Industry Survey Lays Bare Huge Disparities In Access To New Drugs In Europe
Executive Summary
A new survey has shown wide differences in patient access to new medicines across, and even within, European countries, with time to access after drug approval ranging from 100 to 1,000 days. Industry has put the blame on factors such as duplicative clinical assessments, the length of HTA processes, and local formulary decisions.
The wide disparities in patient access to medicines in Europe have come under scrutiny again after updated industry data showed that patients in some European countries sometimes have to wait seven time longer than those in other countries to obtain the same medicine, with access problems being noticeably more acute in the southern and eastern European markets.
In terms of average speed to patient access after marketing approval, Germany topped the rankings, followed by Denmark and Switzerland. The worst performers under this measure was Serbia, followed by Lithuania and Portugal. In terms of the "rate of availability", ie, the number of medicines actually available to patients under a reimbursement scheme in European countries, the UK leads the field.
The “Patient WAIT Indicator” survey was published by the European pharmaceutical industry federation EFPIA. Nathalie Moll, EFPIA's director general, said the reasons for the disparities were often multi-factorial but were almost never clinical.
The survey found that the average delay between a product being authorized for marketing and its availability to patients “can vary by a factor greater than X 7 across Europe, with patients in Northern/Western Europe accessing new products 100-200 days after market authorization and patients mainly in Southern/Eastern Europe between 600-1,000 days.”
Moll said that whatever the reasons for the disparities in access, they were "at the expense of patients’ health and it’s time all actors in the healthcare system come together to address Europe’s access to medicines challenges.”
The survey, which was produced for EFPIA by the biopharmaceutical services company IQVIA, covers 121 new products that gained a centralized EU marketing authorization between January 2015 and December 2017, with the cut-off point for availability being Dec. 19, 2018.
It measures the average time between marketing authorization and access, as well as the rate of availability. A total of 30 countries (24 EU countries plus Iceland, Macedonia, Norway, Serbia, Switzerland and Turkey) were included in the study.
In terms of average speed to patient access after marketing approval, Germany came first at 119 days, followed by Denmark (146 days), Switzerland (171) , the UK (209) and the Netherlands (220). The worst performers were Portugal (634 days), Lithuania (726) and Serbia (925). As for the rate of availability, the UK led the field, followed by Germany, Austria, Denmark and Italy, while bringing up the rear were Lithuania, Latvia, Serbia and Macedonia.
Orphans, Oncology
The survey found that the rate of availability for orphan medicines in more than 80% of the countries was lower than for all products between 2015 and 2017, and that the average delay between marketing authorization and patient access ranged from four months to three years.
By contrast, the rate of availability of cancer drugs was higher than that for all products in 73% of the countries, while the average time to patient access varied from two months to more than 2.5 years.
Even within countries there are large variations in speed of patient access to newly approved medicines. “In fact in many cases,” Moll observed, “the level of variation within a country is greater than between countries. For example, in Estonia the shortest delay was 21 days and the longest 1,443 days, in Ireland the variance was 0 days to 1,321 days and in Austria 33 days vs. 1,383 days.”
"The reasons behind these delays are often multi-factorial, rooted in the medicines access systems and processes in the EU member states” – Nathalie Moll, EFPIA
The reasons behind these delays are often “multi-factorial, rooted in the medicines access systems and processes in the EU member states,” Moll said. “These can range from duplicative clinical assessments to the length of an HTA process, reimbursement delays, local formulary decisions, even IT processes. Access delays are not simply a question of economics but concerns over affordability of new medicines and the sustainability of healthcare play a part. Delays in access can also be used as a cost containment measure.”
The high prices of some new drugs, particularly biologic medicines, have indeed been causing concern among national payers and health technology assessment bodies, as typified by products such as Vertex's Orkambi in the UK. (Also see "‘Extreme Outlier’ Vertex Slammed For Orkambi Pricing Approach In England" - Pink Sheet, 8 Mar, 2019.)
But as Moll points out, the reasons for the disparities in access are “almost never clinical." She says that "patients in one part of Europe should not have to wait seven times longer for a new medicine than citizens in another country. Patients living with one condition in a country should not have to wait longer than a patient living with a different condition. Access to medicines should be based on your clinical need not your post code.”
Ireland Sluggish
Commenting on the survey, Irish industry body the IPHA noted that Ireland ranked 20th for speed of access to new medicines, with patients waiting on average 486 days for some drugs. “By contrast, Denmark, with a population size similar to our own, has a wait time of 146 days. Last year, their figure was 155 days,” IPHA commented. The average wait time across Europe countries was 413 days, it added.
IPHA also said that when it came to the availability of new medicines (ie, the number of drugs available to patients), Ireland “continues to be in a poor position, ranking 16th out of the 27 countries.” Only 42% of the new medicines licensed for prescription to patients in the EU in 2015, 2016 and 2017 “were available and reimbursed in the health services here at the end of 2018.”
Oliver O’Connor, IPHA chief executive, said the data were part of a growing trend of evidence showing that Ireland has a “severe problem” accessing new medicines.
“We rightly aspire to be among the best in Europe,” O’Connor said. “For example, government policy is to achieve cancer survival rates among the top seven countries in Europe. Our speed of access to medicines needs to be the same to deliver that. Ireland actually has income per capita comparable with, or even higher than, countries like Germany, Belgium, Denmark and Spain. Yet, we lag these and many other countries in speed of access to new medicines.”
From the editors of Scrip Regulatory Affairs.