The Spanish Ministry of Health Has Published an Action Plan to Promote the Use of Generics and Biosimilars

January 23, 2020

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Article written by Ana Mozetic, Patricia Lavina, Iñigo Cubillo, and Manuela Martin

Political instability in Spain rubs off on the healthcare system. On their mission toward more sustainability, the Spanish Ministry Of Health has recently published an action plan to promote the use of generic and biosimilar drugs. What are the proposed key measures? And what do manufacturers, physicians, pharmacies, and patients think about the plan?

The key priorities and work streams of the Spanish Ministry of Health are uncertain, due to current political instability in Spain. With four general elections and four different Ministries of Health in the last years, the Spanish Healthcare System has needed to adapt to the changing political environment. 

However, having a sustainable Healthcare System remains a key priority for the Ministry of Health. In this context, the Ministry has proposed an Action Plan to promote the use of generic and biosimilar drugs. This is expected to lead to an increase in competition among manufacturers and eventually reduce pharmaceutical expenditure. 

The key measures proposed in the Plan are the following:

Actions related to P&R setting of generic and biosimilar drugs:

1. Voluntary discounts within the Fixed Reference Price (FRP) System: Products within the same reference group will no longer be required to have the same price. Upon creation of the group, all products (originator and generics/biosimilars) will need to have the same price (reference price), but afterwards, manufacturers can offer discounts. These voluntary discounts will not be considered for the reference price recalculation the next year. 

2. Dynamic prices: Price of the drugs within an FRP group will be re-negotiated based on volume of original and biosimilar sales vs. the total sales of the active substance1.

3. Reference groups by ATC-4: The Plan would create reference price groups based on ATC-4 drug classification (i.e., chemical subgroup) instead of ATC-5 (i.e., chemical substance). For example, currently infliximab drugs, including the originator (Remicade) and its biosimilars (Inflectra, Zessly, Remsima, Flixabi, etc.) are grouped following ATC-5 classification L04AB02. The new system would have a reference price group based on the broader ATC-4 classification L04AB, and include drugs for the same indication, such as infliximab drugs (Remicade and its biosimilars), etanercept drugs (Enbrel and its biosimilars), adalimumab drugs (Humira and its bio¬similars), certolizumab drug (Cimzia) and golimumab drug (Simponi).

4. Lower price for generics and biosimilars vs. originator: Generics and biosimilars’ prices would be fixed to a lower price vs. originator drug. Additionally, this price will be based on the originator’s real acquisition price (instead of list price).

Actions related to the prescription of generic and biosimilar drugs: 

5. Prescription by active substance2: It will become mandatory for physicians to prescribe by active substance. 

Actions related to dispensation of generic and biosimilar drugs: 

6. Pharmacy substitution: It will become mandatory for pharmacists to dispense the less costly drug, allowing automatic substitution of the originator by generic/biosimilar if needed. Together with the prescription by active substance, this aims to foster competition among manufacturers and lower prices3.

7. Clawback system: Pharmacy discounts negotiated between the pharmacy and the manufacturer will need to be refunded by the pharmacies to the National Health System. 

The Plan has not been well received by the majority of pharmaceutical industry stakeholders, who criticize that they have not been involved in the development of these initiatives. Many have publicly opposed the plan: 

  • Pharmaceutical manufacturers contend that the Plan may damage drugs’ competitiveness without generating savings to the system, as originator drugs already have the same price as generics/biosimilars due to the fixed reference price system. The Plan could risk the continuity of innovative companies as their incentives would be tempered
  • Physicians ask for the NHS to respect their responsibilities and decisions as prescribers, and oppose prescription by active substance. Additionally, they argue that this change could lead to drug substitutions that may result in medication errors by patients who are used to a certain presentation. 
  • Pharmacies reject the clawback system as it disincentivizes them from negotiating discounts and their sustainability could be at risk
  • Patients are afraid of experiencing safety and quality issues when prescribed generics and biosimilars. 

So far, this Action Plan only constitutes a list of ideas. Approval and implementation details are still to be defined. In the meantime, the Ministry of Health has welcomed feedback from industry stakeholders. 

There are many uncertainties regarding the Action Plan, due to Spanish political instability which makes it difficult to approve new measures, as well as pushback from the industry. Although it is uncertain whether or not the different measures of this Plan will ever come into existence, it is clear that the Spanish’ Ministry of Health continues to consider potential solutions to mitigate expenditure and guarantee the future sustainability of the Healthcare System.

 

1The price revision date will be set on the resolution of the drug inclusion in the National Healthcare System.
2Except for unsubstitutable drugs: (i) biologics; (ii) drugs which active substance is considered of narrow therapeutic margin, if they do not have intravenous administration; (iii) drugs which active substance is subject to special medical control or tracking; and (iv) respiratory sys¬tem drugs administered via intravenous injection or infusion.
3Originator drug manufacturers realize that their drugs are no longer profitable when generics or biosimilars enter the market, due to their price reduction. Thus, these manufacturers would be incentivized to focus on the launch new originator drugs that are profitable.
 

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