Under the Hood of Product Listing Agreements …...Under the Hood of Product Listing Agreements (PLAs): the NIHB Program’s Automated PLA Invoicing Andrew Portolesi M.Sc., Biostatistician

Under the Hood of Product Listing Agreements (PLAs):

the NIHB Program’s Automated PLA Invoicing

Andrew Portolesi M.Sc., Biostatistician

Non-Insured Health Benefits Program

First Nations & Inuit Health Branch

Indigenous Services Canada

CADTH Symposium

Apr 15-17, 2018

• I have no actual or potential conflict of interest in relation to this topic

or presentation.

Disclosure

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The Non-Insured Health Benefits (NIHB) Program is the Indigenous

Services Canada’s national, medically necessary health benefit program

that provides coverage for benefit claims for a specified range of drugs,

dental care, vision care, medical supplies and equipment, short-term crisis

intervention mental health counselling and medical transportation for

eligible First Nations and Inuit.

• NIHB provides benefit coverage to over 853,000 eligible clients

• Pharmacy expenditures in 2016/17 were $494M (out of $1.20B total

benefit expenditures)

NIHB is a member of the pan-Canadian Pharmaceutical Alliance (pCPA),

the national initiative for federal/provincial/territorial public drug plans to

collectively negotiate Product Listing Agreements (PLAs).

Overview of the NIHB Program

Under the Hood of Product Listing Agreements (PLAs): NIHB’s Automated PLA Invoicing

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• A Product Listing Agreement (PLA) is a negotiated agreement between a

drug plan and a drug manufacturer for the plan to cover a specific drug at a

reduced price, usually through the use of a rebate

• PLAs allow drug plans to cover medications that otherwise would not be

considered cost-effective or affordable, and have become a de facto tool in

the management of public drug plans in Canada

• The result of a PLA negotiation by the pan-Canadian Pharmaceutical

Alliance (pCPA) is a confidential “Net Price” and possibly other risk-sharing

mechanisms such as Total Utilization Caps and/or Individual Patient Caps

• Once a PLA is signed and the drug listed on the plan’s Drug Benefit List,

rebate calculations must be performed on a regular basis in order for

invoices to be issued to the drug manufacturer

• This presentation describes the methodology of NIHB’s automated PLA

Invoicing System, created in SAS Enterprise Guide by NIHB and producing

invoice data for 100+ agreements in one business day every quarter

What are Product Listing Agreements (PLAs)?

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• Since joining the pCPA in

2016, NIHB has seen a large

increase in the number of

PLAs enacted each year

• NIHB is also enacting a larger

proportion of non-standard

PLAs, with 60% of PLAs

enacted in FY2017/18 having

some additional complexity

• Some older PLAs have also

been amended to include

more complex discounts (not

shown)

Increasing PLA Volume & Complexity

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58

25

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2

2

6

5

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1

5

1

3

6

1

4

5

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10

15

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25

30

35

40

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# o

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NIHB PLAs Enacted per Fiscal Year (Apr-Mar)by Complexity at Listing, Apr 2011 – Mar 2018

High Complexity

Medium/High

Medium Complexity

Low/Medium

Low Complexity


There are a number of differences between NIHB and provincial/territorial

drug plans that affect how our PLA invoicing is implemented:

• 100% coverage: No co-pays/deductibles/premiums

• National coverage, but pricing is province/territory-specific

• Reporting tool (Oracle Business Intelligence Enterprise Edition - OBIEE)

updated nightly, including reversed claims updated automatically to “PAID-

REVERSED” status within claims processor & reporting tool

• No medical data, except for approval reason codes for Limited-Use

requests (used in indication-specific PLAs)

• Use each provincial/territorial plans’ pricing as our pricing sources

(markups negotiated separately)

• Produce invoices five times a year (quarterly, plus twice in Jan-Mar due to

end-of-fiscal-year issues)

• SAS platform for advanced analytics, usually using SAS Enterprise Guide

Differences in NIHB program design from other plans

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During PLA Drafting: Invoicing Feasibility/Complexity Review

• For every draft PLA (and draft Letter of Intent – LOI), provide a review of

feasibility/complexity as it pertains to invoicing:

– Keeps PLA invoicing team informed upcoming PLAs

– Allows proactive addressing of feasibility/complexity issues

Upon signing a PLA: Invoicing Implementation

• Implement rebate calculations in NIHB PLA Invoicing System (a SAS

Enterprise Guide project)

Quarterly: PLA Invoicing

• Generate invoice supporting data on a quarterly basis

– Systems team then populates PLA invoices and supporting data templates with

generated data

Ad Hoc Basis: PLA Invoicing Maintenance

• Update existing PLAs rebate calculations (e.g. amendments, price

changes)

• Respond to manufacturer inquiries on rebate amounts & invoice contents

NIHB PLA Invoicing Activities

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NIHB PLA Invoicing System: Development History

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Date Functionality # of PLAs

May 2011 Individual Ad Hoc Reporting Tool queries (2 per drug) 2

Jun 2012 Multi-tab Ad Hoc Reporting Tool queries (1 per drug) 6

Dec 2013 Batch Ad Hoc Reporting Tool queries (2 queries for all drugs) 22

Jan 2015 PLA Invoicing SAS Enterprise Guide project 29

Dec 2015 Automated Total Utilization Caps (TUCs) 41

Jun 2016 Automated Individual Patient Caps (IPCs) 52

Nov 2017Migration of PLA claims data extract query to OBIEE (new Ad

Hoc Reporting Tool)104

Dec 2017Overhaul of Total Utilization Cap and Individual Patient Caps

methodology (“Metric” methodology)105

Jan 2018Automation of Average Utilization Caps (AUCs) and Distinct

Metric (Clients, Days, Months) methodology109

Mar 2018

Automated rebate adjustments (e.g. retroactive correction

amounts included in invoices & totals automatically instead of

manually)

117

Future Plans Outcome-Based PLAs


• In Jan 2015, NIHB implemented its

PLA invoicing in its SAS platform

using SAS Enterprise Guide, a

visual point-and-click interface for

querying data, especially useful for

long sequences of SQL queries

• Large project: approximately 190

query nodes

• Full refresh in about 15 minutes

(most of which is the Claims Data

Import)

PLA Invoicing in SAS Enterprise Guide

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Discount

Factor &

Rebate

Calculations

Subtotals

Finance

Data

Tables

Invoice

Supporting

Data Tables

Individual Patient Caps

Total & Average

Utilization Caps

Special Modules

Supporting

Data

Imports

Claims

Data

Import


1. At the start of each invoicing period, download previous invoicing period’s paid claims data NIHB

claims database using pre-defined, scheduled query in its Ad Hoc Reporting Tool (OBIEE)

2. Run the PLA Invoicing SAS Enterprise Guide Project, which automatically:

– Imports claims data and joins those data with PLA DIN Driver Table

– Computes complex calculations using running total data (e.g. Total Utilization Caps)

– Calculates Discount Factors and rebate amounts for each claim

– Aggregates rebate totals (only provincial/territorial-level utilization provided to manufacturers)

– Exports files of invoice supporting data tables, rebate totals, validation files and running totals

updates

3. Check validation files (e.g. discount factors)

4. Invoice production team produces invoices and populates invoice supporting data templates

(automated in Excel using INDEX and MATCH functions), sent to manufacturers

5. Report to management on invoicing results

NIHB PLA Invoicing Process

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PLA Claims

Data Extract

(from OBIEE)

PLA Driver

DIN Table

Applicable

PLA Claims

Discount Factor

Calculation

(by Claim)

Rebate

Calculation

(by Claim)

Aggregation

(Totals)

Running Totals

Data

Complex

Calculations

Updated

Running Totals

Export Invoice

Supporting

Data Tables

Export Finance

Files

Excel

SAS


Export

Validation Files

PLA Claims Data Extract:

• Quarterly scheduled extract of all paid claims for every PLA drug (from Reporting Tool)

PLA DIN Driver Table: (DIN – Drug Identification Number)

• PLA Driver table of PLAs Names, DINs, Manufacturers and PLA Start Dates

• Group DINs together by PLAs (e.g for subtotals) and PLAs by Manufacturer

Discount Factor CASE statement:

• A CASE statement which assigns a Discount Factor to each claim

• Allows for discounts varying at a claim level, such as by province/territory or by date

• Can use both $ and % values, since all stored in as numbers

Rebate Calculations CASE statement:

• A CASE statement which chooses which rebate formula to use (default calculation is

Drug Benefit Cost x Discount Factor, rounded to nearest $0.01)

Variations:

Transparent PLAs (List Price = Net Price):

• Set Discount Factor to 0, which excludes claims from rebate calculation query

Indication-Specific PLAs:

• Extract Criteria Code data from request approval data

Standard (“First-Dollar”) Rebate Calculation Methodology

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CASE

WHEN PLA = “DRUG 1” THEN 1 – 𝑁𝑃1 𝐿𝑃1WHEN PLA = “DRUG 2” THEN

CASE

WHEN Provider Province = “QC” THEN 1 – 𝑁𝑃2 𝐿𝑃2,𝑄𝐶

ELSE 1 – 𝑁𝑃2 𝐿𝑃2END

WHEN PLA = “DRUG 3” THEN

CASE

WHEN Service Date >= Apr 9, 2018 THEN 1 – 𝑁𝑃3 𝐿𝑃32ELSE 1 – 𝑁𝑃3 𝐿𝑃31

END

WHEN PLA = “DRUG 4” THEN 0

END

Discount Factor CASE Statement Example (4 PLAs)

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Claim ID DIN [Other fields]

C1 DIN 1 …

C2 DIN 1 …

C3 DIN 1 …

C4 DIN 2 Province: ON

C5 DIN 2 Province: QC

C6 DIN 3 Date: Apr 3, 2019

C7 DIN 3 Date: Apr 15, 2019

C8 DIN 4-1 …

C9 DIN 4-2 …

Discount Factor Example, Claim-Level Results

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Company PLA

MFR 1 DRUG 1

MFR 1 DRUG 1

MFR 1 DRUG 1

MFR 2 DRUG 2

MFR 2 DRUG 2

MFR 2 DRUG 3

MFR 2 DRUG 3

MFR 2 DRUG 4

MFR 2 DRUG 4

Discount

Factor (DF)

Rebate

1 – 𝑁𝑃1 𝐿𝑃1 𝐶𝑜𝑠𝑡 × 𝐷𝐹




1 – 𝑁𝑃2 𝐿𝑃2𝑄𝐶 𝐶𝑜𝑠𝑡 × 𝐷𝐹



0 N/A

0 N/A

Imported from

PLA DIN Driver Table

(Excel) & joined to

claims data by DIN

Imported from

PLA Claims Data

Extract (from NIHB

OBIEE reporting tool)

Calculated in SAS

(“Cost” = Drug Benefit Cost

i.e. excluding professional

fees and after Coordination

of Benefits)


For Total Utilization Caps (TUCs), Individual Patient Caps (IPCs) and Average

Patient Caps (AUCs):

Metric methodology:

• Assign each capped PLA a metric type (e.g. “Quantity”, “Drug Benefit Cost”,

“Dose Conversion”, etc.), which tells SAS what to measure in a single column

that is compared against each agreement’s cap(s)

Running Totals:

• Keep a file of running totals for each metric agreement year of each PLA that

the new quarter’s metric can be added to

Discount Tiers:

• Separating claims before/after caps into different utilization tables, with different

Discount Factors (100% for hard caps)

• Also separates utilization from different agreement years when the cap reset

date is during a quarter

Discount Tier Proportions:

• Calculating what proportion of a claim belongs in each Discount Tier, splitting

the claim as required into different Discount Tiers

Utilization Cap Methodology

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Discount Tier Proportion Example

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Individual Patient Cap of $1,000 on DRUG 1 (from previous example)

Previous running totals (from this year) for client: $850

This quarter: 3 claims for $100 each

Claim Metric Tier A (before cap) Tier B (after cap)

C1 $100 100% 0%

C2 $100 50% 50%

C3 $100 0% 100%

Claim ID DIN

C1 DIN 1

C2 DIN 1

C2 DIN 1

C3 DIN 1

Company PLA

COMP 1 DRUG 1

COMP 1 DRUG 1

COMP 1 DRUG 1

COMP 1 DRUG 1

Discount

Factor (DF)

Rebate

1 – 𝑁𝑃1 𝐿𝑃1𝐴 𝑃𝑟𝑜𝑝 × 𝐶𝑜𝑠𝑡 × 𝐷𝐹

𝟏 – 𝑵𝑷𝟏 𝑳𝑷𝟏𝑨 𝑃𝑟𝑜𝑝 × 𝐶𝑜𝑠𝑡 × 𝐷𝐹

𝟏 – 𝑵𝑷𝟏 𝑳𝑷𝟏𝑩 𝑃𝑟𝑜𝑝 × 𝐶𝑜𝑠𝑡 × 𝐷𝐹

1 – 𝑁𝑃1 𝐿𝑃1𝐵 𝑃𝑟𝑜𝑝 × 𝐶𝑜𝑠𝑡 × 𝐷𝐹

Discount

Tier

Proportion

(Prop.)

A 100%

A 50%

B 50%

B 100%


Variations:

Total Utilization Caps (TUC)

• Proportions calculated based on all claims so far that Agreement Year

for that PLA and applied to all corresponding claims

Individual Patient Caps (IPC)

• Time frames can be specific to individual clients, i.e. “Treatment Years”

defined by date of client’s first claim

Average Utilization Caps (AUC)

• Ratio of two metrics, usually only calculated in the last quarter of an

agreement year (too many exceptional cases to calculate and true-up

on each invoice)

– Additional exception in case annual utilization exceeding the average cap is

more than the utilization on the current invoice

Utilization Cap Methodology (cont.)

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A number of files are reviewed to validate the PLA invoicing results:

• List of all Discount Factors calculated by SAS for each PLA

– Compared against an Excel spreadsheet of all Discount Factors for each PLA

• List of claims invoiced against more than once in the same PLA

– Only acceptable when using Proportion/Discount Tier methodology, total

proportion cannot exceed 1

• Summary tables of cap calculations

– Check calculations of Proportions and Discount Tiers

• Invoice Supporting Data Tables (main outputs)

– Check that all new/amended/updated PLAs are included in outputs, with

rebates calculated correctly

Validation of PLA Invoicing

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1. Push-button: No manual programming required on invoicing day (all

implementation is done beforehand)

2. Proactive: turnaround time on implementing new PLAs is usually fast

since already reviewed draft LOI/PLAs

3. Fast results: SAS project runs in around 15 minutes (not including PLA

Claims Data Extract query, scheduled to run in early morning)

4. No arrears: Invoices are designed to change to correct discount

immediately once a cap is reached

5. Uniformity of outputs: Easier for systems team to populate supporting

data excel files

6. Replicable: Can re-run the SAS project to produce all results

7. Expandable: New PLAs easily added by adding the DINs to the PLA DIN

Driver table and the PLA Claims Data Extract query, and adding the

Discount Factor to the CASE statement in SAS plus any other parameters

for utilization caps

Attributes of NIHB’s PLA Invoicing System

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A new type of PLA being considered by the pCPA is Outcome-Based PLAs

(OBAs), which will use external outcome data to determine the rebate amount

(i.e. Discount Factor personalized to each client)

• For invoicing patient-level Outcome-Based PLAs, NIHB is considering a

“Parking Lot” methodology:

– Claims invoiced against first-dollar discounts, then held in “Parking Lot” table

until notified of the outcome for that client

– When outcomes data are received, additional rebates are applied to claims in

“parking lot” as external data dictates

– What form these data will take and how they will be handled remains to be

determined

• Outcome Based PLAs using population-level outcomes not as complicated

Future Plans: Outcome-Based PLA Methodology

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• NIHB has developed a robust, automated system for producing its

quarterly PLA invoices, resulting in all PLA invoicing data being generated

within 1 business day

• Early engagement of invoicing team during PLA development has been

critical in ensuring feasibility of implementation

• Uniformity in future PLAs is important to maintain feasibility of producing

invoices for all PLAs, especially as the number and complexity of PLAs

continues to increase

• Important to consider PLA Invoicing as a database problem on claim-level

data instead of an Excel problem on aggregate data

Conclusion

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Questions?

Andrew Portolesi M. Sc.

Biostatistician

Non-Insured Health Benefits Program

First Nations & Inuit Health Branch

Indigenous Services Canada

[email protected]

Thank You!

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Documents

Under the Hood of Product Listing Agreements …...Under the Hood of Product Listing Agreements (PLAs): the NIHB Program’s Automated PLA Invoicing Andrew Portolesi M.Sc., Biostatistician