Conference Insider: AMCP 2023

By Hannah Musick

Understanding biosimilars and legislative interchangeability designation is a growing concern for payers, manufacturers, prescribers, pharmacies, and patients, according to session speakers at AMCP 2023. Presenters addressed the regulatory landscape of biosimilars in the United States and outlined the evolving role of interchangeability. 

Regulatory Landscape 

Interchangeability refers to when biological products that meet federally mandated criteria are deemed an acceptable alternative to a reference product. The biological product must be biosimilar to the reference product, and using the biological product instead of the reference product should not cause any safety risks or decrease its efficacy, explained Adam Colburn, JD, Director, government relations AMCP. 

While a federal definition of interchangeability exists, regulations can differ from state to state. Some states base their biosimilar substitutions based on drugs listed as therapeutically equivalent in the US Food and Drug Administration’s (FDA) Approved Drug Products With Therapeutic Equivalence Evaluations (referred to as the Orange or Purple Book); other states maintain their own lists. 

The speakers used California, New York, and Hawaii as examples of diverse regulatory practice approaches concerning biosimilars. In California, the FDA’s standards according to Section 262(k)(4) of Title 42 of the United States Code should be met for interchangeability, or equivalence should be established in the Purple Book. 

In New York, in addition to the prior requirements, interchangeability requires FDA licensing. Hawaii is the only state to not accept the federal definition of interchangeability for biosimilars and instead relies on director approval to be included on a state list of generic drug products and interchangeables. 

In some cases, pharmacists may use their discretion when deciding to switch a patient to an interchangeable biosimilar. However, in most states, the patient must be notified of the change at the point of sale and the prescriber must be informed within 3 to 5 days. Certain states may require the prescriber’s approval before substitution, while others adhere to the “dispense as written” law.

The presenters highlighted cost as a crucial factor in the conversation around biologics. Substitution can sometimes be required if a biosimilar is a lower cost than the reference. Some states prohibit substitution for a Medicaid recipient if the state agency determines that a prescribed biologic is lower in net cost after rebates or pharmacists may be required to explain to patients the cost comparison of a biologic and a biosimilar.  

Notice and consent policies also differ between states. For the prescriber, many states allow them to prevent substitution. States may be required to send notice of substitution to a prescriber within a set time, other states consider updating electronic records accessible by the prescriber as adequate notice. For patients, they may receive notice of substitution, but other states only require the patient’s prior consent. The same variation by region holds true for substation practices. 

“Legal immunity is broadly unclear at a legislative level,” said Mr Colburn. 

Immunity is currently available in select states for pharmacists as long as their substitution complies with state law or applies the same liability standards as for prescribing generics. 

Practical Considerations

“Since 2015, biosimilars have generated more than $13 billion in health care savings,” said Gary Rice, RPh, MS, MBA, CSP, senior advisor, MedImpact Healthcare System, Inc. “The latest projections suggest that savings could exceed $180 million in the next 5 years.” 

Despite the significant cost and care implications of biologics from a managed care perspective, Medicare generally encourages the use of biosimilars but still has been slow to prioritize biosimilars over reference biologics. Medicaid-preferred drug lists vary from state to state, but the Centers for Medicare & Medicaid Services encourages states to include biosimilars. Commercial payers could prioritize biosimilars in formulary placement or could cover both the reference and the biosimilar.

Mr Rice emphasized that while biosimilars may be a relatively new pharmaceutical development, many therapies such as human growth hormones, insulin, and influenza vaccines have faced similar concerns to biosimilars. He also highlighted that understanding and embracing biosimilars has never been more relevant as many have already been launched in the United States to date and in 2023, multiple adalimumab biosimilars will enter the market. The first adalimumab biosimilar, adalimumab-atto (Amjevita), was already approved in January 2023.

Seven key considerations for evaluating biosimilars were shared: 

• clinical efficacy;
• toxicity and immunogenicity;
• supplier manufacturer capability;
• supplier reliability;
• cost savings to payer;
• dosage form for target population; and
• patient adherence. 

“Price will also be a significant guiding force,” said Mr Rice. 

It is yet unknown what influence biosimilar interchangeability will have on payer formulary coverage, provider prescribing, and patient acceptance for biosimilars. 

“Because interchangeability designation is unique to the United States, we do not have any historical perspective,” said Mr Rice. “We do not have the luxury of looking to see what the experience of other countries has been with biosimilars.” 

Biosimilar Influencers 

While many details of the future of biosimilars remain to be seen, the speakers charged the audience to consider their own influence. 

“The payer, manufacturer, prescriber, pharmacy, and patient will be the key influencers when it comes to acceptance and utilization of biosimilars,” said Mr Rice.

Payers can increase competition as the market fills with options and optimize the opportunity for lower costs and generate additional savings. 

Pharmacies, regardless of the distribution model, can influence a prescriber’s decision. Pharmacies can also assist with prior authorization, provide patient funding help and training, as well as utilize digital and fax communication tools to initiate contact with a prescriber. All these factors are crucial in determining a patient’s health care plans and outcomes.

“Manufacturers have to work on developing trust in their biosimilars. They must educate patients and prescribers and demonstrate safety, efficacy, and viability,” said Mr Rice. “At the end of the day if the prescriber is not comfortable with the product, they will not prescribe it. If the patient is not comfortable with the product, they will not get it filled.”  

The presenters emphasized existing research identifies the main hurdles to biosimilar adoption include education/awareness, a streamlined prescriber process, and financial incentives for patients and prescribers. 

“The three Es of biosimilars are educate, educate, and educate,” said Mr Rice. 

It is important to understand the complexities of substitution laws concerning biosimilars, and all influencers in the health care ecosystem should be involved in the optimization of biosimilar use. More guidance and regulations are on the way, and the health care system will all be faced with a learning curve as this developing technology continues to gain prominence. 

“There needs to be an overall collaborative effort so that we all are aligned,” said Mr Rice.

By Maria Asimopoulos

Speakers at AMCP 2023 discussed strategies payers can use to promote provider adoption of real-time benefit check (RTBC) tools, strengthen trust between stakeholders, and improve patient access to lower-cost medications.

In a 2022 Medication Access Report by CoverMyMeds, 78% of surveyed patients said costs were greater than expected when they went to pharmacies to pick up their medications. From 2020 to 2021, patients increasingly sacrificed medications (36% vs 51%) and essentials (43% vs 52%) or modified their treatments (41% vs 56%) due to costs, said Michael Burger, senior consultant, Point-of-Care Partners, LLC.

“As a health plan, that’s concerning because we want and need our members to be on the right medications,” said Rick Jennejahn, director of pharmacy innovation programs, Excellus BCBS, Pharmacy Solutions. 

National data also show that when patients chose a lower-cost alternative in 2021, average savings per prescription were:

• $51 for antidepressants;
• $27 for antihypertensives;
• $32 for cholesterol-lowering drugs;
• $116 for diabetic therapies; and 
• $26 for peptic-ulcer therapies.

Raising provider awareness and utilization of RTBC can provide clinical value, lower cost expectations, enhance provider satisfaction, and improve the patient experience, Mr Jannejahn said.

“It’s complicated today. Just getting an appointment sometimes can be a challenge. Real-time benefit check can help in terms of making sure patients can get on their treatment quickly,” Mr Jennejahn said.

All electronic health records (EHRs) have RTBC tools built in, but the challenge is ensuring providers and patients use them, Mr Burger said.

“There’s a pretty big disconnect between the number of providers that have the information and the number of providers that believe they have out-of-pocket costs. It’s a challenge all the way around, for the [pharmacy benefit managers], for the providers, for the patients, that this information is available but isn’t being widely used,” Mr Burger said.

Excellus Health Plan implemented RTBC in 2019. Excellus provides pharmacy benefits to 1.4 million members enrolled in both public and private plans in New York. Excellus has approximately 37,000 in-network providers, and between 70,000 and 100,000 prescriptions are filled daily, Mr Jennejahn said.

Throughout 2020, provider adoption of RTBC was slow, complaints mounted, and reporting was limited due to the pandemic, Mr Jennejahn said. 

Providers said RTBC added to the complexity of their workflow, as they were required to use multiple systems, networks, and portals, which sometimes had slow response times or data lags, Mr Jennejahn said. There were also gaps in knowledge, as providers and their staff lacked awareness about RTBC tools and how to use them. Additionally, the information provided through RTBC tools was not always actionable or accurate.

In turn, the health plan could not always assist providers due to multiple EHRs being used across the service area, limited visibility into the RTBC tool’s functionality, and limited data utilization, Mr Jennejahn said.

Excellus sought to improve RTBC adoption through increased provider outreach, Mr Jennejahn said.

“We’re engaging with our health systems [and] our provider partners who are not using real-time benefit check and trying to get their questions answered and get them on board,” Mr Jennejahn said.

Excellus developed a training curriculum for the tool, reference material for top EHRs on how to activate and use RTBC, and a “help desk” to address any questions.

“We focused a lot on messaging. We can talk about all these things that are for the betterment of mankind, and that’s great, but the providers and patients are all about, ‘What’s in it for me?’” Mr Burger said.

He recommended emphasizing how, through using RTBC tools, providers can improve patient trust and rapport; speed access to therapy; increase patient adherence; and decrease administrative burden. 

For patients, RTBC can reduce delays due to prior authorization, ensure patients are fully informed, reduce surprising prices at the pharmacy, promote medications that balance cost and convenience, and more. 

“We think that if we can get more providers using real-time benefit check, if we can put these tools in their hands…we can help achieve [affordable access to care],” Mr Jennejahn said.

By Edan Stanley

The AMCP Policy & Government Relations staff reviewed the latest federal activity related to health policy including prescription digital therapeutics (PDTs), performance-based reimbursement, and other legislative roads being pursued. 

Jennifer L Mathieu, MA, senior vice president, professional and government affairs, AMCP, kicked off the session highlighting the recently enacted Preapproval Information Exchange (PIE) Act (HR 9297), which creates a safe harbor for the exchange of both clinical and economic data between manufacturers and payers, and clarifies previous communication guidance from 2018. 

The PIE Act was passed as part of the omnibus spending bill (HR 2617) on December 2, 68 to 29 in the senate and 225 to 201 in the house, then signed by President Biden on December 29. “Americans now live under a law that AMCP helped pass,” noted Ms Mathieu, adding that it took 6 years, and would not have been possible without the support of AMCP and its members.

Recently Passed or Must-Pass Legislation

A notable piece of legislation reintroduced March 8, 2023 is the Prescription Digital Therapeutics (PDT) Act of 2023 (S.723/H.R.1458). 

Ms Mathieu emphasized the significance of the robust bipartisan support of the Access to PDTs Act, particularly during a time of great political divide in the United States. 

“The PDT bill will create a benefit category” which is necessary for reimbursement and “is limited to digital therapeutics that are reviewed and cleared by [US Food and Drug Administration] and prescribed by health care providers,” Ms Mathieu explained.  

Key points of the Access to PDTs act include the following:

• It does not require Centers for Medicare and Medcaid services [CMS] to cover a specific PDT or PDTs as a class of products under Medicare/Medicaid
• Programs use normal formulary decision processes to ascertain appropriateness of including PDTs in their formularies
• Direct CMS to establish framework for HCPCS coding

The Access to PDT Act is needed, Ms Mathieu points out, because CMS does not currently have the necessary authority to cover PDTs. Medicare/Medicaid also do not have the flexibility to cover products like PDTs beyond the statutorily defined benefit categories. 

The Biosimilars Research Fund and National Biosimilars Project Act are both dedicated to securing funds for large population, epidemiological research on biosimilars for 2023/2024.

The Equitable Community Access for Pharmacist Services Act (ECAPS) was reintroduced March 24, 2023. The goal of ECAPS is to authorize pharmacists to receive reimbursement under Part B for certain COVID-19 care beyond the end of the public health emergency (PHE). It is also designed for Part B reimbursement for care under any future PHE issued under the same Public Readiness and Emergency Preparedness (PREP) Act authority as the COVID-19 PHE. 

Another piece of new legislation is the Pharmacy Benefit Manager Transparency Act of 2023 (S 127), which would prohibit pharmcy benefit manager’s from charging health plans different amounts for a prescription than what is reimbursed to a pharmacy, among other restrictions. 

The Inflation Reduction Act, signed by President Biden on August 16, 2022 and in effect this year, has several components related to drug price negotiation, inflationary rebates, Part D redesign, enhanced payments for biosimilars, Affordable Care Act premium tax credit extensions through 2025, and rebate rule delay until January 1, 2025. 

“The timing of this presentation is very early in the 118th congress,” noted Ms Mathieu. “There was a delay in appointing the house speaker and then organizing all of the committees. So although it is March 22, it is still early for congress’ work. In fact, March 6 was the first time they actually began work.”

She continued, “The reality is, we have a split congress. Both margins in the house and the senate are very narrow … Highly partisan legislation is likely not going to pass. Fortunately the PDT bill and ECAPs are both bipartisan pieces of legislation but we do expect it to be tougher than the 117th congress.”

Ms Mathieu concluded her portion of the session noting there are definitely more pieces of health-related legislation on the horizon but we may have to wait a few weeks for more solid information.

“We do think we’re going to see the house/congress take up legislation around utilization legislation,” she added. “Beyond that, it is still unclear but over the next 4 weeks we’ll get a better sense on what they’re pushing/advocating for and how and where we can partner.”

By Maria Asimopoulos

From conference sessions to poster presentations, biosimilars were a prominent topic of discussion at AMCP 2023. Professionals across the spectrum of managed care discussed how biosimilars’ arrival to the market could impact drug costs and formulary considerations

In this interview with First Report Managed Care, Courtney Quinn, PharmD, provides insight into how biosimilar conversion in the insulin space has the potential to impact costs for both patients and the health plans that cover them.

Can you provide an overview of your research? What was your study’s design, and who participated in it?

The goal of my research project was to investigate the potential cost savings associated with interchangeable biosimilars, particularly in the insulin space. Semglee (insulin glargine-yfgn) was the first interchangeable biosimilar for the reference product Lantus (insulin glargine) that became available on the market. Navitus made a formulary change to prefer Semglee over Lantus because Semglee had the lowest net cost for plan sponsors and health plans. This project was proposed as a way to analyze the success of that formulary change, as well as quantify any potential savings that came from coverage of an interchangeable biosimilar.

This project was a retrospective claims analysis where we analyzed members of 4 large commercial health plans who had at least 1 claim for Lantus from July 1, 2021, to December 31, 2021 (preintervention), and at least 1 claim for any long-acting insulin on the formulary from January 1, 2022, to June 30, 2022 (postintervention).

Because most states do not require prescriber intervention to switch from a reference product to an interchangeable biosimilar, patients generally did not need to wait for a new prescription, so the transition was very successful. Approximately 80% of patients in my study population who were previously using Lantus switched to either Semglee or the unbranded version of it, which we were excited to see. We had successful conversion of patients to a biosimilar product that had introduced price competition to the market and was preferred on a cost basis. 

For the cost savings analysis, we matched members from pre- to postintervention and calculated the average savings overall, or the mean decrease in total cost and net cost. Total cost was determined using sticker price and the net cost included rebates as well. We saw significant savings for clients. Total cost savings ranged from 28% to 54% depending on the plan. Regarding net cost, we found approximately 28% to 48% overall savings. 

We were really happy to see these numbers. We always want to save money for clients and members, especially in the insulin space. There have been a lot of recent changes in the insulin space, but when this project first began, the market was still very cost-prohibitive for patients, plan sponsors, and health plans. We were excited this project was successful and had a statistically significant impact on spending when compared on a member-by-member basis pre- and postintervention. 

Do you intend to do more work with insulin biosimilars in the future?

With the recent announcements of price changes in the insulin space, the landscape continues to evolve. As a company, we are definitely paying attention. We want to provide the lowest cost option and improve access and affordability for both members and plans. Navitus will continue to monitor and assess savings incremental opportunities as additional biosimilars are expected mid-year.

Is there anything else you would like to add?

Navitus is committed to achieving the lowest net cost for clients. Our 100% pass-through business model helps drive this, as all manufacturer rebates and discounts are passed on to clients. The decision to prefer the biosimilar on formulary was based on a cost analysis to identify the lowest-net-cost option rather than on rebate value. This approach lowers the upfront cost for plan sponsors, as opposed to spending more now and awaiting a rebate several months later.

There are several other interchangeable biosimilars launching now and in the near future, and there is limited information on their impact on costs for prescription plans. This project helped compile data to show interchangeable biosimilars can be a powerful cost-saving option. As an advocate for more affordable medications for the people who need them, Navitus is focused on future opportunities to prefer lower-cost, clinically appropriate interchangeable biosimilars.