This presentation summarises the results of experts interviews aiming to identify the key factors which have influenced the access and the uptake of direct acting antivirals (DAAs) in selected European countries. This qualitative piece of analysis was conducted as part of a larger project studying the development and the diffusion of innovation in the market of treatments for hepatitis C. The interviews shed light on the reimbursement strategies and other factors, relating to the ability of individual health care systems to supply the treatments, which may have influenced, positively of negatively, access and speed of uptake of DAAs in Europe. Author(s) and affiliation(s): Margherita Neri, Office of Health Economics; Mikel Berdud, Office of Health Economics; Martina Garau, Office of Health Economics; Phill O’Neill, Office of Health Economics; Chris Sampson, Office of Health Economics; Adrian Towse, Office of Health Economics. Conference/meeting: EuHEA Conference 2018 Location: Maastricht, Netherlands Date: 11/07/2018

1. Key factors driving access and
uptake of hepatitis C treatments
in Europe. Results from experts
interviews
Margherita Neri, Office of Health Economics (OHE)
EuHEA Conference
11-14 July 2018, Maastricht

2. The key factors for the access and uptake of hepatitis C
treatments in Europe
Acknowledgements
This study was funded by a research grant
from Gilead Sciences Ltd
I thank the other authors of the study:
Mikel Berdud, Martina Garau, Phill O’Neill,
Chris Sampson, Adrian Towse

3. The key factors for the access and uptake of hepatitis C
treatments in Europe
Outline
1. Aims
2. Methods
3. Results
4. Discussion
5. Limitations
6. Conclusions

4. The key factors for the access and uptake of hepatitis C
treatments in Europe
Aims
• Berdud M, Garau M, Neri M, O’Neill P, Sampson C, Towse A, “R&D,
competition and diffusion of innovation in EU: the case of Direct Acting
Antivirals (DAAs) for hepatitis C”
• The objectives of Berdud et al. were to explore whether:
i. Existing IP incentives – including SPCs – allow in-class competition whilst
on-patent in European markets for DAAs (i.e. France, Germany, Italy,
Portugal, Spain, UK)
ii. In-class competition led to price decreases, hence facilitated patient
access to and uptake of DAAs in European markets
iii. Other factors related to the characteristics of the healthcare system and of
the condition, played a role in determining prices and access to DAAs
• Use results from quantitative analysis (interviews) to interpret uptake patterns
of the quantitative analysis

5. The key factors for the access and uptake of hepatitis C
treatments in Europe
Methods
• Semi-structured interviews to identify key factors that have influenced
positively and negatively access and uptake in the selected countries
(France, Germany, Italy, Portugal, Spain, UK)
• For each country, we recruited interviewees with clinical and decision
making expertise (HTA or payers representatives) on the provision of
HCV treatments
• We secured interviews with 12 experts
Clinicians
HTA experts/ payers
representatives
France x
Germany x x
Italy x x
UK x x
Spain x x
Portugal x x
Pan-European expert
x

6. The key factors for the access and uptake of hepatitis C
treatments in Europe
Results
• We identified factors with an impact on (i) uptake onset, (ii)
speed of adoption and (iii) degree of competition
• We classify these factors into “Pricing & Reimbursement (P&R) and
funding mechanisms” and “other factors”
• Budget impact was very large and represented a challenge for all
countries
P&R and funding mechanisms
• Controlling the patient population
treated
• Funding arrangements (budget cap,
specific budget for HCV treatment)
• Commercial agreements impacting price
• Encouraging market forces
• Enabling early access
Other Factors
• Nature of treatment
• Service delivery
• Health system capacity

7. The key factors for the access and uptake of hepatitis C
treatments in Europe
Results - P&R and funding mechanisms
• In the UK, 12-week treatment was first authorised for
compassionate use and then annual patient quotas were
introduced (10,000 patients per year)
• Italy established seven eligibility criteria (extended to 11 in
2017)
• In Spain and France, priority was given to patients with liver
fibrosis, or patients awaiting transplant/ with liver transplant
complications
In the first years of DAAs, eligibility criteria were
introduced to prioritise the most severe HCV patients
1. Controlling the
patient population
treated

8. The key factors for the access and uptake of hepatitis C
treatments in Europe
Results - P&R and funding mechanisms
 In the UK, the budget for HCV was increased to £190 million in
2015 from £40 million the year before (NHS England, 2015)
 France set annual caps on HCV total spending, the so called ‘W
rate’ (€450 million in 2014, €700 million in 2015 and €600
million in 2016 and 2017)
 Some countries such as Portugal, Italy and Spain set specific
budgets for funding DAAs and chose other mechanisms to limit
total expenditures (price-volume agreements)
Some countries set budget caps to control
expenditures, others introduced specific budgets for
funding DAAs
2. Funding
Arrangements

9. The key factors for the access and uptake of hepatitis C
treatments in Europe
Results - P&R and funding mechanisms
• The UK, Portugal and Germany achieved direct discounts on
list prices
• Italy and Spain used price-volume agreements
• In Portugal, outcome-based agreements (pay-for-cures) not
considered effective at lowering prices due to poor monitoring
of patient outcomes and high cure rates of DAAs
Negotiation of deals on DAAs prices, price-volume
and outcome-based agreements
3. Commercial
agreements
impacting price

10. The key factors for the access and uptake of hepatitis C
treatments in Europe
Results - P&R and funding mechanisms
• In the UK, biannual tendering processes: access is provided to
the treatment associated with the lowest price bid
• Italy, and Spain, accelerated their HTA or P&R processes to
foster access of new entrants
Use of market forces to reduce prices and acceleration of
HTA/ P&R processes to accelerate access of new entrants
4. Encouraging
market forces
• In France, sofosbuvir was reimbursed through a temporary
authorisation for market use (ATU)
Authorisation for reimbursement and/or use before
marketing authorisation
5. Enabling early
access

11. The key factors for the access and uptake of hepatitis C
treatments in Europe
Results - P&R and funding mechanisms
1. Controlling
the patient
population
treated
X X X X
2. Funding
Arrangements
(budget caps,
specific
budgets for
HCV)
X
(budget cap)
X
(specific
budget for
HCV)
X
(specific
budget for
HCV)
X
(specific
budget for
HCV)
X
(budget cap)
3. Commercial
agreements
impacting price
X X X X X
4. Encouraging
market forces X X X
5. Enabling
early access X X X

12. The key factors for the access and uptake of hepatitis C
treatments in Europe
Results – other factors
• Diagnosis and treatment with DAAs are seen as worthwhile and
effective by patients and clinicians
Expanded patient population suitable for treatment, improved
efficacy compared to interferon-based treatments
1. Improved nature
of treatment
Opportunity to decentralise and localise the system of
prescribing, to be driven by addiction centres and general
practitioners (GPs)
2. Possible
simplification of
service delivery
• More effective at reaching ‘vulnerable’ patient groups including
people who inject drugs (PWID)
• However, this transition appears not to have taken place yet in
the countries considered:
• In Germany and the UK nurses cannot prescribe new treatments
for HCV

13. The key factors for the access and uptake of hepatitis C
treatments in Europe
Results – other factors
• Testing is common among high risk groups, drug and alcohol clinics and, to
a certain extent, in prisons
• The effort to identify new patients has increased over time in response to
the availability of budgets for treatment and lower prices. Nonetheless,
current testing strategies are still patchy
Testing for HCV is routinely performed in specific patient groups
and settings
3. 1 Health system
capacity
The capacity of health systems to prescribe and administer
treatments for HCV varied across countries
3. 2 Health system
capacity
• Appropriate distribution and number of HCV treatment centres in Germany,
Spain and the UK
• In Italy and France, capacity constraints resulting in some instances in
waiting lists

14. The key factors for the access and uptake of hepatitis C
treatments in Europe
Discussion
• How do the factors identified relate to the (i) uptake onset, (ii) speed
of adoption and (iii) degree of competition, as observed in the
uptake analysis?
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France ItalyGermany
Portugal Spain UK

15. The key factors for the access and uptake of hepatitis C
treatments in Europe
Discussion – uptake onset
• Part of the fast access of DAAs in all countries was due to
DAAs’ improved clinical outcomes compared with
interferon-based treatments and their cost-effectiveness
• In France, early adoption was facilitated by existing
arrangements that prioritise early access to medicines
(e.g. ATU in France)
• In Germany and the UK early adoption was facilitated by
the launch-HTA sequence
Uptake charts

16. The key factors for the access and uptake of hepatitis C
treatments in Europe
Discussion – speed of adoption
• In France and Italy, restrictions on patients eligibility and
bottlenecks due to health system capacity constraints may have
limited the speed of uptake
• In the UK, the uptake has been slow due to strict treatment
eligibility, as determined by compassionate use and patient
quotas (10,000 patients per year c.ca).
Patient volumes have increased over time as a result of lower
prices and the eradication target
Uptake charts

17. The key factors for the access and uptake of hepatitis C
treatments in Europe
Discussion – degree of competition
• In Spain and Italy, competition has been encouraged through
accelerated HTA and P&R timelines of competing products.
Both countries struck price-volume agreements leading to
potential discounts in the order of 60% of the list price
• In the UK, the tendering process introduced in 2016 is based
on the awarding large market shares to the companies bidding
the lowest prices
• Portugal is the only country showing “limited competition”.
The small size of the market may have rewarded first entrant
and not attracted additional entrants
Uptake charts

18. The key factors for the access and uptake of hepatitis C
treatments in Europe
Limitations
1. The information collected in the interviews was based on
convenience sample of 12 interviews
• Although we covered most relevant expertise in most
countries, a larger sample including both national and
regional (or local) payers and HTA bodies would have
increased the accuracy of the evidence
2. We were not able to collect information with the
same level of detail and consistency for all countries.
Information on price agreements was confidential or not
readily available in certain countries (e.g. Germany and
Portugal)

19. The key factors for the access and uptake of hepatitis C
treatments in Europe
Conclusions
• The uptake analysis showed that the European system of
IP incentives has not hindered the development of in-class
and in-patent competition in the market of DAAs
• In-class and in-patent competition is a necessary but not
sufficient condition for early adoption and fast uptake
• Results from the interviews suggest that characteristics of
the healthcare system and institutional factors of each
country can affect, positively or negatively, the adoption
of new medicines

20. The key factors for the access and uptake of hepatitis C
treatments in Europe
References
INFARMED, 2015. Define os critérios clínicos de doentes no acesso a medicamentos para o tratamento da
Hepatite C e a assunção de garantias de cumprimento de prazos e critérios que assegurem equidade de acesso
dos doentes aos respetivos tratamentos e por consequência a integração no Formulário Nacional de
Medicamentos. In: Contencioso, G. J. e. (ed.). Legislação Farmacêutica Compilada.
Mouterde, A.-L., Bocquet, F., Fusier, I. and Paubel, P., 2016. Hepatitis C: how has France limited the expenses
related to new treatments? : Taylor & Francis.
NHS England, 2015. Thousands more patients to be cured of hepatitis C [Online]. Available:
https://www.england.nhs.uk/2015/06/patients-hep-c/.

21. The key factors for the access and uptake of hepatitis C
treatments in Europe
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