Biological Products.
Biological products are regulated by the Food and Drug Administration (FDA) and are used to diagnose, prevent, treat, and cure diseases and medical conditions. ?There are many types of FDA-approved biological products including therapeutic proteins, monoclonal antibodies, and vaccines. ?Biological products are more complex than traditional chemical-based drugs because they are manufactured from living organisms and so a replicated biological product will not be identical to the original, reference product and slight variations in manufactured lots of the biological product are normal. ?When assessing the comparability of biological products, there are two federal FDA classifications.

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Biosimilars are biological products that are highly similar, but not identical, to an already FDA-approved biological product, the original biologic medication, also known as the reference biological product. ?For the FDA to approve a biosimilar, there must be no differences in the safety and effectiveness of the products. ?Biosimilars provide the same benefits when treating a disease or condition, are the same strength and dose, and have the same potential side effects.

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Interchangeable biological products (interchangeable products) are biosimilars that meet additional FDA requirements. ?A manufacturer of a proposed interchangeable product must provide additional information to show that an interchangeable product is expected to produce the same clinical result as the reference product in any patient. ?An interchangeable product may be substituted for the reference product without the involvement of the prescriber.

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Regulation of Substitutions.
Federal law allows a product that has been determined by the FDA to be an interchangeable product to be substituted for the reference product without intervention of the health care provider who prescribed the original product.?

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State law, however, governs the substitution of drugs by pharmacists and requires that every prescription must contain an instruction on whether a therapeutically equivalent generic drug or an interchangeable product may be substituted in its place, unless substitution is permitted under a prior-consent authorization. ?If substitution is permitted, and a less expensive alternative for the prescribed biological product is in stock, the pharmacist must substitute the interchangeable product with the original.

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Health Carrier Prescription Drug Utilization Management.

Clinical review criteria used to establish a prescription drug utilization management protocol must be evidence-based and updated on a regular basis through review of new evidence, research, and newly developed treatments. ?When coverage of a prescription drug for the treatment of any medical condition is subject to prescription drug utilization management, the patient and the prescribing practitioner must have access to a clear, readily-accessible, and convenient process to request an exception. ?A carrier or prescription drug utilization management entity may require a patient to try an AB-rated generic equivalent or a biological product that is an interchangeable product prior to providing coverage for the equivalent branded drug.

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State-Procured Qualified Health Plan.

Only health plans certified by the Washington Health Benefit Exchange (Exchange) as qualified health plans (QHPs) may be offered on the Exchange. ?All QHPs must be offered by licensed carriers and therefore must meet requirements generally applicable to all individual market health plans, including offering the essential health benefits, having their premium rates reviewed and approved by the Insurance Commissioner, and meeting network adequacy requirements. ?The Health Care Authority (HCA), in consultation with the Exchange, must contract with at least one health carrier to offer QHPs on the Exchange for plan years beginning in 2021. ?A health carrier contracting with the HCA must offer at least one bronze, one silver, and one gold QHP in a single county or in multiple counties. ?The goal of the procurement is to have a choice of QHP offered in every county. ?The QHPs offered pursuant to an HCA contract must employ utilization management processes that meet national accreditation standards, comply with requirements established by the HCA to address amounts expended on pharmacy benefits including increasing generic utilization and use of evidence-based formularies, and focus on care that has high variation, high cost, or low evidence of clinical effectiveness.

Regulation of Substitutions.
A pharmacist filling a prescription order for a drug product prescribed by its trade or brand name may substitute a biosimilar or an interchangeable product, unless the practitioner personally indicates "do not substitute," "dispense as written," or words of similar meaning. ?Provisions authorizing pharmacists to substitute generic drugs are removed. ?The person who selects the drug product to be dispensed assumes the same responsibility for selecting the dispensed drug product as would be incurred in filling a prescription for a drug product prescribed by generic name. ?The practitioner is not liable for an act or omission by a pharmacist in selecting, preparing, or dispensing a drug product. ?A pharmacist may only substitute selected drug products that cost the patient less than the prescribed drug product, including any professional fee. ?The dispensed drug product must be communicated to the patient with the name of the dispensed drug product indicated on the prescription label.

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Unless the prescribed biological product is requested by the patient or patient's representative, or the prescriber has indicated "do not substitute" the pharmacist must substitute an available interchangeable product or biosimilar if the wholesale price of the interchangeable biological product or biosimilar is less than the wholesale price for the prescribed biological product.?

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Health Carrier Prescription Drug Utilization Management.
A carrier or prescription drug utilization management entity may require a patient to try an AB-rated generic equivalent, an interchangeable biological product, or a biosimilar prior to providing coverage for the equivalent branded drug.

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State-Procured Qualified Health Plan
The state-procured QHPs offered pursuant to an HCA contract must comply with requirements established by the HCA to address amounts expended on pharmacy benefits including increasing generic and biosimilar utilization and use of evidence-based formularies.