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SB 5935, HB 1675
2015-2016 Session: Convene: 1/12/15 and Adjourn: 3/14/16
SB 5935
5/12/15: Governor Inslee has signed the bill into law. It is now Chapter 242 of the 2015 Laws, effective 7/24/15.
4/17/15: Senate concurred with the House amendments and will now be sent to . Governor Inslee.
4/7/15: House Committee on Appropriations Majority recommended passage as amended. The minority recommended not to pass.
3/31/15: Executive action taken in the House Committee on Health Care & Wellness. Recommended for passage.
3/25/15: Scheduled for executive session in the House Committee on Health Care & Wellness (materials).
House: 3/24/15: Scheduled for public hearing in the House Committee on Health Care & Wellness (materials).
Senate: 3/10/15: Floor amendment adopted. Passed 3rd reading (48/1).
3/26/15: Scheduled for executive session in the House Committee on Health Care & Wellness (materials).
HB 1675
3/31/15: Executive action taken in the House Committee on Health Care & Wellness. Recommended for passage. The House has referred the bill to the Appropriations Committee.
House: 1/26/15: First reading, referred to Health Care & Wellness.
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Bill Information
SB 5935
Amends existing generic drug substitution law, RCW § 69.41.100 et seq.
Defines “biological product;” defines “interchangeable” as a biological product that is determined by FDA to be interchangeable and listed in the purple book, or a biological product determined to be therapeutically equivalent and listed in the orange book.
Requires every prescription to contain an instruction on whether an interchangeable biological may be substituted in place of a biologic. Requires the substitution in all cases where a prescription marks “substitution permitted,” so long as the wholesale price for the biosimilar is lower, except in cases where a patient requests the prescribed biologic. (Sunsets on August 1, 2020). Requires pharmacist to:
—disclose the substitution to the patient;
— notify prescriber within 5 days, electronically if possible (and by other means if not), except when (1) there is no FDA-approved interchangeable biosimilar, (2) the prescription is a refill that is unchanged from the prior filling, or (3) pharmacist communicated to prescriber before dispensing, and got confirmation of the product to be dispensed. (Sunsets on August 1, 2020.)
Permits the substitution of a biologic for an out-of-state prescription, provided that the prescriber does not indicate that substitution is prohibited.
Requires pharmacist to note the manufacturer of the drug dispensed, and to retain a copy of the prescription.
Establishes that a pharmacist who substitutes a biosimilar is not subject to greater liability than would be incurred in filling the biologic prescription.
Directs pharmacies to post a sign stating “Under Washington law, a less expensive interchangeable biological product or equivalent drug may in some cases be substituted for the drug prescribed by your doctor. Such substitution, however, may only be made with the consent of your doctor. Please consult your pharmacist or physician for more information.”
Directs the pharmacy quality assurance commission to maintain a link on its website to the current list of all interchangeable biological products.
HB 1675
Amends existing generic drug substitution law, RCW § 69.41.100 et seq.
Defines “interchangeable” as a biologic product that meets FDA’s standards for interchangeability or a biological product that is determined to be therapeutically equivalent to another biological product.
Requires every prescription to contain an instruction on whether an interchangeable biological may be substituted in place of a biologic. Requires pharmacist to substitute a biologic if the biosimilar is cheaper, and at least 60% of the savings are passed on the purchase, unless the patient requests the biologic.
Permits the substitution of a biologic for an out-of-state prescription, provided that the prescriber does not indicate that substitution is prohibited.
Requires pharmacist to note the manufacturer of the drug dispensed, and to retain a copy of the prescription.
Requires pharmacist to notify prescriber within a reasonable time, electronically if possible (and by other means if not), except when there is no FDA-approved interchangeable biosimilar, or the prescription is a refill that is unchanged from the prior filling.
Establishes that a pharmacist who substitutes a biosimilar is not subject to greater liability than would be incurred in filling the biologic prescription.
Directs pharmacies to post a sign stating “Under Washington law, a less expensive interchangeable biological product or equivalent drug may in some cases be substituted for the drug prescribed by your doctor. Such substitution, however, may only be made with the consent of your doctor. Please consult your pharmacist or physician for more information.”
Directs the pharmacy quality assurance commission to maintain a link on its website to the current list of all interchangeable biological products.
HB 1679
Amends existing generic drug substitution law, RCW § 69.41.100 et seq.
Defines “interchangeable” as a biologic product that meets FDA determined meets standards for interchangeability and may be substituted without notification/intervention of the health care provider.
Requires every prescription to contain an instruction on whether an interchangeable biological may be substituted in place of a biologic. Requires pharmacist to substitute a biologic if the biosimilar is cheaper, and at least 60% of the savings are passed on the purchase, unless the patient requests the biologic.
Permits the substitution of a biologic for an out-of-state prescription, provided that the prescriber does not indicate that substitution is prohibited.
Requires pharmacist to note the manufacturer of the drug dispensed, and to retain a copy of the prescription.
Establishes that a pharmacist who substitutes a biosimilar is not subject to greater liability than would be incurred in filling the biologic prescription.
Directs pharmacies to post a sign stating “Under Washington law, a less expensive interchangeable biological product or equivalent drug may in some cases be substituted for the drug prescribed by your doctor. Such substitution, however, may only be made with the consent of your doctor. Please consult your pharmacist or physician for more information.”
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Archive
Washington State Medical Society – WSMA Reports – May/June 2011 – Biosimilars and the Cost-safety Balance
June 23, 2011
Less expensive, follow-on biologics are expected to be a boon to patients and Washington’s biotechnology industry. But as the FDA implements a new approval pathway for these complicated drugs, the medical community wants to ensure patient safety comes first. Read More
Governor’s Life Sciences Summit & Annual Meeting
June 21, 2011
November 18, 2011 Seattle, WA Read More
Stem Cell & Regenerative Medicine: Today and Tomorrow
June 21, 2011
September 20, 2011 Institute for Stem Cell & Regenerative Medicine Seattle, WA Read More
Life Sciences Leadership Summit
June 15, 2011
June 15, 2011 Washington State University Spokane, WA Read More
Washington State Preferred Drug List and the Therapeutic Interchange Program (TIP)
June 15, 2011
The Therapeutic Interchange Program (TIP) has developed a process allowing physicians and other prescribers to endorse the Washington State Preferred Drug List (PDL), and requires pharmacists to automatically substitute the preferred drug for non preferred drugs prescribed by these practitioners unless the prescription is for a refill of an antipsychotic, antidepressant, chemotherapy, antiretroviral, or immunosuppressive […]
Washington State Legislature – Therapeutic Interchange Program
June 15, 2011
This section contains the department’s rules for the endorsing practitioner therapeutic interchange program (TIP). TIP is established under RCW. The statutes require state-operated prescription drug programs to allow physicians and other prescribers to endorse a Washington preferred drug list (PDL) and, in most cases, requires pharmacists to automatically substitute a preferred, equivalent drug from the […]
Washington State Legislature – Therapeutic Interchange Program
June 15, 2011
This section contains the department’s rules for the endorsing practitioner therapeutic interchange program (TIP). TIP is established under RCW. The statutes require state-operated prescription drug programs to allow physicians and other prescribers to endorse a Washington preferred drug list (PDL) and, in most cases, requires pharmacists to automatically substitute a preferred, equivalent drug from the […]
