The Hong Kong Hospital Authority's Drug Advisory Committee (DAC) reviewed 17 drugs in July 2016 and issued six approvals, including German firm Boehringer Ingelheim's Pradaxa (dabigatran etexilate).
Implications | The nine rejections include US company Bristol-Myers Squibb's programmed cell death protein 1 (PD-1) inhibitor Opdivo (nivolumab) due to lack of cost effectiveness, although the precise indication applied for was not specified. |
Outlook | Swiss firm Roche's Gazyva (obinutuzumab) and Kadcyla (trastuzumab emtansine), and Danish company Novo Nordisk's Victoza (liraglutide) were included in the Hospital Authority's drug formulary for the first time, which is expected to lead to an uptick in sales. |
The Drug Advisory Committee (DAC) of Hong Kong's Hospital Authority reviewed 17 drugs in July, issuing six approvals and nine rejections, with two decisions still pending.
Drug | Company | Therapeutic class | Primary reason for rejection |
|---|---|---|---|
Approved | |||
Xalkori (crizotinib) | Pfizer (US) | Malignant disease and immunosuppression | N/A |
Pradaxa (dabigatran) | Boehringer Ingelheim (Germany) | Cardiovascular | N/A |
Victoza (liraglutide) | Novo Nordisk (Denmark) | Endocrine system | N/A |
Gazyva (obinutuzumab) | Roche (Switzerland) | Malignant disease and immunosuppression | N/A |
MabThera (rituximab) | Roche | Musculoskeletal and joint disease | N/A |
Kadcyla (trastuzumab emtansine) | Roche | Malignant disease and immunosuppression | N/A |
Pending | |||
Ilaris (canakinumab) | Novartis (Switzerland) | Musculoskeletal and joint disease | Pending further information |
Afinitor (everolimus) | Novartis | Malignant disease and immunosuppression | Pending further information |
Rejected | |||
Saphris (asenapine) | Merck & Co. (US) | Central nervous system | Lack of high quality level of evidence to demonstrate its efficacy Alternative(s) available in HADF with comparable benefits |
Imbruvica (ibrutinib) | Janssen (subsidiary of Johnson & Johnson, US) | Malignant disease and immunosuppression | Insufficient comparative studies versus existing treatment Insufficient evidence of long-term clinical outcome benefits |
Procough (levodropropizine) | DongKoo (South Korea) | Respiratory | Alternative(s) available in HADF with comparable benefits |
Opdivo (nivolumab) | Bristol-Myers Squibb (US) | Malignant disease and immunosuppression | Justification of treatment''s cost in relation to its benefits is insufficient |
Keytruda (pembrolizumab) | Merck & Co. (US) | Malignant disease and immunosuppression | Justification of treatment''s cost in relation to its benefits is insufficient |
Pomalyst (pomalidomide) | Celgene (US) | Malignant disease and immunosuppression | Justification of treatment''s cost in relation to its benefits is insufficient |
Stivarga (regorafenib) | Bayer (Germany) | Malignant disease and immunosuppression | Justification of treatment''s cost in relation to its benefits is insufficient |
Tepadina (thiotepa) | Adienne (Italy) | Malignant disease and immunosuppression | Alternative(s) available in HADF with comparable benefits |
Xeljanz (tofacitinib) | Pfizer (US) | Musculoskeletal and joint disease | Insufficient evidence of long-term safety |
Source: Hospital Authority Drug Advisory Committee (July recommendations, announced in October) | |||
Outlook and implications
Although Hong Kong's DAC does not specify the exact indication for which drugs are given approval by the Hospital Authority (HA), it is nevertheless possible to glean from the HA drug formulary (available here) which active pharmaceutical ingredients (APIs) have been included for the first time, for any indication.
Among these are Roche's Gazyva and Kadcyla, and Novo Nordisk's Victoza, all of which are listed as self-financed without safety net. These first-time inclusions in the HA's drug formulary are expected to lead to an uptick in sales for the companies, as the drugs gain access to Hong Kong's public hospitals.
However, neither BMS's PD-1 inhibitor Opdivo nor Merck & Co's Keytruda (pembrolizumab) were added to the formulary on cost-effectiveness grounds. If and when they are next under consideration by the HA, there is likely to be price negotiation of the kind that has been seen in Japan and New Zealand, with authorities looking to drive reimbursement prices down by effectively playing the two drug makers off against each other.