The transparency board of Poland's health technology agency has issued a series of mixed reimbursement recommendations for three innovative drugs at its 21st session of 2013.
IHS Global Insight perspective | |
Significance | The transparency board of the Agency for Health Technology Assessment in Poland (AOTM) has issued a mixed series of reimbursement recommendations for three innovative drugs at its 21st session in 2013, including a negative recommendation for Japanese firm Eisai's breast cancer drug Halaven (eribulin mesylate), and a positive one for Danish firm Novo Nordisk's long-acting insulin analogue Levemir (insulin detemir). |
Implications | In general, the AOTM's transparency board continues to employ a cautiousness about reimbursing high-cost medicines, which is demonstrated in these recommendations. |
Outlook | There is a certain degree of cheer for the innovative pharmaceutical industry from these recommendations, although it is limited by the strict conditions and restrictions attached to them. |
Three innovative drugs considered in AOTM's 21st session
At its 21st session of 2013 on 29 July, the transparency board of Poland's Agency for Health Technology Assessment (AOTM) issued reimbursement recommendations for three innovative drugs.
Halaven obtains negative recommendation
The board gave a negative recommendation for the reimbursement of Japanese firm Eisai's Halaven (eribulin mesylate) in the treatment of locally advanced or metastatic breast cancer for patients who had experienced disease progression after using at least two chemotherapy regimens, under a drug programme dedicated to this indication. In its justification for the negative recommendation, the board mentioned that the control group registered in the EMBRACE clinical trial consisted of patients receiving a variety of different therapies, using a variety of medicines, which made the assessment of Halaven's effectiveness with regard to specific treatment schemes in Poland difficult. It also stated that results from non-randomised trials have limited credibility. Additionally, it states that under independent analysis, treatment with Halaven does not result in a significant improvement in progression-free survival. The board also pointed to the fact that the United Kingdom's National Institute for Health and Care Excellence (NICE) does not recommend Halaven in this indication.
Simponi gains mixed recommendation
The transparency board also considered the question of reimbursing US firm Johnson & Johnson's Simponi (golimumab) in several indications – severe, active ankylosing spondylitis; severe psoriatic arthritis; and severe rheumatoid arthritis. for each one, the proposal was made for reimbursing the drug as part of a separate drug programme, which the board rejected in each case. However, in each indication, it recommended that Simponi be added as another potential treatment in the appropriate existing drug programme.
In the case of severe, active ankylosing spondylitis, the board recommended that reimbursement be granted as part of the existing drug programme relating to this condition, and also recommended that it be made available with no co-payment as part of a separate reference group, on the grounds of the cost of treatment with the drug being reduced to the lowest annual cost of therapy among the currently reimbursed medicines in this programme from the tumour necrosis factor (TNF)-alpha inhibitor group.
A similar stipulation was made in the case of severe psoriatic arthritis, with the recommendation being dependent on the cost of treatment with the drug being brought down to the lowest annual therapy cost among the currently reimbursed TNF-alpha inhibitors in this indication. Exactly the same recommendation applies in the case of severe rheumatoid arthritis.
Levemir gains positive recommendation in new indication
Finally, the AOTM's transparency board also issued one positive recommendation at this session. That was for the reimbursement of Danish firm Novo Nordisk's insulin analogue Levemir (insulin detemir) in the treatment of patients with type 2 diabetes who have been treated for at least six months with neutral protamine Hagedorn insulin and have during this time had an HbA1c score of 8 or higher (i.e. insufficient glycaemic control), or have had at least one severe or nocturnal hypoglycaemic episode. The board recommends Levemir's reimbursement in this indication as part of the existing reference group for long-acting insulins, and proposes that it be made available with a 30% patient co-payment required. It emphasises that the risk-sharing agreement proposed by the producer is not acceptable, although no details of this are given.
The full press release from the 21st session can be accessed, in Polish, here.
Outlook and implications
The negative reimbursement decision for Halaven comes over two years after the drug's approval at the central level in the European Union in March 2011; although the UK's NICE rejected the drug, it received a more favourable verdict in Germany, where the Federal Joint Committee judged that it had an additional benefit.
In order to obtain reimbursement, it will be necessary for the cost of treatment with Simponi to be brought down to the level of the medicine that provides the lowest cost of treatment within the existing drug groups – it will come up against competition from Remicade (infliximab; Merck & Co, US) and Humira (adalimumab; Abbott, US), among others, which are already reimbursed under the drug programmes. Thus, the producer will most likely be required to bring the drug's price down to some extent.
The decision on Levemir is fairly positive, although the 30% co-payment level means a significant proportion of the potential patient population will not be able to afford treatment. However, considering the fact that a positive decision will expand the group of people that is able to obtain Levemir with reimbursement (at present it is reimbursed for people with type 1 diabetes), it is still an encouraging development.
It should be emphasised that the recommendations still have to be considered by the president of the AOTM, with the final decision to be made by the health minister.