Gavin Howe
In the United States, 45 states and Puerto Rico have enacted laws that allow pharmacists to dispense interchangeable biological products in certain situations. Ohio is one of the states that has passed a biosimilar substitution law, which outlines the parameters for substitution of interchangeable biologic drugs, guaranteeing patients access to safe and high-quality biologic medicines. This law also requires pharmacists to notify physicians when interchangeable biologic drug substitutions are made, allowing physicians to maintain accurate medical records and respond to any complications or side effects. The goal of these laws is to increase access to biologic therapies and lower costs for patients, as biologics represent the most expensive drug category globally.
| Characteristics | Values |
|---|---|
| Number of states with biosimilar substitution laws | 45 |
| States without biosimilar substitution laws | Alabama, Arkansas, Maine, Mississippi, Oklahoma, and the District of Columbia |
| State with focus on lowering the cost of drugs and biologics | Nevada, Michigan, New York |
| State that requires patient consent for substitution | Colorado |
| State that requires pharmacist to explain the cost of the biologic and biosimilar | Georgia |
| State that requires the pharmacist to retain records of substituted medication | Illinois |
| State that grants immunity to pharmacists for compliant substitutions | North Carolina |
| State that maintains a list of permissible interchangeable products | Texas |
| Ohio's biosimilar substitution bill | HB505 |
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What You'll Learn
- Ohio's HB505 bill outlines parameters for substitution of biologic drugs
- Pharmacists must notify physicians of interchangeable drug substitutions
- Interchangeability allows pharmacists to substitute branded biologics with biosimilars
- State laws vary, pharmacists must adhere to state-specific regulations
- The FDA evaluates biosimilars, state legislatures address substitution methods
Ohio's HB505 bill outlines parameters for substitution of biologic drugs
In Ohio, House Bill 505 (HB505), also known as the Community Pharmacy Protection Act, was signed into law by Governor Kasich to outline parameters for the substitution of interchangeable biologic drugs. The bill was passed with the help of Arthritis Foundation Ambassadors, who highlighted the need for better access to costly medications for arthritis treatment.
HB505 guarantees patients access to safe and high-quality biologic medicines, addressing a previous concern where pharmacists could substitute prescribed biologic drugs with interchangeable biologic products without informing the patient's physician. The new law requires pharmacists to notify physicians of any interchangeable biologic drug substitutions, enabling doctors to maintain accurate medical records and address potential side effects or complications. This maintains the patient-provider relationship and ensures the medical team is aware of any changes, which could impact treatment.
The bill also sets new requirements for health plan issuers and pharmacy benefit managers (PBMs). Health plan issuers are prohibited from imposing accreditation standards on pharmacies beyond those of the state board of pharmacy for network participation. Additionally, PBMs must report detailed monthly data on drug costs and reimbursements to insurers, plan sponsors, and the Medicaid program. Minimum reimbursement rates for PBM payments to pharmacies for drug products and dispensing fees are also established.
The passage of HB505 is expected to improve access to biologic medications, particularly for arthritis treatment, and ensure that patients receive safe and effective care. This development aligns with the progress made on biosimilars, which are designed to increase access and reduce costs for patients requiring biologic therapies, the most expensive drug category globally. With the FDA approving the first interchangeable biosimilar in the US, states are now focusing on implementing laws to regulate biosimilar substitutions and ensure patient accessibility to affordable treatment options.
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Pharmacists must notify physicians of interchangeable drug substitutions
In the United States, 45 states and Puerto Rico have enacted laws that allow or require pharmacists to dispense an interchangeable biological product in certain situations. The remaining states that have not yet passed legislation on the topic are Alabama, Arkansas, Maine, Mississippi, Oklahoma, and the District of Columbia.
Ohio is one of the states that has passed a biosimilar substitution bill, which was signed into law by Governor Kasich. The bill, HB505, outlines the parameters for the substitution of interchangeable biologic drugs, guaranteeing patients access to high-quality and safe biologic medicines. Importantly, it requires pharmacists to notify physicians when interchangeable biologic drug substitutions are made, allowing physicians to maintain accurate medical records and respond to any complications or adverse side effects.
The requirement for pharmacist notification to physicians about interchangeable biologic substitutions is not unique to Ohio. In fact, almost all states have this requirement, with 45 states having more stringent requirements for interchangeable biologic substitutions than for generic drug substitutions. This mandate is important for maintaining the patient-provider relationship and ensuring the medical team is aware of any substitutions, as even small changes can affect treatment.
While the specific laws vary across states, the general principle is that the biosimilar must be deemed interchangeable with the prescribed biologic by the FDA, and the pharmacist must provide notice to both the patient and the prescriber. Some states, like South Carolina, allow pharmacists to substitute a biosimilar if they determine it to be therapeutically equivalent based on their professional judgment. Other states, like Nevada, do not allow patients to refuse a substitution of a less expensive, interchangeable biosimilar if the product is being paid for by a governmental agency.
Pharmacists play a crucial role in providing patients with the medication that best meets their needs, and understanding state laws regarding interchangeability is essential. Resources like the interactive map created by Cardinal Health can help pharmacists navigate the complex landscape of state requirements and make appropriate treatment decisions.
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Interchangeability allows pharmacists to substitute branded biologics with biosimilars
In the United States, biosimilars are among the fastest-growing products in the prescription drug industry. However, the real-world experience with interchangeability is still in its infancy, and different countries have different regulatory approaches. The US is the only country with a second specific category of interchangeability in its laws for biosimilars. This means that an interchangeable biosimilar is a biosimilar that meets additional requirements outlined by the law, allowing the FDA to approve biosimilar and interchangeable biosimilar medications. Interchangeability designation is likely to have the greatest impact on biosimilars dispensed by pharmacists in the retail/specialty pharmacy setting.
Interchangeability designation can position pharmacists to further enhance patient accessibility to biologics at a lower cost through automatic substitution authority. Biosimilars are developed with the promise of increasing access and lowering costs for biologic therapies, which represent the most expensive drug category globally. Biosimilars are as safe and effective as the original biologic, and both are rigorously and thoroughly evaluated by the FDA. The same quality manufacturing standards that apply to the original biologic also apply to the biosimilar.
As of August 2023, 47 states and Puerto Rico allow substitution of an interchangeable biosimilar for the prescribed reference medicine without requiring prescriber permission. However, it is important to note that interchangeability remains the exception, not the rule, when it comes to biosimilars. In addition, some states require that interchangeable products can only be swapped if the cost is lower, which adds a need for pharmacists to understand the managed care landscape.
In Ohio, the Biosimilar Substitution Bill (HB505) was signed into law by Governor Kasich. The bill outlines parameters for the substitution of interchangeable biologic drugs, guaranteeing patients access to high-quality and safe biologic medicines. It also requires pharmacists to notify physicians when interchangeable biologic drug substitutions are made, allowing physicians to maintain accurate medical records and knowingly respond to any complications or adverse side effects.
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State laws vary, pharmacists must adhere to state-specific regulations
State laws vary significantly when it comes to biosimilar substitutions, and pharmacists must exercise caution and adhere to the specific regulations in their state. While the FDA has approved biosimilars as interchangeable, state-specific laws and regulations must be followed. For instance, 45 states and Puerto Rico have enacted laws that allow or require pharmacists to dispense interchangeable biosimilars under certain conditions. However, the remaining states, including Alabama, Arkansas, Maine, Mississippi, Oklahoma, and the District of Columbia, have yet to pass such legislation.
The laws governing biosimilar substitutions differ in various ways. For example, some states require that interchangeable biosimilars can only be swapped if they result in lower costs for the patient or the government. Nevada, for instance, mandates that patients cannot refuse a less expensive biosimilar if a governmental agency is paying for the drug. In contrast, Michigan requires pharmacists to pass on the cost savings to the purchaser when substituting a less expensive biosimilar.
Another point of variation is the requirement for pharmacists to communicate substitutions to the prescribing physician and the patient. While some states mandate such communication, others do not explicitly address this issue. For instance, Ohio's House Bill 505 (HB505) requires pharmacists to notify physicians when interchangeable biologic drug substitutions are made, allowing physicians to maintain accurate medical records and respond to any complications.
To navigate these complex state-specific regulations, pharmacists can utilise resources such as interactive maps and state-specific guidelines developed by organisations like Cardinal Health. These resources help pharmacists understand the requirements and definitions of interchangeability in each state, ensuring they can educate and support their patients effectively.
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The FDA evaluates biosimilars, state legislatures address substitution methods
In 2015, the FDA approved the first biosimilar product in the United States, filgrastim (Zarxio). Since then, biosimilars have become available for the treatment of several conditions, including arthritis, kidney conditions, and some cancers. These biosimilars are as safe and effective as the original biologic medications and are evaluated and approved by the FDA. As of 2023, the FDA has approved the first interchangeable biosimilar in the US, Semglee (insulin glargine-yfgn).
As of July 1, 2017, 35 states and Puerto Rico had passed laws regarding biosimilar substitution requirements, and as of 2019, 45 states and Puerto Rico had enacted laws permitting or requiring pharmacists to dispense interchangeable biosimilars in certain situations. These laws typically require the biosimilar to be deemed "interchangeable" with the prescribed biologic by the FDA and the pharmacist to notify both the patient and the prescriber. Some states, such as Nevada and Michigan, focus on lowering drug costs by requiring substitution with a cheaper interchangeable biosimilar, while others, like South Carolina, allow pharmacists to determine if a biosimilar is therapeutically equivalent and can be substituted.
Ohio is one such state that has passed a biosimilar substitution bill, HB505, which outlines the parameters for substitution of interchangeable biologic drugs and guarantees patients access to safe and effective medications. This bill also requires pharmacists to notify physicians of any substitutions made, allowing them to maintain accurate medical records and respond to any adverse effects.
As the FDA continues to evaluate and approve biosimilars, state legislatures must address the appropriate methods for substituting biologic reference products with biosimilars. While none of the approved biosimilars in the US are currently designated as interchangeable by the FDA, state laws will come into effect once this occurs, and pharmacists will need to be aware of the impact on their practices.
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Frequently asked questions
The Ohio Biosimilar Substitution Bill, or HB505, outlines the parameters for substitution of interchangeable biologic drugs, guaranteeing patients access to high-quality and safe biologic medicines.
The bill requires pharmacists to notify physicians when interchangeable biologic drug substitutions are made, allowing physicians to maintain accurate medical records and respond to any complications or adverse side effects.
Biosimilar substitution laws aim to increase access to biologic therapies and lower their costs, as biologics represent the most expensive drug category globally.
No, while 45 states and Puerto Rico have enacted biosimilar substitution laws, Alabama, Arkansas, Maine, Mississippi, Oklahoma, and the District of Columbia have not passed legislation on the topic as of 2019.
