The Hong Kong Hospital Authority (HA) Drug Advisory Committee (DAC) reviewed 21 drugs in October, approving 13 including Gilead Sciences (US)'s hepatitis C virus treatment Harvoni (sofosbuvir + ledipasvir).
Implications | Although the DAC does not release the exact indications for which treatments are reviewed, this marks Hong Kong's first approval of Harvoni after it approved Gilead's Sovaldi (sofosbuvir) in January. |
Outlook | The DAC's approvals are expected to lead to an uptick in sales for the sponsor companies, and indicate that despite the publicly-funded Health Authority's increasing focus on cost-effectiveness, reimbursement of innovative treatments is picking up pace. |
The Hong Kong Hospital Authority's Drug Advisory Committee (DAC) reviewed 21 drugs in October, issuing 13 approvals (of which two are approved in principle), and five rejections, with three pending a decision.
Drug | Company | Therapeutic class | Primary reason for rejection |
|---|---|---|---|
Approved | |||
Humira (adalimumab) | AbbVie (US) | Musculoskeletal and joint disease | N/A |
Eliquis (apixaban) | Bristol-Myers Squibb (US), Pfizer (US) | Cardiovascular | N/A |
Inlyta (axitinib) | Pfizer (US) | Malignant disease and immunosuppression | N/A |
Duratocin (carbetocin) | Ferring (Switzerland) | Obstetrics, gynaecology, and urinary-tract disorders | N/A |
Jardiance (empagliflozin) | Boehringer Ingelheim (Germany) | Endocrine system | N/A |
Afinitor (everolimus) | Novartis (Switzerland) | Malignant disease and immunosuppression | N/A |
Opsumit (macitentan) | Actelion (US) | Cardiovascular system | N/A |
Mifegyne (mifepristone) | Laboratoire Exelgyn (France) | Obstetrics, gynaecology, and urinary-tract disorders | N/A |
Elidel (pimecrolimus) | Valeant (Canada) | Skin | N/A |
Harvoni (sofosbuvir + ledipasvir) | Gilead Sciences (US) | Infections | N/A |
Herceptin (trastuzumab) | Roche (Switzerland) | Malignant disease and immunosuppression | N/A |
Approved in principle | |||
Eklira Genuair (aclidinium) | Almirall (Spain) | Respiratory system | N/A |
Duaklir Genuair (aclidinium/formoterol) | AstraZeneca (UK) | Respiratory system | N/A |
Pending | |||
Ilaris (canakinumab) | Novartis (Switzerland) | Musculoskeletal and joint disease | Pending for further information |
Avastin (bevacizumab) | Roche (Switzerland) | Malignant disease and immunosuppression | Pending for further information |
Xtandi (enzalutamide) | Astellas (Japan) | Malignant disease and immunosuppression | Pending for further information |
Rejected | |||
Zykadia (ceritinib) | Novartis (Switzerland) | Malignant disease and immunosuppression | Lack of high quality level of evidence to demonstrate its efficacy |
Lignopad (lidocaine 5% medicated plaster) | Teikoku Seiyaku (Japan) | Anaesthesia | Alternative(s) available in HADF with comparable benefits |
Ofev (nintedanib) | Boehringer Ingelheim (Germany) | Respiratory system | Insufficient evidence to demonstrate significant clinical outcome benefits |
Esbriet (pirfenidone) | Roche (Switzerland) | Respiratory system | Insufficient evidence to demonstrate significant clinical outcome benefits |
Brintellix (vortioxetine) | Lundbeck (Denmark) | Central nervous system | Alternative(s) available in HADF with comparable benefits |
Source: Hospital Authority Drug Advisory Committee (October recommendations, announced in November)© 2016 IHS | |||
No extra detail was provided, with the DAC declining to respond to IHS Markit enquiries on the exact indications for which the drugs were reviewed.
However, this marks Hong Kong's first approval of Harvoni after it approved Gilead's Sovaldi (sofosbuvir) in January (see Hong Kong: 8 February 2016: Hong Kong's DAC approves six drugs including Gilead's Sovaldi, AbbVie's Viekira Pak).
Outlook and implications
The DAC's approval decisions are expected to lead to an uptick in sales for the sponsor companies, and indicate that despite the publicly-funded Hong Kong Health Authority's stretched finances and increasing focus on cost-effectiveness, reimbursement of innovative treatments is picking up pace.
The approval of Gilead Sciences (US)'s Harvoni comes months after the DAC approved HCV treatments Sovaldi and Viekira Pak (ombitasvir + paritaprevir + ritonavir + dasabuvir), offering significantly expanded options for patients in the city-state, where under 0.5% of the population carry the virus. Despite Hong Kong's relatively low prevalence of HCV, the DAC's approval is a positive, given Gilead's falling sales of both Sovaldi and Harvoni (see United States: 3 November 2016: Gilead's antiviral sales drop 12% y/y in Q3, as Harvoni/Sovaldi realise 44% revenue declines).
In particular, the approval of Novartis (Switzerland)'s Ilaris (canakinumab) is a significant positive, given a decision by the DAC had been pending since January 2016. The DAC decision follows three new approvals by the US FDA for periodic fever syndromes (see United States: 26 September 2016: Novartis' Ilaris gains US approval for three rare periodic fever syndrome conditions).
In addition, the DAC's approval of Actelion (Switzerland)'s pulmonary arterial hypertension (PAH) drug Opsumit (macitentan) is expected to support continued strong sales of the drug, which drove company growth in the third quarter (see Switzerland: 20 October 2016: Actelion reports 17% y/y increase in product sales for Q3, driven by strong Uptravi launch).