PT Roche Indonesia

Working Instruction on Pricing Governance

Document Name: Working Instruction on Pricing Governance

Document Number: COGE 26-01
Effective Date:
Working Instruction on Pricing Governance

Document Information
General Document Working Instruction on Pricing Governance
Information Name
Type of Working Instruction
Document
Document Market Access and Corporate Affairs
Owner
Document Physically: DSC
Location Electronically: Touchpoint

Authors Name Dept. Signature Date

Perdamen Sagala Market Access and

Corporate Affairs

Review Name Dept. Signature Date

Kunal Samanta Market Access and

Corporate Affairs

Welly Market Access and

Corporate Affairs

Approvals Name Dept. Signature Date

Lucia Erniawati Market Access and

Corporate Affairs,
Head

Document Versio Reason for Change Effective

History n Date
1.0 New Document
This policy has to be reviewed every 1 (one)
year

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Working Instruction on Pricing Governance

TABLE OF CONTENTS

A. Purpose 4

B. Scope 4

C. General Principles 4

D. Definitions 4

E. Process Flow 5
E.1 Price Determination for New Product Launches 5
E.2 Price Determination for Existing (Traded) Products in Public
Reimbursement 6
E.3 Price Determination for Existing (Traded) Products in Private Market 7
E.3.1 Determination of HNA and standard trading terms by product 7
E.3.2 Trading terms implementation 7
E.3.2.1 Trading terms for pharmacies 7
E.3.2.2 Trading terms for hospital/institution 8
E.3.2.3 Request for discount exceeding the trading terms for ad hoc transaction
11
E.3.2.4 Pricing Agreement 11
E.3.2.5 Pricing/Discount Reconciliation 12
E.4 Price Determination for Pre-regulatory Approval Products 12

F. Reference Documentation 12

G. Document History 12

H. Appendices 13

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Working Instruction on Pricing Governance

A. Purpose

The purpose of this working instruction is to provide comprehensive technical guidance on

pricing governance in PT Roche Indonesia as regulated in SOP on Pricing Governance.

B. Scope

This local working instruction applies to all new launch products, all existing traded products and
all pre-regulatory approval products within all business units.

C. General Principles

N/A

D. Definitions

Pricing specific terms relevant to this document include:

Term Definition
Commercial A letter signed by PTRI and the Customer to agree on the price
Arrangement Agreement and scheme between the two parties, over a defined time
period
Ex-factory Price The price from PTRI to the distributor
Flexible Pricing Solution Any type of commercial arrangement / agreement
Leopard The system that records the pricing proposal from affiliates to
the Global Operational Pricing department.
Maximum retail price Retail Price + Retailer Margin Acquisition (MOH
recommendation is up to 28% from Retail Price), also known
as HET (Harga Eceran Tertinggi)
Net retail price Ex-factory price + distribution cost (5.75%), also known as
HNA (Harga Net Apotik)
Offering Letter A letter on behalf of PTRI to offer the products with specific
discount to the customer
Retail price Net retail price + value added tax (10%), also known as
HNA+PPN (Harga Net Apotik+Pajak Pertambahan Nilai)

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The table below contains acronyms specific to this document.

Acronym Definition
ABP Annual Brand Planning
BASE Business Analytics and Strategic Effectiveness
BPJS Badan Penyelenggara Jaminan Sosial (National Social Security
Operator)
BU Business Unit
DM District Manager
DRA Drug Regulatory Affairs
FORNAS Formularium Nasional (National Formulary)
FPS Flexible Pricing Solution
GM General Manager
GRM Government Relations Manager
HA/MOH Health Authority/Ministry of Health
HCP Health Care Professional
IASM Innovative Access Solutions Manager
KAM Key Account Manager
LKPP Lembaga Kebijakan Pengadaan Barang Jasa Pemerintah
(National Public Procurement Agency)
MAC Market Access and Corporate Affairs
MoH Ministry of Health
OOP Out of Pocket
OP-IMPL Operational Pricing (Global) In-Market Pricing Leader
P-AM Pricing-Access Manager
PAPMD Pre-Approval and Pre-Marketing Distribution
PED Permintaan Ekstra Diskon (Extra Discount Request)
P&L Profit & Loss
PM Product Manager
PTRI PT Roche Indonesia
RACI Responsible, Accountable, Consulted, Informed
SM Sales Manager

E. Process Flow

General pricing timeline, pricing rationale and price determination process are identical for new
launches, existing traded products and pre-regulatory approval products in all BUs and across
different markets or segments (please refer to SOP on Pricing Governance). Some additional
unique processes may apply for a specific product category or segment.

E.1 Price Determination for New Product Launches

In general price determination for new product launches follows the process flow, resposibilities
and procedure stated in the SOP with additional specific processes, as follows:
Price for regulatory submission (pre approval):

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1. DRA informs P-AM about new launch at T-24 to T-12 or upon regulatory dossier
submission.
2. P-AM reviews global pricing policy and initiates cross-functional collaboration for price
assessment.
3. P-AM prepares estimated price (HNA and HET). Where price assessment does not
produce a reasonable estimated price, P-AM should follow the global policy. The
estimated price serves only as an indicative price for registration purpose. (Appendix 1.
Estimated Price Form).
4. DRA submits the price information to regulatory body.
Price for launch (post regulatory approval or during registration):
1. Price determination follows the process flow, resposibilities and procedure as regulated
in the SOP.
2. Price recommendation (proposal) that offers Roche commercial arangement should
follow the business case template (Appendix 2. Business Case/FPS Template).
3. Once price is approved and ready to be implemented, P-AM announces the new price to
all related internal stakeholders (DM, SM, PM, KAM, DRA, Controller, Supply Chain).
4. Controller informs distributor to maintain the new price. (Appendix 3. Notification Letter
to Distributor to inform New HNA and Standard Trading Terms)
5. DRA informs regulatory body in case of price change from previous submission
(estimated price).
6. P-AM ensures pricing approval and communication recorded as per COREMAP policy.

E.2 Price Determination for Existing (Traded) Products in Public Reimbursement

In general price determination for existing (traded) products in public reimbursement follows the
process flow, responsibilities and procedure stated in the SOP with additional specific
processes, as follows:
1. GRM informs P-AM about FORNAS process and timeline
2. GRM engages with MoH and other governmental related stakeholders to gain
reimbursement related insight.
3. Price determination follows the process flow, responsibilities and procedure as regulated
in the SOP.
4. P-AM prepares price scenario and phasing for negotiation with MoH and LKPP.
5. GRM, GAM, Head of MAC negotiate the price with MoH and LKPP
6. GRM ensure signing of “berita acara negosiasi” both in case of agreement and
non-agreement.
7. When agreement is achieved GRM ensures product listing in e-catalogue.
8. GRM informs P-AM the price agreed with MoH and LKPP.

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9. In case of price agreed is different with proposal in Leopard but within approval range,
P-AM updates the price in Leopard.
10. P-AM announces the new BPJS price to all related internal stakeholders (DM, SM, PM,
KAM, DRA, Controller, Supply Chain).
11. Controller informs distributor to maintain the new BPJS price in their system. (Appendix
4. Notification Letter to Distributor to inform new BPJS Price)
12. P-AM ensures framework contract and berita acara negosiasi are recorded as per
COREMAP policy.

E.3 Price Determination for Existing (Traded) Products in Private Market

Private market includes:

a. Out of pocket (OOP) market,
b. Private health insurance,
c. Patient support program, and
d. Any other commercial arrangement outside public reimbursement.
Thus price determination in this section includes determination of HNA, discount level (trading
terms) and any other commercial arrangement and price in patient support programs.

E.3.1 Determination of HNA and standard trading terms by product

HNA and standard trading terms are set annually to serve as pricing guidance for the fiscal year
effective from January 1st to December 31st of that year.
In general price determination for existing (traded) products in private market follows the
process flow, responsibilities and procedure stated in the SOP with additional specific
processes, as follows:
1. After price approval is obtained P-AM announces the new HNA and standard trading
terms to all related internal stakeholders (DM, SM, PM, KAM, DRA, Controller, Supply
Chain).
2. Controller informs distributor to maintain the new HNA and standard trading terms in
their system. (Appendix 3. Notification Letter to Distributor to inform new HNA and
Standard Trading Terms)
3. Controller documents the new HNA and Standard Trading Terms (Appendix 5. Final
Approved HNA and Standard Discount Documentation).
4. Pricing Manager ensures soft copy of offering letter and notification letter are recorded
as per COREMAP policy.

E.3.2 Trading terms implementation

E.3.2.1 Trading terms for pharmacies

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HNA and Trading Terms for Pharmacies are maintained in the Distributor system after the
Controller informs the Distributor through the Notification Letter (Appendix 3).

E.3.2.2 Trading terms for hospital/institution

Trading Terms for Hospitals or Institutions are not automatically maintained in the Distributor
system. The discount given should follow the Final Approved HNA and Standard Discount
(Appendix 5) and is maintained by outlet.
Discount (trading terms) level is defined as:
▪ Level 1: target discount
▪ Level 2: maximum discount
▪ Level 3: above maximum, only for select hospital/clinic/institution and/or ad-hoc
transaction.
The discount will be maintained in the system after the discount offered is documented through
the signed Offering Letter or Standardization Letter (Appendix 6).
The process in preparing such Letters until the final signatures are obtained should follow the
flow charts below.

1. If all the product discounts are in Level 1

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*Notes: DM may start the process only for clinic/hospital/institution that is not under KAM focus
area; however DM should not sign the offering letter. For such case Pricing-Access Manager
and Group Access Manager should sign the letter.
2. If any products discount is beyond level 1 and up to Level 2

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*Notes: DM may start the process only for clinic/hospital/institution that is not under KAM focus
area; however DM should not sign the offering letter. For such case Pricing-Access Manager
and Group Access Manager should sign the letter.

3. If any products discount is in Level 3

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*Notes: DM may start the process only for clinic/hospital/institution that is not under KAM focus
area.

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E.3.2.3 Request for discount exceeding the trading terms for ad hoc transaction

Request for discount exceeding trading terms apply only for select hospital/institution for a
justifiable reason and/or for ad hoc transaction. The approval process and authority level is the
same with level 3 discount approval process (Appendix 9. Request & Approval Form). The
procedures should follow the Flow Chart below:

*Notes: DM may start the process only for clinic/hospital/institution that is not under KAM focus
area.

E.3.2.4 Pricing Agreement

Trading terms for hospital/institution may need to be translated into a pricing agreement
between Roche and the hospital/institution. In such case business owner (originator) has to
prepare the agreement in consultation with legal and compliance department. Where agreement
is available the price and trading terms will be maintained automatically in the distributor
system. Controller has to inform the distributor on the agreed price and trading terms.
In case that hospital/institution requires binding price level to be applied more than one year
where Roche has not decided the price level, the following process should be followed:
1. Business owner (KAM/DM) should negotiate with the hospital to apply agreement timeline
that is aligned with Roche pricing timeline (1st January to 31st December),or
2. Business owner (KAM/DM) should negotiate with the hospital to apply non-binding price
level (harga tidak mengikat) such that Roche may submit a price level and may change it
when required,

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3. Failure to achieve agreement in process 1 or 2, additional approval and process are

required:
i) Roche agrees to submit a binding price level that apply for more than one year,
ii) In the case that Roche increases the price for the next year and the new price
deviates from the agreed trading terms (discount), Roche will absorb the new
discount level,
iii) Approval process and authority for the new discount level will follow the process in
E.3.2.2 section.

E.3.2.5 Pricing/Discount Reconciliation

The implemented price (including trading terms, extra discount, and price agreement) should be
monitored through a regular reconciliation process with realized price. The process is as follows:
1. Pricing-Access Manager request Strategic Insight & Analytic team to provide data on price
and discount realization by product, outlet by transaction.
2. Pricing-Access Manager and Strategic Insight & Analytic conduct analysis on the realized
price (discount) by comparing with the predetermined price and trading terms.
3. Pricing-Access Manager prepare report and recommendation from the analysis and
communicate them to ILT for decision.
4. ILT to make decision when necessary.

E.4 Price Determination for Pre-regulatory Approval Products

Pre-regulatory approval products are also known as Pre-Approval and Pre-Marketing
Distribution (PAPMD)or special access scheme (SAS). In general price determination for
PAPMD products follows the process flow, responsibilities and procedure stated in the SOP with
additional specific processes, as follows:
1. PAPMD request should come from third party such HCP, HA/MOH.
2. Internal process is required to evaluate and approve the request (not in the scope of SOP
& LWI on Pricing Governance).
3. Once PAPMD request is internally approved, responsible person (Medical/Commercial)
informs Pricing-Access Manager to continue with pricing determination process as
regulated in SOP on Pricing Governance.

F. Reference Documentation
SOP COGE 25-01 SOP on Pricing Governance

G. Document History
N/A

H.
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Appendices
Appendix 1. Estimated Price Form
Appendix 2. Business Case/FPS Template-Available in different file
Appendix 3. Notification Letter to inform New HNA and Standard Trading Terms
Appendix 4. Notification Letter to inform New BPJS Price
Appendix 5. Final Approved HNA and Standard Discount Documentation
Appendix 6. Offering Letter to Pharmacy/Hospital/Clinic/Institution
Appendix 7. Approval Form for Offering Letter with Level 2 Discount
Appendix 8. Business Case for Extra Discount Request
Appendix 9. PED Request and Approval Form
Appendix 10. Approval Form for Business Case & Pricing Proposal before Leopard Submission

 
Appendix 1. Estimated Price Form

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PT Roche Indonesia
Price Information Form

Product Name Presentation HNA HET

Product A Pack, 1 vial @40 ml IDR 62,379,000.00 IDR 87,829,650.00
Product B Pack, 1 vial @40 ml IDR 62,379,000.00 IDR 87,829,650.00

Prepared by, Reviewed by, Approved by, Approved by,

Name Name Name Name

Pricing-Access Group Access
Head of MAC BUH
Manager Manager

The price information serves as indicative price for registration purpose only
HNA: Harga Net Apotik (Pharmacy Net Price)
HET: Harga Eceran Tertinggi (Maximum Pharmacy Selling Price)

 
Appendix 2. Business Case/FPS Template

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