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1
DEPARTMENT OF REGULATORY AGENCIES
Division of Insurance
PRESCRIPTION DRUG AFFORDABILITY BOARD
3 CCR 702-9
[Editor’s Notes follow the text of the rules at the end of this CCR Document.]
_________________________________________________________________________
Part 1 GENERAL PROVISIONS
1.1
Definitions
A.
Authority
The statutory authority for this rule includes but is not limited to section 10-16-1403(5), C.R.S.
B.
Scope and Purpose
The purpose of this rule is to provide necessary definitions of terms used throughout the rules.
C.
Definitions
“Advisory Council” has the same meaning set forth in section 10-16-1401(1), C.R.S.
“Affordability Review” means a review of a as prescription drug performed by the Board pursuant to
section 10-16-1406(3)-(7), C.R.S., to determine whether use of the prescription drug consistent with the
labeling approved for prescription drug by the FDA or with standard medical practice is unaffordable for
Colorado consumers.
“All-Payer Health Claims Database” or “APCD” has the same meaning as set forth in section 10-16-
1401(3), C.R.S.
“Authorized Generic Drug” has the same meaning as set forth in section 10-16-1401(4), C.R.S.
“Average Sales Price” has the same meaning as set forth in section 42 U.S.C. § 1395w-3a(c).
“Biological Product” has the same meaning as set forth in section 10-16-1401(5), C.R.S.
“Biosimilar Drug” has the same meaning as set forth in section 10-16-1401(6), C.R.S.
“Board” has the same meaning as set forth in section 10-16-1401(7), C.R.S.
“Board Activity” has the same meaning as set forth in section 10-16-1401(7.5), C.R.S.
“Board Staff” means any individual employed by the Division of Insurance providing support to and/or
doing work on behalf of the Board.
“Brand-name Drug” has the same meaning as set forth in section 10-16-1401(8), C.R.S.
“Carrier” has the same meaning as set forth in section 10-16-102(8), C.R.S.
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Secretary of State
State of Colorado
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dividual employed by the Division of Insurance providing support to and/or
doing work on behalf of the Board.
“Brand-name Drug” has the same meaning as set forth in section 10-16-1401(8), C.R.S.
“Carrier” has the same meaning as set forth in section 10-16-102(8), C.R.S.
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Secretary of State
State of Colorado
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“Days” means calendar days.
“Division” or “Division of Insurance” means the Colorado Division of Insurance or any successor entity.
“FDA” has the same meaning as set forth in section 10-16-102(27.5), C.R.S.
“Generic Drug” has the same meaning as set forth in section 10-16-1401(12), C.R.S.
“HCPF” means the Colorado Department of Health Care, Policy & Financing or any successor entity.
“Health Benefit Plan” has the same meaning as set forth in section 10-16-102(32), C.R.S.
“Initial WAC” means the earliest listed WAC for a prescription drug.
“Manufacturer” has the same meaning as set forth in section 10-16-1401(16), C.R.S.
“Medicare Maximum Fair Price” has the same meaning as determined by section 42 U.S.C. § 1320f(c)(3).
“National Drug Code” or “NDC” means the numeric code associated with a finished drug product or
unfinished drug that identifies its labeler, product, and package size and type.
“Off-label usage” means the use of a prescription drug for a disease or medical condition that is outside
the FDA-approved indication(s).
“Optional Participating Plan” has the same meaning as set forth in section 10-16-1401(17), C.R.S.
“Out-of-Pocket Costs” means the amount a covered person is required to pay in the form of cost-sharing
for covered benefits in a plan year, including deductibles, coinsurance, and copayments.
“Person” includes an individual, limited liability company, partnership, corporation, association, county,
and public or private organization of any character other than an agency.
“Pharmacist” has the same meaning as set forth in section 12-280-103(35), C.R.S
son is required to pay in the form of cost-sharing
for covered benefits in a plan year, including deductibles, coinsurance, and copayments.
“Person” includes an individual, limited liability company, partnership, corporation, association, county,
and public or private organization of any character other than an agency.
“Pharmacist” has the same meaning as set forth in section 12-280-103(35), C.R.S.
“Pharmacy Benefit Management Firm” or “PBM” has the same meaning as set forth in section 10-16-
102(49), C.R.S.
“Plan ID” means the unique health benefit plan identifier, including number and/or name, and, as
applicable, the plan identification number used for Centers for Medicare and Medicaid Services’ Health
Insurance and Oversight System
“Plan Year” means a consecutive 12 month period during which a health plan provides coverage for
health benefits. A plan year may be a calendar year or otherwise.
“Prescription Drug” has the same meaning as set forth in section 10-16-1401(19), C.R.S.
“Pricing Information” has the same meaning as set forth in section 10-16-1401(20), C.R.S
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“Priority Populations” means people experiencing homelessness; people involved with the criminal justice
system; black people, indigenous people, and people of color; American Indians and Alaska natives;
veterans; people who are lesbian, gay, bisexual, transgender, queer, or questioning; people of
disproportionately affected sexual orientations, gender identities, or sex assigned at birth; people who
have AIDS or HIV; older adults; children and families; and people with disabilities, including people who
are deaf and hard of hearing, people who are blind and deafblind, people with brain injuries, people with
intellectual and developmental disabilities, people with other co-occurring disabilities; and other
populations as deemed appropriate by the Prescription Drug Affordability Board.
“Provider” has the same meaning as set forth in section 10-16-102(56), C.R.S
th disabilities, including people who
are deaf and hard of hearing, people who are blind and deafblind, people with brain injuries, people with
intellectual and developmental disabilities, people with other co-occurring disabilities; and other
populations as deemed appropriate by the Prescription Drug Affordability Board.
“Provider” has the same meaning as set forth in section 10-16-102(56), C.R.S.
“State Entity” has the same meaning as set forth in section 10-16-1401(22), C.R.S.
“Therapeutic Alternative” means a drug product that contains a different therapeutic agent than the drug
in question, but is the same pharmacological or therapeutic class and has been shown through peer-
reviewed studies to have similar therapeutic effects, safety profile, and expected outcome when
administered to patients in a therapeutically equivalent dose or has been recommended as consistent
with standard medical practice by medical professional association guidelines.
“Therapeutically Equivalent” means approved drug products that are pharmaceutical equivalents for
which bioequivalence has been demonstrated, and that can be expected to have the same clinical effect
and safety profile when administered to patients under the conditions specified in the labeling.
“Upper Payment Limit” has the same meaning as set forth in section 10-16-1401(23), C.R.S.
“Wholesale Acquisition Cost” (“WAC”) has the same meaning as set forth in section 10-16-1401(24),
C.R.S.
“Wholesaler” has the same meaning as set forth in section 12-280-103(55), C.R.S.
1.2
Severability
A.
Authority
The statutory authority for this rule is section 10-16-1403(5), C.R.S.
B.
Scope and Purpose
The purpose of this rule is to clarify the severability of these rules.
C.
Severability
If any portion of these rules is found to be invalid, the remaining portion of the rules shall remain
in force and effect.
1.3
Declaratory Orders
A.
Authority
The statutory authority for this rule includes but is not limited to section 10-16-1403(5), C.R.S., and
section 24-4-105(11), C.R.S.
B.
Scope and Purpose
The purpose of this rule is to clarify the severability of these rules.
C.
Severability
If any portion of these rules is found to be invalid, the remaining portion of the rules shall remain
in force and effect.
1.3
Declaratory Orders
A.
Authority
The statutory authority for this rule includes but is not limited to section 10-16-1403(5), C.R.S., and
section 24-4-105(11), C.R.S.
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B.
Scope and Purpose
The purpose of this rule is to set forth the declaratory order procedures as required by section 24-4-
105(11), C.R.S.
C.
Declaratory Orders
1.
Who May Request a Petition for Declaratory Order: Any person as defined in section 24-4-
102(12), C.R.S., may request the Board to issue a declaratory order to terminate controversies or
to remove uncertainties concerning any provision of the Prescription Drug Affordability Act, or any
regulation of the Board.
2.
Board Response: The Board will determine, in its sound discretion, whether to rule upon the
submitted petition. If the Board determines not to rule on the petition, the Board shall issue a
written order disposing of the submitted petition, including the reasons for such action. A copy of
the order will be provided to the petitioner.
3.
Ruling on a Petition for Declaratory Order: In determining whether to rule upon a petition filed
pursuant to this rule, the Board may consider the following:
a.
Whether a ruling on the petition will terminate a controversy or remove uncertainties as to
the applicability of any statutory provision, rule, or order of the Board to the petitioner;
b.
Whether the petition involves any subject, question, or issue which is the subject of a
formal or informal matter or investigation currently pending before the Board, or a court,
involving one or more of the petitioners, and which will terminate the controversy or
remove the uncertainties as to the applicability or any statutory provision, rule, or order of
the Board to the petitioner;
c
ioner;
b.
Whether the petition involves any subject, question, or issue which is the subject of a
formal or informal matter or investigation currently pending before the Board, or a court,
involving one or more of the petitioners, and which will terminate the controversy or
remove the uncertainties as to the applicability or any statutory provision, rule, or order of
the Board to the petitioner;
c.
Whether the petition involves any subject, question, or issue which is at-issue in an
Affordability Review or Upper Payment Limit currently being conducted by the Board, but
does not involve the petitioner, and which will terminate the controversy or remove the
uncertainties as to the applicability of any statutory provision, rule, or order of the Board
to the petitioner;
d.
Whether the petition seeks a ruling on a moot or hypothetical question, or will result in an
advisory ruling or opinion;
e.
Whether the petitioner has other adequate legal remedies, other than an action for
declaratory relief pursuant to Rule 57, Colorado Rules of Civil Procedure, which will
terminate the controversy or remove any uncertainty as to the applicability of the statute,
rule, or order in question to the petitioner; and
f.
Any response to the petition filed by Board Staff. Such response must be filed by the
Board Staff within 14 days of the filing of the Petition.
4.
Petition for a Declaratory Order: Any petition or request to intervene filed pursuant to this rule
shall include the following:
a.
The name and address of the petitioner;
b.
The statute, rule, or order to which the petition relates; and
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ff. Such response must be filed by the
Board Staff within 14 days of the filing of the Petition.
4.
Petition for a Declaratory Order: Any petition or request to intervene filed pursuant to this rule
shall include the following:
a.
The name and address of the petitioner;
b.
The statute, rule, or order to which the petition relates; and
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c.
A concise statement of all of the facts necessary to show the nature of the controversy or
uncertainty and the manner in which the statute, rule, or order in question applies or
potentially applies to the petitioner.
5.
Ruling on a Petition: If the Board determines that it will rule on a submitted petition and any
response filed by the Board Staff, the following procedures shall apply:
a.
The Board may rule solely on the petition and any response filed by the Board Staff. In
such a case:
i.
Any ruling of the Board will apply only to the extent of the facts and issues
presented in the petition and the Board Staff’s response to the petition;
ii.
The Board may order the petitioner and the Board Staff to submit additional facts,
file written briefs, memorandums, or statements of position;
iii.
The Board may dispose of the petition on the sole basis of the matters set forth in
the petition and the Board Staff’s response;
iv.
The Board may take notice of facts pursuant to section 24-4-105(8), C.R.S., and
may utilize its experience, technical competence, and specialized knowledge in
the disposition of the petition; and
v.
If the Board rules on the petition without a hearing, the Board shall promptly
notify the petitioner and the Board Staff of the decision.
b.
The Board may, in its discretion, set a hearing, after appropriate notice, for the purpose of
obtaining additional facts or information, to determine the truth of any facts set forth in the
petition, or to hear oral argument on the petition. The notice of the hearing may include
the factual or other matters to be addressed at the hearing
otify the petitioner and the Board Staff of the decision.
b.
The Board may, in its discretion, set a hearing, after appropriate notice, for the purpose of
obtaining additional facts or information, to determine the truth of any facts set forth in the
petition, or to hear oral argument on the petition. The notice of the hearing may include
the factual or other matters to be addressed at the hearing. At the hearing, to the extent
necessary, the petitioner shall have the burden of proving all of the facts stated in the
petition, all of the facts necessary to show the nature of the controversy, or uncertainty,
the manner in which the statute, rule or order in question applies or potentially applies to
the petitioner, and shall include any other facts the petitioner desires the Board to
consider.
6.
Parties: The parties to any proceeding pursuant to this rule shall be the Board Staff and the
petitioner. Any other person may request permission to intervene in the proceeding, and leave to
intervene will be granted at the sole discretion of the Board. A petition to intervene shall be
submitted in accordance with Section C(4) of this rule within 14 days of the filing of the petition for
the declaratory order. Any reference to a “petitioner” in this rule also refers to any person who has
been granted leave to intervene in a proceeding by the Board.
7.
Final Agency Order: Any declaratory order or other order disposing of a petition pursuant to this
rule shall constitute a final agency order subject to judicial review pursuant to section 24-4-106,
C.R.S.
8.
Public Inspection: Files of all petitions and declaratory orders will be maintained by the Board.
Except with respect to any material required by law to be kept confidential, such files shall be
available for public inspection.
9.
Posted on Website: The Board shall post a copy of all statements of position and all declaratory
orders on the Board’s website.
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es of all petitions and declaratory orders will be maintained by the Board.
Except with respect to any material required by law to be kept confidential, such files shall be
available for public inspection.
9.
Posted on Website: The Board shall post a copy of all statements of position and all declaratory
orders on the Board’s website.
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Part 2 REPEALED
Part 3 AFFORDABILITY REVIEWS OF PRESCRIPTION DRUGS
3.1
Affordability Reviews of Eligible Prescription Drugs
A.
Authority
The statutory authority for this part 3 is sections 10-16-1403(5) and 10-16-1406, C.R.S.
B.
Scope and Purpose
The purpose of this part 3 is to establish a methodology and process for the Board to annually identify
and select prescription drugs eligible for affordability review and conduct affordability reviews of
prescription drugs to determine whether use of the prescription drug consistent with the labeling approved
for the prescription drug by the FDA or with standard medical practice is unaffordable for Colorado
consumers pursuant to section 10-16-1406(3), C.R.S.
C.
Identifying Prescription Drugs for Affordability Reviews
1.
The Board will adopt the list of prescription drugs eligible for an affordability review prior to
consideration of which prescription drug(s) to select for an affordability review. The Board will
identify eligible prescription drugs in accordance with the statutory criteria set forth in section 10-
16-1406(1), C.R.S.
2.
Prescription drugs that meet the following requirements qualify for an affordability review.
a.
Any prescription drug that, has:
i.
A wholesale acquisition cost of three thousand dollars or more
ii..
An increase of three hundred dollars or more above the wholesale acquisition
cost for the prescription drug in the preceding twelve months;
iii.
An increase of two hundred percent or more above the wholesale acquisition
cost for the prescription drug in the preceding twelve months; or
iv
iew.
a.
Any prescription drug that, has:
i.
A wholesale acquisition cost of three thousand dollars or more
ii..
An increase of three hundred dollars or more above the wholesale acquisition
cost for the prescription drug in the preceding twelve months;
iii.
An increase of two hundred percent or more above the wholesale acquisition
cost for the prescription drug in the preceding twelve months; or
iv.
A current wholesale acquisition cost for an average course of treatment per
person per year of thirty thousand dollars or more; and
b.
Any biosimilar drug that has an initial wholesale acquisition cost that is not at least fifteen
percent lower than the wholesale acquisition cost of the corresponding biological product.
D.
Selecting Prescription Drugs for Affordability Reviews
After identifying prescription drugs as described in Section C above, the Board will determine whether to
conduct an affordability review for an identified prescription drug by considering the following:
1.
Class of the Prescription Drug and Therapeutic Equivalents:
a.
Determine the date of FDA approval of the eligible prescription drug and whether the
prescription drug was approved through an expedited pathway.
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b.
For brand-name drugs and biological products, the Board will determine the class and
whether there are any approved and marketed generic drugs or biosimilar drugs for the
specific brand-name drug or biological product.
c.
Where there are therapeutic equivalents, the Board may consider for each equivalent the
cost and availability by considering utilization data and spending data.
2.
Aggregated Data:
a.
Historical and current pricing data, including wholesale acquisition cost and average
sales price of the prescription drug;
b.
Expenditures associated with the prescription drug, including expenditures identified in
APCD data, including data collected pursuant to 10-16-1405, C.R.S.;
c
ach equivalent the
cost and availability by considering utilization data and spending data.
2.
Aggregated Data:
a.
Historical and current pricing data, including wholesale acquisition cost and average
sales price of the prescription drug;
b.
Expenditures associated with the prescription drug, including expenditures identified in
APCD data, including data collected pursuant to 10-16-1405, C.R.S.;
c.
Utilization associated with the prescription drug, including utilization identified in APCD
data;
d.
Health equity impact, including whether the prescription drug is utilized to treat a
condition disproportionately experienced by priority populations; and
e.
Information regarding the estimated manufacturer net-cost and net-sales amounts for
eligible prescription drugs.
3.
Average Patient’s Out-Of-Pocket Cost: Consideration of the average patient’s out-of-pocket cost
for the prescription drug, which may include copayment amounts, cost-sharing amounts,
coinsurance amounts, and other information relevant to out-of-pocket costs.
4.
Input from Advisory Council:
a.
To the extent practicable, information regarding therapeutic alternatives, aggregated
data, and the average patient’s out-of-pocket cost will be presented to the Advisory
Council.
b.
The Board will seek input from the Advisory Council regarding which prescription drugs
the Advisory Council recommends for the Board to select for an affordability review.
i.
The Board may request the Advisory Council provide specific information, data,
or its positions concerning a particular prescription drug.
ii.
The Advisory Council will provide input in a form and manner determined by the
Advisory Council.
c.
The Board will consider input provided to it by the Advisory Council before selecting
drugs for an affordability review.
5.
Input Regarding Orphan Drug Designation: Consideration of whether the prescription drug has an
approved orphan drug designation for one or more rare diseases and no other indications
visory Council will provide input in a form and manner determined by the
Advisory Council.
c.
The Board will consider input provided to it by the Advisory Council before selecting
drugs for an affordability review.
5.
Input Regarding Orphan Drug Designation: Consideration of whether the prescription drug has an
approved orphan drug designation for one or more rare diseases and no other indications. If the
prescription drug has an approved orphan drug designation for one or more rare diseases and no
other indications, then the Board will consider input from consumers and the Colorado Rare
Disease Advisory Council created in section 25-1-1503, C.R.S.
6.
The Board may use information from D.1-D.5 to prioritize affordability goals in the selection of
prescription drugs for an affordability review.
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E.
Conducting an Affordability Review
After selecting an eligible prescription drug from the list adopted under D, the Board will conduct an
affordability review to determine whether use of the prescription drug consistent with the labeling
approved for the prescription drug by the FDA or with standard medical practices is unaffordable for
Colorado consumers. The Board will conduct an affordability review by considering, to the extent
practicable, all of the factors set forth in section 10-16-1406(4), C.R.S., as discussed in this section E.,
including the additional factors created by the Board and set forth in section E.2.j. Finally, the Board may
consider the factors set forth in section 10-16-1406(6), C.R.S., as discussed in section E.3.
1.
To the extent the information submitted to the Board contains confidential information, the Board
will consider such information in executive session and will not disclose the information publicly
pursuant to section 10-16-1404(3), C.R.S.
2.
In accordance with section 10-16-1406(4), C.R.S., in conducting an affordability review, to the
extent practicable, the Board shall consider:
a
ection E.3.
1.
To the extent the information submitted to the Board contains confidential information, the Board
will consider such information in executive session and will not disclose the information publicly
pursuant to section 10-16-1404(3), C.R.S.
2.
In accordance with section 10-16-1406(4), C.R.S., in conducting an affordability review, to the
extent practicable, the Board shall consider:
a.
Wholesale Acquisition Cost: The Board will consider both the current wholesale
acquisition cost of the prescription drug and changes in the prescription drug’s wholesale
acquisition cost over time.
b.
Therapeutic Alternatives: The Board will consider the cost and availability of therapeutic
alternatives to the prescription drug in the state. The Board may review any relevant data
regarding costs and expenditures related to the prescription drug and its therapeutic
alternatives, as well as any relevant data regarding availability and utilization related to
the prescription drug and its therapeutic alternatives.
c.
Price Effect on Colorado Consumer Access: The Board will consider the effect of price on
Colorado consumers’ access to the prescription drug by reviewing changes in pricing,
expenditure, and utilization over time. To the extent the data is available, the Board may
consider the impact of the drug’s price on insurance premiums and out-of-pocket costs,
the impacts of formulary placement on access, and the extent to which rebates are
shared with patients purchasing the drug.
d.
Relative Financial Effects of the Prescription Drug on Health, Medical, or Social Services
Costs:
i.
To the extent such information can be quantified, the Board may consider the
relative financial effects of the prescription drug on broader health, medical,
and/or social services costs, compared with therapeutic alternatives and/or no
treatment. This may include considering results from external analyses and
modeling studies, or impacts on premiums, state expenditures on the drug or
disease, and other broader system financial impacts.
ii
tified, the Board may consider the
relative financial effects of the prescription drug on broader health, medical,
and/or social services costs, compared with therapeutic alternatives and/or no
treatment. This may include considering results from external analyses and
modeling studies, or impacts on premiums, state expenditures on the drug or
disease, and other broader system financial impacts.
ii.
The Board may identify if the literature uses a quality-adjusted life-year analysis
or a similar measure that discounts the value of a life because of an individual’s
disability or age. The Board may use information that uses a quality-adjusted life
year analysis to evaluate relative financial effects, but will not use quality
adjusted life year analysis to determine an upper payment limit or other
appropriate costs of a prescription drug. If quality-adjusted life year analysis is
used during affordability review, the Board will acknowledge any health equity
impacts to priority populations.
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e.
Patient Copayment or Other Cost Sharing: The Board will consider the copayment and
other cost sharing data, across different health benefit plan designs, to the degree such
information is available in the APCD, including:
i.
Copayment;
ii.
Coinsurance;
iii.
Deductible;
iv.
Formulary placement; and/or
v.
Any other copayment and cost sharing data.
f.
Impact on Safety Net Providers: When the prescription drug is available through Section
340B of the Federal “Public Health Service Act”, Pub.L. 78-410, the Board will evaluate:
i.
The utilization of the prescription drug by the safety net provider’s patients;
ii.
Whether the safety net provider receives a 340B discount for the prescription
drug;
iii.
Where the safety net provider does not receive a discount, whether access to the
prescription drug is impeded; and
iv.
Any other topics identified by safety net provider stakeholders for discussion.
g.
Orphan Drug Status: The Board will consider:
i
e prescription drug by the safety net provider’s patients;
ii.
Whether the safety net provider receives a 340B discount for the prescription
drug;
iii.
Where the safety net provider does not receive a discount, whether access to the
prescription drug is impeded; and
iv.
Any other topics identified by safety net provider stakeholders for discussion.
g.
Orphan Drug Status: The Board will consider:
i.
The Board will identify whether the prescription drug is an orphan drug, as
designated by the FDA pursuant to the Orphan Drug Act (Pub.L. 97-414).
ii.
The Board may further consider:
(1)
The use of the prescription drug for indications with an orphan drug
designation as compared to the use of the prescription drug for other
indications; and/or
(2)
The extent to which the drug addresses an unmet need or treats a rare
or serious disease for which limited therapeutic alternatives are
available.
h.
Input from Specified Stakeholders:
i.
Patients and Caregivers
(1)
The Board will seek input from patients and caregivers affected by a
condition or disease that is treated by the prescription drug by gathering
information related to:
(a)
The impact of the disease,
(b)
Patient treatment preferences,
(c)
The availability of therapeutic alternatives,
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(d)
Patient perspective on the benefits and disadvantages of using
the prescription drug,
(e)
Caregiver perspective on the benefits and disadvantages of
using the prescription drug, and/or
ing
information related to:
(a)
The impact of the disease,
(b)
Patient treatment preferences,
(c)
The availability of therapeutic alternatives,
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(d)
Patient perspective on the benefits and disadvantages of using
the prescription drug,
(e)
Caregiver perspective on the benefits and disadvantages of
using the prescription drug, and/or
(f)
Entities providing patient assistance in purchasing the
prescription drug.
(2)
In seeking additional information, the Board will attempt to gather a
diversity of experience among patients from different socioeconomic
backgrounds.
(3)
The information gathered from patients and caregivers pursuant to this
section will include on-label usage, off-label usage, or usage during a
clinical trial.
ii.
Individuals with Scientific or Medical Training: The Board will seek input from
individuals who possess scientific or medical training with respect to a condition
or disease treated by the prescription drug that is under review by the Board,
including:
(1)
The impact of the disease,
(2)
The availability of therapeutic alternatives,
(3)
Perspectives on benefits and disadvantages of the prescription drug,
including comparisons with therapeutic alternatives if any exist, and/or
(4)
Input regarding the prescription drug utilization in standard medical
practice, as well as input regarding off label usage and usage during a
clinical trial.
iii.
The Rare Disease Advisory Council: The Board will seek input from the Rare
Disease Advisory Council with respect to a rare condition or disease treated by
the prescription drug that is under review by the Board, including:
(1)
The impact of the disease,
(2)
Perspectives on benefits and disadvantages of the prescription drug, and
(3)
Findings and recommendations concerning the needs of individuals with
a rare disease living in Colorado who are affected by the prescription
drug.
e Advisory Council with respect to a rare condition or disease treated by
the prescription drug that is under review by the Board, including:
(1)
The impact of the disease,
(2)
Perspectives on benefits and disadvantages of the prescription drug, and
(3)
Findings and recommendations concerning the needs of individuals with
a rare disease living in Colorado who are affected by the prescription
drug.
(4)
The Rare Disease Advisory Council may provide the Board with
connections to individuals with scientific and medical training who are
knowledgeable with regard to the rare condition being treated by the
prescription drug under review.
i.
Information Voluntarily Submitted from a Manufacturer, Carrier, Pharmacy Benefit
Management Firm, or Other Entity:
i.
The Board will consider information voluntarily provided by a manufacturer,
carrier, pharmacy benefit management firm, or other entity.
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ii.
Manufacturers, carriers, pharmacy benefit management firms, or other entities
shall have 90 days from the commencement of the affordability review to provide
such information to the Board for its consideration.
j.
Additional Factors, including:
i.
Rebates, Discounts, and Price Concessions: To the extent practicable, the Board
may consider estimated manufacturer net-sales or net-cost amounts (including
rebates, discounts, and price concessions) for the prescription drug and
therapeutic alternatives; and
ii.
Health Equity Factors: The Board will consider whether the pricing of the
prescription drug results in or has contributed to health inequities in priority
populations.
iii.
Information from the Department of Health Care Policy and Financing:
(1)
Additional analyses HCPF conducts relevant to the prescription drug or
therapeutic alternative under review; and/or
and
therapeutic alternatives; and
ii.
Health Equity Factors: The Board will consider whether the pricing of the
prescription drug results in or has contributed to health inequities in priority
populations.
iii.
Information from the Department of Health Care Policy and Financing:
(1)
Additional analyses HCPF conducts relevant to the prescription drug or
therapeutic alternative under review; and/or
(2)
Information regarding safety net providers participating in the 340B,
including information to assist with gathering input to assess the impact
to safety net providers for a prescription drug under review that is
available through Section 340B of the Federal “Public Health Service
Act”, Pub.L. 78-410.
iv.
Non-adherence and Utilization Management Information: The Board may use
information regarding non-adherence to the prescription drug, as well as
information related to utilization management restrictions and prior authorization
requirements placed on the prescription drug.
v.
Patient Assistance Program Information: The Board may use information
regarding eligibility criteria for and the utilization of patient assistance programs.
3.
Pricing Information
a.
The Board may also consider documents and information relating to the manufacturer’s
selection of the introductory price or price increase of the prescription drug including
information related to:
i.
Life-cycle management;
ii.
Average cost of the prescription drug in Colorado;
iii.
Market competition;
iv.
Projected revenue;
v.
Estimated cost-effectiveness of the prescription drug; and/or
vi.
Off-label usage of the prescription drug.
b.
Pursuant to section 10-16-1406(7)(a), C.R.S., to the extent practicable, the Board may
access pricing information for prescription drugs by:
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he prescription drug in Colorado;
iii.
Market competition;
iv.
Projected revenue;
v.
Estimated cost-effectiveness of the prescription drug; and/or
vi.
Off-label usage of the prescription drug.
b.
Pursuant to section 10-16-1406(7)(a), C.R.S., to the extent practicable, the Board may
access pricing information for prescription drugs by:
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i.
Accessing publicly available pricing information from a state to which
manufacturers report pricing information;
ii.
Accessing available pricing information from the APCD and from state entities;
and/or
iii.
Accessing information that is available from other countries.
4.
Pursuant to section 10-16-1406(7)(b), C.R.S., to the extent that there is no publicly available
information with which to conduct an affordability review, the Board may request that a
manufacturer, carrier, or pharmacy benefit management firm provide pricing information for any
prescription drug eligible for an affordability review.
a.
Such interested parties shall have 30 days from the date of the request of a prescription
drug for affordability review to provide such information to the Board for its consideration.
b.
Failure of an entity to provide pricing information to the Board for an affordability review
does not affect the authority of the Board to conduct the affordability review, as described
in this section.
5.
Determination of Unaffordable: After consideration of the factors set forth in section E.2. and
Section E.3., pricing information pursuant to section 10-16-1406(7)(a), C.R.S., and pricing
information collected and received from manufacturers, carriers, and pharmacy benefit
management firms pursuant to section 10-16-1406(7)(b), C.R.S., the Board shall determine
whether the use of the prescription drug consistent with the labeling approved for the drug by the
FDA or with standard medical practice is unaffordable for Colorado consumers
to section 10-16-1406(7)(a), C.R.S., and pricing
information collected and received from manufacturers, carriers, and pharmacy benefit
management firms pursuant to section 10-16-1406(7)(b), C.R.S., the Board shall determine
whether the use of the prescription drug consistent with the labeling approved for the drug by the
FDA or with standard medical practice is unaffordable for Colorado consumers. In reaching such
a determination, the Board may consider whether the drug is unaffordable for:
a.
Colorado consumers using the prescription drug;
b.
Colorado consumers with diseases or conditions that the prescription drug is approved to
treat;
c.
Colorado consumers whose taxes fund health care costs for public employees, including
employees of the state, county, and local governments, school districts, and institutions
of higher education, and to public retirees whose health care costs are funded by public
programs; and
d.
Colorado consumers accessing the health care system in Colorado whose health care
costs and health insurance premiums may be impacted by the cost of the prescription
drug in the state.
6.
Summary Report of Affordability Review: The Board will issue a report summarizing information
considered by the Board in conducting the affordability review and reaching its determination as
to whether a prescription drug is unaffordable. All reports adopted by the Board will be made
public on the Board’s website.
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rug in the state.
6.
Summary Report of Affordability Review: The Board will issue a report summarizing information
considered by the Board in conducting the affordability review and reaching its determination as
to whether a prescription drug is unaffordable. All reports adopted by the Board will be made
public on the Board’s website.
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7.
Confidentiality: A person submitting information for the Board’s consideration pursuant to this Part
3 shall clearly designate the specific information it deems to be confidential, trade-secret or
proprietary. The Board may also determine that information submitted to it is confidential, trade
secret, or proprietary. The Board may seek additional information regarding whether the
information is confidential, trade-secret, or proprietary from the person submitting the information
or, to the extent the Board is able to determine who created the document or information, the
person who created the document or information. The Board will not disclose confidential, trade
secret, or proprietary information in an open meeting, its public meeting materials, or its summary
report. To the extent the information submitted to the Board contains confidential information, the
Board will consider such information in executive session and will not disclose the information
publicly pursuant to sections 10-16-1404(3), or to others except as provided by section 10-16-
1406(5), C.R.S.
Part 4 UPPER PAYMENT LIMITS
4.1
Upper Payment Limit Methodology
A.
Authority
The statutory authority for this part 4.1 is sections 10-16-1407, 10-16-1412(2), and 10-16-1403(5), C.R.S.
B.
Scope and Purpose
The purpose of this part 4.1 is to establish the methodology required pursuant to section 10-16-1407,
C.R.S., for the Board to establish upper payment limits for prescription drugs it has determined to be
unaffordable pursuant to section 10-16-1406, C.R.S., and part 3 of these rules.
C.
Methodology to Establish Upper Payment Limits
1
7, 10-16-1412(2), and 10-16-1403(5), C.R.S.
B.
Scope and Purpose
The purpose of this part 4.1 is to establish the methodology required pursuant to section 10-16-1407,
C.R.S., for the Board to establish upper payment limits for prescription drugs it has determined to be
unaffordable pursuant to section 10-16-1406, C.R.S., and part 3 of these rules.
C.
Methodology to Establish Upper Payment Limits
1.
Number of Upper Payment Limits on Prescription Drugs: The Board may establish an upper
Payment limit for any prescription drug for which the Board has performed an affordability review
pursuant to section 10-16-1406, C.R.S., and part 3 of the Board's rules and determined that the
use of the prescription drug is unaffordable for Colorado consumers.
a.
The Board may not establish more than twelve upper payment limits each calendar year
from 2022 through 2024. If the Board finds a need to establish upper payment limits for
more than twelve prescription drugs in the 2023 and 2024 calendar years, the Board may
establish an additional six upper payment limits during that calendar year.
b.
Beginning in 2025, the Board may establish any number of upper payment limits.
2.
Upper Payment Limit Methodology: In establishing an upper payment limit, the Board shall review
the following factors to determine an upper payment limit for a prescription drug, in accordance
with section 10-16-1407(2)-(4), C.R.S.
a.
Prescription Drug Costs: To approximate prescription drug costs, the Board may consider
one or more price and cost metrics as an estimation of the cost of administering or
dispensing the prescription drug, the cost of distributing the prescription drug, and other
relevant costs. Price and cost metrics include but are not limited to:
i.
Wholesale Acquisition Cost,
ii.
Average Sales Price,
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rug costs, the Board may consider
one or more price and cost metrics as an estimation of the cost of administering or
dispensing the prescription drug, the cost of distributing the prescription drug, and other
relevant costs. Price and cost metrics include but are not limited to:
i.
Wholesale Acquisition Cost,
ii.
Average Sales Price,
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iii.
National Average Drug Acquisition Cost as reported by the Center for Medicare
and Medicaid Services,
iv.
Out-of-pocket amounts,
v.
Carrier paid amounts,
vi.
Retail discount amounts,
vii.
Public health care program fee schedules,
viii.
Estimates of manufacturer net-cost and net-sales amounts,
ix.
Medicare’s Maximum Fair Price, and
x.
Cost information voluntarily provided by a wholesaler, pharmacist, or provider.
b.
Drug Shortage List: The Board will consider the status of the prescription drug on the
Drug Shortage List published by the Drug Shortage Program within the Food and Drug
Administration and the American Society of Health System Pharmacists. The Board’s
consideration may include:
i.
Whether the prescription drug is listed on the Drug Shortage List on the day the
Board adopts an upper payment limit for the prescription drug, as well as whether
the prescription drug is subject to a resolved or discontinued shortage.
ii.
If the prescription drug is listed on the Drug Shortage List, the Board may
consider:
(1)
Availability and estimated shortage duration,
(2)
Shortage reason,
(3)
Therapeutic classification, and
(4)
Other related information.
c.
Impact to Older Adults and Persons with Disabilities: The upper payment limit
methodology must consider the impact of the upper payment limit methodology to older
adults and persons with disabilities and shall not place a lower value on their lives.
i.
Impact to Older Adults - the Board will consider the following metrics for
individuals 65 years and older: to the extent such information is readily available
in the APCD:
nd Persons with Disabilities: The upper payment limit
methodology must consider the impact of the upper payment limit methodology to older
adults and persons with disabilities and shall not place a lower value on their lives.
i.
Impact to Older Adults - the Board will consider the following metrics for
individuals 65 years and older: to the extent such information is readily available
in the APCD:
(1)
To the extent such information is available in the APCD:
(a)
Utilization of the prescription drug,
(b)
Cost of the prescription drug, and
(c)
Insurance coverage type for individuals utilizing the prescription
drug; and
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(2)
Qualitative or quantitative analyses and information submitted by
stakeholders with lived experience or expertise of the prescription drug’s
impact to older adults. The Board will not consider any analyses or
information submitted that utilizes a cost-per-QALY or similar measure
that discounts the value of life because of an individual’s disability or
age.
ii.
Impact to Persons with Disabilities: The Board will consider the following metrics
for persons with disabilities:
(1)
Therapeutic classification of the prescription drug, including the
prescription drug’s therapeutic purpose and any conditions or diseases
the prescription drug may treat,
(2)
To the extent it is known that any conditions or diseases the prescription
drug may treat are considered disabilities, or to the extent it is known the
drug treats a condition or disease causes disabilities, and to the extent
such information is available in the APCD, the Board may consider:
(a)
Utilization of the prescription drug,
(b)
Cost of the prescription drug, and
iption drug may treat,
(2)
To the extent it is known that any conditions or diseases the prescription
drug may treat are considered disabilities, or to the extent it is known the
drug treats a condition or disease causes disabilities, and to the extent
such information is available in the APCD, the Board may consider:
(a)
Utilization of the prescription drug,
(b)
Cost of the prescription drug, and
(c)
Insurance coverage type for individuals utilizing the prescription
drug; and
(3)
Qualitative or quantitative analyses and information submitted by
stakeholders with lived experience or expertise of the prescription drug’s
impact to persons with disabilities. The Board will not consider any
analyses or information submitted that utilizes a cost-per-QALY or similar
measure that discounts the value of life because of an individual’s
disability or age.
d.
Reasonable Pharmacy Fees: An upper payment limit established by the Board does not
preclude a pharmacist or pharmacy (as defined by section 12-280-103(43), C.R.S.)
licensed by the State Board of Pharmacy to charge reasonable fees, to be paid by the
providing health benefit plan of the consumer, for dispensing or delivering a prescription
drug for which the Board has established an upper payment limit.
e.
Research and Methods that Employ a Dollars-Per-Quality Adjusted Life Year (QALY):
The Board shall not consider research or methods that employ a dollars-per-QALY or
similar measure in estimating impact to older adults and persons with disabilities, or in
any other upper payment limit methodology considerations.
f.
Stakeholder Input: The Board shall receive stakeholder information submitted through an
upper payment limit rulemaking, containing information relevant to any of these
considerations that the Board may take into account in establishing an upper payment
limit.
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bilities, or in
any other upper payment limit methodology considerations.
f.
Stakeholder Input: The Board shall receive stakeholder information submitted through an
upper payment limit rulemaking, containing information relevant to any of these
considerations that the Board may take into account in establishing an upper payment
limit.
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D.
Process for Establishing Upper Payment Limits
1.
Process: The Board will establish upper payment limits through rulemaking, as required
by section 10-16-1406(1)(a)(II), C.R.S., and in compliance with section 24-4-103, C.R.S.
The Board will select drugs for which to establish an upper payment limit and initiate a
rulemaking for a rule establishing an upper payment limit for the prescription drug. An
upper payment limit may apply to multiple NDCs that are indicated for the prescription
drug.
a.
If the Board has determined a prescription drug to be unaffordable pursuant to
section 10-16-1406, C.R.S, the Board may choose to establish an upper
payment limit for that prescription drug. The Board will select drugs for which to
establish an upper payment limit and initiate a rulemaking for a rule establishing
an upper payment limit for the prescription drug.
b.
The Board may terminate a rulemaking to establish a specific upper payment
limit for a prescription drug.
2.
Consumer Notice: The Board’s initiation of a public rulemaking pursuant to section 24-4-
103, C.R.S., shall constitute notification to consumers of the Board’s decision to establish
an upper payment limit as required by section 10-16-1407(6), C.R.S.
3.
Effective Date: rules establishing upper payment limits promulgated by the Board will
identify an effective date for the upper payment limit as required by section 10-16-
1407(5), C.R.S.
4.
Unit: The Board will identify the unit to which the upper payment limit applies for the
prescription drug.
E.
Prescription Drug Availability Inquiries and Reporting
1.
Withdrawal Information from Manufacturers:
a
fective Date: rules establishing upper payment limits promulgated by the Board will
identify an effective date for the upper payment limit as required by section 10-16-
1407(5), C.R.S.
4.
Unit: The Board will identify the unit to which the upper payment limit applies for the
prescription drug.
E.
Prescription Drug Availability Inquiries and Reporting
1.
Withdrawal Information from Manufacturers:
a.
Inquiry process:
i.
For any upper payment limit established, the Board shall inquire of
manufacturers:
(1)
Whether the manufacturer is able to make the prescription drug
available for sale in the State of Colorado, and
(2)
The rationale for the manufacturer’s response.
ii.
Manufacturers shall have 30 days to respond.
b.
Notification to Consumers: If the Board receives notification that a manufacturer
intends to withdraw a prescription drug for which the Board has established an
upper payment limit from the sale or distribution within Colorado, the Board will
notify consumers within ten days, as required by section 10-16-1412(2), C.R.S.
2.
Reporting to the General Assembly: The Board shall submit the manufacturer’s inquiry
response annually to the Health and Human Services Committee of the Senate and the
Health and Insurance Committee of the House of Representatives, or to any successor
committees.
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F.
Confidentiality
A person submitting information for the Board’s consideration pursuant to this part 4 shall clearly
designate the specific information it deems to be confidential, trade secret or proprietary. The Board may
also determine that information submitted to it is confidential, trade secret, or proprietary. The Board will
not disclose confidential, trade-secret, or proprietary information in an open meeting or its public meeting
materials
the Board’s consideration pursuant to this part 4 shall clearly
designate the specific information it deems to be confidential, trade secret or proprietary. The Board may
also determine that information submitted to it is confidential, trade secret, or proprietary. The Board will
not disclose confidential, trade-secret, or proprietary information in an open meeting or its public meeting
materials. The Board may seek additional information regarding whether the information is confidential,
trade-secret, or proprietary from the person submitting the information or, to the extent the Board is able
to determine who created the document or information, the person who created the document or
information. To the extent the information submitted to the Board contains confidential information, the
Board will consider such information in executive session and will not disclose the information publicly
pursuant to sections 10-16-1404(3), and 10-16-1407(7), C.R.S.
4.2
Upper Payment Limit Methodology
A.
Authority
The statutory authority for this part 4.2 is sections 10-16-1407 and 10-16-1403(5), C.R.S.
B.
Scope and Purpose
The purpose of this part 4.2 is to establish the applicability of all upper payment limits for prescription
drugs set by the Board pursuant to section 10-16-1407, C.R.S. and part 4.1 of these rules.
C.
Applicability of Upper Payment Limits
1.
An upper payment limit established by the Board, plus any reasonable fees charged by the
pharmacy or pharmacist for dispensing or delivering a prescription drug, applies to a consumer’s
purchase from a pharmacy (as defined by section 12-280-103(43), C.R.S.) or provider of a
prescription drug that is dispensed or administered to the Colorado consumer in person, by mail,
or by other means
Limits
1.
An upper payment limit established by the Board, plus any reasonable fees charged by the
pharmacy or pharmacist for dispensing or delivering a prescription drug, applies to a consumer’s
purchase from a pharmacy (as defined by section 12-280-103(43), C.R.S.) or provider of a
prescription drug that is dispensed or administered to the Colorado consumer in person, by mail,
or by other means. If the Colorado consumer is insured, the consumer’s portion of the payment
together with the reimbursement to the pharmacy and provider by the carrier, state entity, or
optional participating plan should not exceed the upper payment limit plus any reasonable fees
charged by the pharmacy or pharmacist for dispensing or delivering a prescription drug.
2.
An upper payment limit established by the Board also applies to any pharmacy (as defined by
section 12-280-103(43), C.R.S.) or provider’s purchase of a prescription drug that is dispensed or
administered to a Colorado consumer in person, by mail, or by other means.
Part 5 REPORTING REQUIREMENTS FOR USE OF SAVINGS
5.1
Reporting Requirements for Use of Savings
A.
Authority
The statutory authority for this part 5 is sections 10-16-1410(3) and 10-16-1403(5), C.R.S.
B.
Scope and Purpose
The purpose of this part 5 is to establish a formula and process for carriers issuing health benefit plans to
calculate savings attributable to the establishment of an upper payment limit (UPL) by the Prescription
Drug Affordability Board (Board) and document their use of savings for the purposes of complying with
section 10-16-1410(1), C.R.S., and establish the process by which state entities and carriers that issue a
health benefit plan or optional participating plans shall submit reports to the Board describing savings
achieved during the preceding plan year pursuant to section 10-16-1410(2), C.R.S.
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savings for the purposes of complying with
section 10-16-1410(1), C.R.S., and establish the process by which state entities and carriers that issue a
health benefit plan or optional participating plans shall submit reports to the Board describing savings
achieved during the preceding plan year pursuant to section 10-16-1410(2), C.R.S.
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C.
Reporting Requirements for Savings Attributable to Upper Payment Limits
1.
On or before March 15, 2023 and each year after, each carrier, state entity, and optional
participating plan subject to the requirements of section 10-16-1410, C.R.S., shall submit
one report to the Board describing the savings achieved during the preceding plan year
for each prescription drug for which the Board has established a UPL. For carriers, this
report shall include the elements set forth in subsections C.2 and C.3. For state entities
and optional participating plans, the report shall include the elements set forth in section
C.3.
a.
If the Board has not established any upper payment limits, a carrier, state entity,
and optional participating plan is not required to submit a report.
b.
If the Board has established upper payment limits but a carrier, state entity, or
optional participating plan did not make any reimbursements for any of the
prescription drugs for which there is a UPL, then a carrier, state entity, or optional
participating plan shall not submit a report, but shall notify the Board that they did
not reimburse pursuant to a UPL.
2.
Carrier Use of Savings Formula
Carriers shall provide the Board with aggregated claims savings, cost-sharing savings,
and premium savings, for each prescription drug with a UPL for each plan ID the carrier
offered in the preceding plan year.
Claims savings are calculated and reported by determining the difference between
utilization and cost of a prescription drug with a UPL compared to the estimated utilization
and cost of the prescription drug without the UPL
ith aggregated claims savings, cost-sharing savings,
and premium savings, for each prescription drug with a UPL for each plan ID the carrier
offered in the preceding plan year.
Claims savings are calculated and reported by determining the difference between
utilization and cost of a prescription drug with a UPL compared to the estimated utilization
and cost of the prescription drug without the UPL.
Cost-sharing savings and premium savings are calculated and reported in a manner that
demonstrates how carriers utilized any savings generated for a health benefit plan from a
prescription drug’s UPL to reduce costs to consumers, prioritizing the reduction of out-of-
pocket costs.
Estimated total claims savings (C.2.a.x) must be approximately equal to the sum of both
total estimated total cost-sharing savings (C.2.b.vi.) and estimated total premium savings
(C.2.c.vi.). Carriers shall provide a narrative description of any discrepancies between
estimated total claims savings and the sum of estimated total cost-sharing savings and
estimated total premium savings.
a.
Calculation of Carrier Claims Savings from Upper Payment Limits: Each carrier
shall provide to the Board the following information for each prescription drug
with a UPL using the “Prescription Drug Affordability Board Carrier Use of
Savings Template” spreadsheet located on the Board’s website.
i.
The utilization of each prescription drug with a UPL in the preceding plan
year, expressed as the total utilization per 1000 members per year and
report for each prescription drug with a UPL the reported measurement,
such as “per treatment”, “per dose”, “per 30-day supply”;
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ings Template” spreadsheet located on the Board’s website.
i.
The utilization of each prescription drug with a UPL in the preceding plan
year, expressed as the total utilization per 1000 members per year and
report for each prescription drug with a UPL the reported measurement,
such as “per treatment”, “per dose”, “per 30-day supply”;
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ii.
The estimated utilization of each prescription drug assuming there was
no upper payment limit in the preceding plan year, expressed as the total
estimated utilization per 1000 members per year and report for each
prescription drug with a UPL the reported measurement, such as “per
treatment”, “per dose”, “per 30- day supply”. The carrier shall provide the
calculations for how the estimated utilization per 1000 members per year
were determined along with a narrative description;
iii.
The cost per utilization for each prescription drug with a UPL;
iv.
The estimated cost per utilization of each prescription drug assuming
there was no upper payment limit in the preceding plan year. The carrier
shall provide the calculations for how the estimated costs per utilization
were determined along with a narrative description, including an
explanation of any estimated trend used to determine the estimated cost;
v.
Total cost per member per month for each prescription drug with a UPL;
vi.
Estimated total cost per member per month without a UPL for each
prescription drug with a UPL;
vii.
Estimated total savings per member per month for each prescription drug
with a UPL;
viii.
Estimated total claims savings, per member per month for all prescription
drugs with a UPL; and
ix.
Estimated total claims savings for all prescription drugs with a UPL.
b.
Reduction of Consumer Out-of-Pocket Costs Resulting from Carrier Claims
Savings
without a UPL for each
prescription drug with a UPL;
vii.
Estimated total savings per member per month for each prescription drug
with a UPL;
viii.
Estimated total claims savings, per member per month for all prescription
drugs with a UPL; and
ix.
Estimated total claims savings for all prescription drugs with a UPL.
b.
Reduction of Consumer Out-of-Pocket Costs Resulting from Carrier Claims
Savings. Each carrier shall provide to the Board the following information for
each prescription drug with a UPL using the “Prescription Drug Affordability
Board Carrier Use of Savings Template” spreadsheet located on the Board’s
website.
i.
Whether each prescription drug with a UPL is subject to consumer copay
or coinsurance;
ii.
Cost-sharing amount for each prescription drug with a UPL that the
consumer is responsible for, prior to the consumer satisfying their out-of-
pocket maximum;
iii.
Estimated cost-sharing amount for the prescription drug assuming there
was no upper payment limit in the preceding plan year. The carrier shall
provide the calculations for how the estimated cost-sharing was
determined along with a narrative description, including if the estimated
cost-sharing was based on cost sharing from a previous year, and any
trend assumptions, if applicable;
iv.
Estimated total cost-sharing savings for each prescription drug with a
UPL;
v.
Estimated cost-sharing savings, per member per month for all
prescription drugs with a UPL; and
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th a narrative description, including if the estimated
cost-sharing was based on cost sharing from a previous year, and any
trend assumptions, if applicable;
iv.
Estimated total cost-sharing savings for each prescription drug with a
UPL;
v.
Estimated cost-sharing savings, per member per month for all
prescription drugs with a UPL; and
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vi.
Estimated total cost-sharing savings for all prescription drugs with a UPL.
c.
Reduction of Consumer Premiums Resulting from Carrier Claims Savings. Each
carrier shall provide to the Board the following information for each prescription
drug with a UPL using the “Prescription Drug Affordability Board Carrier Use of
Savings Template” spreadsheet located on the Board’s website.
i.
Total allowed paid claims amount for each prescription drug with a UPL;
ii.
Estimated total allowed paid claims amount without a UPL for each
prescription drug with a UPL;
iii.
Premium savings per member per month due to implementation of a
UPL for each prescription drug with a UPL;
iv.
Total premium impact expressed as a percentage due to implementation
of the UPL for each prescription drug with a UPL;
v.
Estimated total premium savings, per member per month for all
prescription drugs with a UPL; and
vi.
Estimated total premium savings for all prescription drugs with a UPL.
3.
Savings Description Report
Carriers, state entities, and optional participating plans shall prioritize the reduction of
out-of-pocket costs for consumers and provide a detailed analysis and description of the
out-of-pocket cost savings achieved during the preceding plan year for each prescription
drug for which the Board has established a UPL. The analysis shall include at a
minimum:
a.
An explanation of how total claims savings were achieved;
b
es, and optional participating plans shall prioritize the reduction of
out-of-pocket costs for consumers and provide a detailed analysis and description of the
out-of-pocket cost savings achieved during the preceding plan year for each prescription
drug for which the Board has established a UPL. The analysis shall include at a
minimum:
a.
An explanation of how total claims savings were achieved;
b.
An explanation of how total claims savings were used to reduce out-of-pocket
costs for prescription drugs including prescription drugs subject to an upper
payment limit and prescription drugs not subject to an upper payment limit, and,
as appropriate, any reductions in premiums; and
c.
Any changes made to the plan formulary resulting from the Board establishing a
UPL, including removing or adding prescription drugs to the formulary or
changing tiering of a prescription drug.
D.
Confidentiality
Reports submitted to the Board pursuant to section 10-16-1410(1)-(3), C.R.S., may contain trade secret
or confidential commercial or financial information such that the information is not subject to the Colorado
Open Records Act, as determined after review by the Board. A carrier, state entity, and optional
participating plan that submits a report pursuant to this part 5 shall clearly identify any such information in
its report that it asserts is not public as “confidential” and provide a justification for the assertion of
confidentiality. Any information not marked as confidential or otherwise confidential under state law may
be disclosed pursuant to the Colorado Open Records Act.
CODE OF COLORADO REGULATIONS
3 CCR 702-9
Division of Insurance
21
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.