The Danish Health and Medicines Authority has published five assessment reports on behalf of the Reimbursement Committee in the country.
IHS Global Insight Perspective | |
Significance | The Reimbursement Committee at the Danish Health and Medicines Authority (DHMA) has approved general reimbursement for five innovative drugs. The announcements were published by the DHMA separately in early-to-mid September and the assessment reports are available via the DHMA's website, in Danish, here. |
Implications | The decisions concern major multinationals from Europe's Boehringer Ingelheim (Germany) and Asia's Eisai (Japan), to North America's Medicare Link (United States). The decisions were all made in accordance with the Danish Health Act. |
Outlook | Although there were several reimbursement decisions published by the DHMA's reimbursement committee this month, the structure for drug reviews in Denmark is soon to undergo a significant change as the Ministry of Health reportedly plans to create a new agency, inspired by the United Kingdom's National Institute for Health and Clinical Excellence (NICE). |
The Danish Health and Medicines Authority (DHMA) has published five assessment reports on behalf of the Reimbursement Committee (Medicintilskudsnævnet), reflecting positive funding decisions for the following innovative drugs.
Innovative Drugs Approved for Funding, September 2012 | ||||
Drug | Company | Reimbursement Category | Market Approved Indication | Reimbursement Details |
Jentadueto (linagliptin, metformin) | Boehringer Ingelheim (Germany) | General reimbursement | For the treatment of adult patients with type 2 diabetes mellitus as supplement to diet and exercise to improve glycaemic control in adult patients who have inadequately controlled their maximum tolerated dose of metformin alone, or patients who are already being treated with a combination of linagliptin and metformin in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adults who have not adequately controlled their maximum tolerated dose of metformin and a sulphonylurea. | The drug was granted funding for its film-coated tablets and the basis for the review was the treatment comparison with individual products of linagliptin or metformin, or to the combination comprising metformin with either vildagliptin or sitagliptin. The committee justified its positive funding decision claiming Jentadueto's price to be proportionate in relation to its therapeutic value when compared to the aforementioned treatment alternatives. The decision may be re-evaluated as per the ongoing assessments of diabetes drugs in the country. The full review is available, in Danish, here. |
Onytec (ciclopirox) | POA Pharma Scandinavia (Sweden) | General reimbursement | For the treatment of adults with mild to moderate infections caused by nail fungus, matofyter, yeasts and moulds without involvement of the nail bed/lunula. | The evidence for the decision was based on clinical trials showing that Onytec carried significantly superior clinical effects in comparison to Mycofen (ciclopirox; Nycomed, subsidiary of Takeda, Japan) after 82 weeks treatment with 12 weeks follow up. The committee subsequently found Onytec to be appropriately priced in relation to the efficacy of Onytec, compared to the alternative treatment. The full review is available, in Danish, here. |
Fycompa (perampanel) | Eisai AB (Japan) | General reimbursement | For the treatment of partial seizures with or without secondary generalisation in patients aged 12 years and older, with epilepsy. | The review comprised a comparison between Fycompa and treatment with other antiepileptic drugs used for adjunctive treatment of partial seizures. It was noted in the review that there are no existing studies available with add-on treatment. Eisai's drug was approved for reimbursement in Denmark in the aforementioned indication, despite its many side effects as it was demonstrated that its price in relation to clinical benefits was reasonably set. No price details were disclosed. The decision is available, in Danish, here. |
Hydromed (hydrochlorothiazide) | Medicare Link (United States) | Hydromed (hydrochlorothiazide) | For the treatment of hypertension; edema associated with congestive heart failure; and edema from any other reason. | The committee considered the price of Hydromed to be reasonable in relation to the clinical benefits gained by patients who had undergone treatment with the drug. The price of its comparator, bendroflumethi acid in combination with calcium chloride, was found to be in line with Hydromed's (<DKK1/day or EUR0.13/day). However, the DHMA did not provide any further details about how it arrived at the reimbursement decision in their review, available in Danish, here. |
Eklira Genuair (aclidinium bromide) | Almirall SA (Spain) | General reimbursement | For maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. | A study with 30 participants comparing Eklira Genuair versus tiotropium investigating their efficacy and cost-effectiveness found them to be comparable. The price offered by Almirall for Eklira Genuair was, according to the committee, appropriate in relation to its therapeutic value. The price was not disclosed in the announcement and the decision is available, in Danish, here. |
Source: DHMA | ||||
Outlook and Implications
Although the Reimbursement Committee discloses little information about how it arrives at reimbursement decisions; the general principle for the decision-making is to assess the price of the drug in relation to its therapeutic benefit, in accordance with the Executive Order on Reimbursement in Denmark. There are currently three types of reimbursement in Denmark; general reimbursement for prescription drugs; conditional reimbursement for prescription drugs and; conditional reimbursement for over-the-counter (OTC) drugs. All those drugs approved by the DHMA in September fall in the first category.
This may indicate an emerging positive trend for the innovative industry. However, the Reimbursement Committee has been criticised by various pharma players for lacking the ability to adequately consider total treatment cost to society in drug reviews. There are reasons to believe this trend may not be sustained over the long-term as the Danish Ministry of Health (MoH) is currently looking at ways to streamline the structure for drug reviews in the country and may adopt an agency structure inspired by the UK's National Institute for health and Clinical Excellence (see Denmark: 20 September 2012: Danish MoH Plans to Introduce Agency Based on UK's NICE). Although this development may mean stricter drug funding recommendations in the future, there are reportedly four agency scenarios under consideration and the plan is yet to be fully developed by the MoH.