Proton therapy is a method of radiotherapy using high-energy proton beams to irradiate cancerous lesions. It is applied more and more often when the cancer location in relation to critical structures, sensitive to irradiation, significantly limits or prevents the application of a standard radiotherapy. This method delivers a dose precisely to the tumour area while minimising the dose applied to the surrounding tissue. That reduces remote consequences, which is particularly important in case of children.
Until the end of the 1980s, proton radiotherapy centres were established in nuclear physics laboratories having accelerators at their disposal which facilitate acceleration of protons to energy used for radiotherapy. The first accelerator of this type designed for the proton radiotherapy originated in the United States in the Loma Linda University Medical Center. It has operated since 1990. Most proton therapy centres currently operate in the USA, Japan and Germany.
The only isochronous cyclotron AIC-144 in Poland started to operate in 2015 as part of the Henryk Niewodniczański Institute of Nuclear Physics at the Cracow Branch of the Polish Academy of Sciences. This cyclotron enables eye cancer proton therapy. Now it operates as part of the Cyclotron Centre Bronowice (CCB) which is the only centre in Poland providing the proton therapy which is considered as a guaranteed medical service.
While preparing to launch the proton therapy as a medical service, the CCB was already equipped with two cyclotrons: AIC-144 and Proteus C-235. The AIC-144 cyclotron delivered a beam to the eye cancer proton therapy machine until 2015. Since October 2015, it was the Proteus C-235 cyclotron that has delivered a beam of protons to the eye cancer proton therapy device and to two Gantry machines providing proton therapy of cancers other than eye cancer.
In many countries the proton therapy centres are under construction or are only in the design phase. Most centres under construction or in the design phase are located in China (16) and in the USA (11).
In 2015–2020, the technical capacity of the CCB was not used for oncological treatment in an optimal way. Neither the Minister of Health, nor the National Health Fund took sufficient measures to provide required access to one of the most state-of-the-art cancer treatment methods to oncological patients.
The National Institute of Oncology in Cracow did not properly perform the proton therapy agreement signed in 2016 with the Małopolski Branch of the National Health Fund. Among other things, since April 2019, it has no longer provided the proton therapy of oncological conditions other than paediatric eye cancers.
The Minister of Health failed to design a strategy to develop the proton therapy in Poland. He thus made it difficult to implement and propagate the state-of-the-art cancer treatment method or organise the provision of this medical service. Only in November 2019, it established a team tasked to draft the strategy.
The CCB was prepared to provide the therapy to paediatric and adult patients. The number of medical physicians and electroradiology technicians complied with the requirements set out in the ordinance on guaranteed medical services. The personnel also met the eye proton therapy requirements. It needs to be stressed, though, that the Institute of Nuclear Physics at the Cracow Branch of the Polish Academy of Sciences could not provide medical services as it is not a healthcare institution.
In June 2016 (8 months after opening the CCB), the Minister of Health added the proton therapy for oncological conditions other than eye cancer to the list of guaranteed medical services. However, the first patient underwent the proton therapy only 11 months after opening the Centre. Thus, in that period the CCB was in the state of passive readiness to provide proton therapy which entailed the cost of nearly PLN 2.5 million.
In 2015–2020, the CCB’s potential was not used. Only 360 patients with oncological conditions other than eye cancer were subject to proton therapy, whereas the Centre’s capacity was established at 400 persons per year. The reason was that the ordinance of the Minister of Health on guaranteed medical services in hospital treatment presented a shorter list of indications. As a result, from 16 October 2015 to 30 June 2020 the CCB lost nearly PLN 4.7 million on healthcare activity.
Initial recommendations of experts (including the National Consultant Team for Proton Beam Therapy) concerned nearly 50 malignant cancers. Though, at the request of the Minister of Health, the list provided to the Agency for Health Technology Assessment and Tariff System (AHTATS) covered only 10 indications, of which AHTATS approved only seven cases of malignant cancers qualifying for the proton therapy. As a consequence, only in 2016–2018, more than half of 429 patients could not take advantage of the proton therapy. Only in 2019, nine more indications were added to the list.
The Małopolski Branch of the National Health Fund improperly and ineffectively managed organisation and availability of the cancer proton therapy for paediatric patients (excluding eye cancer). Competitive procedures in July 2016 resulted in selecting only one provider of cancer proton therapy (excluding eye cancer). The agreement, comprising both adult and paediatric patients, was concluded with the National Institute of Oncology in Cracow (NIO). Although the Institute was not prepared for the paediatric proton therapy, it committed to its performance from 1 July 2016. Because of delays in signing agreements, the proton therapy services was not provided to paediatric patients. Neither the Minister of Health, nor the Małopolski Branch of the National Health Fund, nor the National Institute of Oncology in Cracow took efficient measures to make the proton therapy available for children.
In 2019-2020, the National Institute of Oncology prolonged the competition for a subcontractor for the proton therapy in children (despite the absence of offerers) as many as fourteen times. Interestingly enough, the University Children’s Hospital in Cracow declared previously that the existing conditions make further cooperation impossible.
The Institute of Nuclear Physics of the Polish Academy of Sciences in Cracow established higher tariffs for proton therapy services for paediatric patients as compared with the amounts refunded by the Małopolski Branch of the National Health Fund. The reason was that the therapy in children took longer than in adults. Higher costs in settlements with the Institute of Nuclear Physics were compensated by the National Institute of Oncology by adopting lower tariffs for planning paediatric treatment in the subcontracting agreement with the University Children’s Hospital than the amount refunded by the Małopolski Branch of the National Health Fund. Besides, the National Institute of Oncology paid its liabilities to the Institute of Nuclear Physics with delay which posed a threat of breaking the continuity of services.
Recommendations
to the Minister of Health to:
- take measures to extend the list of indications for the proton therapy of oncological conditions other than eye cancer, included in the ordinance of the Minister of Health of 22 November 2013 on guaranteed medical services in hospital treatment;
- work out, in consultation with the NHF President and in cooperation with representatives of public healthcare institutions offering oncological treatment, the principles of providing proton therapy, including the possibility of signing agreements with service providers Poland-wide, separately for adults and for children;
- analyse and update tariffs of the proton therapy of oncological conditions other than eye cancer, separately for adults and for children;
- take efforts to restart the proton therapy of paediatric patients as part of the existing agreement for those services or to consider the selection of new service providers.
to the President of the National Health Fund to:
- take efforts to provide the proton therapy – as soon as possible - to children suffering from cancer other than eye cancer, by:
- enforcing the therapy restart by the existing service provider, i.e. the National Institute of Oncology,
- considering the competition on proton therapy for paediatric patients to select a new service provider (one or more).
- enable all provincial branches of the NHF to conduct competitive procedures to conclude agreements for the proton therapy of oncological conditions other than eye cancer, separately for adults and for children.
