New Polish drug reimbursement list tailored for crisis

2010-01-27

After several months of announcements, the Polish Health Ministry has published the update to the new reimbursement lists. The new law came into effect on 16 December 2009. It vividly shows the cost-containment policy prompted by the economic downturn.

The existing regulation includes only two new disorders:

• cytomegalovirus (CMV) infections in patients after organ transplantation – prophylaxis after hospitalisation associated with transplantation for 110 days after intervention
• venous thromboembolic complications in adults after planned total alloplasty of hip or knee joint − primary prevention.

Along with the introduction of new disorders, two new innovative active substances joined the schedules. Valganciclovirum (Valcyte marketed by Roche), for cytomegalovirus infections, exist in the form of 75 mg or 110 mg hard capsules. Dabigatran etexilate (Pradaxa manufactured by Boehringer Ingelheim), used in the treatment of thromboembolism, are available in the form of 450 mg coated tablets.
Four other new drug combinations composed of familiar substances have found a place on the schedules: Fostex (Torrex Chiesi), which contains beclometason and formoterol, is an aerosol used for asthma; Angeliq (Bayer), which is composed of estradiol and drospirenone in the form of coated tablets, used in the treatment of symptoms associated with the menopause; Co-Prenessa (Krka), in the form of tablets, contains perindopril and indapamide and can be used for hypertension; and the fourth is DuoTrav (Alcon Laboratories), eye drops with timolol and travoprost, used to treat glaucoma.

New lists not universally available
Because of concerns about the substantial deficit of the National Health Fund (NFZ), there are still no long-acting insulin analogues on the lists, despite strong public pressure. These are very important because they reduce the number of injections to only one per day. On the other hand, the ministry acknowledges the potential risks associated with the use of this group of medicines: increased incidences of breast and colon cancer. The amended schedules also do not contain Synagis (palivizumab), manufactured by MedImmune, used to enhance the resistance of premature babies to respiratory syncytial viruses (RSV), which can induce pneumonitis. The processing of this medicine has been stopped because of deliberations within the Polish Health Ministry. These were prompted by the negative comments of the Health Technology Assessment Agency (AOTM). On the updated lists we could not find the anti-tuberculosis drug isoniazid, which is no longer produced by Jelfa, but is available from abroad by means of direct import (after approval by the health minister, reimbursement decision is taken by the NFZ).

Slow progress in terms of innovations
One can conclude that the medicines added are necessary and up-to-date in terms of medicinal knowledge. Although there are only two innovative entities, the next four fixed-dose combinations increase the scope of therapy in common diseases. The Health Ministry estimates that the cost of reimbursing these innovative drugs will be as much as PLN 35m (€8.3m). About PLN 5m (€1.2m) is accounted for by Pradaxa, and PLN 22m (€5.2m) by Valcyte. Interestingly, although the Ministry included new active substances on the reimbursement lists more sparingly, no formerly accepted illnesses or innovative drugs were removed.
Over 100 generics were added to the new lists, and about 50 drugs were removed. The new schedule consists of preparations used in the treatment of, among other things, asthma, cystic fibrosis, phenylketonuria and attention-deficit hyperactivity disorder (ADHD).

Renegotiations in order to reduce prices
The Health Ministry has renegotiated many medicine prices with pharmaceutical companies. In more than 250 cases the cost was reduced. The Ministry predicts that because of the cutting of official drug prices and the substantial reduction in limits, particularly in the case of montelukast (Singulair owned by MSD), olanzapine (Eli Lilly's Zyprexa) and fentanyl, the payer will spend PLN 80m (€19m) less every year on reimbursement. It is important to remember that the NFZ spends the most substantial amount, approximately PLN 260m (€70m) in 2007 and in 2008, on the reimbursement of olanzapine. Renegotiation was possible because of, among other things, the addition to the lists of Singulair generics produced by different companies (Krka, Teva and Genexo). The price of montelukast medicines has been brought down to PLN 75.03 (€17.86) per package (Singulair had previously cost PLN 126.76, or €30.18). It is estimated that this will save PLN 30m (€7.1m) year on year.

Rushed update, but Ministry predicts savings
The lists were brought in very quickly, because, according to the Deputy Health Minister, Marek Twardowski, of the necessity to achieve the instant savings anticipated with the new regulations. The schedules have come into force in an atmosphere of scandal – pharmacists and wholesalers have only a few days to update their databases. Given the overall savings and new spending levels, the ministry envisages net savings of about PLN 45m (€10.7m).
The Health Ministry is obliged to upgrade the reimbursement lists four times every year. Unfortunately the December renewal succeeded that of March, only the second in 2009. The ministry blames the lengthy legislative procedure. Lists are issued in the form of regulations, rather than announcements, and this impedes the proceedings.
There is no reason to conclude that the introduction of the new lists will have a significant impact on the performance of the pharmaceutical market in Poland. An analysis of the actual effect should be possible in the longer term, ideally after the Q1 2010 data become available. The second half of December 2009 will probably bring very good sales results boosted by patients waiting for cheaper drugs. There are winners and losers after the introduction of the new regulations. Roche, the owner of Valcyte, has probably benefited the most from the upgraded lists.


PharmD, Radoslaw J. Ekiert

The NFZ spent almost PLN 8bn (€1.9bn) on reimbursement in 2009. The upgrade in December 2009 brought two innovative drugs and over 100 new generics.