Forum Patients and Their Role in Market Acess

7/26/2019 Forum Patients and Their Role in Market Acess

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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

[email protected]

Ioana BIANCHI, MD, Publ ic Health Specialist

President, ISPOR Romania Regional Chapter and counselor

to the Minister of Health, [email protected]

Sorin PAVELIU, MD, PhD

AssociateProfessor at Titu Maiorescu University,

Pharmacoeconomics Department, Bucharest, Romania

[email protected]

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Presentation Content

Market access and reimbursement systems

Role of patients

Romanian situation

Conclusions

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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

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Market access (MA) in pharmacoeconomics (1)

The process used by a company to bring a drug onthe 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.

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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

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Reimbursement system (1)

The key stakeholder influencing market access inhealth 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 onvoluntary 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 patientswithin available funds and satisfy own interests (e.g.

profit, political influence etc.)

The reimbursement systems are key to market

access

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Role of patients (1)

Different perspective betweenpatientsandpotential 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)

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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 andhealth 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 havecontrol 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. theinvolvement 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 examplesome 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)14


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Compulsory health care insurance system run bythe 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

Drugs reimbursement in Romania (1)

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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 Heal th Insurance House (NHIH)

ANMDM (National Agency for Drugs and Medical Devices)

Local authorities (for public hospi tals)

Drugs reimbursement in Romania (2)

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Parliament- budg et controller

National HealthInsurance House

Health service payerMinistry of HealthRegulator and Payer

Ambulatory & Hospital Care,Reference Prices for drugs

Medical Services List

Patients

Population Employer & Employee Taxes 5,2+5,5%

SocialHealth

Insurance

Covers some preventivese rvices and preventive part

National Programs

Establish re imbursement lists

Budget financing Insurance based financing

Drug Delivery Medical Services Delivery

Health Care Provision & Financing Medical

services in Romania

HTA Unit

Budget financing

Taxation

on

alcohol,dru

gs

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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 List18


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Reimbursed Drugs Listlast 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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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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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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Drugs reimbursed by the NHIH, incl. those in National ProgramsThe Reimbursed List in Romania

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T o tal reimbursement expenses

Na tional Health Insurance House M i nistry of Health

Ho spitals drugs

Re i mbursement lists

Su bli st A, 90 reimbursement

Sublist B, 50 reimbursement

Sub lists C1, C3 100 reimbursement

Na tional Health Programs

Su bli st C2, 100 reimbursement

th ro ugh transfer of funds to NHIH


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Drugs from the Reimbursement List forambulatory 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

The regulations for MApharmacies (1)

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For all drugs the prescription has to be done on

generic name (INN) with brand name only for post-

transplant 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

pharmacies (2)


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Hospitals have to organize a public tender for eachINN, 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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The regulations for MAhospitals

Patients not directly involved in any of the stepsregarding 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 ReimbursedList through the Government representatives and

through negotiations with representatives of patientassociations, BUT

Patients/population voice is too quiet comparedwith the loud voice of unions, employers, politicalparties etc.

Often they have to buy and to bring drugs for thehospitalization period due to their lack in hospitals

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Patient role in reimbursementRomania (1)


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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 inthe social insurance scheme (in addition to unofficialout-of-pocket payments)!

Whilst the Government is pressured to introduce co-payment as part of the Memorandum with IMF, WB andUE

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Patient role in reimbursementRomania (2)

According to regulation and because of INNprescription, the patients could decide on the drugsdelivered in open-circuit pharmacies, but:

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Patient role in MA

Romania (1)


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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 theprescribing physician (as long as funding is available ascopayment

The pharmacies should dispense the drugs at the reference

price (unless the patient declares that he wants a specificbrand within the same INN), BUT in case of several brands

the availability of drugs is based on their commercialbenefits.

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Patient role in MARomania (2)

Example 2: The prescription on INN is compulsory in Romania

Based on some AEs from switching the post-transplantimmuno-suppression medication, physicians and patientsrequested a change in prescription and reimbursement ofsuch medication

Consequently the authorities modified the rules andfor this medication the prescription should be done bothon INN and brand level, therefore the reimbursement is100% from the full price of the drug (not the referenceprice only!)

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Patient role in MA

Romania (3)


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The new HTA legislation considers patientinvolvement: patients are invited to participate indiscussions over the resolution of decisionregarding the drugs that were not approved forintroduction on the list

Patients associations are very active in supportingthe reimbursement of new drugs as long as theydont have to make any additional out of pocketpayments.

Also the patient associations and media are pushing

for removal of the waiting lists, which reducepatient access to drugs for several seriousconditions (e.g. cancer).

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Patient role in MARomania (4)

Example 3: The MoH published the draft of a newHealth Reform Law, waiting for feed-back from thedifferent stakeholders (incl. patients): In several public conferences, the Minister of Health

declared that the feed-back from the society is veryreduced and it seems that the health system reform isnot on the public agenda of the population/patients

Even if patient associations, professional associations,unions etc. claim that they are not involved in the healthreform, there are situations when they dont participatein the public debate, or their messages are notconsistent:

It reflects a lack of education on their specific role!

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Patient role in MA

Romania (5)


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IMAS published (Sept. 2012) results of a survey onthe behavior of Romanian citizens facing drugsconsumptions Most Romanians would like to get access to modern

medicines (including drugs), but without additionalpayment,

88,5% from Romanians consider that its necessary to getaccess to new drugs for serious diseases (hepatitis,cancer, diabetes etc.), but most of them do not agree topay more for health insurance premium and

Most of the responders (72%) dont agree an increase ofthe health insurance premium with 1,5% (which wouldaffect 7% of their income).

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Patient opinion regarding reimbursement

in Romania

There are too few visible initiatives to increase patienteducation and information regarding health/healthcare

In Romania patients are seldom involved in theconsultations regarding the reimbursement process

Most of discussions regarding reimbursement are onthe level of payment/co-payment and there is little

room for other aspects (effectiveness, efficiency, ethicsetc.)

Patients are not seen as key stakeholders in thedecision-making processes

Patients become important (are used?) when thereare reimbursement decisions with quick politicalimpact!

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Conclusions

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