In recent years, the rise of new cancer drugs has been responsible for the increase in efficacy and overall survival of patients. These include combination therapies. These treatments are composed of two or more drugs that are administered together and often include drugs already authorised for other indications and even off-patent. Sometimes, they may be contained in a single drug, but most of those currently authorised are independent drugs, which seek different mechanisms of action and therefore multiply their effect against cancer.
The importance of these combination therapies in cancer treatment, together with the peculiarities they present, have motivated a recent report by the European Federation of the Pharmaceutical Industry (Efpia), entitled Access to cancer combination therapies in Europe: current challenges and solutions. It highlights their importance and a promising scenario for the next five years. They are expected to increase from approximately 10% to 20% of new approvals, according to the document.
However, these therapies are “lagging behind”, says Efpia, in national pricing and reimbursement decisions. “Without further action, limitations in the availability of treatments and their consequences for patients are expected to increase,” the report says, adding that “if this challenge persists, manufacturers may be discouraged from investing in the development of combination therapies, limiting the potential for future research”.
In Spain, one of the countries where information was collected for the report, these barriers to access to combination therapies also exist. “Numerous combinations of drugs are being authorised in Europe that would increase the efficacy against the disease, but they are not reaching patients. This means that we have patients who could have a better approach to the disease. We need the administration to establish clear criteria that will allow their financing and allow them to reach patients without delay,” says Isabel Pineros, director of Farmaindustria’s Access Department.
Combination therapies are, in fact, one of the major therapeutic innovations that will have the greatest impact in 2024 – and are already having an impact – as outlined in Efpia’s pipeline of innovations, published in August 2022.
Pineros explains how combination therapies have come on strong in recent years: “Until recently we talked about these treatments as the oncology of the future, but they are already on the table. Progress has been made in research and now it is necessary to make it fundable.
Beyond the old classical chemotherapy combinations, the new immuno-oncology combinations, together with treatments targeting specific genes or proteins, approach cancer in a more personalised way, looking for synergies between molecules and thus beating the disease. “When we talk about cancer, we are not talking about a single disease, so we often tend to compare cases or think that there should be a single treatment for all patients. As research progresses, as the alterations become known, they are going to determine a different evolution. And, therefore, it needs a different approach,” Pineros explains.
The latest Access Indicators for Innovative Therapies in Europe (W.A.I.T.) report reveals that Spain is not in a good situation in terms of access to new cancer drugs. In the period 2018-2021 our country had 57% availability of new drugs, compared to 61% in the previous study. Moreover, in other neighbouring countries availability is much higher, with 72% in France, 76% in England, 83% in Italy and 98% in Germany.
The Farmaindustria spokeswoman stresses the need to seek solutions for combination therapies: “One of the options that could be considered is to establish pricing and reimbursement conditions per indication, instead of per medicine as is currently the case. This would be the best way to achieve funding for medicines when they are to be used in monotherapy and also in indications where they need to be combined with others. With the rise of this type of therapy, the pharmaceutical industry believes in dialogue with the Administration to find a solution to a problem faced by an increasing number of healthcare professionals who want to prescribe the best treatment for their patients.
Efpia’s report also assesses the situation and proposes formulas in which these drugs are evaluated on the basis of results or with systems that take into account that therapies can come from several manufacturers. In the next five years, 68 new cancer combination therapies are expected to be authorised. “There is a clear societal need to develop evaluation and pricing frameworks for combination therapies to ensure that patients have access to them in a timely manner,” the report says.
The aim, as Pineros stresses, is to “ensure that patients in need have access to these therapies and to do so, together with all stakeholders, seek solutions with different approaches and the necessary will, as the pharmaceutical industry has shown”.