EDA Starts Receiving Value-Based Pricing Files

Understanding Innovator Pricing under Article (3) of EDA Decree 480/2026

Following the Egyptian Drug Authority’s announcement on the start of receiving Value-Based Pricing submissions, pharmaceutical companies should first understand where this new pathway sits within the broader Innovator pricing framework introduced under EDA Decree 480/2026.

The Value-Based Pricing pathway is not applicable to every medicinal product. It forms part of Article (3) of Decree 480/2026, which specifically regulates the pricing of Innovator Products in Egypt.

The main concept is simple: Start with the international reference price of the Innovator Product, then determine the applicable pricing pathway according to its Reference Ex-Factory Price and its market situation in Egypt.

1. Starting Point: External Reference Pricing

For an Innovator Product submitted for pricing for the first time, or an Innovator Product that has already been priced but has not yet been marketed in Egypt, the starting point is External Reference Pricing (ERP).

EDA reviews the price of the product in the countries where it is marketed and which are included in Egypt’s reference pricing country list.

The starting point for pricing is the Lowest Reference Ex-Factory Price, to which the applicable distributor and pharmacist margins are subsequently added.

The Reference Ex-Factory Price is the manufacturer selling price of the product in the reference country before distributor and pharmacist margins are added.

It should therefore not be confused with the Public Price, which represents the final selling price after the applicable distribution and pharmacy margins are included.

The Reference Ex-Factory Price is particularly important because it determines which pricing pathway applies to the Innovator Product.

2. Reference Ex-Factory Price Between EGP 50,000 and EGP 500,000

If the Lowest Reference Ex-Factory Price of the Innovator Product falls between EGP 50,000 and EGP 500,000, the product moves into the Value-Based Pricing pathway.

This is the pathway addressed by EDA’s recent announcement regarding the submission of Value-Based Pricing files.

At this stage, pricing is no longer based only on the international reference price. EDA also evaluates the clinical and economic value of the product.

Under Article (3), there are two possible assessment routes.

A. An Appropriate Comparator Exists in Egypt

If there is an Innovative or Targeted Therapy that is:

·       Registered in Egypt

·       Priced in Egypt

·       Used for the same therapeutic purpose

·       Supported by a direct or indirect clinical comparison with the new product

the company is required to provide an Economic Evaluation.

The purpose is to compare the cost and clinical benefit of the new Innovator Product with the relevant comparator.

In simple terms, the assessment asks: What additional clinical benefit does the new product provide, and does that additional benefit justify its additional cost?

The Economic Evaluation may consider several elements, including:

·       Treatment cost

·       Clinical effectiveness

·       Adverse events

·       Patient-related costs

·       Administration requirements

·       Monitoring requirements

·       Other healthcare costs associated with treatment

The objective is therefore not simply to compare the prices of two medicines. It is to understand the overall cost and therapeutic value of one treatment compared with another.

B. No Appropriate Innovative or Targeted Comparator Exists

If there is no Innovative or Targeted Therapy registered and priced in Egypt for the same therapeutic purpose, the assessment follows a different pathway: MCDA – Multi-Criteria Decision Analysis.

In this situation, the product cannot easily be evaluated economically against one specific innovative comparator. Instead, its value is assessed using several criteria.

According to Decree 480/2026, these include factors such as:

·       Disease rarity

·       Disease severity

·       Clinical efficacy

·       Safety

The value of the medicine is therefore assessed from several perspectives rather than through one direct economic comparison.

In simple terms: Comparator available → Economic Evaluation | No appropriate comparator → MCDA

3. Reference Ex-Factory Price Above EGP 500,000

If the Lowest Reference Ex-Factory Price exceeds EGP 500,000, a different pricing mechanism applies.

EDA considers the Lowest Ex-Factory Price in any country where the product is marketed.

An important difference here is that the country does not have to be one of Egypt’s official reference pricing countries.

These very high-cost Innovator Products are also subject to closer price reassessment:

·       First reassessment after 9 months

·       Then every 6 months

·       Maximum of 3 reassessments

This establishes a separate monitoring mechanism for Innovator Products with very high international prices.

4. What Happens If the Innovator Enters Egypt After a Generic or Biosimilar?

Article (3) also considers the timing of the Innovator Product’s entry into the Egyptian market.

If the Innovator Product is submitted for pricing after a Generic or Biosimilar has already been registered and marketed in Egypt, its pricing is linked to the product already available in the market.

If a Generic is already registered and marketed: Innovator Price = Generic Price + 35%

If a Biosimilar is already registered and marketed: Innovator Price = Biosimilar Price + 20%

This means that the timing of market entry can directly influence the achievable price of an Innovator Product in Egypt.

Pricing strategy should therefore not be considered independently from the product’s registration and market-entry strategy.

5. What Happens When Three Generics or Biosimilars Become Available?

Article (3) also introduces a post-market pricing mechanism linked to competition.

If three Generic or Biosimilar products are marketed and available in sufficient quantities to cover the needs of the Egyptian market, the price of an Innovator Product that was first priced under Decree 480/2026 may be reduced.

The new Innovator Price will be based on the lower of:

·       A 20% reduction from its existing price

·       The lowest market price of the Innovator Product in the reference pricing countries

However, there is an important safeguard: the reduced Innovator Price must not fall below the highest-priced Generic or Biosimilar marketed in Egypt.

This creates a direct link between increasing competition in the Egyptian market and the future pricing of the Innovator Product.

6. Localization Incentive

Article (3) also provides an important exception related to localization.

If an imported Innovator Product becomes fully localized and manufactured in Egypt, the price reduction associated with the presence of three Generics or Biosimilars does not apply for at least 5 years, starting from the date the locally manufactured packs are marketed.

This creates an important pricing incentive for companies considering full local manufacturing of Innovator Products.

Article (3) in One Simple Flow

→ Innovator Product

→ Check the Lowest Reference Ex-Factory Price

→ Below EGP 50,000 → External Reference Pricing

→ EGP 50,000–500,000 → Value-Based Pricing

→ Comparator available in Egypt? Yes → Economic Evaluation | No → MCDA

→ Above EGP 500,000 → Lowest Ex-Factory Price in any country where the product is marketed

→ First reassessment after 9 months → Then every 6 months → Maximum 3 reassessments

→ Generic already registered and marketed? → Innovator priced 35% above the Generic

→ Biosimilar already registered and marketed? → Innovator priced 20% above the Biosimilar

→ Three Generics/Biosimilars marketed and sufficiently available? → Innovator Price may be reduced according to Article (3)

→ Imported Innovator fully localized and manufactured in Egypt? → Protection from this reduction for at least 5 years

What Does the New EDA Announcement Mean for Companies?

The recent implementation of the Value-Based Pricing submission pathway makes one part of Article (3) particularly important for companies now preparing Innovator pricing applications.

Companies should first determine whether their product falls within the VBP range by identifying the Lowest Reference Ex-Factory Price of the Innovator Product.

If this price falls between EGP 50,000 and EGP 500,000, the company should then determine whether an appropriate Innovative or Targeted Comparator exists in the Egyptian market.

This determines whether the assessment will be based on Economic Evaluation or MCDA.

The company will then need to prepare the clinical, epidemiological, comparator and economic evidence required under the Value-Based Pricing submission template.

Key Takeaway

The launch of Value-Based Pricing submissions marks the practical implementation of an important part of Article (3) of EDA Decree 480/2026.

For Innovator Products, pricing is no longer determined solely by international reference prices.

The applicable pricing pathway may now depend on: Reference Ex-Factory Price + Clinical Value + Economic Value + Availability of Comparators + Market Entry Timing + Competition + Localization

For pharmaceutical companies, this means that Innovator pricing strategy should begin well before the pricing submission itself.

Regulatory strategy, clinical evidence, market access, health economics and market-entry planning now need to work together from an early stage.

Source basis: Egyptian Drug Authority Decree 480/2026 and the EDA Value-Based Pricing submission announcement/template.