Combination Therapies and Cost-Containment: a European Update

Last November, the UK Competition and Markets Authority (CMA) published a Prioritisation Statement on combination therapies.  The Statement sets out the circumstances in which the CMA will not open an antitrust investigation into competing pharmaceutical companies exchanging information and entering into commercial agreements on combination therapies for NHS patients. Our earlier post on this topic can be found here. 

Across the Channel, some EU Member States have been exploring and adopting alternative approaches to reduce the cost burden of combinations of patented therapies, and to facilitate their reimbursement.

Germany

As part of its wide-ranging ‘Financial Stabilization of Statutory Health Insurance System’ reform, the German government introduced a 20% rebate (fully operative as of May 2, 2023) for drugs that are used as part of a combination therapy.  The rebate has no effect on the selling price of any product, which remains independently negotiated by the drug manufacturers, thereby mitigating antitrust-related concerns.  Instead, it operates as a retroactive payment to sickness funds (i.e., third party payers that make up the Statutory Health Insurance System) based on actual combination use in clinical practice. 

The German approach has limitations.  The rebate only applies to combination therapies where:

• The component drugs are “new active ingredients” (launched after 2011) and have explicit market authorisation for the combination use;
• The component drugs are not packaged together (i.e., they are “free-dose”, on the basis that the price of fixed-dose combination medicinal products is already regulated);
• The combination therapy has been expressly designated by the Federal Joint Committee (G-BA) and added to its (evolving) list;
• The combination treatment does not have a considerable or major added benefit rating; and
• The combination does not include a biosimilar.

We expect the G-BA approved list of combination therapies to expand as manufacturers and statutory payer representatives negotiate new framework agreements. 

France

In line with Germany, France has also embraced a significant reform known as “AMM Miroir”, which enables the reimbursement of an add-on drug without market authorisation (MA) used in a combination treatment with a backbone drug which already holds the MA for the combination itself. 

This procedure only applies when the add-on drug without the MA for the combination is already on the T2A exclusion list (or “Liste-En-Sus”, a list of high-cost hospital drugs eligible for reimbursement) for at least one indication, and if the manufacturer of the backbone drug in the combination submits a Pricing and Market Access dossier for the reimbursement of this combination. The “mirror” MA ensures unchanged reimbursement prices and mandatory rebates for the drug without the MA when used in the combination.

Sweden

Sweden trialled a digital platform in 2019, which sought to operate as a “guarantor” facilitating price negotiations between manufacturers of combination therapies and payers.  The introduction of an independent “third party” has previously been considered as an option to mitigate antitrust risk associated with price coordination.  The platform presented various technical challenges, including on the alignment between price and value of the drug, and the project was abandoned. 

More recently, in June 2023, the Swedish trade association for the research-based pharmaceutical industry Läkemedelsindustriföreningen (Lif), the New Therapeutics (NT) Council, and representatives of the regions collaborated on a report proposing a new access model for combination therapies to the Tandvårds- och läkemedelsförmånsverket (TLV) (the Swedish National Health System).  As for the UK, the model proposes to enable negotiations among pharmaceutical manufacturers under a framework blessed by the Swedish Competition Authority.  The report proposes, among other things:

• A voluntary commitment for interested parties to collaborate and enable combination treatments;
• Enabling drug manufacturers to share confidential health economic data pursuant to waivers issued by the TLV; and
• Enabling manufacturers to agree on assumptions on the future use of component drugs, and tailor their pricing depending on whether the drugs are used as a monotherapy or in combination therapy. 

The report also suggests running a pilot project to test the efficacy of the proposal.

Belgium 

In September 2023, the Belgian General Association of the Pharmaceutical Industry (Pharma.be) published a newsletter discussing the shortcoming of the existing reimbursement regime in Belgium.  In particular, the article highlights the National Institute for Health and Disability Insurance (INAMI)’s inability to negotiate simultaneously with two (or more) companies in relation to the assessment of a single combination therapy. 

Pharma.be calls for a new tailored reimbursement procedure (also referred to as the “mirror” procedure), which ensures the parallel and simultaneous reimbursement of all component drugs of a combination therapy.  The association highlights the importance of receiving guidance from the Belgian Competition Authority regarding how manufacturers could engage in limited coordination without infringing competition law. 

Outlook for other EU countries

There is a generalised need to make combination therapies better available to patients and more affordable to health systems across Europe.  However, given differences in reimbursement systems, a one-size-fits-all approach seems infeasible.  Poland, for example, has been exploring innovative pricing agreements whereby different rebates are granted for the same drugs depending on their use as monotherapy vs. combination therapies.  No firm proposals have yet been adopted.

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