INTERIM HEALTH TECHNOLOGIES ASSESSMENT (HTA) IN ROMANIA. A proposal for a better transition to...

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INTERIM HEALTH TECHNOLOGIESINTERIM HEALTH TECHNOLOGIESINTERIM HEALTH TECHNOLOGIES ASSESSMENT (HTA) IN ROMANIA. ASSESSMENT (HTA) IN ROMANIA. ASSESSMENT (HTA) IN ROMANIA.

A proposal for a better transition to full HTA A proposal for a better transition to full HTA A proposal for a better transition to full HTA

Marian Sorin PAVELIU MD, PhD,

assoc. prof. At Titu Maiorescu University,

Bucharest Romania, dept. of Pharmacology

HEALTH POLICYManagement in health

XVII/3/2013; pp. 4-8

”Order”). This methodology of "interim HTA" - was in-tended as a form of transition to a future evaluation allow-ing a revision of the reimbursement drug list starting im-

mediately. Although it should have been a step forward in

introducing HTA, the new procedure does not approachthe minimum requirements of an economic evaluation; its

effects represent just another version of the previous legalframework.

From the standpoint of innovative medicines, the mainevaluation criteria are: the result of the evaluation in

France and the UK (1 point each), reimbursement status in

the rest of the EU countries (up to 2 points), the relativeeffectiveness (max. 2 points), the relative safety (max. 2 points) and the results reported by patients (max. 2 points).

Obtaining a minimum of 6 points draws the inclusion on

the reimbursement drug list.

Marketing authorizations holders must provide furtherinformation regarding (but without influencing the accep-

tance process):

• Choosing a comparator drug;

• Analysis of the budgetary impact, and

• The cost-effectiveness, as shown in published studies. [6]

Some of the drawbacks of the Order include:

• The absence of a time table for the transition from a

interim to a full HTA;

The scorecard used, decisive for accepting the compensa-

tion status, is not enough influenced by the reimbursement

status in other jurisdictions,

1. INTRODUCTION

Health Technology Assessment (HTA) is a multidis-

ciplinary process that aims to use multiple ap-

proaches and techniques in order to provide health policy makers with a broad perspective on products

or services designed to have access to public fund-ing. The assessment takes into account efficacy,

safety, efficiency, social, legal and ethical aspects,etc. A large range of medical interventions benefit

from HTA, such as: the introduction of a new drug

or a biological product, an intervention like organtransplant, a practice protocol, finally allowing a compari-

son of them. [1]

2. PREVIOUS EFFORTS AND RECOMMENDA-

TIONS FOR HTA INTRODUCTION IN ROMANIA

Introduction of HTA in Romania is a goal and effort to

start this process is dating back for more than a decade.The need of using HTA in health policy decisions in Ro-

mania was highlighted in 1992, following a study funded

by the World Bank. [2] [3] Even at the time, the use ofHTA was a well established process in many EU countries.For example, Spain has appealed to HTA specialists since

1988, and in 1991 was created the HTA Office in the Min-

istry of Health of Catalonia [4] National Institute forHealth and Care Excellance (NICE), the best known insti-

tution of this type in the world, was founded in the UK in

1999 [5].

The following will highlight a proposal for a methodology

which takes into account a modified version of severalrecommendations made for Romania by foreign consult-

ants and supplemented with measures to minimize the biasand direct involvement of officials in the interim evalua-

tion of health technology.

3. A CRITICAL ANALYSIS OF THE CURRENT LE-

GAL FRAMEWORK ON ACCESS TO THE REIM-

BURSEMENT DRUG LIST

After a period of six years, the authorities have not grantedaccess to the list of subsidized drugs due to substantial ar-rears toward drug manufacturers. In June 2013 the Minis-

try of Health (MoH) issued Order 724 (referred to as

For more than a decade health technologies assessment (HTA) introduction

in Romania was a recommendation made by various consultants engaged in

reforming the Romanian health system. In the last 6 years no new products have

been accepted on the reimbursement drug list. In the spring 2013 Ministry of

Health issued a new methodology for assessing pharmaceutical products,

considered to be a form of interim HTA, and to start the use of similar

methodologies to the ones used in most European countries.

We deem that this process is a stagnation or even a step backward in

introducing full health technology assessment and we listed some of the pressing

issues.

Given these shortcomings we presented a proposal for a methodology inspired

by some of the foreign consultants' reports, amended and completed with new

recommendations, with the purpose of ensuring the transition from 2015 to full

HTA, aiming ultimately for an increase in cost-effectiveness of the health system

and, eventually an increase in equity.

Keywords: HTA - Health Technology Assessment, health policy, health

reform, economic evaluation

4




XVII/3/2013; pp. 4-8

• comparable to the economic status of Romania; the

points awarded for efficacy and safety profile can beviewed as formal given that most products have al-ready passed through the filter of the European Medi-

cines Agency. It has qualified the the drugs in questionas being equal or greater to the the comparison treat-ment in terms of aforementioned criteria! Most of can-

didate products generally receive at least 6 points andlead to automatic compensation!;

• Budgetary Impact Analysis serves only an informative purpose; it is self-assessed and does not bind in any

way the manufacturer for undervaluation. This analy-sis could have been one of the main grounds for nego-

tiating the future sales of the reimbursed drug;

• The procedure does not indicate how the additional

costs will be covered and what will be the impact on

the pharmaceuticals budget; a welcomed measurewould have been to allocate a designated budget for

innovative medicines. In Romania over-spending ofthe reimbursed drug’s budget is supported entirely by

the drug manufacturers. Today drug producers have to“payback” to National Health Insurance House

(NHIH) around 10% of their income. An increase by10-15% in the market will force the manufacturers to

pay in addition to VAT, income tax, etc,. almost 25%of their turnover, which is unlikely to be accepted. The

reimbursement of new technologies will require a sub-stantive change to the payback system which will rise

the risk that this will leave behind a financial imbal-ance which will be difficult to manage for the NHIH;

• The Order fails to provide any negotiation mechanism

of the price after the new drugs will be accepted on thereimbursement list. Once the assessment is concluded,

the third party payer, NHIH, will be obligated to in-clude the new products on the reimbursed list without

having any legal means of negotiating the quantity

and/or price of the products;

• There is no procedure in place that can reevaluate over

the course of time the admission decision on the reim-

bursement list;

• The order does not provide evaluation of the productsalready reimbursed, some of which have questionable

cost and effectiveness. At least theoretically, in theabsence of any barrier, the Order allows drugs consid-

ered to be too expensive or even not cost-effective insome economically advanced countries to access the

list of subsidized drugs in Romania! In 2011, 30 of the

top 50 drugs ranked by spending were rated by NICEinternational consultants as being too expensive, con-

sidering the purchasing power of our country; [7]

• We believe that the current methodology marks a stag-

nation which will have negative consequences. It isnot based on a budget impact analysis which can lead

to malfunctions and arrears and thus waste the oppor-tunity to make a full assessment of more than 150

molecules and new indications.

In a previous issue of the journal [8], Radu and Pana raisedthe idea that different evaluation agencies usually come to

the same conclusions - giving the example of NICE (UK)and the SMC (Scotland) evaluations, the last one’s meth-

odology being more pragmatic and using far less re-sources; this could back up the idea for the use of evalua-

tion from other countries in the case of Romania or at leastthe most simplified methodology possible. The extrapola-

tion of study results without regard to the specifics of Ro-

mania is completely erroneous and misleading for the un-informed reader. There are supporters of the idea that theHTA process may be carried out centrally, at an EU level,

as the actual centralized licensing for a new drug. Article

15 of the Cross-border Patients’ Rights Direc-tive (2011/24/EU) includes cooperation on Health Tech-nology Assessment as relevant area for cooperation be-

tween Member States in the field of public health and setsup a voluntary network connecting national authorities and bodies responsible for HTA. In my opinion this is an im-

portant step to a harmonization of HTA around UE, butthe process will be long and difficult.[9]

The actual procedure requires mentioning the cost-

effectiveness indicator (incremental cost -effectivenessratios – ICER) as it was calculated using data from ad-

vanced economic countries. Several studies have shownthat the transfer of conclusions from studies conducted in jurisdictions of greater economic power than the target

countries is unlikely to be suitable and a proper adaptation

of these conclusions and results should be made. [10] Ro-mania does not meet most of the criteria for the transfer-

ability of cost-effectiveness studies and budget impactanalysis, and consequently, new studies should be per-

formed, using our country specific data.

4. PROPOSALS FOR THE TRANSITION TO A

FULL HTA IN ROMANIA

In order to properly defining the current assessment as‘interim’ the first step is to determine when and how a full

assessment of new technologies will be carried out. In ouropinion an interval of 6 to 9 months is sufficient for Ro-

mania to have a stabilized method of assessment and asufficient number of officials trained in HTA to verify the

validity of the assessments provided by the manufactur-

ers.

Our proposal is that the new drugs, which meet the mini-

mum criteria to be included in the evaluation process,should be accepted for financing under special conditions

for a period of 12 mothns with the possibility to extend foranother 6 months. In the first 12 months all the necessary

data will be gathered regarding the clinical efficacy, epide-miology and healthcare structure specific for Romania. In

the last 6 months of funding the producers will have tocomplete their studies and submit the results to the au-

thorities for a final reimbursement decision, without pa-

tients already receiving treatment in question to beforced to stop their treatment. 5



The transition period will be split into a series of

phases, some of them already suggested by inde-

pendent experts who advised the Romanian Govern-

ment. [7]

Phase I – cessation of ineligible products that are

ineligible

Given that Romania is among the EU's poorest

countries [11] - borrowing experience from some ofthe richest countries, like the UK or France, is inade-

quate. We believe that, for the moment, and at leastuntil the development of its own expertise, Romania

should rely on precedents set in five countries, withan close GDP / capita according to Eurostat -

namely Slovakia, Hungary, Estonia, Lithuania, Bul-

garia.A. Seiter proposed in his Pharmaceutical Sector

Analysis Report [12] a scorecard considering juris-dictions with close economic power superior to Ro-

mania. Each product would receive 2 points for theirstatus recorded unrestricted 1 pt - pt product regis-

tered with restrictions (limited number of patients,stated, price-volume, etc) and 0 points for unregis-

tered products.

For a product to qualify should accumulate at least 5 points obtained from the comparison with the

reference countries. A product reimbused with

restrictions in all 5 countries will accumulate 5 points. The same number of points can be obtainedif the two countries have unrestricted reimbursed the

product and one reimbused with restrictions.

In conclusion, if comparable countries with

Romania were given 2-6 years and have not decided

for listing, provided that all applicablecomprehensive economic assessment procedureswere used it is not appropriate for Romania to proceed

otherwise.

Afterwards products will be evaluated using specific crite-

ria as follows (see table 1):

From the special criteria the eligible items should accumu-late at least 7 points. In an extreme scenario, a productwould be intended only for the individual treatments

(1pct), have a higher price than current therapy (0 pts),

have clear advantages over current treatment (2 points),could be applied in Romania (2 points) and should be pos-

sible to prevent off-label administration (2 points).

Phase II Checking the provision of relevant informa-

tion of benefits compared with current standard of

care.

The the manufacturer’s submitted application will includeall the relevant data on cost-effectiveness of the product -

indicating studies that were submitted to the authorities in

other countries and those who came later.

Priority will be granted to studies using as a comparator

products already reimbursed in Romania. From these data

we can extract the number of QALY gain by introducingnew technology compared to standard technology, infor-

mation that will be used in the next step.

Phase III Setting budget and number of patient to be

treated in the transitional state till full HTA

- III.1 – Budget setting for each product

For each tranche of innovative products that will enter into

transitional reimbursement phase the Government / Parlia-ment will allocate a budget to them according to economic

opportunities.

Each product will be assigned a budget in accordance withthe number of QALYs generated (eg. Let assume the ap-

proved budget of 200 million Euros - and a total generated

of 50 QALY per patient gathered from all products6


XVII/3/2013; pp. 4-8

Table 1 - Special evaluation criteria for candidate pharmaceutical

products [after Seiter, modified] [12]

Special criteria Coding

The disease has a high im- portance for public health in

Romania 2= It affects Public health 1= It affects only certain individuals 0= other situation (Note = the most of products them will get

1 pct)

• The new treatment is not

more expensive than current

standard treatments in Ro-

mania

2= Is not more expensive 1=Is in a coplarable range (0-10% morethan current therapy) 0= Is more expensive than current therapy (Note = the most of products will receive

0 pct)

• The new treatment has

clear clinical advantagesover older treatments in a

way that patient’s wellbeing,

functioning or life expec-

tancy are improved in a sig-

nificant and relevant way

2= Has proven and semnificative advan-

tages in clinical trials.

1= Is a “mee too” drug. 0= Has no proven advantages. (Note = most of products will receive 2

pcts)

• It is possible to deliver the

new treatment according to

good practice in the Roma-

nian health system

(diagnostic tools available,

control instruments avail-

able etc.)

2= Similar medical practice in Romania 1= Is requesting supplimentary costs tomonitor the treatment 0 = there are not similar conditions com- pare to those where the drug was tested (Note = the most of products will receive

2 pcts)

Out-of-label use can be con-

tained easily 2= Out-of- label use can be prevented 1= Out-of- label use can be prevented ifadditional preventive measures will be

enforced 0= Out-of- label use can’t be prevented (Note = the most of product will get 2

pcts)




XVII/3/2013; pp. 4-8

Phase V-a Reassesement of data – at every 5 years

from acceptance on the reimbursment list

Given the changes in time of costs and prices of various

procedures and drugs entering the market, and the occur-

rence of new technologies, etc, periodically a reassess-ment of the initial decisions is justified. Reassessment ofthe initial evaluation will be based on the economic mod-

els originally submitted or using new studies that could be

carried out every 3-5 years.

DISCUSSION AND CONCLUSIONS

• This methodology would be a transition period, andsince 2015 all products will aspire to public financing

will opt for the use it or providing their own funded

studies using Romania data.

• NHIH may demand of the manufacturers of the first

150-200 medicinal products (ranked according cost per year / course) already reimbursed to produce sci-

entific evidence for a full HTA. During this evalua-tion a temporary price could be imposed, for exemple

low enough to cover the treatment of the patients ex-

isting on the waiting list.

• The same principles, with minor modifications, could

be applied to any other medical technologies that arecurrently publicly funded, such as devices, vaccines,

dialysis, etc.

• NHIH and/or MH must publish guidelines for emer-

gency budgetary impact assessment studies and for

studies of cost-effectiveness and to fund a clinical trial

for calibration of utility values specific to Romania.

• Agreeing on the the World Health Organization rec-ommendation for a threshold for ICER or Country

specific thresholds.• Integrated Information System (SIUI) should be ad-

justed to allow even before the introduction of elec-

tronic patient safety modules that act as patient regis-tries or disease used to assess new technologies under

evaluation.

• Products in transitional period of assessment should

not be taken into account in computing the clawback

tax.

• In 12 months the Ministry of Health should complete

training of officers who will be responsible for HTA.a year ago MS started a training process, a total of 15

physicians completing courses through a projectfunded by the World Bank specialists only one of

them beeing used in the current evaluation sys-

tem.

included; if a product that will generate 0.5 QALY will

receive a budget of 2 million for the transitional period of

18 months of assessment).

- III.2– Price setting for transitional state

For the transitional state the contract the price shall be de-

termined as follows (de facto HTA) [7]:

Where A - is one of the countries chosen by the manufac-turer of the 5 mentioned above provided that the product

has been fully reimbursed or with restrictions, PPP is pur-chasing power parity, GDP is Gross Domestic Product.This formula of calculation will be used only till 2015,

staring when producers will have to provide pharma-coeconomic evaluation performed entirely on their ex-

penses.

- III.3. - Determining the number of patients and

clinical centers that will be designated for administer-

ing a product in the transitional state

To achieve the purpose of the existence of a transitional

period - obtaining Romania specific data on the effective-ness and efficiency of the product a Phase IV clinical trialwill be run - meeting all the requirements laid down inlegislation, with the approval of the National Agency for

Medicines and Medical Devices.

The manufacturer will be responsible for bearing the costsof monitoring - including those related to implementation

of a disease or patients registry.

the number of patients will be determined by dividing the

allocated budget to each product to the treatment tran-

siently cost.

Phase IV full HTA

In the next 6 months after the first 12 months, the manu-

facturer will be able to provide to authorities all the neces-sary data used to perform the actual HTA, mainly for cost-

effective studes using comparator reimbursed in Romaniaand a full budget impact analysis. The collected data will

enable the achievement of other recommendations of vari-ous experts who have advised Romania – signing cost-

volume-outcome contracts or other forms of risk-sharing

contracts from more than 100 different types currently inuse around the world. Then authorities may decide unre-

stricted compensation of the product according to clinicalexperience and budgetary impact, limited compensation or

reject of the reimbursment request.

Prices in Romania = Price in country A X PPP adjusted acording GDP per capita in Romania

PPP-adjusted according GDP per capita in the country of reference

7




XVII/3/2013; pp. 4-8

tients who achieve the outcomes (pay for perform-

ance) [13].

• Such a system would also reduce the interim evalua-

tion bias and suspected corruption, imposing maxi-

mum transparency, aimeing for a higher standard as isthe case in all advanced countries.

• The prospect of implementing a full system of HTA in

2015 must be done simultaneously with the enactmentof a series of legislative changes such as the introduc-tion of new levels of compensation, the change of the

claw-back tax and the introduction of cost-volumecontracts, cost -volume-outcome and even switchingto contracts where payment to be made only for pa-

8

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health, 9:30-34., 2003;

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nology assessment initiative în România: an example for countries with limited experience of assessing health

technology, Int J Technol Assess Health Care, 2005 Fall; 21(4):522-5., 2005;

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sessment: Spain. Int J Technol Assess Health Care. 2009 Jul;25 Suppl 1:163-73., 2009;

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10. WELTE, R., FEENSTRA, T., JAGER, H., LEIDL, R., -A decision chart for assessing and improving the transfer-

ability of economic evaluation results between countries. Pharmacoeconomics. 2004;22(13):857-76; 2004;11. Eurostat: GDP per capita, consumption per capita and price level indices http://epp.eurostat.ec.europa.eu/

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s16762e.pdf descarcat în august 2013;

13. GARBER, A.M., McCLELLAN, M.B., -Satisfaction guaranteed--"payment by results" for biologic agents. N

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