Many countries use Health Technology Assessment (HTA) organizations to evaluate the clinical and economic impact of new therapeutic interventions. In some markets, HTA outcomes directly link to reimbursement decision-making based on the manufacturer's submitted price (e.g. NICE and SMC [UK]). In others, the HTA outcome leads to price negotiations with manufacturers by a separate body (e.g. HAS/CEPS [France] and G-BA/GKV [Germany]). This research compares major examples of each approach to inform a discussion on whether such price negotiations align with HTA best practice.

Publically-available technology assessment outcomes for G-BA/GKV, NICE and SMC (01/01/2011-31/12/2015) were extracted and compared.

Of 112 G-BA benefit assessments, 45 percent offered no additional benefit with automatic reference pricing; 55 percent offered additional benefit, qualifying for price negotiations; 77 percent had prices negotiated, 14 percent had price fixed by court, and eight percent withdrew from market. Of 156 NICE Single Technology Appraisals, 51 percent were recommended, 17 percent restricted, 20 percent not recommended, and 12 percent non-submissions. Of 497 SMC appraisals, 35 percent were accepted, 28 percent restricted, 17 percent not recommended and 19 percent non-submissions. Forty-eight percent and 24 percent of NICE and SMC positive appraisals were associated with a Patient Access Scheme (PAS), with 86 percent and 88 percent being simple discounts schemes, respectively.

Making reimbursement decisions for new medicines based on a clear set of criteria may be the most objectively fair and transparent method of HTA; however, as the NICE and SMC examples show, although strong downward price pressure is exerted (high frequency of PASs), this may come at the cost of many therapies (~33 percent) being denied access. By contrast, the flexibility enabled by a distinct price negotiation phase may enable more therapies access, as shown by the G-BA/GKV example (<10% medicines withdrawn). Nevertheless, the relative effectiveness of the downward price pressures, a key determinant of HTA process effectiveness, cannot be compared due to the confidential nature of UK PAS discounts.