Author: Adam Toris

Service Spotlight: Bill Check Service

When pharmacists, wholesalers, manufacturers, or physicians see a state other than their own pass a bill favorable to the life sciences or healthcare sector, they often look for ways to enact a similar law in their state. Unfortunately, copying a law from another state is not as straight forward as it seems.

When it comes to hot button issues like PBMs, for example, some states not only have legislators advocating against PBM interests, but they may also have willing regulators that will enforce the law as well. Additionally, some legislation may be written more aggressively than what a state may be used to, may not work for with laws currently on the books, or may be written in a way that invites litigation.

For life sciences and healthcare stakeholders, Frier Levitt Government Affairs (FLGA) offers a Bill Check process which examines an organization’s proposed language, verifies the correct statutes, while having it reviewed by a team of healthcare attorneys with extensive experience and hands-on industry knowledge, including many clinician attorneys.

Drafting a bill by simply borrowing language from other sources could cause issues and delay, resulting in the use of valuable political capital to fix the problem. FLGA’s Bill Check Service helps life sciences and healthcare stakeholders make the most out of their resources to get bills passed. Contact FLGA today to have your voice heard.

HHS’ Final Rule Requiring Drug Prices in TV Advertising Presents an Opportunity for Manufacturers

Earlier this month, Health & Human Services (HHS) Secretary Azar announced a final rule from the Centers for Medicare & Medicaid Services (CMS) requiring direct-to-consumer television advertisements for prescription pharmaceuticals covered by Medicare or Medicaid to include the list price – the Wholesale Acquisition Cost – if that price is equal to or greater than $35 for a month’s supply or the usual course of therapy. This policy comes from the American Patients First Blueprint to reduce drug costs.

Lately, the culprit behind higher drug prices has been sharply debated. Some in the manufacturing community point to two issues: better science and rebate pressure. Improved patient outcomes due to scientific advances justifies higher prices, especially since near curative prescription drugs lead to a possible decrease in future healthcare costs. Additionally, manufacturers have rightly been pointing to the pressures by PBMs to increase rebates or face the potential of having certain drugs either removed from the formulary or in the alternative, subjected to increased formulary competition.

While the life sciences industry understands the complexities surrounding drug prices, many state and federal policymakers do not. Hence, there have varied and sometimes disproportionate responses to higher drug prices, which may not solve the problem.

There are many opportunities for manufacturers on the state and federal level to help alleviate policymaker concerns about drug prices, while also helping to provide a grounded response to ensure a stable market that promotes patient access.

Frier Levitt Government Affairs is active on the state and federal level, including both legislative and regulatory developments concerning drug prices. If you are a manufacturer, contact Frier Levitt Government Affairs today for help maximizing your existing resources to get control of the growing drug pricing issue.

North Dakota: A Model Opportunity for Advancing Pharmacy Law

In 2017, North Dakota enacted S.B. 2258 and S.B. 2301, which among several PBM issues, addressed gag orders, clawbacks, PBM transparency, and accreditation standards. In their objective response filed through their national trade association, the Pharmaceutical Care Management Association (PCMA), the PBMs sued North Dakota in an attempt to use the courts to invalidate North Dakota’s legislative efforts.

On September 5, 2018, the North Dakota federal court decision PCMA v. Tufte was issued by Chief Judge Hovland in favor of North Dakota pharmacy. Surprisingly, PCMA filed the appeal with the Eight Circuit just two days later on September 7th. The appeal is currently pending in the 8th Circuit and the case is “fully submitted” and awaiting oral argument. The ruling is expected by the end of the year, and regardless of the outcome, an appeal to the U.S. Supreme Court is almost guaranteed, making this one of the most important cases pending in the federal court system to pharmacies and state pharmacy associations.

PBMs are a formidable force nationwide, strategically fighting against pharmacy interests by using their legislative, regulatory and legal resources. When it comes to legal efforts, PBMs take an aggressive stance whenever a law has been enacted by the legislature that threatens their market share. North Dakota’s PCMA v. Tufte serves as a prime example of law that could stand as a model for state and national pharmacy interests and is an excellent illustration of pharmacy stakeholders can take action against abusive PBM tactics.

For pharmacy stakeholders, North Dakota’s law lays the groundwork for helping formulate and pass the similar laws in other states. However, the real action happens with enforcement as PBMs try to get around compliance with these laws. Frier Levitt Government Affairs (FLGA) works with pharmacy stakeholders at both the state and federal level to not only formulate and pass the laws, but also litigate to defend them. Contact FLGA today for help maximizing your organization’s resources to fight against PBMs through government affairs and lobbying efforts to enact similar laws in your state and get you the fairness you deserve.

Service Spotlight: Frier Levitt Government Affairs Gap Analysis

The first step to achieving effective change at a legislative and policy level is understanding where the current
weaknesses lie. To do this, any organization seeking to be a part of change must conduct a “Gap Analysis” as to the
existing laws and policy to better understands where to direct its efforts and “political capital.”

To assist with this process, Frier Levitt Government Affairs (FLGA) can perform a comprehensive Gap Analysis of a
state’s pharmacy and pharmacy benefits laws. This in-depth service will help organizations understand where it
may be missing an opportunity, while also providing you with a proactive solution.

As part of the Gap Analysis, FLGA provides a summary of where current laws stand on certain identified issues and
identifies weak areas within a state’s laws, as well as realistic opportunities for change/improvement, based off of
what has been recently enacted in other jurisdictions. When weaknesses or gaps are identified, FLGA provides a
“model bill,” containing suggested language that will be helpful in addressing each particular issue.

This “bill check” service process examines proposed or existing language, verifies the correct statute that the
language would be added to, and ensures that the language has been reviewed by healthcare attorneys with
extensive backgrounds in pharmacy and pharmacy benefits laws, making it applicable to an organization’s
membership.

FLGA’s comprehensive Gap Analysis of a state’s pharmacy and pharmacy benefits laws includes:

• Any Willing Provider Laws
• Maximum Allowable Cost (MAC) Laws
• Prompt Payment Laws
• Fair Pharmacy Audit Laws
• PBM Licensure Laws
• Direct and Indirect Remuneration (DIR) Fee Laws

Contact FLGA today to have a Gap Analysis of your organization’s state pharmacy laws.

Is Your State a “True” Any Willing Provider State?

Pharmacists and pharmacies nationwide are constantly fighting for network inclusion with Pharmacy Benefit Managers (PBMs) and various payors. One of the issues that has been frustrating the pharmacy community are the various interpretations from the PBM and payor community regarding how they read Any Willing Provider statutes vs. how the pharmacists read the law.

Status of Any Willing Provider Laws

This legislative session has seen two states address some form of expanded access for pharmacy: Oklahoma through SB 841 and Louisiana through SB 41. There are currently 26 states that have any willing provider laws that expressly applies to pharmacies. However, there are 10 other states that have Any Willing Provider laws, but they apply either generally to “providers” or are otherwise expressly limited to only certain types of providers which do not include pharmacies. Pharmacies should not assume that that they are covered just because their state has an Any Willing Provider law. Sometimes that may not be the case.

Pharmacies need to recognize whether their state is a “true” Any Willing Provider. Even if there is a law in place, often a state’s language can either be tightened or clarified. Frier Levitt Government Affairs (FLGA) works with pharmacies, pharmacy organizations, and other stakeholders regarding language to use to improve their position and opportunities regarding Any Willing Provider laws. Additionally, FLGA provides lobbying for stakeholders on the state level to help them get into more networks, reach more potential patients, and expand their margins.

Contact Frier Levitt Government Affairs today for help with Any Willing Provider laws and expanding more market opportunities.

CMS Makes Proposed Copay Accumulator Rule Final

In January 2019, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule titled, “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020,” targeting Accountable Care Organizations (ACOs), payers and Affordable Care Act (ACA) exchange stakeholders, with one component of the proposed rule focusing on copay accumulators. CMS has now finalized this proposed rule, allowing payers to implement copay accumulator programs to prevent the application of manufacturer coupons from applying to patient out of pocket costs.

Currently, copay accumulators are being implemented by insurance companies and Pharmacy Benefit Managers (PBMs), harming patient access. With this payor program, the value of copay assistance cards/coupons issued by manufacturers do not count towards out-of-pocket costs that are applied toward deductibles. The result has caused a cost shift onto consumers and away from employers and payers. Unfortunately, in the proposed rule, the Administration defends the use of copay accumulators.

In contrast, Arizona, Virginia, and West Virginia are leading the state legislative efforts this year to ban copay accumulator programs, although Arizona’s approach to this issue is much more measured.

CMS has stated that its final rule would apply to individual market, small, and large group and self-insured group health plans starting in 2020. The final rule is effective June 25, 2019 which will be sixty days from its April 25, 2019 publication date. There will be no further public comments taken for this rule.

States are currently trending against CMS’ position regarding copay accumulators. If you would like to target your state legislation, Frier Levitt Government Affairs (FLGA) can lobby state legislators to prohibit copay accumulator programs. Contact FLGA today to get started.

Demystifying CBD: What You Need to Know About the Growing Cannabidiol Market

Cannabidiol (CBD) products have seemingly flood the market, suddenly springing up in many places. This has lead pharmacies, natural health food stores and other retailers to discuss new strategies to position themselves in the developing market of CBD. However, recent market saturation and uncertain regulatory oversight have caused massive confusion of whether these products are legal or not.

In this recorded webinar, Ron W. Lanton, Esq., Executive Director of Frier Levitt Government Affairs, explores several issues around CBD, including:
• CBD vs. THC
• An examination of current state and federal CBD and Marijuana policies
• A discussion of current administration viewpoints, including the FDA and DEA
• Other related business trends

Viewers of this webinar will be able to:
• Understand relevant CBD terms
• Comprehend the current viewpoints CBD and Marijuana policies and business trends
• Pinpoint the relationship of the FDA and DEA on CBD

Contact Frier Levitt Government Affairs today.

FDA Seeking Comments on New Guidance Regarding Rare Diseases

The FDA has released a new draft guidance document titled, “Rare Diseases: Natural History Studies for Drug Development.” The guidance document impacts pharmacy supply chain stakeholders, especially drug manufacturers and specialty interests.

What Does the Guidance Do?

According to the FDA, the Agency is publishing this draft guidance to help inform the design and implementation of natural history studies that can be used to support the development of safe and effective drugs and biological products for rare diseases. A natural history study collects information about the natural history of a disease in the absence of an intervention, from the disease’s onset until either its resolution or the individual’s death. Although knowledge of a disease’s natural history can benefit drug development for many disorders and conditions, natural history information is usually not available or is incomplete for most rare diseases, therefore, natural history information is particularly needed for these diseases.

Why You Should Participate:

If you are supply chain stakeholder looking to diversify your business into biological products or to serve rare disease patients, the trend is pointing towards greater utilization of specialty products. Comments are suggested to ensure that the government has your viewpoint in mind when developing further guidance and proposed rules.

There are multiple ways to respond to the “Rare Diseases: Natural History Studies for Drug Development” guidance document. Contact Frier Levitt Government Affairs to have your voice heard.

What You Need to Know about Biosimilars with Brian Lehman, Director, Medical Account Management and Strategic Alliances for Sandoz Inc.

In the first of a series of interviews for the Frier Levitt Government Affairs blog, Executive Director Ron Lanton, Esq. speaks with Brian Lehman, Director, Medical Account Management and Strategic Alliances for Sandoz Inc. about everything Biosimilars – the current biosimilar marketplace, PBMs and biosimilars, and opportunities in the biosimilar marketplace.

Ron Lanton: How have recent FDA policies affected the biosimilars marketplace?

Brian Lehman: My perspective from working with pharmacy benefit managers (PBMs), health plans and employer groups, these stakeholders would benefit from being included in the U.S. Food and Drug Administration’s (FDA) biosimilar education and outreach efforts geared towards patients and the providers who treat them. We included this suggestion in our comments to the FDA Notice of Hearing entitled Facilitating Competition and Innovation in the Biological Products Marketplace.

The need remains for additional FDA-driven, educational efforts to enhance biosimilar understanding among these groups. Doing so could benefit decision making on formulary and utilization management programs.

The FDA has stringent requirements and regulations for the development and approval of all reference biologics and biosimilar medicines.1 The FDA’s authority has the power to help increase payers’ confidence that a biosimilar matches the reference biologic in terms of safety, efficacy and quality via rigorous development and testing processes.

The economic impact for real-world evidence and simulation models is compelling.  Approximately $100 billion worth of biologics are expected to be off patent by 2020, which present a substantial opportunity for biosimilar medicines to create savings for the US healthcare system[i]. Biosimilars may help to provide millions of patients with more affordable and accessible treatment options. They create the potential to save the US healthcare system an estimated $54 billion over 10 years[ii].

 

RL: What types of obstacles are there for biosimilars in the marketplace?

BL: Only 1 in 18 biosimilars in the U.S. market is currently a success story, and that’s Sandoz Zarxio® (filgrastim-sndz) – the first biosimilar to surpass its reference biologic in market share[iii].  To that end, several health systems, integrated delivery networks and payers have realized savings when switching to Zarxio – including Yale New Haven Health System, Robert Wood Johnson Barnabas Healthcare System and Carolina Blood and Cancer Care[iv],[v],[vi],[vii]. Many obstacles for biosimilars in the U.S. exist along the path that begins with discovery and development; continues with the process of obtaining regulatory approval; and ends with patients accessing their biosimilar for treatment. Of those 18 FDA-approved biosimilars, only seven are available for use.

We’ve observed significant obstacles barring biosimilar medicines getting to market, which hinders patient access and is detrimental to healthcare savings.

It is beyond time that all stakeholders work together to overcome the gridlock and provide additional incentives so more patients can access these important medicines.

 

RL: Will doctors or PBMs be the deciding factor for how fast biosimilars make it into the market?

BL: All stakeholders play a significant role in fast-tracking the adoption of biosimilars into the US healthcare system. Actions taken by providers, professional societies, payers, healthcare plan administrators, patients and policy makers send signals back to manufactures on why it is important to continue investing in biosimilars.  Positive signals in support of biosimilars and removal of barriers will favorably impact how the US is able to realize savings in healthcare spending and improvements in patient access – now and for the future.

In order to increase support of biosimilars, we need a multi-channel approach focused on amplifying education. The FDA, along with professional organizations, patient advocates and manufacturers play an essential role in educating our community about biosimilars to help earn an equitable level of trust that they expect with reference biologics.

 

RL: With increasing political scrutiny on high-priced medications such as insulin, are there opportunities for biosimilars within this space?    

BL: Yes- there is a clear unmet need for people with diabetes. Each year, 1.4 million Americans are diagnosed with diabetes. Approximately six million Americans with diabetes use a form of insulin[viii]. Among adults diagnosed with diabetes, some may struggle to afford their insulin, putting them at risk of disease-related complications that drive up healthcare costs.

The good news is that the FDA released guidance to help reframe the narrative. Starting in March 2020, medicines that include insulins will be regulated as biologics versus drugs or small molecules. This will allow manufacturers to file for approval of their insulin medicines via the biosimilar similar pathway. That makes a big difference because currently it is not possible to submit an application for a biosimilar to insulin in the US – a transformative move to promote competition[ix].

We hear a lot about the problem of skyrocketing healthcare costs, but very few are doing something about it. The future of insulin biosimilars will be significant due to the increase in competition that will help bring down prices for patients and the healthcare system.  Anticipating the growing needs for insulin biosimilars, Sandoz entered into an agreement to commercialize biosimilar versions of insulins used in patients with type 1 and type 2 diabetes. (Press release source: https://www.sandoz.com/news/media-releases/sandoz-enters-commercialization-and-supply-agreement-insulin-biosimilars). This will ultimately result in increased access, adherence and reduced complications for individuals who use insulin.

*Zarxio and Erelzi are registered trademarks of Novartis AG.

 

References:

[i]GBI Research. $100 billion of revenues up for grabs for drug manufacturers by 2020 as patents for key biologics expire [press release]. March 13, 2017. https://drug-dev.com/100-billion-of-revenues-up-for grabs-for-drug-manufacturers-by-2020-as-patentsfor- key-biologics-expire/. Accessed December 14, 2018.

[ii]Mulcahy AW, Hlávka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Santa Monica, CA: Rand Corporation, 2017. Available at: https://www.rand.org/pubs/perspectives/PE264.html.Accessed February 27, 2019.

[iii]IMS Health Institute for Healthcare Informatics. Delivering on the potential of biosimilar medicines: the role of functioning competitive markets. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/delivering-on-the-potential-of-biosimilarmedicines.

pdf?la=en&hash=7705453CF0E82EF41402A87A44744FBF8D84327C&_=1518722219951. Accessed December 14, 2018.

[iv]Evans M. Barnabas and Robert Wood Johnson sign deal to form biggest New Jersey health system. Modern Healthcare Website. Available at: http://www.modernhealthcare.com/article/20150714/NEWS/150719965. Published July 14, 2015. Accessed October 5, 2018.

[v]Data on file. RWJBH Raw Sales Data. Sandoz Inc. March 2018.

[vi]Davio K. Oncologist sees biosimilars playing a role in the oncology care model. The Center for Biosimilars Website. Available at: http://www.centerforbiosimilars.com/news/oncologist-sees-biosimilars-playing-a-role-in-the-oncology-care-model. Published April 12, 2018. Accessed June 11, 2018.

[vii]Leber MB, Abdelghany O, Miller L. Biosimilar adoption: health system challenges and strategies for success. Poster presented at: 2016 Vizient Clinical Connections Summit, Dallas, TX, September 29, 2016.

[viii]American Diabetes Association. Fast Facts: Data and Statistics about Diabetes. Available at: https://professional.diabetes.org/sites/professional.diabetes.org/files/media/fast_facts_12-2015a.pdf. Accessed February 27, 2019.

[ix]US FDA. Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628121.htm. Accessed February 27, 2019.

Biosimilar Naming: Where We’ve Been and Where We Are

This article originally appeared in The Center for Biosimilars.

March has been a rollercoaster month for the healthcare industry. From the sudden resignation of FDA Commissioner Scott Gottlieb, MD, to the announcement of the FDA’s current thinking on nonproprietary names of biological products, I have been hearing many questions from stakeholders on what, exactly, is happening with biosimilars. Let’s take a quick look at the FDA’s latest guidance on naming and at where the FDA is headed with new leadership.

According to Commissioner Gottlieb, the guidance, titled Nonproprietary Naming of Biological Products, accomplishes 3 things:

• The FDA no longer intends to modify the proper names of biological products that have already been licensed or approved without an FDA-designated suffix in their proper names.

• The FDA does not intend to apply the naming convention to the proper names of transition biological products.

• Going forward, for interchangeable biosimilars, the FDA intends to designate a proper name that is a combination of the core name and a distinguishing suffix.

Since the Affordable Care Act created the biosimilar pathway, the FDA has been trying to create the most appropriate policies for naming biological products, as well as trying to ensure drug safety or pharmacovigilance. In 2015, the FDA released 3 guidance documents, including a question-and-answer document, on the FDA’s viewpoint on the Biologics Price Competition and Innovation Act and on quality and scientific considerations for demonstrating biosimilarity. In 2017, the FDA deviated from the European Medicines Agency and the World Health Organization and finalized guidance saying that both originator biologics’ and biosimilars’ names would include 4-letter, FDA-designated meaningless suffixes.

Regarding the FDA’s 2017 suffix policy, Commissioner Gottlieb stated that “By applying this policy to originator and biosimilar products alike, the FDA sought to advance the goal of patient safety—which the suffixes promote—without creating a misimpression that products with such suffixes are somehow inferior to those without. In addition, the FDA announced in that guidance that the agency was considering retrospectively changing the names of biological products already on the market to begin adding distinguishable suffixes. Many believed that the FDA would continue to evolve on this issue, and this month’s release proves them right.

So what happens next? First, the comment period ends on May 7, 2019, so the industry has until then to submit viewpoints on this particular policy. I do not think that Commissioner Gottlieb’s resignation will create setbacks to the FDA’s ambitious views of encouraging greater generic and biosimilar utilization. It is expected that acting FDA Commissioner Norman “Ned” Sharpless, MD, will fill the void starting in April until a permanent replacement is found. Sharpless does have significant industry experience, and, in my opinion, it seems as though HHS Secretary Alex Azar has confirmed in a recent statement the FDA’s path of aggressively introducing competition into the market to lower drug prices will remain for some time. The only question is whether this new naming guidance document by the FDA will achieve clarity and safety for industry stakeholders, including patients.