In addition to various publications dating back to circa 2010, consulting firms specializing in Pharma and Biotech have reported an increased stringency in health technology assessment (HTA) processes especially in Europe. The causes are PESTLE and ultimately demonstrate that a wait-and-watch strategy is not effective negotiation. Special interest has been paid to rare and ultra-rare diseases due to the interest in the commercialization of advanced therapeutic medicinal products (ATMPs), however, nearly all products that are approved for reimbursed in these countries require an assessment in addition to regulatory approval. Unfortunately, company estimates of profitability and peak sales are typically affected both through timing/uptake and price suggesting that recent asset valuations in the news are also drastically warped.
This study design builds on secondary and primary market research previously conducted on behalf of clients and colleagues while working for Lifescience Dynamics (UK). APAC (except China and Japan), LatAm, and MEA have not been thoroughly evaluated for market entry requirements though documentation exists with information on key stakeholders in the national healthcare systems. Due to economic and political factors in low-to-middle income countries, the scope drastically shifts to involve national governments and NGOs. Health Techonology Agencies and assessments are most commonly observed in high-income countries.
Should Pharma decide to focus mostly on commercial operations in the United States, the implications to high-income countries could be far beyond the profits of the overall company. Value-based contracts are an evolution from rebates/discounts commonly seen in the U.S. and are rooted in utilizing HEOR studies of RWD to keep manufacturers accountable. They are also not always required if sufficient clinical and economic evidence is provided. For project timelines, sample sizes, and additional considerations, please contact us for further consultation!