HTA Audit

 

Welcome to HTA Audit

Financing and organisation of the health care system are areas of social life which are subject to constant change both in Poland as well as worldwide. Therefore, it is of key importance that decisions in these areas always be taken in an objective way and basing on the most current knowledge.

Such an approach may in consequence lead to improvement of the health care system with regard to:

  • streamlining access to health benefits,
  • rational use of funds with regard to financing health car,
  • improving the quality of health services,
  • increase in patient satisfaction with regard to medical health benefits obtained and in consequence
  • improving the health status of the society.

We are looking forward to cooperating with you!

 
 

Company

HTA Audit has operated on the market since 2008. By way of the Associates’ decision, in November 2010 it took the form of a general partnership.

We deal with quality assessment (audit) of clinical and economic studies in the field of health care, health technology assessment reports. We meet our clients’ expectations in the area of strategic decision making with regard to pricing of drugs and medical technologies, negotiations and risk-sharing.

We employ qualified analysts who meet the criteria of proficient command of English, thoroughness and perceptiveness, ability of fast learning, teamwork and self-reliance, an innovative approach to solving problems, and above all a thorough knowledge in the areas of:

  • Evidence Based Medicine, EBM
  • Heath Technology Assessment, HTA
  • current legal regulations and organisational solutions in health care.

In times of limited resources available in health care, it is important that valuable therapeutic or diagnostic technologies can be within reach of patients who need them. It is also essential that ineffective, non-cost effective, and above all harmful technologies are eliminated from daily clinical practice. We believe that by controlling the quality of reimbursement documentation in the broad sense, our activities contribute to taking equitable reimbursement decisions in the health care system.

Therefore HTA Audit is not engaged in business, marketing or public relations activities.

We provide a reliable, objective and professional approach to every project.

Associates:

Leszek Stabrawa
Economist, public health specialist; in the years 2003-2005 Chief Specialist in the Drug Policy and Pharmacy Department Ministry of Health; expert in health economics; expert in the market access, pricing and reimbursement; lecturer of Central and Eastern European Society of Technology Assessment In Health Care (CEESTAHC).
Anna Kordecka
Expert in health technology assessment and health economics. For several years she has been specialising in quality assessment (audits) of analyses included in HTA reports. Author and co-author of systemic studies in healthcare and scoping aiming at determining the directions and scope of analyses required for reimbursement and pricing purposes. Lecturer of the Central and Eastern European Society of Technology Assessment In Health Care (CEESTAHC). Active instructor in the fields of EBM, HTA and Pricing in public institutions and the pharmaceutical industry.

 

Services


Audit
An audit makes it possible to verify the quality of an HTA report, its compliance with the HTA guidelines, MoH and AOTMiT formal requirements as well as the precision and validity of inference. It may also be helpful in verifying the competition’s HTA reports or their verification analyses published on the AOTMiT’s website.

An audit serves as a quality benchmark for analyses included in the health technology assessment report. The assessment of the study pertains to its usefulness in the decision-making process regarding reimbursement, i.e. the possibility of it being used in examining applications for financing of health technologies from public funds regarding the criteria for taking reimbursement decisions (in the broad sense of that term).

To accommodate the Commissioning Party’s needs, HTA Audit provides two types of audit:

  • A basic audit entails conducting a quality assessment without verifying the calculations. The basic audit includes a compliance assessment with regard to the HTA guidelines and the regulation of the Minister of Health of 2 April 2012 on minimum requirements to be met by analyses included in reimbursement applications.
  • An in-depth audit includes the basic audit as well as an additional verification of calculations, an analysis of key source studies and often also collecting and analysing additional data or information not included in the audited document.


Opinion
An opinion on the HTA report has a more limited scope that the basic audit. It is based on superficial reading and inspection of the elements or the content of a publication within the time frame specified by the Commissioning Party in the commission. It constitutes a basis for formulating a position on a specific topic included in the paper which is the subject of the opinion. It is a very useful tool for double-checking results of verification analyses on the competition’s HTA reports published on the AOTMiT website.

The Commissioning Party is allowed to use parts of the Opinion or other reviews without indicating the authors’ names, the Contractor’s logo nor name, always presenting the position as its own.

Competitive emerging technology report, CETR
CETR projects aim at reducing uncertainty related to not only to the assessment of the product’s efficacy in the current competitive environment but also in respect of technologies which are beyond the horizon and which alter the competitive conditions in a given market segment. In the report we present possible financing options for a given technology, by using the value-based pricing method we estimate the price at which competitive products can enter the market and we also estimate the impact on the payer’s budget for the specific area. CETR is created taking into consideration individual determinants and specificity of the decision problem.

HTA Audit carries out comprehensive horizon scanning of the medical area of choice along with a critical appraisal of available sources of medical information. CETR includes both an analysis of the competition (justification for the selection of comparators for the health technology in question) as well as the possible market access strategies related to introducing the said health technology into the Polish market. For the purpose of determining the technology’s market potential we perform an assessment of the said health technology’s therapeutic and pharmacological innovativeness and determine the added value in comparison to possible treatment options. Assessment of the said technology’s strength of intervention takes into account the level of uncertainty of estimates. With the above-mentioned data in mind we determine the most likely future effective price of the health technology in question or those from beyond the horizon adjusted by price erosion and possible types of RSS.


Scoping analysis
A scoping analysis sets out the directions and scope of the analyses included in the reimbursement application dossier (clinical analysis, economic analysis, BIA) and indicates the method of financing of the health technology from public funds in Poland.
A scoping analysis takes into account the following aspects:

  • description of the health problem,
  • current guidelines and clinical standards in a given indication – in Poland and worldwide,
  • detailed description of the intervention in question,
  • detailed description of treatment options,
  • current status of financing treatment options in the indication in question from public funds in Poland,
  • a preliminary clinical analysis,
  • justification of comparator selection,
  • the proposed scope, directions and methods of analyses required to apply for financing a health technology from public funds in Poland.


System analyses
HTA Audit prepares system analyses on issues of health care and its financing in the context of emerging needs or threats.

Main areas of the system analyses are:

  • an analysis on risk and opportunities associated with changes in specific guaranteed health care services,
  • a market analysis, competitive environment analysis as well as proposals of system changes for given guaranteed health care services which would better comply with the evidence-based health care (EBHC) principles,
  • an HTA report feasibility study which sets out the directions and scope of the analyses included in the reimbursement application dossier along with an indication of the method of financing of the health technology from public funds in Poland.


Fundholding
HTA Audit offers a comprehensive solution entailing preparation of a reimbursement application dossier for products applying for reimbursement. It includes preparation of all necessary documents (HTA report, risk-sharing schemes, reimbursement application) which meet the formal requirements.

HTA Audit prepares and coordinates drafting of the HTA report on behalf of the Commissioning Party. HTA Audit commissions preparation of the HTA report to a company which provides such services. HTA Audit supervises the works at each stage of drafting of the report. After the report has been drafted, HTA Audit performs an audit of the report, both in terms of content and of meeting the formal requirements included in the guidelines of the Agency for Health Technology Assessment and Tariff System in Poland and the regulation of the Minister of Health of 2 April 2012 on minimum requirements to be met by analyses and provisions of the Act of 12 May 2011 on reimbursement.

In result the Commissioning Party receives high-quality reimbursement applications, verified and ready for submission.

Training courses
HTA Audit has extensive experience in running training courses in the following areas:

  • EBM,
  • HTA,
  • pricing,
  • market access,
  • drafting risk-sharing scheme proposals.


Other services

  • Reviews of primary and secondary research,
  • Popularising, sponsored press articles related to EBHC,
  • Drafting risk-sharing scheme proposals or rebate proposals based on audited or revived analyses,
  • Drafting protocols for control registers, clinical registers as well as clinical and economic registers,
  • Audit or reviews of primary and secondary, clinical and economic study protocols.


 

Partners

Our clients are the biggest pharmaceutical companies and manufacturers of medical devices.
We performed HTA audits and other studies audits for the majority of Polish companies which prepare HTA analyses.
Our clients include foreign partners.

 

Contact
HTA Audit Stabrawa Kordecka Spółka Jawna
31-032 Kraków, ul. Starowiślna 8/2
NIP: 675 144 04 12, REGON: 12 13 75 829,
National Court Registry No. 0000369216
phone +48 12 42 22 381
email: sekretariat@htaaudit.eu

Associates:

Leszek Stabrawa – President
Anna Kordecka

Employees:
We employ graduates of Public Health, economist
and statistician.


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