Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0010 - Prescription drug affordability board-Definitions

Current through Register Vol. 24-14, July 15, 2024
The definitions in this section apply throughout this chapter
				  unless the context clearly requires otherwise.
"Authority"
means the health care authority, as
				  defined in WAC
				  182-02-045.
"Biological product"
has the same meaning as in
				  42 U.S.C. Sec.
				  262 (i)(1).
"Biologics"
means biological products and
				  biosimilars.
"Biosimilar"
has the same meaning as in
				  42 U.S.C. Sec.
				  262 (i)(2).
"Board"
means the prescription drug
				  affordability board.
"Brand name drug"
means specific legend drug
				  products that are sold by a manufacturer under certain trademarks or
				  patents.
"Confidential information"
means:
(a) Specific information collected by the
				authority that is not publicly available for the purposes of this chapter;
				or
(b) Proprietary data provided by
				any entity in accordance with this chapter that is not subject to public
				disclosure.
"Conflict of interest"
means an association,
				  including a financial or personal association, that has the potential to bias
				  or appear to bias an individual's decisions in board matters or
				  activities.
"Data recipient"
means an individual or entity
				  authorized to receive data under chapter 70.405 RCW.
"Drug"
means a substance:
(a) Recognized as drugs in the official
				United States Pharmacopeia, official Homeopathic Pharmacopoeia of the United
				States, or official national formulary, or any supplement to any of
				them;
(b) Intended for use in the
				diagnosis, cure, mitigation, treatment, or prevention of disease in human
				beings;
(c) Other than food,
				minerals, or vitamins intended to affect the structure of any function of the
				body of human beings; and
(d)
				Intended for use as a component of any article specified in (a), (b), or (c) of
				this definition.
"Excess costs"
means costs of appropriate
				  utilization of a prescription drug that exceed the therapeutic benefit relative
				  to other alternative treatments; or, costs of appropriate utilization of a
				  prescription drug that are not sustainable to public and private health care
				  systems over a 10-year time frame.
"Generic drug"
has the same meaning as in
				  RCW
				  69.48.020.
"Health carrier"
or
"carrier"
has
				  the same meaning as in
				  RCW
				  48.43.005.
"Legend drug"
means brand drug, generic drug, or
				  biological product which is required by state law or regulation of the pharmacy
				  quality assurance commission to be dispensed on prescription only or are
				  restricted to use by practitioners only.
"Manufacturer"
means a person, corporation, or
				  other entity engaged in the manufacture of prescription drugs sold in or into
				  Washington state. "Manufacturer" does not include a private label distributor
				  or retail pharmacy that sells a drug under the retail pharmacy's store, or a
				  prescription drug repackager.
"Out-of-pocket costs"
means the amount of money
				  the patient, another person on behalf of the patient, or entity on behalf of
				  the patient paid to the pharmacy each time a prescription is filled, excluding
				  the amount paid by insurance. Out-of-pocket costs include deductibles,
				  coinsurance, and copayments for covered drugs plus all costs for drugs that are
				  not covered.
"Prescription drug"
means a drug regulated under
				  chapter 69.41 or 69.50 RCW, including generic drugs, brand name drugs,
				  specialty drugs, and biological products.
"Publicly available"
means information that is
				  available to the general public, whether through internet search, Freedom of
				  Information Act request or similar request, or through purchase or
				  subscription, and includes information submitted to or reviewed by the Food and
				  Drug Administration, information contained in financial statements, and
				  information published or otherwise made available through drug information
				  resources. "Publicly available" does not include trade secrets as defined by
				  RCW
				  19.108.010 and information protected by
				  copyright law. Publicly available information includes:
(a) Drug name;
(b) Drug class;
(c) Price and pricing;
(d) Course of treatment;
(e) Manufacturer name;
(f) Price increase over time;
(g) Competitors; and
(h) Competitor price and pricing.
"Rebate"
means negotiated price concessions,
				  discounts, however characterized, that accrue directly or indirectly to an
				  entity in connection with utilization of prescription drugs including, but not
				  limited to, rebates, administrative fees, market share rebates, price
				  protection rebates, performance-based price concessions, volume-related
				  rebates, other credits, and any other negotiated price concessions or discounts
				  that are reasonably anticipated to be passed through to an entity during a
				  coverage year, and any other form of price concession prearranged with a
				  manufacturer, dispensing pharmacy, pharmacy benefit manager, rebate aggregator,
				  group purchasing organization, or other party which are paid to an entity and
				  are directly attributable to the utilization of certain drugs.
"Therapeutic alternative"
means a drug product
				  that may contain a different chemical or biological structure than the drug
				  prescribed and can be expected to have a similar therapeutic effect and adverse
				  reaction profile when administered to individuals in a therapeutically
				  equivalent dose.
"Therapeutic equivalent"
means a drug product of
				  the identical base or salt as the specific drug product prescribed with
				  essentially the same efficacy and toxicity when administered to an individual
				  in the same dosage regimen.