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The Evolution of HTA in Emerging Markets Health-Care ... - TREE

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OHE Consult<strong>in</strong>g Report for PhRMA<br />

5 January 2011<br />

Figure 3. Taiwan Drug Review Process<br />

A3.7 Pric<strong>in</strong>g <strong>of</strong> New Drugs<br />

Doherty, et al. (2004) note that there are, at least, three methods used to determ<strong>in</strong>e the price <strong>of</strong><br />

new pharmaceuticals: (1) the <strong>in</strong>ternational median price <strong>of</strong> 10 countries, (2) the <strong>in</strong>ternational price<br />

ratio us<strong>in</strong>g treatment comparators and (3) the treatment course or daily cost us<strong>in</strong>g treatment<br />

comparators. Advantages or disadvantages <strong>of</strong> new products, along the dimensions <strong>of</strong> efficacy,<br />

dosage form and pharmacok<strong>in</strong>etic pr<strong>of</strong>ile, are considered <strong>in</strong> decisions to <strong>in</strong>crease or reduce price.<br />

Pharmaceutical companies provide evidence to experts <strong>in</strong>vited by the BNHI and a drug benefit<br />

committee. Evidence from RCTs are required (with preference for head-­‐to-­‐head comparisons <strong>of</strong><br />

efficacy and safety) whilst submission <strong>of</strong> pharmacoeconomic evidence is encouraged <strong>in</strong> 2008.<br />

In 2010, a new “Pric<strong>in</strong>g Pr<strong>in</strong>ciples” document was issued by the Bureau <strong>of</strong> National <strong>Health</strong> Insurance<br />

(BNHI, 2010). A dist<strong>in</strong>ction is made between Category I and Category II new drugs, and the<br />

reference pric<strong>in</strong>g benchmarks and pric<strong>in</strong>g rules are different for the two categories. For a new drug<br />

to be <strong>in</strong> Category I, drug license holders must justify a “substantial cl<strong>in</strong>ical improvement” via head-­to-­‐head<br />

or <strong>in</strong>direct comparison. Category 2A new drugs exhibit at “moderate improvement, while<br />

Category 2B new drugs have similar cl<strong>in</strong>ical outcomes as therapeutic reference class products.<br />

Category I drugs are priced (i.e., reimbursed) at the median <strong>of</strong> 10 reference countries (with a 10%<br />

premium if a Taiwanese trial <strong>of</strong> a reasonable scale has been done). <strong>The</strong> pric<strong>in</strong>g <strong>of</strong> Category II drugs<br />

100

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