WARSAW, Dec 22 (APM) - Pharma companies are concerned about the new reimbursement regulations, which could result in their negotiations with the ministry of health (MoH) being made public, reported Rzeczpospolita (pC5) on Tuesday.
Pharmas say the change could be very bad for business, as the prices of reimbursable drugs negotiated with the MoH can be up to 50% lower than in other European countries, which is either achieved by discounts or risk sharing schemes. However, they agree to such terms on the condition that the deals are kept confidential, so they do not affect the price negotiations in more affluent European countries.
If the regulations take effect, some pharmas may either withdraw their drugs from reimbursement or no longer be interested in selling in Poland, which could result in higher drug prices or restricted access to some medicines that are currently available on the market.
Ewa Rutkowska from the Kieszkowska Rutkowska Kolasinski law firm said pharmas are most concerned that the new regulations may not only apply to deals negotiated after the regulations take effect, but also to those negotiated in the past.
According to an anonymous expert, the NHF receives around 200 million zlotys (47.6 million euros) a year from pharma companies selling reimbursable drugs through the payback mechanism.
Drug transportation will be closely monitored
The government decided on Tuesday that all drug transportation will be monitored to tackle the problem of illegal drugs exports, which are estimated at up to 2 billion zlotys (476 million euros) per year, reported Dziennik Gazeta Prawna (pB1) on Wednesday.
According to the new regulations, all companies will have to report the intention to transport drugs abroad to the Chief Pharmaceutical Inspector. In addition, all pharma wholesalers and drug manufacturers will be obliged to provide the officials with a complete list of vehicles used for transporting medicines, together with their registration numbers, within 30 days of the new regulations entering into force.
Administrative court overruled minister's negative reimbursement decision
The administrative court in Warsaw overruled the health minister’s negative decision regarding the reimbursement of a drug produced by Biomarin Europe Ltd for a patient, reported Rzeczpospolita (pC5) on Thursday.
The health minister’s decision was based on the fact that the drug is approved in the EU, whereas, according to the reimbursement regulations, only drugs that are not approved or are not available at all in Poland and have to be imported to save patients’ health or lives may be reimbursed upon the decision of the health minister.
However, the court disagreed with the health minister’s interpretation and ruled that the drug should be provided to the patient, as the regulations allow for a positive decision even if the drug is already approved in the EU, as long as the patient’s health or life is at stake, especially since there are no equivalents available on the Polish market.
Cancer patients request increase in reimbursement budget
Organisations of cancer patients filed a request with prime minister Mateusz Morawiecki and health minister Konstanty Radzwill to increase the drug reimbursement budget to 17% of the national health fund’s (NHF) total budget, reported Dziennik Gazeta Prawna (pB10) on Tuesday.
Wojciech Wisniewski from the Alivia Foundation said that, while the reimbursement policy has been improved in recent months, patients are concerned that the 0.9% increase in drug spending planned for 2018 is disproportionate to the 7.6% increase in the NHF’s total budget.
He added that, without appropriate budget reserves for drug reimbursement, the NHF’s regional units could find themselves unable to contract for all the necessary drug programmes, leaving patients with no access to therapies that are theoretically guaranteed by the state.
While, according to the regulations, the NHF should be allocating 17% of its total budget to drug reimbursement, the actual spending is lower, as the money is often shifted, for example, to pay for hospital procedures. Wisniewski reiterated that the officials recently announced that the money on drug reimbursement could be kept on a separate account, which would be a good move towards resolving the recurring problem.
Representatives of the pharma industry support the requests of patients, adding that they are doing their best to keep drug prices as low as possible, accounting for the Polish realities and levels of financing that can be achieved by the NHF.
Pharmacists want special labels for strong drugs
Pharmacists claim the most potent drugs should have special labelling, which would reduce the risk of mistakes, reported Rzeczpospolita (pC5) on Wednesday.
This request arises from an incident that took place in 2017, in which a pharmacy technician dispensed Briglau instead of Biodacyna to a mother of an infant. After the administration of the drug, the child fell into a coma for three days and, according to the investigators, the incident, at least to some extent, took place because the drugs produced by the same company had very similar packaging.
Pharmacists claim the risk of such mistakes could be significantly reduced if strong drugs had special labels, enabling them to easily distinguish the types.
Selvita will resume trials of SEL24
Phase I/II of Selvita’s particle, SEL24, to be potentially used in chronic myelogenous leukaemia, will resume, reported Parkiet Gazeta Gieldy (p5) and Puls Biznesu (p9) on Tuesday.
The trials were suspended by the U.S. Federal Drug Administration following the death of a patient due to a stroke in early October, reported the newspapers.
SEL24 is the most advanced molecule in Selvita’s R&D pipeline. Selvita sold the rights to it in March to Italy's Menarini for 20 million zlotys (4.8 million euros), with the possibility of increasing the payment up to 360 million zlotys (85.7 million euros), as well as a revenue share if the drug is successfully marketed. After the suspension, Edison Research reduced its forecast of the probability of Selvita successfully completing the project from 15% to 7.5%, reported Puls Biznesu.
The company is also working on another molecule, SEL120, which could potentially be used in chronic myelogenous leukemia and other types of cancer. Selvita intends to continue the research until Phase II and only then sell the rights to the molecule, which would bring it significantly higher profits than the SEL24 deal, reported Puls Biznesu.
Selvita reported nine-month revenues of 80.1 million zlotys (19.1 million euros) and a net profit of 9.7 million zlotys (2.3 million euros), reported Puls Biznesu.
With the SEL24 trials resumed, Selvita can now continue with a share issue, from which it expects to obtain 140 million zlotys (33.3 million euros), reported both newspapers.
OncoArendi Therapeutics prepares to float
Polish biotech, OncoArendi Therapeutics, working on new drugs for use in inflammatory diseases and cancer, intends to debut on the Warsaw Stock Exchange in the first half of 2018, report Parkiet Gazeta Gieldy (p5) on Tuesday and Rzeczpospolita (pA32) on Friday.
OncoArendi is focusing on the development of two substances, OATD-01 and OATD-02. The former could be potentially used for treating asthma, sarcoidosis or idiopathic pulmonary fibrosis, while the latter could increase the efficacy of other drugs used in bowel, lung, skin and brain cancers. OATD-01 is currently in Phase I, with the trials being conducted near Munich, Germany, whereas OATD-02 is still in its pre-clinical phase, reported both newspapers.
OncoArendi expects to obtain several dozen million zlotys from the market to continue its R&D activities, reported both newspapers. It does not currently report any revenues and operates with the money obtained from private investors and via grants, reported Parkiet.