Economic Evaluation Studies Guidelines

1. INTRODUCTION

1.1. Definitions

Economic Evaluations Studies (EES) are the “comparative analysis of alternative courses of action in terms of both their costs and their consequences”, with a view for decision making on their added value to the current standard of practice in the healthcare system.

There are two main types of Economic Evaluations Studies used for resource allocation decisions:

A. Partial Economic Studies is a sub-discipline of economic evaluation where an analysis of cost or consequence occurred independently e.g.:

o Budget Impact Analysis (BIA): an economic evaluation that assess the financial impact of the adoption of new intervention that can aid in setting and allocating resources relative to its affordability.

B. Full Economic Studies or Pharmacoeconomics Evaluation Studies (PES) is a sub-discipline of economic evaluation where an analysis of different intervention compared in terms of both their costs and their added value for an outcomes. There are four main types of PESs:

o Cost Effectiveness Analysis (CEA): is a comparative economic evaluation of two or more alternatives intervention in terms of their relative costs and outcomes, where the later are measured in a natural unit.

o Cost Minimization Analysis (CMA): is a comparative economic evaluation in which the outcomes of the two or more comparators are assumed to have equivalent health effects.

o Cost Utility Analysis (CUA): is a comparative economic evaluation where the outcomes are expressed by a using either generic preference-based measure or condition specific-based measure that considers both the effect on mortality and morbidity.

o Cost Benefit Analysis (CBA): is a comparative economic evaluation, where both the costs and outcomes are expressed in monetary terms.

1.2. Objective

This guidance helps manufacturers, marketing authorization holders, or agents in describing a standard method for performing, submitting, or publishing an EES. These will be evaluated at the Saudi Food and Drug Authority (SFDA) to determine the added value and premiums deserved over the current standard of practice utilized in Saudi Arabia’s healthcare system.

1.3. Scope

This guidance applied to all Human pharmaceutical products submitted for registration and renewal in SFDA. It is mandatory to provide at least one of the best-suited EES based on product type:

Product Type	BIA	CMA	CEA	CUA
New Chemical	√	Ꭓ	√	√
Biological	√	Ꭓ	√	√
Generic Chemical	√	√	Ꭓ	Ꭓ
Biosimilar	√	C	Ꭓ	Ꭓ

1.4. Related guidelines

• The Pharmaceutical Product Pricing Rules

• Data Requirements for Human Drugs Submission

2. GENERAL REQUIREMENTS

2.1. Epidemiological Data

Information on the disease, its prevalence, incidence, targeted population, no. of patients both globally and in Saudi Arabia are required to be documented within the submission file to the SFDA.

2.2. Market Share

Refers to the proportion of the pharmaceutical product sells in volume and value compared to the total number of alternatives used in treating the same condition. Information on the current market share of the product in Saudi Arabia are required to be documented in the submission file to the SFDA. In case of a new product, the estimates of the market share for the upcoming five years are required to be documented.

2.3. Drug Marketing Plan

Drug marketing plan refers to the targeted segment of healthcare in Saudi Arabia that the product is mainly distributed in. Information on the targeted segment should be presented in the submission file to the SFDA. It could be one or more of the following:

Distribution in:
i.	Tender Item only
ii.	Retail Pharmacy only
iii.	Public (whole market)

Prescription Type:
i.	Prescription only medicine
ii.	Controlled prescription medicine
iii.	Pharmacist only medicine
iv.	Over the Counter (OTC)

2.4. Access Agreements

Access agreements defined as arrangements between the healthcare institution and the company that allow for controlling the cost of medicines while managing uncertainty around their financial impact or performance. There are two main types of agreements:

• Financial Agreements: aim to manage uncertainty around the budget impact of a technology.

• Outcome Agreements: the analysis of data on product performance, with payment contingent on the collection of data and/or on the outcomes achieved.

The applicant must clearly state the type of access agreements planned for Saudi Arabia and present it to the SFDA upon registration. If any changes in the access agreement happened later, the applicant must notify the SFDA at the time of the nearest updated submission or when required whichever is the nearest.

It is worth noting that there are considerations when applying for access agreement, including the following:

- Compliance with the agreement is essential, as a commitment letter should be submitted from the company.

- SFDA can suggests alterations on the access agreement proposed by the manufacturers given the stakeholders input.

2.5. List of Published EES’s and Health Technology Assessment Decisions

Information on the published EES(s) are required to be documented in the submission file to the SFDA showing the following information (title, disease area, time horizon, method of analysis, model used, comparators, cost measure, outcomes measure, results, and conclusion). In addition, a summary conclusion from the following Health Technology Assessment (HTA) agencies are required to be presented such as The National Institute for Health and Care Excellence (NICE), Institute for Clinical and Economic Review (ICER), Canadian Agency for Drugs and Technologies in Health (CADTH), Haute Autorité de santé (HAS), Therapeutic Goods Administration (TGA)…etc.

3. EES’s REQUIREMENTS

Below are a summary table of the required information to be included in each EES:

Criteria	Description	BIA	CMA	CEA	CUA
Study objective	The study objective(s) should be clearly stated including research questions for each goal.	√	√	√	√
Targeted population	The specifications of targeted population should be included. Sub-group analyses are encouraged.	√	√	√	√
Perspective of analysis	The viewpoint of the study should be indicated. A healthcare payer or provider perspective are sufficient for the evaluation, but a societal perspective is preferred if the data is available.	x	√	√	√
Time horizon	The length of the study should include the natural disease history or encapsulate all differences either in cost or outcomes.	√ 2-5 years		√ Lifetime
Comparator	The comparator should be included from the current standard of practice. This include the least expensive and the most effective treatments available at least. Inclusion of future technologies are encouraged.	√	√	√	√
Method of analysis	The type of EES used in the study should be stated clearly. A CEA is preferred to be submitted. If not applicable, a BI or a CMA should be submitted at least. The willingness-To-Pay (WTP) threshold in the evaluation is 3 times the GDP of Saudi Arabia. WTP of 2 and 4 times the GDP of Saudi Arabia are encouraged to be provided. As the stated thresholds are categorized based the GDP.	√	√	√	√
Modeling	The details of the model utilized and justifications for using it should be included. Validation of the model is encourage to be provided.	x	√	√	√
Costs calculations	All relevant costs determined by perspective choice should to be included. The direct healthcare costs are required to be included at least. Intangible costs are encouraged to be provided.	√ In SAR or USD
Long-term care and productivity loss costs	The costs resulted from a long period of patient care or inability to work during illness are encouraged to be included in the analysis. The method for calculating these costs is required to be included.	x	√ In SAR or USD
Outcomes measurement	The outcome effectiveness measurement should be stated clearly in the evaluation. Based on the type of analysis, the relevant outcome measure is chosen. Utility measurement is required to be included if CEA or CUA is submitted.	x	x	√ Natural units	√ QALYs
Additional benefit in efficacy or safety	The evaluation should highlight the additional benefit in either safety or efficacy of the new health technology. Non-health benefits and Effectiveness data resulted from Real World Evidence (RWE) are encouraged to be submitted.	x	x	√	√
Sources of cost or clinical data	All sources of data used in the evaluation should be included. Cost data is encouraged to be collected form Saudi's healthcare system while clinical trials (CT) and RWE are encouraged to be the sources of clinical data.	√	√	√	√
Discounting	This is the monetary value depreciation over time. The yearly discount rate is 3% - 5%. It is mandatory to be included for cost calculations at least.	√ 3% - 5%
Uncertainty and sensitivity analysis	All uncertainties (Parametric, methodological and Structural) in the base-case scenario should be addressed in the sensitivity analyses. Probabilistic Sensitivity Analyses (PSA) is preferred to be used in the evaluation. Deterministic Sensitivity Analysis (DSA) should be provided including one-way sensitivity analysis, multi-way sensitivity analysis and scenario sensitivity analysis.	x	√	√	√
Presentation of results	Results of the base-case should be presented in cost-outcomes increments demonstrated in cost effectiveness plane. For PSA and DSA, the result should be depicted in a cost effectiveness acceptability curve and tornado diagram, respectively. Results of BIA should be presented in table format.	x	√ In SAR or USD	√ ICER	√ ICUR
Data Source, Equity and generalizability to Saudi Arabia	The data in the evaluation should be applicable to generalize it to Saudi Arabia with all patients having a fair opportunity for participation and for obtaining the expected treatment outcomes.	√	√	√	√
Other	Conflicts of interests and funding should be reported if any.	√	√	√	√

Economic Evaluation Studies Guidelines

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1. INTRODUCTION

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2. GENERAL REQUIREMENTS

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3. EES’s REQUIREMENTS

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4. PHARMACOECONOMICS SUBMISSION FORM:

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5. APPENDIX

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6. REFERENCES

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