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How drug reimbursement policies happen

Meet Malwina Hołownia-Voloskova - PhD, health economist, Health Tech Assessment (HTA) specialist and market access consultant. She's worked with all the big pharma companies including Roche, Pfizer and AbbVie. We sat with Malwina to learn more about HTA and its key role in guiding drug reimbursement policies.


Hi Malwina, thanks for joining us. Malwina, you're an HTA specialist. What is HTA?

Thanks for having me. HTA is a systematic evaluation of a given health product or service. It involves a literature review, cost effectiveness analysis, budget impact analysis, and sensitivity analysis. This evaluation is conducted by both governmental agencies and pharmaceutical companies, who create a dossier to submit to the governmental HTA agency. The HTA dossier is key to evaluate if a product or service should be reimbursed.

Does it mean that the HTA agency is the one deciding which product or service gets reimbursed?

Actually there is one more step before agreeing on reimbursement. The HTA agency's role is to provide advice, not to be the payer. The final decision rests with the Ministry of Health.

What are the advantages and the disadvantages of HTAs?

In my experience, Health Technology Assessments (HTAs) have both advantages and disadvantages. When it comes to popular drugs such as those used in cardiology or oncology, HTAs work well. However, when it comes to rare diseases, alternative approaches such as Multi-Criteria Decision Analysis or Value-Based Healthcare may be more suitable. And then there is the question of equity versus quality that HTA doesn't answer. Should you prioritize reimbursement for an expensive drug that addresses 1 case or a cheap drug that addresses 100 others?

Accumulating data for HTAs is expensive. Is that why there is so little done for Complementary and Alternative Medicine (CAM)?

Totally, HTAs prohibitive cost is a problem for CAM. How do you reimburse herbal therapies, which have been used for centuries but lack the necessary data to go through the HTA process?

So what is the solution to be reimbursed if you cannot benefit from an HTA?

It's a country by country thing. In countries such as the UK and Germany, there are ways to be reimbursed for medical technologies, such as acupuncture, even if there is no Health Technology Assessment in the first place. Governments may contact their HTA agencies and suggest that they assess the effectiveness of CAM and rare disease drugs too. Then there isn't the need for external funding. But that's very rare.

Could you tell us a little more about the HTA process?

Sure, when conducting a Health Technology Assessment, there are three parts: a systematic literature review, a cost-effectiveness analysis, and a budget impact analysis.

The systematic literature review involves searching for relevant publications using specific keywords in databases such as PubMed and BaseMedline. The Prisma scheme is then used to extract the necessary data from the publications and explain why other data was excluded.

The cost-effectiveness analysis involves comparing the cost of the medical technology to the cost of alternative technologies. This is done by calculating the cost-effectiveness ratio, which is the cost divided by the effectiveness. Different perspectives, such as societal and governmental, can be used to determine the cost.

The budget impact analysis is a six-step approach that involves selecting a population, timeframe, and horizon. A scenario is then created to determine the cost of not using the technology and the additional cost of using the technology. This allows for the budget impact to be calculated.There are several types of cost-effectiveness analysis, the most popular being cost-effectiveness analysis, cost-utility analysis, cost-benefit analysis, and cost-minimization analysis.

It seems very standardized. Would you say it's fair?

Yes, the process of assessing technologies is highly organized and fair, as all technologies are assessed in the same way.

How do you check the reliability and accuracy of the data?

To ensure the accuracy and reliability of the data it's important to follow the formal procedures of the country and to conduct sensitivity analysis. This involves changing the time horizon or using different studies to see what changes in the output it will cause. But no matter, it's important to keep in mind that it's only a model and may not reflect real life.

Is all this work public?

It's partly public, meaning that the data about the costs of the drugs is often not officially published. That's because HTAs are often done before a drug is released to market. However, the remaining data is published and can be found on various websites, such as on NICE in the UK. Actually HTA agencies always look at HTA results from other countries before publishing their own.

So you have an HTA in favor of reimbursing a drug. What are the typical challenges of implementing it?

Implementing an HTA can be challenging due to a lack of public funding. Even if an HTA report recommends reimbursement, the Ministry of Health may not have the necessary budget. This is something that is re-evaluated each year, and additional data or a re-evaluation of the HTA by different channels may result in a larger budget for the drug.

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