ISPOR 15th Annual European Congress

3-7 November 2012, ICC Berlin, Berlin, Germany

Forum:
PATIENTS AND THEIR ROLE IN MARKET ACCESS:
WHERE IS THE PLACE AND WHAT IS THE ROLE OF
PATIENTS IN REIMBURSEMENT SYSTEMS?
- Romania Speaker:
Paul Radu, MD, PhD, ISPOR Romania
Market Access Manager
Roche Romania

ISPOR Romania Presentation for Berlin

Authors:
Paul Radu, MD, PhD
Market Access Manager, Roche Romania
paul.radu@roche.com
Ioana BIANCHI, MD, Public Health Specialist
President, ISPOR Romania Regional Chapter and counselor
to the Minister of Health, Romania
ioanabianchi@yahoo.com
Sorin PAVELIU, MD, PhD
Associate Professor at Titu Maiorescu University,
Pharmacoeconomics Department, Bucharest, Romania
sorinpaveliu@yahoo.com
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Presentation Content
Market access and reimbursement systems

Role of patients
Romanian situation

Conclusions

Market access in health care

Reflects the openness of the health care market to
goods (drugs, materials, medical devices, etc.) and
health care services
Particularities are derived from the specifics of the
health care market:
Not a free market
High costs for many goods and services
Very often conditioned by the role of the third-party
payer (insurance company, Government etc.)
Strongly regulated
4

Market access (MA) in pharmacoeconomics (1)

The process used by a company to bring a drug on
the market and to make it available (accessible) to
the patients
Multiple stakeholders involved in the MA process,
with different perspectives:

Medical/clinical developers
Product marketing teams
Health care providers
Patients
Payers
Regulatory bodies etc.
5

Market access (MA) in pharmacoeconomics (2)

Emerging aspects influencing MA:
Rising costs of drugs increase pressure on/from payers
Increasing concern over safety and ensuring benefits
exceed risks
Role of HTA in providing evidence on the drug added
value
Greater demand for evidence development on drug
effectiveness that translates into improved health
outcomes

Reimbursement system (1)

The key stakeholder influencing market access in
health care is the third-party payer (i.e.
reimbursement system)
Most European countries have reimbursement
systems based on compulsory insurance schemes via:
Public general taxation (e.g. UK, Italy, Spain etc.)
Social health insurance run by public /private institutions
(e.g. Austria, France, Germany, Romania, Slovakia, etc.)

Few countries have reimbursement systems based on

voluntary insurance schemes (Swiss, US)
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Reimbursement system (2)

The system needs to be strongly regulated to
maintain a balance between parties :
The insured/patient who asks for more services and less
payment
The providers want to get more value for their goods or
health care services
The payer who has to maximize benefits for patients
within available funds and satisfy own interests (e.g.
profit, political influence etc.)

The reimbursement systems are key to market

access
8

Role of patients (1)

Different perspective between patients and
potential patients (i.e. the insured healthy
population)
The insured healthy population:
Pay the premium/taxes thinking at its potential health care
needs
Have the willingness to participate in decisions who
support a rationale and efficient use of resources (in order
to be sure that they can benefit in case of need)

Role of patients (2)

The patients (the consumers):
Think and live for the present
Ask for the best NOW!
Want to feel that they get what they need, based on
their payments

Both patients and insured population have to be

involved in the decisions about their health and
health care through Patient Empowerment (PE):
Individual empowerment linked with patients
Community empowerment linked with insured people

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Individual patient empowerment

The individuals ability to make decisions and have
control over his or her personal life and health
Patient empowerment
Begins with information and education,
Seeking out information about own illness or condition,
Actively participating in treatment decisions

Empowerment requires an individual to take care of

him and make choices from the options
recommended by the doctor

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Community patient empowerment

Individuals act together to gain greater influence
and control over the determinants of health and
quality of life in their community
A person has to take an informed position and make
an informed choice; it involves conscious effort at
the policy-making level to ensure that informed
participation is possible
Community empowerment becomes an integral
element of the health care reform

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Patient empowerment and reimbursement

Empowerment key word = adherence, i.e. the
involvement in joint decisions (with payer) regarding
use of resources.
Challenges:

How much funding for health care/drugs?

Which illness to cover (allocative efficiency)?
Which treatments to reimburse (technical efficiency)?
Patients requests vs. patients needs
People mobility (more specific for EU)
Access of patients to new drugs/technologies
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Romania example some data

Population 21,7 million , 10% are working abroad

GDP =12.300 USD/per capita (PPP-2011)
GDP growth in 2010 = -1,3%, in 2011 = +1,5%
Inflation rate 2011 = 5,7%, expected in 2012 = 3%
520 hospitals (public and private) and around 137.000
beds (6,3 beds/1000 inhabitants)
50.267 doctors in 2008 (2,3 doctors per 1000
population)
Life expectancy: 76,7 years (female), 69.5 (male) in 2008
Infant mortality: 11/1000 (2008)
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Drugs reimbursement in Romania (1)

Compulsory health care insurance system run by
the National Health Insurance House (NHIH)
Financed mainly from employer and employee
taxes (5,2+5,5%), contributions of free
entrepreneurs and State Budget subsidies:
~ 4,0 bn Euro in 2011 from ~ 6 mil. contributors

Very small market for voluntary private health

insurance (~ 10 mil. Euro), mainly for ambulatory
services and emergency transportation

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Drugs reimbursement in Romania (2)

Ministry of Health (MoH) covers emergency care,
public health, National Health Programs and
investments:
Revenues from the earmarked taxation of alcohol,
tobacco etc. and from the State Budget
~1 bn Euro in 2011

Main decision bodies:

Ministry of Health (MoH)
National Health Insurance House (NHIH)
ANMDM (National Agency for Drugs and Medical Devices)
Local authorities (for public hospitals)

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Health Care Provision & Financing Medical

services in Romania
Parliament

Budget financing

Insurance based financing

- budget controller

Budget financing

Ministry of Health

Health service payer

Regulator and Payer

HTA Unit
Covers some preventive
services and preventive part
National Programs
Establish reimbursement lists

Medical Services List

Am bulatory & Hospital Care,
Reference Prices for drugs

Drug Delivery

Social Health Insurance

Taxation on alcohol, drugs

National Health
Insurance House

Medical Services Delivery

Patients
Population

Em ployer & Em ployee Taxes 5,2+5,5%

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Access to innovative medicines: the process (1)

Step 1: Drug registration based on EMA centralized
procedure
Step 2: Dossier filed at MoH for Romanian price
Reference price based on lowest price in 12 EU
countries!

Step 3: Once the drug has a price, it can be sold,

but it is not yet reimbursed by the public payers
Most innovative treatments could become available
to patients only if included on the Reimbursed
Drugs List
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Access to innovative medicines: the process (2)

Reimbursed Drugs List last updated in 2008
(a politically driven process and requires a Government
Decision)
The official process to gain access to the List:
Appraisal and positive recommendations from the MoH
Transparency Commission (to be replaced by the approval of
the HTA Unit from MoH)
Approval from the MoH
Publication though a Government Decision of the new List

There is a constant struggle from pharma companies

and patients associations, for better patient access to
innovative treatments.
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Access to innovative medicines: the process (3)

A formal HTA unit was created within MoH to
evaluate the new medicines or new indications and
to support decision-making (the unit will most likely
functional as of December 2012)
Increased pressure on the public funds for the health
system
Decreased budget for drugs in 2012 compared with
drugs expenditures in 2011
Existing clawback taxation reduces the Government
expenditures on drugs (5,9 mil. RON in 2012 ~ 1,3 bn
Euro).
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Access to innovative medicines: the process (4)

The HTA Unit is not yet functional
but criteria were developed for the Reimbursement
Dossier:
Relevant clinical studies results
Relevant costeffectiveness studies from France and UK

Status and level of reimbursement in the EU countries

Price approved in Romania
Prices approved in other EU countries
Daily cost and average total cost of treatment
Cost comparison with drugs used for same indication etc.
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The Reimbursed List in Romania

Drugs reimbursed by the NHIH, incl. those in National Programs
T o tal reimbursement expenses

N a t ional Health Insurance H ouse

H ospitals drugs

R e i mbursement lists

M i nistry of Health
N a t ional Health Programs

Sublist A, 90% reim bursement

Sublist C2, 1 00% reimbursement
Sublist B, 50% reimbursement

t hrough transfer of funds to N HIH

Sublists C1, C3 100% reimbursement

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The regulations for MA pharmacies (1)

Drugs from the Reimbursement List for
ambulatory care are dispensed as follows:
For drugs from sublists A, B, C1 and C3 (oral, IV, IM or SC
formulation) through the open-circuit pharmacies
For drugs from sublists C2, oral formulation through the
open-circuit pharmacies

For drugs from sublists C2, IV, IM or SC formulation

through hospital pharmacies
Maximum prices for open and hospital pharmacies are
established by the MoH
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The regulations for MA pharmacies (2)

For all drugs the prescription has to be done on
generic name (INN) with brand name only for posttransplant drugs
Physicians could prescribe also in some cases on
brand name, but providing a clear documentation
of the case
In open-circuit pharmacies the patient should cover
the % from the reference price not covered by the
NHIH, and the difference from the reference price
to the pharmacy price
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The regulations for MA hospitals

Hospitals have to organize a public tender for each
INN, each formulation and each presentation mode
Drugs dispensed through the hospital pharmacies,
are covered 100% (of the reference price)
It means that all drugs have to be sold in hospitals at
the reference price!

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Patient role in reimbursement Romania (1)

Patients not directly involved in any of the steps
regarding MA or reimbursement
Formally the population is involved in:
NHIH administration through the representative of
unions and employers
Definition of basic packages of care and the Reimbursed
List through the Government representatives and
through negotiations with representatives of patient
associations, BUT

Patients/population voice is too quiet compared

with the loud voice of unions, employers, political
parties etc.
Often they have to buy and to bring drugs for the
hospitalization period due to their lack in hospitals
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Patient role in reimbursement Romania (2)

Example 1 :
The new law regarding co-payment established a direct
negotiation with patient associations in the moment of
establishing the co-payment

Results: the process of co-payment regulation is blocked,

because the patients refuse any type of co-payment in
the social insurance scheme (in addition to unofficial
out-of-pocket payments)!
Whilst the Government is pressured to introduce copayment as part of the Memorandum with IMF, WB and
UE
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Patient role in MA Romania (1)

According to regulation and because of INN
prescription, the patients could decide on the drugs
delivered in open-circuit pharmacies, but:

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Patient role in MA Romania (2)

There are several issues and alternatives for patients:
They have to pay the user charges above the reference
price and the % from reference price not covered by the
health insurance
Usually they follow the recommendations of the
prescribing physician (as long as funding is available as
copayment
The pharmacies should dispense the drugs at the reference
price (unless the patient declares that he wants a specific
brand within the same INN), BUT in case of several brands
the availability of drugs is based on their commercial
benefits.
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Patient role in MA Romania (3)

Example 2:
The prescription on INN is compulsory in Romania
Based on some AEs from switching the post-transplant
immuno-suppression medication, physicians and patients
requested a change in prescription and reimbursement of
such medication
Consequently the authorities modified the rules and
for this medication the prescription should be done both
on INN and brand level, therefore the reimbursement is
100% from the full price of the drug (not the reference
price only!)

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Patient role in MA Romania (4)

The new HTA legislation considers patient
involvement: patients are invited to participate in
discussions over the resolution of decision
regarding the drugs that were not approved for
introduction on the list
Patients associations are very active in supporting
the reimbursement of new drugs as long as they
dont have to make any additional out of pocket
payments.
Also the patient associations and media are pushing
for removal of the waiting lists, which reduce
patient access to drugs for several serious
conditions (e.g. cancer).
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Patient role in MA Romania (5)

Example 3: The MoH published the draft of a new
Health Reform Law, waiting for feed-back from the
different stakeholders (incl. patients):
In several public conferences, the Minister of Health
declared that the feed-back from the society is very
reduced and it seems that the health system reform is
not on the public agenda of the population/patients
Even if patient associations, professional associations,
unions etc. claim that they are not involved in the health
reform, there are situations when they dont participate
in the public debate, or their messages are not
consistent:
It reflects a lack of education on their specific role!
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Patient opinion regarding reimbursement

in Romania
IMAS published (Sept. 2012) results of a survey on
the behavior of Romanian citizens facing drugs
consumptions
Most Romanians would like to get access to modern
medicines (including drugs), but without additional
payment,
88,5% from Romanians consider that its necessary to get
access to new drugs for serious diseases (hepatitis,
cancer, diabetes etc.), but most of them do not agree to
pay more for health insurance premium and
Most of the responders (72%) dont agree an increase of
the health insurance premium with 1,5% (which would
affect 7% of their income).
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Conclusions
There are too few visible initiatives to increase patient
education and information regarding health/health
care
In Romania patients are seldom involved in the
consultations regarding the reimbursement process
Most of discussions regarding reimbursement are on
the level of payment/co-payment and there is little
room for other aspects (effectiveness, efficiency, ethics
etc.)
Patients are not seen as key stakeholders in the
decision-making processes
Patients become important (are used? ) when there
are reimbursement decisions with quick political
impact!
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