The time they do not have: providing patients rapid access to innovation (Guest blog)
02.09.20
In the past several years, innovative medicines have reshaped the way we treat cancer. Yet we know patients and physicians often face significant delays in accessing new cancer treatments. The magnitude of the problem is quantified in the most recent Patients W.A.I.T. Indicator Survey conducted by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in 2019, which found that the average delay between market authorization and patient access for Oncology products ranges from 2 months to more than 2.5 years. (1)
To exemplify this, patients in Estonia and Latvia – at the high end of the spectrum – have to wait over 900 days until a novel cancer treatment is publicly reimbursed. That is 28 times longer than patients in Germany. Patients in France, which is in the middle of the spectrum, have to wait 560 days, 15 times longer than patients in Germany. This is time that many people diagnosed with advanced cancer do not have. (1)
Moreover, although many patients with advanced or metastatic kidney cancer in Europe have access to drugs in the first-line setting, access to potentially curative surgery and innovative treatments such as surgery and immuno-oncology remains limited. Barriers that have hindered these patients’ access to innovative treatments include complex regulatory and reimbursement pathways, reduced healthcare resources, and a lack of skilled healthcare workforce. (2)
Shortening the time it takes to get new treatments to patients is one of three priority areas of EFPIA’s Oncology Platform. One of the means to achieve this is to raise awareness of flexible access agreements and showcase good examples of practice. The recent approval of an innovative combination therapy (jointly developed by Merck and Pfizer) for advanced Renal Cell Carcinoma (RCC) by the UK’s National Institute for Health and Care Excellence (NICE) shows how important conditional approvals and use of real-world evidence (RWE) are in bringing innovative medicines to patients. Conditional approvals have the advantage of speeding new therapies to patients who need them based on positive safety and efficacy data – while enabling more comprehensive RWE to be supplied within a finite period of time to further confirm that the medicine is working for the patient.
At the European level, we call for an increased focus on rapid access to innovative treatments in Europe’s “Beating Cancer” Plan. We hope this Plan will emphasize trust in the use of real-world data, along with standardized data-collection practices and infrastructure. Industry is committed to playing its part in supporting the roll-out of these practices; Merck’s proactive participation in early access programs, such as the Early Access to Medicines Scheme (EAMS) initiative in the UK, is a sign of our commitment to this cause. We want to remain a key partner to governments, regulatory authorities, and patients in ensuring that we all have an effective innovation ecosystem that drives new treatments to patients as fast as possible.
At Merck we hope to give patients more time: more time to dream, more time to give back, more time to spend with loved ones.
But we know that the discovery and development of innovative new medicines is only part of the equation. We play our part, and policymakers must play theirs. Getting patients access to these new life-saving and time-giving therapies is key, because for patients, this is time that critically matters.
