Treatments delayed lead to lives lost.

Abstract

As we are all too painfully aware, heart failure patients, especially those with reduced ejection fraction (HFrEF), have a very poor prognosis and a life expectancy that is markedly shorter than even those with severe chronic conditions, including cancer.1-4 Over the past decade new drug classes and devices have demonstrated a significant mortality and morbidity benefit in HFrEF. However, despite reasonably rapid assessment by the European Medicines Agency and other regulatory bodies, the availability and implementation of these drugs/devices has remained limited, slow and sub-optimal. The uptake of drug therapies with ivabradine, sacubitril/valsartan and the implant of the devices for cardiac resynchronization therapy and defibrillation are well below their expected implementation rates if guideline-recommended use had been adhered to. In many European countries the access first to ivabradine and later to sacubitril/valsartan has been limited by administrative hurdles, that a sceptic may consider were designed with the intent of limiting their implementation. Despite their clear mortality/morbidity benefits, cardiovascular drugs in general are poorly regarded by National Agencies and regulatory bodies. It is worth remembering that more than 90% of the costs related to heart failure are not related to drugs at all, with 58% of the the total cost being attributable to rehospitalizations. A rapid implementation of heart failure therapies that are both life-saving and reduce hospitalizations can therefore provide a rapid return of investment for healthcare systems. Although most patients with HFrEF are treated with renin–angiotensin–aldosterone system inhibitors and beta-blockers, newer drug classes have in the last decade been shown to reduce mortality on top of these established drug classes. There is ample evidence to show that full implementation of drug therapy with all proven prognosis-modifying agents is associated with a 62% reduction in mortality and hospitalizations compared to conventional therapy.5 It has become increasingly evident that the sodium–glucose co-transporter 2 inhibitor (SGLT2i) drug class has a significant effect in reducing mortality and morbidity in heart failure. Despite being on the market for almost a decade (albeit initially only for diabetes) their access remains limited, even in many countries for the treatment of diabetes mellitus. These drugs have not, for example, been reimbursed in France until recently and in Italy their prescription is still limited to specialist diabetology centres. The SGLT2i agents, dapagliflozin and empagliflozin, have recently demonstrated a consistent and significant prognostic benefit in patients with diabetes mellitus, and in patients with heart failure, with and without diabetes mellitus. Given the significant clinical effect of these new drugs, we urge the national regulatory bodies in Europe to extend the coverage of these essential cardiovascular drugs to patients with heart failure, and to do so as matter of urgency. Every single day of delay in making heart failure drugs available for patients with heart failure will be associated with a significant loss of lives and an increased healthcare burden for which competent authorities should arguably be held to account.