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European hospital and med-tech-related reimbursement news for the pharmaceutical companies
Stay up-to-date about reimbursement developments of hospital drugs, gene and cell therapies, companion diagnostics, drug delivery solutions and e-health in Europe. We bring you updates from more than 100 stakeholders in Europe for free
September 2020

In July 2020, the Austrian Institute for Health Technology Assessment (AIHTA) issued a policy brief “ATMPs and gene therapies in development, Horizon Scanning.”

In late August 2020, with the recognition of a minor added benefit, the Federal Joint Committee (G-BA) has completed the renewed benefit assessment of an inhibitor of cyclin D1/CDK4 and CDK6 in the treatment of breast cancer patients in certain therapeutic situations. The improved data on the advantages and disadvantages served as the basis for decision-making.

At the beginning of September, the updated list of add-on drugs with tariffs for August 2020 was posted on the website of the Technical Agency for Information on Hospitalizations (ATIH).

In August 2020, Tirol Kliniken, in collaboration with the Austrian Institute for Health Technology Assessment (AIHTA), issued an Evidence-based decision support/AIHTA Policy Brief “CAR T-Cell Therapy, Horizon Scanning.”

On August 31, 2020, Decision Forum for New Methods was conducted, and protocol with decisions was published. The meeting considered six treatment methods (Abemaciclib, Trastuzumabemtansine, Apalutamide, Pembrolizumab, Avelumab, and Upadacitinib) and one IVD-test (for preeclampsia).

By the request of the Austrian Ministry of Health, Horizon Scanning System (HSS) for medicines and vaccines for potential use for COVID-19 treatment is created in Austria with European cooperation. It is updated monthly. The August update is available on the AIHTA website.

In mid-July 2020, the Federal Joint Committee (G-BA) has commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to carry out a comparative benefit assessment of seven active ingredients for the treatment of highly active relapsing-remitting multiple sclerosis (MS) in adult patients.

On August 20, 2020, NHS England released an updated version of National Cancer Drugs Fund (CDF) list. Four (4) treatments (Treosulfan, Brentuximab vedotin, Gilteritinib, Entrectinib) moved to routine commissioning, two (2) drugs (Lorlatinib and Obinutuzumab with bendamustine) moved to section B of the list, one (Polatuzumab vedotin) is recommended for routine commissioning and receiving CDF interim funding, and treatment criteria published for Entrectinib (in 3 clinical indications).

The Italian Drugs Agency (AIFA) had posted the results of the meeting of their pricing and reimbursement committee (CPR) held on August 7, 2020. The documents contain a total of nine pages of outcomes of the CPR assessment.

The technical-scientific committee (CTS) of the Italian Drugs Agency (AIFA) held their meetings on August 5, 2020. The outcomes are published.

On July 13, 2020, NHS England updated the clinical commissioning policy work program. There are no updates for other two work programs - specialized commissioning service specification and commissioning through evaluation.

The Medicines Evaluation Board (CBG) will draw up an overview of medicines for which switching to generics is unwanted based on scientific conditions.

On August 03, 2020, the National Institute of Health Care and Excellence (NICE) issued a draft guideline for chronic pain assessment and management in people aged 16 years and over. It includes recommendations on pharmacological management in chronic primary pain. Comments on this draft guideline can be submitted until September 14, 2020.

August 2020

Since August 2020, 24 drugs will be reimbursed as add-on medicines, including nineteen antineoplastic agents, two immunosuppressants, two antimycotics for systemic use and one ophthalmological antineovascularisation agent

On August 03, 2020, NHS England announced £160 million extension funding for cancer treatments that have a lower impact on the immune system or other benefits such as fewer hospital visits, so-called ‘COVID-friendly’ drugs. Available treatment options now include: Venetoclax, Nivolumab, Ixazomib, and Atezolizumab

From August 8, 2020, to December 31, 2021, foreign medicines for the treatment of leukemia and lymphoma will be admitted to public procurement without restrictions. The Russian Prime Minister signed this resolution.

According to the analysis, published by the statistics service provider IQVIA in early August 2020, sales of antineoplastic agents increased by 84% in the five-year period from 2015 to the end of 2019 in Germany.

In France, the funding of medical services using DRG includes all patients' expenditures. However, in accordance with Article L.162-22-7 of the Social Security Code, the innovative and highly expensive drugs are reimbursed on top of the DRG via the specific list called "Liste en sus." The updated list of add-on drugs with tariffs for July 2020 is already available.

In mid-July 2020, the German Dermatological Society (DDG) has updated the S2k guideline on neurodermatitis. The chapter “Systemic therapy for neurodermatitis” was revised.

The Italian Drugs Agency (AIFA) had posted the results of the meeting of their pricing and reimbursement committee (CPR) held on July 14, 27-30, 2020. The documents contain a total of seven pages of outcomes of the CPR assessment.

In early August 2020, the Federal Joint Committee (G-BA) has published the 2019 Annual Report. According to the report, the G-BA evaluated the benefits of 90 drugs with new active ingredients in 2019. Since the start of the early benefit assessment procedure in 2011, the G-BA has developed a total of 440 resolutions.

On 16 June 2020, the Reimbursement Commission made changes to the Healthcare Implementation Communique. Main drug updates were related to the addition of new drugs and changes in the conditions of the use of existing drugs.

In July 2020, Swedish Dental and Pharmaceutical Benefits Agency (TLV) issued four (4) positive decisions on drug inclusion in high-cost protection – Alunbrig (brigatinib) and Utrogestan (progesterone) for a general subsidy (without restrictions), Mayzent and Evenity for limited subsidy. One drug receives an increased subsidy - Jardiance (empagliflozin). Melatonin Orifarm (melatonin) was rejected for inclusion in high-cost protection.

The first part of the National Care Guideline for Type 2 Diabetes is now available for online comments submission. Interested parties and experts are invited until August 27, 2020, to critically review the guideline and send their comments to the editorial team.

The technical-scientific committee (CTS) of the Italian Drugs Agency (AIFA) held their meetings on July 1, 15-17, 27, 2020. The outcomes are published.

Within the framework of the authorization procedure, the Swiss Agency for Therapeutic Products (Swissmedic) assesses the quality, safety, and effectiveness of the drugs based on the comprehensive scientific documentation submitted by the applicant. In Q2, Swissmedic authorized seven drugs.

On the 24th of July, the European Medicines Agency (EMA) has published outcomes of the meeting of the Committee for Medicinal Products for Human Use (CHMP). Ten (10) positive opinions, two (2) negative opinions, nine (9) recommendations on extensions of therapeutic indications, one (1) change to non-prescription status, and two (2) withdrawn applications for new medicines were made.

The Italian Drugs Agency (AIFA) had posted the results of the meeting of their pricing and reimbursement committee (CPR) held on June 4-5, 23-25, 2020. The documents contain a total of nine pages of outcomes of the CPR assessment.

July 2020

On June 30, 2020, the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) announced changes in drug reimbursement that is came into force from July 01, 2020. Сhanges mostly affected already existing measures aimed at reducing the price of drugs, and new related drug lists were added.

On July 5, 2020, NHS England launched a new digital service. The new 'Your COVID Recovery' service forms part of NHS efforts to improve access to COVID-19 rehabilitation treatments for those who survived the virus but who have respiratory problems, mental health issues, or other complications.

In June 2020, NICE recommended entrectinib (Rozlytrek, Roche) in the final draft decision for use within the Cancer Drugs Fund, a revolutionary treatment for a number of types of cancers, which is the second histology-independent drug.

On June 25, 2020, the German Society for Hematology and Medical Oncology (DGHO) presented a position paper on how the recommendation of the European Medicines Agency (EMA) concerning genetic testing before cancer therapy with 5-fluorouracil (5-FU) can be implemented in Germany.

On 2 July of 2020, the Dutch Organization for Health Research and Development (ZonMw) announced the ‘Open subsidy round 10’ within their program ‘Good Use of Medicines (GGG)’. There are no restrictions regarding specific themes or disease areas. The deadline for applications is 22 September 2020.

In June 2020, NHS England announced that patients with the deadly genetic condition could benefit from the triple combination treatment includes ivacaftor, tezacaftor, and elexacaftor, produced by Vertex Pharmaceuticals.

On June 26, 2020, the European Medicines Agency (EMA) has published outcomes of the meeting of the Committee for Medicinal Products for Human Use (CHMP). Eight (8) positive opinions on new medicines, one (1) negative opinion, five (5) recommendations on extensions of therapeutic indications, and three (3) withdrawn applications for new medicines were made.

The share of generics in total pharmaceutical supply in Germany rose further: from 67.1% in 2009 to 78.7% in 2019. This emerges from the analysis provided in "Generics in Figures 2019", published by the Pro Generics Association on June 19, 2020.

Within the pilot “Parallel Procedures CBG-ZIN” the innovative drugs become available quicker because it allows obtaining reimbursement in parallel to the registration process. The first drug Rybelsus® (semaglutide tablets) used in type 2 diabetes has completed the pilot.

NHS Digital works with more online consultation suppliers on how to best integrate their products into the NHS App. The goal is that an even greater amount of patients will be able to ask for help and advice from their GP surgery through this route in the future.

On 9 May 2020, the Reimbursement Commission made changes to the Healthcare Implementation Communique. Main drug updates were related to the addition of new cancer drugs to the list of drugs exempt from patient participation shares.

The German Society for Neurology (DGN) has reissued the S1 guideline "Neurosyphilis". The reason is increasing numbers of new infections, which reached a new high of 7,332 cases in 2018 in Germany.

On the 1st of July 2020, the Dutch Healthcare Authority (NZa) has officially adopted tariff decision for new add-on drugs. The list of add-on drugs includes those for treatment of fungal infection, leukemia, non-small cell lung cancer, colorectal cancer, and others.

On June 25, 2020, Danish Medicines Council (Medicinrådet) issued five recommendations (on C1-esterase inhibitor, talazoparib, lorlatinib, pembrolizumab, trastuzumab), two drug recommendations (for breast cancer and melanoma), one protocol for the treatment guide for chronic liver inflammation and one supplement to a treatment guide for chronic rheumatoid arthritis.

The French High Authority for Health (HAS) develops national diagnostic and care protocols whose objective is to guarantee the quality and safety of care delivery within the French setting. In the first half of 2020, national diagnostic and care protocols have been developed for eighteen topics.

On June 25, 2020, the European Medicines Agency (EMA) has recommended Veklury (remdesivir) for treatment COVID-19 pneumonia in adults and adolescents older 12 years who require oxygen supplement. It is the first anti- COVID-19 drug recommended for conditional marketing authorization in the EU.

On June 9, 2020, NHS England announced new online services for diabetes patients. This remote support will supplement the appointments of patients, many of whom have been going on during the pandemic, via video or telephone consultations, and more recently in protected areas under COVID.

By the request of the Austrian Ministry of Health, Horizon Scanning System (HSS) for medicines and vaccines for potential use for COVID-19 treatment is created in Austria with European cooperation. It will be updated monthly. The June update is available at the AIHTA website.

June 2020

On 9 May 2020, the Reimbursement Commission made changes to the SUT regarding response to the COVID-19 pandemic and introduced codes for IVD tests for Covid-19 (SARS-CoV-2) reverse transcriptase PCR and detection of Covid-19 antigen, IgG, IgM.

The technical-scientific committee (CTS) of the Italian Drugs Agency (AIFA) held their meetings on June 9-12, 2020. The outcomes are published.

The Italian Drugs Agency (AIFA) had posted the results of the meeting of their pricing and reimbursement committee (CPR) held on May 7, 27-29, 2020. The documents contains a total of six pages of outcomes of the CPR assessment.

Five out of nine decisions of the G-BA on early benefit assessment within the AMNOG (Arzneimittelmarktneuordnungsgesetz, Act on the Reform of the Market for Medical Products), process on May 14, 2020, had the result of "considerable additional benefit."

From June 2020, NHS England will provide patients with cystic fibrosis and those recovering from coronavirus with devices and apps so physicians can track their condition remotely as part of the NHS drive to deliver connected, assisted, personalized care to more individuals in their own homes.

The technical-scientific committee (CTS) of the Italian Drugs Agency (AIFA) held their meetings on May 11-13, 2020. The outcomes are published.

On June 4, 2020, the Dutch Healthcare Institute (ZIN) announced positive recommendations for the combination of drugs dabrafenib / trametinib (Tafinlar® and Mekinist®) in melanoma treatment.

In response to the Covid-19 outbreak, NHSX looks for remote monitoring technology suppliers to help scale solutions across the UK. The organization invited technology companies to apply in a tender notice published on May 15.

The German Neurological Society (DGN) has updated the guideline "Insomnia in Neurological Diseases" (Insomnie bei neurologischen Erkrankungen). It differentiates between insomnia in headache, neurodegenerative movement disorders, multiple sclerosis, traumatic brain damage, epilepsy, neuromuscular diseases, stroke, as well as dementia and prion diseases.

In April and May 2020, Danish Medicines Council (Medicinrådet) issued two new treatment guides (on metastatic kidney cancer and ovarian cancer), two recommendations (on cemiplimab and voretigene neparvovec) and two drug recommendations (on antimycotics and HIV)

In accordance with the order of the Government of the Russian Federation, the list of drugs necessary to provide patients suffering from unspecified aplastic anemia and hereditary deficiency of factors II (fibrinogen), VII (labile), X (Stuart-Prower) has been supplemented.

On May 29, 2020, the European Medicines Agency (EMA) has published outcomes of the meeting of the Committee for Medicinal Products for Human Use (CHMP). Eight (8) positive opinions on new medicines, five (5) recommendations on extensions of therapeutic indications, and two (2) withdrawn applications for new medicines were made.

On the 1st of June 2020, the Dutch Healthcare Authority (NZa) has officially adopted performance and tariff decision for add-on drugs. The list of add-on drugs includes those for chemotherapy, treatment of cystic fibrosis, severe refractory eosinophilic asthma, multiple sclerosis, and sickle cell anemia.

Public Health England has carried out a number of rapid evaluations of commercial serological tests for their suitability for detecting the production of COVID-19 antibodies. Abbott SARS-CoV-2 IgG assay and the Roche Elecsys Anti-SARS-CoV-2 serology assay were evaluated by Public Health England.

With aminolevulinic acid synthase 1 (ALAS1)-targeting RNAi drug, long-term therapy has been available for the first time since April 2020 for patients with acute hepatic porphyria, the rare hereditary disease.

Coronavirus testing kits that allow a swab or other type of sample to be taken at home, or in the pharmacy setting, followed by a result within about 10 minutes, are selling by some manufactures. These tests differ from the postal kits that are being used whereby the swab is taken by the patient at home and then returned by post or courier. Currently, Public Health England does not advise the use of products that give a very rapid result.

May 2020

The platform is looking for innovative and creative ways to help increase Coronavirus testing methods, supplies, and capacity across the UK. This platform is a partnership between the Department of Health and Social Care, British In Vitro Diagnostics Association, the UK Bioindustry Association, and the Royal College of Pathologists.

As part of efforts to increase the effectiveness of measures to prevent the spread of coronavirus infection, the Ministry of Health of Russia informed suppliers, manufacturers and executive authorities that, subject to the rules for submitting documents for registration of medical devices intended for the diagnosis of coronavirus infection, their registration will be carried out as soon as possible deadlines.

On April 30, 2020, the European Medicines Agency (EMA) has published outcomes of the meeting of the Committee for Medicinal Products for Human Use (CHMP). Eight (8) positive opinions on new medicines and nine (9) positive opinions on extensions of therapeutic indications were made.

Revolutionary therapy is the first to be made available on the NHS in a new generation of 'tumor agnostic' medications following the agreement endorsed by NICE, the organization that guarantees clinical and cost-effectiveness.

The new gene therapy option is available in Germany since April 2020. The orphan drug is approved for the treatment of certain patients with the rare inherited disease β-thalassemia.

The federal and state governments have agreed on a new distribution scheme for COVID-19 therapy-relevant medicinal products, which ensures the best possible care for Austrian hospitals. In each federal state, there will be a central COVID 19 pharmacy, which is known as the "single point of communication" (SPOC) acts.

An updated version of the S3 guideline "Diagnostics, therapy, and aftercare of malignant ovarian tumors" has been published in Germany. Twenty-nine specialist societies and organizations, led by the German Society of Gynecology and Obstetrics (DGGG), took part in the work on the update within the framework of Guideline Program "Oncology."

After the consultation phase, an updated version of the S3 guideline "Long-term use of opioids in chronic non-tumor-related pain (LONTS)" has been published in mid-April 2020. Representatives of 30 specialist societies and organizations, including two patient self-help organizations, worked on an update of the guideline under the leadership of the German Pain Society.

On April 27, 2020, the Italian Ministry of Health shared the invitation of the Italian “Alliance against cancer,” which is intended for all the interested companies that wish to participate in the CAR-T research project.

The Association of Private Health Insurance (PKV) has signed a supply contract for the treatment of children suffering from life-threatening spinal muscular atrophy (SMA) with a biotechnology company that develops treatments for rare neurological genetic disorders.

The German Society for Urology (DGU) and the German Cancer Society (DKG) have revised the S3 guideline "Early detection, diagnosis, therapy and follow-up of bladder cancer". The update had become necessary due to new approvals of immune checkpoint inhibitors.

The use of an automated robotic pouch dispensing device for inpatient medication for complicated intermediate care patients has shown a decrease in medication mistakes, reduced pharmacy staff time to prepare medication for patients, and reduced nursing staff time for drug administration – with an approximate savings of £7.160 to one trust.

Netherland’s Medicines Evaluation Board (MEB) conducted the assessment on Zolgensma - new gene therapy for treatment spinal muscular atrophy in young children. The European medicines agency gave a positive advice for Zolgensma's marketing authorization under certain conditions.

April 2020

On April 24, 2020, the Italian Drugs Agency (AIFA) had posted the results of the meeting of their pricing and reimbursement committee (CPR) held on April 21-23, 2020. Furthermore, an extraordinary meeting was held on April 9.

The Department of Health and Social Care has introduced an NHS Discharge Medicines Service to provide patients with additional advice on newly prescribed medicines after they are discharged from the hospital.

The technical-scientific committee (CTS) of the Italian Drugs Agency (AIFA) held their meetings on April 6-8, 2020. An extraordinary meeting was held on April 17. The outcomes are published.

NHSX provides funding through 'Techforce 19' to innovators who can find digital ways to benefit those in need of help, including those in need of mental health support and social care. The technology is intended to help people who might be most impacted by the long term effects of remaining housebound during the COVID-19 pandemic.

The Danish Medicines Agency restricted the dispensing provision for azithromycin in the primary care sector with a few exceptions. The measure is intended to ensure the provision in the hospital setting for the treatment of critically ill patients.

The Federal Joint Committee (G-BA) has restricted the off-label use of valproic acid for the prevention of migraines in adults. Also, the provisions for the off-label use of intravenous immunoglobulins (IVIG) in polymyositis and dermatomyositis have been slightly adapted. The G-BA made the corresponding decisions in late March 2020.

On March 27, 2020, the Italian Drugs Agency (AIFA) had posted the results of the meeting of their pricing and reimbursement committee (CPR) held on March 24-26, 2020. The document contains eight pages of outcomes of the CPR assessment.

As of April 1, 2020, a new service was added to the EBM (German Uniform Evaluation Standard). It will be used for reimbursement of a genetic test that is necessary before the administration of the drug for the treatment of multiple sclerosis with selective sphingosine-1-phosphate receptor modulator.

The technical-scientific committee (CTS) of the Italian Drugs Agency (AIFA) held their meetings on March 11-13, 2020. The outcomes are published.

On March 27, 2020, the European Medicines Agency (EMA) has published outcomes of the meeting of the Committee for Medicinal Products for Human Use (CHMP). Eight (8) positive opinions on new medicines and six (6) positive opinions on extensions of therapeutic indications were made.

In connection with the early benefit assessment of the Federal Joint Committee for the HIV drug, which combines the integrase strand transfer inhibitor dolutegravir, with the nucleoside reverse transcriptase inhibitor lamivudine, it was necessary to restructure the HIV resistance tests in the EBM (German Uniform Evaluation Standard).

March 2020

On March 24, 2020, it was announced that, as part of the epidemiological emergency of Coronavirus, the Italian Drugs Agency (AIFA) has been entrusted with the task of evaluating all clinical trials on medicines for patients with COVID-19.

The German Society for Urology (DGU) and the German Society for Hematology and Oncology (DGHO), as the leading specialist societies, have presented an updated S3 guideline "Diagnostics, therapy and aftercare of renal cell carcinoma." Experts, but also those affected and interested, are invited to submit suggestions for improvement and additional information by April 5, 2020.

NHSX is creating a Digital Health Technology Standard to enhance the way the NHS assesses digital technology for use by patients and staff. It is meant to help developers understand what is required of them, and simplify and streamline how health technologies are assessed and commissioned for use in the NHS. The consultation continues until 22 April 2020 Wednesday.

Through an attempt to benefit a small group of people, NHS England is to finance a life-changing, innovative drug for people with rare conditions that cause frequent episodes of fever, joint pains, and swelling. On February 29, 2020, the NHS confirmed a deal for the drug canakinumab that modifies the immune system, turning off the inflammatory process, dramatically reducing the number of ‘flares’ children and adults’ experience.

In line with the report of the market research services provider IQViA, sales in the German pharmaceutical market rose in 2019 by almost 7% to 46.4 billion euros. The assessment covered the hospital and pharmacy segments, as well as vaccines and diagnostics. According to the analysis, expenditure growth was mainly formed by the use of innovative therapeutic agents against severe diseases.

On March 1, 2020, the Italian Drugs Agency (AIFA) had posted the results of the meeting of their pricing and reimbursement committee (CPR) held on February 26-28, 2020. The document contains seven pages of outcomes of the CPR assessment.

On February 28, 2020, the European Medicines Agency (EMA) has published outcomes of the meeting of the Committee for Medicinal Products for Human Use (CHMP). Two (2) positive opinions on new medicines and three (3) positive opinions on extensions of therapeutic indications were made.

In May and November each year, NHS England makes decisions on which new treatments should be included for routine commissioning. The decisions are taken by the NHS England Board based on recommendations from the Clinical Priorities Advisory Group (CPAG), which is made up of doctors, health experts, and patient representatives. November 2019 prioritization decisions announced in February 2020.

After extensive negotiations, the German Pharmacists Association (DAV) and the Central Association of Statutory Health Insurance (GKV) have agreed on new rules and prices for the production of cytostatics. The adjustments to the so-called Auxiliary tax came into force on March 1, 2020.

On February 12, 2020, the Italian Drugs Agency (AIFA), published the “2020 drugs Horizon Scanning report” in which they analyzed the 2019 recommendations from the European Medicines Agency (EMA), but also the predictions for EMA recommendations in 2020.

On February 14, 2020, the entity that manages the Swiss DRG system, SwissDRG, clarified the add-on reimbursement ZE-2020-129 for Elbasvir and Grazoprevir.

The technical-scientific committee (CTS) of the Italian Drugs Agency (AIFA) held their meetings on February 11-14, 2020. The outcomes are published.

February 2020

In February 2020, the Norwegian Institute of Public Health released a health technology assessment regarding the disease-modifying drugs for the treatment of primary progressive multiple sclerosis. Ocrelizumab and Rituximab may reduce the risk of confirmed disease progression more than Fingolimod and placebo. Full health economic evaluation was not conducted due to the substantially lower price of Rituximab and the absence of strong evidence that one specific drug is better or worse than the other.

In Finland, the Health Care Services Selection Council is responsible for making recommendations regarding the research, treatment, and rehabilitation methods. In February 2020, the PALKO has initiated the assessment of atezolizumab in combination with nab-paclitaxel in the treatment of triple-negative breast cancer. The final recommendation would be published on the website of the Council.

New therapeutic options in oncology are available for patients faster in Germany than in any other European country - on average, 82 days after European approval. This conclusion was reached by the Scientific Institute of Private Health Insurance (WIP). According to the study, market access takes 163 days in the Netherlands and 309 days in Switzerland. The European average is 445 days.

In February 2020, the Norwegian Institute of Public Health (NIPH) has released a systematic review regarding the treatment options for metastatic prostate cancer. Maximal androgen blockade compared to monotherapy probably improves survival slightly at two and five years follow up. Docetaxel, chemotherapy, in addition to standard care, may slightly increase survival.

An update on the current requests to the Drug Reimbursement Commission concerning drugs related to a molecular biology test. In 2019, the reimbursement requests for lorlatinib, gilteritinib, larotrectinib, dasatinib, and their linked molecular biology markers were submitted.

At the end of January 2019, the Russian Ministry of Health (RMoH) released the Order that approves the one-year provision of medicines for ambulatory treatment of patients after stroke, myocardial infarction, those who underwent coronary artery bypass grafting, angioplasty with stenting or catheter ablation for cardiovascular diseases. Patients included in the Additional Medicines Supply Program (DLO) are out of the funding within the described list. The RMoH Order enters into force on February 7, 2020.

On January 31, 2020, the European Medicines Agency (EMA) has published outcomes of the meeting of the Committee for Medicinal Products for Human Use (CHMP). Fifteen positive opinions on new medicines and six positive opinions on extensions of therapeutic indications were made.

At the end of January 2020, the Decision Forum released several drugs’ assessments with the only positive decision for Ipilimumab (Yervoy) in combination with Nivolumab (Opdivo) for previously untreated patients in advanced or metastatic renal cell carcinoma. The rest of the drugs were rejected due to insufficient evidence and its higher price compared to standard treatment.

On January 15-17, 2020, the technical-scientific committee the technical-scientific committee of the Italian Drugs Agency (AIFA) met. Various decisions are made at these meetings, including those regarding the Market Authorization, and reimbursement.

In December 2019, the Basque Office for HTA (OSTEBA) has released an assessment report regarding the evaluation of closed vs. open systems for the preparation and administration of cytostatic and other hazardous drugs. It was observed that close systems are considered more secure due to the fewer chances of exposure risk but more expensive.

January 2020

In January 2020, the Reimbursement Commission made changes to the Healthcare Implementation Communique. The main changes are associated with the addition of new laboratory test codes, updating the price list of drugs abroad, and more.

At the end of December 2019, the Agency for Health Quality and Assessment of Catalonia (AQuAS) has released an assessment report regarding the economic, organization, and safety impact of robotic drug dispensing. The investment return for the drug dispensing automated system in hospitalized patients would correspond to more than 10 years in the basic case for any number of beds.

Special Solidarity Fund published an annual report for 2018, where it suggests considering including a number of medicines in the regular reimbursement.

On December 20, 2019, the Italian Drugs Agency (AIFA) had posted the results of the meeting of their pricing and reimbursement committee (CPR) held on December 17-19, 2019. The document contains five pages of outcomes of the CPR assessment.

The NHS in England is providing a new form of DNA test capable of quickly diagnosing rare diseases for critically ill babies and children, as part of its Long Term Plan to use world-leading technologies to improve care for the sickest infants.

On December 13, 2019, the European Medicines Agency (EMA) has published outcomes of the meeting of the Committee for Medicinal Products for Human Use (CHMP). Five positive opinions on new medicines and eight positive opinions on extensions of therapeutic indications were made.

In mid-December 2019, the Swiss Federal Department for Home Affairs (FDHA) has decided that two new autologous cell therapies (CAR-T therapies) for the treatment of leukemia and lymphoma will be reimbursed by compulsory health care insurance.

December 2019

The new fee order item (GOP) 11601 will be added to EBM on January 1st, 2020. It will cover the detection or exclusion of a germline mutation in the breast cancer genes BRCA1 and BRCA2 before a prescription of the specific chemotherapy.

New international collaboration is established to map and share information on important innovative medicines.

The S3-guideline “Long-term use of opioids for non-tumor-related pain” (LONTS) was revised under the leadership of the German Pain Society. Interested parties can comment on the published consultation version until January 12th, 2020.

The Drug Commission of the German Medical Association (DCGMA, AkdÄ in German) has published a new, third edition of the guideline "Oral anticoagulation in non-valvular atrial fibrillation".

The technical-scientific committee (CTS) of the Italian Drugs Agency (AIFA) held their meetings on December 4-6, 2019. The outcomes are published.

At the end of November 2019, the updates of the lists mentioned above were released at the website of the Technical Agency for Information on Hospital Care (ATIH). The latest list included information concerned Keytruda, Arzerra, Helixate Nexgen, Bendamustine, and other drugs.

The Danish Health Authority (Sundhedsstyrelsen), in collaboration with the regions’ drug consultants, has updated the ‘Discontinuation List.’ This list can be used during medication review as it provides advice on when treatment with a range of drugs can be advantageously stopped.

In December 2019, three clotting factors and 15 medicines were added to the Dutch list of add-on medicines and clotting factors.

In early November 2019, the Efforts for Rational Pharmacotherapy (IRF), department of the Danish Health Authority (Sundhedsstyrelsen), sent new recommendations for the selection of drugs for the treatment of acute musculoskeletal pain for public consultation.

On January 1, 2020, the order of the Government of the Russian Federation No. 2406-r comes into force approving the list of vital and essential medicines for 2020, the list of medicines for treating people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, persons after transplantation of organs and / or tissues (high-cost diseases), the list of drugs prescribed by decision of the medical commissions of medical organizations, as well as the minimum assortment of drugs needed for the provision of medical care .

On November 21, 2019, the Italian Drugs Agency (AIFA) has posted the results of the meeting of their pricing and reimbursement committee (CPR) held on November 18-20, 2019. The document contains five pages of outcomes of the CPR assessment.

November 2019

On November 14, 2019, NHS Digital published information on the estimated costs at the list price of medicines used in hospitals and prescribed in primary care in 2018-19.

On November 11, 2019, the Italian Drugs Agency (AIFA) has published outcomes of the meeting of the technical-scientific committee (CTS). The meetings were held on November 6-7, 2019.

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. The CCSD Group has approved the new seven diagnostics codes in October 2019. New diagnostic codes concern alpha-melanocyte stimulating hormone, NK cell inhibition panel, NK assay full panel, XR whole spine, and others. The codes are introduced with a recommended adoption date being the 1st of February 2020.

On November 15, 2019, the European Medicines Agency (EMA) has published outcomes of the meeting of the Committee for Medicinal Products for Human Use (CHMP). Seven positive opinions on new medicines and two positive opinions on extensions of therapeutic indications were made.

The first artificial pancreas for diabetes treatment is available in Germany since September 2019. The costs of the device will be taken over by the health insurance companies. Since 2018, the device has been CE-approved in Europe.

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in the healthcare region Uppsala-Örebro. In September 2019, CAMTÖ released an HTA report on PD-L1 positivity tested by McAb SP263 to guide immune checkpoint therapy in non-small-cell lung cancer. No safe conclusions could be drawn, but the wide range of positivity rates implies the difficulties in the standardization of PD-L1 expression and the need for better predictive biomarkers.

The NHS England has agreed to fund a new drug for around 2,000 people in the country who live with the condition.

In order to be able to respond promptly to delivery bottlenecks in prescription medicines, Austria is planning a central registration requirement for marketing authorization holders. In addition, there should be an export ban for respective drugs.

In early September 2019, the Innovation Committee of the Federal Joint Committee (G-BA) has published an overview of new research projects in the area of health services to be funded by the Innovation Fund in the future.

Enesi Pharma secures Innovate UK funding to enable scalable aseptic manufacturing of ImplaVax®-enabled solid dose viral vector vaccines.

On October 21, 2019, the Italian Drugs Agency (AIFA) has posted the results of the meeting of their pricing and reimbursement committee (CPR) held on October 21-23, 2019. The document contains five pages of outcomes of the CPR assessment.

In September 2019, the Andalusian Health Technology Assessment Department (AETSA) has released an assessment report regarding the evaluation of epigenetic profiling to classify cancer of unknown primary (EPICUP). It was observed that people received empirical therapy without considering the results of EPICUP had a three times higher risk of dying compared to those with specific treatment of the location of the primary tumor, adjusting due to possible confounding factors.

The German Association of General Practitioners (HÄVG) and the mail-order pharmacy DocMorris have started a pilot project for electronic prescription (eRezept) transmission. In the next step, a test module for drug therapy safety (AMTS) will be integrated.

The New Therapies (NT) Council provides comments on medical technology products and methods that are evaluated within the framework of the Dental and Pharmaceutical Benefits Agency (TLV) medical technology assignment. In October 2019, the NT Council recommended the use of FoundationOne CDx comprehensive genomic profiling test as support for the drug treatment choice in the context of clinical studies as there is a great need for knowledge and validation.

NHSX is working with the market at a national level to create a platform of digital tools like NHS Login that can be built on by digital health innovators.

October 2019

In September 2019, the French High Authority for Health released an assessment report for analysis on DNA chips (ACPA) in different types of oncological conditions to determine its place in comparison with more conventionally used techniques. The ACPA allows to detect a large number of copy number of variations at the whole genome level, ploidy abnormalities, and heterozygosity losses; it is of interest as a cytogenetic technique with some specific advantages among existing technologies.

On October 22, 2019, the Italian Drugs Agency (AIFA) has published outcomes of the meeting of the technical-scientific committee (CTS). The meetings were held on October 14-16, 2019.

The Artificial Intelligence Lab will bring together the industry’s best academics, specialists, and technology companies to work on some of the biggest challenges in health and care, including earlier cancer detection, new dementia treatments, and more personalized care.

On October 18, 2019, the European Medicines Agency (EMA) has published outcomes of the meeting of the Committee for Medicinal Products for Human Use (CHMP). Seven positive opinions on new medicines and four positive opinions on extensions of therapeutic indications were made.

Outcomes-Based Healthcare and My Diabetes My Way have been chosen as Health Data Research UK (HDRUK) Sandbox projects.

Draft guidance published in October 2019 by NICE does not recommend atezolizumab (also called Tecentriq and made by Roche) for treating people with a type of breast cancer called triple-A breast cancer that has spread to other parts of the body and who can’t have surgery to remove it.

Total spending on pharmaceuticals and medications will increase by 4.2% and 0.9% correspondingly in 2020. This is the result of the nationwide framework agreed by the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband).

The Clinical Coding and Schedule Development (CCSD) group develops and maintains procedural and diagnostics nomenclature for private payers in England. New diagnostic codes for exercise-induced laryngeal obstruction, myriad breast and ovarian cancer panel 101, clinical exome sequencing MPLA, beta-catenin mutation, MAI complex RNA, and other tests. The codes are introduced with a recommended adoption date being the 1st of February 2020.

On October 4, 2019, the Italian Drugs Agency (AIFA) has posted results of the meeting of their pricing and reimbursement committee (CPR) held on September 24-26, 2019. The document contains eight pages of outcomes of the CPR assessment.

The French High Authority for Health (HAS) develops care protocols and recommendations whose objective is to guarantee the quality and safety of care delivery within the French setting. In the third quarter of 2019, care protocols have been developed for three topics.

On September 20, 2019, the European Medicines Agency (EMA) has published outcomes of the meeting of the Committee for Medicinal Products for Human Use (CHMP). Seven positive opinions on new medicines and eight positive opinions on extensions of therapeutic indications were made.

A revolutionary new gene therapy that restores sight will be provided by the NHS, chief executive Simon Stevens has announced. The life-changing treatment for children and adults – voretigene neparvovec – is the first in a new generation of gene therapies that can be directly administered to patients, in this case, through an injection.

Another new life-extending treatment for some people with lung cancer is to be made available on the Cancer Drugs Fund (CDF) following its approval by NICE in draft guidance published on August 8, 2019.

On the 19th of September 2019, the Federal Joint Committee (G-BA) concluded on the possible applications and limits of non-invasive molecular genetic tests (NIPT) at the expense of the statutory health insurance (SHI). The decision provides that a NIPT can be used in justified individual cases and after medical consultation.

In late September 2019, the national guideline for the treatment of pain was published in Denmark resulting from the National Health Authority (Sundhedsstyrelsen) and the five regions collaboration. The pain guidelines provide the type of medication to choose for various types of pain.

More children with the rare genetic disorder spinal muscular atrophy (SMA) can now be treated with Spinraza after NICE published on July 3, 2019, amended draft guidance following a proposal for extending the terms of the managed access agreement between NHS England and Biogen for funding it.

On September 20, 2019, the Italian Drugs Agency (AIFA) has published outcomes of the meeting of the technical-scientific committee. Various decisions are made at these meetings, including those regarding the Market Authorization, and reimbursement).

NICE’s Highly Specialised Technology committee provided a positive recommendation for cerliponase alfa (Brineura, BioMarin) for children with neuronal ceroid lipofuscinosis type 2 (CLN2) – a very rare inherited condition affecting between one and six babies each year in the UK – in the context of a managed access agreement.

In September 2019, the Technical Agency for Information on Hospital Care (ATIH) released the updated version of the historical listee en sus with the add-on reimbursement tariffs for hospital drugs. The latest list included information concerned Clairyg, Privigen, Idacio, and other drugs.

September 2019

As part of the HCV infection eradication plan in Italy, the Italian Drug Agency (AIFA) has redefined the treatment criteria for chronic hepatitis C with new, second-generation direct antiviral drugs (DAAs) monitored through the AIFA Registers. Furthermore, AIFA publishes weekly updates on treatment data with DAAs.

On September 13, 2019, the Italian Drugs Agency (AIFA) has published the last report of the innovativeness assessment for drugs submitted for reimbursement.

The insurance company AOK Saxony-Anhalt concluded that patients are much less frequently prescribed an antibiotic after the examination via a rapid test for a bacterial cause of the infection. In more than 40% of the tested patients, the doctors waived the antibiotics prescription.

On August 7, 2019, the Italian Drugs Agency (AIFA) announced that the CAR-T cell therapy obtained reimbursement. It will be reimbursed through the ‘payment at result’ model, which AIFA used for the first time.

The HTA center of Swedish Västra Götaland region has published a report for gene expression profiles to guide adjuvant chemotherapy in luminal, HER2-negative breast cancer. It was concluded that withholding adjuvant chemotherapy in breast cancer patients with intermediate clinical risk of recurrence and low/intermediate risk according to a gene expression assay, compared with providing chemotherapy, probably results in little or no difference in overall survival within nine years and can probably not exclude a small increased risk of recurrence.

Predictive Analysis for Therapy (PATH) is a collaboration between 35 pathology departments in the Netherlands, oncologists, pulmonologists, Pathological-Anatomical National Automated Archive (PALGA) and the Netherlands Integrated Cancer Center (IKNL)

The French High Authority for Health (HAS) develops clinical guidelines and recommendations whose objective is to guarantee the quality and safety of care delivery within the French setting

The draft for a "Digital Supply Law," approved by the Cabinet on July 10, 2019, promotes digitization in the health sector.

Telemedicine and mobile health apps in Belgium

In May and November each year, NHS England makes decisions on which new treatments should be included for routine commissioning. The decisions are taken by the NHS England Board based on recommendations from the Clinical Priorities Advisory Group (CPAG), which is made up of doctors, health experts, and patient representatives.

August 2019

Zorg van Nu information team published a brochure with regulations for stimulating digital care in the Netherlands. The brochure with the description of 16 schemes clearly explains which regulations are applicable for which e-health innovations.

NHSX has officially launched in July 2019 bringing together teams from the Department of Health and Social Care and NHS England and NHS Improvement, to lead the largest digital health and social care transformation program in the world. With an investment of more than £1 billion pounds a year nationally and a significant additional spend locally, NHSX has been created to give staff and citizens the technology they need.

The Clinical Coding and Schedule Development (CCSD) group develop and maintains procedural and diagnostics nomenclature for private payers in England. New diagnostic codes concern tests for primary hyperoxaluria panel, myeloid panel, and hereditary angioedema. The codes are introduced with a recommended adoption date being the 1st of August 2019.

July 2019

The Danish Health Authority published new codes for the Health Care Classification System in July 2019, including the code for subretinal injection of gene modulating drug.

In June 2019, the Dental and Pharmaceutical Benefits Agency (TLV) has published a completed health economic evaluation regarding the cost-effectiveness of the comprehensive genomic profiling test for all solid tumors FoundationOne CDx. TLV believes that in most cases, the use of FoundationOne CDx is more expensive in comparison to current treatment methods. However, it has greater sensitivity and accuracy in the diagnostics.

In late June 2019, the Federal Joint Committee (G-BA) took its first decision on the use of biomarker-based tests. Patients with breast cancer in the early stages, in which the risk of relapse cannot be determined with certainty, can be provided in the future with a biomarker test as a statutory health insurance (SHI) benefit.

On 17th June 2019, the company in charge of the development of the DRG system in Switzerland, SwissDRG SA, has announced the catalog version of SwissDRG 9.0/2020 (2017/2020). Eleven days later, the planning version of SwissDRG (2018/2020) has been published as well.

After having identified the eligibility conditions for teleconsultation and teleexpertise in 2018, the French High Authority for Health (HAS) published a series of documents in late June 2019, for the operational deployment of eHealth services. Each of the new modalities of practice is discussed: teleconsultation, teleexpertise, and teleimaging. Also, the HAS proposed an information document to be given to patients before a teleconsultation.

June 2019

The German Institute for Quality and Efficiency in Health Care (IQWiG) has investigated whether patients suffering from non-Hodgkin lymphoma have (better) chances of recovery in case of allogeneic stem cell transplantation. IQWiG concluded that the benefit of allogeneic SCT is unclear.

Disease management programs (DMPs) should be updated on a regular basis in order to adapt them to the current medical knowledge level. The Institute for Quality and Efficiency in Health Care (IQWiG) has thus researched current evidence-based guidelines on diabetes mellitus type 2, summarized their recommendations and checked the need for DMP update.

In March 2019, NICE published an updated version of its evidence standards framework for digital health technologies (DHTs) that sets out the evidence requirements for different types of DHTs.

The Clinical Coding and Schedule Development (CCSD) group develop and maintains procedural and diagnostics nomenclature for private payers in England. New diagnosis codes concern the tests for common and rare mutations.

Four updated pathways for gynecological cancers describe the whole process of management patients – from the first examination for suspicion of cancer to the follow-up and rehabilitation with the management of late effects.

HealthTech Connect, a new online resource provided by NICE to help identify and support new health technologies as they move from inception to adoption in the UK health and care system, was formally launched April 29th, 2019. The system, which is free to use, will help companies to understand what information is needed by decision makers in the UK health and care system, and clarify possible routes to market access.

In April 2019, the Andalusian Agency for Evaluation of Health Technologies, AETSA, has released a report updating the map of genetic tests available in the Spanish National Health System.

The NHS Innovation and Technology Payment (ITP) 2019/20 program went live on April 1, 2019, and builds on the Innovation and Technology Tariff (ITT) and ITP 2018/19.

May 2019

Between the 3rd of June and the 15th of July, SwissDRG will be receiving the requests/suggestions regarding the DRG system in the country.

The Federal Joint Committee (G-BA) has signed a further contract for scientific monitoring and implementation of a trial study for NYHA III heart failure therapy optimization by means of continuous blood pressure measurement and monitoring using an implanted sensor in the pulmonary artery.

In April 2019, the Ministry of Health, Consumption and Social Welfare announced the update of the common package of benefits of the Spanish national health system with the inclusion of cervical cancer screening, nipple and areola micropigmentation and update of orthoprosthesis catalog.

Starting April 1, 2019, NHS England opens in a new window, and NHS Improvement comes together to act as a single organization.

The colorectal cancer screening program became organized in Germany on April 19, 2019. Until now, only the breast cancer screening program was the only organized screening program. The Evaluation Committee has already updated the EBM catalog.

NHS England is inviting nominations for additions to, and removals from, the high-cost drugs and devices lists for the next national tariff come into effect in April 2020. All submissions must be submitted by May 31, 2019.

The 2019/20 national tariff payment system has been published and took on the 1st of April 2019. There have been no substantial changes to the proposed tariff consulted on during January and February 2019. Under the published tariff, blended payment will be the default payment approach for emergency care services.

The Innovation Fund in Germany was created in 2015 for the period from 2016 to 2019, with the primary aim to improve health care for policyholders and patients in statutory health insurance (SHI). In March 2019, the governing parties have agreed in the coalition agreement that the innovation funding should be continued at least until March 2021 with an annual budget of €200 million.

April 2019

In Finland, the Health Care Services Selection Council is responsible for making recommendations regarding the research, treatment and rehabilitation methods. Currently, PALKO is working on the only one assessment related to in-vitro diagnostics - screening for a Serious Combined Immune Deficiency (SCID) from newborn heel. In final report, the Council will conclude whether the procedure is a part of publicly funded services or not.

The 13 innovations joining the NHS Innovation Accelerator were announced on March 5, 2019, as part of an event to launch the fourth year of this award-winning national accelerator.

In early 2019, the Memorandum of Understanding was signed to support HTA in Ireland, Scotland, and Wales. The Memorandum of understanding establishes a collaborative approach to the identification and assessment of new health technologies between Health Information and Quality Authority Ireland, Health Technology Assesment Group Ireland, Health Technology Wales, and the Scottish Health Technology Group. These bodies assess and give guidance on health technologies within their national healthcare systems.

March 2019

On the Interterritorial Council that took place March 4th, 2019, the Working Plan for the Spanish Network for Health Technology Assessment was agreed and published. The working plan includes 22 health technology assessment reports, 7 monitoring studies, 9 clinical practice guidelines, and 1 evidence-based product.

NHS Digital is launching a pilot to build the process that will enable partner services to connect to NHS login, providing a single way for patients in England to verify their identity and then use the login to access digital health and care services. The five selected partners represent the range of organizations who will connect with NHS login - from large, established organizations to new players in the market. The service will begin its activities in April 2019.

The Dutch Healthcare Authority (NZa) wants to contribute to stimulating the right care in the right place by making it possible to deploy e-health applications more broadly. In 2019 NZa will examine the possibilities for declaring e-health with the focus on district nursing and long-term care. Also, a large part of the e-health projects is in the pilot phase and the Dutch ‘Care for Innovation’ organization developed a step-by-step plan for a systematic approach for e-health introduction.

During November-December 2018, the Federal Joint Committee (G-BA) has introduced an organized screening program for the early detection of cervical cancer and initiated consultation procedure for prostate cancer screening.

On February 19, 2019 the new “Catalog of Goods and Services” for the centralized purchasing platform was presented to the regional health authorities by the Minister of Health. This new catalog includes up to 25,000 items, including drugs and health products.

In February 2019, the entity that is in charge of the DRG system in Switzerland, SwissDRG, announced the publication dates of the SwissDRG 9.0/2020 catalog, but also information that concerns the suggestions regarding SwissDRG.

Key changes in the Norwegian DRG system in 2019 include novel payment schemes for dialysis treatment, emergency conditions that occur as outpatient or day case, digital services. Pilot DRG payment models will be implemented for selected medical quality registers and selected procedures for contract specialists.

ore than 50 new DRGs were introduced in the Swedish system in 2019, while two have been deleted. The changes affected nursing care, psychiatry, hospital and day case services of different major disease categories. Important changes relate to cardiac ablation, placement of neurostimulator.

February 2019

Eleven new DRGs have been added in 2019, while three DRGs have been deleted. The significant changes have been made for disorders of the circulatory organs (MDC 5) and musculoskeletal, skeletal and connective tissue disorders associated with prosthetic surgery (MDC 8). They concern insertion of vagus stimulator, ablation of heart, percutaneous valve replacement, and others.

The NHS Long Term Plan, released on 7th of January 2019, will save almost half a million more lives with practical action on significant killer conditions and investment in world-class, cutting edge treatments including genomic tests for every child with cancer. Local NHS allocated £570 billion to fund the NHS Long Term Plan.

Promising care must find its way to patients more quickly through inclusion in the basic health insurance. That is why the Dutch Ministry of Health, Welfare and Sport has adjusted the promising care with the new subsidy scheme. Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) carries out the scheme in collaboration with the Dutch Organization for Health Research and Development (Nederlandse organisatie voor gezondheidsonderzoek en zorginnovatie, ZonMw). The scheme will replace existing procedure with conditional reimbursement of medical technologies.

January 2019

In late 2018, the French Ministry of Health announced that the telemedicine pilot project “ETAPES” will be maintained for four more years.

Dutch Healthcare Authority (NZa) has released key features of the DRG package for 2020, including complex chronic lung failure, stem cell transplant care and indexation of DRG tariffs.

In mid-June, 2018, the Catalan Agency for Quality and Healthcare Evaluation, AQuAS, published the Clinical Practice Guidelines for open-angle glaucoma.

On December 14, 2018, the Center of Competence and Coordination of Confederation and Cantons, Swiss eHealth, has published version 2.0 of the Swiss eHealth strategy. This version replaces the 2007 version and will be applied until 2022. With the "Swiss eHealth Strategy 2.0", the Confederation and the cantons intend to enhance the promotion of digitalization in the healthcare sector, whose priority is the introduction and dissemination of the patient's digital record.

In December of 2018, the completed mini-method assessment for targeted deep sequencing panel for patients with varying types of hematological neoplasia was released by the Norwegian Institute of Public Health (NIPH). The method was determined as safe and efficient and was recommended to become a part of routine clinical practice.

On November 30, 2018, the DRG-regulating body in Switzerland, SwissDRG, has notified the public that the tariff version of SwissDRG 8.0/2019 has been published.