun in many states and in Congress and that it is an election year, it is difficult to determine whether there will be a unifying drug-legislative solution for drug prices.

However, California’s Governor Gavin Newsom (D-CA) has recently proposed that California become the first US state to manufacture its own generic prescription label, with a goal of making affordable medications available to the state’s almost 40 million residents. However, the governor’s proposal has yet to pass the California legislature.

According to Lanton, a manufacturer could leverage its influence over smaller states to stop legislation such as Governor Newsom’s from advancing. However, due to its size and the fact that its policies may influence other state legislatures, California may be a harder market for a manufacturer to confront.

“I [have to] question as to whether California’s efforts would further drive down an already deflated generic drug market and whether California would be able to determine how much it will charge for generics once manufacturing costs, such as raw materials, are concerned. Not to mention how much this is going to cost since that remains unknown at this point in time,” Lanton explained to Directions in Specialty PharmacyTM.

Although the proposal marks the first state-wide attempt to lower prescription drug prices, there have been attempts within federal legislation to corral drug prices. The Trump administration recently attempted to lower drug costs through its Blueprint to Lower Drug Costs, and the FDA has recently been an advocate for greater generic and biosimilar utilization.

“To date, there has been no silver bullet to deal with rising prescription drug costs. Notwithstanding whether I agree with this plan, I applaud California in trying to solve a problem that refuses to go away quietly,” Lanton said.

Biosimilar Implementation
Specialty drugs, with nearly 700 therapies currently under development for treatment areas such as cancer, hepatitis C virus, HIV, autoimmune disorders, and multiple sclerosis, are expected to claim 9 of the top 10 spots among bestselling drugs in 2020.3 Although specialty drugs have been hallmarked as important treatment options for patients with cancer or other complex diseases, there can be issues surrounding access and affordability.

The cost of specialty medications and the increased adoption of high-deductible health plans have placed a higher financial burden on patients. As out-of-pocket costs increase, including insurance denials, patients are more likely to abandon their treatment plans.4

Biosimilars are potentially more affordable specialty medications for patients with complex disease states. According to Managed Health Executive, biosimilars could bring approximately $250 billion in savings by 2024.3

Pending legislation may have a large impact on biosimilar implementation across the specialty pharmacy landscape. There are several bills that Lanton singled out for the 2020 year1:

HR 4597 Acting to Cancel Co-pays and Ensure Substantial Savings for Biosimilars (ACCESS) Act would eliminate a patient’s co-pay for a biosimilar if they normally would pay full cost of a biologic drug under Medicare Part B. The bill seeks to drive down medical costs by increasing access to lower-cost biosimilar drugs and give Americans more treatment options.
HR 4629 Star Rating for Biosimilar Act would require the Secretary of Health and Human Services to add a new set of measures to the 5-star rating system under the Medicare Advantage program in order to encourage increased access to biosimilar biological products.
HR 4913 would require Medicare prescription drug plan (PDP) formularies to include covered generic drugs and biosimilars for which the wholesale acquisition cost is less than that of the reference (ie, brand-name) product. PDP sponsors must also establish specific cost-sharing tiers that apply lower cost-sharing requirements for such covered generic drugs and biosimilars as compared to those for brand-name products. The bill also prohibits PDP sponsors from instituting certain requirements relating to access to such covered generic drugs and biosimilars that are more restrictive than those for brand-name products (eg, prior authorization requirements).
HR 2375 would prohibit prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market.
S 1681 proposes to educate health care providers and the public on biosimilar biological products. Under this bill, the Secretary shall establish, maintain, and operate a website consisting of educational materials regarding the meaning and use of biosimilar biological products and interchangeable biological products.

Affordable Care Act (ACA) Transition
On March 23, 2020, the life sciences industry will undergo “the transition,” according to Lanton. Currently, the FDA has and will continue to regulate biologics, but historically the agency regulated biologics as drugs under the Food, Drug and Cosmetic Act instead of as products licensed under the Public Health Service (PHS) Act.

“In order to bring all biologics under the same legal and regulatory system, the Biologics Price Competition and Innovation Act of 2009 found in the ACA included the ‘Deemed to be a License’ provision,” Lanton said.

This meant that 10 years after enactment, on March 23, 2020, applicable biologics will automatically be deemed biologics licensed under the PHS Act. Unfortunately, the statute did not provide instructions to the FDA on how to do this, meaning the agency will decide on which products transition and how, according to Lanton.

“This basically means no more new drug applications or abbreviated new drug applications for select biologics, only biologic license applications of the 351(a) and 351(k) varieties. Also, not only will they be categorized as biologic[s], but they will be subject to the biosimilar, not generic competition. Specifically, drugs [to] be transitioned are insulins and other naturally occurring proteins, such as hyaluronidase, human growth hormones, and menotropins,” Lanton said.

Reference

Lanton, Ron, III, Esq. Interview with Pharmacy Times [email]. Accessed February 11, 2020.
5 Trends Health System Pharmacies Can Expect in 2020. Becker’s Hospital Review. Published December 9, 2020. https://www.beckershospitalreview.com/pharmacy/5-trends-health-system-pharmacies-can-expect-in-2020.html. Accessed February 12, 2020.
Biologics Build Oncology Drug Pipeline. Managed Healthcare Executive. Published November 1, 2019. https://www.managedhealthcareexecutive.com/news/biologics-build-oncology-drug-pipeline. Accessed February 12, 2020.
Galante, Dominic. Accreditation Explosion Among Top Specialty Pharmacy Trends. J Clin Pathways. 2018;4(7):35-38. doi:10.25270/JCP.2018.09.00037. Accessed February 12, 2020.