The value of the market for medicines reimbursed by Germany's statutory health insurance funds grew by 4.2% year on year to EUR27.495 billion in the first nine months of 2016.
Implications | The growth was focused in the patent-protected market segment. |
Outlook | Changes set to be implemented under the Pharmaceutical Care Strengthening Act are likely to have a slight negative impact on the GKV market from 2017. |
GKV market value rises 4.2% y/y in January–September
In the first nine months of 2016, the value of the market for medicines reimbursed by Germany's statutory health insurance (GKV) funds – or "GKV market" – grew by 4.2% year on year (y/y) to EUR27.495 billion (USD29.215 billion), according to data from QuintilesIMS. This figure is based on the pharmacy retail price, with the mandatory discounts due from producers and pharmacies deducted, and also with the discounts on reimbursement prices negotiated between producers and the National Association for Statutory Health Insurance Funds (GKV-Spitzenverband) discounted. The GKV market's volume grew by just 1.8% y/y, according to the source, reaching a total of 530 million packages.
Strong sales growth for mAbs used in oncology
Particularly strong growth in terms of sales value was seen in a number of drug groups dominated by patent-protected originators. Sales of monoclonal antibodies used in cancer were up by 22.2% y/y, at EUR974.3 million, while, in volume terms, there was an increase of 19.1% in the sales of these. According to QuintilesIMS, an important reason for this is that an increasing number of cancer treatments are becoming available in the ambulatory sector. The source compares the proportion of the revenue from cancer medicines realised respectively in the ambulatory and inpatient sectors in Germany with those in other nations. Germany had the largest proportion realised in the ambulatory sector, with 73%. Indeed, in no other country included in the comparison (among which are the United States, Japan, France, and the United Kingdom) does the proportion realised in the ambulatory sector reach even half Germany's total.
Also growing substantially was the value of the sales of the direct factor Xa inhibitor group of anticoagulants, which increased by 36% to EUR748.4 million. In this group, the volume of sales grew by 33.3% y/y.
Discounts reduce costs of new HCV drugs dramatically
Noteworthy was the substantial decline of 37.7% y/y in the value of the sales of direct-acting antiviral agents (excluding HIV treatments), while, at the same time, the volume of these only dropped 1.2% y/y. This was due to the effect of the discounts negotiated on the reimbursement price of new hepatitis C virus (HCV) medicines used in interferon-free regimens.
More patent-protected drugs subject to discount contracts
Data from QuintilesIMS on the proportion of the value of sales in various market segments accounted for by medicines subject to discount contracts show that there was a strong increase in the importance of discount contracts in the patent-protected medicines segment. It is estimated that 25% of the patent-protected segment, by sales value, was accounted for by medicines subject to discount contracts in the first nine months of 2016, compared with 18% in the equivalent period of the previous year. In the generics and off-patent originator segments, the increase was substantially smaller.
The full report can be accessed here, in German.
Outlook and implications
The figures for the first three quarters indicate a slight increase in the pace of growth of the GKV market, considering that it was estimated to have grown by 4.1% y/y in the first half. Some of the dynamism in the growth in sales of patent-protected medicines can be ascribed to the transfer of certain therapies from the hospital to the ambulatory sectors. However, the stand-out feature of the GKV market remains the dynamic growth in sales of patent-protected drugs, and this is even despite the very large increase in savings from discounts negotiated with the GKV-Spitzenverband after benefit assessment procedures.
The increasing proportion of patent-protected treatments subject to discount contracts with GKV funds is a clear area of concern for the innovative industry. This may be exacerbated by proposed measures in the Pharmaceutical Care Strengthening Act to enable funds to sign discount contracts directly with producers for parenteral cytostatic preparations in oncology (see Germany: 13 October 2016: German SHI funds and pharma industry criticise cabinet draft of Pharmaceutical Care Strengthening Act). Changes envisaged in the aforementioned act are likely to have a slight negative effect on the market from next year (see Germany: 17 August 2016: Germany's draft Pharmaceutical Care Strengthening Act contains positives and negatives for pharma industry).